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TRANSCRIPT
Minutes for 266th Meeting Registration Board held on 06-07th February, 2017.
Item No. Detail of Item Page No(s)
Item No.I Confirmation for minutes of 265th Registration Board meeting 04
Item No.II Medical Device & Medicated Cosmetics 05 – 95
Item No.III Pharmacy Services Division 96 – 100
Item No.IV Pharmaceutical Evaluation & Registration Division 101 – 168
Item No.V Biological Drugs Division 169 – 219
Item No.VI Quality Assurance & Laboratory Testing 220 – 231
Item No.VII Additional Agenda
A. Medical Device & Medicated Cosmetics Division
B. Biological Division
C. Pharmaceutical Evaluation & Registration Division
D. Quality Assurance & Lab. Testing Division
232 – 246
247 – 249
250 – 253
254 – 256
Minutes for 266th Meeting of Registration Board. 1
266th meeting of Registration Board was held on 06-07th February, 2017 in the
Committee Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting
was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &
Registration Division, DRAP. The meeting started with recitation of the Holy Verses. The
meeting was attended by the following:-
1. Maj.Gen.Dr. Tahir Mukhtar SyedCommandant AFIRM / Head Department of Medicine, Army Medical College
Member
2. Prof.Dr.Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah Women University, Karachi
Member
3. Dr.Qurban Ali, Director General National Veterinary Laboratory, Islamabad.
Member
4. Mr.Aslam Shah, Senior Manager Pharmacy, Indus Hospital, Karachi
Member
5. Jam Muhammad AslamAssistant Draftsman-II, Ministry of Law & Justice
Member
6. Mr.Ammar LateefRepresentative IPO
Member
7. Dr.Amanullah KhanDirector, Drugs Testing Laboratory, QuettaGovernment of Baluchistan
Member
8. Dr. Muhammad Saleem ButtDirector, Drugs Testing Laboratory, RawalpindiGovernment of Punjab.
Member
9. Mr.Khalid JavedRepresentative of Director, Drugs Testing Laboratory, Peshawar, Government of Khyber Pakhtunkhwa
Member
10. Dr.Noor-us-SabaDirector, Biological Drugs Division, DRAP
Member
11. Ms.Tehreem Sara,Additional Director, Representative of Medical Device Division, DRAP
Member
12. Dr.Abdur RasheedAdditional Director, QA< Division, DRAPRepresentative of QA< Division
Member
13. Dr. Obaidullah, Additional Director (Reg.I) Secretary
Mr.Khalid Javed, representative of Director, Drugs Testing Laboratory, Peshawar
attended the meeting on 07.02.2016.
Zaheer-ud-Din M. Babar (Deputy Director R.I/R IV), Abdullah (Deputy Director,
PEC, R V/ Incharge, PEC), Babar Khan (Assistant Director RIII), Abdul Mughees (Assistant
Director RII), Ms.Sana Kanwal (Assistant Director RV) and Assistant Directors,
Minutes for 266th Meeting of Registration Board. 2
Pharmaceutical Evaluation Cell, Medical Device Division, Biological Drugs Division,
Quality Assurance & Lab testing assisted relevant Director with agenda.
Mr. Khalid Muneer, Akbar Siddique, Nadeem Hussain Alamgeer, Dr.Zafar Hashmi
and Shahzad Hussain attended the meeting as observer on behalf of PPMA, Pharma Bureau
and PCDA respectively.
Brig (R) Prof.Dr.Qaiser Khan, Head Department of Cardiology attended meeting as
technical expert during consideration of cases pertaining to Medical Device Division as
decided by National consultative meeting held on 03.02.2017.
Minutes for 266th Meeting of Registration Board. 3
Item No.I: Confirmation of minutes of 265th meeting Registration Board.
265th meeting of Registration Board was held on 24-25th January, 2016. Draft minutes
were circulated to members (who attended the meeting) on 02.02.2017 with the request to
forward their comments (if any) within 05 days.
Members were again requested on 04.02.2016 to forward comments (if any) on Item
No.V: Additional Agenda Item; Case No. C: Medical devices & Medicated Cosmetics by
05.02.2016 to enable concerned Division to proceed further. This urgent processing was
requested in view of HR case No.623-P/2017 in the Supreme Court of Pakistan.
No comments have been received yet.
Decision: Registration Board approved minutes for 265th meeting.
Minutes for 266th Meeting of Registration Board. 4
Item No.II: Medical Device & Medicated Cosmetics.
Case No.01: Deferred Applications for Registration of Medical Devices for Import.
Registration Board was apprised that keeping in view directions of Honorable
Supreme Court of Pakistan in HR Case 623-P/2017, a consultative meeting on issues retalted
to registration, use and pricing of medical devices was held on 3 rd February, 2017 under the
Chairmanship of Secretary, Ministry of NHSR&C / Chairmain Policy Board. Following
recommendations were agreed unanimously in order to facilitate the registration and use of
medical devices registered as drug.
(i) Registration Board meetings shall be conducted with short intervals for consideration of the applications of medical devices declared as drug, and ensure quick disposal of pending as well as fresh applications and increase supply of registered products. For this purpose two urgent meetings i.e. on 6 th-7th February and 20th-21st February have already been convened and wide publicity through Press Advertisement has also been ensured.
(ii) Two cardiologists shall be taken as observer members to attend the forthcoming meetings of Registration Board for the agenda of cardiac devices. Secretary NHSR&C in consultation with Maj Gen (R) Prof Azher Kiyani will propose the names. These observers shall provide clinical input.
(iii) Registration process of these products shall be made speedy and Registration Board be advised to accept original required documents (without the condition of embassy attestation) at the time of issuance of registration certificate with an Affidavit on stamp paper that the documents furnished are original and that Embassy attested documents and certificates (where applicable) shall be provided by the firm to DRAP within 6 months. Furthermore, similarly the Authorization letter/sole agency agreement and Credentials of manufacturer shall be accepted in original (without notarization) at the time of issuance of registration certificate with an Affidavit on stamp paper that the documents are original and that notarized copies of these shall be provided to DRAP within 2 months.
Secretary, NHSR&C / Chairmain Policy Board in a meeting held on 07.02.2016 with
officers of Medical Device Division, Secretary Registration Board and CEO, DRAP clarified
applicant shall submit original documents i.e. free sale certificates and authorization letter /
sole agency agreement and credentials of manufacturer abroad (as recorded in point iii/
above) before consideration by Registration Board along with an affidavit as recorded above.
Registration Board deliberated the matter in detail and decided that in order to
expedite the registration application of the medical devices declared as drug (disposable
syringe, disposable set for collection or transfusion of blood or giving any infusion, stents,
catheters, cannula, auto disposable syring or butterfly needle). Following criteria / parameters
shall be considered for the approval of medical devices placed before the Registration Board.
i. Registration Board agreed that applicant shall provide original Free slae certificate (without embassy attestation) before consideration by the Board with an Affidavit (to
Minutes for 266th Meeting of Registration Board. 5
be signed by owner of the company / applicant / authorized person) on stamp paper that the documents furnished are original and that embassy attested Free Sale certificates shall be provided by the firm to DRAP within 6 months. Registration letter shall be issued with the condition that applicant will provide aforementioned document in 6 months time and in case of non compliance to this condition, the Registration Board shall revoke its registration certificate.
ii. Applicant shall provide Authorization letter/sole agency agreement and credentials of manufacturer abroad in original (without notarization) before consideration by Registration Board with an affidavit on stamp paper that the documents are original and that notarized copies of these documents shall be provided to DRAP within 2 months. Registration letter shall be issued with the condition that applicant will provide aforementioned document in 2 months time and in case of non compliance to this condition, the Registration Board shall revoke its registration certificate.
iii. The products approved (having Free Sale Certificate) by regulatory authorties of reference countries (as approved by the Registration Board in 249th meeting viz.USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway or drugs registered in atleast three European Union counties), will be considered as benchmark to certify the safety, efficacy and quality of these medical devices declared as drug.
iv. For assigning shelf life to the product, applicant shall either provide document confirming shelf life of the product by regulatory authority of country of origin or stability data conducted by the manufacturer of the product for consideration of Registration Board.
v. Registration Board was apprised that in some cases more than one authorization letter/ sole agency agreement has been granted by the manufacturer / licence holder / distributors for the same product of same manufacturing site but with different or same brand names. Registration Board deliberated and decided that in such cases sole agency agreement of manufacturer shall be considered for the grant of registration of the product.
vi. Approved products are subject to compliance of Import Policy for Finished Drugs.
vii. Registration Board decided that registration letters for already approved medical devices declared as drugs shall be processed on same principals for free sale certificate, sole agency agreement, authorization letter as decided in instant meeting.
viii. As most of the applications are pending since long, and applicants have been informed about the shortcomings of their application. However, Registration Board decided to give final letter to all applicants for rectification of shortcoming within 7 days from the date of issuance of letter. Accordingly, cases will be placed before Registration Board for decision in its forthcoming meeting on 20-21st February, 2017.
ix. In order to expedite registration process and thorough evaluation applications of medical devices declared as drug, Registration Board constituted an evaluation cell for scrutinization of registration applications of cardiac stents, catheters and cannulas. Recommendations of the committee shall be placed Registration Board for its consideration and further decision. Composition of the evaluation cell is as under:S.No Designation Status
1. Director, Medical Devices Chairman & Convenier
2. Respective officers of Medical Device Division Members
Minutes for 266th Meeting of Registration Board. 6
3. 02 nominees of concerned professional medical associations
Technical expert
For cardiac stents, catheters and cannulas, one nominee each of Cardiologist Socities and Pakistan Society of Interventional Cardiologists and one expert each from Cardiology Department PIMS and Rawalpindi Institute of Cardiology, Rawalpindi shall attend meeting as technical experts.
A) Stents.
S. No.
Name of Importer and Manufacture/
Exporter.
Name of Medical Device
Price &
Pack size
Shelf life
Remarks Decision
1. M/s ACP Systems,13, Naval Fleet Club, Iqbal (S.J) Shaheed Road Karachi.
Manufactured by:M/s Medtronic Ireland, Parkmore Business Park West, Galway Ireland.
Resolute Integrity (DES) Coronary Stent
Cobalt Chromium Alloy Stent coated with Zotarolimus (Rapamycin analog)
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
24 mont
hs
Applied on03-08-2012Differential fee not depositedLetter issued on23-10-2012. Reminder issued on 20-1-2017.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as product
is already registered with same brand name but different manufacturer.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Clinical data, if any,f. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
g. OrigInal Credentials of manufacture as decided above by Registration Board.
h. Copy Valid Drug Sale License.
2. M/s ACP Systems,13, Naval Fleet Club, Iqbal (S.J) Shaheed Road Karachi.
Manufactured by:M/s Medtronic Ireland,
Integrity BMS Coronary Stent
Cobalt Chromium Alloy Stent
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Government
24 mont
hs
Applied on 03-08-2012Differential fee not depositedLetter Issued on 23-10-2012.Reminder issued on
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as Product
already registered with same brand name but different manufacturer.
c. Original Free Sale Certificate as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 7
Parkmore Business Park West, Galway Ireland.
Applied on03-08-2012
1’s
20-1-2017. d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Clinical data, if any,f. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
g. Original Credentials of manufacture as decided above by Registration Board.
h. Copy Valid Drug Sale License,
3. M/s ACP Systems,13, Naval Fleet Club, Iqbal (S.J) Shaheed Road Karachi.
Manufactured by:
M/s Medtronic Ireland, Parkmore Business Park West, Galway Ireland.
Endeavor Sprint (DES) Coronary Stent
Cobalt Alloy Stent coated with Zotarolimus (Rapamycin analog)
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
24 mont
hs
Applied on 03-08-2012Differential fee not depositedLetter Issued on 23-10-2012.Reminder issued on 20-1-2017.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/b. Clarification as Product
already registered with same brand name but different manufacturer.
c. Original Free Sale Certificate as decided above by Registration Board.
d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Clinical data, if any,f. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
g. Original Credentials of manufacture as decided above by Registration Board.
h. Copy Valid Drug Sale License, `
4. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad.
Manufactured by:M/s Biotronic
Orsiro Drug Eluting Coronary Stent
(Sirolimous)
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federa
Not mentioned.
Applied on 10-12-2012Letter Issued on 14-4-2013. Reminder issued on2-3-2015.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as
different manufacturing site.
c. Original Free Sale Certificate as decided
Minutes for 266th Meeting of Registration Board. 8
AG Ackerstrasse 6, 8180 Bulach, Switzerland. Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.Applied on10-12-2012
l Government
1’s
Final reminder issued on 20-1-2017.
above by Registration Board.
d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Original Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
5. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad. /Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach, Switzerland. Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.
Applied on10-12-2012
PRO Kinetic Energy Coronary Stents.
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.1’s
Not mentioned.
Applied on 10-12-2012Letter Issued on 14-4-2013.Reminder issued on2-3-2015.Final reminder issued on 20-1-2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as
different manufacturing site.
c. Original Free Sale Certificate as decided above by Registration Board.
d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Original Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
6. M/s. Trans Angio System, 507 Progressive square, P.E.C.H.S, Block-6, Shahra-e-Faisal Karachi-75400
Manufactured by:M/s Translumina GmbH, Neue
Yukon ® CC Stent SystemSizes and product codes as per FSC
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
03 years
Applied on 12-4-2011Letter for deficiencies issued on 23-10-2012Reminder issued on4-3-2015.Final reminder issued on6-10-2016
Deferred for rectification of following shortcomings:a. Original Free Sale
Certificate as decided above by Registration Board.
b. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Original Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 9
Rottenburger Strabe 50, 72379, Hechingen, Germany.
Applied on12-4-2011
d. Clinical data, if any.e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
7. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.
Manufactured by:M/s. ClearStream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.
Applied on18-4-2011
ClearFlex-X Coronary Stent
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
03 years
Applied on 18-4-2011Letter for deficiencies issued on26-9-2012Reminder issued on4-3-2015.Final reminder issued on6-10-2016
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-.b. Original Free Sale
Certificate as decided above by Registration Board.
c. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Original Credentials of manufacture as decided above by Registration Board.
e. Clinical data, if any.f. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
g. Copy of valid drug sale licence.
8. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.
Manufactured byM/s. ClearStream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.
SatinFlex Coronary Stent
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.1’s
03 years
Applied on18-4-2011Letter for deficiencies issued on26-9-2012Reminder issued on4-3-2015.Final reminder issued on6-10-2016
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-.b. Original Free Sale
Certificate as decided above by Registration Board.
c. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Original Credentials of manufacture as decided above by Registration Board.
e. Clinical data, if any.f. Approval of shelf life
from regulatory authority or Stability data to support claimed
Minutes for 266th Meeting of Registration Board. 10
shelf life.g. Copy of Valid Drug
Sale Licence.9. M/s. Maxims
Medical,534-H-Block, Phase-5,Street no-13, Defence, DHA, Lahore.
Responsible Manufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.
Manufacturing Site:M/s Abbott Vascular, Belgium.
Multilink 8 Coronary Stent
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.1’s
02 years
Applied on23-4-2011Letter Issued on 23-10-2012Reminder issued on7-10-2016.
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-.b. Original Free Sale
Certificate as decided above by Registration Board.
c. Copy of Valid Drug Sale Licence.
d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Original Credentials of manufacture as decided above by Registration Board.
f. Clinical data, if any.g. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
10. M/s. Maxims Medical,534-H-Block, Phase-5,Street No-13, Defence, DHA, Lahore.Responsible Manufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.Manufacturing Site:M/s. Abbott Vascular, Instruments Deutsuhland, GmbH, Rudolf-diesel-dtrabe 29, 72414, Rangendingen,
JO Stent Graft Master
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
02 years
Applied on23-4-2011.Letter Issued on 23-10-2012Reminder issued on7-10-2016.
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-.b. Original Free Sale
Certificate as decided above by Registration Board.
c. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Original Credentials of manufacture as decided above by Registration Board.
e. Clinical data, if any.f. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
g. Copy of Valid Drug Sale Licence.
Minutes for 266th Meeting of Registration Board. 11
Germany.11. M/s Maxims
Medical,534-H-Block, Phase-5, St.No-13, DHA, Lahore.Responsible Manufacturer:M/s Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.Manufacturing Site:M/s. Abbott Vascular, Instruments Deutsuhland, GmbH, Rudolf-diesel-dtrabe 29, 72414, Rangendingen, Germany.
Flex Master F1 Coronary Stent
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
02 years
Authorization letter/sole agency agreement issued by Indian region.Applied on23-4-2011Letter for deficiencies issued on23-10-2012
Reminder issued on7-10-2016.
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-.b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Original Credentials of manufacture as decided above by Registration Board.
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. Copy of Valid Drug Sale Licence.
g. Clinical data, if any.
12. M/s. Stents Specialties, 47 kahuta triangle industrial area, Islamabad.Manufactured by:
M/s. Plasmachem GmBH, alte gaertnerei 22-55128mainz,Germany
SupplierM/s. Mack & Co.GmBH, Bahnhofstrasse, 27356,ROTENBURG, Germany
Bio Diamond Delivery System (Coronary pre-mounted Stent)
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.1’s
2 years
Applied on23-6-2011.Letter Issued on 13-9-2012.Reminder issued on20-1-2017.
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-.b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Original Credentials of manufacture as decided above by Registration Board.
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. Copy of Valid Drug Sale Licence.
g. Clinical data, if any.13. M/s. Stents
Specialties, 47 Bio Diamond mF12 Stent
Decontrolled
2 years
Applied on
Deferred for rectification of following shortcomings:
Minutes for 266th Meeting of Registration Board. 12
kahuta triangle industrial area, Islamabad.
Manufactured by:M/s Plasmachem Gmbh, alte gaertnerei 22-55128 mainz,Germany
SupplierM/s. Mack & Co.GMBH, BahnhofstrTTasse, 27356,ROTENBURG,Germany
(12mm)
(As per FSC)
till policy decision by Policy Board/ Federal Govt.1’s
27-6-2011.Letter Issued on 13-9-2012.No reply received till date.Reminder issued on20-1-2017.
a. Differential Fee PKR.35,000/-.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Original Credentials of manufacture as decided above by Registration Board.
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. Copy of Valid Drug Sale Licence.
g. Clinical data, if any.14. M/s Intek
Corporation, # 30,1st Floor, Al-Amin Plaza, The Mall, Rawalpindi.Legal manufacturer:M/S Terumo Corporation. 44-1,2 Chome, Hatagya, Shibuya-Ka, Tokyo 151-0072, JapanActual Manufacturer:M/s Ashitaka Factory of Terumo Corporation, 150, Maimaigi-cho, Fujinomiya city, Shizuoka Prefecture 418-0015, Japan.
Tsunami ® Gold Coronary Stent System
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.1’s
36 mont
hs
Application date 27.3.2013.Letter issued on 14.10.2013. Reminder issued on 19-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
15. M/s Interex Company,195 Block 7/8 KMCHS
CP Stent (Bare & Covered)
Decontrolled till policy
Not mentioned
in
Applied on 24-9-2013.Letter
Deferred for rectification of following shortcomings:a. Clarification as two
Different Products
Minutes for 266th Meeting of Registration Board. 13
Justice Inamullah Road, KarachiManufactured by:
1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.
2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.
(Sizes as per FSC)
decision by Policy Board/ Federal Government
1’s
form 5-A.
issued on 6.6.2014.Reminder issued on 20-1-2017.
applied in one Application.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Clinical data, if any.
16. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.
Architect CoCr Coronary Stent System
(Codes and Sizes as per Free Sale Certificate)
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
3 years.
Applied on9-1-2014Letter Issued. Reminder issued on2-3-2015Final reminder issued on18-1-2017.Letter Issued3-2-2017
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Original Credentials of manufacture as decided above by Registration Board.
17. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera,
Synergy TM
Monorail TM
Everolius Eluting Platinum Chromium Coronary Stent System
Decontrolled till policy decision by Policy Board/
18 mont
h
Applied on11-9-2014Letter issued on 12.2.2015.
Approved as per Import Policy for Finished Drugs.
Minutes for 266th Meeting of Registration Board. 14
Legal Manufacturer:M/s. Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 017603-1537.USA.Manufacturing Site:M/s. Boston Scientific Ireland Ltd, Ballybrit Business Park, Galway, Ireland.
Codes and sizes as per Free Sale Certificate.
Federal Govt.
1’s
18. M/s. Health Tec,10-B, Street No.24, Valley Road, Westrige-I Rawalpindi.Legal Manufacturer:M/s Cardionovum Sp. Z.o.o., Panska Str.73,00-834 Warsaw, Poland.Coating manufacturer: DOT GmBH, Charles Darwin-Ring1a, 18059 Rostock, Germany.Assembling of Finished products:Arthesys S.A.20 Rue Traversiere, 92230GENNEVILLIERS, France.
Xlimus Sirolimus Eluting Coronary Stent System
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
2 years
Applied on27-8-2015Letter issued on 25.11.2015Reminder issued on19-1-2017.
Deferred for rectification of following shortcomings:a. Clarification as status
of impurities in conclusion of stability study.
19. M/s. Ferozsons Laboratories, P.O. Ferozsons,
Rebel TM
Monorail TM
PtCr Coronary Stent System
Decontrolled till policy decisio
3 years
Applied on17-9-2015Letter Issued on
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by
Minutes for 266th Meeting of Registration Board. 15
Amangarh, Nowshera,Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific Corporation, Maple Grove & plymouth, MN 55311, USA.
(As per FSC)
n by Policy Board/ Federal Government
1’s
9-8-2016. Registration Board.b. Clarificaiton as status
of export only on copy of Free Sale Certificate.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
20. M/s Genus,220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.
Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.
Silver Stent-CC Cobalt Chromium Drug Eluting Stent
Product codes as per Free Sale Certificate.
Decontrolled till policy decision by the Policy Board/Federal Government
1’s
2 years
Applied on 4-11-2015Letter Issued on 11-8-2016.Reminder issued on 18-1-2017Letter issued on 3-2-2017Following shortcomings:
1. Outline of Method of Manufacturing.2. Last Inspection report3. Free Sale Certificate of USFDA provided but not embassy attested.
Approved as per Import Policy for Finished Drugs and as per decision of Registration Board regarding Free Sale Certificate.
21. M/s Genus,220,
Affinity CC Cobalt
Decontrolled
2 years
Applied on
Approved as per Import Policy for Finished Drugs
Minutes for 266th Meeting of Registration Board. 16
D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.
Chromium Sirolimus Eluting Stent.
Product codes as per Free Sale Certificate.
till policy decision by the Policy Board /Federal Govt.1’s
4-11-2015Letter Issued on 11-8-2016.Reminder issued on 18-1-2017Letter issued on3-2-2017
and as per decision of Registration Board regarding Free Sale Certificate.
22. M/s Digital Imaging Systems, 121, Habitat Apartment, Ghaus-ul-Azam Road, Shadman II,,Lahore /Responsible Manufacturer:M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.
Manufacturing Site:M/s Abbott Vascular, Cashel Road, Clonmel, County Tipperary, Ireland.
Xience Alpine Stent
(Codes and sizes as per Free Sale Certificate).
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
02 years
Applied on 3-12-2015Letter Issued on 17-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. OrigInal Credentials of manufacture as decided above by Registration Board.
23. M/s Cardevo International (Pvt) Ltd, Office No.120, 4th Floor, Main Boulevard Mega Tower, Gulberg-II, Lahore.Manufactured By:M/s Accura Medizintechnik GmbH, Max-Planck-
Accura Decent S Sirolimus- Eluting Coronary Stent SystemProduct codes and sizes as per Free Sale Certificate.
.
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
12 mont
hs
Applied on2-2-2016Letter sent on20-1-2017Reminder issued on3-2-2017
Deferred for rectification of following shortcomings:a. Clarification of Brand
Name requested and Change of Product name from Itrix II to decent S and manufacturer of the product.
b. Clarification of address of applicant is different on credentials, Form-5A,Drug sale Licence and letter of authorization
Minutes for 266th Meeting of Registration Board. 17
Str.33, 61184, Karben, Germany.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
24. M/s Digital Imaging Systems, 121, Habitats Apartments, Shadman-II, Ghaus-ul-Azam Road, Lahore/Legal Manufacturer :M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.Manufacturing Site:M/s Abbott Vascular, Cashel Road, Clonmel, County Tipperary, Ireland.
Multilink 8 Coronary Stent System
Product and codes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
2 years
Applied on16-3-2016Letter sent on 20-1-2017
Deferred for rectification of following shortcomings:c. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
25. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.Manufactured byM/s. Scitech Products Medicos Ltda, Sao Paolo Brazil.
Drug Eluting Stents Inspiron
Stent Length (mm): 13, 16, 19, 23, 29, 33,38.
Stent Dia (mm)2.5, 2.75, 3.0, 3.5.
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
2 years
Applied on 4-4-2016Letter sent on19-1-2017
Deferred for rectification of following shortcomings:a. Application on the
prescribed Form.5-Ab. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of
Minutes for 266th Meeting of Registration Board. 18
manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
h. Manufacturing and analytical procedure.
26. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.Manufactured byM/s. Scitech Products Medicos Ltda, Sao Paolo Brazil
Bare Metal Stent Cronus (Chromium Cobalt)
Stent Length (mm): 13, 16, 19, 23, 29, 33,38.
Stent Dia (mm)2.5, 2.75, 3.0, 3.5.
Decontrolled till policy decision by Policy Board/ Federal Government
1’s
2 years
Applied on 4-4-2016Letter issued on20-1-2017
Deferred for rectification of following shortcomings:a. Application on the
prescribed Form.5-Ab. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
h. Manufacturing and analytical procedure.
27. M/s. Promed International, CB-6349 Amarpak Plaza, Jhelum Road, Rawalpindi.Legal Manufacturer:M/s Biosensors Europe SA, Rue De Lausanne 29, 1110 Morges, Switzerland.Manufacturing Site:M/s Biosensors Interventional Technologies
Axxess TM
Drug Coated Coronary Bifurcation Stent System.Product sizes and codes as per FSC
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
24 mont
hs
Applied on20-4-2016Letter issued on 18-1-2017
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Clinical data, if any,d. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
e. Original Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 19
Pte Ltd, 36 Jalan Tukang, Singapore 619266, Singapore.Sterilization Sites:
i. BGS-Beta-Gamma-Service GmbH & Co Kg, Fritz-Kotz-Strasse 16, 51674 Wieth, Germany.
ii. Electron Beam Sdn, Bhd, Lot 7, Jalan Sungai Pinang 4/3, Taman Perindustrian Pulau Indah (Fasa 2), 42920 Port Klang, Selagnor, Malaysia.
f. Copy Valid Drug Sale License,
28. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Legal Manufacturer:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Manufacturing Site:M/s Medtronic Ireland, Parkmore Business Park West Galway, Ireland.
Driver Sprint Rapid Exchange Coronary Stent System
(As per FSC of Ireland)
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
2 years
Applied on 4-5-2016Letter issued on18-1-2017
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
29. M/s. Maxims Medical, 534
Amazonia SIR Drug
Decontrolled
2 years
Applied on 7-6-
Deferred for rectification of following shortcomings:
Minutes for 266th Meeting of Registration Board. 20
H Block, St. No.13, Phase-5,DHA, Lahore.Manufactured by:M/s Minvasys, 7, rue du Fosse Blanc-92230, Gennevilliers France.
Eluting Stent
Stent Length (mm):8, 12, 16, 20, 24, 28, 32, 36, 40.
Stent Dia (mm)2.25, 2.50, 2.75, 3.00, 3.50, 4.00. (As per FSC)
till policy decision by Policy Board/ Federal Government
1’s
2016Letter issued on 19.1.2017
a. Original and valid Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Clinical data, if any,d. Approval of shelf life
from regulatory authority or brnaad specific stability data to support claimed shelf life.
e. OrigInal Credentials of manufacture as decided above by Registration Board.
30. M/s Bio Medics Medical System, F-597, F-Block, Satellite Town, Rawalpindi.Manufactured By:M/s Alco Advanced Lightweight Constructions GmbH, Am Borsigturm 50, 13507, Berlin, Germany.
OSIRA CR ® L 605 Cobalt Chromium Rapamycin Eluting Coronary Stent.
Stent Dia (mm): 2.5, 2.75, 3.0, 3.5.Stent Length (mm): 8, 12, 16, 20, 24, 28, 32, 38, 42.(As per FSC)
Decontrolled till policy decision by the Policy Board/ Federal Govt.
1’s
18 mont
hs
Applied on1-4-2016Letter issued on19-1-2017.
(The firm given undertaken that they need one-month time period to fulfill deficiencies/documents required for registration.)
Deferred for rectification of following shortcomings:a. OrigInal Credentials of
manufacture as decided above by Registration Board.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Clinical data, if any,d. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
31. M/s Bio Medics Medical System, F-597, F-Block, Satellite Town, Rawalpindi.
Manufactured By:M/s Alco Advanced Lightweight
OSIRA R4 ® 3l6 LVM(Rapamycin Eluting Coronary Stent)
Stent Inner Dia (mm): 2.5, 2.75, 3.0, 3.5, 4.0.Stent Length (mm): 8, 12, 16, 20, 24,
Decontrolled till policy decision by the Policy Board/ Federal Government
18 mont
hs
Applied on 7-4-2016Letter issued on 19.1.2017. (The firm given undertaken that they need one-month time period to
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Clinical data, if any,c. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided
Minutes for 266th Meeting of Registration Board. 21
Constructions GmbH, Am Borsigturm 50, 13507, Berlin, Germany.
28, 32, 38, 42.(As per FSC)
1’s fulfill deficiencies/documents required for registration.)
above by Registration Board.
32. M/s SLT Saving Life Technologies, 126-H, Model Town, Lahore.Manufactured by:M/s Eucatech AG, Rebgartenweg 27, 79567 Weil and Rhein/ Germany.
EUCALIMUSSirolimus Eluting Stent System
Sizes and codes as per Free Sale Certificate.
Decontrolled till policy decision by the Policy Board/ Federal Government1’s
24 mont
hs
Deferred for provision of following documents/ information:Stents from same source already registered with M/s Radiant Devices Biomedical Pvt. Lahore.Principal manufacturer has issued embassy attested letter of cancellation to previous agent and inform that previous agent is not allowed to sell any their products in Pakistan.
Registration Board deferred and decided to Showcause to M/s Radient Devices for explaination in next meeting in this regard and following shortcomings.a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
33. M/s Promed International, CB-6349 Amar Pak Plaza, Jhelum Road,Rawalpindi.Legal
BioMatrix Alpha TM
Drug Eluting Coronary Stent System
Codes and sizes as per
Decontrolled till policy decision by the Policy
12 mont
hs
Applied on 17-11-2016Letter issued on20-1-2017Further deficiencie
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 22
Manufacturer:M/s Biosnsor Europe SA, Rue De Lausanne 29, 1110 Morges, Switzerland.Manufacturing Site:M/s Biosensors Interventional Technologies Pte Ltd, 36 Jalan Tukang, Singapore 619266, Singapore.Sterilization Site:1. BGS-Beta-Gamma-Service GmbH & Co Kg, Fritz-Kotz-Strasse 16, 51674 Wieth, Germany.
2. Electron Beam Sdn, Bhd, Lot 7, Jalan Sungai Pinang 4/3, Taman Perindustrian Pulau Indah (Fasa 2), 42920 Port Klang, Selagnor, Malaysia.
FSC. Board/ Federal Govt.
1’s
s communicated on 02.02.2017
b. OrigInal Credentials of manufacture as decided above by Registration Board.
34. M/s. SES Associates, 61 Bank Square Market, Model town, Lahore
Manufactured by:M/s. QualiMed GmbH, BoschstraBe 16, D-21423, Winsen,
UNA TM
Stent Delivery System (Stainless Steel Coronary Stent)
Stent Length (mm): 10, 14, 18, 24, 28, 34, 38.
Balloon Dia
Decontrolled till policy decision by Policy Board/ Federal Government
1’s
2 years in 5-
A3
years Shelf life
report
Applied on 14-6-2011.Letter issued 23-10-2012.Reminder issued on 20-1-2017.Letter issued on 03.2.2017
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. OrigInal Credentials of manufacture as decided above by Registration Board.
c. Clinical Data, if any.d. Valid copy of Drug
Sale Licence.e. Approval of shelf life
from regulatory
Minutes for 266th Meeting of Registration Board. 23
Germany. (mm): 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00.(As per FSC)
authority or Stability data to support claimed shelf life.
f. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
35. M/s. SES Associates,61-Bank Square Market, Model Town, Lahore.
Manufactured by
M/s. QualiMed GmbH, BoschstraBe 16, D-21423, Winsen, Germany.
SUNA TM
Stent Delivery System (Cobalt Chromium Coronary Stent)
Stnt Length (mm): 8, 10, 12, 14, 16, 18, 19, 24, 28, 34, 38.(As per FSC)Balloon Dia (mm): 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00.
Decontrolled till policy decision by Policy Board/ Federal Government
1’s
2years in 5-
A3
years Shelf life
report.
Applied on 14-6-2011.Letter issued 23-10-2012.Reminder issued on 20-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. OrigInal Credentials of manufacture as decided above by Registration Board.
c. Clinical Data, if any.d. Valid copy of Drug
Sale Licence.e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
B) CathetersS.No
Name of Importer and Manufacture/
Exporter.
Name of Medical
Device (s)
Price &
Pack size
Shelf life
Remarks/ shortcomi
ngs
Decision
1. M/s. SES Associates Institutional Distributors & Government Suppliers, Lahore
Manufactured by:M/s. Kimal Plc. Arundel Road, Uxbridge, Middlesex, UB8, United Kingdom.
Angio FLOWCardiac Catheter
(Product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by Policy Board/ Federal Government
02 years
Applied on 23-8-2011.Letter Issued on24-10-2012.Reminder issued on 16-11-2016.Final reminder on 3-2-2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory
Minutes for 266th Meeting of Registration Board. 24
authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
2. M/s Intek Corporation, # 30,1st Floor, Al-Amin Plaza, The Mall, Rawalpindi.Legal Manufacturer:M/s Terumo Corporation, 44-1-2 Chome, Hatagaya, Shibuya-ku, Tokyo, Japan.
Actual manufacturer:Ashitaka factory of terumo corporation 150,maimaigi-cho,fujinomiya city, schizouka prefecture 418-0015,Japan.
Radifocus Optitorque Angiographic Catheters.
Size: 4fr, 5fr, 6frLength: 80cm, 100cm, 110cm.(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.
36 months
Applied on 20-10-2011Letter issued on 14-10-2013.Reminder issued on 20.01.2017Further deficiencies communicated on 01.02.2017
Approved as per Import Policy for Finished Drugs.
3. M/s Intek Corporation, # 30,1st Floor, Al-Amin Plaza, The Mall, Rawalpindi.Legal Manufacturer:M/S Terumo Corporation, 44-1-2 Chome, Hatagaya, Shibuya-Ku, Tokyo, Japan.Actual manufacturer:Ashitaka Factory Of Terumo Corporation
Ryujin Plus, PTCA Dilatation Catheter.
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Govt.
36 Months
Applied on 20-10-2011Letter issued on 14.10.2013Reminder issued on 20.01.2017Further deficiencies communicated on 01.02.2017
Approved as per Import Policy for Finished Drugs.
Minutes for 266th Meeting of Registration Board. 25
150,Maimaigi-Cho,Fujinomiyacity, Schizouka Prefecture 418-0015, Japan.
4. M/s Surgi World,303 Mohammadia Plaza, College Road, Rawalpindi.
Manufactured by:M/s Medcomp, 1499 Delp Drive Harleys Villa, USA.
Pro-Picc ® Central Vein Infusion Catheter. (All sizes)
Decontrolled till policy decision by Policy Board/ Federal Govt.
5 years
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
5. M/s Surgi World,303 Mohammadia Plaza, College Road, Rawalpindi.
Manufactured by:M/s Medcomp, 1499 Delp Drive Harleys Villa, USA.
Vascu-Picc ® Central Vein Infusion Catheter (All sizes)
Decontrolled till policy decision by Policy Board/ Federal Government
5 years
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 26
g. Copy Valid Drug Sale License,
6. M/s Surgi World,303 Mohammadia Plaza, College Road, Rawalpindi.
Manufactured by:M/s Medcomp, 1499 Delp Drive Harleys Villa, USA.
Pro-Fuse ® CT Ports (Central Vein Infusion Catheter with port) (All sizes)
Decontrolled till policy decision by Policy Board/ Federal Government
5 years
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
7. M/s Surgi World,303 Mohammadia Plaza, College Road,Rawalpindi
Manufactured by:M/s Medcomp, 1499 Delp Drive Harleys Villa, USA.
Multi-Cath Central Vein Infusion Catheter(All sizes, Single, Double and Triple Lumen)
Decontrolled till policy decision by Policy Board/ Federal Government
5 years
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
8. M/s Johnson & Johnson (Pvt) Ltd, Plot.No.10
Envoy Guiding Catheters
Decontrolled till
3 years
Applied on 4-5-2012
Deferred for rectification of following shortcomings:a. Differential fee
Minutes for 266th Meeting of Registration Board. 27
& 25, Sector 20, Korangi Industrial Area, Karachi.Legal ManufacturerM/s Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA, USA.Manufacturing Site:M/s Codman & Shurtleff. Calle Cirrcuito Interior Norte No.1820, Parque Industrial Salvarcar, Ciudid Juarez, Chihuaha, CP 32575, Mexico.
Exporting & Releasing Site:European Distribution Cente, Johnson & Johnson,Belgium.
-
Envoy 5f
-
Envoy 6f
-
Envoy-XB
policy decision by Policy Board/ Federal Government
Differential fee not paid.Letter issued on 18-3-2013.Reminder on 24-1-17
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
9. M/s ACP Systems, Karachi.
Manufactured by:M/s Medtronic Ireland, Parkmore Business Park West, Galway Ireland.
Shipped From:Medtronic Trading NL BV, Earl Bakkenstraat 10, Neatherland.
Sprinter NC/SC RX Balloon Dilatation, Intravascular Catheters.
Decontrolled till policy decision by Policy Board/ Federal Government
24 months
a. Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided
Minutes for 266th Meeting of Registration Board. 28
above by Registration Board.
10. M/s ACP Systems, Karachi.
Manufactured by:M/s Medtronic Ireland, Parkmore Business Park West, Galway Ireland.
Shipped From:Medtronic Trading NL BV, Earl Bakkenstraat 10, Neatherland.
Sprinter Legend RX Balloon Dilatation, Intravascular Catheters.
Decontrolled till policy decision by Policy Board/ Federal Government
24 months
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
11. M/s ACP Systems, Karachi.
Manufactured by:M/s Medtronic Mexico s.de R.L.de CV,Mexico
Shipped From:Medtronic Trading NL BV, Earl Bakkenstraat 10, Neatherland.
Sprinter Legend RX Balloon Dilatation, Intravascular Catheters.
Decontrolled till policy decision by Policy Board/ Federal Government
24 months
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
12. M/s ACP Systems, Karachi.
Manufactured b:yM/s Medtronic
Catheters. Decontrolled till policy decision by Policy
24 months
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as product
applied for not specified.
Minutes for 266th Meeting of Registration Board. 29
Mexico s.de R.L.de CV, Mexico
Board/ Federal Govt.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Clinical data, if any,f. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
g. OrigInal Credentials of manufacture as decided above by Registration Board.
h. Copy Valid Drug Sale License,
13. M/s ACP Systems, Karachi.
Manufactured byM/s Medtronic, Inc, USA
Catheters. Decontrolled till policy decision by Policy Board/ Federal Government
36 months
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as product
applied for not specified.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Clinical data, if any,f. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
g. OrigInal Credentials of manufacture as decided above by Registration Board.
h. Copy Valid Drug Sale License,
14. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad./
Pantera Coronary Balloon
Balloon Length (mm)
Decontrolled till policy decision by
Not mentioned.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as
Minutes for 266th Meeting of Registration Board. 30
Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach, Switzerland.
Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.
6,10,15,20,25, 30.
Balloon Dia (mm): 1.25, 1.5, 2.0, 2.5,3.0, 3.5, 4.0.
Policy Board/ Federal Govt.
decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
15. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad./Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach, Switzerland. Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.
Pantera Leo- Non-Compliant High Pressure Balloon.
Balloon Length (mm) 8,12,15,20,30.
Balloon Dia (mm):2.0, 2.25,2.5, 2.75, 3.0, 3.25, 3.5, 3.75, 4.0, 4.50, 5.00.
Decontrolled till policy decision by Policy Board/ Federal Government
Not mentioned.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
16. M/s. SES Associates Distributors & Government Suppliers, LahoreManufactured byM/s. QualiMed Innovative Medizinproduk
Juturna-V TM
PTA Balloon Catheter
Balloon Length (mm):20,30,40,50,60,80,100, 120.
Decontrolled till policy decision by Policy Board/ Federal Gover
3 years
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability
Minutes for 266th Meeting of Registration Board. 31
et GmbH, Winsen, Germany.
Balloon Dia (mm):3,4,5,6,7,8,9,10,12, 14.
Usable Catheter Length :50cm, 75cm, 135cm.
nment data to support claimed shelf life.
c. OrigInal Credentials of manufacture as decided above by Registration Board.
d. Copy Valid Drug Sale License,
17. M/s. SES Associates Distributors & Government Suppliers, Lahore
Manufactured byM/s. Kimal Plc. Arundel Road, Uxbridge, Middlesex, UB8, 2SA,U.K
Manufacturing Site:Sher Wood Road, Aston Fields Industrial Estate, Bromsgrove, Worcesterhire, UK.
Central Venous Catheter Altius.Sizes, types and products codes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Clarification as manufacturing site not specified.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
18. M/s Cardiac Care, 848-C, Shadman-I, Lahore.
Manufactured byM/s Vygon-5 rue Adeline -95440-Ecouen, France.
Leader- Cath
Codes:115.090, 115.092, 115.094115.096, 115.11, 115.118
Decontrolled till policy decision by the Federal Government
60 months
Applied on 1-1-2013.Letter Issued on 16-6-2014. Reminder issued on 19-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .
c. Clinical data, if any,d. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
e. OrigInal Credentials of manufacture as decided
Minutes for 266th Meeting of Registration Board. 32
above by Registration Board.
19. M/s Cardiac Care, 848-C, Shadman-I, Lahore.
Manufactured byM/s Vygon-5 rue Adeline -95440-Ecouen, France.
Multicath 2, Multicath 3.
Codes of Multicath 2:6202.20, 6202.24, 6202.27, 6204.17.
Codes of Multicath 3:6208.25, 6209.25.
Decontrolled till policy decision by the Federal Government
60 months
Applied on 1-1-2013Letter issued on16-6-2014. Reminder issued on 19-1-2017
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Clinical data, if any,d. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
e. OrigInal Credentials of manufacture as decided above by Registration Board.
20. M/s. Ontech Corporation, M-02 Mezzanine Floor, Lakhani corner Block.13-A, Gulshan-e- Iqbal,Karachi.
Manufactured by:M/s. Ameco Medical Industries, Industrial Zone B4 Plot 119, East 10th
Ramadan City, Egypt.
Central Venous Catheters
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Government
05 years
Applied on 5-4-2011Letter issued on 6-12-2013.Reminder issued on 7-10-2016.
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Clinical data, if any,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. Valid Drug Sale Licence.
21. M/s. Saru International,Flat A/4 Mehboob Heights’ Sector 11-C-1-North Karachi.
Manufactured byM/s. Nanchang
Healthicon, Central Venous Catheter/ Kit-Single/ Double /Triple Lumen (Infusion Series).
Decontrolled till policy decision by Policy Board/ Federal Gover
05 years
Applied on 12-4-2011.Letter issued 26-9-2012.Reminder issued on 27-2-2015 and
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-,b. Clarification as
different types applied on same application.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 33
Biotek Medical Device Co. Ltd., No.18,2nd
gaoxin road, high-tech development zone, Nanchang City. China.
nment 7-10-2016.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Clinical data, if any,f. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
g. OrigInal Credentials of manufacture as decided above by Registration Board.
22. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.
Manufactured byM/s. ClearStream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.
Nimbus Pico U PTCA Catheter(Catheter).
Decontrolled till policy decision by the Federal Government
03 years
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Valid Drug Sale Licence.
23. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.Manufactured by:M/s. Clear Stream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.
Nimbus Salvo PTCA Catheter(Catheter).
(As per FSC)
Decontrolled till policy decision by the Federal Government
03 years
Applied on 18-4-2011Letter Issued on 26-9-2012Reminder issued on 4-3-2015Final reminder issued on 6-10-2016.
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. OrigInal Credentials of
Minutes for 266th Meeting of Registration Board. 34
manufacture as decided above by Registration Board.
f. Valid Drug Sale Licence.
24. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.
Manufactured byM/s. Merit Medical Systems, Inc. 1600 Weat merit, Parkway, South Jordan, Utah, 84095-2416 U.S.A.Manufacturing location:Merit Medical System, Inc, 1111 South Velasco Angleton, TX 77515 USA.
Concierge Guiding Catheter
(As per FSC)
Decontrolled till policy decision by the Federal Government
03 years
Applied on 18-4-2011Letter Issued26-9-2012Reminder issued on 4-3-15Final reminder issued on 6-10-2016
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. OrigInal Credentials of manufacture as decided above by Registration Board.
f. Valid Drug Sale Licence.
25. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.
Manufactured byM/s. Merit Medical Systems, Inc. 1600 Weat merit, Parkway, South Jordan, Utah, 84095-2416 U.S.A.
Manufacturing location:Merit Medical
Performa ®, Softouch ® Diagnostic Catheter
(As per FSC)
Decontrolled till policy decision by the Federal Government
03 years
Applied on 18-4-2011Letter Issued 26-9-2012Reminder issued on 4-3-15Final reminder issued on 6-10-2016
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-,b. Clarification as 2 major
groups of catheter applied on one application.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. OrigInal Credentials of
Minutes for 266th Meeting of Registration Board. 35
System, Inc, 1111 South Velasco Angleton, TX 77515 USA.
manufacture as decided above by Registration Board.
g. Valid Drug Sale Licence.
26. M/s. Maxims Medical, 534 H Block, St. No.13, Phase-5,DHA, Lahore.
Responsible Manufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.
Manufacturing Site:M/s. Abbott Vascular, Instruments Deutsuhland,GmbH, Rudolf-diesel-dtrabe 29, 72414, Rangendingen, Germany.
Mercury PTCA Balloon Catheter
(As per FSC)
Decontrolled till policy decision by the Federal Government
02 years
Applied on 23-4-2011Stents and Catheters from Ireland Source already registered in the name of M/s Digital Imaging System, Lahore.Authorization letter/sole agency agreement issued by Indian region.Letter for deficiencies issued on 23-10-2012Reminder issued on 7-10-2016.
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. OrigInal Credentials of manufacture as decided above by Registration Board.
f. Valid Drug Sale Licence.
g. Clarification for product sizes and codes and different sites of manufacture.
27. M/s. Maxims Medical,534-H-Block, Phase-5,St.No-13, Defence, DHA, Lahore.
Responsible Manufacturer:M/s. TemMed Medical Co. Ltd.,no 48, Keji road. Miyun Industrial district, Beijing, 101500, P.R. China.
Path Maker PTCA Balloon Catheter
(As per FSC)
Decontrolled till policy decision by the Federal Government
02 years
Applied on 23-4-2011Letter for deficiencies issued on 23-10-2012Reminder issued on7-10-2016.
Deferred for rectification of following shortcomings:a. Differential Fee
PKR.35,000/-,b. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
Minutes for 266th Meeting of Registration Board. 36
e. OrigInal Credentials of manufacture as decided above by Registration Board.
f. Valid Drug Sale Licence.
g. Clarification for product sizes and codes and different sites of manufacture.
h. Last inspection report28. M/s Interex
Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured byM/s.Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.Shipped FromM/s Maquet Middle East FZ-LLC, G005 Nucleotide Complex,Dubai Biotechnology & Research Park, P.O.Box 214742.
Sensation Plus Intra Aortic Balloon Catheter.
(As per FSC)
Decontrolled till policy decision by the Federal Government
Not mentioned in form 5-A.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
e. Valid Drug Sale Licence.
29. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured byM/s.Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.Shipped FromM/s Maquet Middle East FZ-LLC, G005 Nucleotide
Linear Intra Aortic Balloon Catheter.
7.5 FR.
Decontrolled till policy decision by the Federal Government
Not mentioned in form 5-A.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration
Minutes for 266th Meeting of Registration Board. 37
Complex,Dubai Biotechnology & Research Park, P.O.Box 214742.
Board.e. Valid Drug Sale
Licence.
30. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured byM/s.Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.Shipped FromM/s Maquet Middle East FZ-LLC, G005 Nucleotide Complex, Deferred.Board decided that final reminder shall be issued that the firm will provide following deficiencies with in 7 days in case of non compliance the application shall be dispose off.
Dubai Biotechnology & Research Park, P.O.Box 214742.
Mega Intra Aortic Balloon Catheter.
Decontrolled till policy decision by the Federal Government
Not mentioned in form 5-A.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
e. Valid Drug Sale Licence.
31. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured by
Z-Med II Catheter.
Balloon Dia (mm): 23, 25, 26, 28, 30.
Balloon
Decontrolled till policy decision by the Federal
Not mentioned in form 5-A.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from
Minutes for 266th Meeting of Registration Board. 38
1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.
2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.
Length (cm): 2, 3, 4, 5,6.
Government
manufacturer as decided above by Registration Board .
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
e. Valid Drug Sale Licence.
32. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/
Manufactured by1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.
2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.
Tyshak II Catheter (GMDN Code 17453).
Balloon Dia (mm): 12, 13, 14, 15, 16, 17, 18, 20, 22, 23, 25, 30.
Balloon Length (cm): 2, 3, 4, 5,6.
Decontrolled till policy decision by Policy Board/ Federal Government
Not mentioned in form 5-A.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
e. Valid Drug Sale Licence.
33. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/
Manufactured by1. M/s.NuMed, Inc 2880 Main
Z-5 Catheter.(GMDN Code 10747).Balloon Dia (mm): 9.5, 13.5.Balloon Lengh (cm): 0.95, 1.35.
Decontrolled till policy decision by Policy Board/ Federal Government
Not mentioned in form 5-A.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life
Minutes for 266th Meeting of Registration Board. 39
Street, Hopkinton, NY, 12965, USA.
2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.
1’s from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
e. Valid Drug Sale Licence.
34. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/
Manufactured by1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.
2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.
BIB Stent Placement Catheter
Balloon Length (mm): 12, 14, 15, 16, 18, 20, 22, 24.
Balloon Dia (cm): 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5.
Not mentioned in form 5-A.
1’s
Not mentioned in form 5-A.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
e. Valid Drug Sale Licence.
35. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169,
Xperience Coronary Balloon Dilatation Catheter
Balloon Length (mm): 10, 15, 20, 25,30, 40.
Balloon Dia (cm): 1.50, 2.00, 2.50, 3.00, 3.50,
Decontrolled till policy decision by the Policy Board/Federal Government
3 years.
Applied on 9-1-2014Letter Issued on 18-3-2014.Final reminders issued on2-3-2015Letter Issued18-1-2017.Letter Issued3-2-2017.
Deferred for rectification of following shortcomings:a. OrigInal Credentials of
manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 40
Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.
4.00, 4.50.
36. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.
Oceanus 35 PTA Balloon Dilatation Catheter
Balloon Length (mm): 20, 40, 60, 80,120, 150, 200.
Balloon Dia (cm): 5, 6, 7,8, 9, 10, 12.
Catheter Length (cm): 80, 140.
Decontrolled till policy decision by the Policy Board/Federal Government
3 years.
Letter Issued on 18-3-2014.Final reminders issued on2-3-2015Letter Issued
18-1-2017.Letter Issued3-2-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. OrigInal Credentials of manufacture as decided above by Registration Board.
c. Labeling information.
37. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT
Oceanus 14 Peripheral Balloon Dilatation Catheter
Balloon Length (mm): 40, 60, 80,120, 150, 200.
Balloon Dia (cm): 1.5, 2.0, 2.5, 3.0, 3.5, 4.0.
Catheter Length (cm): 100, 150.
Decontrolled till policy decision by the Policy Board/Federal Government
3 years.
Letter Issued on 18-3-2014.Final reminders issued on2-3-2015Letter Issued18-1-2017.Letter Issued3-2-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. OrigInal Credentials of manufacture as decided above by Registration Board.
c. Labeling information.
Minutes for 266th Meeting of Registration Board. 41
VICENC, DELS HORTS, Barcelona, Spain.
38. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.Legal ManufacturerM/s Cordis Corporation, 14201 North West 60th
Avenue,Miami Lakes, FL 33014, USAASSEMBLERM/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte# 1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua Mexico 32574.
ADROIT TM
Guiding Catheter.
Useable Catheter Length (cm): 55, 90, 100, 125.
Size: 6 F
(As per FSC)
Decontrolled till policy decision by the Policy Board/Federal Govt.
3 years
Applied on 4-3-2014Letter issued on20-2-2015.2nd letter issued on 02-02-2017.
Deferred for rectification of following shortcomings:a. Application on Form-
5A as per format prescribed.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
39. M/s Johnson & Johnson Pakistan (Pvt) Limited, Karachi.Legal Manufacturer:M/s Siemens Medical Solutions USA, Inc. 685 East Middlefield Road, Mountain View, CA 94043 USAPhysical Site:M/s Siemens Ltd Seoul, 2nd
AcuNav TM
Diagnostic Ultrasound Catheter
Sizes and codes as per Free SaleCertificate.
Decontrolled till policy decision by the Policy Board/Federal Government
3 years
Deferred for rectification of following shortcomings:a. Application on Form-
5A as per prescribed format.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
Minutes for 266th Meeting of Registration Board. 42
& 3rd Venturee Building, Pohang Technopark, 394,Jigok-ro-Nam-gu Pohang-si, Gyeongsangbugdo, 790-834, Republic of Korea.
e. OrigInal Credentials of manufacture as decided above by Registration Board.
40. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/Manufactured by1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.
2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.
Bonhoeffer Multi-Track Mitral Dilatation Kit.
Balloon Length (mm): 12, 14, 15, 16, 18, 20, 22, 24.
Balloon Dia (cm): 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5.
Decontrolled till policy decision by the Policy Board/Federal Government
1’s
Not mentioned in form 5-A.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Valid Drug Sale Licence.
41. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.Legal Manufacturer:M/s Cordis Cashel, Cahir Road, Cashel, Co. Tipperary, Ireland.Physical Manufacturer:
Aviator Plus PTA Balloon Dilatation Catheter
Decontrolled till policy decision by the Federal Govt.
3 years
Applied on 8-9-2014Letter issued on23-2-2015.Letter Issued on3-2-2017
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. OrigInal Credentials of manufacture as decided above by Registration Board.
d. Valid Drug Sale Licence.
Minutes for 266th Meeting of Registration Board. 43
M/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte # 1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua CP 32574 Mexico.
42. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.Legal Manufacturer:M/s Cordis CashelCahir Road, Cashel Co. Tipperary, Ireland.Physical Manufacturers:M/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte # 1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua CP 32574 Mexico.
Slalom PTA Balloon Dilatation Catheter
Codes and sizes as perFree sale certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 23-9-2014.Letter issued on26-2-2015.Letter Issued on3-2-2017
Deferred for rectification of following shortcomings:a. Application on Form-
5A not as per prescribed format.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. OrigInal Credentials of manufacture as decided above by Registration Board.
43. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.
Manufacturer:
Sleek PTA Balloon Dilatation Catheter
(Sizes as per Free Sale Certificate).
