minutes of 229th meeting of central licensing ... of... · web viewrana m. maqsood advocate stated...

MINUTES OF 232 ND MEETING OF CENTRAL LICENSING BOARD HELD ON 29 TH & 30 TH JULY 2013

232nd meeting of the Central Licensing Board (CLB) was held on 29 th & 30th July, 2013 in the committee room of Ministry of National Health Services, Regulation & Coordination, Islamabad under the Chairmanship of Mr. Faqeer Muhammad Shaikh, Director Drug Licensing, DRAP/ Chairman CLB.

Following members attended the meeting: -

Sr. # Name & Designation Position in CLB

1.Mr. Faqeer Muhammad Shaikh.Director Drug Licensing, Drug Regulatory Authority of Pakistan, Islamabad.

Chairman CLB

2. Mr. Ayaz Ali Khan, Chief Drugs Controller, Health Department, Government of Punjab, Lahore. Member

3. Mr. Salim Isharat Husain, Chief Inspector of Drugs, Health Department, Government of Sindh, Karachi. Member

4. Syed Jawed Yousaf Bukhari, expert in Drug Manufacturing (Karachi). Member

5. Mr. Nadeem Iqbal, expert in Drug Manufacturing (Lahore). Member

6. Dr. Ali Akbar Sial, Wafaqi Urdu University, Karachi Member7. Mr. Khalid Yousuf, Expert in Quality Control, Karachi. Member

8. Prof. Dr. Gul Majeed Khan, Chairman Pharmacy Department, Quaid-e-Azam University, Islamabad. Member

9.

Mr. Zaheeruddin M. Baber, DDC (QC), DRAP, Islamabad,Representative of Directorate of Quality Assurance and Lab Testing.

Member

10.Mr. Ahmad Din Ansari.Deputy Director General (Licensing), Drug Regulatory Authority of Pakistan, Islamabad.

Secretary CLB/ Member

11. Mr. Ahsan Awan, Representative of PPMA (South). Observer12. Mr. Khalid Munir, Representative of PPMA (North). Observer13. Mr. M. Rashid Representative of Pharma Bureau Observer

The Chairman CLB welcomed the honorable members of this Apex Forum & participants of the meeting. The Chairman briefly introduced himself and the members of the Board also gave their introduction. The meeting started with the recitation of verses from the Holy Quran. The Chairman apprised the members of the Board regarding the reconstitution of the CLB and that strong responsibility devolves on the members of the Board to conduct the proceedings of CLB in an amicable and responsible way to deliver to the public and stake holders in a transparent and efficient manner. He further added that all the legal and codal formalities regarding convening of the meeting has been fulfilled. He also disclosed that the Federal Government desires to ensure transparency at

of 78

all forums of delivery by Drug Regulatory Authority of Pakistan. The Secretary CLB informed the honorable members of the Board that no person who is the member of CLB can be the member of any other Board / Committee constituted under the Drugs Act, 1976 or Rules framed there under to avoid conflict of interest as provided under Section 11-A of the Drugs Act, 1976. He further added that in his opinion, giving consultancy to Pharma Industry by a CLB member will also be contrary to these provisions of the law. However, Mr. Khalid Yousuf, Member CLB, was of the view that if a member gives consultancy to Pharma Industry, he/she should not participate in any discussion / decision of the case where conflict of interest arises. Syed Jawed Yousaf Bukhari, and Mr. Nadeem Iqbal, Members of CLB supported the version of Mr. Khalid Yousuf, and also added that such member should not participate in discussion, proceeding, conduct inspection of those cases and should remain impartial to avoid such conflict. Secretary CLB presented the agenda and started proceedings of the Board. Mr. Khalid Mehmood, DDC (Lic.), Mr. Zaheeruddin M. Baber DDC (Q.C.), Mr. Adnan Faisal Saim, DDC (Q.A.) and Mr. Salateen Waseem Philip ADC (Lic.) DRAP Islamabad assisted the Secretary CLB in presenting the agenda.

2. The proceedings of the Board are as follows:-

A. LICENSING SECTION Item I: - CONFIRMATION OF THE MINUTES OF 231 ST MEETING

The Minutes of 231st meeting of the Central Licensing Board, held on 30-01-2013, were circulated to all members after getting approval of Chairman Board. Since no objection was received from any member so the Minutes are presumed to be confirmed / approved.

Item II: - CASES OF GRANT OF DRUG MANUFACTURING LICENSES.

The Board decided the following cases of Grant of Drug Manufacturing License in the light of recommendations by panel of experts/inspectors.

Sr. # Name of the firm Type of

License Decision of CLB

1. M/s Crystolite Pharmaceuticals, Rawat, Rawalpindi

Formulation Grant of DML to the Firm with following six (06) Sections was approved by CLB.

i). Tablet (General) ii). Capsule (General)iii).Cream/Ointment (General)iv). Cream/Ointment (Steroidal)v). Lotion (General)vi). Lotion (Steroidal)

2. M/s Filix Pharmaceuticals, Rawat, Rawalpindi.

Formulation Grant of DML to the Firm with following two (02) Sections was approved by CLB.i). Tablet (General)ii). Capsules (General)

of 78

3. M/s Wisdom Pharmaceutical Industry, Peshawar

Formulation Grant of DML to the Firm with following seven (07) Sections was approved by CLB.i). Dry Powder Suspension

(Cephalosporin).ii). Capsule (Cephalosporin)iii).Capsule (General)iv). Liquid Syrup (General)v). Tablet (General)vi). Ointment/Cream Steroid.vii). Ointment/Cream (General).

4. M/s Ravi Medical Supplies (Pvt.) Ltd, Kasur.

Formulation The case of grant of DML to the firm was deferred by CLB.The Board further decided to get the premises re-inspected with regard to verification of rectification of points as identified by the panel for grant of Drug Manufacturing License in its report dated 08-01-2013. The Board delegated the power to Chairman Central Licensing Board that the case shall be processed for constitution of panel for grant of DML. The case shall be placed before CLB in its next meeting after the receipt of panel inspection report. The FID / Panel should be directed to furnish report with clear and candid recommendations. The case will be decided by CLB accordingly in the light of fresh report by the panel of experts.

Item-III: CASES OF GRANT OF ADDITIONAL SECTIONS.

The Board decided the following cases of Grant of Additional Sections of the already licensed Pharmaceutical manufacturers in the light of recommendations by the panel of experts/inspectors. However the sections which are not approved / deferred for re-inspection are also placed under this provision of Item III.

Sr. #

Name of the firm Type of License

Decision of CLB

1. M/s Hansel Pharmaceuticals (Pvt.) Ltd, Lahore.

Formulation The CLB approved grant of following two (02) additional sections to the firm.i). Eye Drops (General)ii). Skin Ointment (General)

2. M/s Bosch Pharmaceuticals (Pvt.) Ltd, Karachi.

Formulation The CLB approved grant of following four (04) additional sections to the firm.i). Penicillin Injectable section.

of 78

ii). QC Laboratory.iii).Raw material Store.iv). Finished goods store.

3. M/s Merck Pharmaceuticals (Pvt.) Ltd, Karachi.

Formulation The CLB approved the following:i). Alteration and expansion in existing manufacturing and packaging facility (Ground Floor and First Floor).ii). Alternation and expansion in existing packing, Raw Material and Finished Good ware houses (Ground Floor).

4. M/s NovaMed Pharmaceuticals (Pvt.) Ltd, Lahore.

Formulation The CLB approved grant of following two (02) additional sections to the firm.i). General Liquid Injection

(Ampoule).ii). General Liquid Injection Vial

(SVP).5. M/s Sanofi Aventis Pakistan

Limited, Korangi Industrial Area, Karachi.

Formulation The CLB approved grant of following two (02) additional sections to the firm.i). Secnidal Dry Suspension

Area.ii). Gel & Cream Area. The case of Psychotropic/Narcotic (Tablet & Capsule) area was deferred till finalization of decision on policy of Psychotropic/Narcotic drugs.

6. M/s Saaaf Pharmaceutical Industries, Risalpur.

Formulation The CLB approved grant of following one (01) additional section to the firm.i). Liquid (General) Section

7. M/s WelWink Pharmaceutical, G.T Road Gujarawala.

Formulation During proceeding / discussion, the Secretary, Central Licensing Board, after perusing the firm’s file, apprised the Board that the case had inadvertently been included in the agenda and as per available record, approval of two additional sections under reference/as mentioned in agenda i.e. Liquid Injection (General) and Powder Sachet (General) had already been communicated to the Firm vide letter No. F. 1-33/2006-

of 78

Lic, dated 18-02-2013 (Page93/ Corr.) by the then Secretary, Central Licensing Board. The Board after considering the facts unanimously decided to drop the agenda item / case accordingly.

8. M/s Hamaz Pharmaceutical (Pvt.) Ltd, Multan.

Formulation The CLB approved grant of following two (02) additional sections to the firm.i). Liquid Section (Antibiotics)ii). Sachet Section (Non Antibiotics)

9. M/s Zakfas Pharmaceutical (Pvt.) Ltd, Multan.

Formulation The CLB approved grant of following three (03) additional sections to the firm.i). Bolus & Granules Section.ii). Ointment Section.iii). Spray Section.

10. M/s Jaens Pharmaceutical Industries, Lahore.

Formulation The CLB approved grant of following one (01) additional section to the firm.1). Eye/Ear Drops (Steroidal)

11. M/s Elite Pharma, Lahore. Formulation The CLB approved grant of following one (01) additional section to the firm.i). Liquid Injectable Infusion (100 ml vial)

12. M/s S.N.B. Pharmaceuticals (Pvt.) Ltd, Industrial Estate, Hayatabad, Peshawar.

Formulation The CLB approved grant of following two (02) additional sections to the firm.i). Liquid syrup Generalii).Cephalosporin (Capsule & Dry Powder Suspension)

13. M/s Vega Pharmaceuticals (Pvt.) Ltd, Lahore.

Formulation The CLB approved grant of following three (03) additional sections to the firm.i) Dry Powder for Injectable

(Cephalosporin).ii) Dry Powder for oral

suspension (Cephalosporin).iii) Capsule (Cephalosporin).

14. M/s Farmigea Pakistan (Pvt.) Ltd, Lahore.

Formulation The CLB deferred the case of grant of two (02) additional Sections to the firm.The Board decided to get

of 78

clarification from QA/QC regarding stoppage of production since 2008 and non-compliance of cGMP of firm. A surprise re inspection of the facility by a panel of experts was desired by the Board to check over all GMP compliance Level of the Firm. The Board also decided that Provincial Governments may be asked to check availability of products of M/s Farmigea Pakistan, Lahore in the market / institution as production has been stopped since 2008.

15. M/s Wellmark Pharmaceuticals, Hattar.

Formulation The CLB approved grant of following three (03) additional sections to the firm.(i). Dry Suspension (General)(ii). Sachet (General)(iii). Dry Injection (General)

16. M/s A & K Pharmaceutical, Faisalabad.

Formulation The CLB approved grant of following one (01) additional section to the firm.(i). Liquid Injectable.

17. M/s Friends Pharma (Pvt.) Ltd. Lahore.

Formulation The CLB approved grant of following one (01) additional section to the firm.(i). Cephalosporin Dry Powder Injection.

Item-IV: CASES OF ADDITIONAL SECTIONS (NOT APPROVED)

Following case for grant of additional sections of already licensed manufacturers inspected but not recommended by the panel of experts were decided by the Board as follows.

S#

Name of Firm Type of License

Decision of CLB

1. M/s Pharmacare Laboratories (Pvt.) Ltd, Kot Lakhpat, Lahore.Grant of two additional sections i.e. Quinolone and Capsule Section General was not recommended by the Panel of Inspectors as per inspection report dated 01-03-2013.

Formulation The Board did not approve the grant of two additional sections to the firm as per recommendation of panel of inspectors in its report dated01-03-2013.

of 78

Item-V: CASES OF GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSES.

The Board approved / deferred the following cases of the grant of renewal of Drug Manufacturing Licenses of already Licensed Pharmaceutical Manufacturers in the light of recommendations of the respective panels of experts/inspectors subject to installation / confirmation of HVAC system and updated deposition of CRF as admissible under the rules.

S #

Name of the firm Type of License

Decision of CLB

1. M/s Valor Pharmaceuticals, Islamabad.

Formulation The CLB approved the Renewal of DML of Firm.

2. M/s Pharmacare Laboratories (Pvt.) Ltd, Kot Lakhpat, Lahore.


3. M/s Saffron Pharmaceuticals (Pvt.) Ltd, Sheikhupura Road, Faisalabad.


4. M/s MBL Pharma, Hub, Balochistan


5. M/s Delux Chemical Industries, Karachi.

Formulation The case of Renewal of DML of firm was deferred by the CLB.The Board decided to get the unit re-inspected by the same panel along with Chief Drug Inspector Sindh Mr. Salim Isharat Husain, Member CLB. The case shall be presented before the Board after receipt of report of re-inspection by the panel.

6. M/s Fedro Pharmaceuticals Labs, Peshawar.


7. M/s Akhai Pharmaceuticals (Pvt.) Ltd, Lasbela, Balochistan.

Formulation The CLB approved the Renewal of DML of Firm.However, the Board deferred approval of layout plan and additional section of Psychotropic/ Narcotics drugs of the firm pending before Licensing Directorate till finalization of policy on Psychotropic/ Narcotics Drugs and recommendations of Ministry of Narcotics Control. The Board also decided to send a reference to Director Controlled Drugs, till then the cases for

of 78

approval of layout plan and grant of additional sections for Psychotropic/ Narcotics Drugs are with held.

8. M/s Sanofi Aventis Pakistan Limited, Korangi Industrial Area, KarachiDML NO.(000368) (By way of basic manufacture)-

Basic Manufacture

The Board approved the renewal of DML by way of basic manufacture. However, as there was no rating given to the firm given in the inspection report so the Board directed that all members of this panel should be asked to send their recommendations in clear and candid way on evaluation form in future so as to ease the decision making for CLB.Regarding the issue of Psychotropic / Narcotic Drugs, the Board decided to send a reference to Director Controlled Drugs, till then the cases for approval of layout plan and grant of additional sections for Psychotropic/ Narcotics Drugs are with held.

9. M/s Saaaf Pharmaceutical Industries, Risalpur


10. M/s Z-Jans Pharmaceutical (Pvt.) Ltd, Peshawar.


11. M/s Trigon Pharmaceutical (Pvt.) Ltd, Lahore.


12. M/s Hamaz Pharmaceutical (Pvt.) Ltd, Multan.-


13. M/s Zakfas Pharmaceutical (Pvt.) Ltd, Multan

Formulation The CLB approved the Renewal of DML of Firm other than liquid injectable section.The Board also decided that the matter regarding Liquid Injectable Section should be referred to Q.C section for collecting the reasons of stoppage of production in the aforesaid section on decision / order by the Registration Board communicated vide letter No. F.3-75/2010-Q.C dated 29-08-2012 and same shall be presented before the CLB.

of 78

14. M/s Jaens Pharmaceutical Industries, Lahore.


15. M/s Saydon Pharmaceutical Industry, Peshawar.


16. M/s BSN Medical (Pvt.) Ltd, Karachi.

Formulation The case of Renewal of DML of firm was deferred by the CLB.The Board decided to get the unit re-inspected by a new panel. The case shall be presented before the Board after the report of re-inspection by the panel as desired by Board is received.

17. M/s CSH Pharmaceuticals (Pvt.) Ltd, Peshawar.


18. M/s Mediceena Pharma (Pvt.) Ltd, Lahore.-


19. M/s Faisal Pharmaceutical (Pvt.) Ltd, Faisalabad.-

Formulation The Board by majority approved the renewal of DML of the Firm.The Board further decided to get an affidavit / undertaking from the management of the firm that they will either purchase land / plot very much adjacent to the existing site (if possible) so as to amalgamate with existing premises to fulfill requirement of Plot size of 2000 square yards as required under Schedule B of Drugs (L,R& A) Rules 1976 framed under the Drugs Act, 1976, or they will shift their present facility at some other place in Industrial Area with required land of minimum 2000 Sq yards as per requirement of Schedule B of Drugs (L, R & A) Rules 1976. The process should be completed within next two years and detail of proposed project should be described in the undertaking by the Firm. However Mr. Ayaz Ali Khan, Chief Drugs Controller, Health Department, Govt. of Punjab (Member CLB) did not support renewal of DML on existing premises of 1000 Sq. yards which was granted on said premises in the year 1994 prior to

of 78

promulgation of the SRO 470 (I)/98 dated 15-05-1998 vide which requirement of area of 2000 Sq. yards was declared medatory.

20. M/s Medimarker Pharmaceuticals (Pvt.) Ltd, SITE, Hyderabad.


21. M/s Alpha Chemicals (Pvt.) Multan Road, Jamber (District Kasur).

Basic Manufacture

The CLB approved the Renewal of DML of Firm.

22. M/s Raazee Therapeutics (Pvt.) Ltd, Kasur.


23. M/s SchazooZaka (Pvt.) Ltd. Lahore.


24. M/s Focus & Rulz Pharmaceuticals (Pvt.) Ltd. Islamabad.


Item-VI: CASES OF RENEWAL/GRANTOF DRUG MANUFACTURING LICENSES (NOT RECOMMENDED).

Following cases were not recommended by the respective panels of experts for grant of Drug Manufacturing Licenses/Renewal of Drug Manufacturing Licenses. The Board took the decisions as under.

S#

Name of Firm Type of License applied

Decision of CLB

1. M/s Umer Usman Surgical Cotton Industries, Jhang DML (No.000361) Formulation.

Remarks:-Renewal of DML of the firm was not recommended by panel being unsatisfactory at the time of inspection on 01-03-2013.

Formulation In the light of the show cause notice served to the firm due to violations of conditions of DML reported by the panel vide its report dated 01-03-2013, the firm availed the opportunity of personal hearing. Adnan Latif , Chief Operating Officer appeared before CLB along with his counsel Muhammed Shahzad Siddiq. The Board heard the persons in detail and asked some questions / raised queries related to the observations of the panel and contraventions of provisions of law as reported by the panel on above said date.

After hearing the above named persons of the firm and thorough deliberations among the members,

of 78

and taking into consideration the legal provisions, the CLB unanimously decided as follows:

i). The Board did not approve the renewal of drug manufacturing license of the firm as the unit was declared unsatisfactory and not recommended by the panel of inspectors / experts vide it’s report dated 01.03.2013.

ii). The Board further decided that the production of the firm should be stopped immediately, as the firm’s production In-charge and Quality Control In-charge have not been approved by the DRAP.

iii). The Board also decided that the firm should recall all its stocks from the market / institution and distributors manufactured without the supervision of approved technical persons.

iv). The Board authorized the Chairman CLB to constitute a panel for a surprise visit / inspection of the facility. This will confirm / verify the firm’s statement given before the Board that they have rectified 90% of the shortcomings as pointed out by the panel on 01-03-2013 and have upgraded their unit. The panel will also submit in its report the record of all recalled batches/products. The panel inspection report shall be presented before the Board in its meeting as and when the same is received.

v). In the light of presentation made by the firm before the Board stating that their unit / facility was never inspected by

of 78

the area FIDs / panel of experts for GMP and renewal purpose in last nineteen years, the Board took serious note of casual behavior of FIDs / field Officers who are not performing their duties under the provision laid down under The Drug (Federal Inspectors, Federal Drugs Laboratory & Federal Government Analyst) Rules 1976 promulgated vide S.R.O 783(I)/76 in which Rule 4 defines the duties to be performed by Federal Inspectors.The Board further recommended that strict action be taken against the FID / field officers not fulfilling the duties as per requirement of rules.

2. M/s Nortech Pharmaceuticals, Islamabad.

Remarks:-Grant of DML to the firm was not recommended by panel being unsatisfactory at the time of inspection on 29-03-2013.

Formulation i). The Board did not approve the grant of new Drug Manufacturing License to the firm as the facility was declared unsatisfactory and was not recommended by the panel of inspectors / experts in its inspection report dated 29-03-2013.

ii). As per decision of the CLB, the application of the firm for grant of DML stands rejected under Rule 10 (4) of Drugs (Licensing, Registering, Advertising) Rules, 1976 due to the following major critical observation of the panel reported in inspection report dated 29-03-2013.

a) Firm has changed layout plan in Tablet Section with shuffling of areas. Creation of packing material store in place of Psychotropic Injectable Section (which was cancelled), change of stairs place for lift.

b) Numbers of changes have

of 78

been made in injectable area and microbiological lab which needs approval from licensing section under the Drugs (Licensing, Registering and Advertising) Rules, 1976.

c) Some equipment of Q.C like HPLC, UV Spectrophotometer and Production Machinery were not operational. IQ/OQ needs to be performed.

d) HVAC system in injection Section needs to be validated with reference to class A, B, C & D for sterile operations as per GMP requirements.

iii). Due to the above said shortcomings the unit was declared as unsatisfactory in the above referred report by the panel of inspectors / experts, hence grant of DML was not approved by the CLB.

3. M/s Pharmedic Laboratories (Pvt.) Ltd, 17-KM, Multan Road, Lahore.

Remarks:-Grant of DML to the firm was not recommended by panel being unsatisfactory at the time of inspection on 05-03-2013.

Formulation i). The Board did not approve the grant of new Drug Manufacturing License to the firm as the facility was reported to be unsatisfactory and not recommended by the panel of inspectors / experts in its report dated 05-03-2013.

ii). As per decision of the CLB, the application of the firm for grant of DML stands rejected under Rule 10 (4) of Drugs (Licensing, Registering, Advertising) Rules, 1976 due to the following major/critical observations of the panel mentioned in inspection report dated 05-03-2013.

a). Change rooms were not completed, civil work and electricity work was going onb). HVAC system has been installed but not yet functional at

of 78

the time of inspection. c.). Q.C Lab was under construction at the time of inspection, equipment and instruments were not available.d). It was observed that water treatment/purification system is still under the process of installation and not ready for use.e). No staff for QA Department.f). Area was not neat and clean.g). No QA / QC In charges were hired.h). Machinery was not installed and ready for use at the time of inspection.i).SOPs were not developed for Production & QC.

Due to the aforementioned shortcomings the unit was declared as unsatisfactory in the referred to report by the panel of inspectors / experts, hence grant of DML was not approved by the CLB.

Item-VII: CASE OF M/S GELCAPS (PAKISTAN) LIMITED (DML.NO. 000282 SEMI BASIC MANUFACTURE) HUB, BALOCHISTANFOR SUSPENSION OF DML.

Decision of CLB

The Board decided to get the unit re-inspected for cGMP compliance as well as for renewal of their DML. The Board also decided to direct the firm not to open the factory till the firm is inspected and panel recommends with clear and candid recommendations in the report as well as on the evaluation form & case is accordingly decided by the CLB. The Board further decided to suspend the production of the firm till the decision of the case by the Board. The case shall be placed before Central Licensing Board, along with the inspection report of the panel constituted for the purpose of verification of redressal of shortfalls / deficiencies reported previously in panel inspection report dated 28-02-2011and under taking by the firm to address these shortcomings for consideration & decision by the Board.

of 78

Item-VIII: MISCELLANEOUS CASES.

(a) RENEWAL OF DRUG MANUFACTURING LICENSE OF M/s NOVARTIS PHARMA PAKISTAN LTD, KARACHI DML NO. 000193 (FORMULATION)

Mr. Khalid Yousuf excused himself from discussion / decision with regards to this case as he disclosed that he is a Pharmaceutical Consultant for Novartis and wants to remain impartial in deciding the matter.

Decision of CLB

In the light of detailed background of the case mentioned in agenda, thorough discussion & deliberation among the members, the Board decided to get the firm re-inspected by panel of experts / inspectors for verification of conditions of Drug Manufacturing License No. 000193 (Formulation). The Board also decided that the firm may be directed to submit formal application for grant of additional section for Capsule (General) and application for renewal of their DML (Formulation) on Form 1A along with all necessary enclosures as the pervious application was for renewal of DML (Re-packaging) which is not defined in Law and Rules. The Board also decided to give three months time to the firm for doing the needful as recommended by panel of experts in its report dated 20-06-2013. It was also decided that no further time will be given to the firm on the issue / matter. The case was deferred due to aforementioned reasons and will be placed before the Board as and when a fresh report by panel is received as mentioned above.

(b) APPLICATION OF M/s ABBOTT LABORATORIES PAKISTAN LTD, KARACHI FOR CANCELLATION OF THEIR DMLNO. 000005 (BASIC MANUFACTURE).

Decision of CLB.