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 11-12-2014Letter Issued on 14-9-2015.Letter Issued on3-2-2017
Deferred for rectification of following shortcomings:a. Application on Form
5A as per prescribed format.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory
Minutes for 266th Meeting of Registration Board. 44
M/s Clear Stream Technologies Ltd, Moyne Upper Enniscorthy County Wexford, Ireland.
authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
e. Valid Drug Sale Licence.
44. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.
Manufacturer:M/s Clear Stream Technologies Ltd, Moyne Upper Enniscorthy County Wexford, Ireland.
Sleek OTW PTA Balloon Dilatation CatheterBalloon Length (mm): 20, 40,80, 100,120, 150, 220, 280.
Balloon Dia (cm): 1.75, 2.00, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0.
Decontrolled till policy decision by Policy Board/ Federal Govt.
3 years
Applied on 26-1-2015Letter Issued on 14-9-2015.
Deferred for rectification of following shortcomings:a. Application on Form
5A as per prescribed format.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. OrigInal Credentials of manufacture as decided above by Registration Board.
e. Valid Drug Sale Licence.
45. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi/
Manufacturer:M/s Pendra Care International B.V. Van der Waalspark 22, 9351 VC Leek, The Netherlands.
Serpia Hydrophilic Guiding Catheter.
5Fr, 6Fr, 7Fr, 8Fr.
(Diff. product codes available)
Decontrolled till policy decision by Policy Board/ Federal Govt.
3 years
Applied on 3-4-2015Letter Issued on 15-9-2015.
Convey TM
Guiding Catheter applied by M/s Ferozsons Labs.
Primum Hydrophillic guiding Catheter applied by M/s Health Tec from same source.Various
Rejected.Cases in which more than one authorization letter/sole agency agreement has been granted by the manufacturer/ licence holder for the same product with different brand names, the sole agency agreement of manufacturer will be considered for the grant of registration.
Minutes for 266th Meeting of Registration Board. 45
configurations (one hole, two hole, without hole) given in catheter.
46. M/s. Health Tec,10-B, Street No.24, Valley Road, Westridge-I Rawalpindi.
Manufacturer:M/s PendraCare International B.V. Van der Waals Park 22, 9351 VC Leek, The Netherlands.
Pointer Angiographic Catheter.
Sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 30-9-2015Letter Issued on 19-01-2016
Same product “Angiodyn Angiography Catheter” already registered with same source.
Deferred for clarification as for the Same product “Angiodyn Angiography Catheter” already registered from same source to the applicant via M/S B.Braun Germany to B.Braun Pakistan, the Board Decided to issue showcause to M/S B.Braun Pakistan regiarding the clarification of their sole agency agreement from the manufacturer.
47. M/s Genus,220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.
Hawk PTCA Ballon Catheter Non Compliant
Sizes and codes as per Free Sale Certificate.
Decontrolled till policy decision by the Policy Board/ Federal Govt.
2 years
Applied on 4-11-2015Letter Issued on 11-8-2016. Reminder issued on 18-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Valid Drug Sale Licence.
48. M/s Genus,220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450
Falcon Guiding Catheter
Sizes and codes as per Free Sale Certificate.
Decontrolled till policy decision by the Policy Board/Federal Government
3 years
Applied on 5-11-2015Letter Issued on 11-8-2016.Reminder issued on 18-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Valid Drug Sale Licence.
Minutes for 266th Meeting of Registration Board. 46
USA.49. M/s Genus,
220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.
Hawk PTCA Balloon Catheter Semi Compliant
Sizes and codes as per Free Sale Certificate.
Decontrolled till policy decision by the Policy Board/Federal Government
2 years
Applied on 5-11-2015Letter Issued on 11-8-2016. Reminder issued on 18-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Valid Drug Sale Licence.
50. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752. USAManufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.
Flextome TM Cutting Balloon TM
Monorail TM
Microsurgical Dilatation Device
Balloon Length (mm): 06, 10, 15, 20, 24, 28, 32.Balloon Dia (mm)2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.76, 4.00.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 1-12-2015Letter Issued on 11-8-2016.
Approved as per Import Policy for Finished Drugs.
51. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh,Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752.
NC Emerge TM Monorail TM PTCA Dilatation Catheter
(As per FSC)
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 1-12-2015Letter Issued on 11-8-2016.Further deficiencies communicated on02-02-2017
Deferred for rectification of following shortcomings:
a. OrigInal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 47
USAManufacturing Site:M/s. Boston Scientific Ltd, Ballybrit Business Park, Galway, Ireland.
52. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752. USAManufacturing Site:M/s. Availmed S.A de C.V. Av. Paseo Reforma No.8950, C.P.22116 La Mesa, Tijuana Baja California, Mexico.
Runway TM
Guide Catheter
Product code and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Govt.
3 years
Approved as per Import Policy for Finished Drugs.
53. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s Pendra Care International B.V. Van der Waals park 22, 9351 VC Leek, Netherland.Manufacturing Site:M/s Pendra Care International
Convey TM
Guiding Catheter
Product code and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 7-12-2015Letter Issued on 11-8-2016.
Primum Hydrophillic guiding Catheter applied by M/s Health Tec from same source.Serpia Hydorphilic Guiding Catheter applied by
Rejected.Cases in which more than one authorization letter/sole agency agreement has been granted by the manufacturer/ licence holder for the same product with different brand name, the sole agency agreement of manufacturer will be considered for the grant of registration.
Minutes for 266th Meeting of Registration Board. 48
B.V. Van der Waals park 22, 9351 VC Leek, Netherland.
M/s B. Braun from same source.
54. M/s. Health Tec,10-B, Street No.24, Valley Road, Westrige-I Rawalpindi.
Manufacturer:M/s PendraCAre International B.V. Vander Waals Park 22, 9351 VC Leek, The Netherlands.
Primum Hydrophilic Guiding Catheter.
Sizes as per Free Sale Certificate.
Free Sale Certificate has configuration of catheter holes and without holes.
Decontrolled till policy decision by Policy Board/ Federal Government
1’s
3 years
Applied on 2-2-2016Serpia Hydrophilic Guiding Catheter applied by M/s B. Braun from same source.Convey TM
Guiding Catheter applied by M/s Ferozsons Labs from same source.Letter of shortcomings sent on19-1-2017Shortcoming received.
Approved as per Import Policy for Finished Drugs.
Cases in which more than one authorization letter/sole agency agreement has been granted by the manufacturer/ licence holder for the same product with different brand name, the sole agency agreement of manufacturer will be considered for the grant of registration.
55. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Owner Operator:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Legal Manufacturer:M/s Medtronic Vascular37A Cherry Hill Dr DANVERS MA USA
Pro-Flo Diagnostic Angiography Catheter
Types, Sizes & Models as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on16-3-2016.Letter issued on 18-1-2017.Letter Issued on3-2-2017
Deferred for rectification of following shortcomings:a. Form 5A as per not
information provided.b. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Copy Valid Drug Sale License,
Minutes for 266th Meeting of Registration Board. 49
01923Contract Manufacturing Site:M/s Availmed S.A. De C.V. Av. Paseo Reform No. 8950 Interior (B1, C1, E1, E2, F2, G1) (Local A.B.C.G.H) La Mesa, Tijuana, Baja California 22116, Mexico.
56. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Owner Operator:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Legal Manufacturer:M/s Medtronic Vascular37A Cherry Hill Dr DANVERS MA USA 01923Contract Manufacturing Site:M/s Availmed S.A. De C.V. Av. Paseo Reform No. 8950 Interior (B1, C1, E1, E2, F2, G1) (Local A.B.C.G.H) La Mesa, Tijuana, Baja California 22116,
Site Seer Cardiovascular Diagnostic Angiography Catheters
Types, Sizes & Models as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 16-3-2016Letter issued on 18-1-2017.Letter issued on 3-2-2017
Deferred for rectification of following shortcomings:
a. Form 5A as per not information provided.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Copy Valid Drug Sale License,
Minutes for 266th Meeting of Registration Board. 50
Mexico.57. M/s. ACP
System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Name of Owner Operartor:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Manufacturing Site:M/s Medtronic Vascular37A Cherry Hill Dr DANVERS, MA USA 01923
Launcher Guiding Catheters
Types, Sizes & Models as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
2 years
Applied on 16-3-2016Letter issued on 18-1-2017.Letter issued on 3-2-2017
Deferred for rectification of following shortcomings:
a. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Copy Valid Drug Sale License,
58. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Owner/ Operator:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Manufacturing Facility:M/s Medtronic Vascular, 37-A, Cherry Hill Drive, Danvers, MA 01923, USA.
Sherpa NX Guiding Catheter
Types, Sizes & Models as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
2 years
Applied on 16-3-2016Letter issued on 18-1-2017.Letter Issued on3-2-2017
.
Deferred for rectification of following shortcomings:
a. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Copy Valid Drug Sale License,
59. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman, Lahore.
Biosensors Central Venous Catheter Kit
Decontrolled till policy decision by
36 months
Applied on 8-3-2016.Letter issued on 18.1.2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 51
Manufactured by:M/s Biosensors International Pte. Ltd, 36 Jalan Tukang, Singapore 619266.
the Policy Board/Federal Government
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. OrigInal Credentials of manufacture as decided above by Registration Board.
60. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman, Lahore/
Manufactured by:M/s Biosensors International Pte. Ltd, 36 Jalan Tukang, Singapore 619266.
Safety wedge thermodilution catheters with biotray
Decontrolled till policy decision by the Policy Board/Federal Government
36 months
Applied on 8-3-2016.Letter issued on18-1-2017.
Deferred for rectification of following shortcomings:a. Application on
Prescirbed Form-5Ab. Original and valid Free
Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. OrigInal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License,
g. Clinical Data, if any.h. Complete
specifications with details of analytical procedures
61. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman, Lahore/
Manufactured by:M/s Biosensors International Pte. Ltd, 36 Jalan Tukang, Singapore 619266.
Biosensors Embolectomy Catheters
Decontrolled till policy decision by the Policy Board/Federal Government
36 months
Applied on 8-3-2016.Letter issued on 18-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. OrigInal Credentials of manufacture as decided above by Registration Board.
d. Copy Valid Drug Sale
Minutes for 266th Meeting of Registration Board. 52
License,62. M/s. Promed
International, CB-6349 Amarpak Plaza, Jhelum Road, Rawalpindi.Legal Manufacturer:M/s Biosensors Europe SA, Rue De Lausanne 29, 1110 Morges, Switzerland.Manufacturing Site:M/s Biosensors Interventional Technologies Pte Ltd, 36 Jalan Tukang, Singapore 619266, Singapore.
Powerline TM
PTCA CatheterProduct sizes and codes as per FSC
Decontrolled till policy decision by Policy Board/ Federal Govt.
1’s
36 months
Applied on 20-4-2016Letter of shortcomings issued on 18-1-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Copy Valid Drug Sale License,
f. Clinical data, if any.
63. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office: Office no.05,2nd floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany
Venoseld Central Venus Catheter-I Lumen.
Sizes:14G, 16G, 18G, 20G,24G.
Length (cm): 9, 13, 16, 20, 30.(As per free sale certificate)
Decontrolled till policy decision by the Policy Board/Federal Government
5 years
Deferred for rectification of following shortcomings:
a. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
b. Orignal Credentials of manufacture as decided above by Registration Board.
64. M/s Hashir Surgical Services (Pvt) Ltd,
Trilucath Central Venous Catheter-3
Decontrolled till policy
5 years
Applied on 2-5-2016Letter
Deferred for rectification of following shortcomings:
a. Approval of shelf life
Minutes for 266th Meeting of Registration Board. 53
1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office: Office no.05,2nd floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany
Lumen.(As per FSC)
Ref:323085, 323015, 323025, 323035, 323017, 323027, 323037, 323028Sizes:5.5F, 7F, 8.5F.Length (cm): 8, 13, 16, 20, 30.
decision by the Policy Board/ Federal Government
Issued on 2-11-2016.
from regulatory authority or Stability data to support claimed shelf life.
b. Orignal Credentials of manufacture as decided above by Registration Board.
65. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office:Office no.05,2nd floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany
Duocath Central Venus Catheter 2-Lumen.
Sizes: 4F, 5F, 7F, 8F.
Length (cm): 5, 6, 8, 10, 13, 15, 20, 30.
Decontrolled till policy decision by the Policy Board/ Federal Government
5 years
Deferred for rectification of following shortcomings:
a. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
b. Orignal Credentials of manufacture as decided above by Registration Board.
66. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector
Quadrocath Central Venus Catheter4-Lumen.
(As per
Decontrolled till policy decision by the
5 years
Applied on 2-5-2016Shortcoming letter sent on26-10-
Deferred for rectification of following shortcomings:
a. Approval of shelf life from regulatory authority or Stability data to support claimed
Minutes for 266th Meeting of Registration Board. 54
F-2, Phase-6, Hayatabad, Peshawar.Sub-office:Office no.05,2nd floor syed’s tower, university road,Peshawer.Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany.Sterilization Site:PFM Medical msg GmBH, Am soterberg 4; D-66620 Nonnweller-Otzenhausen;Germany.
FSC) Policy Board/ Federal Government
2016 2nd letter sent on19-10-163rd
shortcoming communicated on02-02-2016.
shelf life.b. Orignal Credentials of
manufacture as decided above by Registration Board.
67. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA
Coyote TM ES Monorail TM
PTA Balloon Dilatation Catheter.
Codes and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
37 months
Applied on 15-7-2016Letter issued on18-1-2017.
Deferred for rectification of following shortcomings:
a. Original and valid Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Clinical Data, if any.
68. M/s. Ferozsons Coyote TM Decont 37 Applied Deferred for rectification of
Minutes for 266th Meeting of Registration Board. 55
Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA
Monorail TM
PTA Balloon Dilatation Catheter.
Codes and sizes as per Free Sale Certificate.
rolled till policy decision by Policy Board/ Federal Government
months
on 15-7-2016Letter issued on 18-1-2017.
following shortcomings:
a. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
69. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA
Coyote TM ES Over The Wire TM PTA Balloon Dilatation Catheter.
Codes and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
25 months
Applied on 15-7-2016Letter issued on18-1-2017.
Deferred for rectification of following shortcomings:
a. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
70. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh,
Mustang TM
Over The Wire PTA Balloon Dilatation
Decontrolled till policy decisio
37months
Applied on 15-7-2016Letter issued on
Deferred for rectification of following shortcomings:
a. Original and valid authorization letter/sole
Minutes for 266th Meeting of Registration Board. 56
Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Ballybrit Business Park, Galway , Ireland.
Catheter.
Codes and sizes as per Free Sale Certificate.
n by Policy Board/ Federal Government
18-1-2017.a.
agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
71. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Contract Manufacturing Site:M/s. Teleflex Medical, Unit 7,8 & 9, Annacotty Business Park, Annacotty Country Limerick, Ireland.
Imager TM II Angiographic Catheter.
Product codes and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
25months
Applied on 15-7-2016Letter issued on 18-1-2017.
Deferred for rectification of following shortcomings:
a. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
72. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston
Coyote TM
Over The Wire PTA Balloon Dilatation Catheter.
Product codes and sizes as per Free Sale
Decontrolled till policy decision by Policy Board/ Federal Gover
37 months
Applied on 15-7-2016Letter issued on 18-1-2017.a.
Deferred for rectification of following shortcomings:
a. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability
Minutes for 266th Meeting of Registration Board. 57
Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA
Certificate. nment data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
73. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.
Sterling TM
Monorail TM
PTA Balloon Dilatation Catheter
Product codes and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Govt.
37months
Applied on 15-7-2016Letter issued on 18-1-2017.
Deferred for rectification of following shortcomings:
a. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
74. M/s Bio Medics Medical System, F-597, F-Block, Satellite Town, Rawalpindi.
Manufactured By:M/s Alco Advanced Lightweight Constructions GmbH, Am Borsigturm 50, 13507, Berlin, Germany.
OSIRA PTCA ® Catheter(Rapamycin Eluting Coronary Dilatation Catheter)
(As per FSC)
Decontrolled till policy decision by the Policy Board/ Federal Govt.
18 months
Applied on 6-4-2016Letter issued on19-1-2017.Further shortcoming communicated on01-02-2017.
(The firm given undertaken that they need one-month
Deferred for rectification of following shortcomings:
a. Original and valid Free Sale Certificate as decided above by Registration Board.
b. OrigInal Credentials of manufacture as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Clinical data, if
any.
Minutes for 266th Meeting of Registration Board. 58
time period to fulfill deficiencies/documents required for registration)
75. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5 Main Boat Basin, Clifton, Karachi.
Legal Manufacturer:M/s BioSense Webster, Inc. 15715 Arrowy Hwy, Irwidale, CA USA 91706.
Pentaray Catheter
(product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by the Policy Board/ Federal Govt.
3 years
Applied on 25-8-2016.Letter issued on 19-1-2017.Reminder issued on 02-02-2017.
Deferred for rectification of following shortcomings:a. Application on Form-
5A duly signed and stamped.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Clinical Data, if any.76. M/s Johnson &
Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton, Karachi.Legal ManufacturerM/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CA, USA 91706.
EZ Steer Catheter
(product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by the Policy Board/ Federal Government
3 years
Applied on 25-8-2016.Letter issued on 19.1.2017.Reminder issued on 02-02-2017.
Deferred for rectification of following shortcomings:
a. Application on Form-5A duly signed and stamped.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
77. M/s A.H Distributors,Kh-1183, Lane No.5, Peshawar Road, Rawalpindi./Legal
Ursa Angiographic Catheter
(product codes and sizes as per Free Sale
Decontrolled till policy decision by the Policy
36 months
Deferred for rectification of following shortcomings:
a. Original and valid Free Sale Certificate with clear status as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 59
Manufacturer:M/s Curatia Medical Ltd, 198 Xiangjiang Road, New District Suzhou 215011, China.Manufacturing Facility:M/s Curatia Medical Ltd, 198 Xiangjiang road, New District Suzhou 215011, China.
M/s Curatia Medical Ltd, 9 Peiyuan Road, New District Suzhou 215163, China.
Certificate) Board/ Federal Government
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data,e. Approval of shelf life
from regulatory authority or Stability data to support claimed shelf life.
f. Method of manufacturing and Analytical Specification.
78. M/s Johnson & Johnson Pakistan (Pvt) Limited, ///Fl.19,/ Sub Plot F-1, /Kehkashan Scheme TNo.5,Main Boat Basin, Clifton, Karachi.
Legal ManufacturerM/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CA, USA 91706.
Webster Catheters
(product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by the Policy Board/ Federal Government
3 years
Applied on 25-8-2016.Letter issued on02-11-2016.Reminder issued on 02-02-2017.
Deferred for rectification of following shortcomings:a. Original and valid Free
Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Clinical trial data, if any,
79. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5,Main Boat Basin, Clifton,
Thermocool Catheters
(product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by the Policy Board/ Federa
3 years
Applied on 20-9-2016Letter issued on 12.1.2017.Letter Issued on3-2-2017 (Firm Has
Deferred for rectification of following shortcomings:a. Application on Form
5A duly signed and stamped.
b. Clarification as many types/products applies in application.
c. Original and valid Free Sale Certificate as
Minutes for 266th Meeting of Registration Board. 60
Karachi.
Legal ManufacturerM/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CA USA 91706.
l Government
Requested to grant 10-12 weeks for furnishing above mentioned data)
decided above by Registration Board.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. Orignal Credentials of manufacture as decided above by Registration Board.
g. Clinical trial data, if any
80. M/s Mediland Pakistan (Pvt) Limited, Office No. B-09, 2nd
Floor, Masood Arcade, IJP Road, Near Saidpur Road, Rawalpindi.
Manufactured by:M/s Datascope Corporation, 1300Macarthur Blvld MAHWAH, NJ USA 07430
Intra Aortic Balloon Catheter
Decontrolled till policy decision by the Policy Board/ Federal Government
Not mentioned
Applied on 27-10-2016.Letter issued on 19-1-2017.
i.
Deferred for rectification of following shortcomings:a. Application on Form-
5A as per prescribed format.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clincal Data, if any.
Case No.02: Fresh applications for registration of Medical Devices.Following firms have applied for registration of medical devices for import.
A) CanullaS. Name of
Importer and Manufacture/
Exporter.
Name of Medical
Device (s)
Demanded price &
Pack size
Shelf life
Remarks Decision
1. M/s Cardiac Care, 848-C, Shadman-I,
Aortic Root Cannula-with Vent
Decontrolled(12Ga,
3 years
Applied on 20-7- 2012
Deferred for rectification of following
Minutes for 266th Meeting of Registration Board. 61
Lahore.Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th
Way,Arvada, CO, 80004, USA.
Line.(Aortic Perfusion Cannula)
Product codes as per Free Sale Certificate and Form 5-A.
14Ga, 16Ga)
Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 and3-2-2017.
shortcomings after personal hearing of authorized representative:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clarification as manufacturer status is not clear on copy of free sale certificate.
g. Clarification as product name is different on Form 5A and free sale certificate copy.
2. M/s Cardiac Care, 848-C,Shadman-I, Lahore.
Manufactured byM/s Sorin Group USA,
Cannulation Tourniquet Set (Perfusion Set)
Product
Decontrolled(TS-10130, TS-10262,TS-10066, TS-10015, TS-10020,TS-10061,TS-10050,
3 years
Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders
Deferred for rectification of following shortcomings after personal hearing of authorized representative:a. Differential fee
PKR.35,000/-,
Minutes for 266th Meeting of Registration Board. 62
Inc, 14401 W. 65th
Way,Arvada, CO, 80004, USA.
codes as per Free Sale Certificate and Form 5-A.
TS-10040, TS-10010)
issued on 01-02-2017 & 3-2-2017.
b. Original and valid Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clarification as manufacturer status is not clear on copy of free sale certificate.
3. M/s Cardiac Care, 848-C,Shadman-I, Lahore.
Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th
Way,Arvada, CO, 80004, USA.
Retrograde Cardioplegia Cannula Self Inflating (Perfusion Cannula)
Product codes as per Free Sale Certificate and Form 5-A.
Decontrolled(Different size)
3 years
Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 and 3-2-2017.
Deferred for rectification of following shortcomings after personal hearing of authorized representative:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.
Minutes for 266th Meeting of Registration Board. 63
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clarification as manufacturer status is not clear on copy of Free sale certificate.
4. M/s Cardiac Care, 848-C,Shadman-I, Lahore.
Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th
Way,Arvada, CO, 80004, USA.
One Piece Venous Return Cannula-Non Reinforced (Venous Perfusion Cannula)
Product codes as per Free Sale Certificate and Form 5-A.
Decontrolled(Different sizes)
3 years
Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 and 3-2-2017.
Deferred for rectification of following shortcomings after personal hearing of authorized representative:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory
Minutes for 266th Meeting of Registration Board. 64
authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clarification as manufacturer status is not clear on copy of free sale certificate.
5. M/s Cardiac Care, 848-C,Shadman-I, Lahore.
Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th
Way,Arvada, CO, 80004, USA.
Coronary Artery Perfusion Cannula
Product codes as per Free Sale Certificate and Form 5-A.
Decontrolled
3 years
Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017.
Deferred for rectification of following shortcomings after personal hearing of authorized representative:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clarification as
Minutes for 266th Meeting of Registration Board. 65
manufacturer status is not clear on copy of free sale certificate.
6. M/s Cardiac Care, 848-C, Shadman-I, Lahore.Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th
Way,Arvada, CO, 80004, USA.
Aortic Arch Cannula- Non Reinforced(Aortic Perfusion Cannula)
Product codes as per Free Sale Certificate and Form 5-A.
Decontrolled(Different size)
3 years
Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 & 3-2-2017.
Deferred for rectification of following shortcomings after personal hearing of authorized representative:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clarification as manufacturer status is not clear on copy of free sale certificate.
7. M/s Cardiac Care, 848-C,Shadman-I, Lahore.
Manufactured by
Vessel Cannula With/Without Wing and Valve.
Product
Decontrolled
3 years
Applied on 20-7- 2012Letter of deficiencies issued on 31-10-
Deferred for rectification of following shortcomings after personal hearing of authorized representative:
Minutes for 266th Meeting of Registration Board. 66
M/s Sorin Group USA, Inc, 14401 W. 65th
Way,Arvada, CO, 80004, USA.
codes as per Free Sale Certificate and Form 5-A.
2012Reminders issued on 01-02-2017.
a. Differential fee PKR.35,000/-,
b. Original and valid Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clarification as manufacturer status is not clear on copy of free sale certificate.
8. M/s Cardiac Care, 848-C, Shadman-I, Lahore.Manufactured byM/s Sorin Group USA, Inc, 14401 W. 65th
Way,Arvada, CO, 80004, USA.
Pericardial Sump(Aortic Perfusion Cannula)
Product codes as per Free Sale Certificate and Form 5-A.
Decontrolled(Different size)
3 years
Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 & 3-2-2017.
Deferred for rectification of following shortcomings after personal hearing of authorized representative:
a. Differential fee PKR.35,000/-,
b. Original and valid Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site
Minutes for 266th Meeting of Registration Board. 67
as decided by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clarification as manufacturer status is not clear on copy of free sale certificate.
9. M/s Medica,C-9-C, 24th
Commercial Street-II, Ext-DHA, Karachi.
Manufactured byM/s Sorin Group Italia, Italy.
Stockert Cannula.
Decontrolled
3 years
Applied on 08-05-2012Letter issued on 24.4.2013Reminder issued on 11.07.2013Letter issued on 3rd March, 2015Final reminder given on 2nd
February, 2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory
Minutes for 266th Meeting of Registration Board. 68
authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
CathetersS.#
Name of Importer &
Manufacture/ Exporter.
Name of Medical
Device (s)
Demanded price &
Pack size
Shelf life
Remarks Decision
1. M/s Iqbal & Company,Islamabad.
Manufacturing Site:M/s Renax Medical Co. Ltd, Thailand.
Arrow Catheters (Blood Tubing/Lines Set for Hemodialysis) Single & Double Chamber).
DecontrolledDifferent sizes, gauges, types)
Not clear.
Applied on 22-5-2012Letter of shortcoming issued on 24-4-2013.Reminders issues on 2-3-2015 and 1-2-2017.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clinical Data, if any.
g. Copy Valid Drug Sale License,
h. Specification and analytical methods.
i. Method of manufacturing.
Minutes for 266th Meeting of Registration Board. 69
2. M/s Cardiac Care, 848-C,Shadman-I, Lahore.
Manufactured byM/s Vygon-5 rue Adeline -95440-Ecouen, France.
Umbilical Catheter
Sizes 3FR, 4FR, 5FR, 6FR, 7FR, 8FR
Length: 38cm
Decontrolled
5 years
Applied on 1-1-2013Letter of shortcoming issued on 16-6-2014.Reminder issues on3-2-2017.
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Clinical Data, if any.
3. M/s Cardiac Care, 848-C,Shadman-I, Lahore.
Manufactured byM/s Vygon-5 rue Adeline -95440-Ecouen, France.
Easydrain
(Catheter for Pleural/Thoracis Drainage)
Codes:681.06,681.08, 681.082, 681.10.
Decontrolled
60 months
Applied on 1-1-2013Letter of shortcoming issued on 16-6-2014.Reminder issues on3-2-2017.
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed
Minutes for 266th Meeting of Registration Board. 70
shelf life.d. Orignal
Credentials of manufacture as decided above by Registration Board.
e. Clinical Data, if any.
4. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, Defence Housing Authority, Lahore Cantt.
Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.
Fargo Line (Braided Guiding Catheters)
Codes & sizes as per FSC.
- 5 years
Applied on 21-11-2016Shortcoming letter issued on 20-1-2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clinical Data, if any.
g. Copy Valid Drug Sale License.
5. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, Defence Housing Authority, Lahore Cantt.Manufactured By:
Magic & Baltacci (Flow guided Micro Catheters)
Codes & sizes as per FSC.
- 5 years
Applied on 21-11-2016Shortcoming letter issued on 20.1.2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as 2
products appliedc. Original and valid
Free Sale
Minutes for 266th Meeting of Registration Board. 71
M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.
Certificate as decided above by Registration Board.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. Orignal Credentials of manufacture as decided above by Registration Board.
g. Clinical Data, if any.
h. Copy Valid Drug Sale License,
6. M/s Al-Hamd Enterprises, FL-11/1/1, Block-6, Gulshan-e-Iqbal, Karachi.
Manufactured By:M/s Ribbel Interntional Ltd, 20th Mile, Jatheri Road, P.O.Rai, Haryana, India.
Silky Gold Foley Balloon Catheter
Not mentioned
5 years
Applied on 21-12-2016Letter of shortcoming issued on2-2-2017
Deferred for rectification of following shortcomings:a. Clarification as
address on sole agency agreement is different on Form 5A.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 72
e. Clinical Data, if any.
f. Copy Valid Drug Sale License,
g. Specification and analytical methods.
h. Method of manufacturing.
i. Importability of product from India as per present Import Policy Order.
7. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way,MarlboroughMA, 01752, USA.Manufacturing Site:M/s. TechDevice Corporation, 650 Pleasamt Street, Watertown, MA 02472, USASterilization Site:M/s Boston Scientific Coventry (formally Steris Isomedix) 8 Industrial Drive Coventry, RI-02816, USA.
Rigiflex TM II Single Use Achalasia Balloon Dilator
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
Oneyear
Applied on 23-1-2017Shortcoming letter issued on 02-2-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from legal manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Clinical Data, if any.
8. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal
Hurricane RX Biliary Balloon Dilatation Catheter
Codes &
Decontrolled till policy decision by Policy Board/ Federal Governmen
02months
Applied on 23-1-2017Shortcoming letter issued on 02-2-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as
Minutes for 266th Meeting of Registration Board. 73
Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Business & Technology Park, Model Farm Road, Cork, IrelandSterilization Site:M/s Synergy Health Ireland Ltd, IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
sizes as per FSC.
t decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from legal manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Clinical Data, if any.
f. Clarification as Address on letterof authorization is different than on Form 5-A.
9. M/s. Maxims Medical, 534-H Block, St. No.13, Phase 5, DHA, Lahore.
Manufactured by:M/s MINVASYS, 7 REU DU FOSSE Blanc 92230, France.
Yangtze PTCA Balloon Dilatation Catheter
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 23-1-2017Shortcoming letter issued on2-2-2017.
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to
Minutes for 266th Meeting of Registration Board. 74
support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Clinical Data, if any.
f. Copy Valid Drug Sale License.
10. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, H#No.16, St.#1, F-2, Phase-6, Hayatabad, Peshawar.
Sub-office: Office no.05,2nd
floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany
Trilucath Hemodialysis Catheter-3 Lumen.
Sizes: 12F
Length (cm): 13, 16, 20, 24.
Decontrolled till policy decision by the Policy Board/ Federal Government
5 years
Applied on 2-5-2016Shortcoming Letter issued on 14-12-2016 & 2-2-2017.
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Orignal Credentials of manufacture as decided above by Registration Board.
11. M/s. Universal Enterprises, 29 Block-3 OVCHS Stadium Road,Karachi.
ManufacturerM/s. Haidylena For Advanced Medical Industries, Egypt.
Dual Lumen Catheter Kit
Decontrolled
3 years
Applied on 11-5-2011
Shortcoming letter issued on 12-10-2012.Reminders issued on2-3-2015 &6-10-2016
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as
Address and name of manufacturer not mentioned on Form 5A.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
d. Original and valid authorization letter/sole agency
Minutes for 266th Meeting of Registration Board. 75
agreement from manufacturer as decided above by Registration Board.
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. Orignal Credentials of manufacture as decided above by Registration Board.
g. Clinical Data, if any.
h. Copy Valid Drug Sale License,
i. Specification and analytical methods
j. Method of manufacturing.
12. M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi.
Legal Manufacturer:M/s. Mediquip Son, BHD., Kangar Perlis, Malaysia,
Manufacturer:M/s Mediquip SDN, BHD., Kangar Perlis, Malaysia.
Dover Silicone/Hydrogel Coated Latex Foley Catheter (all types, sizes & accessories)
Decontrolled
5 years
Applied on 16-5-2011
Shortcoming letter issued on8-11-2012Reminders issued on 18-4-2014 & 31.10.2016.
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
e. Copy Valid Drug Sale License,
f. Analytical procedure
Minutes for 266th Meeting of Registration Board. 76
g. Clarification as product applied is silicone or hydrogel coated.
13. M/s. Sakuf Trading,34-G Phase I, Commercial Area, Defence Housing Authority, Lahore Cantt Pakistan.
Manufactured by:M/s BALT EXTRUSION, 10, ru de la Croix Vigneron 95160 MONTMORENCY FRANCE.
Eclipse & Copernic 2L (Double Lumen Occlusion Balloons)
Decontrolled till policy decision by the Federal Government
05 Years
Applied on 21-11-2016Letter for short comings issued on 02-02-2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clinical Data, if any.
g. Copy Valid Drug Sale License
h. Clarification regarding application of 2 products together
14. M/s. Universal Enterprises, 29 Block-3 OVCHS Stadium Road,Karachi.
Manufactured byUnit I:M/s Romsons International,62
Peritoneal Dialysis Catheter Set
Decontrolled
05 years
Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on 2-3-2015Final
Deferred for rectification of following shortcomings:
a. Original and valid Free Sale Certificate as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 77
industrial estate Nunhai, Agra-282006 India.
Unit II:Romsons International Unit II 59jC, Noida Dadri Road, Phase II, Noida-201 301, Uttar Pardesh, India.
Reminder issued on 07-10-2016Reply received on 24-10-2016,
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Clinical Data, if any.
f. Copy Valid Drug Sale License,
g. Specification and analytical methods.
h. Method of manufacturing.
15. M/s. Universal Enterprises, 29 Block-3 OVCHS Stadium Road,Karachi.
Manufacturer:M/s Ameco Medical Industries, Industrial Zone,B4, Plot 119 East, 10th of Ramadan City, Arab Republic of Egypt.
Amecath Catheter Kit
Decontrolled
3 years
Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on 2-3-2015Reply received on 01-04-2015 Final Reminder issued on 26-10-2016
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of
Minutes for 266th Meeting of Registration Board. 78
manufacture as decided above by Registration Board.
e. Copy Valid Drug Sale License,
f. Analytical procedure and outline of method of manufacturing.
16. M/s. Universal Enterprises, 29 Block-3 OVCHS Stadium Road,Karachi
Manufactured byM/s. Ameco Medical Industries, Industrial Zone,B4, Plot 119 East, 10th of Ramadan City, Arab Republic of Egypt..
Amecath Double Lumen Catheter.
Decontrolled
03 years
Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on2-3-2015Final Reminder issued on 07-10-2016Reply received on 24-10-2016, the firm requested for an extension of one month till07-11-2016 for the submission of short comings.
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
e. Copy Valid Drug Sale License,
f. Analytical procedure and outline of method of manufacturing.
17. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, NowsheraKPKLegal Manufacturer:M/s. Boston
Flexima Nasobiliary Catheter with Guidewire
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
03Years
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 79
Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
18. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston
MaxForce TTS High Performance Balloon Dilatation Catheter
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
24 months
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization
Minutes for 266th Meeting of Registration Board. 80
Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Business and Technology Park , Model Form Road, Cork, IrelandSterilization Site:M/s Synergy Health Ireland Ltd, IDA Business and Technology Park, Sragh Tullamore County, Offaly, Ireland.
letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
19. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive
Flexima Nasobiliary Catheter with Jagware Guidewire
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
03Years
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 81
Coventry, RI 02816, USA.
M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.
M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
20. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.
Flexima Nasobiliary Catheter
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
03Years
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 82
M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.
M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
21. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Sites:M/s. Boston Scientific Limited, Business and Technology Park , Model Form Road, Cork, IrelandSterilization Sites:M/s Boston Scientific Corporation. 8 Industrial Drive Coventry, RI 02816, USA.
Extractor TM
Pro Retrieval Balloon Catheter
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
2 Years
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 83
M/s Synergy Health Ireland Ltd, IDA Business and Technology Park, Sragh Tullamore County, Offaly, Irelamabd.
M/s Synergy Health AST, Venlo Faunalaan 38, 5928 RZ Venlo, Netherlands.
STERIS Isomedix Services, 3459 South Clinton Avenue, South Plainfield, New Jersey 07080, USA.
M/s Synergy Health AST, SRL, B13.1, Street 4, Avenue 1, EI Coyol Free Zone, EL Coyol Alajeula 20102, Costa Rica.
22. M/s Hakimsons Pvt. Ltd, (2011) Hakimsons House, A/56, S.I.T.E. Manghopir Road, Karachi.
Manufactured byM/s Pennine Health Care Ltd. City Gate, London Road, Derby De, 24 8WY United Kingdom.
Catheters Nelaton/Suction.
Decontrolled
3 years
Applied on 05-03-2011.Letter Issued on 24-10-2012.Reminder issued on 02-03-2015Reminder issued on 06-10-2016Final Reminder issued on4-2-2017.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Clarification as
many types are applied.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 84
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. Orignal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
23. M/s. Fresenius Medical Care Pakistan (Pvt) Ltd., 137-A, Faisal Town, Lahore.Legal Manufacturer:-M/s. Health Line International Corporation, Centerville, USA.Manufacturing Plant and Asia Office:M/s Health Line International Corporation Nanzhuang, (Foshan), China.(Free Sale China Provided)
HLIC Hemodialysis Catheters
Decontrolled
3 years
12-3-2011Letter issued on26-7-2013Reminder Letter issued 14-11-2016
Approved as per Import Policy for Finished Drugs.
24. M/s. Ali Gohar& Co. (Pvt) Ltd., Karachi. /
Legal Manufacturer:M/s. CovidienIIc Hampshire Sstreet, Mansfield, MA, USA.
Manufacturer:M/s. Mallinckrodt
Endobronchial Suction Catheters/ Tubes and accessoriesProduct Size and codes as per FSC
Decontrolled
05 years
Applied on 24-03-2011Letter issued on 29-03-2011Letter issued on 04-12-2013Letter issued on 18-04-2014Final Reminder
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as
Minutes for 266th Meeting of Registration Board. 85
Medical Cornmaddy, Athlone, Co. Westmeath, Ireland.
issued on 26-10-2016
decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License,
25. M/s Mana& Co,204 New Medicine Market, Near Densohall, Karachi.
Manufactured byM/s SuzhouYudu Medical Co.Ltd, Eastern XinzhuangTown, ChangshuJiangsu, China.
Exported byNingbo Greetmed Medical Instrument Co.Ltd. 18F, Building 1, Wante Center, Ningbo, China.
Medicare Suction Catheter
De-controlled
05years
Applied on 16-8-2011Letter issued on 25-10-2012Reminder issued on 2-3-2015Final Reminder 31-10-2016
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
26. M/s Mana& Co,204 New Medicine Market, Near
Medicare Nelton Catheter.
De-controlled
05 years
Applied on 16-8-2011Letter
Deferred for rectification of following shortcomings:
Minutes for 266th Meeting of Registration Board. 86
Densohall, Karachi.
Manufactured byM/s SuzhouYudu Medical Co.Ltd, Eastern Xinzhuang Town, Changshu Jiangsu, China.
Exported byNingbo Greetmed Medical Instrument Co.Ltd. 18F, Building 1, Wante Center, Ningbo, China
issued on 25.10.2012Reminder issued on 2-3-2015Final Reminder 31.10.2016
a. Differential fee PKR.35,000/-,
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License,
27. M/s Sadqain HealthCare (Pvt) Ltd, Rawalpindi.
Manufactured byM/s Intersurgical Limited Crane House, Molly Millars Lane Wokingham, Berkshire,United Kingdom.
Intersurgical – Paediatric/ Neonatal/Adult Catheter Mount-Patient Connection-3535000-3514000-3508000
De-controlled
Applied on 20-8-2011Letter issued on 24-10-2012Final Reminder 31-10-2016Final reminder 3-2-2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed
Minutes for 266th Meeting of Registration Board. 87
shelf life.e. Orignal
Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
28. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, DHA, Lahore Cantt.Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.
Sonic (Detachtable Tip Braided Microcatheters)
Codes & sizes as per FSC.
Decontrolled till policy decision by the Policy Board/Federal Government
5 years
Applied on 21-11-2016Letter issued 28-12-2016Letter Issued on 01-02-2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License,
29. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, DHA, Lahore Cantt.
Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron
Goldballoon (Detachable Balloon)
Codes & sizes as per FSC.
Decontrolled till policy decision by the Policy Board/Federal Government
5 years
Applied on 21-11-2016Letter issued 28-12-2016Letter Issued on 01-02-2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid
Minutes for 266th Meeting of Registration Board. 88
95160, Montmorency, France.
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
30. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.
Rubicon TM
18 Support Catheter
Product codes and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
37months
Applied on 25-7-2016Letter issued 18-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
31. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons,
Mustang TM
Over The Wire PTA Balloon
Decontrolled till policy decision by Policy
37months
Applied on 25-7-2016Letter
Deferred for rectification of following shortcomings:
Minutes for 266th Meeting of Registration Board. 89
Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.
Dilatation Catheter.
Balloon Dia (mm):3, 4, 5, 6, 7, 8, 9, 10, 12.
Balloon Length (mm):20, 30, 40, 60, 80, 100, 120, 150, 180, 200.
Board/ Federal Government
issued 18-01-2017
a. Original and valid Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
32. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.
Rubicon TM
35 Support Catheter
Product codes and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
37months
Applied on 25-7-2016Letter issued 18-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration
Minutes for 266th Meeting of Registration Board. 90
Board.33. M/s. Ferozsons
Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Business & Technology Park, Model Farm Road, Cork , Ireland.
Renegade Fiber Braided Microcatheter.
Product codes and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
37months
Applied on 25-7-2016Letter issued 18-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
34. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.
Rubicon TM
14 Support Catheter
Product codes and sizes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
37months
Applied on 25-7-2016Letter issued 18-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
Minutes for 266th Meeting of Registration Board. 91
d. Orignal Credentials of manufacture as decided above by Registration Board.
35. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.
Sterling TM 14 Monorail TM
PTA Balloon Dilatation Catheter
Balloon Dia (mm):1.5, 2.0, 2.5,3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6,0, 6.5, 7.0, 8.0.
Balloon Length (mm):10, 15, 20, 30, 40, 60, 100, 150, 200, 220.
Decontrolled till policy decision by Policy Board/ Federal Government
37months
Applied on 25-7-2016Letter issued 18-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
36. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific
Interject Clear/Contrast Injection Therapy Needle Catheter
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
37months
Applied on 24-1-2017
Deferred for rectification of following shortcomings:a. Clarification as
Brand is not as per free sale certificate.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by
Minutes for 266th Meeting of Registration Board. 92
Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.
M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
Registration Board
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
37. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi/Legal Manufacturer:M/s B.Braun Melsungen AG, Caril-Braun-StraBe 1, 34212 Melsungen, Germany.Manufacturing Site:B. Braun Medical Industries Sdn. Bhd, Bayan Lepas Free
Espocan(Set for Combined Spinal and Epidural Anaesthesia)
(Sizes and codes as per Free Sale Certificate)
Decontrolled till policy decision by Policy Board/ Federal Govt.
5 years
Applied on 23-6-2016Letter issued on 01-02-2017
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by
Minutes for 266th Meeting of Registration Board. 93
Industrial Zone 11900 Penang, Malaysia.
Registration Board.
38. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi.
Legal Manufacturer:M/s B.Braun Melsungen AG, Caril-Braun-StraBe 1, 34212 Melsungen, Germany.
Manufacturing Site:B. Braun Medical Industries Sdn. Bhd, Bayan Lepas Free Industrial Zone 11900 Penang, Malaysia.
Pencan Pencan Paed, Spinocan , GuideNeedle & Spinal Introducer.
(Sizes and codes as per Free Sale Certificate)
Decontrolled till policy decision by Policy Board/ Federal Govt.
5 years
Applied on 23-6-2016Letter issued on 01-02-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clarification for Brand name of product applied.
39. M/s. Digital Imaging System,121 habitat, Shadman II , Ghaus-ul-Azam Road,Lahore.
Name of Owner Operator and manufacturing Facility:Volcano Corporation2870 Kilgore rd, Rancho cordova, CA USA 95670
Eagle Eye Paltinum & ST-IVUS Catheter
Decontrolled till policy decision by Policy Board/ Federal Govt.
2 years
Applied on 03-02-2017Letter Issued on 04-02-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Orignal Credentials of manufacture as decided above by Registration Board.
40. M/s. Digital Imaging System,
Traveller RX Coronary Dilatation
Decontrolled till policy decision by
3 years
Applied on 03-02-2017
Deferred for rectification of following
Minutes for 266th Meeting of Registration Board. 94
121 habitat, Shadman II , Ghaus-ul-Azam Road,Lahore
Responsible Manufacturer:M/s Abbott Vascular,3200 Lakeside Drive, Santa Clara, California 95054, USA.Manufacturing Site:M/s Abbott Vascular,26351 Ynez road, temecula, CA 92591, USA.
M/s Abbott Vascular Costa Rica, 52 Calle 3, B31, Coyol Free Zone, El Coyol, Alajuela, Costa Rica(Free Sale Costa Rica)
Catheter Policy Board/ Federal Govt.
Letter Issued on 04-02-2017
shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Orignal Credentials of manufacture as decided above by Registration Board.
c. Analytical procedure and specification.
41. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.
Manufactured byM/s. Marflow AG, Soodstrase 57, CH-8134 Adliswil, Zurich, Switzerland.
Urology Catheters
Decontrolled till policy decision by the Federal Government
5 years
Applied on 26-3-2014Letter issued on 4.8.2014Letter Issued on 02-02-2017
Deferred for rectification of following shortcomings:a. Application on
prescribed Form 5A.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or
Minutes for 266th Meeting of Registration Board. 95
Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License,
42. M/s Life CaresM-20, Falaknaz plaza, Shahra-e-Faisal,Karachi.
Manufactured by:M/s Yilson Medical Technology Co., Ltd, 5/F, Fuxuan, Bldg, 28 East Hepping Road, Longhua, New District, Shenzhen Guangdong, China.
PTCA Ballon Catheter (ADVAN) SC/NC/CTO all sizes
3 years
Applied onLetter Issued on 02-02-2017
Deferred for rectification of following shortcomings:a. Application on
prescribed Form 5A.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
43. M/s Dora Enterprises, 54-B, Model Town, Lahore.
Manufactured by:M/s Giant Medical Equipment
Dora Hemodialysis Catheter Kits
(product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by the Policy Board/ Federal Government
Not mentioned
Applied on 31-10-2016Letter issued on 01-02-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate with clear status as decided above by Registration
Minutes for 266th Meeting of Registration Board. 96
(Guangzhou) Co. Ltd, No.10, Juncheng Road, Eastern Area, Economic & Technical Development, District 510760 Guangzhoy, China.
Board.b. Approval of shelf
life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Clinical Data, if any.
e. Method of manufacturing and QC Testing.
f. Copy Valid Drug Sale License,
44. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Business & Technology Park, Model Farm Road, Cork, IrelandSterilization Site:M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology
CRE Pulmonary Balloon Dilatation Catheter
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
03 years
Applied on 27-1-2017Letter issued on01-02-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 97
park Sragh Tullamore Co. Offaly, Ireland.
45. M/s F.W Distributors, F.W Building, Opp Poonch House, Adamjee Road, Rawalpindi.
Legal Manufacturer:M/s Coloplast A/S, Holtedam 1, 3050Humlebaek, Denmark.
Supraflow Suprapubic Catheter
(product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by the Policy Board/ Federal Government
Not mentioned
Applied on 27-10-2016Letter issued on 01.2.2017
Deferred for rectification of following shortcomings:a. Copy Valid Drug
Sale License,b. Clinical Data, if
any.
46. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area,Defence Housing Authority, Lahore Cantt.Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.
Vasco + (Braided Micro Catheters)
Codes & sizes as per FSC.
- 5 years
Applied on 07-12-2016Letter issued on 01-02-2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
B) Stents:
S. Name of Name of Demanded Shelf Date of Decision
Minutes for 266th Meeting of Registration Board. 98
# Importer and Manufacture/
Exporter.
Medical Device (s)
price & Pack size
life application / Letter issuance
date1. M/s. Sakuf
Trading,34-G Phase I, Commercial Area, Defence Housing Authority, Lahore Cantt Pakistan.Manufactured by:M/s BALT EXTRUSION, 10, ru de la Croix Vigneron 95160 MONTMORENCY FRANCE.
LEO+ / LEO + Baby Intracranial Stents
Decontrolled till policy decision by the Federal Govt.
05 Years
Applied on 21.11.2016Letter for short comings issued on 02.02.2017
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
g. Clarification regarding application of 2 products together
2. M/s. Sakuf Trading,34-G Phase I, Commercial Area, Defence Housing Authority, Lahore Cantt.
Manufactured by:M/s BALT EXTRUSION,
Silk + (Intracranial Self Expandable Stents)
Decontrolled till policy decision by the Federal Government
05 Years
Applied on 21-11-2016Letter of short comings issued on 02-02-2017
Deferred for rectification of following shortcomings:
a. Differential fee PKR.35,000/-,
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid
Minutes for 266th Meeting of Registration Board. 99
10, ru de la Croix Vigneron 95160 MONTMORENCY FRANCE.
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License.
3. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.
M/s Synergy
Flexima Biliary Stent with Delivery System
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
3Years
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 100
Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.
M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
4. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.
M/s Synergy
C-Flex Double Pigtail Biliary Stent
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
03 Years
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 101
Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.
M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
5. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.Sterilization Site:M/s Synergy Health Wesport Ltd., Lodge Road, Westport Co Mayo, Ireland.
Wallstent Biliary Endoscopic Biliary Endoprosthesis (Uncovered)
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
24months
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
6. M/s. Ferozsons Laboratories Limited, P.O.
Wallstent Enteral Endoprosthes
Decontrolled till policy decision by
02Years
Applied on 24-1-2017
Deferred for rectification of following
Minutes for 266th Meeting of Registration Board. 102
Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.Sterilization Site:M/s Synergy Health Ireland Ltd., (Isotron), IDA Business & Technology Park Co. Offaly, Ireland.
is with Unistep Plus Delivery System (Colonic and Duodenal)
Codes & sizes as per FSC.
Policy Board/ Federal Government
Letter of shortcomings issued on01.01.2017
shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
7. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization
Biliary Stent Introducer
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
03Years
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal
Minutes for 266th Meeting of Registration Board. 103
Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.
M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.
M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
Credentials of manufacture as decided above by Registration Board.
8. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:
RX Biliary Stent with RX Delivery System
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
03Years
Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of
Minutes for 266th Meeting of Registration Board. 104
M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.
M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.
manufacture as decided above by Registration Board.
9. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.
Advanix Biliary Stent with NaviFlex RX Delivery SystemPre-loaded center bend.
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
1’s
2 Years
Applied on 24-1-2017Letter issued on 01-2-2017.
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by
Minutes for 266th Meeting of Registration Board. 105
Registration Board.
10. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific Corporation, two scimed place MAPLE GROVE, MN USA 55311
Epic TM Over The Wire Self- Expanding Nitinol Stent with Delivery System
Product codes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
37 months
Applied on 15-07-2016Letter Issued on 01-02-2017.
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .
c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
d. Orignal Credentials of manufacture as decided above by Registration Board.
11. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.
Manufactured by:M/s. Marflow AG, Soodstrase 57, CH-8134 Adliswil, Zurich, Switzerland.
Urology Stents
Decontrolled till policy decision by the Federal Government
5 years
Applied on 26-3-2014Letter Issued on 04-08-2014 and 02-02-2017.Previously registered in the name of \M/s Burraq International, Lahore in 231st
meeting. Now deregistered.
Deferred for rectification of following shortcomings:a. Original and valid
Free Sale Certificate as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board
c. Approval of shelf life from regulatory authority or Stability data to support claimed
Minutes for 266th Meeting of Registration Board. 106
shelf life.d. Orignal
Credentials of manufacture as decided above by Registration Board.
e. Copy Valid Drug Sale License,
12. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.Sterilization Site:M/s Synergy Health (Tullamore), IDA Business & Technology Park, Tullamore County Offaly, Ireland.
Wallstent-Uni TM
Endoprosthesis Self Expanding Stent
Product codes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
25months
Applied on 25-7-2016Letter issued 18-01-2017
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
13. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi/Legal Manufacturer:M/s B.Braun Melsungen AG, Caril-Braun-
Coroflex Blue Neo Coronary Stent System(Sizes and codes as per Free Sale Certificate)
Decontrolled till policy decision by Policy Board/ Federal Govt.
2 years
Approved as per Import Policy for Finished Drugs.
Minutes for 266th Meeting of Registration Board. 107
StraBe 1, 34212 Melsungen, Germany.Manufacturing Site:M/s B.Braun Melsungen AG Vascular System Sieversufer 8, 12359 Berlin, Germany.
14. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, Ballybrit Business Park, Galway, Ireland.
Wallgraft TM
Over The Wire Endoprosthesis with Unistep TM
Plus Delivery System
Decontrolled till policy decision by Policy Board/ Federal Government
30months
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
15. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific
Express TM Vascular SD Monorail TM Premounted Stent System
Product codes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
37 months
Applied on 15-7-2016Letter issued on 01.02.2017
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
Minutes for 266th Meeting of Registration Board. 108
Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.Sterilization Site:M/s BSC Coventry, 8 Industrial Drive Coventry, RI 02816, USA.
c. Orignal Credentials of manufacture as decided above by Registration Board.
16. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific Corporation, BAllybrit Business Park, Galway, Ireland.Sterilization Site:M/s Synergy Health Ireland Limited (Tullamore) IDA Business & Technology Park, Tullamore,Co, Offaly, Ireland., RI 02816, USA.
Express TM LD Vascular Over The Wire Premounted Stent System
Product codes as per Free Sale Certificate.
Decontrolled till policy decision by Policy Board/ Federal Government
37 months
Applied on 15-7-2016Letter issued on 01.02.2017
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
17. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s Boston
Ultraflex TM Esophageal NG Stent System
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
02Months
Applied on 15-7-2016Letter issued on 01.02.2017
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as
Minutes for 266th Meeting of Registration Board. 109
Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.
decided above by Registration Board.
b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
c. Orignal Credentials of manufacture as decided above by Registration Board.
18. M/s F.W Distributors, F.W Building, Opp Poonch House, Adamjee Road, Rawalpindi.Legal ManufacturerM/s Coloplast A/S, Holtedam 1, 3050Humlebaek, Denmark.
Biosoft Duo Multi Length Hydro-Coated Urethral Stent Kit Kits (Long Term)
(product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by the Policy Board/ Federal Government
Not mentioned
Applied on 27.10.2016Letter issued on 01-2-2017
Deferred for rectification of following shortcomings:a. Approval of shelf
life from regulatory authority or Stability data to support claimed shelf life.
b. Copy of valid drug sale licence.
19. M/s. Maxims Medical, 534-H Block, St. No.13, Phase 5, DHA, Lahore.Manufactured by:M/s Eurocor GmbH In den Dauen 6a 53117 Bonn Germany.
E Magic PlusDrug Eluting Stent
Codes & sizes as per FSC.
Decontrolled till policy decision by Policy Board/ Federal Government
3 years
Applied on 27-1-2017Letter issued on 01.2.2017Following deficiencies are required:
Deferred for rectification of following shortcomings:a. Application on
Form 5A duly signed and stamped.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to
Minutes for 266th Meeting of Registration Board. 110
support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Valid drug sale licence.
20. M/s F.W Distributors, F.W Building, Opp Poonch House, Adamjee Road, Rawalpindi.Legal ManufacturerM/s Coloplast A/S, Holtedam 1, 3050Humlebaek, Denmark.