After hearing the firm’s representative Mr. Anis Shah, Director Plant Operation, considering written request mentioned in agenda and thorough discussion and deliberation among the members of the Board on the issue, the Central Licensing Board did not accede to the request of the firm for cancellation of their DML No. 000005 (Basic Manufacture). The board directed to get the clarification from the firm on following issues.

Documentary evidence supported by relevant documents / information mentioning that why this license has not been feasible to operate.

The drugs registration directorate shall be asked for clarification regarding approval of change of source of their Aluminum Hydroxide Gel for use in their registered products (i.e. Antacids like Dijex MP and Dijex).

The firm shall be asked to clarify that how the import of Aluminum Hydroxide Gels had been feasible in spite of enhanced duty structure where said API is approved for local production under the rules?

The firm shall also be asked how their Formulation Products are being manufactured if they have changed their source after closure of their facility?

of 78

Since, the representative of firm stated that they had been enhancing the capacity of this plant from 500 kg to 1000 kg in the past and now how this plant is suddenly unfeasible to run at once?

The Drug policy has given different incentives to basic / semi basic manufacture so the firm’s request for cancellation of DML No. 000005 (basic manufacture) is absolutely illogical / irrational that tantamount to deprive this country from an API, being manufactured indigenously.

It was also decided that the case shall be presented before CLB in its next meeting after getting the response / clarification from the concerned on the above stated queries.

(c) M/S BRAND PHARMA INTERNATIONAL, KARACHI. DML NO. 000684 (FORMULATION) - CASE OF NON-COMPLIANCE OF CONDITIONS OF DML/cGMP).

DECISION OF CLB.

The case was discussed in detail wherein Dr. Ali Akbar Sial, Mr. Salim Isharat Husain, Syed Jawed Yousaf Bukhari and Mr. Khalid Yousuf (All Members of CLB from Karachi / Sindh) were of the opinion that closure of the unit due to Law & Order situation in Phase II S.I.T.E Super Highway Karachi is a lame excuse by the management as mentioned in their reply received in DC (QA) office on 24-08-2012. These members of CLB argued that about 20 Pharma units are operational in the same industrial area of Karachi where M/s Brand Pharma International is located. In the light of facts narrated by honorable members of the Board as stated above and deliberations made in the meeting, the Board concluded and decided as under:-

i). The Board unanimously decided to suspend the DML No. 000684(Formulation) of the firm for a period of six months, as the firm had contravened the conditions of DML No. 000684 (Formulation) and due to non-compliance of cGMP under Schedule B of Drugs (L, R & A) Rules 1976 and failed to appear before the Board in spite of five show cause notices / opportunities of personal hearing given to the firm.

ii). The Board further decided to get explanation from the panel for not submitting inspection report in the matter as directed by the Board vide DRAP letter dated 20-05-2013. It was further decided to get the facility inspected by some other panel for facts finding and present the report in the next meeting of the Board.

(d) CASE OF RENEWAL OF DML (NO. 000497) FORMULATION M/s MACQUINS INTERNATIONAL, KARACHI .

DECISION OF CLB.

The Board observed that as the provision in the Rule 5[2A] of Drugs (L, R & A) Rules 1976 is present to deal the matters regarding submitting application for renewal of DML and rectifying the shortcomings / deficiencies therein, if any, as in the instant case their application made by M/s Macquins International Karachi for renewal of their DML was observed grossly deficient of requirements laid down in the said rules. Rule 5[2A] of Drugs (L, R & A) Rules 1976 is reproduced as under:

of 78

“On receipt of an application for renewal of a license any objection or shortcoming in the application observed by the CLB may be notified to the applicant and he shall be given a time period of thirty days for rectification or completion of the application. In case he fails to rectify or complete the application within the specified period, the application may be rejected.”

The Board also observed that in spite of two letters issued to the firm by Drug Regulatory Authority of Pakistan on 01-03-2013 and 17-04-2013, the firm failed to rectify the shortcomings and complete their application as provided under Rule 5[2A] of Drugs (L, R & A) Rules 1976. In light of afore said legal provision and facts narrated, the CLB decided as under:

“The Board took serious notice of the casual attitude of the management of the firm in submitting/completing the application for renewal of DML despite notifying them twice and decided to reject the application for renewal of DML of the firm.”

(e) REQUEST FOR CHANGE OF MANAGEMENT OF M/S WELLBORNE PHARMACHEM LABS, HATTAR-DML NO. 000657 (FORMULATION) AND DML No.000653 (SEMI BASIC MANUFACTURE) AND STANCE FOR RETAINING OF NAME OF FIRM AS M/s WELLBORNE PHARMACHEM AND BIOLOGICALS, HATTAR ISSUED ON DML.

Decision of CLB.

The Board acceded to the request of the firm M/s Wellborne Pharmachem and Biologicals, Hattar DML No. 000657 (formulation) and DML No.000653 (semi basic manufacture) for change of its management based on provision of relevant documents for this purpose and retaining of name of firm as M/s Wellborne Pharmachem and Biologicals, Hattar as per it’s DMLs, and also for correction of record of licensing section as described in agenda item. Further the new management had already been the partner (s) / share holder (s) of said firm previously. The Board further decided that if any legal anomaly arises at later stage between partners, the sole responsibility would lie on the deponents. The CLB and the DRAP would not be held responsible in any case.

(f) M/S SYNTEX PHARMACEUTICALS, KAMRA ROAD, ATTOCK CITY, DML NO. 000290 (FORMULATION) .

BACKGROUND

The Central Licensing Board was apprised that the Federal Inspector of Drugs along with Mr. Ahmad Mahmood Mumtaz, DDG (E&M) Islamabad visited M/s Syntex Pharmaceuticals, Kamra Road, Attock City, DML (No. 000290) Formulation on 30-05-2013 to check and verify the compliance of firm towards GMP and reported that the firm was found closed for the time being and that the Management had informed further that they intend to open the factory premises within a month. Thereby the firm had violated the condition of Drug Manufacturing License under Drugs (Licensing, Registering & Advertising) Rules, 1976.

of 78

DECISION OF CLB.

The Board after thorough discussion / deliberation and taking into consideration the legal provisions as laid down under Section 41 of the Drugs Act, 1976 and the rules framed there under decided as follows: -

1. To issue a show cause notice to the firm as why the firm had been closed without prior permission from or information to the Competent Authority and provide the firm an opportunity of personal hearing in the upcoming meeting of the Board.

2. To get the unit inspected by a larger panel of experts to verify compliance of the firm towards the conditions of DML and cGMP as required under the Drugs (Licensing, Registering & Advertising) Rules, 1976 as reportedly by the FID, the facility had been closed by the management at their own. The inspection report by panel shall be placed before the Board in its next meeting for consideration / decision.

3. The Board also desired to direct the FIDs / Field Officers to inspect such premises in their respective area of jurisdiction for which he/she may take assistance of the law enforcing agencies and that no stone should be left unturned to inspect such units promptly even by follow up visits.

(g) M/S EVEREST PHARMACEUTICALS, ISLAMABAD, DML NO. 000535(FORMULATION) .

BACKGROUND OF THE CASE

The Central Licensing Board was apprised that the Federal Inspector of Drugs, Islamabad-I had informed that he visited M/s Everest Pharmaceuticals (Pvt) Ltd, Plot No.124, Industrial Triangle Kahuta Road, Islamabad on 18-06-2013 for the purpose of GMP inspection. The firm was found closed and that the security supervisor present at the gate informed him that the owner of the property has got the possession of the building through learned Court Order. Thereby the firm had violated the condition of DML.

Decision of CLB

The Board after thorough discussion / deliberation and taking into consideration the legal provisions as laid down under Section 41 of the Drugs Act, 1976 and the rules framed there under decided as follows: -

a. To issue a show cause notice to the firm as why the firm had been closed without prior permission from or information to the Competent Authority and provide the firm an opportunity of personal hearing in the upcoming meeting of the Board.

b. To get the unit inspected by a larger panel of experts to verify compliance of the firm towards the conditions of DML and cGMP as required under the Drugs (L, R & A) Rules, 1976 as reportedly by the FID, the possession of the building / Licensed Premises has been taken up by Owner of Property through some Court Order. The inspection report by panel shall be placed before the Board in its next meeting for consideration / decision.

c. The Board also desired to direct the FIDs / Field Officers to inspect such premises in their respective area of jurisdiction for which he/she may take assistance of the law enforcing agencies and that no stone should be left unturned to inspect such units promptly even by follow up visits.

of 78

Item-IX:- POLICY REGARDING ESTABLISHMENT OF PHARMACEUTICAL UNITS LOCATED IN RESIDENTIAL AREAS.

The Central Licensing Board in its 228th meeting had decided to issue show cause notices to the firms located in the residential area with the directions to shift their units to the industrial areas. Accordingly as per directions of the Board show cause notices were served to the M/s Bliss Industries Ltd, Karachi, M/s Cresent Cotton, Okara, M/s Soma Laboratories, Lahore and M/s Shamsi Pharmacy, Lahore and opportunities of personal hearing had also been given to the firms. The firms’ replies to the show cause notices were discussed in the previous meetings of the Board. The cases were again discussed in 232ndmeeting held on 29th& 30th July 2013 of CLB too in view of decisions taken in 231st

meeting of CLB held on 31-01-2013. The cases of the individual firms in detail and the decision of the Board taken thereof in 232nd meeting are as under: -

S.# Name of Company / Case background Decision of CLB1. M/s Bliss Industries Ltd, 225/2, J.M. Sadhu Naval

Rai Road, Karachi.In response to show cause notice bearing No. F. 2-15/95-Lic (Vol-I) dated July 2012. M/s Bliss Pharmaceuticals had informed that they had started construction of their facility at new site in Korangi as per approved layout plan. But because of law and order situation in Korangi Karachi they could not completed their construction timely.

In compliance to the decision of CLB taken in its 231st meeting a panel comprising Syed Jawed Yousaf Bukhari, Member CLB, Area FID and Area ADC was constituted to conduct the inspection of the firm. Due to delay, a reminder was also issued for timely conduction of inspection of the firm to verify progress made by the firm at the new site so far. In compliance to the decision of CLB taken in its 231st meeting show cause notice/letter for personal hearing dated 25thJuly 2013, was issued and the firm’s representative was called before the Board. None of the accused/ representative of the firm appeared before the Board for personal hearing.

The Board in its 232nd

meeting discussed the case in the light of decision taken in 231st

meeting of the Board in detail. Syed Jawed Yousaf Bukhari member CLB furnished a panel report which was asked to inspect the new site of the firm in Korangi Industrial area.

The Board was apprised by him that Panel tried to contact Mr. Ashraf, representative / spokesman of the firm so that the new site may be inspected to check the progress but the management was not serious and that he did not coordinate and respond for the needful. It was also disclosed by the worthy member that the panel also tried to trace out the location of the new site in Korangi

of 78

Industrial area, but failed to find out the same.

The Board in the light of above said report of the panel and decision taken in 231st meeting of the CLB decided that(i) To defer the case of firm located in the congested residential area of Karachi.(ii) One more but the last opportunity of personal hearing be given to the owner / management of the firm.(iii) Failing to appear before the CLB, the license of the firm shall be suspended/ cancelled and case shall be forwarded to Registration Board for cancellation / suspension of products registered in the name of firm.

2. M/s Cresent Cotton, Chowk Depalpur, Okara.A show cause notice was issued to M/s

Cresent Cotton, Okara regarding their unit located in residential area. In response to Show Cause notice the firm has informed that it is located in commercial / industrial area instead of residential area and got NOC from TMA, Okara.

2. The Board in its 230th meeting decided to direct the area FID to inspect the premises again and take the necessary documents as the firm is claiming for verification. The Board also directed to advise the area FID to take and verify the NOC obtained from TMA, Okara and approval from concerned provincial Building Control Authorities (BCA).

3. Subsequently the Area FID reported that the facility is located on Main Adda Road. In front of the factory there is a shop of Fazal Broast, TV

The Board after thorough discussion / deliberation, considering the report of the FID and keeping in view the legal provisions decided as under: -i). The case should be processed and actions shall be taken as per provisions of Schedule B of Drug (L, R & A) Rules 1976.

ii). Management of the firm be asked to shift to some Industrial area as there is no provision of

of 78

repairing shop, a clinic, on left there are furniture making shops, Qamar Cotton Industries is also on same road, and beside the industry one house has been built above the shops. The firm has also produced an attested copy (verified) of a letter of Tehseel Officer TMA Okara certifying that Cresent Cotton Industry situated at Chowk Depalpur Road is a commercial / industrial area.

4. The FID in her report concluded that the firm is located in commercial area.

5. Tehseel Officer (P&C), TMA Okara was also requested vide letter No. F. 1-7/84-Lic (Vol-I) dated 20-05-2013 for verification of a separate Industrial Area in Tehseel Okara but the reply is still awaited.

The Board was apprised about the provisions of Schedule “B” of Drugs (Licensing, Registering & Advertising) Rules, 1976.

The case was placed before the Board for its consideration/ decision, keeping in view various industrial incidents/disasters which coasted loss of precious human lives as in case of unfortunate incident of M/s Orient Labs, Lahore.

Law &Rules that allows Pharma unit in industrial/ commercial area, as per current status of the firm.

iii). Renewal of DML of the firm will be decided in the light of commitment of firm for shifting of their unit to some industrial area as per requirement of Law & Rules.

3. M/s Soma Laboratories 692-N, Samanabad, Lahore. A show cause notice was issued to M/s Soma Laboratories, Lahore regarding their unit located in residential area. In response to Show Cause Notice the firm stated that they are not contravening the section 41 of Drugs Act, 1976 because they got license in 1981 while the rules for condition of location of manufacturing was added in the year 1998. The firm was called for personal hearing in 230th meeting of CLB but they did not appear before the Central Licensing Board. The Board took serious notice regarding manufacturing of drugs in residential area and decided to defer the case till next meeting and one more opportunity for personal hearing was granted.Mr. Mian Ghulam Jelani appeared for personal hearing meeting of the Central Licensing Board in its 231st held on 30-01-2013 and committed that they will shift their unit within one year and has voluntarily stopped the production. The Board

The Board after thorough discussion / deliberations, taking into account commitment of the firm before the CLB in its previous meeting and keeping in view the legal provisions decided as under: -

(i). Suspension of DML of the firm with immediate effect for a period of six months so as to avoid any industrial incident / disaster which may cost loss of precious human lives as occurred in case of M/s Orient

of 78

decided to suspend the production for a period of three months and verification from Area FID was also advised.

The area FID has submitted report dated 03-06-2013 stating that the firm was closed and no production activities was observed.

The case was placed before the Board for its consideration/ decision, keeping in view various industrial incidents / disasters which coasted loss of precious human lives as in case of unfortunate incident of M/s Orient Labs, Lahore.

Labs Lahore as the firm is located in congested residential area of Samanabad Lahore. The area FID should ensure the closure of unit / stoppage of production and report in this regard be submitted to CLB on monthly basis without fail.

ii).The Drug Registration Board is informed about the suspension of DML of the firm for further necessary action.

iii). The management be directed to shift their unit in industrial area and to furnish the progress report regarding the shifting of unit as per their commitment made before the CLB in its 231st meeting held on 30-01-2013.

iv). Area FID be directed to inspect the new site and submit its progress report.

4. M/s Shamsi Pharmacy, Samanabad, Lahore.

A show cause notice was issued to M/s Shamsi Pharmacy, Lahore regarding their unit located in residential area. In response to show cause notice the firm has replied that they are not working in old unit since 2010. Area FID as reported that the firm has suspended its production and it is not operational. They also want to postpone the matter because of their father death and some family issues.

2 The firm was called for personal hearing in 230th meeting of CLB but they did not appear before the Central Licensing Board. The Board took serious

The Board after thorough discussion / deliberation, considering the report of the FID, taking into account commitment of the firm before the CLB in its previous meeting and keeping in view the legal provisions decided as under: -

of 78

notice regarding manufacturing of drugs in residential area and decided to defer the case till next meeting and one more opportunity for personal hearing was granted.

3. Mr. Faisal Maqbool the Son of deceased owner appeared before the Board in 231st meeting of CLB who committed that they are ready for inspection at new place. The Board in 231st meeting decided to get the inspection of the premises where firm intends to shift their unit and decided to suspend the production at the congested area of Samanabad. Lahore. The board further decided to get an inspection conducted by Area FID so as to verify the production activity at existing site.

4. The Area FID in response to DRAP letter dated 17-05-2013 has reported that she has inspected the facility to check the production status of the firm 20-06-2013 in the presence of Mr. Faisal Maqbool Son of deceased owner of the firm. It has been further reported that no production activity was going on at the time of inspection. However, finished goods were stored in large quantities in two rooms without any temperature control. Bundles of fresh units cottons of different products were also store bearing manufacturing date 2009 & 2010 etc. The FID also took samples of two products i.e. Mag. Sulphate B.P. Batch No. 43 Manufacturing date 06-2011 and Kaolin Light Batch No. 30 Mfg. date 06-2010 for test / analysis purpose. The FID has also stated that as per availability of sample of Mag. Sulphate bearing Manufacturing date 06-2011 and expiry date use within 04 years clearly show that the firm has manufacturing the products after 2010 which is contrary to the reply of firm about the closure of the unit since 2010. FID has also mentioned that the products of M/s Shamsi Pharmacy are also available in the Market bearing manufacturing dates 2009, 2010 and 2011 etc.

5. Now the firm has been called for personal hearing again in 232nd meeting of CLB. None of the representative of the firm appeared before the Board for the said personal hearing.

(i). Suspension of DML of the firm with immediate effect for a period of six months so as to avoid any Industrial incident / disaster which may cost loss of precious human lives as occurred in case of M/s Orient Labs Lahore as the firm is located in congested residential area of Samanabad Lahore.

ii). The Drug Registration Board be informed about the suspension of DML of the firm for further necessary action.iii). The management be directed to shift their unit in industrial area and to furnish the progress report regarding the shifting of unit as per their commitment made before the CLB in its 231st meeting held on 30-01-2013. iv). Area FID be asked about the action taken on availability of products manufactured in the period of closure of firm available in the market.

of 78

Item-X: CHANGE OF NAME OF FIRMS.

DECISION OF CLB.

The Board approved the cases for change of names of following firms on the basis of documents submitted by firms.

S.NO FROM TO

1. M/s Searle Pakistan Limited, Karachi DML No. (000016) Formulation.

M/s Searle Pakistan Limited, Lahore DML No. (000647) Formulation.

M/s The Searle Company Limited, Karachi DML No. (000016) Formulation.M/s The Searle Company Limited, Lahore DML No. (000647) Formulation.Both subject to provision of SECP documents.

2. M/s Chas. A. Mendoza, Karachi. DML No. (000140) Formulation

M/s LE Mendoza Pharmaceutical (Pvt.) Ltd, Karachi. DML No. (000140) FormulationSubject to provision of SECP documents

The Board also decided to get the facilities of M/s Searle Pakistan Limited, Karachi at Korangi site inspected by a panel as this site is reportedly used for manufacturing nutraceutical products as informed by Mr. Salim Isharat Chief Drug Inspector, Sindh (Member CLB). The Board further decided to get the inspection of two separate premises of M/s Searle Pakistan Limited in Karachi i.e. Korangi Industrial area and S.I.T.E Karachi by panel of experts to ascertain the status of licenses of these Sites and check production activities being carried out at these two sites.

The Board was also apprised by Mr. Salim Isharat Husain, Chief Drug Inspector, Sindh (Member CLB) that M/s Searle Pakistan Limited is already using its new proposed name i.e. “The Searle Company Limited” w.e.f. 04-09-2012 as observed on the packaging components of the products of the firm manufactured by M/s Novamed Pharma Lahore on contract basis for which explanation / clarification needs to be obtained from both these firms for using the new name without approval from CLB.

Mr. Ayaz Ali Khan, Chief Drugs Controller, Health Department, Govt. of Punjab (Member CLB) also reported that M/s Searle Pakistan Limited, Lahore is using two separate buildings for their Lahore plant. The Board decided to get a verification report by a panel regarding the status of license of the firm for these two premises and check production activities being carried out at these two sites.

of 78

The reports regarding the above said clarification/ queries/ issues will be presented before the CLB after receipt of the same.

Item-XI DELEGATION OF POWERS TO THE MEMBERS OF THE BOARD.

DECISION OF CLB.

The Central Licensing Board in its 232nd meeting approved delegation of following powers to its Chairman and Secretary for a period of one year with immediate effect under Rule 8 (10) of the Drugs (Licensing, Registering & Advertising) Rules, 1976 in order to facilitate timely disposal of routine / day to day business of Central Licensing Board.

Sr # Powers Powder to be Delegated toi). Show Cause Notice regarding contravention

of any of the provisions of the Drugs Act, 1976 and rules framed there under.

Chairman CLB

ii). Suspensions of Production Chairman CLBiii). Lodging of FIR Chairman CLBiv). Issuance of Inspection Book Secretary CLB

v). Approval of layout plan Chairman CLB through a committee comprising of DDG(L&A), DDC(L&A), DDC(Lic) and ADC (Lic)

vi). Approval of Technical Staff and communication/issuance of Decisions of Central Licensing Board.

Secretary CLB

vii). Site approval. Secretary CLBviii). i) Approval of change of name of an

unlicensed firm / unit (before the approval of site).

Secretary CLB

ix). ii) Approval of change of name of a firm for licensed units/unlicensed units (after the site approval).

iii) Approval of drugs (molecules) for basic and semi basic manufacturing.

iv) Implementation of decisions of Appellate Board

v) Approval of Repacking items under Schedule D of drugs Act 1976 and Rules framed there under.

Chairman Central Licensing Board.

x). Constitution / amendments in constitution of panel for inspection for grant/renewal of Drug Manufacturing License, grant of Additional Section and verification/ checking of conditions of License etc of firms.


xi). Extension in Sealing period of Licensed Chairman Central Licensing of 78

manufacturers where Contravention(s) is/are of Conditions of DMLs only.

Board.

xii). Correction of typographical error in recording minutes of the meeting of the CLB.


The Central Licensing Board unanimously observed that under the rules, the matters relating to verification / compliance of GMP requirements by the Licensed Manufacturing Facility are dealt by the Central Licensing Board so, in order to have uniform standards in this effect for evaluation of manufacturers both inside the country and abroad, the matter relating to the foreign facilities inspections should also be dealt by the same Board as such inspections are undertaken for verification of compliance towards the GMP requirements by the Manufacturers abroad . The Central Licensing Board directed to refer its aforementioned observation to the DRAP for its consideration / implementation.

Item-XII: GRANT OF CASES / LAYOUT PLANS OF ADDITIONAL SECTIONS FOR PSYCHOTROPIC / NARCOTIC DRUGS PENDING / DEFERRED.

The Central Licensing Board in its 227th meeting deferred the approvals of Psychotropic / Narcotic sections of all the firms placed on the agenda till recommendation of the inter-ministerial committee specifically constituted for Psychotropic/Narcotic Drugs. The concerned section of Narcotic / Psychotropic / Controlled Drugs of DRAP has informed that the subject case was placed before the 11 th meeting of the committee on allocation of the controlled drugs under Ministry of National Narcotics Control held on 6th May 2013 and forwarded the extract of the minutes of the meeting which is being reproduced as under: -

“The Committee decided that CLB may consider the Licensing and approval of additional sections for manufacture of controlled drugs/substances in the light of relevant Act and rules. The Committee on Allocation of Controlled Drugs will consider matter for allocation of Controlled Drugs in the light of relevant laws and rules after registration”.

DECISION OF CLB.

The Board after taking into consideration all pros and cons of the matter and taking in account decision of meeting of Inter-Ministerial Committee on allocation of the controlled drugs, decided to withheld / defer the cases for approval of layout plans and grant of additional sections for Psychotropic / Narcotics Drugs due to the following reasons: -

The Board decided to send a reference regarding the above mentioned decision to Director Controlled Drugs, DRAP with the recommendations of CLB to take up the matter with Ministry of National Narcotics Control on following issues as the

of 78

Central Licensing Board is of opinion that clarification is required to be solicited to proceed further in to the matter.

There is no provision under the Drugs Act, 1976 and rules framed there under to process the cases for approval of Building Layout plans & sections / additional sections for production of Psychotropic / Narcotic drugs.

The above mentioned decision of the Inter Ministerial Committee and previous decisions of CLB & DRB need to be revisited as most of the CLB members attending the meeting were of view that as per international practice there is no need of segregated / dedicated facility for manufacturing of Psychotropic / Narcotic products.