Double Loop Urethral Stent in PA OR PU (Short Term)
(product codes and sizes as per Free Sale Certificate)
Decontrolled till policy decision by the Policy Board/ Federal Government
Not mentioned
Applied on 27.10.2016Letter issued on 01.2.2017
Deferred for rectification of following shortcomings:a. Application on
Form 5A duly signed and stamped.
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Valid drug sale licence.
g. Clinical data, if any.
Minutes for 266th Meeting of Registration Board. 111
Item No.III: Pharmacy Services Division.
Case No 01: Prevailing capacities of approved Bio-Equivalence study centers in Pakistan
Registration Board in its 265th Meeting held on 24th and 25th January 2017 vide Case
No 04 advised Pharmacy Services Division to present prevailing capacities of approved Bio-
Equivalence Study Centers in Pakistan. Requisite data has been acquired and is asunder:
Sr. No.
Name of centers
Capacity to
conduct studies/
year
Anticipated time to complete one study Operational
Labs
Bed / volunteer capacity
CertificationsSingle Drug
Compound Drug
1
Dr. Panjwani Center for Molecular Medicine and Drug Research, Karachi
5003
Months
04 Months
Microbiological Lab
Analytical LabComputer lab
100
i. ISO 17025: 2005
ii. ISO 9001: 2008
iii. GCP vendor Assessment Certificate by Abbott
2
Pharma Professional Services. Karachi
1203-04 Month
s
03-04 Months
Microbiological Lab
Analytical LabComputer lab
30
Pre-assessment for the ISO–17025 accreditation; by Pakistan National Accreditation Council (PNAC)
3 BeSt Centre, UVAS, Lahore 04
03-04 Month
s
04-05 Months
Microbiological Lab
Analytical LabComputer lab
30 ISO 17025
4
Institute of Biological Biochemical & Pharmaceutical Sciences, Dow University, Karachi
1603-04 Month
s
03-04 Months
Microbiological Lab
Analytical LabComputer lab
28 ISO 17025:2005
5
Pakistan Drug Testing and Research Center, Lahore
1503
Months
03 Months
Microbiological Lab
Analytical LabComputer lab
24
i. ISO 1702-2005 by PNAC
ii. MoU with USP, USA
It has been prayed earlier that the condition of Bioavailability / Bioequivalence studies be
made mandatory to establish interchangeability for multisource generics as per
recommendations of the Drug Registration board according to Biopharmaceutical
classification system (BCS).
Minutes for 266th Meeting of Registration Board. 112
Decision: Registration Board deliberated the case in detail that in order to make mandatory conditions of Bio-equivalence/Bioavailability studies of registered drug in accordance with the Biopharmaceuticals Classification System (BCS) as per WHO guideline to establish the interchangeability and to ensure the safety, efficacy and quality of marketed drugs. Registration Board advised Pharmacy Services Division to hold a consultative meeting (after consultation from DRAP) of all stakeholders including approved Bio-equivalence centers to further deliberate future course of action.
Case No. 02 Drug Safety Package Inserts/ Prescribing Information updates of Hepatitis-C Antivirals.
The MHLW and the PMDA (Japan) in May 2016 have announced that the package
insert for various Hepatitis C antivirals (telaprevir, simeprevir sodium, daclatasvir,
asunaprevir, vaniprevir, sofosbuvir, ledipasvir acetonate/ sofosbuvir and ombitasvir) will be
updated to include precautions for use in patients currently infected or with a history of
Hepatitis B Virus infection. Cases of reactivation of Hepatitis B reported with simeprevir,
daclatasvir, asunaprevir, sofosbuvir, and ledipasvir acetonate/sofosbuvir have occurred in
Japan as well as other cases outside Japan.
The Food and Drug Administration (FDA) in October 2016 has advised that a boxed
warning about the risk of Hepatitis B Virus (HBV) reactivation is added to the drug labels of
Direct-Acting Antivirals (DAAs) which are being used to treat chronic Hepatitis C virus
(HCV) infection. HBV reactivation was not reported as an adverse event in the clinical trials
submitted for the DAA approvals because patients with HBV co-infection were excluded
from the trials.
In this regard all those licensee, manufacturing direct-acting antivirals for Hepatitis C
may be advised to:
1. Update the package inserts/ prescribing information to include risk of Hepatitis B Virus (HBV) reactivation and create box warnings as under:
2. PE & R Division (DRAP) may ensure implementation of package inserts/ prescribing information’s update under intimation to Pharmacy Services Division.
Decision: Registration Board deliberated the case and decided as follows;a. Following shall be added to the warnings and precaution section of the
package inserts of all direct acting anti-viral for hepatitis C, including Ledipasvir, Daclatasvir, Ledipasvir-Sofosbuvir, Simeprevir, and Sofosbuvir etc by the concern Registration holder and intimate the package inserts update to the PE & R divisions of the Drug Regulatory Authority of Pakisatan.
Minutes for 266th Meeting of Registration Board. 113
PRECAUTIONS FOR USE IN PATIENTS CURRENTLY INFECTED OR HAVE A HISTORY OF HEPATITIS-B VIRUS (HBV), BECAUSE
OF REACTIVATION OF HEPATITIS-B VIRUS
Section of Package Inserts to be Updated
Update Information
Warnings & PrecautionsRisk Of Hepatitis B Virus Reactivations.Risk of hepatitis B virus (HBV) reactivation might occur in patients who have a current or previous infection with HBV and are treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus like Ledipasvir, Daclatasvir, Simeprevir, and Sofosbuvir etc. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up
b. All the Registration holder of direct acting anti-viral for hepatitis C shall create a boxed warnings in the package inserts to warn the health care professional, about the risk of hepatitis B virus (HBV) reactivation as under:-
WARNINGS: RISK OF HEPATITIS B VIRUS (HBV) REACTIVATION Direct acting anti-viral like Ledipasvir, Daclatasvir, Simeprevir, and
Sofosbuvir etc have been associated with hepatitis B virus (HBV) reactivation in patients who have a current or previous infection with HBV and are treated with certain Direct-Acting Antiviral (DAA) medicines for hepatitis C virus.Health Care Professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients through blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up.
Case No.03: Drug safety package inserts/ prescribing information updates of the drug oral Ketoconazole
USFDA in 2013 took several actions related to Ketoconazole (Nizoral®) oral tablets,
including limiting the drug’s use by warning that it can cause severe liver injuries, which
may potentially result in liver transplantation or death and adrenal insufficiency by
decreasing the body’s production of corticosteroids. The FDA approved label changes and
added a new Medication Guide to address these safety issues including a strong
recommendation against its use (contraindication) in patients with liver disease, and new
recommendations for assessing and monitoring patients for liver toxicity. As a result,
Ketoconazole oral tablets should not be a first-line treatment for any fungal infection.
Ketoconazole should be used for the treatment of certain fungal infections, known as
endemic mycoses, only when alternative antifungal therapies are not available or tolerated.
Minutes for 266th Meeting of Registration Board. 114
According to the FDA, the topical formulations of Ketoconazole have not been associated
with liver damage, adrenal problems, or drug interactions.
On 25 July 2013, the European Medicines Agency’s Committee (EMA) on Medicinal
Products for Human Use (CHMP) recommended that the marketing authorizations of oral
Ketoconazole-containing medicines should be suspended throughout the European Union
(EU). The CHMP concluded that the risk of liver injury is greater than the benefits in treating
fungal infections. The CHMP concluded that, although liver injury such as Hepatitis is a
known side effect of antifungal medicines, the incidence and the seriousness of liver injury
with oral Ketoconazole were higher than with other antifungals. The CHMP was concerned
that reports of liver injury occurred early after starting treatment with recommended doses,
and it was not possible to identify measures to adequately reduce this risk. The Committee
also concluded that the clinical benefit of oral Ketoconazole is uncertain as data on its
effectiveness are limited and do not meet current standards, and alternative treatments are
available. Taking into account the increased rate of liver injury and the availability of
alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the
risks. Topical formulations of Ketoconazole (such as creams, ointments and shampoos) can
continue to be used as the amount of Ketoconazole absorbed throughout the body is very low
with these formulations. Ketoconazole is an antifungal medicine used to treat infections
caused by dermatophytes and yeasts. The committee approved Ketoconazole HRAa medicine
used to treat adults and children above the age of 12 years with a rare disease of Cushing’s
syndrome because of its greater benefit then risks.
Health Canada in June 2013 has revised to the Product Monograph (PM) regarding
the risk of potentially fatal liver toxicity. Ketoconazole has been associated with rare cases of
serious hepatotoxicity including liver failure and death. The Warnings’ sections of the PM
was updated to include the following additional instructions:
Ketoconazole tablets are indicated for the treatment of serious or life threatening systemic fungal infections and should not be considered for mild to moderate infections.
Oral Ketoconazole has been associated with hepatic toxicity, including cases with fatal outcomes.
Liver function tests should be performed in all patients before starting treatment, at week 2 and 4, and monthly thereafter.
Treatment should be stopped if liver parameters are elevated (> 3 times the normal limit) or if patients develop clinical signs or symptoms consistent with liver disease such as anorexia, nausea, vomiting, jaundice, fatigue, abdominal pain, dark urine, or pale stools.
Minutes for 266th Meeting of Registration Board. 115
In this regard all those licensee, manufacturing oral Ketoconazole may be advised to:
1. Update the package inserts/ prescribing information to include the risk of liver injury hepatotoxicity including liver failure and death and create warnings.
2. Create warnings to restrict the use of oral Ketoconazole for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.
3. To add a strong recommendation against its use (contraindication) in patients with liver disease, and new recommendations for assessing and monitoring patients for liver toxicity.
4. With the approval of Drug Registration Board restricting the use of oral Ketoconazole to be used only in the rare disease of Cushing’s syndrome, removing of all its other indications.
5. PE & R Division (DRAP) may ensure implementation of package inserts/prescribing information update under intimation to Pharmacy Services Division.
Decision: Registration Board deliberated the case and decided that a show-cause notice will be served by the concerned registration section to those firms having registration of oral Ketoconazole in Pakistan.
Minutes for 266th Meeting of Registration Board. 116
Item No. IV: Pharmaceutical Evaluation & Registration Division.
Items Cases No. of Cases
Item No. 1 Deferred cases 8
Item No. 2 Applications with differential fee submitted up to September, 2015 84
Item No. 3 Anomaly applications which were not included in list I 3
Item No. 4 Applications of new licenses / new sections 34
Item No. 5 Stability Cases 4
Item No. 6 Verification of authenticity of stability study 1
Item No. 7 Import cases 14
Item No. 8 Miscellaneous Cases 2
Total 150
Minutes for 266th Meeting of Registration Board. 117
Case No. 01: Deferred casesSr.#
Name and address of
manufacturer / Applicant
Brand Name(Proprietary
name + Dosage Form + Strength)
CompositionPharmacologic
al GroupFinished product
Specification
Type of Form
Initial date, diaryFee
including differential
feeDemanded Price / Pack
size
Remarks on the
formulation (if any)
including International
status in stringent
drug regulatory agencies /
authoritiesMe-too status
GMP status as depicted
in latest inspection
report (with date) by the Evaluator
Previous
Remarks of the Evaluat
or.
Decision
1. M/s AmaanPharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones) No.F.1-6/2013-Lic dated 2nd
March, 2015
Kamelone-25InjectionEach ml contains:NandroloneDecanoate(USP)….25mgAnabolic Steroid(USP)
Form 5Dy.No: 1446Date:06.3.2015Rs.20000/- Rs.60/-Pack of 1×1ml ampoule
Not providedDeca-durabolinInjection (OBSPharma)
249th Meeting Registration Board held on 18-19th May, 2015.Deferred for following:1. Confirmation of formulation in reference drug agencies.2. Clarification from Licensing regarding requirement for manufacturing facility of anabolic steroidal hormones.N.B: (Requirments of LiquidParticle Counter shall be observed as per decision of Registration Board) Division
Evaluation By PEC Firm has provided copy of letter issued by Secretary CLB, dated 02-03-2015, stating
the approval for grant of DML by way of formulation for following sections:i. Liquid Injectable Ampoule (General)
ii. Liquid Injectable Ampoule (Hormone)iii. Liquid Injectable Ampoule (Steroid)
Firm has provided Copy of GMP inspection report conducted on 18-10-2016, confirming the availability of Liquid particle counter
Firm has not provided any evidence of approval by reference regulatory authorities for applied formulation
Minutes for 266th Meeting of Registration Board. 118
Decision: Registration Board deferred the case for evidence of approval by reference regulatory authorities.
2. M/s AmaanPharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones) No.F.1-6/2013-Lic dated 2nd
March, 2015
Kamelone-50InjectionEach ml contains:NandroloneDecanoate(USP)….50mgAnabolic Steroid(USP)
Form 5Dy.No: 1467Dated:06-03-2015Rs. 20,000/-Rs.60/-Pack of 1×1ml ampoule
BNF: Deca-Durabolin(MSD)Deca-durabolinInjection (OBSPharma)
249th Meeting Registration Board held on 18-19th May, 2015.Deferred for Clarification from Licensing regarding requirement formanufacturing facility of anabolic steroidal hormones.N.B: (Requirments of Liquid Particle Counter shall beobserved as per decision ofRegistration Board) Division
Evaluation By PEC Firm has provided copy of letter issued by Secretary CLB, dated 02-03-2015, stating
the approval for grant of DML by way of formulation for following sections:i. Liquid Injectable Ampoule (General)
ii. Liquid Injectable Ampoule (Hormone)iii. Liquid Injectable Ampoule (Steroid)
Firm has provided Copy of GMP inspection report conducted on 18-10-2016, confirming the availability of Liquid particle counter
Decision: Approved3. M/s Amaan
Pharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones) No.F.1-6/2013-Lic dated 2nd
March, 2015
Apelone InjectionEach ml contains:NandrolonePhenpropionate (USP) ….25mgAnabolic Steroid(USP)
Form 5Dy.No: 1463Dated:06-03-2015Rs. 20000/-Rs. 130/-Packof 1ml ×3 ampoule
Not providedDurabolinInjection(OBS)
249th Meeting Registration Board held on 18-19th May, 2015.Deferred for following:1. Confirmation offormulation in reference drug agencies.2. Clarification from Licensing regarding requirement formanufacturing facility of anabolic steroidal hormones.N.B: (Requirments of Liquid Particle Counter shall be observed as per decision ofRegistration
Minutes for 266th Meeting of Registration Board. 119
Board) DivisionEvaluation By PEC
Firm has provided copy of letter issued by Secretary CLB, dated 02-03-2015, stating the approval for grant of DML by way of formulation for following sections:
i. Liquid Injectable Ampoule (General)ii. Liquid Injectable Ampoule (Hormone)
iii. Liquid Injectable Ampoule (Steroid) Firm has provided Copy of GMP inspection report conducted on 18-10-2016,
confirming the availability of Liquid particle counter Firm has not provided any evidence of approval by reference regulatory authorities for
applied formulationDecision: Registration Board deferred the case for evidence of approval by reference regulatory authorities.
4. M/s AmaanPharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones) No.F.1-6/2013- Lic dated 2nd
March, 2015
Jaberone InjectionEach ml contains:TestosteroneEnanthate(USP)…250mgAndrogen / SexHormone(USP)
Form 5Dy.No: 1464Dated: 06-03-2015Rs. 20000/-Rs.275/-Packof1ml ×3ampoule
BNF:TestosteroneEnantate (Nonproprietary)TestovironeInjection(Bayer)
249th Meeting Registration Board held on 18-19th May, 2015.Deferred for clarification from Licensing regarding requirement formanufacturing facility of anabolic steroidal hormones.N.B: (Requirements of Liquid Particle Counter shall be observed as per decision of Registration Board) Division
Evaluation By PEC Firm has provided copy of letter issued by Secretary CLB, dated 02-03-2015, stating
the approval for grant of DML by way of formulation for following sections:i. Liquid Injectable Ampoule (General)
ii. Liquid Injectable Ampoule (Hormone)iii. Liquid Injectable Ampoule (Steroid)
Firm has provided Copy of GMP inspection report conducted on 18-10-2016, confirming the availability of Liquid particle counter
Decision: Approved5. M/s Amaan
Pharma 30km,SheikhupuraRoad Lahore.DML No.000808 dated:25-02-15LiquidInjectionAmpoule(Hormones)
Testerone-100InjectionEach ml contains:Testosteronepropionate(B.P)…30mgTestosteronephenylpropionate(B.P)…60mgTestosteroneIsocaproate(B.P)…60mg
Form 5Dy.No: 1470Dated:06-03-2015Rs. 20000/-Rs. 210/-PackOf 1ml ×3ampoule
BNF: Sustanon250 (MSD)Sustanon (OBS)
249th Meeting Registration Board held on 18-19th May, 2015.Deferred for clarification from Licensing regarding requirement formanufacturing facility of anabolic steroidal hormones.N.B:
Minutes for 266th Meeting of Registration Board. 120
No.F.1-6/2013-Lic dated 2nd
March, 2015
TestosteroneDecanoate(B.P)…100mg(Androgen / SexHormone)
(Requirements of LiquidParticle Counter shall be observed as per decision ofRegistration Board) Division
Evaluation By PEC Firm has provided copy of letter issued by Secretary CLB, dated 02-03-2015, stating
the approval for grant of DML by way of formulation for following sections:i. Liquid Injectable Ampoule (General)
ii. Liquid Injectable Ampoule (Hormone)iii. Liquid Injectable Ampoule (Steroid)
Firm has provided Copy of GMP inspection report conducted on 18-10-2016, confirming the availability of Liquid particle counter
Decision: Approved with Innovator’s specs6. M/s Epharm
Labs, Karachi
Iropharm SyrupEach 5ml contains:-Iron Polymaltose Complex eq. to elemental Iron ……..50mg(Anti anaemic)
Form-529-11-2010Dy No. 767Rs.8000/-Rs.12,000/-04-8-201460mlRs.90.00
Not provided.Rubifer syrup by AGPInspection date 12-04-2011
263rd Meeting Registration Board held on 29-30th November, 2016Deferred for evidence of approval in reference regulatory authorities
Evaluation By PECFollowing reference stated by firm has been verified:“Maltofer syrup by M/s Aspen Pharma, approved by TGA-AustraliaDecision: Approved with Innovator’s specs
7. M/s Epharm Labs, Karachi
Ceftin Injection 250mgEach ml contains:-Cefuroxime as Sodium …..250mg(Antibiotics)Cephalosporin
Form-529-11-2010Dy. No. 2043Rs.8,000/-Rs.12,000/-04-8-201414‘sAs per SRO
Zinacef-MHRADaycef by Shrooq PharmaLast inspection report15-09-2016GMP status is good.
263rd Meeting Registration Board held on 29-30th November, 2016Deferred for clarification of composition as “Each ml contains”
Evaluation By PECFirm has stated that we have applied with following composition:
Ceftin Injection 250mgEach vial contains:-Cefuroxime as Sodium…..250mg
USP monograph for applied formulation is availableDecision: Approved with USP specs
8. M/s Epharm Labs, Karachi
Ceftin Injection 750mgEach ml contains:-Cefuroxime as Sodium …….750mg
Form-529-11-2010Dy No.2042Rs.8000/-Rs.12,000/-04-8-2014N/A
Zinacef by GSK-MHRAZinacef by GSKZecef by BoschLast
263rd Meeting Registration Board held on 29-30th November, 2016
Deferred for clarification of
Minutes for 266th Meeting of Registration Board. 121
(Antibiotics)CephalosporinU.S.P. Specs
N/A inspection report15-09-2016GMP status is good.
composition as “Each ml contains”
Evaluation By PECFirm has stated that we have applied with following composition:
Ceftin Injection 750mgEach vial contains:-Cefuroxime as Sodium…..750mg
USP monograph for applied formulation is availableDecision: Approved with USP specs
Minutes for 266th Meeting of Registration Board. 122
Case No.02: Applications with differential fee submitted up to September, 2015Sr. #
Name and address of manufactu
rer / Applicant
Brand Name(Proprietary
name + Dosage Form + Strength)
CompositionPharmacologi
cal GroupFinished product
Specification
Type of Form
Initial date,diaryFee
including differential
fee
Demanded Price /
Pack size
Remarks on the
formulation (if any)
including International
status in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as depicted in
latest inspection
report (with date) by the Evaluator
Remarks of the
Evaluator.
Decision
1. M/s Pakheim International Pharma LahoreContract manufactured byM/s. Friends Pharma Lahore
Ceftiheim 1000mg Injection
Each vial contains:-Ceftriaxone as sodium USP ….1000mg
Cephalosporin
USP Specs
Form 59-8-2010Dy. No. 74628000/-+42000/-19-8-2014As per SRO
Ceftriaxone (IM/IV) by Lupin(USFDA Approved)
Rocephin by Roche
Last inspection report (Friends Pharma)6-10-2016Firm was operating at good level of compliance.
Firm has initial agreement with Synchro Pharma. Now he wants to make agreement with Friends pharma. Agreement Letter is attached.
Firm has Injection (Dry powder Cephalosporin) Section.
Approved
2. M/s Healthtek (Pvt) Ltd.Plot No. 14, Sector 19, Korangi Industrial AreaKarachi
Cefpi 2g InjectionEach vial contains:-Sterile Powder Cefpirome Sulphate MS eq. to Cefpirome …..…2g
(Cephalosporin Antibiotic)
Form-5Duplicate27-12-2010
Rs.8,000/-27-12-2010+Rs.12,000/-18-11-2014
1’s ampouleAs per SRO
Cefrom 2g/20ml by Sanofi Aventis(ANSM France)
Vcef by Bosch
Last inspection report24-5-2016 confirms that overallGMP is good.
Me-too status could not be confirmed
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Deferred for evidence of me-too status
3. M/s Healthtek (Pvt) Ltd.
Slate MR 375mg TabletsEach modified
Form-5Duplicate12-10-2010
Alfatil LP 375mg film coated SR
Approved
Minutes for 266th Meeting of Registration Board. 123
Plot No. 14, Sector 19, Korangi Industrial AreaKarachi
release film coated tablet contains:-Cefaclor Monohydrate eq. to Cefaclor ………375mg
(Cephalosporin Antibiotics)
USP Specs
Rs.8000/-12-10-2010+Rs.12,000/-18-11-20148’sAs per PAC
tablets by Pharmaceuticals Dexo SA(ANSM Approved)
Ceclor MR 375 mg tab by AGP
Last inspection report24-5-2016 confirms that overallGMP is good.
4. M/s Healthtek (Pvt) Ltd.Plot No. 14, Sector 19, Korangi Industrial AreaKarachi
Slate MR 500mg TabletEach modified release film coated tablet contains:-Cefaclor Monohydrate USP eq. to Cefaclor ……..500mg
(Cephalosporin Antibiotic)USP Specs
Form-5Duplicate30-11-2010
Rs.8000/-30-10-2010+Rs.12,000/-18-11-2014
10’sRs. 475.00
Alfatil LP 500mg film coated SR tablets by Pharmaceuticals Dexo SA(ANSM Approved)
Ceclor MR 500mg tab by AGP
Last inspection report24-5-2016 confirms that overallGMP is good.
Approved
5. M/s Healthtek (Pvt) Ltd.Plot No. 14, Sector 19, Korangi Industrial AreaKarachi
Slate MR 750mg Tablets
Each modified release film coated tablet contains:-Cefaclor Monohydrate eq. to Cefaclor …………750mg
(Cephalosporin Antibiotics)
USP Specs
Form-5Duplicate29-10-2010
Rs.8000/-29-10-2010+Rs.12,000/-18-11-2014
8’sAs per PAC
Alfatil LP 750mg film coated SR tablets by Pharmaceuticals Dexo SA(ANSM Approved)
Ceclor MR 750mg tab by AGP
Last inspection report 24-5-2016 confirms that overallGMP is good.
Approved
6. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial
Rosuvas-10 Tablets
Each film coated tablet contains:-
Form 516-08-2012Dy. No. 771
Rs.8000/-15-8-2012
Crestor 10mg tablets by AstraZaneca(MHRA Approved)
Firm has claimed Mfg. Specs and the product is not present in available
Approved with innovator’s specs
Minutes for 266th Meeting of Registration Board. 124
Estate, HayatabadPeshawar, Pakistan
Rosuvastatin ……10mg
(Hypolipidaemics)
+Rs.12,000/-17-07-2014
1x10’sAs Per SRO
Rovista by Getz Pharma
Last inspection report 03-08-2016Stated grant of additional section and renewal of DML.
versions of BP and USP (B.P 2013 and USP 39)
7. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Macrotac 250mg Tablets
Each film coated tablet contains:-Azithromycin dihydrate equivalent to Azithromycin …250mg
(Macrolide)
USP Specs
Form 5.Dy No. 78715-8-2012Rs.8000/-15-8-2012
+Rs.12,000/-17-07-2014
1x10’sAs Per SRO
Azithromycin 250mg Tablet by Sandoz(MHRA Approved)Azomax tab by Novartis
Last inspection report03-08-2016Stated grant of additional section and renewal of DML
Approved
8. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Macrotac 500mg Tablets
Each film coated tablet contains:-Azithromycin dihydrate equivalent to Azithromycin ….…500mg(Macrolide Antibiotic)USP Specs
Form 516-08-2012Dy No. 774
Rs.8000/- 15-8-2012+12,000/-17-07-2014
1x10’sAs Per SRO
Azithromycin 500mg Tablets by Sandoz(MHRA Approved)
Azomax tab by Novartis
Last inspection report03-08-2016Grant of renewal of DML.
Approved
9. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Droxil 250mg Dry Suspension
Each 5ml contains:-Cefadroxil ……….250mg
(Cephalosporin)
USP Specs
Form 520-01-2011Dy No. 172
Rs.8000/-20-1-2011+Rs.12,000/-17-07-2014
60mlAs Per SRO
Cefadroxil 250mg suspension(MHRA Approved)
Evacef by Highnoon
Last inspection report 03-08-2016Stated grant of additional section & renewal of DML
Approved
Minutes for 266th Meeting of Registration Board. 125
10. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Droxil 500mg Capsules
Each capsule contains:-Cefadroxil………….500mg
(Cephalosporin)
USP Specs
Form 520-01-2011Dy No. 171
Rs.8000/-20-1-2011+Rs.12,000/-17-07-2014
2x6’sAs Per SRO
Cefadroxil 500mg Capsule by Sandoz(MHRA Approved)
Cedrox by Platinum
Last inspection report 03-08-2016Stated grant of additional section and renewal of DML
Approved
11. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Flurbisad Tablets 100mg
Each tablet contains:-Flurbiprofen ……….100mg
(Analgesic NSAID)
USP Specs
Form 516-08-2012Dy No. 783
Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014
1x10’s2x10’s3x10’sAs Per SRO
Froben by Mylan(MHRA Approved)
ANSAID Tablet by PfizerLast inspection report03-08-2016Stated grant of additional section and renewal of DML
Approved
12. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Fungitab Tablets 200mg
Each tablet contains:-Ketoconazole…………200mg
(Antifungal agent)
USP Specs
Form 516-08-2012Dy No. 785
Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014
1x10’sAs Per SRO
Ketoconazole 200mg Tablets by Mylan Pharma(USFDA Approved)
Spike by Highnoon
Last inspection report03-08-2016 Stated grant of additional section and renewal of DML.
Deferred for safety reason as discussed in Pharmacy Services agenda
13. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate,
Melox 7.5mg Tablets
Each tablet contains:-Meloxicam …...7.5mg
Form 516-08-2012Dy No. 792
Rs.8000/-15-8-2012Rs.12,000/-
Meloxicam 7.5mg Tablet(MHRA Approved)
Last inspection report 03-08-
Approved
Minutes for 266th Meeting of Registration Board. 126
HayatabadPeshawar, Pakistan
(Oxicam NSAID)
BP Specs
17-07-20141x10’sAs Per SRO
2016Stated grant of additional section and renewal of DML.
14. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Melox 15mg Tablets
Each tablet contains:-Meloxicam………..15mg
(Oxicam NSAID)
BP Specs
Form 516-08-2012Dy No. 788
Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014
1x10’sAs Per SRO
Meloxicam 15mg Tablet(MHRA Approved)
Meflex by AGP
Last inspection report03-08-2016Stated grant of additional section and renewal of DML.
Approved
15. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Mebaver Tablets 135mg
Each coated tablet contains:-Mebeverine ………135mg
(Antispasmodic: Gastroprokinetic)
BP Specs
Form 5116-6-2012Dy No. 241Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014
3x10’sAs Per SRO
Colofac Tablets by Mylan(MHRA Approved)Mebrin by paramount Pharma
Last inspection report 03-08-2016Stated grant of additional section and renewal of DML.
Approved
16. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Aceclo Tablets 100mg
Each film coated tablet contains:-Aceclofenac………..100mg
(Phenyl Acetic Acid, Analgesic)
Form 516-08-2012Dy No. 775
Rs.8000/-15-8-2012+Rs.12,000/-17-07-20141x10’s2x10’s3x10’sAs Per SRO
Preservex 100mg tablets by Almirall Ltd.(MHRA Approved)
Acemed by Novartis
Last inspection report03-08-2016Stated grant of additional section
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with Innovator’s specs
17. M/s. Aries Pharmaceuticals (Pvt) Ltd.
Cimedin Tablets 400mg
Each film
Form 516-08-2012Dy No. 777
Tagamet 400mg Tablets by Chemidex Pharma
Approved
Minutes for 266th Meeting of Registration Board. 127
1-W, Industrial Estate, HayatabadPeshawar, Pakistan
coated tablet contains:-Cimetidine…………..400mg
(H2 Blocker)
USP Specs
Rs.8000/-15-8-2012+Rs.12,000/-17-07-20141x10’sAs Per SRO
(MHRA Approved)Tagamet by GSK
Last inspection report03-08-2016Stated grant of additional section
18. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Destil Tablets 5mgEach film coated tablet contains:-Desloratadine………..5mg
(Antihistamine)
Form 516-08-2012Dy No. 778
Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014
1x10’sAs Per SRO
Neoclarityn 5mg Tablets by MSD(MHRA Approved)Destina by Hilton Pharma
Last inspection report03-08-2016Stated grant of additional section and renewal of DML.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Approved with innovator’s specs
19. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Sulcare Tablets 25mg
Each tablet contains:-Levosulpiride………….25mg
(Antidepressant)
Form 516-08-2012Dy No. 768
Rs.8000/-15-8-2012
+Rs.12,000/-17-07-2014
2x10’sAs Per SRO
Not provided.
Levopraid tab by Pacific Pharma
Last inspection report03-08-2016Stated grant of additional section
Formulation is rejected as per 250th DRB meeting
Firm has claimed Mfg. Specs and the product is not present in available versions of BP & USP (B.P 2013 & USP 39)
Deferred for review.
20. M/s. Aries Pharmaceuticals (Pvt) Ltd.1-W, Industrial Estate, HayatabadPeshawar, Pakistan
Naproesic 500mg Tablets
Each film coated tablet contains:-Naproxen ………..500mg
(Analgesic NSAID)
USP Specs
Form 516-08-2012Dy No. 741
Rs.8000/-15-8-2012+Rs.12,000/-17-07-2014
2x10’sAs Per SRO
Naprosyn 500mg by Atnahs Pharma(USFDA Approved)
Synflex by ICI
Last inspection report03-08-2016Stated grant of renewal of DML.
Approved
21. M/s Rotexmedica Pakistan
Voxin 500mg CapsulesEach capsule
Form 5Dy. No.
2275
Not provided.
Transamin
Firm has claimed Mfg Specs while
Deferred for evidence of approval by
Minutes for 266th Meeting of Registration Board. 128
(Pvt) Ltd, Islamabad
contains:-Tranexamic Acid …… 500mg
(Anti hemorrhagic)
07-2-2011Rs.8000/=07-2-2011
Rs.12,000/=08-12-2014
30’s20’s
As Per PRC
500mg capsule by Hilton
Last inspection report 29-03-2016Panel recommends the issusance of GMP certificate
the product is present in Japanese Pharmacopeia.
Reference Authority status could not be confirmed
reference regulatory authorities
22. M/s Swiss Pharmaceuticals
Utramax 250mg CapsuleEach capsule contains:Tranexamic Acid….250 mg
(Anti hemorrhagic)
Form-5Duplicate28-7-2010Dy.No.1448
Rs.8000/- (Photocopy)+Rs.12,000/-12-11-201420’sRs.130/-
Hexatron capsule 250 mg byNippon Shinyaku Co., Ltd(PMDA Japan)
Transamin 250mg capsule by Hilton Pharma
Last inspection report 19-04-2016Shows acceptable level of GMP compliance.
Firm has claimed Mfg Specs while the product is present in Japanese Pharmacopeia.
Approved
23. M/s Swiss PharmaceuticalKarachi
Utramax 500mg CapsuleEach capsule contains:Tranexamic Acid…..500 mg
(Anti hemorrhagic)
Form-5Duplicate28-7-2010
Dy.No.1449Rs.8000/-
(Photocopy)+
Rs.12,000/-12-11-2014
20’sRs.250/-
Cyklokapron in USA
Transamin by Hilton Pharma
Last inspection report 19-04-2016Shows acceptable level of GMP compliance.
Reference Authority status could not be confirmed
Firm has claimed Mfg. Specs while the product is present in Japanese Pharmacopeia.
Deferred for evidence of approval by reference regulatory authorities
24. M/s Swiss PharmaceuticalKarachi
Ezidin 2mg Tablet
Each tablet contains:Tizanidine Hydrochloride…2mg(Muscle relaxants)
USP Specs
Form-5Duplicate28-7-2010
Dy.No.1440Rs.8000/-
(Photocopy)+
Rs.12,000/-12-11-2014
10’sRs.160/-
Zanaflex 2mg tablet (USFDA Approved)
Agile 2mg tablet by Wilshire
Last inspection report19-04-2016Acceptable level of GMP.
Approved Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorise issuance of registration
Minutes for 266th Meeting of Registration Board. 129
letter25. M/s Swiss
PharmaceuticalKarachi
Ezidin 4mg Tablet
Each tablet contains:Tizanidine Hydrochloride….4mg
(Muscle relaxants)
USP Specs
Form-5Duplicate28-7-2010
Dy.No.1443Rs.8000/-
(Photocopy)+
Rs.12,000/-12-11-2014
10’sRs.290/-
Zanaflex 4mg tablet (USFDA Approved)
Agile Forte 4mg tablet
Last inspection report19-04-2016Shows acceptable level of GMP compliance.
Approved Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorize issuance of registration letter
26. M/s Swiss PharmaceuticalKarachi
Pulmoflox 250mg InfusionEach 100ml contains:Levofloxacin …250 mg
(Antibiotic)
Form-5Duplicate28-7-2010
Dy.No.1439Rs.8000/-
(Photocopy)+
Rs.12,000/-12-11-2014
1x100mlRs.200/-
Levaquin USA
Levocil by CCL
Last inspection report19-04-2016Acceptable level of GMP compliance.
Levofloxacin Injection is present in Japanese Pharmacopeia
Reference Authority status could not be confirmed
Deferred for evidence of approval by reference regulatory authorities
27. M/s Swiss Pharmaceutical Karachi
Rozet TabletEach film coated tablet contains:Rosuvastatin calcium eq. to Rosuvastatin…5mgEzetimibe…10mg
(anti hyper lipidimic)
Form-5Duplicate
29-10-2010Dy.No.1881
Rs.8000/-(Photocopy)
+Rs.12,000/-12-11-2014
10’sRs.306
Rosuzet by MSD(TGA Approved)
Rovista EZ by Getz
Last inspection report19-04-2016Acceptable level of GMP compliance.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with innovator’s specs.Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorise issuance of registration letter
28. M/s Swiss Pharmaceutical Karachi
Rozet TabletEach film coated tablet contains:Rosuvastatin calcium eq. to rosuvastatin ..…10mgEzetimibe ...…10mg
(anti hyper
Form-5Duplicate
29-10-2010Dy.No.1883
Rs.8000/-(Photocopy)
+Rs.12,000/-12-11-2014
10’sRs.385
Rosuzet by MSD(TGA Approved)
Rovista EZ by Getz
Last inspection report19-04-2016Acceptable
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Approved with innovator’s specs.Reference will be sent to Budget & accounts Division for verification of challan & Chairman
Minutes for 266th Meeting of Registration Board. 130
lipidimic) level of GMP compliance.
registration Board will authorise issuance of registration letter
29. M/s Swiss Pharmaceutical Karachi
Rozet TabletEach film coated tablet contains:Rosuvastatin calcium eq. to rosuvastatin…20mgEzetimibe…10mg
(anti hyper lipidimic)
Form-5Duplicate
29-10-2010Dy.No.1880
Rs.8000/-(Photocopy)
+Rs.12,000/-12-11-2014
10’sRs.513
Rosuzet by MSD(TGA Approved)
Rovista EZ by Getz
Last inspection report19-04-2016Acceptable level of GMP compliance.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with innovator’s specs.Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorize issuance of registration letter
30. M/s Epharm Labs, Karachi
Emycin 250mg CapsuleEach capsule contains:Azithromycin……….250 mg(Antibiotic)
USP Specs
Form-521-05-2012Dy.No.769Rs.8000/-
Rs.12,000/-04-8-2014
6’sRs.200/-
Zithromax 250mg Capsule by Pfizer(MHRA Approved)
Azomax Capsule by Novartis
Inspection date 15-09-2016Firm is operating at Good level of Compliance.
Approved
31. M/s Epharm Labs, Karachi
Emycin DS 500mg CapsuleEach capsule contains:Azithromycin……….500 mg(Antibiotic)USP Specs
Form-521-05-2012Dy.No.770Rs.8000/-
Rs.12,000/-04-8-2014
3’sRs.150/-
Not provided.
Zygrel by Searle
Inspection date 15-09-2016Firm is operating at Good level of Compliance.
Reference Authority status could not be confirmed
Deferred for evidence of approval by reference regulatory authorities
32. M/s. Mcolson Research Laboreatories (Pvt) Ltd,
Alfason 0.5mcg TabletsEach tablet contains:-Alfacalcidol…
Form 525-11-2014Dy No. 332800015-01-2011+
N/ABon-One tab by Martin Dow Pharma
Last inspection
Reference Authority status could not be confirmedFirm has
Deferred for formulation review.
Minutes for 266th Meeting of Registration Board. 131
Sheihupur ………..0.5mcg
(Vitamin-D Analogue)
1200024-11-201410’sAs Per SRO
report23-06-2-15 confirms that the firm displays a positive attitude towards GMP compliance
claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
33. M/s.Mcolson Research Laboreatories (Pvt) Ltd, Sheihupur
Dexifen Tablets 300mgEach film coated tablet contains:-Dexibuprofen ……..300mg
(NSAID)
Form 515-1-2011Dy No. 1421800015-01-2011+1200024-11-201430’sAs Per SRO
Seractil by Gebro Pharma(MHRA Approved)
Tercica tablet by Sami Pharma
Last inspection report 23-06-2-15 confirms that the firm displays a positive attitude towards GMP compliance
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with innovator’s specs
34. M/s. Friends Pharma (Pvt.) Ltd.
Penfred InjectionEach ml containsPentazocine (as lactate)…30mg
Narcotic antagonist/analgesic
BP Specs
Form 531.03.2015Dy. No. 4588000Rs.12000/= 31.03.20151x5’sAs per SRO
Talwin Injection by Hospira Inc(USFDA Approved)
Iscigon by Isis Pharma
Last inspection report 6-10-2016The panel granted the cGMP for export purpose.
Pentazocine is not found in INCB yellow list (for narcotic substances)
Deferred for confirmation of Psychotropic section approval
35. M/s. Wnsfeild Pharmaceuticals, Hattar
Deprelax-50Tablets
Each tablet contains:-Sertraline HCl eq. to Sertraline ……….50mg
(SSRI)
USP Specs
Form 516-4-2012Dy No. 99Rs.8000/-Rs.12000/-26-12-143x10’sAs fixed by Govt.
Zoloft 50mg Tablet by Pfizer(USFDA Approved)
Zoloft by Pfizer
Last inspection report23-11-2016The firm is following cGMP compliance.
Approved
Minutes for 266th Meeting of Registration Board. 132
36. M/s Innvotek PharmaceuticalsIslamabad.
Zesty-500 Tablets
Each film coated tablet contains:-Azithromycin Dihydrate USP……500mg
(Antibiotics)USP Specs
Form 5Dy.No.7605-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-20151x10’sAs Per SRO
Zithromax 500mg Tablet by(USFDA Approved)Azomax by Novartis
Last inspection report 14-07-2016The company is complying with GMP requirement
Approved
37. M/s Innvotek PharmaceuticalsIslamabad.
UDCA-250 Capsules
Each capsule contains:-Ursodeoxycholic Acid BP ……..250mg
(Bile Acids)
BP Specs
Form 5Dy.No.7205-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-20151x10’sAlu Alu packingAs Per SRO
Ursodeoxycholic acid by Concordia(MHRA Approved)
Urso by AGP Pharma
Last inspection report14-07-2016The company is complying with the GMP requirements.
Approved
38. M/s Innvotek PharmaceuticalsIslamabad.
UDCA-500 Capsules
Each capsule contains:-Ursodeoxycholic Acid USP ..……..500mg
(Bile Acids)
BP Specs
Form 5Dy.No.7705-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-20151x10’sAlu Alu packingAs Per SRO
Not provided.
Urso by AGP Pharma
Last inspection report14-07-2016The company is complying with the GMP requirements.
Reference Authority status is not provided
Deferred for evidence of approval by reference regulatory authorities
39. M/s Innvotek PharmaceuticalsIslamabad.
Clin-V Vaginal CreamEach gram contains:-Clindamycin as Phosphate ……...20mg
(Antibacterial, gynecological)
USP Specs
Form 5Dy.No.7805-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-201540gmAs Per SRO
USFDA-Approved
Clycin-V vaginal cream by Shaigan
Last inspection report14-07-2016The company is complying with the GMP requirements
Cream/Ointment section cannot be confirmed.
Reference Authority status cannot be confirmed
Deferred for confirmation of section approval
Minutes for 266th Meeting of Registration Board. 133
40. M/s Innvotek PharmaceuticalsIslamabad.
Clin-T 1% TopicalLotion
Each ml contains:-
Clindamycin Phosphate eq. to Clindamycin USP…..10mg
(Antibiotic)
Form 5Dy.No.7905-01-2011Rs.8000/=05-01-2011+Rs.12,000/=04-02-201530mlAs Per SRO
Dalacin T Lotion by Pfizer(MHRA Approved)
Dalacin-T by Pfizer
Last inspection report14-07-2016The company is complying with GMP requirements
Lotion section cannot be confirmed.
Topical solution and suspension is available in USP while the innovator product is topical emulsion
Deferred for confirmation of section approval
41. M/s Panacea Pharmaceuticals Islamabad
Fluvox 50mg Tablets
Each tablet contains:-Fluvoxamine Maleate (USP)……50mg(5HT Reuptake Inhibitor)SSRI’sUSP Specs
Form 524-02-2015Dy.No.1078Rs.8000/=+Rs.12,000/=24-02-201510’s60’sAs Per SRO
Luvox Tablets by Ani(USFDA Approved)
Voxamine 50 mg tablet by PharmevoLast inspection report8-12-2016GMP compliant.
Approved
42. M/s. Hamaz Pharma
Zeetop 20mg TabletsEach Tablet Contains:-Zinc Sulphate Monohyrate USP eq. to ….20mg elemental Zinc.(Indirectly-acting sympathomimetic)
BP Specs
Form 503.03.2015Dy. No. 351Rs.8000/=+Rs.12000/-2-3-20151*10’sAs per brandleader
Not ProvidedZindigi by Zafa Pharmaceuticals
Last inspection report26-12-2016The firm is following all the legal aspects of GMP requirements.
Reference Authority status is not provided
Applied formulation is approved by WHO as dispersible tablet
Deferred for confirmation of dosage form whether dispersible tablet or otherwise
43. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
Brim – 10 TabletsEach tablet contains:-Cyclobenzaprine HCl (USP) ….10mg
(Autonomic Nervous System Drug)USP Specs
Form 527-03-2015Dy.No.1953Rs.8000/=+Rs.12,000/=25-03-20151x10’sAs Per SRO
USFDA Approved
Flexagil by CCL Pharma
Last inspection report17-08-2016The Panel recommended for the grant of 7 new sections.
Approved
44. M/s Tensin – 8 Form 5 USFDA Firm has Approved
Minutes for 266th Meeting of Registration Board. 134
Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
TabletsEach tablet contains:-Candesartan Cilexetil….. 8mg(Angiotensin II Receptor Antagonist)
27-03-2015Dy.No.1975Rs.8000/=+Rs.12,000/=25-03-20152x7’sRs. 167
Approved
Advant by Getz Pharma,
Last inspection report 17-08-2016The Panel recommended for the grant of 7 new sections.
claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
with innovator’s specs
45. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
Ruwin 200mg Capsules
Each capsule contains:-Cefixime as Trihydrate (USP) ……….. 200mg
(Cephalosporin)USP Specs
Form 527-03-2015Dy.No.1973Rs.8000/=+Rs.12,000/=25-03-20151x5’sRs. 185
Suprax by Lupin PharmaceuticalsIcef Capsule by ICILast inspection report17-08-2016The Panel recommended for the grant of 7 new sections.
Reference Authority status cannot be confirmed.
Deferred for evidence of approval by reference regulatory authorities as stated reference is incorrect
46. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
Trulac Ophthalmic SolutionEach ml contains:-Ketorolac Tromethamine (USP)…………..0.50%(Anti-Inflammatory(NSAIDs)
Form 527-03-2015Dy.No.1960Rs.12,000/=+Rs.8000/=25-03-20155ml(LDPE)Rs 120
USFDA Approved
Ketrosan by Sante PharmaDylac by Dyson PharmaLast inspection report17-08-2016The Panel recommended for the grant of 7 new sections.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with innovator’s specs
47. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
Eyesoft Gel
Each gm contains:-Polyacrylic Acid BP …2mg
(Acrylic Acid Polymer)
Form 527-03-2015Dy.No.1958Rs.12,000/=+Rs.8000/=25-03-20151*10gm (HDPE)Rs. 180
Viscotears by NovartisUSA/UKViscotears by Novartis
Last inspection report17-08-2016The Panel recommended for the grant of 7 new sections.
Reference Authority status cannot be confirmed
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Deferred for evidence of approval by reference regulatory authorities as stated reference is incorrect
48. M/s Ltroze 2.5mg Form 5 Femara by Deferred for
Minutes for 266th Meeting of Registration Board. 135
Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
TabletsEach tablet contains:-Letrozole (USP) …….2.5mg
(Cytostatics)
USP Specs
27-03-2015Dy.No.1962Rs.8000/=+Rs.12,000/=25-03-20151x10’s3x10’sPrice not mentioned.
Novartis(MHRA Approved)
Femara by NovartisLast inspection report 17-08-2016The Panel recommended for the grant of 7 new sections.
decision regarding requirement of manufacturing facility for Letrozole
49. M/s Shaigan Pharmaceuticals Pvt. Ltd, Rawalpindi
GI Stable CapsulesEach capsule contains:-Saccharomyces Boulardii (Lyophilized)……… 250mg(Probiotics)
Form 528-05-2012Dy.No.1970Rs.8000/+Rs.12,000/= dated25-03-20151x10’sRs. 525 /pack
Proflora B by BioHealth(TGA Approved)
Enflor by Hilton PharmaLast inspection report17-08-2016The Panel recommended for the grant of 7 new sections.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for comments of Health &OTC Division as per DRAP Act, 2012
50. M/s Global Pharmacetucials Islamabad
Aloram XR 3mg Tablets
Each extended release tablet contains:-Alprazolam ……….. 3mg(Hypnotic)USP Specs
Form 506-10-2010Dy.No.2110Rs.12000/=+Rs.8000/=26-03-201510’s20’s30’sAs Per SRO
USFDA ApprovedXanax by Pfizer
Last inspection report23,24-08-2016GMP Compliance is good
Me too status is not confirmed
Deferred for submission of application on Form 5-D with all required formalities & correction of pharmacological group
51. M/s Global Pharmaceuticals Islamabad
Dikin-T 32mg Tablets
Each film coated tablet contains:-Dihydroartemisinin ….. 32mgPiperaquine Phosphate. 320mgTrimethoprim ………. 90mg
( Antimalarial )
Form 501-12-2010Dy.No.2138Rs.15000/=+Rs.5000/=26-03-20158’s.As Per SRO
USA
Armiqin by Pharmevo
Last inspection report23,24-08-2016GMP Compliance is good
Firm has initially applied it on Form 5D but now firm changed it on form 5.SRA and me too status are not confirmed
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P
Deferred for evidence of approval by reference regulatory authorities/WHO & me-to status as stated reference is not correct
Minutes for 266th Meeting of Registration Board. 136
2013 & USP 39)
52. M/s Global Pharmaceuticals Islamabad
Sorias 25mg CapsulesEach capsule contains:-Acitretin ……….. 25mg( Antiposriasis )
USP Specs
Form 513-12-2010Dy.No.2140Rs.12000/=+Rs.8000/=26-03-201510’s30’sAs Per SRO
Soriatane by stiefel labs(USFDA Approved)Acetin 25mg capsule by GenomeLast inspection report 23,24-08-2016GMP Compliance is good
Approved
53. M/s. Friends Pharma Lahore
Antibact CreamEach gram contains:-Fusidic acid….2%
Antibiotic
BP Specs
Form 531-3-2015Dy No. 4598000/+12000/31-3-20151x1’s(15gm)As per SRO
FUCIDIN 2% Cream by Leo Pharma(MHRA Approved)FUCIDIN 2% Cream by LeoLast inspection report6-10-2016The panel grant the cGMP for export purpose.
Firm has topical Cream/Ointment Section
Approved
54. M/s. Friends Pharma Lahore
Somafin Injection 250mg /ml
Each ml contains:-Citicolin (as sodium) …..250mg
Neutrotonic
Form 531-3-2015Dy No. 463Rs 8,000/-23-05-2011+Rs 12,000/-31-3-20151x10’sAs per SRO
Not provided.
Cificolin-H by Pharmark
Last inspection report6-10-2016The panel grant the cGMP for export purpose.
Rs 8000, fee challan is not in original.
Reference Authority status cannot be confirmed.
Firm has claimed Mfg. Specs & product is not present in available versions of BP &USP (B.P 2013 & USP 39)
Deferred for clarification of composition as applied formulation is approved in France with strength of 250mg/2 ml
55. M/s. Friends Pharma Lahore
Tramafac Injection
Each 2ml ampoule containsTramadol Hydrochloride: …….100 mg.
Form 531-3-2015Dy.No.4628000/12000/31-3-20151X5’sAs per SRO
Tramadol hydrochloride 50 mg/ml solution for injection.-MHRA
Tramal by Searle
Last inspection
Firm has injectable section.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP
Approved with innovator’s specs
Minutes for 266th Meeting of Registration Board. 137
Opioid analgesic
report 6-10-2016The panel granted cGMP for export purpose.
and USP (B.P 2013 & USP 39)
56. M/s. Friends Pharma (Pvt.) Ltd.
Artemose Dry Suspension
Each 5ml contains:-Artemether……….15mgLumefantrine……..90mg
Antimalarial
Form 531.03.2015Dy. No. 457/R&I8000Rs.12000/=31.03.20151x1’sAs per SRO
Melamet suspension by Advacare Pharma U.S.AArtem Plus by Hilton Pharma
Last inspection report 6-10-2016The panel granted cGMP for export purpose.
Firm has claimed Mfg. Specs and the product is Present in International Pharmacopeia-16
Approved with International Pharmacopeia specs
57. M/s Caraway Pharmaceuticals Rawat.
Cara-Glip 25mg TabletsEach tablet contains:-Sitagliptin ……25mg(Antidiabetic, Hypoglycemic)
Form 510-09-2012Dy.No.3038Rs.8000/=+Rs.12,000/=24-04-201530’sAs Per SRO
Januvia by MSD-MHRASita by CClLast inspection report:9-12-2016Overall GMP compliance was good.
Firm has claimed Mfg. Specs and the product is present in USP 39
Approved with USP specs
58. M/s Caraway Pharmaceuticals Rawat.
Cara-Glip 50mg TabletsEach tablet contains:-Sitagliptin ……..50mg(Antidiabetic, Hypoglycemic)
Form 510-09-2012Dy.No.3036Rs.8000/=+Rs.12,000/=24-04-201530’sAs Per SRO
Januvia by MSD-MHRASita-CCl
Last inspection report:9-12-2016Overall GMP compliance was good.
Firm has claimed Mfg. Specs and the product is present in USP 39
Approved with USP specs
59. M/s Caraway Pharmaceuticals Rawat.
Caravil 50mg TabletsEach tablet contains:-Vildagliptin……50mg(Antidiabetic, Hypoglycemic)
Form 510-09-2012Dy.No.3037Rs.8000/=+Rs.12,000/=24-04-201528’sAs Per SRO
Galvus by Novartis (MHRA Approved)Galza by CCL
Last inspection report: 9-12-2016Overall GMP compliance was good.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Approved with innovator’s specs
60. M/s Caraway Pharmaceuticals Rawat
Dicrays 50mg TabletsEach tablet contains:-Diclofenac Sodium ……
Form 516-11-2011Dy.No.3034Rs.8000/=+Rs.12,000/=
MHRA
Artifen by Abbott.Last inspection report:
Firm has claimed Mfg. Specs and the product is present in available
Deferred for clarification of dosage form as reference product is
Minutes for 266th Meeting of Registration Board. 138
50mg(Phenylacetic Acid)
NSAID
24-04-201520’sAs Per SRO
9-12-2016Overall GMP compliance was good.
versions of BP and USP (B.P 2013 and USP 39)
available as delayed release tablets whereas firm has applied plain tablet
61. M/s Caraway Pharmaceuticals Rawat
Cetazine 10mg TabletsEach tablet contains:-Cetirizine …….. 10mg(Anti Allergic)
Form 516-11-2011Dy.No.3032Rs.8000/=+Rs.12,000/=24-04-201510’sAs Per SRO
Zyrtec(MHRA Approved)Allergo by Pharmix
Last inspection report: 9-12-2016Overall GMP compliance was good.
Firm has claimed Mfg. Specs and the product is present in USP 39
Approved with USP specs
62. M/s Caraway Pharmaceuticals Rawat
Tizenax 2mg TabletsEach tablet contains:-Tizanidine …….. 2mg(Skeletal Muscle Relaxant)
Form 516-11-2011Dy.No.3035Rs.8000/=+Rs.12,000/=24-04-201510’sAs Per SRO
Zanaflex 2mg tablet (USFDA Approved)Agile 2mg tablet by Wilshire
Last inspection report:9-12-2016Overall GMP compliance was good.
Firm has claimed Mfg. Specs and the product is present in USP 39
Approved with USP specs
63. M/s. Alliance Pharmaceuticals, Peshawar
A-Vid 400mg TabletsEach film coated tablet contains:-Ofloxacin ………400mg
(Quinolone)
USP Specs
Form 520-6-2012Dy No. 567Rs.8000+Rs.1200011-6-201510’s(blister pack)As Per SRO
USFDA ApprovedAdiflox by Davis pharma
Last inspection report:24-11-2016Overal GMP is found Satisfactory.
Approved with USP specs
64. M/s. Alliance Pharmaceuticals, Peshawar
Allispar 100mg TabeltsEach film coated tablet contains:-Sparfloxacin….100mg
(Quinolone Antibiotic)
Form 520-6-2012Dy No 577Rs.8000+Rs.1200011-6-201510’sAs Per SRO
USA
Sparaxin by Abbott
Last inspection report: 24-11-2016Overal GMP is found Satisfactory.
Reference Authority status cannot be confirmed
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP
Deferred for formulation review
Minutes for 266th Meeting of Registration Board. 139
39)65. M/s.