The members of CLB namely Mr. Salim Isharat Husain, Mr. Khalid Yousuf, Syed Jawed Yousaf Bukhari, Dr. Ali Akbar Sial and Mr. Nadeem Iqbal were of view to grant approval of Psychotropic/Narcotic drugs in general sections since

i. No Separate Area is required for manufacturing of Solids or Liquids Psychotropic / Narcotics Dugs in other countries including WHO, FDA USA, FDA India etc., hence why should we put extra burden on our manufacturers for dedicated areas with dedicated HVACs.

ii. Cross Contamination in the world is handled by Robust Systems and Validation / Cleaning Validation etc. for Psychotropic / Narcotic substances. Even the API’s of Psychotropic / Narcotics are manufactured in General Sections in the world.

iii. Only Beta Lactams. Cephalosporin, Anabolic Steroids, etc. requires dedicated facilities.

However members of CLB, Mr. Ayaz Ali Khan, Chief Drugs Controller, Health Department, Govt. of Punjab, Prof. Gul Majeed Khan, and Mr. Ahmad Din Ansari, Secretary CLB were of view that there must be some more deliberations on the subject issue and policy of dedication / segregation of Psychotropic / Narcotic drugs may not be discontinued with one pen stroke. Furthermore CL&RB in its 184th meeting held on 23-08-2004 “decided to allow the firms upto 31st December 2005 to establish segregated facilities for Psychotropic / Narcotic Drugs. However, during this period they may manufacture both categories of drugs in their previous facilities but after this period complete shift over to segregated facilities shall be mandatory otherwise they have to surrender their registrations for these drugs”.

It is further decided that every member of CLB will send his recommendations supported by documentary evidence for revisiting policy decision sent by the Directorate of Controlled Drugs in collaboration with Ministry of National Narcotics Control accordingly.

The representatives from PPMA and Pharma Bureau also agreed to issue approvals of the deferred cases / sections of Psychotropic/ Narcotic Drugs after receiving the fresh reference from Directorate of Controlled Drugs as stated above.

Item-XIII. ACQUISITION OF LICENSED PREMISES OF M/s BREEZE PHARMA (Pvt.) LTD, DML No. 000659 (FORMULATION) BY M/s ICI PAKISTAN LIMITED ON LEASE HOLD RIGHTS.

of 78

DECISION OF CLB

The Board decided to defer the case and desired personal hearing from the owners / directors of M/s ICI Pakistan Ltd and M/s Breeze Pharma (Pvt.) Ltd to update the CLB on their request regarding acquisition of licensed premises on lease agreement rights as there is no provision in Law & Rules to acquire licensed Pharma unit on lease hold rights.

Item-XIV. ACQUISITION OF LICENSED PREMISES OF M/s MAC & RAINS (PVT.) LTD, LAHORE DML No. 000586 (FORMULATION) BY M/s SEARLE LABORATORIES(PVT.) LIMITED ON LEASE HOLD RIGHTS

DECISION OF CLB

The Board decided to defer the case and desired personal hearing from the owners / directors of M/s Mac & Rains (Pvt.) Ltd, Lahore and M/s Searle Laboratories (Pvt.) Ltd to update the CLB on their request regarding acquisition of licensed premises on lease agreement rights as there is no provision in Law & Rules to acquire Licensed Pharma unit on lease hold rights.

Item-XV. REQUIREMENT OF PLOT SIZE UNDER SCHEDULE “B” OF THE DRUGS LICENSING, REGISTERING AND ADVERTISING RULES, 1976

DECISION OF CLB

The Board decided to reject the application of M/s Mediflow Pharmaceutical Pvt. Ltd., Karachi for verification of Site for establishment of Pharmaceutical Unit on the basis that area of the plot acquired (1955 square yards) was not meeting the requirement as laid down under section 1 of Para 1.3 of Schedule B of the Drugs (L, R & A) Rules 1976 framed under the Drugs Act, 1976. The Board desired that the provisions of rules shall be strictly adhered to and no relaxation could be granted on the request of the firm.

Item-XVI NOTICE FROM DRUG COURT MULTAN FOR SUSPENSION OF DRUG MANUFACTURING LICENSE OF M/S LAWRANCE PHARMA, LAHORE

BACKGROUND OF THE CASE

A notice was issued by Chairman, Drug Court Multan in Case bearing No.259/2011 under Section 23/27 of the Drugs Act, 1976 of M/s Lawrence Pharma (Pvt) Ltd, 10-KM, Sheikhupura Road, Lahore was received to the Drug Licensing Authority, Islamabad in the aforementioned case in which following directions have been passed by the court.

of 78

“The Drug Licensing Authority, Islamabad in the above said case is directed to suspend the Drug Manufacturing License of M/s Lawrence Pharma, Lahore and its report be submitted to Court by 12.7.2013”.

No supplementary / supportive documents or orders of conviction or decision of The Drug Court Multan, on contravention of any of the provisions of The Drugs Act 1976 and Rules made there under have been provided / attached with the above said Notice.

As provided under Section 41 of the Drugs Act, 1976 and Rule 8(4) and Rule 12 of the Drugs (Licensing, Registering and Advertising) Rules 1976, the cancellation and suspension of Drug Manufacturing License comes under the domain of Central Licensing Board, Drug Regulatory Authority of Pakistan. The Board may cancel or suspend the Drug Manufacturing License on the contravention of such provisions of the Drugs Act, 1976 and Rules framed there under which are likely to endanger the public health and availability of sufficient evidence if a firm is involved in the manufacturing / sale of spurious drugs. Moreover, serving of a Show Cause Notice and giving of an opportunity of personal hearing to the firm / person prior to cancellation or suspension of Drug Manufacturing License is also mandatory under the aforesaid provisions of law / rules.

As no documentary evidence(s) has been provided regarding the contraventions of provisions of The Drugs Act, 1976 and Rules framed there under as required for the above said desired action under the relevant law / rules, so the matter was placed before the Central Licensing Board for consideration, to seek its wisdom and decision.

DECISION OF CLB

The Board unanimously decided that the matter may be referred back to Drug Court Multan for Provision of Supporting documents regarding the case so as to proceed further accordingly. The Boar authorized the Chairman CLB to decide the case as per relevant provisions of law/ rules in the light of the documents / information provided by the relevant Court.

Item-XVI. The Standard Operating Procedures (SOPs) for Licensing Section along with the requirements of documents as per Law/Rules and Practice in Vogue.

DECISION OF CLB.

The Standard Operating Procedures (SOPs) for Licensing Section along with the requirements of documents as per Law/Rules and practice in vogue were placed before the Central Licensing Board for its consideration and vetting. All the Board members appreciated the effort vetted and approved the said SOPs and the requirements of documents/pre-requisites for different purposes/ activities being performed by the Licensing Section of DRAP. The Board also desired that these SOPs etc so approved by the Board shall be posted on official website of DRAP and be implemented for efficient and transparent working of the Licensing Directorate.

of 78

A. SOP OF WORKING IN THE LICENSING DIVISION

Sr. # Activity and Standard Operating Procedure

Time period required for

Activity1. Site Verification:

Application for verification of a site for its suitability to establish a Pharmaceutical Manufacturing Unit submitted by the firm or a person is scrutinized by Licensing Division for the fulfillment of following pre-requisites as required under rules/practice in vogue:

i. Proper application made on covering letter / letter head.

ii. Copy of Challan of Rs.5,000/- as fee for site verification duly attested / endorsed by the Statistical Officer, DRAP and original challan retained by Statistical Officer, DRAP.

iii. Disclosure of status of firm: proprietorship, partnership, public limited or private limited etc.

iv. In case of partnership, copy of Partnership deed duly executed in the court of competent jurisdiction/registrar of the firms.

v. Copy (ies) of CNIC of Chief Executive Officer / Managing Director /Directors/ Partners of the firm.

vi. Copy of Certificate of Registration with Registrar of Firms in case of a registered firm.

vii. In case if firm is Private Limited, the Certificate of Incorporation with SECP, Memorandum of Article of Association, Form-A and Form-29 should also be furnished.

viii. Complete documents of proposed land / plot (purchase document of land/plot, allotment letter, transfer letter/ possession letter, Fard, copy of site map or Aks Shajrah etc.) whatever is applicable.

In case of shortcomings in the above said required

documents the applicant is informed in writing for doing the needful.

On completion of the application, the field officer (DDG/FID/ADC) is asked for site verification with a copy of the letter to the Director of the firm for coordination with the concerned officers of the DRAP.

15 days

02. Inspection for site verification by the field officer: The field officer (DDG/FID/ADC) inspects the site of the

of 78

proposed pharmaceutical unit to check / verify the requirements for suitability of site as laid down under the Drugs Act, 1976 and Schedule B of the Drugs (L, R & A) Rules 1976 framed under the Drugs Act,1976.

The field officer then sends the report to Licensing Division, in either case (positive or negative report) in the light of provision of schedule B of the Drugs (Licensing, Registering and Advertising) Rules, 1976 either recommending or not recommending the site for establishment of Pharmaceutical Manufacturing Unit.

30 days

03. Approval of the site by the Authority: At present the Competent Authority for granting

approval of Site for the establishment of a pharmaceutical unit is Secretary, Central Licensing Board as per delegation of powers approved by CLB under the Rules.

In case field officer recommends the site for establishment of Pharmaceutical Unit, the case/file is initiated / processed by the desk Officer for approval of Secretary CLB and same is communicated to the applicant/person/company.

In case of adverse report by the field officer the proposed site is rejected by the competent authority and communicated to the applicant/person/company accordingly.

In case of approval of the site, the firm is advised to submit the layout plan of the proposed pharmaceutical unit.

The firm is informed accordingly in either case as applicant may file an appeal before Appellate Board under the Law against the decision of CLB.

10 days

04. Approval of the building layout plan by the Authority: At present the Competent Authority for granting

approval of building layout plan of a pharmaceutical unit is Chairman CLB through a committee comprising of DDG (L & A), DDC (L & A)/ DDC (Lic.), ADC (Lic.) as per delegation of powers approved by the CLB.

The firm submits in the Licensing Division the layout plan of the proposed pharmaceutical unit or desired changes therein. The request of the firm is scrutinized for completion of the already defined pre-requisites for the purpose.

The layout plan is scrutinized by the scrutiny committee as per cGMP guidelines. The Chairman of the Central Licensing Board also performs function of Chairman of the scrutiny committee for layout plan. The Layout Plan is approved by the committee in case it is found compliant to the requirement of cGMP as per facilities being constructed and drawn on the proposed layout

30 days

of 78

plan. In case of major shortcomings in the layout plan, the

observations are communicated to the applicant or a technical expert or representative of the firm is asked to discuss the layout plan with the licensing directorate. However, the minor shortcomings are rectified by the licensing directorate in the joint meeting.

After approval, the duly signed and stamped layout plan is sent to the firm for construction of the unit as per approved layout plan and further necessary action. However if approval is granted, the applicant is informed/advised to construct proper building structure with proper provision of safety exits under intimation / seek approval of the relevant building control authorities too.

05. Application for grant of Drug Manufacturing License and panel constitution: The firm applies for the grant of Drug Manufacturing

License on prescribed Form 1, after completion of construction of the unit as per approved layout plan, installation of machinery, equipment, HVAC system, engagement of the required technical personnel and completing other requirements as per the Drugs Act, 1976 and Rules framed there under.

The application is scrutinized by the licensing division and if found same in order, it is processed further and as per delegation of powers, a panel of experts is constituted by the Chairman, Central Licensing Board for inspection of the unit and evaluation of the provided facilities as required under the rules.

The field officer (DDG/FID) is advised for coordinating with the other members of the panel and the firm’s representative and conduct the panel inspection of the firm as per checklist / evaluation form and submit the report of inspection thereof.

If there is any shortcoming in the application, the same is communicated to the applicant for doing the needful in the light of observation made by the concerned officer (s) as per requirement of Rules. As the required information / documents are provided the case is processed as stated above.

20 days

06. Inspection for grant of Drug Manufacturing License by the panel: The panel of experts / inspectors inspects the proposed

pharmaceutical unit and carries out detailed evaluation of the requirements as laid down as per criteria/checklist under the Drugs Act, 1976, rules framed there under and practice in vogue.

In case of having all the required facilities made 20 days

of 78

available and in order, the panel recommends the grant of Drug Manufacturing License for its approval by the Central Licensing Board and vice versa.

The field officer then sends the report to Licensing Division, in either case.

07. Meeting of the Central Licensing Board: The Central Licensing Board constituted under Section 5

of the Drugs Act, 1976 consists of technical experts/personnel from Federal and Provincial Governments, representative of Law and Justice Division & Academia in addition to the observers from Pharma Bureau and PPMA.

Meeting of the Board is held on need basis depending upon the number of cases of grant and renewal of drug manufacturing licenses or additional section etc. or the other agenda items or on directions of the Federal Government to consider and dispose off any specific case/assignment.

The report of the panel of experts (in either case) is presented before the Board for consideration and decision.

If the rep0ort of the panel is negative, the Board rejects the application and no application shall be entertained within next three months of rejection but the applicant may apply for re-inspection after removal of shortcomings before expiry of 06 months period.

Minutes of the meeting are prepared and signed by all the members and the Chairman. Decisions of CLB are communicated/ sent to all concerned after approval by the Competent Authority.

The certificate of Drug Manufacturing License is prepared on prescribed Form-2 and signed by the Secretary Licensing Board and its Chairman as provided under the Rules and communicated to the concerned firm.

In case of negative panel inspection report and subsequent rejection by the Board, the applicant can prefer an appeal to the Appellate Board within a period of 60 days of rejection against the decision of Central Licensing Board.

30-45 days

DOCUMENTS / INFORMATION REQUIRED FOR SITE VERIFICATION FOR ESTABLISHMENT OF A PHARMACEUTICAL UNIT

Following listed documents / information required for processing the request / applicationi). Proper application on covering letter on letter head.ii). Copy of Challan of fee i.e. Rs.5,000/- for site verification deposited for

verification of site for establishment of Pharmaceutical Manufacturing Unit under the following head of account. Original challan is duly retained by Statistical

of 78

Officer, DRAP. The Statistical Officer, DRAP endorses receipt of original challan which is retained for this office record.

A/C No. 0010008463-100018 Allied Bank Limited

iii).Disclosure of status of firm: proprietorship, partnership, public limited or private limited etc.

iv). Copy of Partnership deed duly executed in the court of competent jurisdiction/registrar of the firms in case of partnership.

v). Copy (ies) of CNIC of Chief Executive Officer / Managing Director /Directors/ Partners.

vi). Copy of Certificate of Registration with Registrar of Firms in case of a registered firm.

vii). Complete documents of proposed land / plot (purchase document of land/plot, allotment letter, transfer letter/ possession letter, Fard, copy of site map or AksShajrah etc.)

viii). In case if firm is Private Limited, the Certificate of Incorporation with SECP, Memorandum and Article of Association, Form-A and Form-29 should also be furnished.

ix). All documents submitted should be duly attested by Notary Public /SECP/Registrar of firm’s office as the case may be.

*As per requirement of paragraph 1.1 of Schedule B under the Drugs (Licensing, Registering and Advertising) Rules 1976, the proposed site shall be located preferably in Industrial area and in any case not in any Residential or commercial area and as per paragraph 1.3 of schedule ‘B’, the size of plot shall not be less than 2000 Sq. Yards.

C. DOCUMENTS / INFORMATION REQUIRED FOR APPROVAL OF BUILDING LAY OUT PLAN FOR GRANT OF DML, ADDITIONAL SECTION

OR ANY DESIRED CHANGES/RELOCATION(s).i). Proper application building covering letter on letter head clear mentioning these

in purpose of submission of layout. In case of relocation of certain section or post of section in already approved building layout, the shifting of area/section from where the area/section and layout plan from where the area/section is shifted.

ii). Two (02) copies of proposed layout plan for approval in terms of paragraph 2 of section 1 of Schedule-B, under the Drug (Licensing, Registering & Advertising) Rules 1976. The layout plan may be drawn to comply with the requirement of Good Manufacturing Practices as laid down under the aforesaid rules.

iii).Provision of HVAC system may be given in the layout plan. iv). Schedule of section wise covered areas be given. The minimum requirement of

area for different sections is provided in Schedule B-I of the Drugs (Licensing, Registering and advertising) Rules 1976.

v). Fee @ of Rs 5,000/- per section as may be proposed in the layout plan to be deposited under the following head of account and submit attested copy of challan. Original duly retained by Statistical Officer, DRAP and its endorsement made by Statistical Officer, DRAP for Licensing Division.

A/C No. 0010008463-100018 Allied Bank Limitedvi). If there is any addition in already approved layout plan or any sort of revision is

desired then copy of previously approved layout plan along with newly proposed

of 78

LOP (properly highlighted new proposed areas or changes) should also be submitted.

vii). All documents submitted should be duly attested.

D. DOCUMENTS/INFORMATION REQUIRED FOR APPROVAL OF TECHNICAL PERSONNEL/STAFF OF A PHARMACEUTICAL UNIT

1. Copies of academic degrees, as under the Drugs (Licensing, Registering and Advertising) Rules, 1976.

2. Appointment letter by the employer on the letter head of the company duly signed by the CEO or authorized person of the Company.

3. Job acceptance letter by the appointee. 4. Experience Certificate as per requirement under the Drugs (Licensing, Registering

and Advertising) Rules, 1976. 5. Copy of Computerized National Identity Card (s). 6. Registration certificate from Pharmacy Council in case of appointment of a

pharmacist. 7. Duly signed Resignation or termination letter regarding earlier approved

Production / QC In-charge.8. Undertaking by the newly employed Production In-charge /Q.C In-charge stating

that he /she is a whole time employee in the firm as per requirement of rules and that he/she is not working anywhere else.

9. Undertaking by the employer that the newly employed Production In-charge / Q.C In-charge is the whole time employee of the firm as per requirement of rules and that he/she is not working anywhere else.

10. All documents submitted should be duly attested and stamped by CEO/MD/Director / Owner / Proprietor of the employing firm.

E. DOCUMENTS / INFORMATION REQUIRED FOR GRANT OF DRUG MANUFACTURING LICENSE.

i). Properly filled in application on prescribed Form-1 along-with pro-forma and all other required documents as per schedule A of the Drugs (Licensing, Registering & Advertising) Rules 1976. The prescribed FORM-1 see Drugs (Licensing, Registering & Advertising) Rules 1976 is reproduced as below:

1. I/we …………… of …………………hereby apply for the grant of a license to manufacture Drugs by way of……………….on the premises situated at ……………………….

2. The drug (s) or class (es) of drugs intended to be manufactured: - (I) Class (es) of drugs(II) Dosage form(s) of drugs. (III) Name of drug (s).

3. I enclose: -i. Particulars regarding legal status of the applicant (i.e. in case of

Proprietorship the name(s) of proprietors and their address(es), in case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors).

ii. Details of the premises including layout plan of the factory. iii. Details of the section-wise equipment and machinery for manufacture and

quality control. of 78

iv. Names and qualifications of the Production In-charge and Quality Control In-charge for supervising manufacturing processes and Quality Control Department, and other technical staff working in these departments.

4. The premises and plant will be ready for inspection on ……………….. or are ready for inspection.

Dated……………………… Signed………………………………Place ……………………… Name, Designation & Address……..

ii). Pro-forma as per above referred Schedule A.iii).Copy of Challan of Fee original duly retained by Statistical Officer DRAP as per

following schedule to be deposited under the following head of accountA/C No. 0010008463-100018 Allied Bank Limited

i. Fee of Rs. 100,000/- for Grant of DML by way of Formulation.ii. Fee of Rs. 30,000/- for Grant of DML by way of Basic and Semi Basic

Formulation.iii. Fee of Rs. 60,000/- for Grant of DML by way of Repacking.iv. Fee of Rs. 5,000/- per Drugs specified in Schedule D for repacking.

iv). All documents submitted should be duly attested.

F. DOCUMENTS / INFORMATION REQUIRED FOR RENEWAL OF DRUG MANUFACTURING LICENSE

i). Properly filled in application made to CLB/Licensing Division well before expiry of DML on Form 1-A as prescribed vide schedule A of Drugs (Licensing, Registering & Advertising) Rules 1976 along-with all required documents. The prescribed Form 1-A is reproduced as below:

FORM-1A1. The drug (s) or class (es) of drugs intended to be manufactured: -

(I) Class (es) of drugs(II) Dosage form(s) of drugs. (III) Name of drug (s).

2. There have been / have not been any change in respect of: -I enclose: -

i. Name of the proprietor (s) / directors (s)/ partner (s).ii. Details of the premises including layout plan of the factory.

iii. Details of the section-wise equipment and machinery for manufacture and quality control.

iv. Names and qualifications of the Production In-charge and Quality Control In-charge for supervising manufacturing processes and Quality Control Department, and other technical staff working in these departments.

of 78

3. Statement of the Central Research Fund. Following statement, as per audited accounts/ based on Income Tax Return for the last five years:-

Year Investment Turn-over*** CRF due C.R.F. ** paid as per Col.4.

1 2 3 4 5

*If there is any change it should be furnished.

**(Original Challan attached).

***Central Research Fund at the rate of 1% of gross profit before deduction of

income tax.

(a) Attested copies of the last two income tax assessment order of the Income Tax Department attached.

Dated……………………… Signed………………………………

Place ……………………… Name Designation & Address……..

ii). Copy of Challan of Fee original duly retained by Statistical Officer DRAP as per following schedule, to be deposited under the following head of account:

A/C No. 0010008463-100018 Allied Bank Limited

1) Fee of Rs. 50,000/- for renewal of DML by way of Formulation.2) Fee of Rs. 15,000/- for renewal of DML by way of Basic and Semi Basic

Formulation.3) Fee of Rs. 30,000/- for renewal of DML by way of Repacking.4) Fee of Rs. 5,000/- per Drugs specified in Schedule D for repacking.

iii).All documents submitted should be duly attested.

**************

of 78

B. CASES OF QUALITY CONTROL SECTION

ITEM I: CONFIRMATION OF THE MINUTES OF 231 st MEETING

The Minutes of 231st meeting of the Central Licensing Board, held on 30-01-2013, were circulated to all members after getting approval of Chairman Board. Since no objection was received from any member so the Minutes are presumed to be confirmed / approved.

ITEM II: New Cases

S No

Title of Firm/ Medical Store & Accused Name Offence Brief of the Case / Decision of

CLB1 (i) M/s Surat Khan

Medical Store, Brewery Road, Opp B.M.C Complex, Quetta(ii) Surat Khan, Proprietor of M/s Surat Khan Medical Store, Brewery Road, Opp B.M.C Complex,Quetta.(iii) Muhammad Aslam Shah, Qualified Person of M/s Surat Khan Medical Store, Brewery Road, Opp B.M.C Complex, Quetta.(iv) Snaullah, (person present at the time of visit at M/s Surat Khan Medical Store,)(v) M/s Medicine Point, Jinnah Road, Quetta(vi) ArshadMehmood S/O Sultan Mehmood of M/s Medicine Point, Jinnah Road, Quetta.(vii) Mehmood Hassan. Qualified Person of M/s Medicine Point, Jinnah Road, Quetta. (F. No. 3-37/2010-DDC (QC-I)

Manufacture / Saleof Spurious, Drugs Section 23(1)(a)(i), 23(1)(a)(x), 23(1)(c) of Drug Act, 1976,

Samples of Amoxi-Clave, Batch No AE5475, claimed to be manufactured by M/s Sandoz GmbH Austria, (marketed by Sandoz Division, Novartis Pharma Karachi), drawn from M/s Surat Khan Medical Store, Brewery Road, Quetta, by FID Quetta, on 18-06-2010 were declared Spurious by F.G Analyst vide Test Report No.R-646/2010, dated 08-07-2010.M/s Surat Khan Medical Store, could not provide the valid warranties/ bill in respect of the drug

FIR No. 14/2010 dated 06-07-2010 was lodged against accused persons with FIA, Crime Circle, Quetta, with the permission of Chairman Central Licensing Board. The FIA in its Challan has nominated Surat Khan, Muhammad Aslam Shah, Snaullah, ArshadMehmood as accused in its Challan. The FID later also included name of Mehmood Hassan

of 78

(Qualified person of Medicine Point) in list of accused and requested permission for lodging prosecution against all the accused.

Show cause notices were issued to accused on 09-05-2013 and they were called for personal hearing before the Board on 29-07-2013.

None of the accused appeared before the Board. However a person namely Asadullah, claimed to be brother of one of the accused Snaullah, appeared before the Board and informed that the Surat Khan medical store has already furnished warranty of the medicine point in respect of the drug in question to FID Quetta. He further stated that the accused Snaullah could not come for personal hearing because of the hearing of the case in Drug Court on 30th July, 2013.