Alliance Pharmaceuticals, Peshawar
Allispar 200mg TabeltsEach film coated tablet contains:-Sparfloxacin………..200mg
(Quinolone Antibiotic)
Form 520-6-2012Dy No 577Rs.8000+Rs.1200011-6-201510’sAs Per SRO
Zagam by Mylan(USFDA Approved but Discontinued)
Spactrum by TAGMALast inspection report:24-11-2016Overal GMP is found satisfactory
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for formulation review
66. M/s. Alliance Pharmaceuticals, Peshawar
Tprim 50mg Tablets
Each film coated tablet contains:-Topiramate …50mg
(Antipsychotic)
Form 520-6-2012Dy No 575Rs.8000Rs.1200011-6-20151x10’s2x10’s3x10’s6x10’sAs Per SRO
Topamax-MHRALegent by Amarant
Last inspection report:24-11-2016Overal GMP is found satisfactory
Firm has claimed Mfg. Specs and the product is present in USP 39
Approved with USP specs
67. M/s. Alliance Pharmaceuticals, Peshawar
Astofin Syrup
Each 5ml contains:-Ketotifen as Hydrogen Fumarate ………..1mg
(Histamine H1 receptor antagonist)
Form 520-6-2012Dy No. 570Rs.8000/-Rs.1200011-6-201560ml120ml90ml250ml450mlPrice not mentioned
Zaditen Syrup of M/s Teva-Health Canada approved
Aria by Highnoon
Last inspection report:24-11-2016Overal GMP is found Satisfactory.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with innovator’s specs
68. M/s. Alliance Pharmaceuticals, Peshawar
Allzopic 2mg Tablets
Each film coated tablet contains:-Eszopiclone ………..2mg
(Hypnotics, Sedative)USP Specs
Form 520-6-2012Dy No. 576Rs.8000/-Rs.1200011-6-20151x10’s2x10’sAs Per SRO
Eszopiclone Tablet-USFDA
Clonexa 2mg Tablets by ATCO
Last inspection report:24-11-2016Overal GMP is found Satisfactory.
Eszopiclone is not present in INCB Green list
Approved
Minutes for 266th Meeting of Registration Board. 140
69. M/s. Alliance Pharmaceuticals, Peshawar
Alpride 25mg TabletsEach film coated tablet contains:-Levosulpiride….25mg(Antidepressant)
Form 520-6-2012Dy No. 566Rs.8000/-Rs.1200011-6-20151x10’s2x10’sAs Per SRO
Not provided.
Levoma by GenomeLevopride by Pacific
Last inspection report:24-11-2016Overal GMP is found satisfactory
Formulation is rejected as per 250th DRB meeting
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Deferred according to decision of 250th RB meeting as the formulation is not available in reference drug regulatory agencies.
70. M/s. Don Valley Pharma.
Atostat Tablet 40mgEach tablet contains:-Atorvastatin ………..40mg(HMG-CoA reductase inhibitor, Anti lipemic)
Form 512.08.2015Dy. No. 348Rs.8000/-+Rs.12000/12.08.201510’sAs per brand leader
USFDA
Cholestor by PDHLast inspection report24-8-2015Granted CGMP certificate (Valid for 1 year)
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Approved with USP specs
71. M/s. Don Valley Pharma.
Cardiopil TabletEach tablet contains:-Carvedilol……….12.5mg
Alpha adrenergic blocker(Anti-hypertensive)
Form 512.08.2015Dy. No. 347Rs.8000/Rs.12000/= 12.08.201510’sAs per SRO
Carvedilol tablet-MHRADilatrend by Martin Dow
Last inspection report 24-8-2015Granted CGMP certificate (Valid for 1 year)
Firm has claimed Mfg. Specs and the product is present in USP 39
Approved with USP specs
72. M/s Valor Pharmaceuticals Islamabad.
Adoderm Cream 0.1%Each tube contains:-Methyl Prednisolone Aceponate …….0.1%
(Corticosteroids)
Form 506-04-2015Dy.No.2346Rs.8000/=Rs.12,000/=06-04-20151*1’sN/A
Advantan 0.1% CreamBayer (TGA)Advantan by Bayer Health Care
Last inspection report:01-08-2016 shows that overall GMP compliance is good.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Approved with Innovator’s specs
73. M/s Shaigan Pharmaceuticals (Pvt)
Bliss 200mg TabletsEach film coated tablet
Form 527-03-2015Dy.No.1956Rs.8000/=
Plaquenil by Concordia PharmaUSFDA
Approved
Minutes for 266th Meeting of Registration Board. 141
Ltd, Rawalpindi
contains:-Hydroxychloroquine Sulfate (USP) ……. 200mg
(Anti-Malarial, Anti-Rheumatic)USP Specs
+Rs.12,000/=25-03-20153x10’sRs 270
HCQ 200 by Getz Pharma
Last inspection report 17-08-2016Grant of additional section
74. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
Boost-D SuspensionEach 5ml contains:-Ossein Mineral Complex…250mgVitamin-D …400 IU
( Minerals + Vitamin-D Supplement)
Form 527-03-2015Dy.No.1980Rs.12,000/=+Rs.8000/=25-03-201560 mlRs.120
Not provided.
Bonmin by S.J. & G Fazul Ellahie
Last inspection report17-08-2016Grant of additional section
Reference Authority status could not be confirmed
Atomic absorption is given in equipment list.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Deferred for submission of complete formulation of Ossein Mineral complex
75. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
Dvit 1g InjectionEach ml contains:-Cholecalciferol (BP)……1g
( Vitamin D Analogue)
Form 527-03-2015Dy.No.1972Rs.8000/=+Rs.12,000/=25-03-201510’sAs Per SRO
Clacijex in USA,EU
Calcijex by Abbott PharmaBonky by RG Pharma
Last inspection report 17-08-2016Grant of additional section.
The SRA and Me too provided are that of calcitriol which is 1, 25-dihydroxycholecalciferol (vitamin D).
SRA and Me too in this strength not found. (1mcg/ml)
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Deferred for evidence of approval by reference regulatory authorities & me-too status as stated reference is not correct
76. M/s Shaigan Pharmaceuticals (Pvt)
Pegalin – 100 CapsulesEach capsule contains:-
Form 527-03-2015Dy.No.1969Rs.8000/=
Lyrica by PfizerUSFDA
Firm has claimed Mfg. Specs and the product is not
Approved with Innovator’s specs
Minutes for 266th Meeting of Registration Board. 142
Ltd, Rawalpindi
Pregabalin …….. 100mg
(Anticonvulsant)
+Rs.12,000/=25-03-2015Rs. 325/2x7’s
Gabica by Getz Pharma
Last inspection report 17-08-2016Grant of additional section.
present in available versions of BP and USP (B.P 2013 & USP 39)
77. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
Tensin – 16 Tablets
Each tablet contains:-Candesartan Cilexetil 16mg
(Angiotensin II Receptor Antagonist)
Form 515-11-2010Dy No. 1951Rs.8000/=+Rs.12,000/=25-03-20152x7’s/ Rs. 300
Atacand by AstrazenecaUSFDA
Advant by Getz Pharma,
Last inspection report 17-08-2016Grant of additional section.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with Innovator’s specs
78. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi
Temprin TabletsEach tablet contains:-Artemether ………. 20mgLumefantrine …….120mg
(Anti-Malarial)
Form 527-03-2015Dy.No.1964Rs.8000/=+Rs.12,000/=25-03-20152x28’sRs 272
Coartem by NovartisUSFDAArtheget by Getz
Last inspection report 17-08-2016Grant of additional section.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with USP pharmacopoeia specs
79. M/s.CCL Pharma Lahore
Orinase-Met 1/850 TabletEach tablet contains:-Glimepiride …..1mgMetformin HCl USP extended release ……850mg
(anti-diabetic)
Form528-10-2014Dy No. 1498000+1200028-10-20143x10’sAs per brand leader
Not provided
Getfomin by Getz Pharma
Last inspection report 21-03-2016For renewal of DML.
Reference Authority status could not be confirmed
Me too not available in this strength. (available in 1/500 mg, 2/500 mg)
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Deferred for evidence of approval by reference regulatory authorities & me-too status as stated reference is not correct
80. M/s.CCL Pharma
Orinase-Met 2/850 Tablet
Form528-10-2014
Exermet mfgd by Cipla
Reference Authority
Deferred for evidence of
Minutes for 266th Meeting of Registration Board. 143
Lahore Each tablet contains:-Glimepiride …..2mgMetformin HCl USP extended release ……850mg
(anti-diabetic)
Dy No. 1508000+1200028-10-20143x10’sAs per brand leader
India
Getfomin by Getz Pharma
Last inspection report 21-03-2016For renewal of DML.
status could not be confirmed
Me too not available in this strength. (available in 1/500 mg, 2/500 mg)
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
approval by reference regulatory authorities & me-too status as stated reference is not correct
81. M/s.CCL Pharma Lahore
Orinase- Met ER 2/1000 TabletEach tablet contains:-Glimepiride …..2mgMetformin HCl USP extended release ……1000mg
(anti-diabetic)
Form528-10-2014Dy No. 14880001200028-10-20143x10’sAs per brand leader
N/A
Getfomin by Getz Pharma
Last inspection report 21-03-2016For renewal of DML.
Reference Authority status could not be confirmed
Me too not available in this strength. (available in 1/500 mg, 2/500 mg)
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 & USP 39)
Deferred for evidence of approval by reference regulatory authorities & me-too status as stated reference is not correct
82. M/s.CCL Pharma Lahore
Orinase-Met ER 1/1000 TabletEach tablet contains:-Glimepiride …..1mgMetformin HCl USP extended release ……1000mg(anti-diabetic)
Form528-10-2014Dy No. 14780001200028-10-20143x10’sAs per brand leader
N/A
Getfomin by Getz Pharma
Last inspection report 21-03-2016For renewal of DML.
Reference Authority status could not be confirmed
Me too not available in this strength. (available in 1/500 mg, 2/500 mg)
Firm has claimed Mfg. Specs and the product is not present in available
Deferred for evidence of approval by reference regulatory authorities & me-too status as stated reference is not correct
Minutes for 266th Meeting of Registration Board. 144
versions of BP and USP (B.P 2013 & USP 39)
83. M/s Panacea Pharmaceuticals Islamabad
Donzil 5mg TabletsEach tablet contains:-Donepezil HCl ………… 5mg
Acetyl Cholinesterase Inhibitor
USP Specs
Form 524-02-2015Dy.No.1076Rs.8000/=Rs.12,000/=24-02-201510’s20’s30’sAs Per SRO
Aricept by EisaiUSFDA
DoneceptBy Atco Pharma
Last inspection report8-12-2016GMP status:Good.
Approved
84. M/s Panacea Pharmaceuticals Islamabad
Clofin 50mg TabletsEach tablet contains:-Clomiphene Citrate ….. 50mg
(Estrogen receptor inhibitor)
USP Specs
Form 516-02-2015Dy.No.970Rs.8000/=Rs.12,000/=16-02-201510’s20’s30’sAs Per SRO
Clomid by Sanofi AventisUSFDA
Cerophene by Hilton
Last inspection report 8-12-2016GMP status: Good.
Deferred for decision regarding requirement of manufacturing facility for Clomiphene Citrate
Case No. 3: Anomaly applications which were not included in List-ISr. #
Name and address of
manufacturer / Applicant
Brand Name(Proprietary
name + Dosage Form + Strength)
CompositionPharmacologi
cal GroupFinished product
Specification
Type of Form
Initial date,diaryFee
including differential
fee
Demanded Price /
Pack size
Remarks on the
formulation (if any) including International
status in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as depicted in
latest inspection
report (with date) by the Evaluator
Remarks of the
Evaluator.
Decision
1. M/s. Medisearch Pharmaceuticals Private Limited, Lahore
Calxone 250mg Injection IV/IMEach vial contains:-
Form-525-04-2013Dy No. 2840Rs.8,000/- to be
Rocephin by Roche(MHRA Approved)
Rocephin
Deferred for last GMP inspection report of M/s McOlson Research
Minutes for 266th Meeting of Registration Board. 145
Contract manufactured by M/s McOlson Research Laboratories (Pvt) Ltd. Sheikhupura
Ceftriaxone Sodium eq. to Ceftriaxone USP…250mg
CephalosporinUSP Specs
confirm+Rs.42,000/-25-04-20131’sAs Per SRO
500mg by Roche
Last inspection report (McOlson)23-06-2-15 confirms that the firm displays a positive attitude towards GMP compliance
Laboratories conducted within one year
2. M/s. Medisearch Pharmaceuticals Private Limited, LahoreContract manufactured by M/s. McOlson Research Laboratories (Pvt) Ltd. Sheikhupura
Calxone 500mg Injection IV/IMEach vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone USP…500mg
Cephalosporin
USP Specs
Form-525-04-2013Dy No. 2839Rs.8000/- to be confirm+Rs.42000/-25-04-20131’sAs Per SRO
Rocephin by Roche(MHRA Approved)
Xone-Star 250mg Injection by M.s Mediate Pharmaceuticals
Last inspection report (McOlson)23-06-2-15 confirms that the firm displays a positive attitude towards GMP compliance.
Deferred for last GMP inspection report of M/s. McOlson Research Laboratories conducted within one year
3. M/s. Medisearch Pharmaceuticals Private Limited, LahoreContract manufactured by M/s. McOlson Research Laboratories (Pvt) Ltd. Sheikhupura
Calxone 1gm Injection IV/IMEach vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone USP…1gm
Cephalosporin
USP Specs
Form-525-04-2013Dy No. 2838Rs.8000/- to be confirm+Rs.42000/-25-04-20131’sAs Per SRO
Rocephin by Roche(MHRA Approved)
Rocephin 1gm by Roche
Last inspection report (McOlson)23-06-2-15 confirms that the firm displays a positive attitude
Deferred for last GMP inspection report of M/s. McOlson Research Laboratories conducted within one year
Minutes for 266th Meeting of Registration Board. 146
towards GMP compliance
Minutes for 266th Meeting of Registration Board. 147
Case No. 4: Applications of New licenses / New sectionsSr.#
Name and address of manufact
urer / Applicant
Brand Name(Proprietary
name + Dosage Form +
Strength)Composition
Pharmacological GroupFinished product
Specification
Type of FormInitial date,
diaryFee including differential
feeDemanded
Price /Pack size
Remarks on the
formulation (if any) including International
status in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as depicted in
latest inspection
report (with date) by the Evaluator
Remarks of the Evaluator.
Decision
New LicenseCase-1 M/s Biorific Pharmaceuticals (Pvt) LtdThe CLB in its 250th meeting held on 27th October 2016 has considered and approved the grant of Drug Manufacturing License (by way of formulation) letter No. F.1-48/2003-lic with following section:Dry powder Section (Veterinary)Liquid Syrup Section (Veterinary)Now the firm has applied for following products/molecules in each sectionDry powder Section (Veterinary) 9 Products / 9 moleculesLiquid Syrup Section (Veterinary) 7 Products/6molecule
Dry powder Section (Veterinary) 9 Products/ 9 molecule1. M/s.
Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Doxic Dry PowderEach 100gm powder contains:-Doxycycline HCI……50g(Antibiotic)
Form-514.12.2016.Dy. No.392Rs.20,000/-Decontrolled100g500g1Kg
Not ProvidedSeldox Powder by Selmore Pharma (Reg No 058717)
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Provided me too status has Doxycycline Hyclate while Doxic dry powder has Doxycycline HCl.
Firm has claimed USP Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved
2. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road,
ENCOF Dry PowderEach 100g powder contains:- Enramycin…….4% (w/w)(Antibiotic)
Form-514-12-2016.Dy. No.393Rs.20,000/-Decontrolled \ pack
Not Provided
Endradin by ICI
Inspection Report dated 21-10-2016 stated that
Me too status cannot be confirmed.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP
Deferred for evidence of me-too status as stated reference is not correct
Minutes for 266th Meeting of Registration Board. 148
Islamabad. size100g500g1Kg
overall evaluation and inspection as Good.
and USP (B.P 2013 and USP 39)
3. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Renflush (Vet) PowderEach 100g powder contains:-Ammonium Chloride ………45gMagnesium Sulphate ………25gSodium Sulphate ……………25gSorbitol …………5g(Detoxification, Nephritid & hepatitis/ Laxatives, antacid)
Form-514.12.2016.Dy. No.394Rs.20,000/- Decontrolled\ pack size100g500g1Kg
Not Provided
Renal Powder by Biolab (Reg no 143173)Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for review of formulation by Dr. Qurban Ali (Member Registration Board)
4. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Sondex (Vet) Dry PowderEach g powder contains:-Neomycin Sulphate …….…60mgOxytetracycline HCI ……….…200mgStreptomycin Sulphate ……20mg(Antibiotic)
Form-514.12.2016.Dy. No.395Rs.20,000/-Decontrolled\ pack size100g500g1Kg
Not Provided
Neostrep Powder by Attabak Pharma (Reg no 075720)
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Firm has claimed USP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for review of formulation by Dr. Qurban Ali, (Member Registration Board)
5. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
SP-COX Dry PowderEach 100g powder contains:-Sulfachlorpyrazine SAodium HCI eq. to..... 30g(Antibacterial)
Form-514.12.2016.Dy. No.396Rs.20,000/-Decontrolled\ pack size100g500g1Kg
Not Provided
Chloricox by Intervac pharma (Reg no 046596)
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved
Minutes for 266th Meeting of Registration Board. 149
6. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Tycotop (Vet) Dry PowderEach g powder contains:-Doxycycline HCI ………400mgTylosin Tartrate ………...200mg(Antibiotics)
Form-514-12-2016.Dy. No.397Rs.20,000/-Decontrolled\ pack size100g500g1Kg
Not ProvidedDoxityl by ICI
Inspection Report dated 21-10-2016 stated that overall evaluation and inspection as Good.
Me too status cannot be confirmed
Firm has claimed USP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved
7. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Vitafic (Vet) Dry PowderEach 100g powder contains:-PotassiumCitrate …….18gSodium Citrate ……..12gVit.B1 ……….0.03gVit.B2…..…0.015gNicotinamide.…0.32gMenadioneBisulphate .0.115gVitamin C……1.1g(Multivitamins)
Form-5Decontrolled\ pack size100g500g1Kg 14-12-2016.Dy. No.398Rs.20,000/-
Not Provided
Methex powder by univet pharma
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Me too status is not confirmed
Firm has claimed USP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for review of formulation by Dr. Qurban Ali, (Member Registration Board)
8. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Ronlex (Vet) Dry PowderEach 1000g powder contains:-Tylosine Tartrate ……………38gSulfamethoxy Pyridazine Sodium …………...75gTrimethoprim …….…15gPhenylbutazone Sodium….…25gGuaifenesin……10g(Antibiotics)
Form-514-12-2016.Dy. No.399Rs.20,000/-Decontrolled\ pack size100g500g1Kg
Samyang AnIpharma co., Ltd
Cotrizyn Plus Oral Powder by Biolab Pharma
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Me-too is not confirmed.
Firm has claimed USP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for review of formulation by Dr. Qurban Ali, (Member Registration Board)
9. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta
DOT-C PowderEach 1000g powder contains:-Doxycycline Hcl …….400gmTylosine Tartarate …200gmColistin
Form-514-12-2016.Dy. No.404Rs.20,000/-New
Not Provided
Mexin plus by Meidcure Labs (Reg no 058956)
Firm has claimed USP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP
Deferred for review of formulation by Dr. Qurban Ali, (Member
Minutes for 266th Meeting of Registration Board. 150
Road, Islamabad.
Sulphate .........1000 MIUBromhexine Hcl …10gmAntibiotic/Expectorant
License Decontrolled\ pack size100ml500ml1000ml
Inspection Report dated 21-10-2016 stated that overall evaluation and inspection as Good.
39) Registration Board)
Liquid Syrup Section (Veterinary) 7 Products/6molecule
10. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Trimzin SuspensionEach 100ml contains:-Trimethoprim B.P. (Vet)……8%Sulphadiazine B.P. (Vet)…..40%(Antibiotic/Folic Acid Antagonists)
Form-5New License14.12.2016.
Dy. No.400Rs.20,000/-100ml500ml1000ml
Not provided
Trytont by ICI pakistan
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Me too status cannot be confirmed.
Firm has claimed USP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for review of formulation by Dr. Qurban Ali, (Member Registration Board)
11. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Rofloc LiquidEach 100ml contains:-Enrofloxacin…………10% (w/v)Colistin Sulphate.......400 MIU(Antibiotic/Floroquinolone)
Form-514.12.2016.Dy. No.402.Rs.20,000/Decontrolled\ pack size100ml500ml1000ml
Not Provided
Enrotin Solution by Attabak pharma (Reg no 049793)Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Enrotin (Me too) contains Colistin Sulphate 50MIU while Rofloc contain 400MIU.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for review of formulation by Dr. Qurban Ali, (Member Registration Board)
12. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Rofin LiquidEach 100ml liquid contains:-Florofenicol…………..11% w/v(Antibiotics)
Form-514.12.2016.
Dy. No.403Rs.20,000/-Decontrolled\ pack size100ml500ml1000ml
Not ProvidedNaflofas Oral liquid by Intervac Pharma
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Me too status is not confirmed
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved
13. M/s. Florific Liquid Form-5 Nuflor 2.3% Firm has claimed Approved
Minutes for 266th Meeting of Registration Board. 151
Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Each 100ml liquid contains:-Florofenicol…23gm(Antibiotics)
14.12.2016.Dy. No.405Rs.20,000/-Decontrolled\ pack size100ml500ml1000ml
by Intervec Inc. FDA
Floroforte by D-maarson Pharma (Reg no 074073)
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
14. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Ensufic LiquidEach ml contains:-Enrofloxacin..... 75mgSulfamethoxy pyridazine…75mgSulfamethazine ………50mgTrimethoprim..25mg(Antibiotics)
Form-514-12-2016.Dy. No.406Rs.20,000/-New License2. Decontrolled\ pack size100ml500ml1000ml
Not Provided
Cinafas by Intervac
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Me too status cannot be confirmed.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for review of formulation by Dr. Qurban Ali, (Member Registration Board)
15. M/s. Biorific Pharma,Plot No.143, Industrial Triangle Kahuta Road, Islamabad.
Bromix (Vet) LiquidEach ml liquid contains:-Bromhexine HCI …………20mgMenthol…….40mg(Expectorant)02 years
Form-514-12-2016.Dy. No.407Rs.20,000/-New License2. Decontrolled\ pack size100ml500ml1000ml
Spectra Brom-M by SpectraVet
Bro man by D-Maarson Pharma (Reg no 073994)
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved
16. M/s. Biorific Pharma,Plot No.143,
ACEDEX LiquidEach 1000ml contains:-Propylene glycol……..12000
Form-514-12-2016.Dy. No.408
Tx-nil-t by Ekspol Pharma polandPresti-E by
SRA and me too status cannot be confirmed.Firm has claimed BP. Specs and
Deferred for review of formulation by Dr.
Minutes for 266th Meeting of Registration Board. 152
Industrial Triangle Kahuta Road, Islamabad.
mgAmmonium propionate....10000mgSorbitol……1000mg Vitamin E....20000mgPotassium.....10000mg(Treatment of bovine ketosis Acetonemia)
Rs.20,000/-Decontrolled\ pack size100ml500ml1000ml
Eksfol pharma
Inspection Report dated 21-10-2016 that overall evaluation and inspection as Good.
the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Qurban Ali, (Member Registration Board)
Case-2 M/s Genetics Pharmaceuticals (Pvt) LtdM/s Genetics Pharmaceuticals (Pvt) Ltd was issued new DML for Tablet (General) and Capsule (General Section) dated 25-08-2016 in248th CLB meeting held on 13th July 2016.
The following products were presented in 264th DRB meeting1. Tablet (General) Section- 18 Products (5 Molecules)2. Capsule (General) Section- 9 products (2 Molecules)
Now, following few more products are evaluated and added in 266th DRB meeting1. Tablet (General) Section- 10 Products (3 Molecules)2. Capsule (General) Section- 8 products (2 Molecules)
1. Tablet (General) Section- 10 Products (3 Molecules)
17. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
DIBIAN 10mg Tablets
Empagliflozin
Each Film Coated Tablet contains: Empagliflozin ……..10 mg
Sodium Glucose Co-transporter 2 (SGLT2) Inhibitors
Form 5-DDy No. 43717-11-2016PKR 50,000/-9-11-201610’s14’s20’s28’sPrice AS Per SRO
Jardiance by Boehringer Ingelheim USFDA
N/A
Firm has been granted new DML dated 25-08-2016
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
18. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
DIBIAN 25mg Tab
Each Film Coated Tablet contains: Empagliflozin .…..25 mg
Sodium Glucose Co-transporter 2 (SGLT2) Inhibitors
Form 5-DDy No. 44317-11-2016PKR 50,000/-9-11-201610’s14’s20’s28’s
Price AS Per SRO
Jardiance by Boehringer Ingelheim USFDA
N/A
Firm has been granted new DML dated 25-08-2016
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
Minutes for 266th Meeting of Registration Board. 153
19. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
LURAX 80mg Tab
Each Film Coated Tablet contains:Lurasidone Hydrochloride ……80 mg
Atypical Antipsychotic
Form 5-DDy No. 46417-11-2016PKR 50,000/-9-11-201610’s14’s20’s28’sAs per SRO
USFDA approved
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
20. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
LURAX 120mg tab
Each Film Coated Tablet contains: Lurasidone Hydrochloride …..120 mg
Atypical Antipsychotic
Form 5-DDy No. 45017-11-2016PKR 50,000/-9-11-2016
10’s14’s20’s28’s
As per SRO
Latuda by Sunovion Pharms InC,USFDA approved
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
21. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
LURAX 60mg tab
Each Film Coated Tablet contains:Lurasidone Hydrochloride …….60 mg
Form 5-DDy No. 46717-11-2016PKR 50,000/-9-11-2016
10’s14’s20’s28’s
As per SRO
Latuda by Sunovion Pharms InC,USFDA approved
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
22. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A
LURAX 40mg Tab
Each Film Coated Tablet contains: Lurasidone Hydrochloride
Form 5-DDy No. 46817-11-2016PKR
Latuda by Sunovion Pharms InC,USFDA approved
The product is not present in INCB Green List
Stability data along with relevant
Deferred for submission of stability data as per
Minutes for 266th Meeting of Registration Board. 154
Sundar Industrial Estate, Lahore
…….40 mg
Atypical Antipsychotic
50,000/-9-11-2016
10’s14’s20’s28’sAs per SRO
N/A
Firm has been granted new DML dated 25-08-2016
documents are not provided.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
guidelines of 251st
DRB meeting
23. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
LURAX 20mg TabEach Film Coated Tablet contains: Lurasidone Hydrochloride ……20 mg
Atypical Antipsychotic
Form 5-DDy No. 46217-11-2016PKR 50,000/-9-11-2016
10’s14’s20’s28’s
As per SRO
Latuda by Sunovion Pharms InC,USFDA approved
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
24. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
SAPHRIN 10mg Tab
Each Sublingual Tablet contains: ASENAPINE (as maleate) ….10mg
Atypical antipsychotic
Form 5-DDy No. 43617-11-2016PKR 50,000/-9-11-2016
10’s14’s20’s28’s
Price As per SRO
Saphris by Forest Labs LLC, USFDA
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
25. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
SAPHRIN 2.5mg Tab
Each Sublingual Tablet contains:Asenapine (as maleate)….2.5mg
Atypical antipsychotic
Form 5-DDy No. 46517-11-2016PKR 50,000/-9-11-2016
10’s14’s
Saphris by Forest Labs LLC, USFDA
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
Minutes for 266th Meeting of Registration Board. 155
20’s28’s
Price As per SRO
available versions of BP and USP (B.P 2013 and USP 39)
26. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
SAPHRIN 5mg TabEach Sublingual Tablet contains:Asenapine (as maleate) …….5 mg
Atypical antipsychotic
Form 5-DDy No. 46317-11-2016PKR 50,000/-9-11-2016
10’s14’s20’s28’s
Price As per SRO
Saphris by Forest Labs LLC, USFDA
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
Capsule (General) Section- 8products ( 2 Molecules)27. M/s.
Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
ALZAR 21/10mg Cap
Each Extended release Capsule contains: Memantine Hydrochloride ……21mg, (Extended Release Pellets 10%w/w), Donepezil Hydrochloride………....10mg
NMDA receptor Antagonist
Form 5-DDy No. 444 17/11/2016Fee 50,000/-9-11-2016Rs 50,00022-12-201610’s14’s20’s28’s
Price as per SRO
Namzaric Capsule by Forest Lab USFDA
N/A
Firm has been granted new DML dated 25-08-2016
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
GMP of Alphamed, Formulations, India is attached. Valid upto 27-12-2016. (GMP is expired).
COA of pellets is attached.
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
28. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate,
ALZAR 14/10mg CapEach Extended release Capsule contains: Memantine Hydrochloride…….14 mg,(Extended Release Pellets),
Form 5-DDy No. 442 17/11/2016Fee RS 50,000/-9-11-2016
Namzaric Capsule by Forest Lab USFDA
N/A
Firm has been granted
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in
Deferred for submission of stability data as per guidelines of 251st
DRB Minutes for 266th Meeting of Registration Board. 156
Lahore Donepezil Hydrochloride…….10mg
NMDA receptor Antagonist
Fee Rs 50,00022-12-201610’s14’s20’s28’s
Price as per SRO
new DML dated 25-08-2016
available versions of BP and USP (B.P 2013 and USP 39)
GMP of Alphamed, Formulations, India is attached. Valip upto 27-12-2016. (GMP is expired).
COA of pellets is attached.
meeting
29. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
ALZAR 28/10mg CapEach Extended release Capsule contains: Memantine Hydrochloride ……..28 mg,(Extended Release Pellets), Donepezil Hydrochloride …….10mg
NMDA receptor Antagonist
Form 5-DDy No. 446 17/11/2016Fee RS 50,000/-9-11-2016Fee Rs.50,00022-12-201610’s14’s20’s28’s
Price as per SRO
Namzaric Capsule by Forest Lab USFDA
N/A
Firm has been granted new DML dated 25-08-2016
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)GMP of Alphamed, Formulations, India is attached. Valip upto 27-12-2016. (GMP is expired).
COA of pellets is attached imported from India.
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
30. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
ALZAR 7/10mg CapEach Extended release Capsule contains: Memantine Hydrochloride……7mg,(Extended Release Pellets), Donepezil Hydrochloride…….10mg
NMDA receptor Antagonist
Form 5-DDy no. 439 17/11/2016Fee RS 50,000/-9-11-2016Fee Rs 50,00022-12-201610’s14’s
Namzaric Capsule by Forest Lab USFDA
N/A
Firm has been granted new DML dated 25-08-2016
Stability data along with relevant documents are not provided.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
Minutes for 266th Meeting of Registration Board. 157
20’s28’s
Price as per SRO
GMP of Alphamed, Formulations, India is attached. Valip upto 27-12-2016. (GMP is expired).
COA of pellets is attached.
31. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
CARYLAR 1.5mg CapEach Capsule contains:Cariprazine (As Hydrochloride) …………1.5 mg
Atypical antipsychotic
Form 5-DDy No. 45317-11-2016PKR 50,00010’s14’s20’s28’s
Price As per SRO
Vraylar by Forest RES INST INC, USFDA approved
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
32. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
Carylar 4.5mg Cap
Each Capsule contains: Cariprazine (As Hydrochloride)…....4.5 mg
Atypical antipsychotic
Form 5-DDy No. 45717-11-2016PKR 50,00010’s14’s20’s28’sPrice As per SRO
Vraylar by Forest RES INST INC, USFDA approved
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
33. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
CARYLAR 3mg Cap
Each Capsule contains:Cariprazine (As Hydrochloride) ……3 mg
Atypical antipsychotic
Form 5-DDy No. 45217-11-2016PKR 50,00010’s14’s20’s28’s
Vraylar by Forest RES INST INC,USFDA approved
N/A
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed BP. Specs and the product is not present in available
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
Minutes for 266th Meeting of Registration Board. 158
Price As per SRO
versions of BP and USP (B.P 2013 and USP 39)
34. M/s. Genetics Pharmaceuticals (Pvt) Ltd. 539-A Sundar Industrial Estate, Lahore
CARYLAR 6mg Cap
Each Capsule contains:Cariprazine (As Hydrochloride) ……6 mg
Atypical antipsychotic
Form 5-DDy No. 45517-11-2016PKR 50,00010’s14’s20’s28’s
Price As per SRO
Vraylar by Forest RES INST INC, USFDA approved
N/S
Firm has been granted new DML dated 25-08-2016
The product is not present in INCB Green List
Stability data along with relevant documents are not provided.
Firm has claimed BP. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for submission of stability data as per guidelines of 251st
DRB meeting
Case No. 5 Stability CasesStability Case 1
Sr. No.
Name & Address of
Manufacturer / Applicant
Brand Name(Proprietary Name +
Dosage Form + Strength),
Composition,Pharmacological
Group,Finished Product
Specification
Type of Form,Initial
Diary & Date, Fee (including differential
fee),Demanded Price / Pack
size
International Availability / Local
Availability
GMP Inspection Report Date &
Remarks
Previous DRB Decision / Remarks (if any)
1. M/s Barrett Hodgson Pakistan (Pvt.) Ltd.,
Karachi.
Ocudine Plus Eye Drops
Each ml contains:Olopatadine as HCl…1mgKetorolac Tromethamine…4mg
Anti-inflammatory
Form-5D
Diary No.115/15. AD(II)16-03-2015
Rs. 50,000/-
Rs. 385.50/-5ml(or as per SRO)
Duplicate
Acupat Eye Drops by Allergan, India.
Not applicable
Inspection conducted on 02-02-2016 shows good GMP compliance.
Pharmaceutical Development Studies, Validation of Analytical Methods and Process Validation are not submitted.
Approval of applied formulation in reference authorities has not been not confirmed.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
STABILITY STUDY DATA
Drug Ocudine Plus Eye DropsName of Manufacturer M/s Barrett Hodgson Pakistan (Pvt.) Ltd.,
Minutes for 266th Meeting of Registration Board. 159
Manufacturer of API Olopatadine HCl: Indoco Remedies Ltd., India.Ketorolac Tromethamine: Hetero Drugs Ltd., India.
API Lot No. Olopatadine HCl: RK15OTH001, RK14OTH001Ketorolac Tromethamine: 2KL0761214, 2KL0680715
Description of Pack(Container closure system) LDPE bottle
Stability Storage Condition Accelerated: 40°C ± 2°C / NMT 25%RHReal Time: 30°C ± 2°C / NMT 35% ± 5%RH
Time Period Accelerated: 6 MonthsReal Time: 6 Months
Frequency Accelerated: 0,4,12,26 (Weeks)Real Time: 0,12,26 (Weeks)
Batch No. EXP-OP-157 PLT-OP-001 PLT-OP-002Batch Size 500ml 1,000ml 1,000mlManufacturing Date February 2015 May 2016 May 2016Date of Initiation February 2015 May 2016 May 2016No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. No. Documents To Be Provided Status
1. COA of API Yes
2.Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin.
Indoco: Name of API (Olopatadine HCl) not mentioned in scope of inspection. Hetero Drugs: Not provided
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc. Yes
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents. Yes
7. Commitment to continue real time stability study till assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
Minutes for 266th Meeting of Registration Board. 160
REMARKS OF EVALUATOR(AD PEC-I)
GMP Certificate of API Manufacturer:o Indoco: Name of API (Olopatadine HCl) not mentioned in scope of inspection.o Hetero Drugs: Not provided.
Justify the conditions mentioned for Relative Humidity as follows:o Accelerated: NMT 25%RH.o Real Time: NMT 35% ± 5%RH.
Pharmaceutical Development Studies, Validation of Analytical Methods and Process Validation are not submitted.
International availability referred to Acupat by Allergan India.
Decision: Registration Board deferred the case for following points: Evidence of approval for applied formulation by reference regulatory authorities Justification for conditions mentioned for Relative Humidity Analytical method validation data
Stability Case No 2
Sr. No.
Name & Address of
Manufacturer / Applicant
Brand Name(Proprietary Name +
Dosage Form + Strength),
Composition,Pharmacological
Group,Finished Product
Specification
Type of Form,Initial Diary &
Date, Fee (including
differential fee),Demanded
Price / Pack size
International Availability /
Local Availability
GMP Inspection
Report Date & Remarks
Previous DRB Decision /
Remarks (if any)
1. M/s Helix Pharma (Pvt) Ltd Karachi.
Sofoled 90mg/400mgTabletEach film coated tablet contains:-Ledipasvir……90mgSofosbuvir……400mg(Direct Acting Antiviral)
Form 5-DDairy No. 512dated 11-04-2016Rs.50,000/-As per SROAs per SRO
Harvoni, FDA.Harvoni, Ferozsons, Pakistan.
260th Meeting Registration Board held on 28-29th June, 2016.Deferred for rectification of mentioned deficiencies and submission of stability data
STABILITY STUDY DATA
Drug Sofoled tablets 400/90 mgName of Manufacturer M/s Helix Pharma Karachi.Manufacturer of API
Sofosbuvir Ruyuan HEC Pharm Co.,Ltd.Ledipasvir Ruyuan HEC Pharm Co.,Ltd.
API Lot No. Sofosbuvir YAK-EM201602201W1Ledipasvir YAX-201604002R1
Description of Pack(Container closure system) Alu/Alu blister packed in Unit carton with product insert
Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RHAccelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real Time: 6 MonthsAccelerated: 6 Months
Minutes for 266th Meeting of Registration Board. 161
Frequency Real Time: 0,1,2,3 & 6 (Months)Accelerated: 0,3 & 6 (Months)
Batch No. TF-001 TF-002 TF-003Batch Size 500 tablets 500 tablets 500 tabletsManufacturing Date June 2016 June 2016 June 2016Date of Initiation June 2016 June 2016 June 2016No. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. No. Documents To Be Provided Status
1. COAs of API Yes
2.Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin.
Yes(Copy of GMP
Certificates have been submitted)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc. Yes
5. Documents confirming import of API etc.
Yes(Copy of Invoices Attested by ADC Karachi has been
submitted)
6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents. Yes
7. Commitment to continue real time stability study till assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules, 1978. Yes
REMARKS OF EVALUATOR(AD PEC-II)
Firm has submitted Stability data as per guidelines of 251st RB meeting. Firm has used Ledipasvir in pure form whereas Innovator has used Ledipasvir Spray dried dispersion
as Ledipasvir is susceptible to the influence of gastrointestinal pH and fed state. Method of dissolution applied in stability study is different from that recommended by USFDA
Decision: Registration Board deferred the case for clarification of following points: Firm has used Ledipasvir in pure form whereas Innovator has used Ledipasvir Spray dried
dispersion as Ledipasvir is susceptible to the influence of gastrointestinal pH and fed state. Method of dissolution applied in stability study is different from that recommended by USFDA
Minutes for 266th Meeting of Registration Board. 162
Stability Case 3Sr. No.
Name &Address of
Manufacturer / Applicant
Brand Name(Proprietary Name +
Dosage Form + Strength),
Composition,Pharmacological
Group,Finished Product
Specification
Type of Form,Initial Diary&
Date, Fee (including
differential fee),Demanded
Price/ Pack size
International Availability /
Local Availability
GMP Inspection
Report Date & Remarks
Previous DRB
Decision / Remarks (if
any)
1. M/s The Schazoo Pharmaceutical Laboaratories PVT. LTD. 20kmLahore Jaranwala Road District Sheikhupura.
LIVANZA 30mg Film Coated Tablet, Oral
Each Film Coated Tablet contains;Daclatasvir(as Hydrochloride)…. 30mg
HCV Nucleotide Analogue
Form 5DDy. No. 102323/02/2016
Rs 20,00023/02/2016
Pack size (3 × 10)
Price 7,030/- per pack
Daclinza, MHRA approved
N/A
Last inspection report on 16/01/2010 confirms good level of GMP compliance.
The firm has claimed In House specifications.
STABILITY STUDY DATA
Drug Livanza 30mg film coated tablet (Daclatasvir)Name of Manufacturer M/s. The Schazoo Pharmaceutical Laboratories PVT. LTD.Manufacturer of API M/s Laurus Labs Private Limited, IndiaAPI Lot No. ADCTRVSP10050316Description of Pack(Container closure system)
Laminated Aluminum Foil (cold form) Packed in Bleach Board Carton.
Stability Storage Condition Real Time: 30’C +_ 2’C / 65%+_ 5%RHAccelerated: 40’C +_ 2’C / 75%+_ 5%RH
Time Period Real Time:4 MonthsAccelerated:6Months
Frequency Real Time:0,1,2,3,4 (Month)Accelerated:0,1,2,3,4,6,8,12,16,20,24,26 (weeks)
Manufacturing date June 2016 June 2016 June 2016Date of Initiation 28/06/2016 28/06/2016 28/06/2016Batch Nos. LN-T1-16 LN-T2_16 LN-T3-16Batch Size 2500 Tablets 2500 Tablets 2500 TabletsNo. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. No. Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc. Yes
5. Documents confirming import of API etc. Yes
Minutes for 266th Meeting of Registration Board. 163
6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents. Yes
7. Commitment to continue real time stability study till assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules, 1978. No
REMARKS OF EVALUATOR(AD PEC-I)
Fee submitted is only 20,000/- while required fee is 50,000/- as per requirement of form 5D. Provide Analytical Validation & Pharmaceutical Development. Commitment to follow drug specification rules 1978 is not provided. Provided data for long term tem stability is of 4 months while as per requirement data for 6
months shall be provided.Decision: Registration Board deferred the case for reasons as under:
Submission of differential fee of Rs. 30,000/- as per requirement of Form 5-D Submission of Analytical Method validation data Submission of long term stability data of remaining two months
Stability Case 4Sr. No.
Name &Address of
Manufacturer / Applicant
Brand Name(Proprietary Name +
Dosage Form + Strength),
Composition,Pharmacological
Group,Finished Product
Specification
Type of Form,Initial Diary&
Date, Fee (including differential
fee),Demanded Price/ Pack
size
International Availability /
Local Availability
GMP Inspection
Report Date & Remarks
Previous DRB Decision /
Remarks (if any)
1. M/s The Schazoo Pharmaceutical Laboaratories PVT. LTD. 20kmLahore Jaranwala Road District Sheikhupura.
LIVANZA 60 mg Film Coated Tablet, Oral
Each Film Coated Tablet contains;Daclatasvir(as Hydrochloride)…. 60mg
HCV Nucleotide Analogue
Form 5DDy. No. 102223/02/2016
Rs 20,00023/02/2016
Pack size (3 × 10)
Price 13,770/- per pack
Daclinza, MHRA approved
N/A
Last inspection report on 16/01/2010 confirms good level of GMP compliance.
The firm has claimed In House specifications.
STABILITY STUDY DATA
Drug Livanza 60 mg film coated tablet (Daclatasvir)Name of Manufacturer M/s. The Schazoo Pharmaceutical Laboratories PVT. LTD.Manufacturer of API M/s Laurus Labs Private Limited, IndiaAPI Lot No. ADCTRVSP10050316Description of Pack(Container closure system) Laminated Aluminum Foil (cold form), Pre printed aluminum foil.
Stability Storage Condition Real Time: 30’C +_ 2’C / 65%+_ 5%RHAccelerated: 40’C +_ 2’C / 75%+_ 5%RH
Time Period Real Time:4 MonthsAccelerated:6Months
Frequency Real Time:0,1,2,3,4 (Month)
Minutes for 266th Meeting of Registration Board. 164
Accelerated:0,1,2,3,4,6,8,12,16,20,24,26 (weeks)Manufacturing date June 2016 June 2016 June 2016Date of Initiation 28/06/2016 28/06/2016 28/06/2016Batch Nos. LN-T1-16 LN-T2_16 LN-T3-16Batch Size 2500 Tablets 2500 Tablets 2500 TabletsNo. of Batches 03
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. No. Documents To Be Provided Status
1. COA of API Yes
2.Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin.
Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc. Yes
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents. Yes
7. Commitment to continue real time stability study till assigned shelf life of the product. Yes
8. Commitment to follow Drug Specification Rules, 1978. No
REMARKS OF EVALUATOR(AD PEC-I)
Fee submitted is only 20,000/- while required fee is 50,000/- as per requirement of form 5D. Provide Analytical Validation & Pharmaceutical Development. Commitment to follow drug specification rules 1978 is not provided. Provided data for long term tem stability is of 4 months while as per requirement data for 6
months shall be provided.Decision: Registration Board deferred the case for reasons as under:
Submission of differential fee of Rs. 30,000/- as per requirement of Form 5-D Submission of Analytical Method validation data Submission of long term stability data of remaining two months
Minutes for 266th Meeting of Registration Board. 165
Case No. 6: Verification of authenticity of stability studyA follow up inspection of M/s Macter International Limited, F-216, S.I.T.E., Karachi
was carried out by a team of experts comprising of Prof. Dr. Rafeeq Alam Khan (Member Registration Board), Dr. Saif ur Rahman Khattak (Director, Central Drugs Laboratory, DRAP, Karachi) and Mrs. Muneeza Khan (Area FID, DRAP, Karachi) on 21st January, 2017 as per instructions of DRAP, Islamabad letter No. F.2-17/2016-PEC (M-263), dated 17th January 2017.
The inspection focused mainly on the areas as identified by the previous panel of experts during their inspection for the verification of stability data submitted by the firm in respect of their products namely Daclavir (Daclatasvir) 30mg and 60mg on 21st November 2016. The panel also evaluated other areas related to the production of tablets dosage form for compliance to cGMP. The observations and recommendations are communicated as under.
1. DACLAVIR 30mg TABLETS (Daclatasvir 30mg)
Sr. No.
Name &Address of Manufacturer /
Applicant
Brand Name(Proprietary Name + Dosage
Form + Strength), Composition,Pharmacological Group,
Finished Product Specification
Type of Form,Initial Diary& Date,
Fee (including differential fee),
Demanded Price/ Pack size
International Availability / Local
Availability
GMP Inspection Report Date &
Remarks
1. M/s Macter International LimitedKarachi.
Daclavir Tablets 30mgTabletEach film-coated tablet contains:Daclatasvir ….……...30mgChronic Hepatitis C (HCV) infection in adults.
Form 5 D with fee Rs. 50,000/- vide Dy. # 986, 3.4.2015.Each per tablet, per capsule, per 5ml, per inhalation etc:Rs.2000/ tabRs.28,000/14‘sRs.56,000/28‘s
Internationally available in USA as Daklinza 30 mg Tablet
2. DACLAVIR 60mg TABLETS (Daclatasvir 60mg)
Sr. No.
Name &Address of Manufacturer /
Applicant
Brand Name(Proprietary Name + Dosage
Form + Strength), Composition,Pharmacological Group,
Finished Product Specification
Type of Form,Initial Diary& Date,
Fee (including differential fee),
Demanded Price/ Pack size
International Availability / Local
Availability
GMP Inspection Report Date &
Remarks
1. M/s Macter International Limited. Karachi.
Daclavir Tablets 60mgTabletEach film-coated tablet contains:Daclatasvir ….……...60mgChronic Hepatitis C (HCV) infection in adults.
Form 5 D with fee Rs. 50,000/- vide Dy.# 984, dated 03.04.2015.Each per tablet, per capsule, per 5ml, per inhalation etc:Rs.3000/ tabRs.42,000/14‘sRs.84,000/28‘s
Internationally available in USA asDaklinza 60 mg Tablet
Minutes for 266th Meeting of Registration Board. 166
S. No.
Observations of previous inspection Current status
1. HVAC system is in-effective hence efficient cleaning of the area is impossible.
Efficiency of the related HVAC system has been increased by changing the filters and introduction of booster blowers and slight modification in designing. The system is also re-qualified.
2. False ceiling (where available) is broken and becoming source of contamination and inadequate control on the environment hence new ceiling with smooth surfaces is required.
New false ceiling with smooth surfaces has been introduced.
3. Wooden doors need to be replaced by any suitable and non-reactive material doors.
Wooden doors have been replaced with powder coated miled steel doors which is generally a non-reactive material.
4. No gauges are available to monitor the pressure differential.
New calibrated gauges have been installed and monitoring of pressure differential is properly made.
5. Compression machines and the mixers are very old and becoming the source of contamination and cross contamination.
Polishing/ painting and buffing of all machines in the production area have been done and strict monitoring and measures are also in-place to control the contamination and cross contamination.
6. Floors are highly stained and unsmooth which need to be improved by using non-reactive material.
Epoxy flooring has been introduced with overall smooth surfaces.
7. Overall monitoring and controls be improved to comply GMP regulations.
1. The HVAC system has been properly qualified along with the validation of the area.
2. Specific measures have also been made to control the bioburden.
3. The water system and the water (De-ionized) itself are properly qualified.
4. The compressed air to the area is also qualified.
5. The already executed cleaning validation has been based upon the worst case scenario where N Nitazoxanide and Alpha calcidol are the reference drugs. Since Daclatasvir is water soluble and permeable compound lying in BCS class 2 therefore does not warrant for further cleaning validation studies.
6. The light system in the production area is also as per established ASTM guidelines.
7. Measures have been made to have authorized entry to the production area.
8. The number of technical supervising staff has also increased.
Conclusion: Keeping in view the improvements and up gradations made by the firm in the tablet section to bring it compliant to cGMP, the panel is satisfied technically and scientifically to recommend the facility for the manufacturing of Daclavir (Daclatasvir) 30mg and 60mg tablets and also recommend registration thereof in the name of the firm.
Minutes for 266th Meeting of Registration Board. 167
Decision: Registration Board decided to approve registration of DACLAVIR (Daclatasvir) 30mg Tablets and DACLAVIR (Daclatasvir) 60mg Tablets by M/s Macter International Limited, F-216, S.I.T.E., Karachi. Manufacturer will place first three production batches on long term stability studies through proposed shelf life and on accelerated studies for six months
Case No.07: Import CasesA. Human Import Priority Cases
Sr.#
Name and address of
manufacturer /
Applicant
Brand Name
(Proprietary name + Dosage Form +
Strength)Compositio
nPharmacol
ogical Group
Finished product
Specification
Type of FormInitial date,diaryFee
including differenti
al fee
Demanded Price /
Pack size
Remarks on the
formulation (if any)
including International
status in stringent
drug regulatory agencies /
authorities
Me-too status
GMP status as depicted
in latest inspection
report (with date) by the Evaluator
Remarks of the
Evaluator.
Decision
New Formulation/Combination
1. 2. M/s. Servier Research andPharmaceuticals Pakaistan Private Limited, 65 MainBoulevard Gulberg, Lahore.ManufacturerM/s. Servier Ireland Industries Ltd,. Gorey Road, Arklow_Co. Wicklow Ireland.
TRIPLIXAM 5/1.25/5Film coated Tablet
Each film coated tablet contains;Perindopril Arginine…. 5mgIndapamide…. 1.25mgAmlodipine… 5mg
ACE inhibitorThiazide DiureticCalcium
Form 5ADy. No. 317420/12/16Fee 50,000/-Price not proposedPack size30’s, 60’s
Triplixam By ServeirANSM, FranceN/AOriginal legalized Medicinal Product Certificate of France issued on 25th July, 2014. The product is not in the market for free sale in country of origin. The GMP status of manufacturer is good.
The product has market authorization but it is not available in the market.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
The Registration Board was apprised that firm has provided fresh COPP on the first day of meeting which have not been scrutinized yet.The Board deferred application for consideration in next meeting with proper evaluation regarding fee
Minutes for 266th Meeting of Registration Board. 168
Agonist sale & other details of application.
3. 4. M/s. Servier Research andPharmaceuticals Pakaistan Private Limited, 65 MainBoulevard Gulberg, Lahore.ManufacturerM/s. Servier Ireland Industries Ltd,. Gorey Road, Arklow_Co. Wicklow Ireland
TRIPLIXAM 10/2.5/10Film coated Tablet
Each film coated tablet contains;Perindopril Arginine…. 10mgIndapamide…. 2.5mgAmlodipine…. 10mg
ACE inhibitorThiazide DiureticCalcium Agonist
Form 5ADy No. 317320/12/2016Fee 50,000/-PricePack Size
Triplixam By ServeirANSM, FranceN/AOriginal legalized Medicinal Product Certificate of France issued on 25th July, 2014.The GMP status of manufacturer is good.
The product has market authorization but it is not available in the market.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39).
The Registration Board was apprised that firm has provided fresh COPP on the first day of meeting which have not been scrutinized yet.The Board deferred application for consideration in next meeting with proper evaluation regarding fee sale & other details of application.
5. 6. M/s. Servier Research andPharmaceuticals Pakaistan Private Limited, 65 MainBoulevard Gulberg, Lahore.ManufacturerM/s. Servier Ireland Industries Ltd,. Gorey Road, Arklow_Co. Wicklow Ireland
TRIPLIXAM 5/1.25/10Film coated Tablet
Each film coated tablet contains;Perindopril Arginine…. 5mgIndapamide…. 1.25mgAmlodipine…. 10mg
ACE inhibitorThiazide DiureticCalcium Agonist
Form 5ADy No. 317620/12/2016Fee 50,000/-PricePack Size30’s & 60’s
Triplixam By ServeirANSM, FrnaceN/AOriginal legalized Medicinal Product Certificate of France issued on 25th July, 2014.The GMP status of manufacturer is good.
The product has market authorization but it is not available in the market.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39).
The Registration Board was apprised that firm has provided fresh COPP on the first day of meeting which have not been scrutinized yet.The Board deferred application for consideration in next meeting with proper evaluation regarding fee sale & other details of application.
7. 8. M/s. Servier Research andPharmaceuti
TRIPLIXAM 10/2.5/5Film coated Tablet
Form 5ADy No. 317520.12.201
Triplixam By ServeirANSM, Frnace
The product has market authorization but it is not
The Registration Board was apprised that
Minutes for 266th Meeting of Registration Board. 169
cals Pakaistan Private Limited, 65 MainBoulevard Gulberg, Lahore.ManufacturerM/s. Servier Ireland Industries Ltd,. Gorey Road, Arklow_Co. Wicklow Ireland
Each film coated tablet contains;Perindopril Arginine…. 10mgIndapamide…. 2.5mgAmlodipine…. 5mg
ACE inhibitorThiazide DiureticCalcium Agonist
6Fee Rs.50,000/-PricePack Size30’s & 60’s
N/AOriginal legalized Medicinal Product Certificate of France issued on 25th July, 2014.The GMP status of manufacturer is good.
available in the market.
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39).
firm has provided fresh COPP on the first day of meeting which have not been scrutinized yet.The Board deferred application for consideration in next meeting with proper evaluation regarding fee sale & other details of application.
9. 10. M/s Servier Research and Pharmaceuticals Private limited, 65- main Boulevard Gulberg,, Lahore.
ManufacturerLes Laboratories Servier Industrie, 905, route de Saran 45520 Gidy France
Cosyrel 10/10 Film Coated Tablet
Each Film coated tablet contains:Bisoprolol …10mgPerindopril Arginine …10mgBeta BlockerACE Inhibitor
Form 5-A
Dy. # 536, dated09-06-2016.Fee Rs.50,000/-
Price not proposed
Pack size10’s & 30’s
AcerycalHPRA, IrelandCosimprel By Serveir LithuaniaAsembix by serveir,Latvia
N.A
Original legalized COPP of France is attached which confirms the good level of GMP compliance.
The product has market authorization but it is not available in the market.
Firm has claimed Ph. Eur. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39).
Deferred for confirmation of free sale status in country of origin i.e. France
11. 12. M/s Servier Research and Pharmaceuticals Private limited, 65- main Boulevard Gulberg,, Lahore.