Since Asadullah failed to produce any document / identity in support of his claimed of being representative of the accused Snaullah, so the Board was doubtful about his authenticity of his statement.

DECISION OF CLB:

The Board, however, decided to give final opportunity of personal hearing to the accused in its next meeting and

of 78

accordingly defer the case.

2. i. Saif Medicine Company, Medicine Whole Sale Market, Ghanta Gharr, Multanii. Muhammad Arshad Khan, Saif Medicine Company, Medicine Whole Sale Market, Ghanta Gharr, Multan.iii. Nayab Cotton Products, Maouza Alamgir, Old Shujaabad Road, Multan.iv.. Samih Aziz Khan, Nayab Cotton Products, MaouzaAlamgir, Old Shujaabad Road, Multan.

(F. No. 3-39/2010-QC)

Manufacture & Sale of Unregistered drugSection 23 (1)(a)(i), (v)(vii), 23 (b), (c)Section 23 (1)(a)&(b)

Samples of Kotax Care Crape Bandage(B.No 00018),Fine Quality Cotton Bandge (B No 00016), Fine Quality Cotton Bandge(B No 00015), Export Quality Absorbant Cotton Wool(B No 00015) purported to be manufactured by M/s Nayab Cotton Multan in 2012, drawn by FID Lahore III, from Saif Medicine Company, Multan on 12-04-2010, were declared Sub-Standard by CDL Karachi. On further investigation by FID, it was reveled that Drug Manufacturing Licensing on the firm was declared invalid in March, 1997.

FIR No. 74/2011 dated 12-04-2010 was lodged against the five accused with FIA Multan Circle. The FIA its Challan No. 298DD/M dated 21-01-2013 has nominated Arshad Khan, the owner of Saif Medicine Company, and Samih Khan, of Nayab Cotton Products as accused and guilty. Show cause notices were issued to accused on 18-03-2013 and they along with firms were calledfor personal hearing.

Sami Aziz Khan

of 78

personally appeared on behalf of M/s Nayab Cotton Products Multan while Rana M. MaqsoodAfzal Advocate represented Muhammad Arshad Khan of Saif Medicine Company, Multan.

Sami Aziz Khan denied the charges claiming that the Nayab Cotton Products Multan was not in operation since 1997. He further stated that someone else was manufacturing the products in question in the name of Nayab Cotton. He also termed the FIR against him as false and concocted.

Rana M. Maqsood Advocate stated that bill/warranty of the products in questions was given by the Sami Aziz Khan to his client. He further claimed / alleged that M/s Nayab Cotton Products, Multan remained in operation despites its Drug Manufacturing License declared invalid in March 1997 and a number of cases has been filed against the firm in Drug Courts for manufacturing of products after its manufacturing licenses being declared invalid.

DECISION OF CLB:

The Board in view of personal hearing and after thorough consideration of the

of 78

available record and facts of the case, including the Challan furnished by FIA, decided to allow FID to prosecute all the accused of the firm viz M/s Nayab Cotton Products, Multan and M/s Saif Medicine Company, Multan and the firms through their Managing Directors in Drug Court Multan.

ITEM III MISCELLANEOUS CASES

Case No. 1 Manufacturing of Drugs without valid Drug Manufacturing License by M/s Alfalah Pharma (Pvt.) Ltd, Shaikupura Road, Lahore. (F. No. 3-03/2012-QC)

During proceeding of the case Board was informed that in January, 2012, when the initial reports of deaths / serious reactions in patients taking medicine from Punjab Institute of Cardiology (PIC) were received, the FID Lahore drew samples of Alfagrel Tablets 75mg, Batch No.034, from premises of M/s Alfalah Pharmaceuticals Ltd., Lahore on 13-01-2012, for being one of the suspected drug and also an FIR was lodged against the firm on 23rd January, 2011.

Later the FID, on finding that the firm at that time was operating without valid Drug Manufacturing License, sealed the firm. The aforementioned sample of Alfagrel Tablets was also declared substandard by Federal Government Analyst, Central Drug Laboratory Karachi, on the basis of description. The firm, in response to FID’s letter, calling for explanation, requested Appellate Testing of the sample under Section 22(4) of Drugs Act, 1976.However, since at that time the subject of “Drugs and Medicine” was devolved to the provinces under 18th Constitutional Amendment so, the FID handed over the case along with case property to the Provincial Health Authorities, Punjab. The Provincial Quality Control Board, Punjab later referred back the case to FID, Lahore, pointing out various lacunas and the fact that DRAP had become functional and therefore competent to consider the matter.

The FID Lahore, while reporting the above matter has also forwarded an incomplete Challan, furnished by FIA, wherein after describing the above position, it is stated that the investigation is yet to be completed.

Though, subsequently, it was learned that the drug Alfagrel Tablet of M/s Alfalah Pharma Lahore, may not be associated with the death incidences relating to PIC, however, from perusal of record, following violations appear to be committed by M/s Alfalah Pharma.

Manufacturing drug without valid drug manufacturing license Manufacturing of substandard drug Alfagrel Tablets.

of 78

The Board was also informed in its 231st meeting that the Drug Manufacturing License of the firm has already been re-granted in 230 th meeting of CLB held on 31-08-2012. The Board after review of the available record and facts of the case, inter alia, decided to issue Show cause notice to the firm. Accordingly the show cause notice dated 19th February 2013, was issued and the firm’s representative called for personal hearing before the Board. None of the accused/ representative of the firm appeared before the Board for personal hearing.

DECISION OF CLB:

The Board after detail deliberation of the case decided to defer the case till next meeting in order to provide final opportunity of personal hearing to the accused / firm.

Case No. 2 Appeal by M/s Reko Pharmecal & M/s Ethical Labs Against Decision of Central Licensing Board regarding Suspension of License of their Oral Liquid / Syrup Sections, Taken in its 231 st Meeting held on 30- 01-2013. (F. No. 3-29/2012-QC)

The Board was informed that the Central Licensing Board in its to 231 st meeting considered the recommendations of Provincial Quality Control Board Punjab for cancellation of Drug Manufacturing license of M/s Reko Pharmecal (Pvt.) Ltd Lahore and M/s Ethical laboratories (Pvt.) Ltd., Lahore for utilizing substandard Dextromethorphan raw material for manufacturing of their cough syrups, which resulted in death of number of patients. The Board took following decisions.

i. Import of any raw material / drug form M/s Konduskar India is banned forthwith.

ii. WHO Pakistan may be approached with the request to take up the matter with the Indian authorities through WHO India.

iii. Suspension of License of Oral Liquid / Syrup Section of M/s Reko Pharmaceuticals for one year or till completion of investigation and decision by the competent forum, whichever is earlier.

iv. Suspension of License of Oral Liquid / Syrup Section of M/s Ethical Labs for one year or till completion of investigation and decision by the competent forum, whichever is earlier.

v. Recommendations to the Drug Registration Board for Cancellation of Registration of Tyno SF Syrup of M/s Reko Pharmaceuticals and Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs

vi. Detail panel GMP inspection of the M/s Reko Pharmaceuticals and M/s Ethical Labs

The Board further decided to take up the matter again after completion of investigation by the relevant quarters

Action has been taken on the above decisions. A seven member expert committee under the Chairmanship of Mr. Sultan Ghani (Former Director Health Canada) was constituted by CEO, DRAP having following members.

of 78

i. Syed Shahid Nasir,Ex-Member Central Licensing Board

ii. Prof. Dr. Mahmood Ahmed,Dean, Faculty of Pharmacy & Alternate Medicine, Islamia University, Bahwalpur

iii. Dr. Mohammad S Iqbal,Professor, Department of Chemistry, FC Collage, Lahore

iv. Dr. Riaz Bhatti, Head of Pharmacy, JPMC, Karachi

v. Prof. Dr. Muhammad Sualeh,Head of Pharmacognosy,Federal Urdu University,Karachi

vi. Dr. Iftikhar Jaffery, Sr. Director/Head of Technical Division, Pfizer, Pakistan

vii. Dr. Obaid Ali, DDC (Training& PharmacyServices) DRAP, Islamabad (Secretary / Coordinator)

The Secretary / Coordinator committee vide an email has informed that the committee started work in beginning of April 2013, but could not move forward because of no availability of funds for TA/DA for members.

The Board was further informed that M/s Reko Pharmecal Lahore and Ethical Laboratory (Pvt.) Ltd., Lahore have filed Appeals, through their attorney, before the Central Licensing Board for reconsideration / recall of the aforementioned orders / decisions and for de-sealing of the Oral Liquid / Syrup Section of these firms. The firms in their appeal claimed that before passing such orders an inquiry should be conducted to fix the responsibility as number of initial reports in respect of raw material and finished Cough syrups issued by Federal Government Analyst CDL Karachi and DTL Lahore were of standard quality and the later substandard reports issued were based on guess and surmises because the government analyst has no facilities to perform the quantitative test of levomethorphan in Pakistan. Moreover as per their claim there in no evidence to prove that the syrup in question was the cause of death as the Secretary Health Punjab in its report has mentioned that the all victims were narcotics addicts and were also using other addictions materials.

While submitting the aforementioned appeals for consideration of the Central Licensing Board, it was further informed that M/s Reko Pharmecal Lahore and M/s Ethical Laboratory (Pvt.) Ltd Lahore had also filed Writ Petitions No. 2132/2013 & 2131/2013 respectively before the Islamabad High Court, Islamabad against the aforementioned decision of the Board. The Court vide its order dated 21-05-2013 directed the Central Licensing Board (Respondent No. II) to decide the representation of the Petitioners with in a period of one month from the receipt of the copy of the order.

DECISION OF CLB:

The Board considered both the appeals file by M/s Reko Pharmecal Lahore and M/s Ethical Laboratory (Pvt.) Ltd Lahore and observed that firms have not given any

of 78

additional/ new grounds in their appeals which could justify reconsideration of the earlier decision of the Central Licensing Board taken in its 231st meeting held on 30-01-2013. It was further observed that under Section 9 of Drugs Act 1976 the next higher forum available for parties/persons aggrieved by any decision of Central Licensing Board in the Appellate Board and appeals of both the Appellants are already pending before the Appellate Board for decision/orders. The Central Licensing Board decided to uphold its earlier decision taken in its 231st meeting.

Case No.3 Manufacture and sale of Un-Registered Capsules Ca-Ze (Batch No. MN-05), Tablet Prosine (Batch No.AZ-08), Tablet Livogard (Batch No. SA-03), Drugs by M/s Goldshef int’l (Pvt.) Ltd Lahore. (F. No. 4-10/2011-QC)

During proceedings of the case the Board was informed that The Central Licensing Board in its 227th meeting held on 02-06-2011,granted permission to FID Lahore for launching prosecution against following accused in Drug Court, Lahore for manufacture of unregistered drugs viz Capsules Ca-Ze (Calcium, Zinc, Vit-E), Tablets Prosense (Ginkgobiloba) and Tablets Livogard (Silymarin) by M/s Goldsheff Int’l, Lahore.

i. Mr. Aftab Siddiqi,Chief Executive, M/s Goldsheff Int’l, Lahore.

ii. Mr. Tahir Manzoor,National Sales Manager, M/s Goldsheff Int’l,Lahore.

iii. Mr. Azhar Farooq S/o Muhammad Siddique,Owner of Tauheee-o-Hamd Printers.Royal Park, Lahore

It was further informed that the above accused were given show cause notices and opportunity of personal hearing before the Central Licensing Board prior to taking aforementioned decision in its 227th meeting.

Later the FID Lahore informed that the Departmental Prosecution Officer of Drug Court, Lahore returned the case with the remarks that the company / firm’s names of both the company / firms, involved in manufacturing of unregistered drugs mentioned above, should be added in the list of accused. Accordingly, the permission of Central Licensing Board is sought for including following names of the firms in the list of accused for which prosecution permission has been granted by the Board.

i. M/s Goldsheff Int’l (Pvt.) Ltd.,Through its Chief Executive, 136-A, Canal View Housing Society, Lahore.

ii. M/s Tauheed-o-Hamd Printers,Through its Owner,Royal Park, Lahore

DECISION OF CLB:

The Board after considering facts and available record of the case decided to include names of M/s Goldsheff Int’l (Pvt.) Ltd Lahore and M/s Tauheed-o-Hamd Printers, Lahore through their respective Chief Executives / owner, in the list of accused to be prosecuted in the Drug Court Lahore.

of 78

Case No.4 REFERENCE FROM PROVINCIAL QUALITY CONTROL

BOARD SINDH FOR CANCELLATION / SUSPENSION OF LICENSE OF FIRMS FOR BEING CONVICTED BY DRUG COURTS UNDER DRUGS ACT, 1976

The Board was informed that the Secretary Provincial Quality Control Board (PQCB) Sindh has referred to the orders passed by Sindh High Court in Cr. Revision Applications No. 103/2010 to 107/2010, during hearing dated 14-10-2010, wherein the respondents were directed that, for persons convicted under Drugs Act, 1976, provision of law and rules framed their under, which requires cancellation and or suspension of licenses, be to complied with. The Secretary, PQCB, Sindh has forwarded following cases of the firm convicted in the Drug Court Sindh for compliance of the High Court’s orders.