ManufacturerLes
Cosyrel 5/5 Film Coated Tablet
Each film coated tablet contains:Bisoprolol……5mgPerindopril Arginine…5mg
Form 5-A with fee Rs.50,000/- vide Dy. # 538, dated 09-06-2016.
Price not proposed
Pack size10’s & 30’s
Cosimprel by ServierHPRA, IrelandCosimprel By Serveir LithuaniaAsembix by serveir,Latvia
N.A
Original
The product has market authorization but it is not available in the market.
Firm has claimed Ph. Eur. Specs and the product is not present in available versions of
Deferred for confirmation of free sale status in country of origin i.e. France
Minutes for 266th Meeting of Registration Board. 170
Laboratories Servier Industrie, 905, route de Saran 45520 Gidy France
Beta BlockerACE Inhibitor
legalized COPP of France is attached which confirms the good level of GMP compliance.
BP and USP (B.P 2013 and USP 39).
13. 14. M/s Servier Research and Pharmaceuticals Private limited, 65- main Boulevard Gulberg,, Lahore.
ManufacturerLes Laboratories Servier Industrie, 905, route de Saran 45520 Gidy France
Cosyrel 10/5 Film Coated Tablet
Each film coated tablet contains:Bisoprolol ……10mgPerindopril Arginine …5mg
Beta BlockerACE Inhibitor
Form 5-A with fee Rs.50,000/- vide Dy. # 539, dated 09-06-2016.
Price not proposed
Pack size10’s & 30’s
Cosimprel by ServierHPRA, IrelandCosimprel By Serveir LithuaniaAsembix by serveir,LatviaN.AOriginal legalized COPP of France is attached which confirms the good level of GMP compliance.
The product has market authorization but it is not available in the market.
Firm has claimed Ph. Eur. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Deferred for confirmation of free sale status in country of origin i.e. France
15. 16. M/s Servier Research and Pharmaceuticals Private limited, 65- main Boulevard Gulberg,, Lahore.
ManufacturerLes Laboratories Servier Industrie, 905, route de Saran 45520 Gidy France
Cosyrel 5/10 Film Coated Tablet
Each film coated tablet contains:Bisoprolol ………5mgPerindopril Arginine .....10mg
Beta BlockerACE Inhibitor
Form 5-A with fee Rs.50,000/- vide Dy. # 537, dated 09-06-2016.
Price not proposed
Pack size10’s & 30’s
Cosimprel by ServierHPRA, IrelandCosimprel By Serveir LithuaniaAsembix by serveir,Latvia
N.AOriginal legalized COPP of France is attached which confirms the good level of GMP compliance
The product has market authorization but it is not available in the market.
Firm has claimed Ph. Eur. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39).
Deferred for confirmation of free sale status in country of origin i.e. France
Blood Bags
17. 18. M/s Briogene Pvt Ltd, 303,
MACOPHARMA Blood Bags
Form 5ADy. No.3022
The product is registered by TGA
Deferred for submission of following
Minutes for 266th Meeting of Registration Board. 171
Progressive Centre, Block 6, PECHS, Sharah e Faisal, Karachi.ManufacturerMaco Pharma Rue lorthiois-59420 Mouvaux France
Triple Blood Bags with anti coagulant and preservative solution.The firm has applied for two models,1. MRE6506LO triple blood bags with CPDA1, for collection of 450ml ± 10% of blood.2. MRE7506LO triple blood bags with CPDA1 for collection of 500ml ± 10% of blood.Ph. Eur. Specs for constituents for anti- coagulants
19/12/2016Fee 50,000/- 08/12/2016 & Fee 50,000/- 19/12/2016Price not proposedPack size24 per box
Australia (Certificate attached)N/ACertificates attached:1. EC certificate2. ISO 13485 certificate3. Certificate of registration4. Certificate of conformity5. Copy of Free sale certificate
original & legalized documents :
Free sale certificate from France
ISO 13485 certificate
19. 20. M/s Briogene Pvt Ltd, 303, Progressive Centre, Block 6, PECHS, Sharah e Faisal, Karachi.ManufacturerMaco Pharma Rue lorthiois-59420 Mouvaux France
MACOPHARMA Blood BagsQuadruple Blood Bags with anti-coagulant and preservative solution, the firm has applied for two models,1. MQE6506LO Quadruple blood bags with CPDA1, for Collection
Form 5ADy. No.302119/12/2016Fee 50,000/- 08/12/2016 & Fee 50,000/- 19/12/2016Differential Fee 50,000/-08/12/2016
Price not proposed
The product is registered by TGA Australia (Certificate attached)N/ACertificates attached:1. EC certificate2. ISO 13485 certificate3. Certificate of registration4. Certificate of conformity5. Copy of Free sale certificate
Deferred for submission of following original & legalized documents :
Free sale certificate from France
ISO 13485 certificate
Minutes for 266th Meeting of Registration Board. 172
of 450ml ± 10% of blood.2. MQE7506LO Quadruple blood bags with CPDA1 for collection of 500ml ± 10% of blood.Ph. Eur. Specs for constituents for anti- coagulants
Pack size24 per box
21. 22. M/s Briogene Pvt Ltd, 303, Progressive Centre, Block 6, PECHS, Sharah e Faisal, Karachi.ManufacturerMaco Pharma Rue lorthiois-59420 Mouvaux France
Macopharma Blood BagsDouble Blood Bags with anti cosgulsnt and preservative solution, the firm has applied for two models.1.MDE6502LO Double blood bags with CPDA1 for collection of 450ml ± 10% of blood.2.MDE7501LO double blood bads with CPDA1, for collection of 500ml ± 10% of blood.Ph. Eur. Specs for constituents for anti- coagulants
Form 5ADy. No.302319/12/2016Fee 50,000/- 08/12/2016 & Fee 50,000/- 19/12/2016Price not proposedPack size24 per box
The product is registered by TGA Australia (Certificate attached)N/ACertificates attached:1. EC certificate2. ISO 13485 certificate3. Certificate of registration4. Certificate of conformity5.Copy of Free sale certificate
Deferred for submission of following original & legalized documents :
Free sale certificate from France
ISO 13485 certificate
23. 24. M/S. Briogene
MACOPHARMA
Form 5ADy No.
The product is registered
Deferred for submission of
Minutes for 266th Meeting of Registration Board. 173
PvtLtd 303, Progressive centre, Block 6, PECHS, Sharah e faisal, Karachi 75400-PakistanManufactured byMaco Pharma Rue lorthiois-59420 Mouvaux France
Blood BagsSingle Blood Bag with anti-coagulant and preservative solution, the firm has applied for;MSE6501LO Single blood bag with CPDA1, for collection of 450 ± 10% of blood.Ph. Eur. Specs for constituents for anti-coagulants
163022-08-16Fee 20,000/- 22/08/2016 & 50,000/-19/12/2016 & 30,000/-08/12/2016Total fee 100,000/-Price not proposedPack size24 per pack
by TGA Australia (Certificate attached)N/ACertificates attached:1. EC certificate2. ISO 13485 certificate3. Certificate of registration4. Certificate of conformity5. Copy of Free sale certificate
following original & legalized documents :
Free sale certificate from France
ISO 13485 certificate
25. 26. M/s Pharmatec Pakistan PVT LTDManghopir Road, SITE, Karachi.ManufacturerMinarini Manufaturing Logistics and Services S.r.I Via Campo Di Pile, Italy
BILAXTEN 20mg Tablet
Each tablet contains:Bilastine…… 20mg
Anti Histamine
Form 5A
Dy. No. 142129/11/2016Fee 50,000/-PriceRs 300/- for 10’sRs 600 for 20’sPack size10’s & 20’s
Ilaxten 20mg tablet, by Amerinin farmaceutica international, MHRA approvedN/AOriginal Legalized COPP issued by AIFA ITALI confirms the good level of GMP compliance. The product is in the market of the country of origin.GMP certificate issued by AIFA is also attached
Firm has claimed Mfg. Specs and the product is not present in available versions of BP and USP (B.P 2013 and USP 39)
Approved with innovator’s specs
B. Veterinary Import (Priority) Cases
27.M/s Ghazi Brothers, Ghazi House, D-
Antitermyl Water Soluble Powder
Form 5-ADy No. 7655PKR
International availability not provided
Firm has claimed Mfg. Specs and the product is not
Deferred for review of formulation by Dr. Qurban
Minutes for 266th Meeting of Registration Board. 174
35. K.D.A. Scheme No.1, Miran Muhammad Shah Road, Karachi-75350 /
Manufactured by:
M/s. CEVASA S.A.23rd Street Nº 293 - Pilar Industrial Park, Pilar, State of Buenos Aries, Argentina.
Dosage form: Water Soluble oral Powder
Each 100 gram contains:-Acetyl Salicylic Acid…17gmCaffeine ………..2gmVitamin C (Ascorbic acid) ……….3gm(Non-steroidal Anti-inflammatory, Xanthine derivative, Vitamin).
50,000/-Dated: 16-05-2013
Pack size: 100g, 1 kg, 5Kg
Price: De controlled
N/A
Original legalized free sale certificate of argentina is attached which confirms the free sale of product in country of origin.GMP Status: Certificate issues on 11October 2012 by Argentina
present in available versions of BP and USP (B.P 2013 and USP 39)
Ali. (Member Registration Board)
Case No. 8: Miscellaneous Cases
A. Deferred Cases of Itopride 50mg Tablets
Itopride 50mg tablets were deferred for review since 242nd meeting of registration board for confirmation of reference of registration in PMDA Japan. The reference for Itopride 50mg tablets was confirmed from PMDA Japan and 12 previously deferred cases were presented before the Board in 265th DRB Meeting. The following cases were missed and are hereby presented before the Board.
Sr.# Name and address of
manufacturer / Applicant
Brand Name(Proprietary
name + Dosage Form + Strength)
CompositionPharmacologi
cal GroupFinished product
Specification
Type of Form
Initial date,diaryFee
including differential
feeDemanded
Price /Pack size
Remarks on the
formulation (if any) including International
status in stringent drug
regulatory agencies /
authoritiesMe-too statusGMP status as
depicted in latest
inspection report (with date) by the Evaluator
Decision of previous meeting
Decision of 266th
DRB meeting
1. M/s AGP Limited, B-23, S.I.T.E,
Tablet ProkinEach tablet contains:
30-11-2010Dy.No.335 Form 5
Ganaton –JapanGanaton –
Deferred for confirmation of approval status
Approved with innovator’s specs
Minutes for 266th Meeting of Registration Board. 175
KarachiPriority # 641
Itopride HCl 50mg(Gastro prokinetic )
Rs.8000/-Rs.12,000/-05-09-2013 PhotocopyPack size of10s Rs. 165/-
Abbott
Inspection report dated 10-06-2015Recommends renewal of DML
of formulation in PMDA Japan(259)
Reference will be sent to Budget & accounts Division for verification of challan & Chairman registration Board will authorize issuance of registration letter
2. M/s. Alson Pharmaceuticals, Peshawar
Alsoton TabletsEach film coated tablet contains:-Itopride Hydrochloride….50 mg(Dopamine D2 receptor antagonist)
2x8’sAs Per SRO
Ganaton –JapanGanaton – Abbott
Deferred till the payment of CRF, latest inspection report and correction of Master formulation and M.O.P. (238)
Deferred for review of formulation (250)
Deferred for confirmation of following details of file: Date & Diary number of submission Details of fee submission
3. M/s IcebergPharmaceuticals(Pvt) Ltd, Plot #144, NowsheraIndustrial Estate,Risalpur, KPK
Icepride TabletEach Tabletcontains ItoprideHCl 50mg.Gastroprokinetics
Form-517-06-2015 diaryNo 227.Rs20,000As per SRO/1x10 tabletblister pack.
International availability isnot provided.2. Strength of active ingredientsare given in salt form,however calculations foractive are not given in saltform, which requiresjustifications.3. Role of inactive ingredientsand justification of quantitiesused is not provided.4. The firm has mentionedProduction Manager/inchar
Deferred forrectification ofshortcomingsandconfirmationof formulationby referencedrugregulatoryauthorities(M-252)
Registration board deferred for want of information as under: Strength of active ingredients are given in salt form, however calculations for active are not given in salt form, which requires justifications. Role of inactive ingredient and justification of quantities used is not provided. The firm has mentioned Production Manager/incharge Javed Iqbal in
Minutes for 266th Meeting of Registration Board. 176
ge Javed Iqbal in Form-5 whilein DML approved staff forproduction is Mr. NajeebUllah, which requiresclarification.5. Approval of section is notattached.6. Specifications of raw materialare incomplete and thespecifications of excipientsare not given.7. Master formulation is notprovided by the firm.8. Finished productspecifications are incomplete.
Form-5 while in DML approved staff for production is Mr. Najeeb Ullah, which requires clarification. Approval of section is not attached
Master formulation is not provided by the firm. Finished product specifications are incomplete
4. M/sUnipharma(Pvt) Ltd.4.5kmManga-RaiwindRoad Lahore.
Unipride TabletEach Tabletcontains:Itopride HCl……..50mg(Antispasmodicandgastroprokinetic)
Form-5Dy. No: 1532Rs.8000/-Dated: 08-06-2011Rs.12,000/-Dated: 31-07-2013Rs.150/1x10’s
Productliterature ofGanaton 50 mg(Abbott, Japan)shows that thedrug isavailable inJapan since1983.However, samecannot be verified fromPDMA asofficial websiteprovidesinformationfrom 2004-2014JapanMe-too:GanatonItopride HCl50mgof AbbottLaboratories(Pakistan)Limited.
Deferred forprovision ofcommitmentrequired by the firm(as approved in 251stmeeting)Proposed shelf life ofthe drug is 3 years inthe dossier (max.2 years). As approved in251st meeting of RB). Detail of coatingmaterial is notprovided.Documents in the dossier are not signed by QC & production manager.
Approved with innovator’s specs.
Minutes for 266th Meeting of Registration Board. 177
Last GMPinspection wasconducted on23-01-2015
(Deferred forconfirmation ofavailability offormulation inPDMA Japan in 250thmeeting of RB) (M-255)
Deferred asformulationis under review.(M-257)
5. M/s OBSPakistan (Pvt)Ltd, C14 SITEKarachi.
Obspride 50mgTabletEach film coated tablet contains:Itopride hydrochloride…50mg(Gastroprokinetic agent)
Form-5Dy. No: 1507Dated.05.08.2013Rs.20,000/-Rs.176.47/10’s,
Ganaton (Abbott)
Deferred as per250th meeting ofRB forconfirmation ofavailability ofthis formulationin PMDA Japan(M-257)
Approved with innovator’s specs.
6. M/s MedicraftPharmaceuticalsPvt Ltd,Hayatabad,Peshawar.
Gastopride 50mgTabletsEach tablet contains:-Itopride HCl……50mg(Gastroprokinetic)
Form-525-03-2013vide diaryNo. 176 R&IRs.20,000.As per SRO.
Ganaton byM/s Abbott.Firm is GMPcompliant asper inspectiondated 29-07-2015
Deferred asper decisionof the Boardin 250th meeting‘DeferredFor confirmationofavailabilityofformulationin PMDAJapan’(M-258)
Approved with innovator’s specs.
7. M/s Medisearch Pharmacal (Pvt.) Ltd, 5km, Raiwind Manga Road, LahorePriority # 669
Gerd Cure TabletEach tablet containsItopride HCl …50mg(prokinetic / antiemetic)
31-08-2012 Dy # 85568000/- Form 512000/05 -11-2013Pack size3 x 10 Rs. 425/-
Ganaton –AbbottGMP compliant section vide inspection report dated
Deferred as product is under review and latest inspection report of the firm conducted within one year and decision of CLB on recommendation of PQCB, Punjab(M-260)
Deferred for confirmation of GMP status from QA/L&T Division
Minutes for 266th Meeting of Registration Board. 178
B. Registration of Drugs not included in List-1Following application was received through Letter No. F 6-2/2016(R-III) dated 19 th January, 2017 for the subject cited above. According to the letter, the firm has applied on 03-03-2014 with complete fee 20,000/- submitted on 28-02-2014, but this application was missed in all lists sent to Pharmaceutical Evaluation Cell. The application has now been evaluated and hereby presented before the board. Sr.#
Name and address of manufacturer / Applicant
Brand Name(Proprietary name + Dosage Form + Strength)CompositionPharmacological GroupFinished product Specification
Type of FormInitial date, diaryFee including differential feeDemanded Price / Pack size
Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authoritiesMe-too statusGMP status as depicted in latest inspection report (with date) by the Evaluator
Remarks by Evaluator
Decision
1. M/s Werrick Pharmaceuticals
Islamabad
Progesic Extra TabletsEach Film Coated Tablet contains:Paracetamol…. 325mgTramadol HCL …. 37.5 mg
Analgesic
USP Specs
Form 528-02-2014
Dy. No. 661
20,00028-02-2014
10’s20’s30’s
As per SRO
Tramacet tabletBy Grunenthal
Ltd(MHRA
Approved)
Tonoflex P tablet by Sami
PharmaLast inspection
report dated2-2-2017
recommends the renewal of
DML
Approved
Minutes for 266th Meeting of Registration Board. 179
B. Miscellaneous cases.Case No.01: Drug Product Specifications.
Registration Board in 264th meeting made following observation / decision regarding
the drug product specification assigned to the registered drugs.
“Registration Board noticed that some manufacturers are misleading / mis-interrupting the term Manufacturer’s/In-house/company’s specifications in non-compliance to Drug (Specification) Rules, 1978. It was further noticed that for products that are not yet included in the pharmacopeia of reference regulatory authorities, then Manufacturer’s/In-house/company’s specifications approved by the Board is actually based on innovator’s company specifications approved by the regulatory authority of any reference country including USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway or drugs registered in atleast three European Union counties. Moreover, drug products registered with any official pharmacopoeial specifications shall follow specifications present in the latest edition of that publication.
WHO Specifications shall be followed for biological products, vaccines or other
drugs where pharmacopeial reference of reference regulatory authorities is not available,
but WHO recommended it for developing countries.”
In view of the above decision of the Board, while mentioning specifications for non pharmacopeial products “as per innovator’s specification”, the existing condition in Form-6 regarding drug product specification has been re-drafted/elaborated as under:-
The registered drugs shall conform to the specifications of official pharmacopoeia as provided in the Rules. However, if the drug is not yet included in any of the pharmacopoeia, it shall conform to the innovator’s company specifications as approved by the regulatory authority of any reference countries specified by the Registration Board subject to compliance of Drug (Specifications) Rules, 1978. The innovator’s specifications, however, are valid only till inclusion of the product in the official pharmacopoeia of reference countries as specified by the Registration Board.
Decision: Registration Board reviewed the matter in the light of its earlier decision and decided that for non-pharmacopeial products “as per innovator specifications” may be mentioned as specifications and further revised the conditions regarding specifications of the product as under:
i. The registered drugs shall conform to the specifications of pharmacopoeial reference as provided in the Rules. In case, if the drug is not yet included in any of the pharmacopoeia, it shall conform to the innovator’s company specifications as approved by the regulatory authority of any reference countries specified by the Registration Board subject to compliance of Drug (Specifications) Rules, 1978. The innovator’s specifications, however, are valid only till inclusion of the product in the official pharmacopoeia of reference countries as specified by the Registration Board.
ii. WHO Specifications shall be followed for biological products, vaccines or other drugs where such products are not included in the official pharmacopoeia of reference countries as specified by the Registration Board.Registration Board further advised that all the registrations letters of approved
products pending due to clarification regarding specifications of the product, should be issued immediately without waiting for the minutes.
Minutes for 266th Meeting of Registration Board. 180
Registration-I
Case No.02: Grant of additional packs of already registered drugs.
M/s. Selmore Pharmaceuticals (Pvt) Ltd., Lahore has applied for approval of
additional packs of their following registered veterinary drug for use in close shed poultry
farming where flock size is very high.
S. No. Regn. No. Name of Drug/ Composition
Existing Pack Demanded Additional Pack
1. 035150 Tilcosin SolutionEach ml contains:-Tilmicosin…….250mg
60ml120ml250ml
500ml1000ml
M/s. Selmore Pharmaceuticals (Pvt) Ltd., Lahore has deposited the required fee Rs.10,000/-
and submitted following supporting documents:-
i) Copy of registration letter.ii) Copy of Drug Manufacturing License.iii) Copy of renewal status.iv) Copy of CRF.
The packs of 500ml & 1000ml are already given to different firms.
Decision: Registration Board approved the grant of additional packs of 500ml and 1000ml for Tilcosin Solution (Reg.No. 035150) on same terms and conditions.
Minutes for 266th Meeting of Registration Board. 181
Registration-IICase No.03: Registration of drug after grant of NOC. a) M/s Scilife Pharma (Pvt) Limited Plot # FD-57/58-A2, Korangi Creek Industrial Park
(KCIP), Karachi has applied for change of registration from the name of M/s Opal
Laboratories to their name:-
S.# Regn. No.
Brand Name with Generic Initial Registration Letter Date
Last Renewal
submission date
Applied for Change of
registration
Status in reference
drug agencies
1. 076365 Glusimet 50mg/1000mg tabletEach film coated tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin……..50mgMetformin HCl…..1000mg
22.04.2014 Renewal not yet due
09.01.2017 MHRA, UKJanumet 50/1000Merck, Sharp & Dohme Limited
2. 076370 Glusit 100mg tabletEach film coated tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin……100mg
22.04.2014 Renewal not yet due
09.01.2017 MHRA, UKJanuvia100 mgMerck, Sharp & Dohme Limited
3. 076369 Glusit 50mg tabletEach film coated tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin……50mg
22.04.2014 Renewal not yet due
09.01.2017 MHRA , UKJanuvia50 mgMerck, Sharp & Dohme Limited
4. 076366 Glusimet 50mg/500mg tabletEach film coated tablet contains:Sitagliptin phosphate monohydrate eq. to Sitagliptin…….50mgMetformin HCl……500mg
22.04.2014 Renewal not yet due
09.01.2017 US FDAJanumet50/500MERCK SHARP DOHME
In support the firm has submitted following documents:i. Application on form 5 with Rs. 20,000/- as prescribed fee for each product.
ii. NOC from M/s Getz Pharma and M/s Opal Laboratories, Karachi respectively.iii. Copy of registration letter and renewal status.iv. Undertaking of not have same product registration.v. A copy of DML of M/s Scilife Pharma, Karachi dated 01.06.2016.
vi. Copy of last panel inspection dated 29.03.2016Decision: Registration Board decided as follows:
Cancellation of registration of products Glusimet 50mg/1000mg tablet, Glusit 100mg tablet, Glusit 50mg tablet, Glusimet 50mg/500mg tablet from M/s Opal Laboratories, Karachi.
Approved grant of registration of products mentioned at serial number 1-4 in the name of M/s Scilife Pharma (Pvt) Ltd., Karachi. Reference will be sent to Cost & Pricing Division for confirmation of MRP of the product.
Minutes for 266th Meeting of Registration Board. 182
b) M/s Scilife Pharma (Pvt) Limited Plot # FD-57/58-A2, Korangi Creek
Industrial Park (KCIP), Karachi has applied for change of registration from the name of M/s
Getz Pharma, Karachi and M/s Opal Laboratories (S.No 11-13) respectively to their name:-
S.# Regn. No.
Brand Name with Generic
Initial Registration Letter Date
Last Renewal
submission date
Applied for Change of
registration
Status in reference
drug agencies
NOC from
1. 061705 Trupril 20mg TabletEach tablet contains:Lisinopril as Dihydrate…..20mg(USP Specification)
15.07.2010 03.07.2015 14.11.2016Renewal is OK
USFDA M/s Getz
2. 067315 Norplat 150mg TabletsEach film coated tablet contains:Clopidogrel……150mg
29.12.2010 16.10.2015 14.11.2016Renewal is OK
International availability
not confirmed
M/s Getz has issued NOC for Norplat 300mg
3. 066914 Scitin 8mg TabletsEach tablet contains:Betahistine dihydrochloride…..8mg
18.10.2010Change of brand name08.03.2011
12.01.2016 14.11.2016Renewal is OK
MHRA, UKBetahistineAurobindo Pharma-
Milpharm Ltd
-do-
4. 066915 Scitin 16mg TabletsEach tablet contains:Betahistine dihydrochloride…..16mg
18.10.2010Change of brand name08.03.2011
12.01.2016 14.11.2016Renewal is OK
MHRA, UKBetahistineAurobindo Pharma-
Milpharm Ltd
-do-
In support the firm has submitted following documents:i. Application on form 5 with Rs. 20,000/- as prescribed fee for each
product.ii. NOC from M/s Getz Pharma , Karachi
iii. Copy of registration letter and renewal status.iv. Undertaking of not have same product registration.v. A copy of DML of M/s Scilife Pharma, Karachi dated 01.06.2016.
vi. Copy of last panel inspection dated 29.03.2016Decision: Registration Board decided as follows:
Cancellation of registration of products at S.No. 1, 3 and 4 from M/s Getz Pharma, Karachi.
Deferred product at S.No.02 for NOC of M/s Getz Pharma, Karachi. Approved grant of registration of products mentioned at S.No. 1, 3 and 4 in
the name of M/s Scilife Pharma (Pvt) Ltd., Karachi. Reference will be sent to Cost & Pricing Division for confirmation of MRP of the product.
Minutes for 266th Meeting of Registration Board. 183
Case No.04: Request by firm for De-registration of pharmaceutical Drug ProductM/s Abbott, Karachi has requested the Registration Board to de-register their
following registered product.
S.No
Reg. No Name of Drug(s) & Composition
Pack Size Initial Date of Registration
Reason for De-registerion
1 005407 Isoptin InjectionEach ml contains:Verapamil HCL….. 2.50 mg
5 x 2 ml 27th June, 1997
“We do not have significant demand of the said product from market justifying our minimum order quantity”
Decision: Registration Board did not accede to the request of M/s Abbot, Karachi and directed the firm to ensure availability of Isoptin Injection in the country.
Case No.05: Re-grant of Drugs Manufacturing License to M/s. Kohs Pharmaceuticals (Pvt) Ltd., Plot No. P/8, S.I.T.E Hyderabad
Drugs Manufacturing License (DML) of M/s. Kohs Pharmaceuticals (Pvt) Ltd., Plot
No. P/8, S.I.T.E Hyderabad (DML No. 000132) was declared invalid by the Drug Licensing
Division, DRAP. The DML was again granted on 17-10-2015 with same license number .i.e.
(DML No. 000386).
The case was also discussed in the 265th meeting of Registration Board where
representative of the firm admitted for re-grant of drugs manufacturing license. The case is
submitted for consideration of Registration Board with regards to deliberation on status of
registration of drugs registered with the firm after its DML was declared invalid.
Decision: Registration Board observed that as a result of declaration of Drug Manufacturing License invalid, the registration of drugs of Kohs Pharmaceuticals (Pvt) Ltd., Plot No. P/8, S.I.T.E Hyderabad shall also become invalid. The firm, therefore, has to apply a fresh for getting registration of the products after grant of (re-grant) of Drug Manufacturing License. These applications, however, will be given priority consideration in view of the position explained above.
Minutes for 266th Meeting of Registration Board. 184
Registration-IV
Case No.06: Re-grant of Drugs Manufacturing License to M/S Rakaposhi Pharmaceuticals, Peshawar.
The drugs manufacturing license of M/s. Rakaposhi Pharmaceuticals, Hayatabad
Industrial Estate, Peshawar (DML NO.000386) was declared invalid by the Drug Licensing
Division, DRAP, vide letter dated 26th May, 2015 as the application for renewal of DML
from 21-6-2014 to 20-6-2019 was received seven months after due date of renewal i.e. 21-6-
2014.
Subsequently the Licensing Division vide letter dated 5 th August, 2015 Board
informed that the Central Licensing Board in its 242nd meeting held on 8th July, 2015 has
approved the grant (re-grant) the Drug Manufacturing License with same license number .i.e.
(000386).
The case is submitted for consideration of Registration Board with regards to status of
registration of drugs registered with the firm after its DML was declared invalid.
Decision: Registration Board observed that as a result of declaration of Drug Manufacturing License invalid, the registration of drugs of M/s Rakaposhi Pharmaceuticals, Hayatabad Industrial Estate, Peshawar shall also become invalid. The firm, therefore, has to apply a fresh for getting registration of the products after grant of (re-grant) of Drug Manufacturing License. These applications, however, will be given priority consideration in view of the position explained above.
Minutes for 266th Meeting of Registration Board. 185
Registration-V
Case No.07: Change in formulation / change of description of dosage form
a. M/S. Schazoo Zaka (Pvt) Ltd, Sheikhupura
M/s. Schazoo zaka (Pvt), Ltd, Sheikhupura has requested for change of description of
dosage form from Syrup to Suspension of below mentioned product as per detail below:-
S. No
Reg No. Name of Drug (s) & Composition Proposed New Dosage form
1 013084 Rifapin H Dry SyrupIsoniazid……………………….50mgRfiampicin……………………..100mg
Rifapin Suspension
According to firm Assistant Director (I&E), DRAP, Lahore has pointed out that
“Rifapin-H Dry Syrup is registered product but it is mentioned as Rifapin H Dry Suspension
on COA, and invoices etc”.
Firm informed that they are already manufacturing dry powder suspension instead of
syrup. Moreover no fee has been deposited in this regard by considering it correction in
registration letter. There is no evidence of approval of liquid formulation (syrup/suspension)
containing Rifampicin and Isoniazid in reference regulatory authority or WHO.
Decision: Registration Board deferred the case for confirmation of approval status of applied formulation in reference regulatory authorities / WHO.
b. M/S. Don Valley Pharmaceuticals (Pvt), Ltd, Lahore.
M/s. Don Valley Pharmaceuticals (Pvt), Ltd, Lahore has requested for change of
dosage form of their registered products as per detailed below:-
S.No. Reg.No. Existing Formulation Proposed Formulation1 017758 Clamentin Syrup
Each 5ml contains:-Amoxycillin trihydrate eq to:Amoxycillin (as trihydrate)……..250mgClavulenic acid (as potassium salt)……..62.5mg
Clamentin SuspensionEach 5ml contains:-Amoxycillin trihydrate eq to:Amoxycillin (as trihydrate)……..250mgClavulenic acid (as potassium salt)……..62.5mg
2. 017394 Clamentin SyrupEach 5ml contains:-Amoxycillin trihydrate eq to:Amoxycillin (as trihydrate)……..125mgClavulenic acid (as potassium salt)……..32.8mg
Clamentin SyrupEach 5ml contains:-Amoxycillin trihydrate eq to:Amoxycillin (as trihydrate)……..125mgClavulenic acid (as potassium salt)……..32.8mg
Minutes for 266th Meeting of Registration Board. 186
Firm has submitted following documents
i. Initial registration letter and transfer of product registration to new manufacturing site.
ii. Product renewal status.ii. Justification/reason for change of formulation.
Firm has not submitted fee the reason provided that they want to revise formulation as
per innovator (GSK), the applied formulation also provided in BNF-72 .
Decision: Keeping in view status of product in BNF-72, Registration Board acceded to request of M/s Don Valley Pharma, Lahore for correction in description of dosage form in registration letter. Moreover, the Board advised registration sections to proceed for correction in brand names of already registered products.
Case No.08: Issuance of registration letter of approved products of M/s. Hamaz Pharmacetuical (Pvt) Ltd, Multan
M/s Hamaz Pharmaceuticals, Multan has requested for issuance of registration letters
for their products approved in 255th meeting of registration board as per detailed below:-
S/No
Name and address of
manufacturer / Applicant
Brand Name(Proprietary
name + Dosage Form +
Strength)Composition
Pharmacological GroupFinished product
Specification
Type of FormInitial date,
diaryFee including differential fee
Demanded Price / Pack
size
International
status in stringent regulatory agencies
Me-too status
GMP status as depicted
in inspection report (dated)
Decision (255th
meeting)
Remarks
1. M/s Hamaz Pharmaceuticals (Pvt.) Ltd, 13-km, Lutafabad, Bosan Road, MultanADDITIONAL SECTION - Liquid Injectable (Ampoule/Vial) (General and General Antibiotics) approved in 242nd meeting
Nixin IV InfusionEach 100 ml bottle contains Ciprofloxacin (as Lactate) 200 mgQuinolone Antibiotics(USP Specification)
Form 5Rs. 20,000/- vide Dy. No. 4844 dated 04-08-2015
Pack of1 x 100 ml/ price 971.
FDA approved Ciproxin (Bayer)Caralox (Caraway)
As per letter issued by Licensing Section the firm has ampoule / Vial section. Registration Board approved only 10 products in the section (ampoule/ vial).
Minutes for 266th Meeting of Registration Board. 187
of CLB2. -do- Lupin IV
Infusion 500 mgEach 100 ml contains Levofloxacin 500mgQuinolone Antibiotic(USP Specification)
Form 5Rs. 20,000/- vide Dy. No. 4830 dated 04-08-2015Pack of1 x 100 ml vial / price 300.
FDA approved Livaquin (Johnson)Leflox (Getz)
Approved
3. -do- ESTADOL IV Infusion 1gEach 100 ml contains Paracetamol USP… 1 gmAntipyretic / analgesic(USP Specification)
Form 5Rs. 20,000/- vide Dy. No. 4816 dated 04-08-2015Pack of1 x 100 ml vial / price 80.
TGA approved paracetamol (Bristol)Provas (Sami)
Approved
4. -do- Ocian (WFI)
Each ampoule contains Water for Injection… 10ml
WFI(USP Specification)
Form 5Rs. 20,000/- vide Dy. No. 4812 dated 04-08-2015MRP. Rs 5.00 for 1’s per 10mlMRP. Rs 250.00 for 25’s per 10mlMRP. Rs. 500 for 50’s per 10 mlMRP. Rs. 4.00 for 1’s per 5mlMRP. Rs. 100.00 for 25’s per 05 mlMRP Rs. 200 for 50’s per 05 mlMRP Rs. 400 for 100’s per 05 mlMRP Rs. 150 for 50’s per 03 mlMRP Rs 300 for 100’s per 03ml.
MHRA approved WFI (TARO)
WFI (Epoch)
Approved
Minutes for 266th Meeting of Registration Board. 188
5. -do- 3-D InjectionEach ampoule (1 ml) contains Cholecalciferol (Vit D3)…. 250,000 IU equal to 5 mgVitamin(USP Specification)
Form 5Rs. 20,000/- vide Dy. No. 4821 dated 04-08-2015
MRP. Rs 165 for 01 Ampoule
International availability
Indrop-D (Neutro)
Approved
6. -do- Phonac Injection 75 mgEach ampoule (2 ml) containsDiclofenac Sodium USP 75 mgLignocaine HCl 20 mgPhenylacetic acid/ anesthetic(Manufacture Specification)
Form 5Rs. 20,000/- vide Dy. No. 4828 dated 04-08-2015
MRP Rs 140 per 05 Ampoule
Afenac – plus (ACMA Laboratories Pakistan Ltd)
Deferred for confirmation of approval status of same dosage form in reference regulatory authorities.
Same dosageform isapproved in 3 countries ofEMA Latvia, Lithuania andpoland
7. -do- Cloprel Injection 10 mgEach ampoule (2ml) containsMetoclopramide HCl … 10mgAntidopaminergic(USP Specification)
Form 5Rs. 20,000/- vide Dy. No. 4841 dated 04-08-2015MRP Rs 230 per 10 AmpouleMRP Rs. 410 per 20 ampoules
MHRA approved metoclopramide (Ennogen)Maxolon (GSK)
Approved
8. -do- Dinate Injection....... 50 mgEach ampoule (1ml) containsDimenhydrinate … 50mgAntihistamine(USP Specification)
Form 5Rs. 20,000/- vide Dy. No. 4845 dated 04-08-2015MRP Rs 250 per 25 AmpouleMRP Rs. 410 per 20 ampoules
FDA approved Dimenhydrinate (APP Pharma)Gravinate (Searle)
Approved
9. -do- Lignox Injection 20 mgEach ampoule (2ml) containsLignocaine HCl anhydrous… 20 mgLocal anesthetic(BPSpecification)
Form 5Rs. 20,000/- vide Dy. No. 4845 dated 04-08-2015
MRP Rs 187 per 100 Ampoules
MHRA approved Lidocaine Injection BP (B-Braun germany)Xylocaine (Barrett)
Approved
10. -do- Ferin Injection 100 mgEach ampoule (5
Form 5Rs. 20,000/- vide Dy. No.
MHRA approved Ferrologic
Approved
Minutes for 266th Meeting of Registration Board. 189
ml) containsIron Sucrose Complex … 100 mgHaematinic(USPSpecification)
4834 dated 04-08-2015
MRP Rs 1831 per 05 Ampoules x 5ml
20 mg/ml (Fresenius germany) Bisleri (Sami)
While processing registration letters it was found that firm had been issued show cause notice
(24.06.2016) from Q,A for stoppage of production/prosecution in the Drug court /any other
action taken by concerned board . The observations of FID included following areas:
General/General Antibiotic Area Cephalosporin area Penicillin Area Quality Assurance Validation and Caliberation
Firm had submitted reply on 09.07.2016 in which firm assured to rectify all shortcomings
within 6 months and requested to withdrawn show cause. The case was submitted in 249 th
meeting of CLB (held on 29.08.2016) and the Board decided to conduct panel GMP
inspection of the firm on approved format under schedule B-II of Drugs (LR&A) rules , 1976
and directed panel to submit brief report in tabulated form identifying previous observations
and current status with clear recommendations
Firm has submitted GMP inspection report conducted by DDC Bosan Town Multan
(26.12.2016), where GMP compliance has been reported. Firm has requested to grant
registration of above mentioned approved products of new section (Liquid injectable
ampoule/vial)
Decision: Keeping in view above position, Registration Board advised to issue registration letters of products approved in 255th meeting of Registration Board and also approved product at S.No.06 as it is approved by regulatory authorities of three European countries.
Case No.09: Deferred products of M/s. 3S Pharmaceuticals (Pvt) Ltd. Lahore.
Registration Board in its 237th meeting deferred following products of M/s. 3S Pharma
Lahore due to following short comings.
S.No Name of the drugs with composition
Pack Size
Proposed Price
Date of Submission
Remarks
1. Gonasin 150 CapsuleEach capsule contains:-Fluconazole………150mg(Anti fungal)
1x1 Rs.150.00 11-05-10 RM and Finished product specifications. Inspection report is not enclosed. Dissolution is not present.
2 Netel 100 Tablets 2x10 Rs.130.00 11-05-10 -do-Minutes for 266th Meeting of Registration Board. 190
Each tablet contains:-Atenolol………….100mg(Anti-hpertensive)
3 Threefen 200mg TabletEach tablet contains:-Ibuprofen…………200mg(Anti pyretic (NSAIDs)
50x10 As per SRO
11-05-10 -do-
4 Omcid TabletEach tablet contains:-Omeprazole ………20mgSodium bircarbonate ………600mgMagnesium hydroxide ……..700mg(Proton pump inhibitor + Antacid + Laxative)
1x7 Rs.130.00 11-05-10 -do-/ Composition is mentioned for 40mg omeprazole, average wt. is 1300mg which is less then composition of active ingredients. Dissolution is not present.Formulation??
5 Omjet Plus CapsuleEach capsule contains:-Omeprazole…….20mgSodium bicarbonate ………1100mg(Proton pump inhibitor + Antacid)
1x10 Rs.130.00 11-05-10 RM and Finished product specifications. Inspection report is not enclosed. Currently deferred for review committee. Dissolution is not present.
6 Ardis 5mg TabletsEach chewable tablet contains:-Montelukast sodium ………..5mg(Anti ashtamatic (Bronchodilater)
2x7 Rs.225.00 11-05-10 RM and Finished product specifications. Composition is for compressed tablets.
7 Medifen 50mg TabletsEach tablet contains:-Diclofenac Sodium …………50mg(NSAID)
2x10 Rs.100.00 11-05-10 RM and Finished product specifications. Inspection report is not enclosed. Dissolution is not present.
8 Ardis TabletsEach tablet contains:-Glucosamine……….500mgChondroitin Sulfate Sodium …………….400mgGlycosaminoglycan (Amino acid)
20’s Rs.595.00 14-06-10 F.Insp.Report?Dissolution test method not given.
9 Mexet Tablets 400mgEach film coated tablet contains:-Moxifloxacin………400mg(Fluoronquinolone)
5’s Rs.690.00 14-06-10 Final Inspection Report.Dissolution test method not given.
10 Oslo Tablets 200mgEach film coated tablet contains:-Ofloxacin………….200mg(Anti-biotic, Quinolones, Anti-infectives)
10’s Rs.297.00 14-06-10 -do-
11 Felro tablets 100mgEach tablet contains:-Flurbiprofen………100mg(NSAID)
30’s Rs.190.00 14-06-10 -do-
Minutes for 266th Meeting of Registration Board. 191
12 Gema Tablets 320mgEach tablet contains:-Gemifloxacin…….320mg(Fluoro Quinolone)
7’s Rs.1050.00
14-06-10 -do-
13 Threemol TabletsEach tablet contains:-Paracetamol………..500mg(Anti-pyretic)
20x101000 Jar
pack
Rs.140.00Rs.300.00
Deferred for GMP & Product specific inspection
14 Threefen TabletsEach tablet contains:-Ibuprofen………….400mg(Anti pyretic)
25x10 Rs.400.00 -do-
15 Zeesin 250mg CapsuleEach capsule contains:-Azithromycin…….250mg(anti bioitic)
1x62x6
Rs.275.00Rs.398.00
-do-
The case was reconsidered in 263rd meeting of Registration Board
The firm had submitted Rs.8000/- for each product. Now the fee for the registration
procedure has been increase, the firm has submitted the differential fee amounting to Rs.
12000/- for each registration as follows. The firm has provided required documents except
Product specific inspection for S.No 7,13,14 and 15 is not provided. Dissolution profile of
products at S.No 9 and 12 is not provided.
Decision: Registration Board deferred the case for evaluation of registration application as per requirement of Form 5.
Now the firm has provided following documents
1) Form 5 and documents as per Form 5 for each product2) DML (23.06.2009) and copy of fee deposit slip for DML renewal (05.06.2014)3) Evidence of section approval from CLB (Tablet General and Capsule General)4) GMP inspection report (12.02.2015)
Decision: Registration Board deferred for latest GMP status of firm. Moreover product at S.No.04 is also deferred for confirmation of approval status by reference regulatory authorities and product at S.No.05 is deferred for expert opinion.
Minutes for 266th Meeting of Registration Board. 192
Item No.V: Biological Drugs Division.
Registration Board deliberated that since last few meetings, products of non-
reference countries have been deferred for submission of biosimilarity data and clinical data
(where applicable). Such products shall be considered by the Registration Board after getting
aforementioned data, provided that product is licensed for sale and available for sale in
market in country of origin.
Moreover, products from non-reference countries have already been registered by
Registration Board at time of erstwhile Drug Control Organization, Ministry of Health and
DRAP. The safety and efficacy of these molecules/ formulations is already proven in
reference countries. The products if approved by Registration Board are also subject to the
inspection of the facility abroad by the panel of inspectors as nominated by the DRAP. The
Registration Board also advised Biological Division to club all such cases as deferred in
previous meetings for consideration in next Board meeting subject to fulfillment of all
requirements as per Form-5A.
Case No.01 Left over agenda of 265th meeting of Registration Board.i. Imported veterinary biologicals from non-reference countries.
S. No.
Name of Importer & Manufacturer
Brand Name & Composition
Type of FormDy No & Date of applicationFee submittedPack size/ Demanded Price
Document details (CoPP)Me too status/New molecule
Remarks Decision
1. Huzaifa International, Commercial Area, Aziz Bhatti Town, SargodhaKomipharm International Co., Ltd. 17, Gyeongje-Ro, Siheung-Si, Gyeonggi-Do, The republic of Korea
PRO-VACTM CPVEach ml containsAttenuated Canine Parvovirus (FK strain)……100 %Streptomycin...20µg/ml Penicillin…200unit/mlGentamicin….50 µg/ml
For 5-A 119-ADC(BD) 06-12-20161494 30-11-2016Rs. 100000/-24-10-20161’s (1 dose)
Legalized GMP and Legalized Free Sale certificate is submitted.
Deferred for evaluation of strain by Dr.Qurban Ali, Member Registration Board.
2. Huzaifa International, Commercial Area, Aziz Bhatti Town, SargodhaKomipharm International Co., Ltd.
PRO-VACTM FP(lyophilized part)
Each dose (0.5ml) contains: TCH Fowl Pox Virus Culture……50% SPGG……….50%
Form 5-A 118-ADC(BD) 06-12-20161495 30-11-2016Rs. 100000/-24-10-2016Pack: 1’s (1000doses)
Legalized GMP and Legalized Free Sale certificate is submitted.
The diluent is also a part of pack composition; the firm has submitted Rs. 100000/- fee for the registration of diluent.
Deferred for evaluation of strain by Dr. Qurban Ali, Member Registration Board.
Minutes for 266th Meeting of Registration Board. 193
17, Gyeongje-Ro, Siheung-Si, Gyeonggi-Do, The republic of Korea
(Diluent )Each 1000 ml contains:Nacl....8gKCl....0.2gNa2HPO4. 2H2O....2.6gKH2PO4....0.2gPhenol red...q.s.Distilled water....up to 1000ml
Diluent 10ml vial
3. Snam Pharma, 61-G, Defence Housing Authority, Phase I, LahoreBioveta, a.s., Komenskeho 212/12, 683 23 Ivanovice na Hane, Czech Republic
Ornivac ND(Emulsion for injection for domestic fowl)
Each dose contains: Inactivated paramyxovirus Pseudopestis avium, strain NDV SL-93… >4log2HIT*(The geometric mean of specific antibodies determined by hem- agglutination inhibition testing the serum of vaccinated chicken)
Form 5-A797-ADC(BD) 02-08-20163412(R&I)02-08-2016Rs. 100000/-02-08-2016Pack: 10 x 2500 doses10 x 5000 dosesPrice:Decontrolled
Valid Legalized CoPP No. 079/2016 dated04-04-2016
Deferred for evaluation of strain by Dr. Qurban Ali, Member Registration Board.
4. M/s Agriprom Pakistan (Pvt) Ltd.66 west wood colony, thokar niaz baig, Lahore.
M/s Laboratorios VencoFarma Do Brasil Ltda.237 Travessa Dalva de Oliveira, Parque das Industrias Leve, Londrina-PR
Vencomax 12Each dose (1 ml) contains:Lyophilized part:Distemper Virus (Rockborn strain)….. at least 102,5 TCID50/doseCanine adenovirus CAV 2……. at least 102,5 TCID50/doseParvovirus Cornell 916…… at least 102,5
TCID50/doseParainfluenza virus AMV…….. at least 102,5 TCID50/doseGentammicin….. maximum 30 µg/ml Amphotericin B…….. Maximum 2.5 µg/ml.
Liquid Part:Leptospira canicola bacterin……. 1,5 x 106
germs/doseLeptospira icterohaemorrhageni Bacterin…….Leptospira copenhageni bacterin ……. 1,5 x 106
germs/doseLeptospira Pomona bacterin …..1,5 x 106
Form 5-A08-ADC(BD) 04-01-2017312(R&I)04-01-2017Rs. 100000/-03-01-2017
1 dose vial (lyophilized) 20’s1 dose vial (liquid) 20’s
Valid legalize GMP Certificate N0
159/2016Legalize FSC N0
940/2016
Separate fee for the registration of liquid part is required. The firm submitted diluent is part of formulation and can not be used separately.
Stability data is not submitted. The firm was asked to submit data however it was not provided.One of the indications in the vaccine is treatment of hepatitis. The firm was asked to provide clarification regarding which antigen/ viral strain is involved in the prophylaxis against Hepatitis. The firm submitted
Deferred for evaluation of product by Dr. Qurban Ali and submission/ clarification of following by the firm:
1. Separate fee for the registration of liquid part.
2. Stability data.
3. One of the indications in the vaccine is treatment of hepatitis while firm has submitted that CAV2 virus is involved in prophylaxis against hepatitis. However the available
Minutes for 266th Meeting of Registration Board. 194
germs/doseLeptospira grippotyphosora bacterin ….1,5 x 106
germs/doseLeptospira pyrogenes bacterin ….1,5 x 106
germs/doseLeptospira hardjo bacterin …..1,5 x 106
germs/dose
(Vaccine against Canine Distemper, Parvovirus, Coronavirus, Parainfluenza, Hepatitis, Adenoviruses and Leptospirosis)
Shelf Life: 24months
that CAV2 virus is involved in prophylaxis against hepatitis. However the available literature indicates that CAV-1 vaccines provide immunity against Hepatitis. This requires clarification.
literature indicates that CAV-1 vaccines provide immunity against Hepatitis. This requires supporting evidence from published literature/ reference regulatory agencies
5. M/s Agriprom Pakistan (Pvt) Ltd.66 west wood colony, thokar niaz baig, Lahore.
M/s Laboratorios VencoFarma Do Brasil Ltda.237 Travessa Dalva de Oliveira, Parque das Industrias Leve, Londrina-PR
Paraven R2C.Each dose (5ml) contains:Bovine Coronavirus ………..104.5TCID50
Rotavirus G6 …………104.5TCID50
Rotavirus G10 ………….104.5TCID50
Escherichia coli O26 bacterin….105 germsEscherichia coli K99/F41 bacterin sample S30....….105 germsEscherichia coli 0111 bacterin…..105 germsClostridium perfringens C toxoid, β toxin …….atleast 10UI/doseClostridium perfringens D toxoid, ἑ toxin …….atleast 10UI/dose(vaccine against Bovine Rotavirus, coronavirus, Colibacillosis and Enteroxaemia)Shelf Life: 24months
Form 5-A08-ADC(BD) 04-01-2017312(R&I)04-01-2017Rs. 100000/-03-01-2017Pack size 50ml
Valid legalize GMP Certificate N0
159/2016Legalize FSC N0
940/2016
New formulation
Stability data is not submitted. The firm was asked to submit data however it was not provided..
Deferred for evaluation of product by Dr. Qurban Ali and submission/ clarification of following by the firm:a.Stability
data.
6. M/s Agriprom Pakistan (Pvt) Ltd.66 west wood colony, thokar niaz baig, Lahore.M/s Laboratorios
RonvacEach dose contains:Inactivated virus Feline Rhinotracheitis……. minimum 10-4TCID50
Inactivated virus Calicivirosis..minimum 10-4TCID50
Inactivated virus Feline
Form 5-A08-ADC(BD) 04-01-2017312(R&I)04-01-2017Rs. 100000/-03-01-20171 dose vial 40’s
Valid legalize GMP Certificate N0
159/2016Legalize FSC N0
940/2016
Stability data is not submitted. The firm was asked to submit data however it was not provided.
Deferred for review of product by Dr. Qurban Ali and submission/ clarification of following by the firm:
Minutes for 266th Meeting of Registration Board. 195
VencoFarma Do Brasil Ltda.237 Travessa Dalva de Oliveira, Parque das Industrias Leve, Londrina-PR
Panleukopenia................... minimum 10-4TCID50
(Vaccine against Feline Panleukopenia, Calicivirus and RhinotracheitisShelf Life: 24months
a. Stability data.
7. M/s Agriprom Pakistan (Pvt.) Ltd.66 west wood colony, Thokar Niaz Baig, Lahore.
M/s Laboratorios VencoFarma Do Brazil Ltd.237 Travessa Dalva de Oliveira, Parque das Industrias Leve, Londrina-PR
Raiva CannisEach dose (1ml) contains:Suspension of inactivated rabies virus….minimum106.0DL50
(Inactivated vaccine against the rabies)
Shelf Life: 24months
Form 5-A08-ADC(BD) 04-01-2017312(R&I)04-01-2017Rs. 100000/-03-01-20171 dose vial 50’s
Stability data is not submitted. The firm was asked to submit data however it was not provided.
Valid legalized Free Sale Certificate is required as product is not included in the submitted FSC.
Deferred for evaluation of product by Dr. Qurban Ali and submission/ clarification of following by the firm:a.Stability
data.b.Valid
legalized Free Sale Certificate/ CoPP.
8. M/s Ghazi BrothersGhazi House,D-35, K.D.A Scheme No.1,Miran Muhammad Shah Road Karachi
M/s TANGSHAN YIAN BIOLOGICAL ENGINEERING CO.,LTDNo.120,Huoju Rd.,High Tech Developing Zone Dist., Tangshan, Hebei Province ,P.R China
RABEND
Each dose (1ml) contains:Inactivated Rabies Antigen (Strain CTN-1) …….2 I.U
Shelf Life: 24months
Form 5A1210(R&I)19-02-2013Rs. 50,000/-22-01-2013
Multiple pack sizes are demanded(1 dose vial,10 doses vial,1 dose syringe)
Legalized Free Sale certificate No. 121100B0/50648Issuing date: 25/11/2011(Expired)Legalized GMP No. 121100B0/50651Expiry date.14/06/2016(Expired)
Legalized Free Sale Certificate and GMP were Valid at the time submission of the application but now expired.
Multiple dosage forms and Pack sizes are applied.
Approved as per import policy for finished drugs. Firm will select one pack size and provide valid legalized Free Sale Certificate and GMP/ CoPP.Chairman Registration Board shall permit the issuance of registration letter.
9. M/s Orient Traders InternationalCM-10, Block-A, kazimabad, Model colony, Karachi
Bronchipharm(lyophilisate for suspension for chicken)Each dose(0.1ml) contains:Avian Infectious Bronchitis virus, live,
Form 5-A207-ADC(BD) 26-12-20163724(R&I)26-12-2016Rs. 100000/-20-12-2016
Valid Legalized CoPP No.R-92/2016/1/2520 dated 07/09/2016
Multiple Pack sizes are demanded.
In CoPP it is mentioned at # 2A.3 that the
Deferred for clarification of following by the firm:
a. In CoPP it is mentioned at #
Minutes for 266th Meeting of Registration Board. 196
M/s Pharmagal Bio, spol. s r.o.Murgasova 5, 949 01 Nitra, Slovak Republic
strain H120….103.0EID50-104.5EID50**50% embryonic infective dose-the virus titre required to produce infection in 50% of the embryos inoculated
Pack: 1 x 2000 doses1 x 5000 doses1 x 100 doses1x 500 doses1x 1000 dosesPrice: Decontrolled
status of the License holder is “c” (i.e. Firm is not involved in manufacturing and packaging/or Labeling)While at # 2A.3.1 where the name and address of manufacturer is required, the same name and address of Firm is mentioned.
2A.3 that the status of the License holder is “c” (i.e. Firm is not involved in manufacturing and packaging/ or Labelling, While at # 2A.3.1 where the name and address of manufacturer is required, the same name and address of Firm is mentioned.
b. Desired pack size.
10. M/s Orient Traders International CM-10, Block-A, kazimabad, Model colony, KarachiM/s Pharmagal Bio, spol. s r.o. Murgasova 5, 949 01 Nitra, Slovak Republic
Avipharm NDEach dose(0.1ml) contains:Newcastle disease virus, live, strain La Sota, minimum 106.0+EID50- maximum 107.0+EID50**50% embryonic infective dose.
Form 5-A206-ADC(BD) 26-12-20163725(R&I)26-12-2016Rs. 100000/-20-12-2016Pack:10 x 5000 doses10 x 2000 doses10x 1000 dosesPrice: Decontrolled
Valid Legalized CoPP No.R-91/2016/1/2519 dated 06/09/2016
Multiple Pack sizes are demanded.
In CoPP it is mentioned at # 2A.3 that the status of the Licence holder is “c” (i.e. Firm is not involved in manufacturing and packaging/or Labeling)While at # 2A.3.1 where the name and address of manufacturer is required, the same name and address of Firm is mentioned.
Deferred for clarification of following by the firm:
a. In CoPP it is mentioned at # 2A.3 that the status of the License holder is “c” (i.e. Firm is not involved in manufacturing and packaging/or Labelling While at # 2A.3.1 where the name and address of manufacturer is required, the same name and address of Firm is mentioned.
b.Desired pack size.
Minutes for 266th Meeting of Registration Board. 197
ii. Miscellaneous/Deferred Cases
a. Product applied by M/s Hospital Services and Sales, Karachi deferred in 260th
meeting of Registration Board.
Name of Importer & Manufacturer
Brand name & Composition
Fee Status & Pack size
Document Details
Decision of RB
Remarks Decision
Hospital Services & Sales 13-C Annex, Block 6, P.E.C.H.S, Shahrah-e-Faisal, Karachi 75400.
Parent Company/Lic. Holder:QYH Biotech Company Ltd.,Building. No. 20, Part 11, ABP, No. 188, Southwest 4th
Ring Road, Fengtai District, Beijing, China.
Manufacturing Site:Zhengzhou Bio-Pharmaceutical Factory of QYH Biotech Co. Ltd., Shibalihe, South Surburb, Zhengzhou City, Henan Province, P. R. China.
QYH-ND IB EDS(Newcastle Disease, Infectious Bronchitis & Egg Drop Syndrome Vaccine, Inactivated)
Each one dose contains:-Inactivated Newcastle Disease virus La Sota strain (the virus titer is ≥ 3x108.0EID50/ 0.1ml before inactivation), inactivated Infectious Bronchitis virus M41 strain (the virus titer is ≥ 3x106.0EID50/ 0.1ml before inactivation) and inactivated Egg Drop Syndrome virus AV127 strain (the HA titer of the virus is ≥ 1:30720 before inactivation),
(For Veterinary Use)
22-Dec-10
Deposited fee100000/-
Balance FeeNil
Pack Sizes:(250mL / Bottle)
Legalized Free Sale Certificate No. (2011) 160132129 Dated01-06-2013
Legalized CoPP No. 3 Dated10-12-2015
Product License No.(2010) 01008Dated 09-03-2010
Legalized GMP Certificate No.(2014) 220Dated16-10-2014
Deferred for confirmation of local availability/ approval of similar vaccine.
The firm submitted product is locally available with following brand name & Reg. No.MEDIVAC NE-EDS-IB EMULSION(Reg. No. 059195)
Registration Board deferred the above product for evaluation of Egg Drop Syndrome virus AV127 strain by Dr. Qurban Ali, Member Registration Board.
Minutes for 266th Meeting of Registration Board. 198
b. Deferred case of 260th meeting of Registration Board of M/s Opulent International, Karachi.
M/s Opulent International, Karachi applied for the registration of following product.
The product was considered in 260th meeting of Registration Board. The firm has submitted the
valid legalized CoPP vide no. COPP/CERT/MD/26507/2015/11/10485/48273 dated 14-09-2016
indicating availability of product in the country of origin. The detail of the product is as follows:
S. No.
Name of Importer & Manufacturer
Brand Name & Composition
Type of FormDy No & Date of applicationFee submittedPack size/ Demanded Price
Document details (CoPP)Me too status/New molecule
Decision in 260th RB
Decision
1 M/s Opulent International Karachi.
M/s Reliance Life Sciences, Pvt Limited, Plant-1 Sandhra Textile Mills Compound, Ground and First Floor C.S. No. 1621 Plot No. 3 Plan 1 Pandurang Budhkar, Marg Worli Mumbai.
IMMUNOREL(Human Normal Immunoglobulin for Intravenous Administration)Each 50ml contains:Protein…..50g/ LIgG…..2.5gStabilizer Maltose....100g/LIgA content≤ 80mg/LIgG subclasses ………Normal distribution
Immunoglobulin
Shelf life: 36 months
Form-5A
Dy. No 11198 dated 28-05-2014
100000 dated28-06-2013
98 USD / vial
Legalized CoPP /CERT/MD/26507/2015/11/10485/48262 dated 28-4-2015 valid up to 09-3-2017
Deferred for clarification for non-availability of product in the country of origin and valid reason thereof by the regulatory body and confirmation of availability of similar products in country.
Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.
c. Transition of Formulation from Lyophilized to Liquid Form of WinRho SDF Injection (025216) M/s Eastern Trade and Distribution Co. Pvt Limited Karachi.
M/s Eastern Trade and Distribution Co. Pvt Limited Karachi have informed that their
principal M/s Cangene Corporation, Canada is transitioning the formulation of their
registered product WinRho SDF Injection from lyophilized to Liquid formulation. The
existing formulation was supplied as freeze dried powder I vial along with single ampoule of
sterile water for injection, while the new formulation is liquid injection will contain a
convenient formulation ready to use 3ml single dose vial of 1500IU (300mcg) of Anti Rho
(D) in glass vial
Minutes for 266th Meeting of Registration Board. 199
The liquid formulation is approved by Health Canada, detailed below:
Existing WinRho SDF Lyophilized formulation composition
New approved SDF Liquid formulation
Each vial contains:Human Anti-D Immunoglobulin (in house)………300 mcg
Glycine Ph. Eur/ USP……22.5 mgSaodium chloride Ph. Eur/ USP…..7 mgPloysorbate 80 Ph. Eur/ USP…..0.3mgWater for Injection Ph. Eur/ USP……QS ** Removed by lyophilization.
Each vial contains:Human Anti-D Immunoglobulin (in house)………300 mcg
Maltose USP………………..0.135gPloysorbate 80 Ph. Eur/ USP…..0.39mgWater for Injection Ph. Eur/ USP……QS *
The case was considered in 260th meeting of Registration Board and Board decided as follows:“Registration board did not accede to the request of the firm for change of formulation from lyophilized to liquid form of Winrho SDF injection (025216) as present formulation is also approved by regulatory authority of Canada. However firm was advised to apply fresh application with prescribed fee for new formulation/ dosage design.”
It is pertinent to mention that above liquid formulation has already been approved by
Registration Board in its 253rd meeting. The details are as under:
Sr. No.
Name of Importer &
Manufacturer
Brand Name &
Composition
Date ofapplication /
Fee status
Document Details
Remarks Decision in 253rd
meeting
Decision
1 EasternTrade &Distribution Co. (Pvt) Ltd.,Karachi.
CANGENECORPORATION,155 Innovation Drive, Innipeg,Manitoba,Canada,R3T 5Y3
WinRho ® SDFLiquid InjectionEach l vialcontains:-Rho D Immune Globulin Human 1500 units (300mcg).(Biologics).
Date ofapplication17.08.2011Deposited fee100000Balance FeeNil
CoPP No.59723 dated24/02/2015validity 1yearProduct LiscNo.02302578. dated16/06/2008.Indications.Anti-Rho (D)
ProductManufacturedbyCANGENEcorporationManitoba,Canada,R3T 5Y3confirmedCOPPprovidedNo. 59723fromCanada.
Approved Registration Board upheld its decision on product in 253rd meeting of Registration Board in which the product is already approved in liquid formulation. The decision of the board in the 260th
meeting regarding request of firm for transition of formulation from lyophilized to liquid form of WinRho SDF Injection is deleted.
Minutes for 266th Meeting of Registration Board. 200
d. Products applied by M/s Huzaifa International, Sargodha deferred in 262nd
meeting of Registration Board.
Following products of M/s Huzaifa International, Sargodha were considered in 262nd
meeting of Registration Board for the expert opinion of Dr. Qurban Ali. The details are as
follows:
With reference to the product at sr. no. 1 , the firm has submitted a certificate from
Ministry of Security & Public Administration that the address KomiPharm International Co.
Ltd., 1236-6, Chongwang-Dong, Shihung-Si, Kyonggi-Do, The republic of Korea which is
old address based on land lot numbers is same as KomiPharm International Co. Ltd., 17,
Gyeongje –ro, Siheung-si, Gyeonnggi-do, Korea which is based on road names and building
numbers. The both addresses are identical and legally valid.
S. No.
Name of Importer/
Manufacturer
Brand Name / Composition
Date of application/ fee status/
Price/ packs
Documents submitted
Me too
Decision of RB in 262nd
meeting
Expert opinion of
Dr. Qurban Ali
Decision
1 M/s Huzaifa International, Commercial Area, Aziz Bhatti Town Sargodha
KomiPharm International Co, 17, Gyeongje –ro, Siheung-si, Gyeonnggi-do, Korea.
PRO-VACTM
CRDF
Each dose contains:
Mycoplasma gallisepticum culture, (Fstrain)…..more than 105
CCUStabilizer for lyophilized ……20%
Prevention against mycoplasma gallisepticum
Shelf Life: 18 months
Form 5A
18-ADC (BD)10/08/20168526/2016(R&I)08-08-2016
Rs.100,000/-20-08-2016
Decontrolled/1000 doses
Legalized FSC dated 20.1.2015
Legalized GMP dated 20.4.016
Deferred for clarification that Address of manufacturer provided on the FSC and GMP are different and expert opinion of Dr. Qurban Ali.
Firm shall also submit separate fee along with application for registration of diluent.
Recommended for registration.
The firm has submitted seertae fee 100000/- for diluent
Approved as per import policy for Finished Drugs and as per valid legalized CoPP/ FSC &GMP.
2 M/s Huzaifa International, Commercial Area, Aziz Bhatti Town Sargodha
KomiPharm International Co, 17, Gyeongje –
PRO-VACTM
AE-FP(lyophilized part)
Each dose contains:
Avian Encephalomyelitis virus (Calnek 1143 strain).≥10 2.8EID50
17-ADC (BD)10-08-20163525/2016(R&I)08-08-2016
Rs.100,000/-25-07-2016Rs. 100000/-
Decontrolled/1000 dose
Legalized FSC dated 21.11.14
Legalized GMP certificate dated20-4-2016
Deferred for expert opinion of Dr. Qurban Ali, Member Registration Board.
Firm shall also submit separate fee
Recommended subject to warning:i.vaccine virus of Avian Encephalomyelitis (Calnek 1143 strain) is fully
Approved as per import policy for Finished Drugs and as per valid legalized CoPP/ FSC &GMP. The following warning shall be included
Minutes for 266th Meeting of Registration Board. 201
ro, Siheung-si, Gyeonnggi-do, Korea.
Attenuated Fowl Pox Virus, TCH…….≥102.8
EID50LPGG -----50%
(Diluent )Each 1000 ml contains:Nacl....8gKCl....0.2gNa2HPO4 . 12H2O....2.6gKH2PO4....0.2gPhenol red...q.s.Distilled water....upto 1000ml
Prevention against Avian Encephalomyelitis and Fowl pox
Shelf Life: 24 months
Diluent: 10 ml vial
along with application for registration of diluent.
virlent and should therefore not be given to bids younger than 2 months of age or birds in lay.
ii.birds should be separated fron non-vaccinated birds in particular to chicken, pheasants, quail and turkeys.
iii.s must wash and disinfect hand after vaccination.
in the registration letter:i.vaccine virus of Avian Encephalomyelitis (Calnek 1143 strain) is fully virulent and should therefore not be given to birds younger than 2 months of age or birds in lay.
ii.d birds should be separated from non-vaccinated birds in particular to chicken, pheasants, quail and turkeys.
iii.rs must wash and disinfect hand after vaccination.
e. Products applied by M/s Orient Animal Health, Karachi deferred in 262nd
meeting of Registration Board.Following products of M/s Orient Animal Health, Karachi were considered in 262nd
meeting of Registration Board for the expert opinion of Dr. Qurban Ali. The other experts i.e.
Prof. Dr. Masood Rabbani, Prof. Dr. Khushi Muhammad and Dr. Muhammad Arshad has
also recommended the above products for registration in Pakistan. The details are as follows:
S. No.
Name of Manufacturer
Name of Drug and Composition
Date of application / Fee status
Documentary details
Decision of RB in 262nd
Meeting
Expert opinion of Dr.Qurban
Ali
Decision
1 GENERA d.d.Svetonedjelijska2, Kalinovica,10436 RakovPotok, Croatia.
Pestikal La Sota® SPF, Lyophilisate for suspensionEach single dosevaccine contains:Live lento genicNewcastle disease
Dy.No.2407(R&I) dated07-4-2015
Fee Rs.100,000/- dated
LegalizedProductMarketing authorizationregistration No.525-10 /1278-15-2
Registration Board deferred for evaluation by Dr. Qurban Ali, Member
M/s Genera Rakov Potok, Croatia was established in 1901. The manufacturer, M/s Genera
Registration Board approved the product as per import
Minutes for 266th Meeting of Registration Board. 202
virus,La Sota strain ≥ 106.0 EID 50Pharmacological group:Immunological fordomestic fowl live viralvaccine againstNewcastle diseaseOculonasaly, Oral,SprayingRoute of Adm: Oculonasaly, Oral,spraying
07-4-2015
Box of 10 vialof 1000, 2500,& 5000 vaccineDoses
Unit price:Decontrolled /25, doses.
dated28-1-2015Enclosed.
Legalized GMPCertificate No.409-8/ 2013-2Dated17.4.2013enclosed
Registration Board.
are well known for animal health and agriculture, products development, production and sale in Croatia. The company was formally known as Veterina which changed to Genera in 2009.
The products at sr. No. 1-4 are fit for use and recommended for registration
policy for Finished Drugs and as per valid legalized CoPP.
2 Orient AnimalHealth (Pvt) Ltd,Karachi
Manufacturer
GENERA d.d.Svetonedjelijska2, Kalinovica,10436 RakovPotok, Croatia.
Pestikal® B 1 SPFlyophilisate forsuspension
Each single dosevaccine contains;Live lento genicNewcastle disease virus,strain Hitchner B 1 ≥106.0 EID 50 (embryoinfective dose 50) =virus dose which infects50% of inoculatedchiken embryos
Pharmacological group:Immunological fordomestic fowl live viralvaccine againstNewcastle diseaseOculonasaly, Oral.
Dy.No. 2409(R&I) dated07-4-2015
Fee Rs.100000/- dated07-4-2015
Unit price:DecontrolledBox of 10 vialof 1000, 2500,& 5000 vaccinedoses
LegalizedCertificate ofGMP No. 409-8/2013-2 dated17-4-2013enclosed
Legalized MarketauthorizationCertificateregistration No.525-10 / 1278-15-2 dated28.1.2015 enclosed
Registration Board deferred for evaluation by Dr. Qurban Ali, Member Registration Board.
-do- Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.
3 Orient AnimalHealth (Pvt)
Gumbokal® IM FORTE
Dy. No. 2408
Legalized Market
Registration Board
-do- Registration Board
Minutes for 266th Meeting of Registration Board. 203
Ltd,Karachi
Manufacturer
GENERA d.d.Svetonedjelijska2, Kalinovica,10436 RakovPotok, Croatia.
SPF, lyophilisate forSuspension
1 dose of vaccinecontains:Attenuated live virus ofGumboro disease(infectious bursaldisease), strain VMG 91≥ 10 4.0 TCID 50
Pharmacological group:Immunologicalformulation for birds,farm poultry Live virusvaccine, virus ofinfectious bursal disease(Gubmoro disease)For active immunizationof chickens withinherited maternalantibodies againstGumboro disease.
Oral admintration
(R&I) dated07-4-2015
Fee Rs.100000/- dated07-4-2015
10x1000 doses10x 2000 doses10x2500 doses10x5000 doses
Unit price:Decontrolled
authorizationcertificateregistration No525-10/1278-15-2 dated 28-1-2015. enclosed
Legalized GMPCertificate No.409-8/2013-2dated 17-4-2013enclosed
deferred for evaluation by Dr. Qurban Ali, Member Registration Board.
approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.
4 Orient AnimalHealth (Pvt) Ltd,Karachi
Manufacturer
GENERA d.d.Svetonedjelijska2, Kalinovica,10436 RakovPotok, Croatia.
Bronhikal® I SPF,lyophilisate forsuspension
One dose of vaccinecontains:Attenuated live virus ofAvian infectiousbronchitis, strain H-120≥ 103.5 EID50
Pharmacological group:Immunological for aves,domestic fowl.For active immunizationof chickens from dayold onwards to prevent
Dy. No. 2410(R&I) dated07-4-2015
Fee Rs.100000/- dated07-4-2015
10x1000 doses10x 2500 doses
Unit price:Decontrolled
Legalized Marketauthorizationcertificateregistration No.525-10/ 1278-15-2 dated28-1-2015. enclosed
Legalized GMPCertificate No.409-8/ 2013-2Dated17-4-2013enclosed
Registration Board deferred for evaluation by Dr. Qurban Ali, Member Registration Board.
-do- Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.
Minutes for 266th Meeting of Registration Board. 204
mortality, clinical signsand lesions of the avianInfectious bronchitis.
f. Hiprabovis-4 applied by M/s Marush Pharma, Lahore.S.#.
Name of Manufacturer
Name of Drug and Composition
Date of application / Fee status
Documentary details
Remarks Decision
1. LaboratoriosHipr a S.A. Avda. La Selva Amer (Girona), Spain
Hiprabovis-4(Solvent for Injectable suspension)Composition per dose(3ml):Inactivated Infectious Bovine Rhinotracheitis Virus, strain LA.....ELISA≥50Inactivated Parainfluenza-3 virus, strain SF4.....IHA≥1/16Inactivated Bovine Viral Diarrhoea virus, strain NADL........ELISA≥50
Dy.No. 248(R&I) dated03-01-2017
Fee Rs.50000/- dated03-01-2017
30 dose vial
Unit price:Decontrolled
Legalized CoPP dated 01-12-2014
The Registration Board in its 258th
meeting approved the product and accordingly the registration letter was issued to the firm vide registration no. 081815 for the lyophilisate part containing live Bovine respiratory Syncitial Virus, Strain Lym-56 The firm has now requested for the issuance of letter for the solvent part.
Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.
g. Products applied by M/s Bromed Animal Health, Lahore deferred in 262nd
meeting of Registration Board.
Following products of M/s Bromed Animal Health, Lahore were considered in 262nd
meeting of Registration Board for the expert opinion of Dr. Qurban Ali. The details are as follows:
Sr. No.
Name of Manufacturer
Brand Name & Composition
Type of Form
Dy No & Date of application
Fee submitted
Pack size/ Demanded Price
Document details (CoPP)
Me too status/New molecule
Decision of RB in 262nd meeting
1.BroMed animal Health, LahoreMiddle East for Vaccines (ME VAC)Egypt.
ME VAC IB+ND+EDSInactivated tetravalent Virus Vaccine of Inactivated Virus Vaccine
Each dose (0.5ml) contains:Inactivated Virus Vaccine of Infectious Bronchitis Disease of IB Classical
Form-5
Dy No. 276 (R&I) DRAP dated 25-1-2016
Fee deposited; Rs. 100000/- dated 21-1-2016 vide challan no.
Copy of GMP submitted.
Deferred for expert opinion for confirmation of prevalence of strain by Dr. Qurban Ali, Member Registration Board
Minutes for 266th Meeting of Registration Board. 205
(Eg/11539F)& IB Variant type 2 (Eg/1212B)……≥107EID50/dose at release.
Inactivated Newcastle Disease NDV/Chicken/Egypt/11478AF/2011 (ND)……≥108EID50/dose at release (>128PD50).
Inactivated Egg Drop Syndrome Virus (EDS’76) ≥106EID50/dose at release.
Mantonied ISA 70VG..…0.35 mlInactivant BEI…..0.0005ml
Bulk saline …… Q.S.to 0.5mlTotal …. 0.5ml
Immunization agaiunst above viruses
Shelf life : 24 monthsRoute of adm: IM/ SC
0131612.
300 and 500 ml vial
2. BroMed animal Health, Lahore
Middle East for Vaccines (ME VAC)Industrial area 2 Piece 22-24, New Salhia, el Sharkia Head Office: 20 Jospeh teto el nozha el gededa, Cairo, Egypt.
ME FLUVAC H9+ND 0.5Inactivated tetravalent Virus Vaccine of Inactivated Virus Vaccine.
Each dose (0.5ml) contains:
Inactivated Avian Influenza A/Chicken / Egypt/ 114940v/NLQP /2011 (H9N2)…. ≥108EID50/dose before inactivation.
Inactivated Virus Vaccine of Infectious Bronchitis Disease of IB Classical (Eg/11539F)& IB Variant type 2 (Eg/1212B)……≥107EID50/dose at release.
Inactivated Newcastle Disease
Dy. No. 277 (R&I) DRAP dated 25-1-2016
Fee deposited: Rs. 100000/- dated 05-1-2016 vide challan no. 0131611
300 and 500 ml vial
Copy of GMP submitted
Deferred for expert opinion for confirmation of prevalence of strain by Dr. Qurban Ali, Member Registration Board
Minutes for 266th Meeting of Registration Board. 206
NDV/Chicken/Egypt/11478AF/2011 (ND)……≥108EID50/dose at release (>128PD50).
Mantonied Isa 70..…0.35 mlFormaldehyde solution..0.0045ml
Bulk saline…… Q.S.to 0.5mlTotal ….. 0.5ml
Protection against avaian influenza, IB classic and Variant ,ND infections in breedes and layers
Route of adm: SCShelf life: 24 months
Expert opinion of Dr. Qurban Ali:The subject vaccine (1) is a multi-component poultry vaccine against Infectious
Bronchitis, Newcastle disease and Egg DropSyndrom. The formulation is tetravalent
inactivated. Strain types of the virus are as follows:-
i. IB Classical (Eg/11539F)ii. IB Variant type 2 (Eg/1212B)
iii. NDV/Chicken/Egypt/11478F/2011iv. EDS 76
The subject vaccine (2) is ME FLUVAC H9+ND 0.5. It is an inactivated tetravalent Viral Vaccine containing:-
i. Avian Influenza A/Chicken?Egypt/114940v/NLQP/2011(H9N2)ii. IB Classical (EG/11539F)
iii. IB Variant Type 2 (Eg/1212B)iv. NDV/Chicken/Egypt/11478 AF/2011
Before any dicision details on immunological justification for use in poultry of
Pakistan is required for the above two formulations in addition to technical profile of the
manufacturer. Moreover, status of registration in other than country of origin is not known.
Decision: Deferred for submission/ clarification of following by the firm:a. Details on immunological justification for use in poultry of Pakistan
for the above two formulationsb. Technical profile of the manufacturer.c. status of registration in other than country of origin.
Minutes for 266th Meeting of Registration Board. 207
h. Products applied by M/s Hivet Animal Health Business, Lahore deferred in 262nd
meeting of Registration Board.
Following products of M/s Hivet Animal Health Business, Lahore were considered in
262nd meeting of Registration Board for the expert opinion of Dr. Qurban Ali. The details are
as follows:
Sr. No.
Name of Manufacturer
Brand Name & Composition
Type of Form
Dy No & Date of application
Fee submitted
Pack size/ Demanded Price
Document details (CoPP)
Me too status/New molecule
Decision of RB in 262nd
meeting
1.Investigacion Aplicada S.A.de C.V. 7 Norte 416, Col. Centro, C.P. 75700, Tehuacan,Puebla, Mexico.
Emulmax IBH +ND
Inactivated virus emulsified vaccine against Inclusion Body Hepatitis disease and Newcastle disease.
Each 0.5ml contains:
SHP-IAP/92….106.7
dict/ml
SHP-IAP/94…106.7
DICT/ml
SHP-IAP/95…104.7
DICT/mlNewcastle LaSota strain…108.7DIEP50% / ml
Inactivated virus emulsified vaccine
For prevent Hydropericardium Syndrome and Newcastle Disease in broilers.
Proposed shelf life : 18 months
Form 5A
Dy NO. 2871 R&I DRAP dated 23.6.2016
Fee deposited Rs.100000/- dated23-6-2016
Price:De-controlled
Legalized free sale dated03-06-2016
Deferred for expert opinion of Dr. Qurban Ali, Member Registration Board.
2. Investigacion Aplicada S.A.de C.V. 7 Norte 416, Col. Centro, C.P. 75700, Tehuacan, Puebla, Mexico.
Emulmax IBHInactivated virus emulsified vaccine against inclusion body Hepatitis disease
Each 0.5ml e contains:SHP-IAP/92…107.0
DICT/ml
Form 5A
Dy No. 2812 R&I DRAP dated23-6-2016
Fee deposited Rs. 100000/- dated
Legalized free sale dated 03-06-2016
Deferred for expert opinion of Dr. Qurban Ali, Member Registration Board.
Minutes for 266th Meeting of Registration Board. 208
SHP-IAP/94…107.0
DICT/ml
SHP-IAP/95….107.0
DICT/ml
Inactivated emulsified vaccine
SubcutaneousTo prevent Hydropericardium Syndrome disease caused by adenovirus group 1,4 serotype in broilers
Proposed shelf life: 24 months
22-6-2016
De-controlled1000 dose bottle
Expert Opinion of Dr. Qurban Ali:Information on immunological relevance, justification of strains of IBH viz-a-viz
poultry in Pakistan for inclusion Body Hepatitis (IBH) component of vaccine may please be requested to applicant firm.
Moreover, rationale of formulation with ND Lasota; both vaccines route of administration and results of challenge studies as a potential vaccine against Hydro Pericardium Syndrome (HPS) are required.
Decision: Deferred for submission/ clarification of following by the firm:a. Information on immunological relevance, justification of strains of IBH
viz-a-viz poultry in Pakistan for inclusion Body Hepatitis (IBH) component of vaccine.
b. Rationale of formulation with ND LaSota.c. Both vaccines route of administration and results of challenge studies as a
potential vaccine against Hydro Pericardium Syndrome (HPS).
i: Clinical data of Enoxa (Enoxaparin 80, 60,40 & 20 mg) PFS appliedbyM/s Scilife Pharma Karachi.
Sr.No.
Name of Importer / Manufacturer
Brand Name / Composition
Date of application / Fee status / Packing / MRP
Documentary details
Decision in 263rd meeting
Decision
1. SciLife Pharma (Pvt) Ltd. Karachi, Pakistan
Manufacturer:
Hebi Changshan Biochemical Pharmaceutical Co., Ltd. No.9 Fuqiang Road, Zhengding,
EnoxaSolution for injection(Enoxaparin sodium )
Each pre-filled syringe contains:80mg/0.8mlEnoxaparin sodium USP…80mg(equivalent to 8,000 IU anti-Xa activity in 0.8ml)
Pharmacological group:
Dy No. 359 Dir (Bio) dated 08-6-2013
Fee Rs. 50000/- dated 27-6-2013 + 50000/- dated 09-11-2015
Unit pack size: 2 Pre-Filled Syringes
Price Rs. 487/- per
Legalized COPP No. 20150348Date 03.6.2015. enclosed
Product License No. GUOYAOZHUNZIH20063910 dated
Legalized GMP Certificate No. CN20130314 dated
Registration Board deferred above products for submission of clinical trial data.
Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized
Minutes for 266th Meeting of Registration Board. 209
Shijiazhuang, China.
Anti-thrombotic Agent Pre-filled Syringe. 15.10.2013 Valid until 14.10.2018 enclosed
CoPP.
2. SciLife Pharma (Pvt) Ltd. Karachi, Pakistan
Manufacturer:
Hebi Changshan Biochemical Pharmaceutical Co., Ltd. No.9 Fuqiang Road, Zhengding, Shijiazhuang, China.
Enoxa [Specs: USP](Enoxaparin sodium) Injection 40mg/0.4 ml in PFSSolution for injection.
Each pre-filled syringe contains:Enoxaparin Sodium USP….40mg(equivalent to 4,000 IU anti-Xa activity in 0.4ml).
Pharmacolgical group:Anti-thrombotic Agent
Dy No. 357 Dir (Bio) dated 28-6-2013
Fee Rs. 50000/- dated 27-6-2013 +50000/- dated09-11-2015
Unit pack size: 2 Pre-Filled syringesPrice Rs. 625/-Rs.312.50/- per Pre-Filled Syringe
Legalized GMP Certificate No. CN20130314 date 15.10.2013 enclosedValid until14-10-2018.
Legalized COPP No. 20150346 date 03-06-2015 enclosed
Product License No. GUOYAOZHUNZI H20063913Copy of Power of Attorney enclosed
Registration Board deferred above products for submission of clinical trial data.
Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.
3. SciLife Pharma (Pvt) Ltd. Karachi, Pakistan
Manufacturer:
Hebi Changshan Biochemical Pharmaceutical Co., Ltd. No.9 Fuqiang Road, Zhengding, Shijiazhuang, China.
Enoxa [Product Specs: USP](Enoxaparin Sodium) Injection 60mg/0.6 in PFS
Each pre-filled syringe contains:Enoxaparin sodium USP…..60mg (equivalent to 6,000 IU anti-Xa activity in 0.6ml)
Pharmacological group:Anti-thrombotic Agent
Dy No. 360 Dir (Bio) dated 28-6-2013
Fee Rs. 50000/- 27-6-2013 +50000/- dated 09-11-2015
Unit pack size: 2 Pre-Filled Syringes
Price: Rs. 802/-Rs.401/- per Pre-Filled Syringe
Legalized COPP No. 20150347 dated 03-6-2015 valid until 30-4-2017 enclosed
Product License No. GUOYAOZHUNZI H20063919
Copy of GMP Certificate NO. CN20130314 dated15-10-2013 valid until27.10.18.enclosed
Registration Board deferred above products for submission of clinical trial data.
Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized CoPP.
4. SciLife Pharma (Pvt) Ltd. Karachi, Pakistan
Manufacturer:
Hebi Changshan Biochemical Pharmaceutical Co., Ltd. No.9 Fuqiang Road, Zhengding,
Enoxa[Product Specs: USP]Enoxaparin SodiumSolution for Injection20mg/0.2ml in PFS
Each pre-filled syringe contains:Enoxaparin sodium USP….20mg(equivalent to 2,000 IU anti-Xa acitivity in 0.2ml)
Pharmacolgical group:
Dy No. 358 Dir (Bio) dated 18-6-2013
Fee Rs. 50000/- dated 27-6-2013 + 50000/- dated09-11-2015
Unit pack size: 2-Prefilled syringes
Price: 356/-Rs. 178/- per Pre-
Legalized COPP NO. 20150345 dated 03-6-2015 enclosed
Product License No. GUOYAOZHUNZI H20063911
Copy of GMP Certificate No. CN20130314 dated 15-10-
Registration Board deferred above products for submission of clinical trial data.
Registration Board approved the product as per import policy for Finished Drugs and as per valid legalized
Minutes for 266th Meeting of Registration Board. 210
Shijiazhuang, China.
Anti-thrombotic Agent Filled Syringe. 2013 valid until 14-10-2018 enclosed
CoPP.
j. Expert opinion on product applied by M/s Vet Crown Animal Health Lahore.
BIAROMVAC-Pan and AVIPOX-GAL of M/sVet Crown (Animal Health
International Lahore, were considered in 258th meeting of Registration Board and were
deferred for the expert opinion of following experts.
a. Dr Muhammad Afzal, NVL Islamabadb. Dr Masood Rabbani, UVAS Lahorec. Dr. Muhammad Arif Awan, CASQAB, Quetta
The experts have furnished expert opinions and detailed as under:S.#. Company Name and
ManufacturerName of Drug and Composition
Date of application / Fee status
Documentary details
1 Vet Crown(Animal Health) International. Lahore Pakistan
Manufacturer
S.C Romvac Company S.A, Soseaua Centurii nr.7,077190 Voluntari, Jud. llfov-Romania.
BIAROMVAC-PAInfectious Bursal Disease (IBD)
Each dose contains Active substance:Live IBD virus attenuated strain (PA 43-94) contain minimum 103.5 Eid 50 to maximum 105.5 Eid 50.
Pharmacological group:Vaccine (Lypholized).
Route of Adm: Ocular conjuctival, IM, OralShlef life : 18 months
Dy No. 1183 (R&I) dated 24-2-2016
Fee Rs. 50000/- dated 24-2-2016 + 50000/- dated 26-2-2016
Unit price: De- Controlled
Legalized COPP NO. 930/3 dated 28.9.2015
Market authorization no. 120170 dated 17-5-2012
GMP Certificate No. 29/2013/RO dated 17-12-2013
2 Vet Crown(Animal Health) International. Lahore Pakistan
Manufacturer
S.C Romvac Company S.A, Soseaua Centurii nr.7,077190 Voluntari, Jud. llfov-Romania.
AVIPOX-GAL(Avian pox disease.
Each vaccinal dose (0.01ml) contains:The Avian pox virus-Galinar attenuated strainGal-MP1with minimum titre 102 and maximum titre 105
DIE50 / Vaccinal dose.
Pharmacological group:Vaccine (Lyophilized).
Shelf life: 18 monthsRoute of adm: transdermal
Dy.No. 1184 (R&I) DRAP dated 24.2.2016
Fee Rs. 50000/- dated 24-2-2016 + 50000/- dated 26-2-2016
Price: De-controlled.
Legalized COPP No. 930/7/28 dated 28-9-2015
Market authorization No. 120010 dated 17-1-2012.
GMP Certificate No. 29/2013/RO dated 17-12-2013
Drugs available in the country of origin.
Minutes for 266th Meeting of Registration Board. 211
Dr .Muhammad Afzal,TI (Ex-Chief Scientist-II) NVL Islamabad.
i. BIAROMVAC-PA Infectious Bursal Disease.1. BiaRomvac PA is a vaccine against infectious Bursal Disease (IBD) containing attenuated IBD virus strain PA 93-94 of Romanian origin. Antigenic relationship of this strain with those of Pakistan origin IBD strains have not been established in the literature and no data has been presented in this regard. Thus utility of this vaccine in providing protection against local strains cannot be established or predicted.2. The dossier states (page 22-23 and many other places) “The optimum vaccine efficacy depends of the flock epidemiological situation and of the area where the birds are raised and evaluated under the direct coordination of the veterinary doctor which assures the sanitary – veterinary supervision on the base of the immunological status determination;. It further goes on to state “efficacy is influenced by the maternally derived antibodies”. These statements clearly indicate that recommendation on the time of vaccination will depend on local practices and epidemiological situation of the area. No documentation in this regard is available in the supplied dossier.
3. The dossier does not explain various methods used in vaccine preparation but mentions that these were carried out in accordance with company SOP. The details of these SOPs are missing in the dossier.4. The dossier presents different statements in various section regarding the use of embryos from SPF / conventional eggs in the preparation of vaccine. In Part II of the dossier (section II A.3 introductory para, 3.2 composition of vaccine and II.B.1.1 technical flow2 diagram), it is stated that vaccine is manufactured from embryos derived from SPF eggs. However contrary to this, paras 3.1.8 and II.C.1.2.1.2 stats that embryos from SPF / commercial grade or conventional eggs are used.
Opinion: The discrepancy mentioned in comment 4 has to besorted out before any recommendation on registration of the product could be made.
ii. Avipox GalAvi pox Gal contains an Italian strain of Avian Pox virus strain, Gal-MP1. This
vaccine is recommended for vaccination in hens for 90days age, In necessary situation tye minimum age for application in hens is 60days. The manufacturer recommends that in hens 1st vaccination should be done by Avipox-Col-81 vaccine and afterrevaccination with Avipox Gal. the manufacturer further recommends that no other vaccine should be administered before or after14 days from vaccination with Avipox-Gal.SPF/conventional hen embryonated eggs are used in vaccine manufacturing.
Absence of mycoplasma in the vaccine bactes is shown by cuturing on PPLO. It is now universally known that many mycoplasma will not grow on PPLO media or too fgastidious to grow. The standaed method used now universally by all leading vaccine manufacturer mycoplasma detection using PCR with universal mycoplasma primer.Opinion:Attenuated virus vaccine using conventional eggs may be source of introduction of unknown viruses in the country. Thus this vaccine AVIPOX GAL is not recommended for registration for use in Pakistan
Prof. Dr Mohammad Arif Awan CASVAB, Quetta
Minutes for 266th Meeting of Registration Board. 212
Biaromvac-PA & Avipox GalAll the information and technical data represented in the dossier for the two products
are satisfactory. As safety and efficacy of the presented products are concerned, the data meet the international standard and is comparable to the recommendations reflected in OIE manual for veterinary vaccine production. National Veterinary Laboratories (NVL), Islamabad may be requested, if necessary.
Furthermore, the vaccine based on the local strains of IBD and Avain Pox disease needs rigorous experimentation on isolation, characterization, attenuation, vaccine production and quality control. However comparative research studies will also be required to further see the suitability of the vaccine (attenuated or inactivated) based on locally isolated virus strain or the foreign strain vaccine. For this aspect the linkage of industry (commercial vaccine production units) and universities may be motivated, encouraged and financially support to address such research pursuits.
Dr. Masood Rabbani, UVAS Lahorei. Biaromvac-PA
It is freeze dried vaccine containing live attenuated (PA 43-94) strain of Infectious B ursal Disease Virus/Gumboro virus) embryo adapted virus. It is used to control outbreaks of IBD in commercial, rural, wild birds. It contains minimum amount of immunogen as 103.5-5.5 units of EID50/dose.
Gumboro/IBD is prevailing in Pakistan and causing serious economic losses in form of mortility, morbidity, immunodepression, and poor growth response of survivers.
ii. Avipox Gal:It is live attenuated strain of fowl pox virus (Galinar MP1 strain). Each
vaccinal dose (0.01ml) contains 102-5 units of EID50. It is used to control pox in avain species that is serious health hazard for rural, commercial, wild and zoo birds.
Status of the Vaccines in Pakistan: The above mention poltry vaccines are not being propduced in Pakistan and are not used in rural poltry. These vaccines are already registered with many companies in Pakistan.
Comments: Based on the “quality control data, results of the experimental trials and composition of the vaccines”. Each of the above mention vaccines against the poultry disease in Pakistan seem to be safe and effective.
Recommendation: It is therefore recommended that the said vaccines may be registered in Pakistan in the best interest of poultry farmers.
The case is submitted before the board for consideration please.
Decision in 262nd meeting: Registration Board deferred for evaluation by Dr. Qurban Ali, Member Registration Board.
The opinion of Dr. Qurban Ali is as under:a. Biaromvac-PA
Deferredi. Unless manufacturer clarifies with written statement that the production of
vaccine is exclusively and entirely on SPF Eggs.ii. Moveover, manufacturer produces SPF Eggs Quantity, Number and Source of
SPF Eggs Consignments for the last three yrears for vaccine production.
Minutes for 266th Meeting of Registration Board. 213
b. Avipox-GALDeffered
i. Unless manufacturer clarifies with written statement athat the production of vaccine is exclusively and entirely on SPF Eggs.
ii. Moveover, manufacturer produces SPF Eggs Quantity, Number and Source of SPF Eggs Consignments for the last three years for vaccine production.
Decision: Deferred for following clarification by the firm for above products:i. Unless manufacturer clarifies with written statement that the production
of vaccine is exclusively and entirely on SPF Eggs.ii. Moreover, manufacturer produces SPF Eggs Quantity, Number and
Source of SPF Eggs Consignments for the last three years for vaccine production.
iii. Clarification that which strain of Live IBD virus attenuated strain (PA 43-94) is in BIAROMVAC-PA
k. Request for import on bulk basis and individual repack locally by M/s Medi Pak Limited Lahore.M/s Medi Pak Limited Lahore has submitted an application for permission bulk
import and local repacking of teir following registered drugs.
Sr. No.
Product name Reg. No Manufacturer
1. Epogen IV 2000IU vials 043049 Laboratorio Pablo Cassara- Argentina2. Epogen IV 4000IU vials 043050
3. Epogen IV 10000IU vials 059006
The firm informed that bulk vilas will be imported as labelled / pre printed from
manufacturer abroad and only operation done at Medi Pak will be individual outer cartooning
along with insertion of PIL at their controlled packing facility under strict environmental
condition.
The firm has submitted following documents:a. Application on Form-5Ab. Fee of 100000/- for each i.e 300000/- in total.c. Copies of eveidence of renewal.d. Copy of additional pack approval.
Decision: Registration Board deliberated that packaging is the part of manufacturing process and after the aforesaid process the quality control testing and release is responsibility of manufacture, therefore the Board deferred above products for confirmation of following by the firm:
a. Quality control facility for testing of above products.b. Cold storage facility for outer cartooning along with insertion of PIL.
Minutes for 266th Meeting of Registration Board. 214
iii. Local Manufacturing of Biological Drugs1. M/s BF Biosciences, Lahore.a. Eritrogen (Erythropoietin) 2000IU PFS.
Sr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group,Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s BF Biosciences Ltd.,5km- Sunder Raiwind Road, Raiwind, Lahore
Eritrogen 2000IUEach prefilled syringe (1ml) contains:Recombinant Human Erythropoietin alpha........2000IU
Mitosis stimulating factor & differentiating hormoneShelf Life: 24 months
Form-5134/2014(R&I)09-05-2014Rs. 2000007-05-2014Pack of 6’s (PFS)Price:As per SRO
DML No. 000655 dated 30-01-2014GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.
Eprex of Janssen-Cilag Ltd., UK
Sepo 2000IU/ml PFS by Al-Karim Distributors, Karachi
Evaluation as per decision of 246th meeting of Registration Board.S.No.
Documents and data required as per 246th
meeting
Documents and data submitted Remarks
1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Firm has submitted the Legialized GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.
GMP certificate is expired.
2. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Under Eludication of structure of API, comparative analysis with EPO Standard BPR is provided by M/s ZELLTEK S.A, Argentine Republic.
i. Glycoform analysisii. Primary Structure
iii. Secondary Structureiv. Tertiary structurev. Disulfide bridges
vi. N-terminal sequencevii. Sialic Acid Content
viii. Native N-glycans profileix. Neutra N-glycans profile
Clarification is required whether API or bulk concentrate or redy to fill bulk, will be imported as manufacturing process mentioned in Form-5 shows only filling and packing, while GMP certificate shows API export.Structural similarity data of the API is provided with standard BPRStructural similarity performed is of API with
Minutes for 266th Meeting of Registration Board. 215
x. O-glyscosilatin site occupationxi. Content of dimmers and related
substances of high molecular weight
xii. Invivo biological activity.
BPR standard instead of reference product.
As per decision in 246th
meeting, structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator) is required.
Results of structural analysis of EPO standard BPR at sr. No. iv, vi, vii, viii, ix, x, xi and xii are not provided.
3. Authorization to manufacture the finished biological product for trial studies
Not provided Not provided
4. Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Under Bio-comparibility studies, comparison between Eritrogen and Eprex is provided by BF Biosciences Ltd.
i. Immunocharacterization using Western Blot technique
ii. Biological activity using ELISA.
Long term and Accelerated stability data of trial batch is provided by the firm.
Real Time study temp. 50C ±30C.
Accelerated study temp. 250C±20C.
Source of API: Zelltek S.A, Argentine Republic
Trial batch size:120 PFS
Stabilty data provided is of one trial batch.
5. Others
Decision: Registration Board deferred the above product due to paucity of time.
b. Eritrogen (Erythropoetin) 4000IU PFSSr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group,Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s BF Biosciences Ltd.,5km- Sunder
Eritrogen 4000IUEach prefilled syringe (1ml) contains:
Form-5135/2014(R&I)09-05-2014Rs. 20000
DML No. 000655 dated 30-01-2014GMP certificate No. 20132021-000 033-15
Minutes for 266th Meeting of Registration Board. 216
Raiwind Road, Raiwind, Lahore
Recombinant Human Erythropoietin alpha........4000IU
Mitosis stimulating factor & differentiating hormone
Shelf Life: 24 months
07-05-2014Pack of 6’s (PFS)Price:As per SRO
dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.
Eprex of Janssen-Cilag Ltd., UK
Sepo 4000IU/ml PFS by Al-Karim Distributors, Karachi
Evaluation as per decision of 246th meeting of Registration Board.
S.No. Documents and data required as per 246th
meeting
Documents and data submitted Remarks
1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Firm has submitted the Legialized GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.
GMP certificate is expired.
2. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Under Eludication of structure of API, comparative analysis with EPO Standard BPR is provided by M/s ZELLTEK S.A, Argentine Republic.i. Glycoform analysis
ii. Primary Structureiii. Secondary Structureiv. Tertiary structurev. Disulfide bridges
vi. N-terminal sequencevii. Sialic Acid Content
viii. Native N-glycans profileix. Neutra N-glycans profilex. O-glyscosilatin site occupation
xi. Content of dimmers and related substances of high molecular weight
xii. Invivo biological activity.
Clarification is required whether API or bulk concentrate or redy to fill bulk, will be imported as manufacturing process mentioned in Form-5 shows only filling and packing, while GMP certificate shows API export.Structural similarity data of the API is provided with standard BPRStructural similarity performed is of API with BPR standard instead of reference product.
As per decision in 246th
meeting, structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator) is required.
Results of structural analysis
Minutes for 266th Meeting of Registration Board. 217
of EPO standard BPR at sr. No. iv, vi, vii, viii, ix, x, xi and xii are not provided.
3. Manufacturer to manufacture the finished biological product for trial studies
Not provided Not provided
4. Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Under Bio-comparibility studies, comparison between Eritrogen and Eprex is provided by BF Biosciences Ltd.
i. Immunocharacterization using Western Blot technique
ii. Biological activity using ELISA.
Stability data of trial batch is not provided.
5. OthersDecision: Registration Board deferred the above product due to paucity of time.
c. Eritrogen (Erythropoetin) 10000IU PFS
Sr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group, Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s BF Biosciences Ltd.,5km- Sunder Raiwind Road, Raiwind, Lahore
Eritrogen 10000IUEach prefilled syringe (1ml) contains:Recombinant Human Erythropoietin alpha.......10000IU
Mitosis stimulating factor & differentiating hormone
Shelf Life: 24 months
Form-5136/2014(R&I)09-05-2014Rs. 2000007-05-2014Pack of 6’s (PFS)Price:As per SRO
`DML No. 000655 dated 30-01-2014
GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.
Eprex of Janssen-Cilag Ltd., UK
Me Too status needs confirmation.
Evaluation as per decision of 246th meeting of Registration Board.S.No. Documents and data
required as per 246th
meeting
Documents and data submitted Remarks
1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological
Firm has submitted the Legialized GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of
GMP certificate is expired.
Minutes for 266th Meeting of Registration Board. 218
drug in its country of origin. Santa Fe, of the Argentine Republic valid for 01 year.
2. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Under Eludication of structure of API, comparative analysis with EPO Standard BPR is provided by M/s ZELLTEK S.A, Argentine Republic.
i. Glycoform analysisii. Primary Structure
iii. Secondary Structureiv. Tertiary structurev. Disulfide bridges
vi. N-terminal sequencevii. Sialic Acid Content
viii. Native N-glycans profileix. Neutra N-glycans profilex. O-glyscosilatin site occupation
xi. Content of dimmers and related substances of high molecular weight
xii. Invivo biological activity.
Clarification is required bulk concentrate or redy to fill bulk, will be imported as manufacturing process mentioned in Form-5 shows only filling and packing, while GMP certificate shows API export.
Structural similarity data of the API is provided with standard BPRStructural similarity performed is of API with BPR standard instead of reference product.
As per decision in 246th
meeting, structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator) is required.
Results of structural analysis of EPO standard BPR at sr. No. iv, vi, vii, viii, ix, x, xi and xii are not provided.
3. Manufacturer to manufacture the finished biological product for trial studies
Not provided
4. Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Under Bio-comparibility studies, comparison between Eritrogen and Eprex is provided by BF Biosciences Ltd.
i. Immunocharacterization using Western Blot technique
ii. Biological activity using ELISA.
Long term and Accelerated stability data of trial batch is provided by the firm.
Real Time study temp. 50C ±30C.
Accelerated study temp. 250C±20C.
Source of API: Zelltek S.A, Argentine Republic
Trial batch size:119 PFS
Stabilty data provided is of one trial batch.
5. Others
Decision: Registration Board deferred the above product due to paucity of time.
Minutes for 266th Meeting of Registration Board. 219
d. Eritrogen (Erythropoetin) 10000IU VialSr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group, Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status, Me-too
Remarks
1 M/s BF Biosciences Ltd.,5km- Sunder Raiwind Road, Raiwind, Lahore
Eritrogen 10000IUEach vial (1ml) contains:Recombinant Human Erythropoietin alpha.......10000IU
Mitosis stimulating factor & differentiating hormone
Shelf Life: 24 months
Form-5682/2014(R&I)13-06-2014Rs. 20000 11-06-2014Pack of 6’s (Vials)Price:As per SRO
DML No. 000655 dated 30-01-2014
GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.Epogen by Amgen, USAPDpoetin by Nextar Pharma, Karachi.
Evaluation as per decision of 246th meeting of Registration Board.S.No.
Documents and data required as per 246th meeting
Documents and data submitted Remarks
1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Firm has submitted the Legialized GMP certificate No. 20132021-000 033-15 dated 08-6-2015 of M/s ZELLTEK S.A, Ruta Nacional No 168 S/N, Pasaje “EI Pozo’, Parque Tecologico Litoral , of the Province of Santa Fe, of the Argentine Republic valid for 01 year.
GMP certificate is expired.
2. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Under Eludication of structure of API, comparative analysis with EPO Standard BPR is provided by M/s ZELLTEK S.A, Argentine Republic.
i. Glycoform analysisii. Primary Structure
iii. Secondary Structureiv. Tertiary structurev. Disulfide bridges
vi. N-terminal sequencevii. Sialic Acid Content
viii. Native N-glycans profileix. Neutra N-glycans profilex. O-glyscosilatin site
occupationxi. Content of dimmers and
related substances of high molecular weight
xii. Invivo biological activity.
Firm mentioned the erythropotein concentrate will be formulated locally under the manufacturing method, however structural similarity data of the API is provided with standard BPR
Structural similarity performed is of API with BPR standard instead of reference product.
As per decision in 246th
meeting, structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator) is required.
Minutes for 266th Meeting of Registration Board. 220
Results of structural analysis of EPO standard BPR at sr. No. iv, vi, vii, viii, ix, x, xi and xii are not provided.
3. Manufacturer to manufacture the finished biological product for trial studies
Not provided Not provided
4. Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Not provided Not provided
5. Others
Decision of RB in 260th meeting:“Regiatration Board deliberated and deferred these applications that manufacturing and quality control of biological products require specialized facilities and approval from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have already been granted registrations of various biological products for local manufacturing (mostly therapeutic proteins). As theses firms have applied for registration for local manufacturing of various biological products including rDNA products, Theraputic protein, Monocronial antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the Board decided to have opinion of licensing division DRAP regarding approved manufacturing facilities (categories of biological products) of these firms and status of already registerd biological drugs from these firms.”Decision: Registration Board deferred the above product due to paucity of time.
e. Peg-INF 180mcg/0.5ml PFSSr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group,Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s BF Biosciences Ltd.,5km- Sunder Raiwind Road, Raiwind, Lahore
Peg-INF 180mcg/0.5ml(Pre-filled syringe)Each PFS contains:Peginterferon alfa 2a…….180mcg
Immunostimulating agent/ Cytokine
Shelf Life: 24 months
Form-5137/2014(R&I)09-05-2014Rs. 20000 07-05-2014Pack of 1’s (PFS)Price:As per SRO
DML No. 000655 dated 30-01-2014
GMP certificate No. 20132021-000 033-15 dated 27-04-2015 of M/s Gemabiotech S.A., Fray Justo Sarmiento 2350-5th
floor Building E2, The city Buenos Aires of Argentina Rwepublic valid for 01 year.
Pegasys of Roche Products, UKPegasys of Roche Pakistan
Minutes for 266th Meeting of Registration Board. 221
S.No.
Documents and data required as per 246thmeeting
Documents and data submitted Remarks
1. Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Firm has submitted the Legalized GMP certificate No. 20132021-000 033-15 dated 27-04-2015 of M/s Gemabiotech S.A., Fray Justo Sarmiento 2350-5th floor Building E2, The city Buenos Aires of Argentina Republic valid for 01 year.
GMP certificate is expired.
2. Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Under Eludication of structure of API Peg Interferon alfa-2a , comparative analysis with Pegasys is provided by M/s Gemabiotech S.A., Argentina Republic
i. Determination of molecular weight by Mass spectrometry
ii. Identification by HPLCiii. Immunoidentification by Western
Blotiv. Determination of the sequence by
Mass spectrometry (MALDI-TOF)v. Determination of Tertiary structure by
Fluoresence spectrophotometryvi. Biological activity
vii. Determination of impuritiesviii. Determination of related proteins
ix. Microbial assay.3. Manufacturer to manufacture
the finished biological product for trial studies
Not provided
4. Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Biocomparability studies performed by M/s BF Biosciences Limited of Peg-INF with RMP Pegasys includes:i. Physical description
ii. pHiii. Assay Protein concentrationiv. Immunoidentification testv. Presence of free interferon alfa 2a in
Peg-INFvi. Lower molecular weight impurities
vii. Free PEG(Polyethylene glycol)viii. Related protein
ix. Biological activity.5. Others Stability data is required
Decision in 262nd meeting:“Deferred for rectification of shortcomings as mentioned above along with the confirmation of manufacturing facility (PFS). Moreover the board also advised to provide the details of already registered products in the same facility
Decision: Registration Board deferred the above product due to paucity of time.
Minutes for 266th Meeting of Registration Board. 222
2. M/s Macter International Limited, Karachi
a. Redimab (Rituximab) 100mg/10ml VialSr. No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group, Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s Macter International Limited, Karachi
Redimab 100mg(Concentrate for solution for infusion)Each vial (10ml) contains:Rituximab ………10mg.Monoclonal antibodyShelf Life: 2 years
CTD1861/2014 (R&I)22-04-2014Rs. 20000/-20-04-2014Pack of 1’s (Vial)Price: As per PRC
GMP certificate No. CN20110019 dated 09-10-2011
Mabthera by Roche Products Limted, UK
Ristova of Roche Pakistan Limited.
Evaluation as per decision of 246th meeting of Registration Board.Sr. No Documents and data required as per
246th meetingDocuments and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Legalized GMP Certificate No. CN20110019 DATED 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China.
2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Characterization of Primary and secrondary structure of redimab and its comparability analysis with innovator retuximab sold under brand name of Rituxan by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: N-terminal amino acid sequenced
analysis, C-terminal Lys truncation by mass
peptide maping by sequence coverage.
Molecule weight by reducing SDS PAGE.
MALDI-TOF Mass spectrum performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other
Peptide Mapping by RP-HPLCwhich demosntrates that our products are homogeneioujs and stable.
Comparison of Methionine Oxidation for Anti-CD20 innovator.
Biological Charatarization was done by biocactivity determination and affinity comparison by immumofluorescence method.
Impurities by SEC-HPLC, SDS-PAGE
3 Manufacturer to manufacture the finished Not provided.Minutes for 266th Meeting of Registration Board. 223
biological product for trial studies4 Bio-comparability studies including
identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Comparitive analysis of finished drug (Redimab) with Ristova of Roche:Identity by SDS PagePurity by:SDS Page (Silver staining)Gel Filteration HPLCProtein content by UV (280nm)Biological activityGeneral safety tests :BET and sterlity
Stability data of locally manufactured finished product (accelerated and real time) is provided.
5 Others Certificateof analyisis of Rituximab bulk is submitted.Clinical Data has also been submitted.
Decision: Registration Board deferred the above product due to paucity of time.
b. Redimab (Rituximab) 500mg/50ml VialSr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group,Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s Macter International Limited, Karachi
Redimab 500mg/50ml(Concentrate for solution for infusion)Each vial (50ml) contains:Rituximab ………500mg.
Monoclonal antibodyShelf Life: 2 years
Form-51860/2014(R&I)22-04-2014Rs. 20000/01-04-2014Pack of 1’s (Vial)Price:As per PRC
GMP certificate No. CN20110019 dated 09-10-2011
Mabthera by Roche Products Limted, UK
Ristova of Roche Pakistan Limited.
Evaluation as per decision of 246th meeting of Registration Board.Sr. No
Documents and data required as per 246th meeting
Documents and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Legalized GMP Certificate No. CN20110019 DATED 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China.
2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Characterization of Primary and secrondary structure of redimab and its comparability analysis with innovator retuximab sold under brand name of Rituxan by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: N-terminal amino acid sequenced
analysis,Minutes for 266th Meeting of Registration Board. 224
C-terminal Lys truncation by mass peptide maping by sequence coverage.
Molecule weight by reducing SDS PAGE.
MALDI-TOF Mass spectrum performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other
Peptide Mapping by RP-HPLCwhich demosntrates that our products are homogeneioujs and stable.
Comparison of Methionine Oxidation for Anti-CD20 innovator.
Biological Charatarization was done by biocactivity determination and affinity comparison by immumofluorescence method.
Impurities by SEC-HPLC, SDS-PAGE3 Manufacturer to manufacture the
finished biological product for trial studies
Not provided.
4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Comparitive analysis of finished drug (Redimab) with Ristova of Roche:Identity by SDS PagePurity by:SDS Page (Silver staining)Gel Filteration HPLCProtein content by UV (280nm)Biological activityGeneral safety tests :BET and sterlityStability data of locally manufactured finished product (accelerated and real time) is provided.
5 Others Certificateof analyisis of Rituximab bulk is submitted.Clinical Data has also been submitted.
Decision: Registration Board deferred the above product due to paucity of time.c. Epocan (Epoietin Alfa) 2000IU/ml Vial.
Sr. No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group, Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s Macter International Limited, Karachi
Epocan 2000IU/ml(Solution for injection)Each vial (ml) contains:
Form-51626/2014(R&I)15-04-2014Rs. 20000 31-03-2014
Legalized CoPP no. WHO-CPP-CERT-JN-130801 dated 01-08-2013Legalized Free Sale Certificate no. 2013-107
Minutes for 266th Meeting of Registration Board. 225
Epoietin alfa………2000IU(0.0135mg)
Hematopoiettic agent.
Shelf Life: 3 years
Pack of 1’s (Vial)Price:As per PRC
dated 26-08-2013Legalized GMP certificate No. K5087 dated 25-11-2009
Epogen by Amgen, USA
EPO by Nexpharm
Evaluation as per decision of 246th meeting of Registration Board.Sr. No
Documents and data required as per 246th meeting
Documents and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Legalized GMP Certificate No. CN20140140 date of issuance 17-3-2014 valid upto 16-03-2019 M/s Shandong Kexing Bio – Products co., Ltd. Tangwangshan Road, Mingshui Development Zone, Zhangqiu, Shandong, China submitted.
Legalized Free Sale Certificate No. 2015-157 date of issuance 16-11-2015 valid for two year for date of issuance for Erythropoietin injection submitted.Legalized COPP No. WHO. CPP-CERT-ZQ-151116 date of issuance16-11-2015
3 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Not provided Only comparative studies conducted locally are submitted.
Under structural similarity, the firm provided the structural characterization of ready to fill bulk with reference to European Pharmacopoeia.Bioequivalence study is provided by the firm with Eprex.
4 Manufacturer to manufacture the finished biological product for trial studies
5 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing
Comparative analysis of Recombinant Human Erythropoietin (Drug substance) Vs RMP Recormon Roche is submitted and following test are carried out by M/s Macter International, Karachi SDS-PAGE (Silver staining)
Comparative analysis of drug substance vs RMP Recormon Roche is provided instead of Finished drud product Epocan 2000IU.
Minutes for 266th Meeting of Registration Board. 226
data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
SDS-PAGE (Coomassie staining) Isoelectric focusing Purity (By Gel filtration chromatography) Sialic Acid (by Resorcinol Method) Protein content (By ELISA)Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is also submitted and following test are carried out:
Identity by ELISA, Potency by Elisa, Total Protein content (By Lowry Assay), General Safety Test (By Bacterial endotixin test by gel Clot Method (LAL Test), Sterility Test by membrane filtration method.
Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is provided instead of RMP Recormon Roche.
6 Others Specification of ready to filled bulk of M/s Shandong Kexing bioproducts Co., Ltd, ChinaIdentification test, Physical tests (Appearance Visible particles), Chemical tests (pH, Content of sodium ion content of citrate ion content of protein Osmolality, Activity tests (Activity in vitro , Activity in vivo), Sterility and BET , Abnormal toxicity test.
Finished products specification of M/s Macter International Karachi as under:
Physical Appearance, ParticulateMater, Extractable volume, pH, Osmaolality, Immuno-identification, Potency, Content of Protein, BET, Sterility, Abnormal Toxicity.
The firm has also submitted accelerated and real time stability studies
Decision: Registration Board deferred the above product due to paucity of time.d. Epocan (Epoietin Alfa) 4000IU/ml Vial.
Sr. No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group,Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s Macter International Limited, Karachi
Epocan 4000IU/ml(Solution for injection)Each vial (ml) contains:Epoietin alfa………4000IU(0.027mg)
Hematopoiettic agent.Shelf Life: 3 years
Form-51626/2014(R&I)15-04-2014Rs. 20000/-31-03-2014Pack of 1’s (Vial)Price:As per PRC
Legalized CoPP no. WHO-CPP-CERT-JN-130801 dated 01-08-2013Legalized Free Sale Certificate no. 2013-107 dated 26-08-2013Legalized GMP certificate No. K5087 dated 25-11-2009Epogen by Amgen, USA
Minutes for 266th Meeting of Registration Board. 227
Erithromax by Pharmatec Pakistan (Pvt.) Ltd.
Evaluation as per decision of 246th meeting of Registration BoardSr. No
Documents and data required as per 246th
meeting
Documents and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Legalized GMP Certificate No. CN20140140 date of issuance 17-3-2014 valid upto 16-03-2019 M/s Shandong Kexing Bio – Products co., Ltd. Tangwangshan Road, Mingshui Development Zone, Zhangqiu, Shandong, China submitted.
Legalized Free Sale Certificate No. 2015-157 date of issuance 16-11-2015 valid for two year for date of issuance for Erythropoietin injection submitted.Legalized COPP No. WHO. CPP-CERT-ZQ-151116 date of issuance 16-11-2015
GMP submitted reflects that manufacturer is authorize to manufacturer Recombinant Human Erythropoietin injection.
3 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Not provided Only comparative studies conducted locally is submitted.
Under structural similarity, the firm provided the structural characterization of ready to fill bulk with reference to European Pharmacopoeia.
Bioequivalence study is provided by the firm with Eprex.
4 Authorization to manufacture the finished biological product for trial studies
Not provided Not provided
5 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-
Comparative analysis of Recombinant Human Erythropoietin Vs RMP Recormon Roche is submitted and following test are carried out by M/s Macter International, Karachi SDS-PAGE (Silver staining)
Comparative analysis of drug substance vs RMP Recormon Roche is provided instead of Finished biological product Epocan 4000IU.
Minutes for 266th Meeting of Registration Board. 228
Blot and other analytical techniques) and stability studies of finished biological product
SDS-PAGE (Coomassie staining)
Isoelectric focusing Purity(By Gel filtration
chromatography) Sialic Acid (by Resorcinol
Method) Protein content (By ELISA)Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is also submitted and following test are carried out:Identity by ELISA, Potency by Elisa, Total Protein content (By Lowry Assay), General Safety Test (By Bacterial endotixin test by gel Clot Method (LAL Test), Sterility Test by membrane filtration method.
Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is provided instead of RMP.
6 Others Specification of ready to filled bulk of M/s Shandong Kexing bioproducts Co., Ltd, ChinaIdentification test, Physical tests (Appearance Visible particles), Chemical tests (pH, Content of sodium ion content of citrate ion content of protein Osmolality, Activity tests (Activity in vitro , Activity in vivo), Sterility and BET , Abnormal toxicity test.
Finished products specification of M/s Macter International Karachi as under:Physical Appearance, ParticulateMater, Extractable volume, pH, Osmaolality, Immuno-identification, Potency, Content of Protein, BET, Sterility, Abnormal Toxicity.
The firm has also submitted accelerated and real time stability studies
Decision: Registration Board deferred the above product due to paucity of time.
e. Epocan (Epoietin Alfa) 10000IU/ml Vial.
Sr.No Name of Brand Name, Type of Form, Documentary details Remarks
Minutes for 266th Meeting of Registration Board. 229
. Manufacturer Composition, Pharmacological group,Shelf life
Dy. No & date of application, Fee status, Packing & demanded MRP
(CoPP etc.)Reference agencies status,Me too
1 M/s Macter International Limited, Karachi
Epocan 10000IU/ml(Solution for injection)Each vial (ml) contains:Epoietin alfa………10000IU(0.0675mg)
Hematopoietic agent.
Shelf Life: 3 years
Form-51627/2014(R&I)15-04-2014Rs. 20000 31-03-2014Pack of 1’s (Vial)Price:As per PRC
Legalized CoPP no. WHO-CPP-CERT-JN-130801 dated 01-08-2013Legalized Free Sale Certificate no. 2013-107 dated 26-08-2013Legalized GMP certificate No. K5087 dated 25-11-2009
Epogen by Amgen, USA
PDpoetin by Nextar Pharma, Karachi.
Evaluation as per decision of 246th meeting of Registration Board
Sr. No
Documents and data required as per 246th
meeting
Documents and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Legalized GMP Certificate No. CN20140140 date of issuance 17-3-2014 valid upto 16-03-2019 M/s Shandong Kexing Bio – Products co., Ltd. Tangwangshan Road, Mingshui Development Zone, Zhangqiu, Shandong, China submitted.
Legalized Free Sale Certificate No. 2015-157 date of issuance 16-11-2015 valid for two year for date of issuance for Erythropoietin injection submitted.Legalized COPP No. WHO. CPP-CERT-ZQ-151116 date of issuance 16-11-2015
GMP submitted reflects that manufacturer is authorized to manufacturer Recombinant Human Erythropoietin injection.
3 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Not provided Only comparative studies conducted locally is submitted
Under structural similarity, the firm provided the structural characterization of ready to fill bulk with
Minutes for 266th Meeting of Registration Board. 230
reference to European Pharmacopoeia.
Bioequivalence study is provided by the firm with Eprex.
4 Authorization to manufacture the finished biological product for trial studies
Not provided Not provided
5 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Comparative analysis of Recombinant Human Erythropoietin Vs RMP Recormon Roche is submitted and following test are carried out by M/s Macter International, Karachi SDS-PAGE (Silver staining) SDS-PAGE (Coomassie staining) Isoelectric focusing Purity (By Gel filtration
chromatography) Sialic Acid (by Resorcinol Method) Protein content (By ELISA)
Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is also submitted and following test are carried out:Identity by ELISA, Potency by Elisa, Total Protein content (By Lowry Assay), General Safety Test (By Bacterial endotixin test by gel Clot Method (LAL Test), Sterility Test by membrane filtration method.
Comparative analysis of drug substance vs RMP Recormon Roche is provided instead of Finished biological product Epocan 10000IU.
Comparitive analysis of Finished product VS BRP Erythropoetin Alfa EDQM is provided instead of RMP.
6 Others Specification of ready to filled bulk of M/s Shandong Kexing bioproducts Co., Ltd, ChinaIdentification test, Physical tests (Appearance Visible particles), Chemical tests (pH, Content of sodium ion content of citrate ion content of protein Osmolality, Activity tests (Activity in vitro , Activity in vivo), Sterility and BET , Abnormal toxicity test.
Finished products specification of M/s Macter International Karachi as under:Physical Appearance, ParticulateMater, Extractable volume, pH, Osmaolality, Immuno-identification, Potency, Content of Protein, BET, Sterility, Abnormal Toxicity.
The firm has also submitted accelerated
Minutes for 266th Meeting of Registration Board. 231
and real time stability studies.
Decision: Registration Board deferred the above product due to paucity of time.
g. T-Mab (Trastuzumab) 150mg Vial.Sr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group,Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s Macter International Limited, Karachi
T-Mab(Powder for concentrate for solution for infusion)Each vial contains:Trastuzumab………..150mg
Antineoplastic monoclonal antibody
Shelf life: 2 years
Form-5930/2014(R&I)17-04-2014Rs. 2000013-01-2014Pack of 1’s (Vial)Price:As per PRC
Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016
Herceptin 150mg by Roche Products Limited, UK
Evidence of Local availability is required.
Evaluation as per decision of 246th meeting of Registration BoardSr. No
Documents and data required as per 246th meeting
Documents and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China.
2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Charactrization of Primary and secondary structure of anti-HER2 rh.MAb and its comparability analysis with innovator Herceptin by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: The pimary structure of anti-HER2 rhMAb.
Similarity in secondary sturucture by circular dichroism (CD) and Spectra.
Similarity in IEF profile. Similarity in molecular weight by reducing
SDS-PAGE. MALDI-TOF Mass spectrum performed
the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other.
Peptide Mapping by RP-HPLC which demosntrates that our products are homogeneioujs and stable.
N-Glycosylation Analtysis. SDS-PAGE Purity
Minutes for 266th Meeting of Registration Board. 232
SEC-HPLC Purity Similarity in Biological Activities and
Immunological Properties Biological Charatarization was done by
biocactivity determination and affinity comparison by immumofluorescence method.
Impurities by SEC-HPLC, SDS-PAGE3 Authorization to manufacture the
finished biological product for trial studies
Not provided.
4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Biocomparability of finished drug the firm has submitted following data are as under:
Comparative Analysis of Locally Manufactured Drug Product of T-Mab 150 mg with Reference Medicinal Product Harceptin, Materials, Indentificatin (BySDS-PAGE& By Isoelectric focusing), Purity (By SDS-PAGE& By Gel Filtration Chromatography), Biological activity, General Safety Tests By Bacterial Endotoxin Test (By Gel Clot Method), Sterility Test.Stability Studies of Locally Manufactured Drug Product of T-Mab 150mg.Real Time stability studies, Accelerated stability studies
5 Others Non-clinical study The firm submitted data are as under:1. Pharmacology(Primary pharmacology, Secondary Pharmacology, Safety Pharmacology, Pharmacodynamic drug interactions).2. Pharmacokinatics(Absorption, distribution, Metabolism, Excretion, Pharmacokinetics Drug Interaction)3. Single-Dose Toxicity(Acute Single-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into mice)4. Repeat-Dose toxicity(Repeat-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into rhesus)5. Genotoxicity(Genotoxicity of –HER2 rh MAB of CPGJ)6. Hepolytic Study(Hemolytic Study of –HER2 rh MAB of CPGJ)
Decision: Registration Board deferred the above product due to paucity of time.g. T-Mab (Trastuzumab) 440mg Vial.
Sr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological
Type of Form, Dy. No & date of application, Fee
Documentary details (CoPP etc.)Reference
Remarks
Minutes for 266th Meeting of Registration Board. 233
group,Shelf life
status, Packing & demanded MRP
agencies status,Me too
1 M/s Macter International Limited, Karachi
T-Mab(Powder for concentrate for solution for infusion)Each vial contains:Trastuzumab………..440mg
Antineoplastic monoclonal antibodyShelf life: 2 years
Form-5927/2014(R&I)17-04-2014Rs. 20000/-13-01-2014Pack of 1’s (Vial)Price:As per PRC
Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016
Herceptin by Roche Pakistan
Evidence of availability in reference drug agencies is required.
Evaluation as per decision of 246th meeting of Registration BoardSr. No
Documents and data required as per 246th
meeting
Documents and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Legalized GMP Certificate No. CN20110019 dated 09-10-2011 valid until 08-10-2016 M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China
The application of the firm is considered in 257th meeting of RB wherein it was deferred for evaluation by the division.
2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Charactrization of Primary and secondary structure of anti-HER2 rh.MAb and its comparability analysis with innovator Herceptin by M/s Shanghai CP Guojian Pharmaceutical co., Ltd. China following methods: The pimary structure of anti-HER2
rhMAb. Similarity in secondary sturucture by circular dichroism (CD) and Spectra.
Similarity in IEF profile. Similarity in molecular weight by
reducing SDS-PAGE. MALDI-TOF Mass spectrum
performed the test results demonstrate that the main components of basically identical, and the molecular weight of relative to each other.
Peptide Mapping by RP-HPLC which demosntrates that our products are homogeneioujs and stable.
N-Glycosylation Analtysis. SDS-PAGE purity. SEC-HPLC Purity Biological Charatarization was done by
biocactivity determination and affinity comparison by immumofluorescence method.
Impurities by SEC-HPLC, SDS-PAGE3 Manufacturer to manufacture
the finished biological product for trial studies.
Not provided.
Minutes for 266th Meeting of Registration Board. 234
4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Biocomparability of finished drug the firm has submitted following data are as under:
Comparative Analysis of Locally Manufactured Drug Product of T-Mab 440mg WITH Reference Medicinal Product Harceptin, Materials, Indentificatin (BySDS-PAGE& Isoelectric focusing), Purity (By SDS-PAGE& By Gel Filteration Chromatography), Protein Content (By UV), Biological Activity, General Safety Tests By Bacterial Endotoxin Test (By Gel Clot Method), Sterility Test.Stability Studies of Locally Manufactured Drug Product of T-Mab 440.Real Time stability studies, Accelerated stability studies
5 Others Animal Toxicology study The firm submitted data are as under:
1. Pharmacology(Primary pharmacology, Secondary Pharmacology, Safety Pharmacology, Pharmacodynamic drug interactions).2. Pharmacokinatics(Absorption, distribution, Metabolism, Excretion, Pharmacokinetics Drug Interaction)3. Single-Dose Toxicity(Acute Single-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into mice)4. Repeat-Dose toxicity(Repeat-Dose toxicity for intravenous injection anti-HER2 rh MAB of CPGJ into rhesus)5. Genotoxicity(Genotoxicity of –HER2 rh MAB of CPGJ)6. Hepolytic Study(Hemolytic Study of –HER2 rh MAB of CPGJ)
Decision: Registration Board deferred the above product due to paucity of time.
Minutes for 266th Meeting of Registration Board. 235
h. Macgrastim (Filgrastim (rhGCSF) 300mcg/ 1.2 ml) vial.Sr.No.
Name of Manufacturer
Brand Name, Composition, Pharmacological group,Shelf life
Type of Form, Dy. No & date of application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies status,Me too
Remarks
1 M/s Macter International Limited, Karachi
Macgrastim (Filgrastim)Each vial contains:Filgrastim…..300mcg/1.2ml
Colony Stimulating Factor
Shelf Life: 2 years
Form-51118/2014(R&I)10-10-2014Rs. 20000 16-09-2014Pack of 1’s (Vial)Price:As per PRC
Legalized CoPP no. 2013-039 dated 16-08-2013Legalized GMP certificate no. CN20130269 dated 30-09-2013Grastim by CCL Pharma, Lahore.
Evidence of availability in reference drug agencies is required.
Evaluation as per decision of 246th meeting of Registration BoardSr. No
Documents and data required as per 246th
meeting
Documents and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
Legalized CoPP No: CN20130269 dated 30.09.2013 valid upto 29.09.2018 of M/s Hangzhou Jiuyuan Gene Engeineering Co., Ltd, China indication that the manufacturer has approval to manufacture the rhGCSF injection
2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Physicichemical and biosililarity analysis of rhGSCF with Filgrastim produced by Kirin Brewery Co., Japan:rhGSCF Formula/ chemical structure. Molecular weight:
SDS reducing PageHPLC
Purity:Gel electrophoresisIsoelecric focusingRP HPLCSEC HPLCCapillary electrophoresis
Assay for chemical structure:Sequencung of rDNAUV spectrumComposition of amino acidsPepetide mappingN- terminal sequencing
Immunology:Identification by wetstern blotELISA
Bilogical activity:In vitroIn vivo
3 Manufacturer to manufacture the finished biological product for trial studies
Not provided.
Minutes for 266th Meeting of Registration Board. 236
4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical techniques) and stability studies of finished biological product
Comparative Analysis of Locally Manufactured Product Macgrastim Liquid Solution for Injection (300 mcg/ 1.2 ml ) VS Neupogen (Innovator):
Immunoidentification by western blot
Purity by SDS Page Purity by gel filteration Potency protein by Bradford assay Bilogical activity by cell
proliferation assay General safety tests: BET and
sterility
Clarification required as comparative analysis performed by the firm is with Neupogen having composition 300mcg/1 ml while applied product Macgrastim’s composition is 300mcg/1.2ml.
5 Others Certificate of analysis of bulk material to be supplied is submitted.Stability data of finished product (accelerated and real time is provided)Clincal data submitted.
Decision: Registration Board deferred the above product due to paucity of time.
i. Biovac HB (Hepatitis B Vaccine) 10mcg/0.5mlS.#.
Name of Importer/
Manufactruer
Brand Name /Composition
Date of application/Fee
status/price
Documentary details
Remarks
1. Macter International Ltd. 216, SITE, Karachi, Pakistan (Local Manufacturer)
Bulk material source:LG Life Sciences Korea.
Biovac HB 10mcg/0.5ml(Recombinant Hepatitis B Vaccine)Each 100ml of vaccine contains: Purified hepatitis B surface antigen (rDNA) (Host: Saccharomyces cerevisiae AB 110, Vector: pYLBC-A/G-UB-HBs)……2mg
Prevention of Hepatitis BShelf Life: 2 years
Form-5182/2014(R&I)10-03-2014Dy No.40 DDC (BD) Dated17-3-2014
Fee Rs. 20,000/-Dated 21-8-2013Pack Size: 1’s & 10’s (vial)Price: As per PRC
Legalized CoPP No. 2015-A1-0917 Dated16-7-2015Legalized GMP No.2015-F1-0102 dated09-4-2015Engerix B by GSK, UKEngerix B by GSK, Pakistan
a. Firm has submitted the CoPP FSC and GMP of bulk material issued from regulatory body of Korea.
b. Under finished product specifications firm has provided, tests of Physical appearance, aluminum content, Potency by Elisa, identification and purity by SDS-Page, endotoxin bioburden and sterility tests.
2. Macter International Ltd. 216, SITE, Karachi, Pakistan (Local Manufacturer)
Bulk material
Biovac HB 20mcg/ml(Recombinant Hepatitis B Vaccine)Each 100ml of vaccine contains: Purified hepatitis
Out Dy No. 184 dated 10.3.2014
Rs.20,000/- dated21-8-2013Pack Size: 1’s & 10’s (vial)Price. As per PRC
Legalized CoPP No. 2-13-A1-1023 Republic of Korea dated 08-05-2013Legalized Free sale certificate No. 2013-A1-
a. Firm has submitted the CoPP FSC and GMP of bulk material issued from regulatory body of Korea.
b. Under finished
Minutes for 266th Meeting of Registration Board. 237
source:LG Life Sciences Korea.
B surface antigen (rDNA) (Host: Saccharomyces cerevisiae AB 110, Vector: pYLBC-A/G-UB-HBs)……2mgPrevention of Hepatitis BShelf Life: 2 years
1022 dated 08-5-2013Legalized GMP certificatDated 15-3-2013 enclosed.Engerix B by GSK, UKEngerix B by GSK, Pakistan
product specifications firm has provided, tests of Physical appearance, aluminum content, Potency by Elisa, identification and purity by SDS-Page, endotoxin bioburden and sterility tests.
Evaluation as per decision of 246th meeting of Registration BoardSr. no.
Documents/ data as per requirement of DRB 246
Documents / data submitted by Macter
Remarks
1. Legalized GMP certificate of biological drug as evidence that manufacturer is an authorized manufacturer of that particular biological drug in its country of origin
Legalized GMP certificate by KFDA issued on March 15, 2013.
WHO prequalification certificate and Web link of WHO website linkhttps://extranet.who.int/gavi/PQ_Web/ for WHO prequalified vaccine manufacturers included in GAVI program is provided.
Legalized COPP certificate no. 2013-A1-1023 issued on May 08, 2013 is provided.
Notarized and legalized (by Pakistan embassy Soule, South Korea) GMP certificate Issued by Korea Food & Drug Administrationon March 15, 2013 is submitted.
WHO pre-qualification letterIssued by Coordinator quality, safety and standard is submitted.This product & manufacturer are included in the list of prequalified vaccines & manufacturer at WHO web link https://extranet.who.int/gavi/PQ_Web/.
Notarized and legalized (by Pakistan embassy Soule, South Korea) COPP certificate no. 2013-A1-1023 issued on May 08, 2013 is provided.
2. Structural similarity of subject biological drug product (ready to fill bulk) with reference biological product (innovator).
Product characterization is performed for comparability with WHO reference standard of NIBSC Hep B antigen & innovators product Engerix B of GSK by SDS PAGE (mol. Wt.), UV spectrophotometry (identification), Circular Dichorism (secondary structure), electron microscopy (particle morphology), gradient centrifugation (density), gradient Centrifugation (homogeneity), Tryptic digestion & SDS Page, N Terminal sequence (identity), C terminal sequencing (identity), Amino acid composition,
Studies are performed by LG life Sciences South Korea are available in provided CTD dossier.
Minutes for 266th Meeting of Registration Board. 238
thin layer chromatography (phospholipid composition), Antigenicity by ELISA (efficacy), Size Exclusion Charmatography and SDS page for purity,
3. Bio comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity / potency testing and toxicity with support of IEF data, gel electrophoresis, western blot and other analytical methods and stability studies of finished drug.
Comparative analysis of locally produced drug product with Reference medicinal product (Engerix B).Identity: SDS PAGEPurity: SDS PAGEPotency: ELISAGeneral safety testsBacterial Endotoxin test, Sterility test and abnormal toxicity test.Stability data is provided by the firm. (Long term and accelerated stability data)
Comparative studies of local batches with innovators product Engerix B of GSK are provided.
4. Others Animal toxicity studies and clinical trial studies are submitted
Pharmacokinetics and toxicological studies are provided.
Decision of RB in 260th meeting:“Regiatration Board deliberated and deferred these applications that manufacturing and quality control of biological products require specialized facilities and approval from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have already been granted registrations of various biological products for local manufacturing (mostly therapeutic proteins). As theses firms have applied for registration for local manufacturing of various biological products including rDNA products, Theraputic protein, Monoclonal antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the Board decided to have opinion of licensing division DRAP regarding approved manufacturing facilities (categories of biological products) of these firms and status of already registerd biological drugs from these firms.”
Decision: Registration Board deferred the above product due to paucity of time.
j. Neupeg (Peg-Filgrastim) 6mg/ml vial.Sr. No.
Name of Manufacturer
Brand Name, Composition,
Pharmacological group,
Shelf life
Type of Form, Dy. No & date of
application, Fee status, Packing & demanded MRP
Documentary details (CoPP etc.)Reference agencies
status,Me too
Remarks
1 M/s Macter International Limited, Karachi
Neupeg 6mg/ml (Pegfilgrastim)Each vial contains:Pegfilgrastim……..6mg/ml
ImmunomodulatorShelf Life: 2 years
Form-5 OutDy.#163, 10-3-2014Rs. 8000/- 31-10-2011Rs. 12000/-09-10-2012 Pack of 1’s (Vial)Price: Rs. 53730/-
Legalized CoPP No. MFG/WHO-COPP/INTAS/2016/128492, Legalized GMP certificate No. 16091293 dated19-09-2016
Evidence of local and international availability in reference drug agencies is required.
Minutes for 266th Meeting of Registration Board. 239
Evaluation as per decision of 246th meeting of Registration BoardSr. No
Documents and data required as per 246th
meeting
Documents and data submitted by M/s Macter International Karachi
Remarks
1 Legalized GMP certificate of biological drug as an evidence that the manufacturer is an authorized manufacturer of that particular biological drug in its country of origin.
GMP certificate No. 16091293 dated 19.09.2016 valid upto 18-09-2018 issued by Food & Drug Control Administration, Gujrat state, India to Intas Biopharmaceuticals Ltd., Plot No. 423/P/A, Sarkhei Bavla Highway, Village Moraiya, Talika Sanand, Gujrat.
2 Structural similarity of subject biological drug product (concentrate/ ready to fill bulk for further processing) with reference biological product (innovator)
Physicichemical and biosimilarity analysis of Intas’ Pegfilgrastim with RMP Neulasta of Roche Products:Primary sequence/structure analysis(includes sequence correctness, and position of disulphide linkage) N terminal sequence GCSF DNA sequence Amino acid composition Peptide map analysis Western BlotpI determination Isoelectric focusingIdentity (pegylation) SDS-PAGE(non-reducing;iodine
stain)Tertiary structure analysis UV Spectroscopy Fluoresence SpectroscopyMolecular weight determination Mass Spectrophotometry (MALDI)Product related variants, differing in molecular weight SDS-PAGE (Non-reducing; silver
stain) SE HPLCCharge/Hydrophobicity related variants RP HPLCCharge related variants Cation Exchange Chromatography
HPLC (CEx-HPLC)Biological activity In-vitro biological activity
3 Manufacturer to manufacture the finished biological product for trial studies
Not provided.
4 Bio-comparability studies including identity testing to parent molecule, purity testing, in vitro biological activity, potency and toxicity with support of iso-electro focusing data, gel electrophoresis, Western-Blot and other analytical
Biocomparability studies provided by the firm for Neupeg with Neulastim of Roche, Switzerland.Physicochemical comparison of Neupeg with RMP Neulastim: Expression host Molecular size of free filgrastim
molecule Pegylation chemistry
Biocomparability studies are performed with Neulastim of Roche, Switzerland which is available as Pre-filled syringe and its composition is 6mg/0.6ml, While Neupeg of Macter, Pakistan is a vial and its
Minutes for 266th Meeting of Registration Board. 240
techniques) and stability studies of finished biological product
Molecular size of Pegylated Conjugate Concentration of Pegfilgrastim Route of administration Peptide map Non-reducing SDS-PAGE Immunoblot Size exclusion chromatography RP HPLC ChromatogramStability data is provided by the firm.(Long term & accelerated stability data.)
composition is 6mg/ml.
.
5 Others Animal StudiesComparative safety, efficacy clinical trials
Decision: Registration Board deferred the above product due to paucity of time.
Case No.02: Heparin applied by different importers deferred for submission of clinical data.
Following Heparin Injections applied by below mentioned importers were considered
in 264th meeting of Registration Board and were deferred for the submission of clinical data.
All the formalities and documents as per Form-5A are complete and now the firms have
submitted the clinical data for above products. The details are as follows:
Sr.No.
Name of Importer / Manufacturer
Brand Name / Composition
Date of application / Fee status / Packing / MRP
Documentary details
Decision of RB in 264th meeting
Decision
1. M/s Graton PharmaSuit no. 102, The Plaza, Clifton 2 Talwar Karachi.
M/s Tianjin Biochemical Pharmaceutical Co., Ltd.269, South Huanhe Rd, Tianjin Airport Economic Area, Tianjin, 300308, China.
Gratin injection
Each vial containsHeparin Sodium… 5000 IU
Anticoagulant
Shelf life: 3 years
Form 5A
Dy No.973-ADC(BD)01-09-2016Rs.10000013-04-2016
Pack size and price is not provided.
Legalized CoPP No. 2016031 dated 22-08-2016 issued by Tianjin FDA, China.
Heparin Sod. of Wockhort UK(MHRA)
Multiparin Biopharma
Registration Board deferred the above product for submission of clinical trial data.
Approved as per import policy for Finished Drugs and as per valid legalized CoPP.
2. Shamco Traders (Private) Limited, LahoreApproved Manufacturer:M/s MefarIlac San AS RamazanogluMah. Ensar Cad. No: 20 34906 KurtkoyPendik Istanbul Turkey
POLIPARIN 25000 IU/ 5ml IV/ SC Injectable vial
Each 5ml vial contains:Heparin sodium
Form-5A
Dy No. 3120 dated 19-12-16
Rs 100000 dated 15-12-16
Rs. 625/ vial
Legalized CoPP No. 2016/2855 dated21-11-2016
Registration Board deferred above product for submission of clinical trial data.
Registration Board approved product from new manufacturing site i.e. M/s Aroma Ilac San.Ltd. STI. Vakiflar OSB Mahallesi Sanayi Caddesi No. 22/1 Kat.2 Ergene/ TEKIRDAG Turkey as per import policy
Minutes for 266th Meeting of Registration Board. 241
New Manufacturing Site:M/s Aroma Ilac San.Ltd. STI. Vakiflar OSB Mahallesi Sanayi Caddesi No. 22/1 Kat.2 Ergene/ TEKIRDAG Turkey.
.25000IU
Shelf Life: 24 months
for Finished Drugs and as per valid legalized CoPP. The previous approval of the registration Board in its 260th for the said product from M/s MefarIlac San AS RamazanogluMah. Ensar Cad. No: 20 34906 Kurtkoy Pendik Istanbul Turkey is cancelled.
Case No.03: Deferred Case of for additional pack size by M/s. Snam Pharma, Lahore.
M/s Snam Pharma, Lahore has requested for the additional pack size of their
already registered drug Biocan R injection (Reg.No. 057167). The case was considered in
264th meeting of Registration Board and Board decided as follows. The firm has submitted the
stability data for above product.
Name of Importer and manufacturer
Name ofProduct/ Reg.No.
Existingpack size
AdditionalPack
RequiredDocumentary detail
Decision of RB in 264th
meeting
Decision
M/s SnamPharma 61-GDefense HousingAuthority, Phase-1, Lahore
Bioveta, a.s.,Komenskeho212,683 23Ivanovicena Hane, CzechRepubic
Biocan R InjectionReg# 057167Composition 1ml :Virus rabiei inactivatum, strainSAD vnukovo-32 min.2 IU
10x5ml.5x20ml
1ml x20single dose
CoPP No. 021/2015Dated 13.1.2015Prod Lic No. 97/086/02-C dated 16-12-2002
Registration Board deferred above product for submission of stability data.
Approved as per import policy for Finished Drugs and as per valid legalized CoPP.
Minutes for 266th Meeting of Registration Board. 242
Case No.4: Registration of Drugs for Export Purpose.
M/s The Nextar Pharma (Pvt) Ltd. has requested for registration of following
product for export purpose only:-
Sr. No.
Name of Manufacturer
Brand Name & Composition
Type of FormDy No & Date of applicationFee submitted
Pack size/
Document details
Remarks
1 The Nextar Pharma Private Limited.Plot No, E-58, North Western Industrial Zone, Port Qasim, Pakistan.
Sea-Tide Injection (Octreotide Acetate 100mcg Pre Filled Syringe.Octreotide as acetate(1.06 ~ 1 ODB 100mcg)
Form 5-D1921/2017(R&I)19-01-2017Rs.50,000/-17/01/20171’s
-DML-Copy of Last inspection Report-Export order
2 The Nextar Pharma Private Limited.Plot No, E-58, North Western Industrial Zone, Port Qasim, Pakistan.
Sea-Tide Injection (Octreotide Acetate) 50mcg Pre Filled Syringe.Octreotide as acetate(1.06 ~ 1 ODB 50mcg
Form 5-D1920/2017(R&I)19-01-2017Rs.50,000/-17/01/20171’s
-DML-Copy of Last inspection Report-Export order
Decision: Registration Board deliberated that as above products are of synthetic origin, therefore the manufacturer will be asked for further confirmation of manufacturing facility.
Case No.05: Imported veterinary biologicals from non-reference countries.
Sr. No.
Name of Manufacturer
Brand Name & Composition
Type of FormDy No & Date of applicationFee submittedPack size/
Document details
Decision
1 The Marush (Pvt) Ltd K-123 Model Town Lahore.
‘’SHCHELKOVO BIOCOMBINATE’Biocombinat township, SShchelkovskii district, Moscow region, Russian Federation
Cultural monovalent and polyvalent adsorbed inactivated vaccine against foot and mouth disease.
Each dose containAntigen of virus type A (krrasnodarskiy 2013)…….. 10PD50Antigen of virus type O (Pan Asia 2)…….. 6PD50Antigen of virus type Asia1(sindh 08)….. 6PD50
Form 5-A2309/2017(R&I)24-01-2017Rs.100,000/-23/01/2017Multiple pack size:10 DS Vial25 DS Vial50 DS Vial100 DS Vial
Legalized GMP and Legalized Free Sale certificate is submitted
Deferred for evaluation of product by Dr.Qurban Ali, Member Registration Board.
Minutes for 266th Meeting of Registration Board. 243
Item No.VI: Quality Assurance & Laboratory Testing.
Case No.01: Manufacture and Sale of Sub-Standard Ascrepe Bandage Batch No.001143 by M/S Asian Fibre, Karachi. F.No. 3-09/2016-QC.
The sample of Ascrepe Bandage Batch No. 001143 By M/S Asian Fibre, Karachi
drawn by FID Karachi from manufacturing premises on 14th December 2015 for test analysis.
The sample was sent to the CDL Karachi for test analysis, however the sample was declared
Substandard vide test report No.KQ.395/2015 dated 12th February 2016. On the explanation
letter to the firm the firm was not challenged the CDL Test report in Appellate Laboratory
NIH Islamabad under Section 22(5) of the Drugs Act 1976. The result of CDL on the basis of
which sample under reference has been declared sub-standard are reproduced as under
Threads per stated length:- Determined: Limits:Wrap: 144.33/cm Not less than 170.0/cm Does not comply Weight per Unit Area: 20.41gm/m2 Not less that 140.0gm/m2 Does not comply
The sample is of “Sub-Standard” quality under the Drug Act 1976.As per procedure show cause notices was issued to the firm and accused persons,
offering opportunity of personel hearing before the Drug Registration Board. They have been
also called for personal hearing.
259th meeting of Registration Board held on 30th & 31th May 2016. Proceedings: Mr.Muhammad Shakir, Director of the M/s Asian Fiber Karachi, appeared before the 259th meeting of Registration Board held on 30th and 31st May, 2016 and pleaded their case.Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel.
i. Director DTL Karachi, ii. Area FID.
The conclusion of PSI report is as under:-
Mr. Najam-Us-Saqib, FID Karachi submitted PSI report conducted on 23rd January, 2017.
Focus of Inspection: Product Root Cause
Ascrepe Bandage(Batch No. 001143)
The product is manufactured by using cotton Yarn and process involved is, weaving, bleaching, slitting and rolling and packaging. Process of manufacturing of ascrerpe bandage involved rather bleaching.The process of manufacturing for this particular product was mostly dependent the manual operations. Panel observed that this may be a major contributing factor as route cause of the shortage of weight and length of the product.Firm has taken remedial measure by incorporating two more machines (Semi-automatic with weight and length measurement operations facility.On the basis of PSI inspection GMP compliance and verification of different related documents, the panel recommends the resumption of the production under strict
Minutes for 266th Meeting of Registration Board. 244
compliance of GMP/cGMP guidelines.On the basis of PSI inspection GMP compliance and verification of different related
documents, the panel recommends the resumption of the production under strict compliance
of GMP/cGMP guidelines.
Proceedings and Decision of 266th Meeting:The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
“The Board decided to give resumption of registration of Ascrepe Bandage by M/s Asian Fibre Karachi.”
Case No.02: Manufacture & Sale of Sub-Standard Cotton Bandage BP Batch No. 0815723338 by M/S Asian Fibre, Karachi F. No. 3-04/2016-QC
The sample of Cotton Bandage BP Batch No. 0815723338 By M/S Asian Fibre,
Karachi drawn by FID Karachi from manufacturing premises on 14-12-2015for the test
analysis. The sample was sent to the CDL Karachi, however the sample has been declared
Substandard vide test report No.KQ.400/2015 dated 08th February 2016. On the explanation
letter to the firm by the FID Karachi the firm was not challenged the CDL Test report in
Appellate Laboratory NIH Islamabad under Section 22(5) of the Drugs Act 1976 The result
of CDL on the basis of which sample under reference has been declared sub-standard are
reproduced as under
Threads per 10cm:- Determined: Limits:Wrap/10cm: 124.67 135.0 to 163.0 Does not comply Weft/10cm: 57.71 84.0 to 96.0 Does not comply
The sample is of “Sub-Standard” quality under the Drug Act 1976.
As per procedure show cause notices was issued to the firm and accused persons, offering
opportunity of personal hearing before the Drug Registration Board. They have been also
called for personal hearing.
259th meeting of Registration Board held on 30th & 31th May 2016 Proceedings: Mr. Muhammad Shakir, Director of the M/s Asian Fiber Karachi, appeared before the 259th meeting of Registration Board held on 30th and 31st May 2016 and pleaded their case.Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
The Board decided to suspend the Registration for six months (06) and to conduct the
PSI from the following panel.
i. Director DTL Karachi, ii. Area FID.
The Firm will recall the batch and the area FID will supervise the destruction. Mr. Najam-Us-Saqib FID Karachi submitted the PSI report conducted on 23rd January, 2017.Minutes for 266th Meeting of Registration Board. 245
Minutes for 266th Meeting of Registration Board. 246
Focus of Inspection: Product Root CauseCotton Bandage (Batch No. 0815723338)
The product is manufactured by using cotton Yarn and process involved is, weaving, bleaching, slitting and rolling and packaging. Process of manufacturing of ascrerpe bandage involved rather bleaching.The process of manufacturing for this particular product was mostly dependent the manual operations. Panel observed that this may be a major contributing factor as route cause of the shortage of weight and length of the product.Firm has taken remedial measure by incorporating two more machines (Semi-automatic with weight and length measurement operations facility.On the basis of PSI inspection GMP compliance and verification of different related documents, the panel recommends the resumption of the production under strict compliance of GMP/cGMP guidelines
Proceedings and Decision of 266th Meeting:The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
“The Board decided to give resumption of registration of Cotton Bandage by M/s Asian Fibre Karachi.”
Case No.03: Manufacture & Sale of Sub-Standard Gauze Swab/Sponges BP Batch No. 00511 by M/S Asian Fibre, Karachi. F. No. 3-08/2016-QC
The sample of Gauze Swab/Sponges BP Batch No. 00511 By M/S Asian Fibre,
Karachi drawn by FID Karachi from manufacturing premises on 14-12-2015 for test analysis.
The sample was sent to the CDL Karachi, however the sample of subject cited drug has been
declared Substandard vide test report No.KQ.394/2015 dated 10th February 2016. On the
explanation letter to the firm by the FID Karachi the firm was not challenged the CDL Test
report in Appellate Laboratory NIH Islamabad under Section 22(5) of the Drugs Act 1976.
The result of CDL on the basis of which sample under reference has been declared sub-
standard are reproduced as under:-
Bacterial Sterility Test :- Does not complyProcedure:- Put the content (gauze) of the sample in preterilized thioghycollate medium,
kept in medium flask incubate the same medium flask at 35c for 14 days Acceptance criterion. No growth of micro organism occurs
The sample is of “Sub-Standard” quality under the Drug Act 1976.As per procedure show cause notices was issued to the firm and accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.
259th meeting of Registration Board held on 30th & 31th May 2016 Proceedings: Mr. Muhammad Shakir, Director of the M/s Asian Fiber Karachi, appeared before the 259th meeting of Registration Board held on 30th and 31st May 2016 and pleaded their case.
Minutes for 266th Meeting of Registration Board. 247
Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel.
i. Director DTL Karachi, ii. Area FID.
The conclusion of PSI report is as under:-
Mr. Najam-Us-Saqib FID Karachi submitted the PSI report conducted on 23rd January, 2017.
Focus of Inspection:Product Root Cause
Gauze Swab/Sponges (Batch No. 00511)
The product was declared out of specification on the basis of failure of sterility problem. It was observed that the arrangements were insufficient for conducting sterility of the product. The firm has given undertaking that each batch of the product will be dispatched to the M/S Gamma Radiation Lahore for the sterility of the product.On the basis of PSI inspection GMP compliance and verification of different related documents, the panel recommends the resumption of the production under strict compliance of GMP/cGMP guidelines.
Proceedings and Decision of 266th Meeting:Registration Board deferred the case as the firm has not any sterility facility for
sterile product and the Panel also mentioned that arrangements for conducting the sterility of product was insufficient and they has just given the undertaking regarding the sterility of Product through M/s Gamma Radiation Lahore. The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
“The Board deferred the case as the firm does not have sterility facility for sterile Product. The registration will remain suspended till the firm establishes facility for sterility and intimate the same to the Board for its consideration / decision.”
Case 04: Manufacture & Sale of Sub-Standard Drug-Azofin Suspension (Ibuprofen) Batch No.I-339 By M/S Alkemy Pharmaceuticals Laboratories (Pvt) Ltd Hyderabad.
Brief of the Case.
The sample of Azofin Suspension Batch No. I-339 manufactured by Alkemy
Pharmaceuticals Laboratories Pvt Ltd Hyderabad drawn by FID Hyderabad at Karachi on 15th
September 2015 from manufacture premises for test analysis the Federal Government
Analyst, CDL, Karachi vide which sample of subject cited drug has been declared
Substandard vide test report No.KQ.271/2015 dated 09th November 2015. The result of CDL
on the basis of which sample under reference has been declared sub-standard are reproduced
as under:-
Minutes for 266th Meeting of Registration Board. 248
Assay for Ibuprofen.
Determined amount/5ml:- 160.11mg Stated amount/5ml:- 100.0g Percentage:- 160.11%Limits:- 95.0% to 105.0% Does not comply
The sample is of “Sub-Standard” quality under the Drug Act 1976.
On explanation letter issued by the FID, the firm challenged the CDL report and requested for
Appellate testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also
declared the sample as Substandard vide their test report 02-MNHSR/2016 dated 17 th March
2016.
Assay for Ibuprofen Stated amount Found:- Percentage Limits
100.0g/5ml 104.07mg/5ml 104.07%:- 95-105
Unidentical peaks Nil 40%
Remarks:- Some unidentical peak are also eluted along with principle peak (Ibuprofen) and the sum of these impurities is 40% of principle peak
As per procedure show cause notices was issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board. They have been also called for personal hearing.
258th meeting of Registration Board held on 25th & 26th April 2016
Proceedings: Mr. Asif Najeeb Laghari QC Manager of the firm appeared before the Board and pleaded their case.
Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel:-
i. Dr. Abdul Rashid, Chairman quality Control, ii. Area FID.
The Firm will recall the batch and the area FID will supervise the destruction.The conclusion of PSI report is as under:-
PSI report was received from FID Hyderabad at Karachi Mr. Syed Hakim Masood. The PSI of M/s Alkemy Pharmaceutical Pvt Ltd situated at plot No.P/9, S.I.T.E Hyderabad at Karachi was conducted on 6th December 2016 by Dr. Abdul Rasheed, Additional Director, QA & LT, DRAP, Islamabad, Mr. Faraz Sheikh (M.D), Syed Hakim Masood (Area FID). The conclusion of PSI is as under:-
Observation of the Panel:a. No traceability of raw materials was available. No proper records were available. No
thermometer and hygrometer were found for recording of temperature and humidity in the warehouse.
Minutes for 266th Meeting of Registration Board. 249
b. Dispensing area needs renovation and additional calibrated weighing balance required.
c. Old silver son mixers are rusted/ old and required to be replaced with new ones.d. Storage tanks required to be replaced with new ones.e. Floor, walls and ceilings are cracked/old and needs overall, renovation required.f. The rodents’ insects can enter from drainage in the production of syrup section and so
requires better drainage system.g. Vessels need to be replaced.h. Liquid filling machine is old, rusty and must be replaced with semi automatic filling
machine with conveyor belt.i. Water system needs to be upgraded with new one.j. Batch manufacturing instructions were missing from the batch manufacturing records.k. Iron racks are required to be placed in the warehouse. Iron and plastic pallets may
further be added in the warehouse and wooden pellets should be removed from areas.l. There are no racks in the finished goods store and medicines are placed on floor. Few
wooden pellets and plastic pellets are also seen in one room. There is need that iron racks plastic pellets may be provided along with hygrometers to monitor the humidity of the finished goods store. Floors walls and ceiling needs renovation paint and up gradation. Accordingly all the observations were discussed with the management Mr. Faraz
Sheikh (M.D) has submitted an undertaking that management has voluntarily stopped
production in the liquid syrup section for maintenance and renovation and will seek
permission before commencement of production after completion of improvements and
renovation work. The show cause notice and personal hearing may be given for liquid section
for cancellation and suspension of DML.
Proceedings and decision of 266th Meeting:
Additional Director QA & LT who was also the member of panel for PSI, briefed the Board about the non-GMP compliance of the firm particularly regarding liquid section. The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
“The QA section will present the case of non-GMP compliance before Central Licensing Board, and the decision of Central Licensing Board will be presented before Registration Board for consideration / decision. Till that decision, registration of the Azofin Suspension shall remain suspended.”
Case No.05: Manufacture & Sale of Misbranded Inj. Titan -1000 Batch No.4017 By M/S Macter International Ltd, Karachi.
The sample of Injection Titan-1000 batch No. 4017 manufactured by M/S Macter
International Ltd, Karachi drawn by Federal Inspector of Drugs-II on 10-04-2014 from
manufacture premises for test analysis. The Federal Government Analyst, CDL, Karachi vide
which sample of subject cited drug has been declared Misbranded vide test report No.MK-35-
Minutes for 266th Meeting of Registration Board. 250
41/2014-FID-II(K) dated 11th April 2014. The result of CDL on the basis of which sample under
reference has been declared misbranded are reproduced as under:-
Remarks:The outer most label does not contain name and address of the manufacturer,
manufacturing license number of Water for Injection (WFI) as required under rule (3) (s) (i) of the drugs (Labeling and Packaging rules 1986 of Drugs Rules 1986 of the Drugs Act 1976. Hence, sample is declared Misbranded under the Drugs Act 1976 and rules framed there under.
The sample is “Misbranded” under the Drug Act 1976.On explanation letter issued by the FID Karachi-II on 20th May, the firm submitted
their reply vide its letter no. Nil dated 26 th June, 2014 and informed that they had already
been incorporated on the label of Primary container of the diluents vial and provided the
required information. M/s Macter International Ltd Karachi violated the section 23 (1) (a)
(iii) of the Drugs Act 1976 and rules framed there under.
As per procedure show cause notices was issued to the firm and accused persons, offering
opportunity of personal hearing before the Drug Registration Board.
They have been also called for personal hearing.
Proceedings and Decision of 266th Meeting: M/S Macter International Ltd, Karachi was called for personal hearing but they did
not appear before the Board. The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
“The Board deferred the case and give last opportunity of personal hearing to the Firm M/S Macter International Ltd, Karachi.”
Case No.06: Manufacture & Sale of Sub-Standard Dekomycin Capsules Batch No. 8110 By M/S Reko Pharmaceuticals Pvt Ltd Lahore.
The sample of Dekomycin Capsules Batch No. 8110, Reg. No.011001, manufactured
by M/s. Reko Pharmacal (Pvt) Ltd, Lahore has been declared Sub-Standard by Federal
Government Analyst vide test report No. LHR.184/2016, dated 28 th April, 2016. The sample
of failed drug was taken by FID Faisalabad at Lahore, on 30-03-2016 from Manufacturer’s
Premises for test/analysis. On explanation letter issued by the FID Faisalabad at Lahore on
06th May 2016, M/s Reko Pharmacal (Pvt) Ltd, Lahore submitted a reply vide its letter
No.MD/01, dated 16th May, 2016, wherein the firm did not challenged the test/analysis report
of CDL Karachi but stated that the test report is not reliable as certificate issued in the report
is regarding capsule having a color “Off white body & yellow hard gelatin capsule”, which is
not their product as their product is orange and off white color gelatin capsule, in reply of
which FID confirmed that samples were drawn from premises (finished goods store) of
Minutes for 266th Meeting of Registration Board. 251
manufacturer during inspection on 30-03-2016 so the product belongs to M/s Reko
Pharmacal (Pvt) Ltd, Lahore undoubtedly. The results on the basis of which the subject stated
product was declared substandard are as under;
Sub-Standard with regard to Dissolution Test.
Stage-1
Tablet No. (%)age
01. 35.739
02. 15.619
03. 25.414
04 37.327
05. 31.768
06 15.619
Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 80+5=85%
Stage-2
Tablet No. (%)age
01. 29.385
02. 29.650
03. 22.502
04 36.533
05. 34.150
06 57.976
Average of 12 units= 371.682/12=30.973%
Limits for (Stage-2):- Average of 12 unit (S1+S2) is equal to or greater than Q (80%) and no unit is less than Q-15% (80-15=65%)
Stage 3Limits for (stage-3):- Average of 24 units (S1+S2+S3) is equal to or greater than Q (80%) Not more than 2 Units are less than Q-15 (80-15=65%) & no unit is less than Q-25% (80-25=55%)
Since, all the 11 capsules are below 55% and one capsule below 65% therefore, the sample Does not comply
The FID Faisalabad at Lahore furnished the names of the responsible persons of the firm are as under:-
M/s Reko Pharmacal (Pvt) Ltd, Lahorei Mr. Khalid S. Mian, Managing Directorii. Mr. Muhammad Arif Ghauri Production Mangeriii. Ms. Shehnaz Akhter Quality Control Incharge
Minutes for 266th Meeting of Registration Board. 252
In response to show cause notice issued to the firm on 30th December, 2016, the firm
M/s Reko Pharmacal (Pvt) Ltd, Lahore submitted its reply dated 06-01-2017 which stated
that the test report is not reliable as certificate issued in the report is regarding capsule having
a color “Off white body & yellow hard gelatin capsule”, which is not their product as their
product is orange and off white color gelatin capsule and requested to reinvestigate the
matter.
The case was presented in 265th meeting of Registration Board and the accused persons of the firm were called for personal hearing.Decision of the 265th Meeting of Registration Board:The Board decided to defer the case and give last opportunity of personal hearing to the firm in next meeting.Proceedings and decision of 266th Meeting of Registration Board:
The firm requested to adjourn the personal hearing till next meeting of Registration Board because the personal hearing letter was received by the firm on 06-02-2017 late afternoon and did not have sufficient time to compile all the relevant documents. “The Board decided to defer the case and give last opportunity of personal hearing to the firm in next meeting otherwise an ex-parte decision shall be taken by the Registration Board.”
Case No.07: Manufacture and Sale of Substandard Manadol Suspension (Paracetamol) Batch No. 4MD-005 Manufactured by M/s Masfa Industries (Pvt) Ltd Lahore. F.No.3-52/2014-(QC)
The samples of Manadol Suspension (Paracetamol) Batch No. 4MD-005,
Manufactured by M/s Masfa Industrieis (Pvt) Ltd, Lahore drawn by FID- (L-III) Lahore from
manufacture premises on 10-09-2014, was declared Substandard on the basis of assay vide
Test Report No.LHR.230/2014. dated 02-10-2014 by Federal Government Analyst.
Assay forDetermined amount/5ml
Stated amount/5mlPercentage
Paracetamol 84.188 mg 120.0mg 70.15%Limits:- 95.0% to 105.0% Does Not Comply. Remarks:- The sample is of “Sub-Standard” quality under the Drugs Act 1976.On the explanation of FID to the firm the firm made request for Appellate testing to FID. The
Appellate Laboratory vide test report No. 020-MNHSR/2014 Dated 16-12-2014 declared the
sample as substandard on the basis of assay.
Assay for Found Stated Amount/5mlPercentage
Paracetamol 65.64mg/5ml 120mg/5ml 54.7%Limits:- 95.0% to 105.0% Does Not Comply BP 2011 .
Minutes for 266th Meeting of Registration Board. 253
Description:- Pink coloured suspension contained in amber colored glass bottle having un-dissolved solid masses which do not disperse even on shaking. (Does not comply with BP-2011 which states that suspension may show a sediment which is readily dispersed on shaking”Remarks:- The sample is of “Sub-Standard” on the basis of tests performed.The firm has violated the Section 23(1)(a)(v) of the Drugs Act 1976, however the names of
the following persons of the firm have been furnished by the FID.
i. M/s Masfa Industrieis (Pvt) Ltd .Lahore, ii. Mr. Mian Muhammad Usman Ghani, (Chief Executive)iii. Mr. Hafiz Abud Bakar (Production Manager) iv. Mr. Hafiz Murtaza (Quality Control Manager)
As per procedure show cause notices were issued to the firm and above named
accused persons, offering opportunity of personal hearing before the Drug Registration
Board.
In the reply of the show cause notice the firm informed that they have tested the reatained samples by their own Lab. and by some other authentic laboratories the most results shown as standard quality. They further stated that they have never been contravened before this. The firm further stated that this is first time so requested to give a chance. The firm has attached some copies of CDL and Provincial Laboratories tests reports of other batches or other products. They were called for personal hearing.Decision of 257th Meeting of Registration Board:-The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel:-
a. Director DTL Punjab, Lahoreb. Area FID.c. ADC, Lahore.
Product Specification Inspection (PSI):
In response to the decision of Drug Registration Board in its 257th meeting held on 24-
25th March, 2016, the Product Specific Inspection of firm M/s Masfa Industrieis (Pvt) Ltd,
Lahore was carried out on 30-11-2016 by two panel member i.e. Mr. Munawar Hayat,
Director Drug Testing Laboratory and Ms. Aisha Irfan, Federal Drug Inspector. The Assistant
Drugs Controller was not nominated by the Additional Director (E & M) Lahore.
Focus of Inspection: Product Root CauseManadol Suspension (Paracetamol), Batch No. 4MD-005
The product was declared substandard on the basis ofi. Description: Pink coloured suspension contained in amber colored glass bottle having un-dissolved solid masses which do not disperse even on shaking. (Does not comply with BP-2011 which states that suspension may show a sediment which is readily dispersed on shaking).ii. Assay for Paracetamol: Found percentage was 54.7%. (Does not comply with BP-2011 which states the limit as 95-105%).
Minutes for 266th Meeting of Registration Board. 254
Details of Inspection Procedure:
1. PSI report stated that during PSI, the Production Incharge informed that they have changed the formulation of the said product after failed batch, now Methyl Paraben has been replaced by Methyl Paraben Sodium, as salt of sodium is soluble in water and generate less heat during production and the quantity of sucrose has been reduced to 100Kg from 300 Kg per 1500 Liters as crystallization also occurs due to increase amount of sucrose in the product.
2. It was also checked that the paracetamol raw material was purchased from M/s. Zenith Chemical, Lahore and its assay was 99.79 %, hence raw material was of standard quality.
3. The panel observed that test records for HPLC were not saved in HPLC, and column log was also not prepared as approximately 2000 tests can be performed per column.
4. The Production Incharge informed that crystallization of Paracetamol suspension is a very common problem and various factors are involved, especially storage above 40˚C and below 10˚C. The panel asked him to provide reference of this as in Pakistan the temperature is above 40˚C in most of the cities in summer and below 10˚C in winters.
5. The Production Incharge also emphasized that after changing the formulation of the product, they did not face this problem of crystallization again, while the Director DTL, Mr. Munawar Hayat pointed out that their many samples of this product were failed in DTL, Lahore also, which were taken from the medical stores of Multan, Bahawalpur respectively.
6. The manufacturing area was also checked and the firm had installed requisite machineries such as mixing storage tanks, automatic filling machine etc. Supply of R.O water was also provided. However, it was observed that the firm had used the old bottles in their syrup manufacturing instead of new ones, which can also be source of contamination and product degradation as old bottles contain fungus and remnants of other products etc. The firm was directed to immediately curtail this practice. Mr. Abu Bakar, the Production Incharge informed that they would switch to PET bottles in future.
Conclusion of PSI:
The Panel submitted following recommendations:i. The firm M/s Masfa Industries (Pvt) Ltd, Lahore should conduct accelerated
stability studies of at least 05 batches from the retaining samples of Manadol suspension in which the formulation of the product has been altered, in order to determine the outcome of change of formulation.
ii. The firm M/s Masfa Industries (Pvt) Ltd, Lahore should submit the results of stability studies conducted to DRAP for review.
iii. If the registration of the product resumes, then the firm M/s Masfa Industries (Pvt) Ltd, Lahore should intimate the panel after manufacturing first batch, for sampling purpose. Regular production of the product would depend upon the results obtained by CDL, Karachi.
iv. The firm M/s Masfa Industries (Pvt) Ltd, Lahore should immediately curtail the practice of using old bottle in syrup section.
Minutes for 266th Meeting of Registration Board. 255
v. Moreover it is also a question mark that as informed by Production Incharge that the product cannot remain stable above 40˚C and below 10˚C then how it can be delivered to hot or cold climate areas in Pakistan. Hence, the panel concludes that first the firm conduct the accelerated stability studies of Manadol Suspension of minimum five batches of Quality Control retaining samples and submit its data to Registration Board for further consideration in the matter.
The case was presented in 266th meeting of Registration Board dated 07th February, 2017.Proceedings and Decision of 266th Meeting of Registration Board:
Registration Board after thorough discussion, deliberation and in the light of PSI report decided the case as under:
i. QA Division should consider the GMP issues of the firm M/s Masfa Industries (Pvt) Ltd, Lahore, like use of old bottles in syrup manufacturing instead of new ones as it is violation of GMP.
ii. The firm M/s Masfa Industries (Pvt) Ltd, Lahore, shall submit accelerated and real time stability studies of 03 batches for 06 months of the product Manadol Suspension.
iii. The registration of the product Manadol Suspension, Reg. No. 071558 will remain suspended till the submission of stability studies by firm M/s Masfa Industries (Pvt) Ltd, Lahore, for consideration of Registration Board.”
Case No.08: Miscellaneous ItemFollowing functions/powers may be delegated as follows:-In order to facilitate timely disposal of routine cases relating to Quality control section
following consideration is submitted which is in already in practice for the appraisal of the
Board.
Sr.No.
Power/Function Of The Secretary Registration Board Delegated/permitted to
1 To convey the decision, minutes, approved Show Cause Notices and miscellaneous directions etc. on behalf of Board.
Deputy Director And Assistant Directors in QC
The case was presented in 263rd meeting of Drug Registration Board held on 29-30th
November, 2016. Decision of 263rd Meeting of Registration Board:Registration Board Deliberated that any officer authorized by Director QA/LT can convey the decision of the Board.
The matter is again placed for consideration of Board so that the routine matters be
expeditiously processed.
Decision of 266th Meeting of Registration Board:“Registration Board deliberated the case and decided that any officer of the QA< Division (Additional Director, Deputy Director, Assistant Director), as authorized by Director QA/LT can convey the decision of the Registration Board.”
Minutes for 266th Meeting of Registration Board. 256
Additional Agenda:
A. Medical Device & Medicated Cosmetics Division.
Case No.01: Fresh Applications for registration of Medical Devices for import.
Following importing firms have submitted their registration applications of medical
devices for import. Status of each application is mentioned against each.
A. Catheters. S.N Name of
Importer and Manufacture/
Exporter.
Name of Medical Device
Price & Pack size
Shelf life
Remarks Decision
1. M/s Surgi World,303 Mohammadia Plaza, College Road,Rawalpindi
Manufactured by:M/s Medcomp , 1499 Delp Drive Harleys Villa, USA.
Titan HD Long Term Dialysis Catheter(All sizes Straight & Precurved)
Decontrolled 5 years
Applied on 17-11-2011. Shortcoming Letter Issued 18-9-2013. Reminders issued11-7-2013 and31-7-2013,4-3-2015 and 3-2-2017.No reply received till date.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Application on
Form 5A as Duly signed and stamped.
c. Original and valid Free Sale Certificate as decided above by Registration Board.
d. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
f. Orignal Credentials of manufacture as decided above by Registration Board.
g. Copy Valid Drug Sale License,
2. M/s Surgi World,303
Hemo-Flow Long Term Dialysis
Decontrolled 5 years
Applied on 17-11-2011.
Deferred for rectification of following
Minutes for 266th Meeting of Registration Board. 257
Mohammadia Plaza, College Road, Rawalpindi.Manufactured byM/s Medcomp , 1499 Delp Drive Harleys Villa, USA.
Catheter(All sizes Straight & Precurved)
Shortcoming Letter Issued 18-9-2013. Reminders issued 11-7-2013 and 31-7-2013,4-3-2015 and 3-2-2017.
shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License,
3. M/s Surgi World,303 Mohammadia Plaza, College Road, Rawalpindi.Manufactured byM/s Medcomp , 1499 Delp Drive Harleys Villa, USA.
Duo-Flow ® Side Xside Short Term Dialysis Catheter(All sizes Straight & Precurved)
Decontrolled 5 years
Applied on 17-11-2011. Shortcoming Letter Issued 18-9-2013. Reminders issued 11-7-2013 and 31-7-2013,4-3-2015 and 3-2-2017.
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to
Minutes for 266th Meeting of Registration Board. 258
support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License,
4. M/s. Ontech Corporation, M-02 Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.Manufactured byM/s. Ameco Medical Industries, Industrial Zone, Ramadan City, Egypt.
Urodynamic Cathethers
Decontrolled till policy decision by Policy Board/ Federal Government
05 year
s
Applied on 05-4-2011Letter issued on 6-12-2013. Reminder issued on 7-10-2016(Telephonically communicated on10-10-2016 and then20-01-2017, But no reply yet received.)
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
Copy Valid Drug Sale License,
5. M/s. Ontech Corporation, M-02 Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.
Manufactured by
Ureteric Cathether
Decontrolled till policy decision by Policy Board/ Federal Government
05 year
s
Applied on 5-4-2011Letter issued on6-12-2013Reminder issued on 7-10-2016(Telephonically communicated on
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
Minutes for 266th Meeting of Registration Board. 259
M/s. Ameco Medical Industries, Industrial Zone, Ramadan City, Egypt.
10-10-2016 and then20-01-2017, But no reply yet received.)
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
Copy Valid Drug Sale License,
6. M/s. Ontech Corporation, M-02 Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.
Manufactured byM/s. Ameco Medical Industries, Industrial Zone, Ramadan City, Egypt.
Peritoneal Dialysis Catheters Kit
Decontrolled till policy decision by Policy Board/ Federal Government
05 year
s
Applied on 5-4-2011Letter issued on 6-12-2013Letter issued on 7-10-2016(Telephonically communicated on 10.10.2016 and then 20.01.2017, But no reply yet received.)
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug
Minutes for 266th Meeting of Registration Board. 260
Sale License,7. M/s. Ontech
Corporation, M-02 Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.
Manufactured byM/s. Ameco Medical Industries, Industrial Zone, Ramadan City, Egypt.
Precautaneous Nephrostomy Catheter
Decontrolled
03 year
s
Applied on 5-4-2011Letter issued on 6-12-2013Reminder issued on 7-10-2016
Deferred for rectification of following shortcomings:a. Differential fee
PKR.35,000/-,b. Original and valid
Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Copy Valid Drug Sale License,
8. M/s 4S International, Suit No.205, 2nd Floor, Al Fiza Glass Tower, Rashid Minhas Road, Block-10-A, Gulshan-e-Iqbal, Karachi, PakistanManufactured By:M/s Balton Sp. Z o.o. Ul. Nowy swiat 7/ 14, 00-496 Warsaw, Poland.Manufacturing Site.
Introducers Sets to Introduce and Exchange Catheters and Endovavitary Electrodes with Hemostasis Valve
Decontrolled till policy decision by Policy Board/ Federal Government
1’s
4 years & 11
months
Applied on 26-1-2016
Shortcoming Letter issued on19-01-2017.
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board
b. Orignal Credentials of manufacture as decided above by Registration Board.
c. Approval of shelf life from regulatory authority or
Minutes for 266th Meeting of Registration Board. 261
Ul. Modlinska 294 02-156 Warsaw, Poland
Stability data to support claimed shelf life.
d. Clarification as brand name is different on Form 5A.
9. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, PeshawarManufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany
Duocath Hemodialysis Catheter 2-Lumen.
Sizes: 12FLength (cm): 13, 16, 20, 24.
Decontrolled till policy decision by the Policy
Board/ Federal
Government
5 years
Applied on 2-5-2016
Shortcoming Letter Issued on26-10-2016.Reminders issued6-12-2016 and28-12-2016.
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
b. Orignal Credentials of manufacture as decided above by Registration Board.
10. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Legal Manufacturer:M/s Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432, USA.Manufacturing Site:M/s Medtronic Vascular, 37A Cherry Hill Drive, Danvers, MA 01923, USA.
Export Advance Aspiration Catheter
Sizes and codes as per Free Sale Certificate.
Decontrolled till policy decision by
Policy Board/ Federal
Government
2 years
Applied on 31-5-2016
Shortcoming letter issued on18-1-2017. Reminder issued on 3-2-2017.
Deferred for rectification of following shortcomings:a. Original and valid
authorization letter/sole agency agreement from manufacturer as decided above by Registration Board .
Minutes for 266th Meeting of Registration Board. 262
B. STENTS
S.No
Name of Importer and Manufacture/
Exporter.
Name of Medical Device
Price & Pack size
Shelf life
Remarks Decision
1. M/s Allmed Solutions, Karachi.
Manufactured by:Not provided
Esophageal Stents
Decontrolled till policy decision by the Policy
Board/Federal
Government
Not mentioned
Applied on7-6-2012Shortcoming
letter issued on28-10-2013Reminder
issued on 2-3-2015. No reply received till date.
Following shortcomings:-
a. Application Form not provided
b. Differential fees
c. Complete specifications with details of analytical procedures
d. Details of manufacture and QC
e. Stability studies
f. Clinical data
g. FSCh. Sole
agency certificate, duly notarized.
i. Credentials of the company duly notarized.
j. GMP/ISO 13485 certificate
k. Valid drug Sale Licence
l. Clarification of product sizes and codes
m. Last inspection report.
Deferred for rectification of following shortcomings:
a. Differential fee PKR.35,000/-,
b. Form 5-A and all other relevent documents required according to form 5-A, Free sale certificate, sole agency agreement and credentials of manufacturer etc.
(According to manufacturing site decision of Registration Board for related documents will be applicable.)
2. M/s. Ontech Corporation, M-02
Double Loop Stent
Decontrolled
03 years
Applied on5-4-2011Letter issued on
Deferred for rectification of following
Minutes for 266th Meeting of Registration Board. 263
Mezzanine Floor ,Lakhani corner block -13-A, Gulshan e Iqbal,Karachi.
Manufactured byM/s. Ameco Medical Industries, Industrial Zone, Ramadan City, Egypt.
6-12-2013Letter issued on7-10-2016(Telephonically communicated on 10-10-2016 & then 20-01-2017, But no reply yet received.)Following deficiencies;1. Differential fee not paid.2. Form 5-Aduly signed and stamped.3. Equipment detail for manufacturing and QC.4. Components and composition of device.5. Specification of devices with detail of analytical procedure.6. Description and method of manufacturing.7. QMS/ ISO 13485 expired.8. Drug Sale License expired.9. Free sale certificate expired.10. Sole agency agreement, duly notarized.11. Clinical data.12. Stability data.
shortcomings:a. Differen
tial fee PKR.35,000/-,
b. Original and valid Free Sale Certificate as decided above by Registration Board.
c. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.
e. Orignal Credentials of manufacture as decided above by Registration Board.
f. Clinical Data, if any.
g. Copy Valid Drug Sale License
3. M/s. SES Associates,61-Bank Square Market, Model Town, Lahore.
Navalis Peripheral Vascular Self Expending Stent System
Decontrolled till policy decision by Policy Board/ Federal
3 years Applied on11-12-2012Shortcoming Letter issued on24-4-2013. Reminder issued on 2-3-2015.
Deferred for rectification of following shortcomings:
a. Original and valid Free Sale Certificate
Minutes for 266th Meeting of Registration Board. 264
Manufactured byM/s. QualiMed Innovative Medizinproduket GmbH, BoschstraBe 16, D-21423, Winsen, Germany.
Stent Length (mm);20,40, 60, 80, 100, 120, 150.
Stent Dia (mm):6,7,8,9,10,11.
Usable catheter length:80cm, 120cm.
Government
1’s
as decided above by Registration Board.
b. Original and valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.
c. Orignal Credentials of manufacture as decided above by Registration Board.
d. Copy of valid drug sale licence.
Case No.02: Registration applications of Medical devices for local manufacturing.
S.N Name of Manufacture
Name of Medical Device (s)
price & Pack size
Shelf life
Remarks Decision
1. M/s. Silver Surgical Complex Pvt Ltd, C-40 SITE-2, Super Highway Industrial Area Scheme No.33, Karachi.
Silver I.V Cath (Intravenous Catheter Straight Type)16G, 18G, 20G, 22G, 24G
Decontrolled till policy
decision by the Policy Board/ Federal Govt.
5 years
Applied on 3-12-2015.Shortcoming letter issued on 2-2-2017 and 3-2-2017.Provided undertaking for stability and clinical data after registration.
Approved with 02 years shelf life.
Case No.03: Inspection of Manufacturer abroad M/s Yangzhong Jinxiang Emulsion Products Co. Ltd, China.
The Registration Board in its 244th meeting held on 22nd & 23rd July, 2014
considered and approved the following medical devices of M/s Ghazali Brothers, Karachi
subject to inspection of manufacturer abroad, verification of storage facilities, etc as per
policy:-
S.# Name of Importer and Manufacturer/Exporter
Name of Medical Device
Demanded price & Pack size
Shelf Life
1. M/s Ghazali Brothers, Hospital & Homecare Decontrolled till 5 years
Minutes for 266th Meeting of Registration Board. 265
1st Floor Azzainab Court, Campbell Street, Karachi.Manufactured by:M/s Yangzhong Jinxiang Emulsion Products Co. Ltd, No.88 Daqiao Road, Yangzhong, Jiangsu, China.
Latex Foley Catheter(1 way, 2way & 3 way)
(6G,8G,10G,12G, 14G, 16G,18G, 20G,22G,
24G,26G)
policy decision by the Policy Board/Federal Government
Inspection of manufacturer abroad has been carried out by the panel comprising Dr.
Amanullah Khan, Director, DTL, Quetta and Mr. Zaheeruddin M Babar, Deputy Drugs
Controller (Reg-I), DRAP, Islamabad on 7th & 8th March, 2016. The panel did not
recommend the above product for registration due to the following observations:-
“Production area is located in a big hall and shared with production line of gloves and catheters both without any partitioning. No production of catheter was going on at the time of visit and the management informed that the area is under maintenance. The overall condition of production area was unsatisfactory. The area was not specifically designed for the purpose. Environment control was not appropriate. The floor and machines were dirty. Waste matter was found abundantly on the floor and machines. The machines were rusty. The clean room for packing area was though designed properly with appropriate ducting etc but the procedures for maintenance of environment are properly followed and entrance & exit gate to and from is not restricted through change room. The raw material store was badly managed and without proper environment monitoring. The storage tank is not properly covered. The ETO sterilization plant included an area which appears to be bath/wash room previously and some modifications were made to cover the chemicals. The firm’s management could not produce a number of documents. Furthermore, it is highly recommended that the products of this manufacturer shall be banned in the country unless in future the manufacturer is not inspected by DRAP.”
Case was placed before the Registration Board in its 261st meeting and Board
discussed the inspection report of M/s Yangzhong Jinxiang Emulsion Products Co. Ltd,
No.88 Daqiao Road, Yangzhong, Jiangsu, China in detail and keeping in view the nature of
the observations, being critical, rejected the above application for registration due to above
recorded reason as reported by panel.
Registration Board also advised Medical Device and PE&R Divisions to present
details of already registered drugs/products of same manufacturer for consideration.
As per available computer record of MDMC Division and PE&R Division, no
medical device/drug has been registered with Drug Regulatory Authority of Pakistan from the
above said manufacturer.
Decision: Registration Board noted the information.
Case No.04: Cancellation of Sole Agency Certification.
Registration Board in its 236th meeting held on 20th November, 2012 considered
and approved the following medical devices of M/s Intra Health, Karachi subject to Minutes for 266th Meeting of Registration Board. 266
recommendations of ECMD, inspection of manufacturer abroad, local storage facilities etc as
per policy:-
S. # Name of Importer and Manufacturer / Exporter.
Name of Medical Device
DemandedPrice & Pack Size.
Shelf Life
1. M/s Intra Health, 56-A, Unit No.1, Justice Inamullah Road, Block 7/8 KCHS, Karachi.Manufactured byM/s Uro Technology Sdn. Bhd., Malaysia.
Pro Care Foley Balloon Catheters.
(Latex Foley Catheter Silicon Coated)
Decontrolled
Different types i.e 2way, 3way with different product
codes
5 years
The ECMD in its 1st meeting held on 13th December, 2012 recommended the above
product. The registration certificates of above mentioned products could not be issued as the
inspection of manufacturing facility in Malaysia could not be conducted. In the meanwhile,
the Principal manufacturer has sent a letter dated 12-01-2016, wherein they have confirmed
that they have an exclusive contract with M/s Life Cares, Karachi for the exclusive sales and
distribution of whole range of Chroma Foley Catheters and that they will not pursue the
registration of their product Foley Catheter with MOH Pakistan applied by M/s Intra Health,
Karachi.
In this regard M/s Intra Health, Karachi was asked through a letter dated 22nd June,
2016 to confirm their status as being sole agent of M/s Uro Technology Sdn. Bhd., Malaysia
for above mentioned medical device or otherwise within 10 days for further processing the
case.
M/s Intra Health, Karachi has informed vide letter dated 29-06-2016 that they are the
exclusive agent for Procare Foley Balloon Catheters, manufactured by M/s Uro Technology
Sdn. Bhd. Malaysia. The firm has submitted a colored copy of authorization letter/sole
agency agreement from principal manufacturer and requested not to consider any application
as the agreement is still valid. Authorization letter/sole agency agreement was issued on 1 st
April, 2015 for 03 years i.e. till 31st May, 2018. However, the authorization letter/sole agency
agreement in favor of M/s Life Cares, Karachi was issued on 12-01-2016.
Case was placed before the Registration Board and Registration Board
discussed the case and decided to issue show cause notice to M/s Intra Health, Karachi that
why their application may not be rejected due to the aforementioned reasons. The Board also
decided to call the firm representative for personal hearing in the next meeting of the Board.
Accordingly decision of the Board was conveyed to M/s Intra Health, Karachi. In
reply the firm has informed as below:-
(i) Our application has been submitted with the Ministry since 17-10-2011 which gives us the benefit of applying fist and also entitled to the registration of our PROCARE Brand.
Minutes for 266th Meeting of Registration Board. 267
(ii) Our supplier has been providing us all the documents since the day applied and fulfilled all the requirements for this registration. This shows his willingness to get this registration for the PROCARE brand through our company. We have been consistently making efforts to get this brand registered since the last five years.
(iii) We had provided the registration fee as well as the balance fee vide our letter dated 08-03-2013 which makes our file complete in all aspects.
(iv) The exclusive letter provided by the manufacturer is still valid and gives us the benefits of being the rightful applicant for the brand PROCARE in the Pakistani market.
Decision: Registration Board decided to call the firm for hearing in the next meeting of registration Board.
Minutes for 266th Meeting of Registration Board. 268
Case No.05. Cancellation of Sole Agency Certification.
Registration Board in its 241st meeting held on 23rd December, 2013 considered and
approved the following medical devices of M/s. Cardiac Care, Lahore subject to inspection of
manufacturer abroad, verification of local storage facility etc as per policy:-
S.No. Name of Importer and Manufacturer/ Exporter.
Name of Medical Device. Shelf life
1. M/s Cardiac Care, 848-C, Shadman-I, Lahore.Manufactured byM/s CID SPA Strada Crescentino snc, 13040, Saluggia (VC) Italy.
ProHp Pegaso PTCA Balloon Catheter.
Balloon Length (mm): 10,15,20, 30.
Balloon Dia (mm):1.5, 2.0, 2.25, 2.75,3.0,3.25, 3.50, 3.75, 4.0.
36 months
2. -do- Brio Pegaso-SCRX PTCA Balloon Catheter.Balloon Length (mm): 10,15,20, 30.Balloon Dia (mm): 1.5, 2.0, 2.5, 3.0,3.5, 4.0.
36 months
3. -do- Cre8 Amphilimus Eluting Coronary Stent.Stent Length (mm): 12,16,20, 25,31.Stent Dia (mm): 2.50, 2.75, 3.0, 3.50, 4.00, 4.50.
18 months
4. -do- Avantgarde Chrono Carbostent(Coronary carbofilm coated bare metal stent)Stent Length (mm): 7, 8,12,16,20, 24, 25,31.Stent Dia (mm): 2.25, 2.50, 2.75, 3.0, 3.50, 4.00, 4.50.
36 months
5. -do- Chrono Carbostent(Coronary carbofilm coated Cobalt Chromium stent)Stent Length (mm): 7, 8,12,16,20, 24, 25,31.Stent Dia (mm): 2.25, 2.50, 2.75, 3.0, 3.50, 4.00, 4.50.
36 months
6. -do- Janus Optima Tacrolimus Eluting Carbostent(Coronary carbofilm coated drug eluting stent)Stent Length (mm): 11,15,19, 25,31.Stent Dia (mm): 2.50, 2.75, 3.0, 3.50, 4.00.
18 months
The registration certificates of above mentioned products could not be issued due to
clarification regarding the countries located in erstwhile Western Europe and erstwhile
Eastern Europe in import policy approved by the Policy Board in its 4th meeting which was
later on revised and clarified by the Policy Board in its 14 th meeting. In the meanwhile,
authorization issued by the Principal manufacturer M/s CID SPA, Italy in respect of M/s
Cardiac Care, 848-C, Shadman-I, Lahore, submitted in registration application dossiers, was
expired. The Principal manufacturer M/s CID SPA Strada Crescentino s/n, 13040, Saluggia
(VC) Italy has now sent a letter to DRAP submitting that the agreement between CID and
M/s Cardiac Care, 848-C, Shadman-I, Lahore, Pakistan has been terminated on 31st
December, 2015 and M/s Atco Laboratories Ltd., with its office located in B-18, S.I.T.E,
Karachi has now been appointed a sole agent to act as distributor in Pakistan and to attain
Regulatory Approvals for the following products through the local authorities:-
(i) ProHP Pegaso PTCA Balloon Catheter.(ii) Brio Pegaso SCRX PTCA Balloon Catheter.(iii) Cre8 Amphilimus Eluting Coronary Stent.
Minutes for 266th Meeting of Registration Board. 269
(iv) Avantgarde Chrono Carbostent (Coronary carbofilm coated bare metal stent)
M/s CID SPA, Italy has requested the DRAP to issue registration of above listed
products to Atco Laboratories Ltd., having the marketing authorization in Pakistan.
In this regard M/s Cardiac Care, 848-C, Shadman-I, Lahore was asked to confirm
their status as being sole agent of M/s CID SPA, Italy for above mentioned medical devices
within 10 days for further processing the case. Letter was issued on 17 th May, 2016 but no
response received till date.
The case was placed before the Registration Board in its 261st meeting wherein the
Board once again directed the firm for personal hearing in the subject matter in the next
meeting of the Board.
Decision: M/s Cardiac Care submitted written statement that they are not representing the principal that is M/s CID, Itlay and do not intend to further proceed its product line registration. Therefore the Registration Board rejected the above mentioned six applications.
Case No.06. Request for approval of change of address. M/s Kohsar Distributors, Rawalpindi has informed that they have changed their
premises from 3-Khurshid Plaza, Naya Mohallah, Rawalpindi to Hill View Block, Lower
Basement, Block No.516 to 523, Pakistan Town, Islamabad. The detail of their registered
imported medical devices/drugs is as under:-
S.No. Reg.No. Name of medical device/drug
Pack Size
1. 069511 Paramount Syringes 1ml, 2ml, 5ml, 10ml, 20ml2. 069512 Paramount Syringes 30ml, 50ml
2. The firm has submitted the following documents:-
(i) Fee challan of Rs.5000/-.(ii) Copy of registration letter.(iii) Copy of new Drug Sale License.
Decision: Registration Board approved the request of the firm for change of above mentioned address subject to verification of local storage facility by the area FID.
Case No.05: Transfer of Registration.
M/s Asto Life Sciences Private Limited, Lahore has requested for transfer of
following registered imported drugs (Medical Devices) from the name of M/s Becton
Dickinson Pakistan (Private) Limited, Lahore to their name:-
S.# Regn.No. Brand Name of Medical Device
Packing Shelf Life Name of Manufacturer
(i) 074663 BD SoloShot TM Mini Auto Disable
0.5 ml(23G, 24G &
5 years M/s Becton Dickinson, S.A. Ctra, Mequinenza,
Minutes for 266th Meeting of Registration Board. 270
Syringe 25G)0.05 ml
(27G X 3/8)
Fraga (Huesca), Spain.
(ii) 074685 BD Emerald TM Pro (Reuse Prevention) Luer Slip Syringes
2ml, 5ml & 10ml
5 years -do-
(iii) 059218 BD Disposable Syringes
3ml, 5ml, 10ml, 20ml
5 years(Confirmation of renewal status)
M/s Becton Dickinson Medical (Singapore) Tuas Avenue, Singapore.
(iv) 059219 BD Venflon TM Pro IV Cannulas
G16, G18, G20 & G22.
5 years(Confirmation of renewal status)
-do-
2. The firm has submitted following documents:-(i) Application dossier alongwith Form 5-A for each product.(ii) Fee of Rs.100,000/- for each product.(iii) Letters of Authorization regarding above products from the foreign
manufacturer (legalized from High Commission of Pakistan/Embassy) wherein it has also been mentioned that M/s Asto Life Sciences (Private) Limited is authorized to submit the application for transfer of registration in their name to the Drug Regulatory Authority of Pakistan.
(iv) Original NOC from M/s Becton Dickinson Pakistan (Private) Limited, Lahore regarding transfer of registration of above products.
(v) Change of address of M/s Becton Dickinson Pakistan (Private) Limited from 19 D/1, Gulberg-III, Lahore to 202-B, 2nd Floor, City Towers 6-K Main Boulevard, Gulberg-II, Lahore.
It is submitted that as per Free Sale Certificate of BD Venflon TM Pro IV Cannula,
product owner is Becton Dickinson Infusion Therapy AB Florettgatan 29C, PO Box 631, SE-
251 06, Helsingborg, Sweden while manufacturing site is Becton Dickinson Medical (s) PTE
Ltd, 30 Tuas Avenue 2, Singapore.
Decision: Registration Board deferred the case till next meeting for detail discussion.
Case No. 06: Correction of Brand Name on Registration Letter.
M/s Becton Dickinson Pakistan (Private) Limited, Lahore has informed that their
following product manufactured by M/s Becton Dickinson and Company, USA has been
registered as per detailed below:-
S.No. Reg.No. Product Name Packing MRP Shelf Life
1 059212 BD Ultra-Fine TM Insulin Syringe
0.5ml1ml
De-controlled 05 Years
The firm has submitted that product actual name is BD Ultra-Fine II Insulin Syringe
and requested to issue new registration letter with correct name of the product. Product was
approved in 221st meeting of the Registration Board held on 6th November, 2009 wherein
following product descriptions was mentioned:-
“BD Ultra-Fine TM, Ultra-Fine TM I, Ultra-Fine TM II Insulin Syringe”
Minutes for 266th Meeting of Registration Board. 271
In this regard, it is submitted that RRR Section have informed that Registration
Board in its 263rd meeting considered case for renewal of registration for this product and
decided as under:-
“During meeting RRR Section informed Registration Baord that in addition to verification of fee challan by the Budget & Account Division and by R&I Section, original application has been traced later on. Thus the Board granted the renewal till 22-11-2019. Inspection of manufacturing site will be conducted as per import policy for finished drugs.”
Decision: Registration Board deferred the case for till next meeting for detail discussion.
Case No.07. Cancellation of Agency Agreement.
M/s Hope Pharma, Lahore have informed that M/s Delta Med, Italy IV
Catheter/Canula was registered in Pakistan under brand Name “Delta Ven” for M/s Intra
Health, Karachi under registration Nos.071613, 071614 & 071615. The Principal
manufacturer did not want to continue their business with their present distributor M/s Intra
Health, Karachi. In this regard the principal manufacturer has terminated the distribution
agreement of Intra Health, Karachi on 12-07-2016 mentioning all products in the territory of
Pakistan due to the total lack of business provided in year 2015 and 2016 (Termination letter,
Embassy attested). M/s Delta Med also nominated Hope Pharma, Lahore as their Sole Agent
and distributor in registering, importing and selling of IV Cannula and accessories range in
Pakistan (Embassy attested letter of authorization).
Decision: Registration Board decided that showcause notice be issued to M/s Intra Health, Karachi that why there Registration may not be cancelled due to termination of their distribution agreement by the principal manufacturer.
Case No.08. Local storage facility of M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi.
Registration Board in its 253rd meeting held on 5th & 6th October, 2015 approved the
new address of M/s Johnson & Johnson Pakistan (Pvt) Ltd i.e. Fl-19, Sub-Plot F-1,
Kehkashan Scheme No.5 Main Boat Basin, Clifton, Karachi-75600 subject to verification of
local storage facility.
Later on M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has informed that
under the revised Business Model in Pakistan, they have appointed M/s Pak Punjab Cardex
Medical System situated as 257-K-Block, DHA, Lahore Cantt holding License
No.21-A/Cantt/11/2015 as Authorized Distributor who is responsible for import, store, sale
Minutes for 266th Meeting of Registration Board. 272
and exhibit for sale. This process is fully in accordance with Drug Import Rule 3 by issuance
of NOC/Indent to the designated distributor.
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has also submitted following documents:-
i) Copy of Drug Sale License of M/s Pak Punjab Cardex Medical System Lahore Cantt.
ii) NOC for import authorization in respect of M/s Pak Punjab Cardex Medical System, Lahore Cantt
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested that the local
storage condition of their designated warehouse (M/s Pak Punjab Cardex Medical System
situated at 257-K-Block, DHA, Lahore Cantt) may kindly be verified.
Case was placed before Registration Board in its 256 th meeting and the Board allowed
to verify the local storage conditions of M/s Pak Punjab Cardex Medical System, 257-K-
Block, DHA, Lahore Cantt with the direction to bring the case alongwith the inspection
report in the next meeting of Registration Board.
In this regard, it is submitted that local storage facility of M/s Pak Punjab Cardex
Medical System, 202, Eden Heights, Jail Road, Lahore has been verified and recommended
by the Area FID.
Decision: Registration Board deliberated that as products are registered for M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi and firm wants to use M/s Pak Punjab Cardex Medical System, 257-K-Block, DHA, Lahore Cantt as its storage site, who itself is an importer. The Board advised M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi to develop its own storage site and inform DRAP for confirmation of storage facility.
Case No.09. Clarification of Product.It is submitted that the application of Magma Rapamycin-Eluting Coronary Stent
System manufactured by QualiMed Innovative Medzinproduckte, GmbH, Boschstr. 16, D-
21423, Winsen, Germany was approved in 265th meeting of Registration Board. It is further
submitted that Itrix Rapamycin-Eluting Coronary Stent Implantation System is already
registered with registration No. 082015 on 30 th September, 2016 in the name of M/s
Cardiovascular medical system, Lahore. In this case the owner/legal manufacturer is M/s amg
international GmbH, lohnfield, Winsen-Luhe, Germany and manufactured by QualiMed
Innovative Medzinproduckte, GmbH, Boschstr. 16, 21423, Winsen, Germany.
Decision: Registration Board decided that registration certificate for Magma Rapamycin-Eluting Coronary Stent System shall not be issued till clarification of product similarity with already registered Itrix Rapamycin-Eluting Coronary Stent Implantation System from both the applicant and status of sole agent by the manufactuer M/s QualiMed Innovative Medzinproduckte, GmbH, Boschstr. 16,D-21423, Winsen, Germany.
Minutes for 266th Meeting of Registration Board. 273
B. Biological Drugs Division:i. IV Globulin SN Inj. applied by M/s Hi-Warble Pharmaceuticals (Pvt.) Ltd.,
Lahore deferred in 264th meeting of Registration Board.Following product of M/s Hi-Warble Pharmaceuticals (Pvt.) Ltd., Lahore was
deferred in 264th meeting of Registration Board for the submission of clinical trial data. The
detail of the product is as follows:
The firm has submitted the periodic safety update report for the period from 01 st
January 2010 to 30th November 2010. The firm has also submitted the Multi center, single-
arm, phase-IV study to evaluate the efficacy and safety of the combined therapy of aspirin
and high-dose “IVIG-SN” for paediatric patients with Kawasaki disease.
The clinical trial was conducted in accordance with the Korean Good Clinical Practice
regulations and 45 subjects were selected for this trial. The conclusion of the trial is as
follows:
“This clinical trial showed that incidence of coronary artery lesions was 2.38% when IVIG-SN was used in paediatric patients diagnosed with Kawasaki disease. This was lower than the 15% set as the standard in the protocol and the difference was statistically significant. The efficacy of the product was clinically confirmed as well. Moreover, no major issues were discovered in terms of safety. IVIG-SN is believed to be a product that can be used as safely and effectively as previous IVIG agents. Submitted for the consideration of board please.
S. #.
Name of Importer & Manufacturer
Brand Name & Composition
Type of FormDy No & Date of applicationFee submittedPack size/ Demanded Price
Document details (CoPP)
Me too status/New molecule
Decision of RB in 264th
meeting
Decision
1 M/s Hi Warble Pharmaceuticals Pvt Limited Lahore.
M/s Green cross Corporation, 586, Gwahaksaneop 2-ro, Ochang-eup, Chenongwon-gu, Cheoangju-si, Chungcheongbuk, do, Republic of Korea.
I.V. Globulin SN injSolution for injection
Each ml contains:Human normal immunoglobulinG……50mg
Plasma derivative
Form 5-ADy. No 224 dated 12-08-16
Rs.100,000/-dated 11-08-16
Rs. 9,500 per 10mlRs.18,000 per 20mlRs.35,000 per 50 mlRs.66,500 per 100ml
Legalized valid CoPP No: 2016-A1-0427 dated31-03-2016
Intrabolulin of biotest Germany registered with M/s Eastern trade
Flebogamma DIF 50 mg/ml of Grifols UK Ltd. (UK)
Deferred for submission of clinical trial data.
Registration Board approved product as per import policy for finished drugs and as per valid legalized CoPP.
Minutes for 266th Meeting of Registration Board. 274
ii. Imported veterinary biologicals from non-reference countries.S.#. Name of
Importer & Manufacturer
Brand Name & Composition
Type of Form
Dy. No & Date of application
Fee submitted
Pack size/ Demanded Price
Document details (CoPP)
Me too status/New molecule
Decision
1 Marush (Pvt) Ltd K-123 Model Town Lahore.
‘’SHCHELKOVO BIOCOMBINATE’’, Biocombinat township, SShchelkovskii district, Moscow region, Russian Federation
Cultural monovalent and polyvalent adsorbed inactivated vaccine against foot and mouth disease.Each dose contains:Antigen of virus type A(Iran 05)…….. 10PD50Antigen of virus type O ( Pan Asia 2)…….. 6PD50Antigen of virus type Asia1( sindh 08)…….. 6PD50Shelf Life: 18 months
Dy No. 2872/2017(R&I) 30-01-2017Rs.100,000/- 23-01-2017Pack Size:10 DS vial25 DS vial50 DS vial100 DS vial
Legalized GMP certificate No. 01026 dated 29-01-2016
Legalized FSC certificate issued by Ministry of Agriculture of Russian Federation, Federal State Enterprise.
Deferred for evaluation of product by Dr. Qurban Ali, Member Registration Board.
iii. Imported human biologicals from non-reference countries.
S.#.
Name of Importer & Manufacturer
Brand Name & Composition
Type of FormDy No & Date of applicationFee submittedPack size/ Demanded Price
Document details (CoPP)Me too status/New molecule
Remarks Decision
1 RG Pharmaceutica (Pvt.) Ltd. Suit #703 progressive square block 6, P.E.C.H.S Shahrah-e-Faisal, Karachi-75400, Pakistan
North China Pharmaceutical Co. Ltd. No. 115 Hainan Road, Economic &
Freclot Injection 25000IU/5mlEach ml contains: Heparin sodium ….5000 IU
Anti-coagulantShelf Life: 36 months
Dy No. 2524/2017(R&I) 25-01-2017Rs.100,000/- 11-01-2017Pack Size: 5ml x 10vials
Valid Legalized CoPP No. 20150854 dated 18-01-2016
As per submitted CoPP the product is not registered for sale in the market of country of origin.Stability data provided is of 24 months while claimed shelf life is 36 months.Under clinical trial data, the firm has submitted abstracts of three articles instead of complete articles.
Deferred for clarification of following:a. As per submitted
CoPP the product is not registered for sale in the market of country of origin.
b. Stability data provided is of 24 months while claimed shelf life is 36 months.
c. Under clinical trial data, the firm has submitted abstracts of three
Minutes for 266th Meeting of Registration Board. 275
Technological Development Zone, Shijiazhuang, China
articles instead of complete articles.
2 M/s Getz Pharma (Pvt.) Ltd, 29-30, Sector-27, Korangi Industrial area,Karachi.
M/s Biocon Limited, Special Economic Zone, Plot Nos. 2,3,4 & 5 Phase-IV, Bommasandra Post,Bangalore-560099,India
TRAVIA 440MG VIALEach vial contains:Trastuzumab(rDNA Origin)…440mgAnti-neoplasticShelf Life: 4 years
Dy No. 1626/2017(R&I) 17-01-2017Rs.100,000/- 12-01-2017Pack Size: 1s vial(440mg)/ Rs.100,000
CoPP No. DCD/CR-1849/Spl.Cell-I/2015-16 dated 07-12-2016
CoPP and Sole agent certificates are photocopied.
Stability data provided for finished product is of 18 months while proposed shelf life is 4 years.Diluent is a part of pack presentation; therefore separate application on Form-5A along with fee for diluent is required.It is pertinent to mention that M/s AGP has already applied the same product from same manufacturer i.e. M/s Biocon Limited, India through M/s Mylan Pharmaceuticals Private Limited, India.Biosimilarity data is submitted which needs evaluation.
Deferred for clarification of following:a. CoPP and Sole
agent certificates are photocopies. Original legalized CoPP and sole agency agreement is required.
b. Stability data provided for finished product is of 18 months while proposed shelf life is 4 years.
c. Diluent is a part of pack presentation; therefore separate application on Form-5A along with fee for diluent is required.
d. M/s AGP has already applied the same product from same manufacturer i.e. M/s Biocon Limited, India through M/s Mylan Pharmaceuticals Private Limited, India.
Minutes for 266th Meeting of Registration Board. 276
C. Pharmaceutical Evaluation & Registration.
Case No.01: Approved cases in previous meetings of Registration Board.
a) Products of M/s Warafana approved in 234th Meeting of Registration Board.
Registration Board in its 234th meeting approved the following product of M/s
Warafana Pharmaceuticals, Islamabad subject confirmation of source, GMP Stability and fee
Rs.15000/-. The decision of Registration Board was confirmed from the original minutes.
Sr.No.
Name of firm Name of Composition of product
Pack Size
Demanded price
Date of application
Evaluation by the Section
1. M/s Warafana Pharmaceuticals,Islamabad
Rabe-10 CapsuleEach capsule contains:-Rabeprazole as Sodium(enteric coated pellets 8.5%)….10mg
1x10’s As per SRO 01-06-2011 Approved in FDA
Now, the firm has submitted the information regarding source as M/s Vision
Pharmaceuticals, Islamabad alongwith GMP, stability studies and COA. Regarding fee the
firm has submitted evidence of photocopy of Rs.15000/- and original Challan of Rs.5000/-
(F.N.1-11/2011-Reg.III).
Decision: Registration Board deferred the above product Rabe-10 Capsule for verification of me-too status.
b) Products of M/s Warafana approved in 238th Meeting of Registration Board.Registration Board in its 238th meeting approved the following product of M/s
Warafana Pharmaceuticals, Islamabad subject to condition mentioned in 2nd last column. The
decision of Registration Board was confirmed from the original minutes.
S. No.
Brand Name / Label Claim
Demanded Pack
Size
Demanded
Price
Date of Submissio
n
Decision of Registration Board of meeting-
238th
Evaluation by the section.
1. Clinda CreamEach gm contains:-Clindamycin as Phosphate (USP……….20mg(Gynaecological Anti-Infective)
20gm As Per SRO
06-06-2011
Dy.No.1349-R&I
Fee Rs.8,000(Original Challan)25-07-2013
ApprovedHowever
Registration Board
advised the Registration sections to
again review the
Registration
Approved in USFDA
Dossier is not signed by the
quality control manager and production manager
Minutes for 266th Meeting of Registration Board. 277
Dy.No.1832-R-III
Rs.12,000/-
(Original Challan)
Dossiers before
issuance of Registration
letters
2. Feri InjectionEach ampoule contains:-Iron as Iron Sucrose ….100mg(Haematinic)
5mlx5’s As Per SRO
06-06-2011
Dy.No.1324-R&I
Fee Rs.8,000(Original Challan)25-07-2013
Dy.No.1831-R-III
Rs.12,000/-
(Original Challan)
-Do- Approved in USFDA as vial and in
UK as ampoule.
Dossier is not signed by the
quality control manager and production manager
3. Cepha-500 CapsulesEach capsule contains:-Cefadroxil as Monohydrate USP……. 500mg(Anti-Biotic, 1st Generation)
2x6’s As Per SRO
22-06-2011
Dy.No.2671-R&I
Fee Rs.8,000(O
riginal Challan)25-07-2013
Dy.No.1833-R-III
Rs.12,000/-
(Original Challan)
-Do- Approved in UK
The firm mentioned Dry suspension in
the dosage form in form-5 and the dossier is not signed by the quality
control manager and production manager
4. Wefdox100 CapsulesEach capsule contains:-Cefpodoxime (as Proxetil) USP………..100mg(Anti-Biotic, 3rd Generation Cephalosporin)
1x5’s As Per SRO
25-07-2013
Dy.No. 1843Fee
Rs.20,000(Original)
-Do- Not approved in USFDA & UK in capsule dosage form.
5. Waraxim-200 1x5’s As Per 25-07- -Do- Not approved Minutes for 266th Meeting of Registration Board. 278
CapsulesEach capsule contains:-Cefixime (as Trihydrate) USP………..200mg(Anti-Biotic, 3rd Generation Cephalosporin)
SRO 2013Dy.No. 1842Fee
Rs.20,000(original)
in UK &USA (instead as
400mg capsule in FDA)
Now, the firm has requested for grant the registration of above product as they have
deposited the balance fee as per detail mentioned in 3rd last column.
Decision: Registration Board approved products at s. no.1, 2 and 3 while deferred the product at s. no. 4 and 5 for confirmation of approval of formulation in the reference agencies.
Case No.02: Deferred cases in previous meetings of Registration Board.
a) Products Deferred in previous meeting.Registration Board in its 248th meeting approved 07 products of M/s Wenovo
Pharmaceuticals, Taxila except the following while considering these products which were deferred in 244th and 246th meetings for confirmation of availability of TOC analyzer and liquid Particle Counter.
Now, the firm has requested to approve the above product since the same formulation
has been found approved in Lithuania, Poland & Lativa as intramuscular injection instead of
Germany as indicated in the minutes of 261st meeting.
Decision: Registration Board approved WENOFEN 2 ml Injection.
Minutes for 266th Meeting of Registration Board. 279
Sr.No. Brand name and composition Type of FormInitial date, diary
Fee including differential fee
Demanded Price / Pack size
Decision of M-246th
meeting of Registration Board
1. WENOFEN InjectionEach 2 ml of amberglass ampoule contains:Diclofenac Sodium….75mgLidocaine HCl…..20 mgAnalgesic, Local anestheticManufacturer
Form-5Dy No: 1272dated 23-10-201420,000/-As per policyof MOHPack of 5’s & 10’s
Deferred forconfirmationof installationand operationalqualificationsof TOC analyser &liquid ParticleCounter byArea FID.
Case No.03: Registration for export purpose.Registration Board in its 262nd meeting deferred the following products of M/s
Hudson, Karachi for the reason stated in the last column. Now the firm has provided
international availability as per following details:
S.# Name of Applicant
Name of product(s) Date of application, Diary No. & Form
Decision of Registration Board in 262nd Meeting
Approval status in reference regulatory agencies or evidence of registration in the country of importer.
1. M/s Hudson Pharma, Karachi
Resprixo 0.5mgEach 2ml ampoule contains:Fluticasone Propionate…….0.5mg
15.09.20161198Rs. 50,000/-
Deferred for confirmation of approval status by reference regulatory authorities and importing country
FDA ApprovedFLONASE ALLERGY RELIEF spray, metered, nasalGSK CONS
2. -do- Actonide 0.5mgEach ampoule contains:Budesonide BP…….0.5mg(BP Specification)
15.09.20161199Rs. 50,000/-
Deferred for confirmation of approval status by reference regulatory authorities and importing country
MHRA approved as Budesonide 0.5 mg Nebulizer SuspensionBreath Limited UK
3. -do- Formotol 20mcgEach ampoule contains:Formoterol Fumarate ….20mcg(Manufacturer’s Specification)
15.09.20161203Rs. 50,000/-
Deferred for confirmation of approval status by reference regulatory authorities and importing country
FDA ApprovedPERFORMIST,Solution;InhalationMYLAN SPECLT
4. -do- Deeferol Injection 200,000IUEach ampoule contains:Cholecalciferol BP………5mg(Manufacturer’s Specifications)
15.09.20161189Rs. 20,000/-
Deferred for confirmation of approval status by reference regulatory authorities and importing country
Me too formulation
Decision: Registration Board approved the grant of registration of above mentioned products to M/s Hudson Pharma, Karachi for export purpose.
Minutes for 266th Meeting of Registration Board. 280
D. Quality Assurance & Laboratory Testing Division.
Case No.01: Manufacture & Sale of Sub-Standard Drug-Beflam 75mg Tablets (Diclofenac Potassium) Batch No.3827 By M/S Batala Pharmaceutical Gujranwala.
The sample of Beflam 75mg Tablets Batch No. 3827 manufactured by M/s Batala
Pharmaceuticals Gujranwala, was drawn by FID Lahore from the manufacturing premises on
16-06-2015 and sent to the CDL, Karachi for test/analysis. The Federal Government , CDL
Karachi vide test report No LHR-156/2015 dated 31st July 2015, declared the sample of
Beflam 75mg Tablets as of Substandard quality under the Drugs Act, 1976. . The result of
CDL on the basis of which sample under reference was declared sub-standard are reproduced
as under:-
Sub-Standard with regard to Dissolution Test.Stage-1
Tablet No. (%)age.01. 52.08202. 28.43503. 48.06404 48.79805. 28.43506 48.98Average % (S1) 254.794/6=42.465
Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 75+5=80%Stage-2
Tablet No. (%)age01. 72.01902. 31.29803. 38.19704 48.46205. 38.02906 35.505Average % (S2) 263.5/6=43.918
Average of 12 units = 254.794+262.51=517.304517.304/12=43.191%
Limits for (Stage-2):- average of 12 units (S1+S2) is equal to or greater than Q(75%) and no unit is less than Q-15% (75-15=60%)
Stage-3Limits for (Stage-3):- Average of 24 units (S1+S2+S3) is equal to or greater than Q(75%). Not more than 2 Units are less than Q-15 (75-15=60%) & no units is less than Q-25% (75-25=50%)
Since, 01 tablet is below 60% and 10 tablets are already below 50% therefore, the sample Does not comply with USP 37.
Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976.
Minutes for 266th Meeting of Registration Board. 281
On explanation letter issued by the FID, the firm challenged the CDL report and
requested for Appellate testing under Section 22(5) of Drugs Act, 1976. However Appellate
Laboratory declared the sample as Substandard vide their test report 031-MNHRS&C/2015
dated 08th January 2016. The result of Appellate Laboratory on the basis of which sample
under reference has been declared sub-standard are reproduced as under:-
Sub-Standard with regard to Dissolution Test:-
Dissolution: Determined: 54.193% Limit: Not less than 75% of the labeled amount.
Does not comply with USP-32
The names of the following persons of the firm were furnished by the FID. i. Rana Muhammad Yousaf (Chief Executive), M/s Batala Pharmaceuticals.ii. Muhammad Umar Shakir Production Manager.iii. Hafiz Shabir Ahmed Quality Control Manager
As per procedure show cause notices were issued to the firm and above named accused persons, offering opportunity of personal hearing before the Drug Registration Board.
258th meeting of Registration Board held on 25th & 26th April 2016
Proceedings: No representative of M/s Batala Pharmaceuticals Gujranwala appeared before the Board. The Firm submitted the request for giving opportunity to next meeting due to some emergency in the family of the concerned personals.
Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
“Deferred the case and given last opportunity to the M/s Batala Pharmaceuticals Gujranwala if they want to avail personal hearing before the Registration Board. In case of failure of the firm to appear before the Board in its next meeting of Registration Board, the Board will take ex-parte decision.”
259th meeting of Registration Board held on 30th & 31th May 2016
Proceedings: Mr. Hafiz Shabir Ahmad, Quality Control Manager of the M/s Batala Pharmaceutical Gujranwala appeared before the 259th meeting of DRB held on 30-31st May 2016 and pleaded their case.Decision: Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-“The Board decided to suspend the Registration for six months (06) and to conduct the PSI from the following panel:
i. Director DTL Lahore.ii. Mr. Muhammad Adnan Faisal Saim, (DDC- QC-I & II).
iii. Area FID.The Firm will recall the batch and the area FID will supervise the destruction.”
Minutes for 266th Meeting of Registration Board. 282
Product Specific Inspection Report:
With reference to the decision of Registration Board in its 259th meeting held on 31-
05-2016, the above constituted panel visited the firm on 21-11-16 to conduct Product Specific
Inspection and concluded as under:-
Focus of Inspection: Product Root Cause
Beflam 75 mg Batch no. 3827
The product was declared substandard on the basis ofi. Dissolution: Determined was 54.193%. (Does not comply with USP-32 which states the limit as not less than 75% of the labeled amount.)
Details of Product Specific Inspection:The panel scrutinized the documents regarding sub-standard product [Beflam 75 mg
Tablets (Diclofenac Potassium)] including the Batch Manufacturing Record, standard manufacturing procedures, standard testing procedures, testing methods, pharmacopoeial specifications etc. The panel noted that batch of the product was manufactured as per standard procedures, and the released certificate was issued by the Quality Control Department. The firm also issued letters for recall to the distributors. The panel also checked the documents and record. After the detailed discussion and investigation of the record, the panel reached to the conclusion that registration of the product, Beflam 75 mg, may be restored with the directions to the firm to keep strict control and observations on the product by conducting real time stability study and monitoring from the market on regular basis.
Conclusion:After thorough investigations and observations of record, the panel observed that the
firm was not getting calibration of some of their equipment from external source timely. It is directed to the management to get calibrated all of their equipment from the external sources on regular basis well before their next due date. It is also directed to ensure the testing of the product as per current Pharmacopoeial requirements, so the panel recommends that the production may be restored of drug Beflam 75mg tablets (Diclofenac Potassium) as the period of more than six months of suspension of registration of the drug has already been completed, as per the decision of Drug Registration Board.
The case was presented in 266th meeting of Registration Board dated 07th February, 2017.
Proceedings and Decision of 266th Meeting:
Registration Board after detailed discussion, deliberation, considering the facts and in the light of Product Specific Inspection report decided the case as under:-
“The Board decided to give resumption of registration of Beflam 75 mg Tablets (Diclofenac Potassium) Reg. No. 031128 by M/s. Batala Pharmaceuticals, Gujranwala.”
Meeting ended with a vote of thanks to and from the chair.
End of Document
Minutes for 266th Meeting of Registration Board. 283