S.No

Firms Name and Case No

Charges Sentence Awarded

1. M/s Standard Drug Co., HyderabadCase No. 61/2011

Counterfeit and Misbranded Drug Linobex-C Syrup, Batch No. LC-062 (Resemblance with lederplex liquid)

Sentence till rising of the Court to Imtiaz Ahmed Haji Muhammad, Managing partner and Miss Sabeen Usman, QC in-charge and fine of Rs 30,000 and 25,000 respectively

2. M/s Standard Drug Co., HyderabadCase No. 62/2011

Counterfeit Drug Linobex-C Syrup, Batch No. LC-022 (Resemblance with lederplex liquid)

Sentence till rising of the Court to Imtiaz Ahmed Haji Muhammad, Managing partner and Miss Sabeen Usman, QC in-charge and fine of Rs 30,000 and 25,000 respectively

3. M/s Z-Jans Pharmaceuticals PeshawarCase No. 14/2012

Substandard lofsin Tablets Batch No. 435

Sentence the firm and three accused till rising of the Court and fine of Rs 25,000 to each accused

During proceeding of the case, the Chief Drug Inspector Sindh Mr. Saleem Isharat, who is also the member of the Central Licensing Board, apprised the Board that in cases where Drug Courts have awarded lighten sentences to the accused, the PQCB Sindh, on directions of Supreme Court, approached the Sindh High Court, for enhancing these sentences. The case is at present pending with the Sindh High Court However, the Court, in its hearing dated 14-10-2010, gave the directions for cancellation / suspension of licenses of convicts.

The Board was informed that the complete detail of cases which includes the back ground of the case, test report and other relevant document have not been provided by the PQCB, Sindh which are required for consideration of the matter and taking decision there off.

of 78

DECISION OF CLB:

Taking in to consideration of all the facts on record, the Board directed to obtain complete details of all such cases from the PQCB Sindh for consideration of Central Licensing Board in the next meeting. The case was accordingly deferred.

Case No. 5 Delegation of Powers

In order to facilitate timely disposal of routine / day to day business of Central Licensing Board relating to contravention of various provisions of the Drugs Act, 1976 and DRAP Act, 2012, the Board decided to delegate following of its powers to the officer mentioned against each for a period of one year with immediate effect under Rule 8 (10) of the Drugs (Licensing, Registering & Advertising) Rules, 1976.

Sr #

Powers Delegated to

1. Approval of Show Cause Notice regarding contravention of any of the provision of Drugs Act, 1976 and rules framed there under for cases relating to GMP and Quality Control matters

Director Quality Assurance and Laboratory Testing

2. Suspensions of Production (in case of GMP issues)


3. Panel Constitution (GMP Inspection) Director Quality Assurance and Laboratory Testing

4. Constitution / amendments of panel for GMP compliance inspections and Quality Control matters.


5. Monitoring performance and working of all field officers of Drug Regulatory Authority of Pakistan dealing with GMP inspections, clearance of consignments of raw materials and finished drugs and drug testing laboratories.


6. Issuance of Show Cause Notices / Circulars/Communication of Minutes / Decisions / Directions of the Board to the Concerned quarters regarding GMP and Quality Control matters on behalf of Secretary Board.

Deputy Drugs Controller (QA)/Deputy Drugs Controller (QC)

7. To continue custody of the seized stocks by the FID till decision of the case


8. To extend the period of “not to dispose off orders passed by FID “for three months.


9. To grant approval for sending Board’s portion of drug samples to the Appellate Laboratory.


10. Grant of extension in the time of testing to Federal Government Analyst.


11. Lodging of FIR Director Quality Assurance and Laboratory Testing

of 78

The Board further observed that since matters relating to GMP inspections are dealt by the Central Licensing Board so, in order to have uniform standards for evaluation of manufacturers both inside the country and abroad, the matter relating to the foreign GMP inspections should also be dealt by the same Board. The Board directed to refer the aforementioned observation to DRAP for its consideration / implementation.

C. CASES OF QUALITY ASSURANCE SECTION

MINUTES OF 232 ND MEETING OF CENTRAL LICENSING BOARD (CLB) QUALITY ASSURANCE SECTION CASES OF FIRMS WHOSE PRODUCTION WAS STOPPED DUE TO NON-COMPLIANCE OF GMP AND VIOLATIONS OF

DRUGS (LICENSING, REGISTERING AND ADVERTISING) RULES, 1976

Item No. I (New Case):- M/s Rex Pharmaceuticals Pakistan Ltd, Karachi

Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs (Licensing, Registering & Advertising) Rules, 1976 and gross violations of GMP as laid down under Schedule B-II of Drugs (Licensing, Registering & Advertising) Rules, 1976 framed under Drugs Act, 1976. Details of violations are given as per relevant agenda item.

Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/stop production order dated 23.04.2013. The case was placed before CLB in its 232nd meeting but no one appeared from the firm before the Board. The firm informed telephonically that the Director of the firm had gone to Saudi Arabia for performing Umrah and requested to defer the case till next meeting of CLB.

Proceeding:- The members of the Board were provided with the agenda of QA Section. The brief of case was presented before 232nd of Central Licensing Board. The Board was apprised about the cases of firms who have violated the conditions of DML, Rules and non compliance of GMP and action taken by the DRAP including the case under reference. The Board after thorough deliberations on all the agenda items including the instant one, took the decision accordingly on case to case basis.

Decision of CLB

The Board after thorough deliberations and taking in consideration of the legal provisions as laid down under the Drugs Act, 1976 rules framed there under decided as below:-i. The Board decided that the production will remain stopped

till the final approval for resumption of production by the Central Licensing Board.

ii. The case was deferred by Central Licensing Board till its next meeting as per request of the firm and also to fulfill legal requirement w.r.t show cause notice and personal hearing.

of 78

Item No. 2 (New Case):- M/s Ceicil Laboratories (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 25.03.2013. The case was placed before CLB in its 232nd meeting and Mr. Waseem-ud-Din, Director of the firm appeared before the Board wherein he requested for the resumption of production based on recommendation of panel in its inspection report.

Proceeding:- The members of the Board were provided with the agenda of QA Section. The brief of case was presented before 232nd meeting of Central Licensing Board and Board was apprised about the cases of firms who have violated the conditions of DML, Rules and non compliance of GMP and action taken by the DRAP. The Board after thorough deliberations on all the agenda items including the instant case took the decision accordingly on case to case basis.

Decision of CLB The Board after taking into consideration, the recommendation of panel comprising of Dr. Sheikh Akther Hussain, Incharge DRAP Punjab, Mr. Asim Rauf, DDG (E&M), Lahore, Mr. Moazzam Ali Khan, Secretary PQCB Punjab and Mrs. Majida Mujahid, FID Lahore vide its inspection report dated 04.06.2013 and keeping in view the relevant legal provisions/codal formalities and through deliberations of the honorable members decided as under:-

i) The Board on the recommendations of the panel allowed the provisional resumption of production, except manufacturing of steroid containing products.

ii) Conduct the comprehensive broad based inspection by a larger panel on approved audit Performa devised under provisions of Schedule B-II for checking/verifying overall GMP compliance level of firm within 30 days after the resumption of its production.

iii) The firm was directed to submit the application to surrender their registration of Cecidrom Injection (Dexamethasone Sodium Phosphate) and all other steroidal products in injectable dosage form till the provision of separate steroidal section. It was also decided to refer the case to Registration Board/Directorate of Registration for taking appropriate action under the rules.

iv) Ask the firm to appoint qualified and experienced technical personnel in stores and microbiological lab as admissible under Rule 16th of Drug (Licensing, Registering and

of 78

Advertising) Rules, 1976 and get approval therefore from CLB.

Item No. 3 (New Case):- M/s Ardin Pharmaceuticals, Karachi


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 25.03.2013. The case was placed before CLB in its 232nd meeting and Mr. Saeed Taqi, Director of the firm appeared before the Board, wherein he requested the Board that he needs approx 3 months time for the renovation/upgradation work as it is yet not completed and the firm intends to improve their cGMP by investing huge amount on the unit. The firm submitted an undertaking to the Board in this regard that they will not resume production activities till the rectification of shortcomings and completion of renovation/up gradation work and directions of the Board in this effect.

Proceeding:- The members of the Board were provided with the agenda of QA Section. The brief of case was presented before 232nd meeting of Central Licensing Board and Board was apprised about the cases of firms who have violated the conditions of DML, Rules and non compliance of GMP and action taken by the DRAP. The Board after thorough deliberations on all the agenda items including the instant case, took the decision accordingly on case to case basis.

Decision of CLB i) The CLB after hearing the views of the Director of the

firm, acceded to the request of the firm for extension in time period of three months to upgrade/renovate their facility subject to the condition that the production will not be resumed during up-gradation/renovation work and till decision of the CLB after verification of rectification of shortcomings by the panel of experts.

ii) The firm will get the layout plan of their building/sections approved in case of up-gradations/improvements of existing facility if any change or alteration is made in the existing/approved layout. The case shall be brought before the notice of Central Licensing Board. In case of failure to rectify the shortcomings and no further time shall be granted and exparte decision shall be taken by the CLB.

of 78

Item No. 4 (New Case):- M/s Lawrence Pharma (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production dated 03.04.2013. The case was placed before CLB in its 232nd

meeting and Mr. Muhammad Razzaque Asadi, General Manager and Mr. Tariq Javed, QC Manager were appeared before the Board on 30.07.2013, wherein they requested that their panel inspection has been conducted on 29.05.2013 and they may be allowed to resume production in veterinary vial section and syrup section. The firm also informed that their panel inspection has been conducted in other areas on 29.07.2013 but the report is awaited. It was observed by the Board that the firm does not have any approved technical staff so the Board directed the firm to proceed as per codal requirements for the approval of qualified technical staff.


Decision of CLB The Board after taking into consideration, the recommendation of panel comprising of Mr. Asim Rauf, DDG (E&M), Lahore, Mr. Moazzam Ali Khan, Secretary PQCB Punjab and Mrs. Aisha Khalil, FID Lahore vide its inspection report dated 29.05.2013 hearing the views of the firm and keeping in view the relevant legal provisions/codal formalities, and through deliberations of the honorable members concluded and decided as under:-i) The Board on the recommendations of the panel

allowed the provisional resumption of production in veterinary vial (general) section and syrup section only.

ii) The Board also decided to conduct the comprehensive inspection of the entire facility on approved audit Performa as per Schedule B-II of Drugs Act, 1976 for monitoring/evaluation of GMP compliance and conditions by the larger panel within 30 days.

of 78

iii) The Board decided to ask the firm to provide copies of approval of technical staff by Licensing Section i.e. Production In charge and QC In charge to QA Section.

Item No. 5 (New Case):- M/s Kakasian Pharmaceuticals (Pvt) Ltd, Lahore

Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs (Licensing, Registering & Advertising) Rules, 1976 and of GMP as laid down under Schedule B-II of Drugs (Licensing, Registering & Advertising) Rules, 1976 framed under Drugs Act, 1976. Details of violations are given as per relevant agenda item.

Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 03.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Iqbal Khan, Chief Executive appeared before the Board, wherein he informed the Board that they were in phase of shifting to new unit at Sunder Industrial Estate. They further informed that machineries of all sections except Injectable section were under the phase of shifting. He added that, they were in process of deciding whether the Injectable section be shifted to their new unit in Sunder Industrial Estate or not.


Decision of CLB The Board after hearing the views of the Chief Executive of the firm and facts of the case, decided as under:-

i) Directed the Licensing Section to verify whether the codal formalities for shifting to new premises have been observed/fulfilled by the firm or otherwise.

ii) To conduct market survey through FIDs and Provincial Drug Inspectors for the availability of stocks of the firm in the market/ institutions as the firm was closed since 15.02.2012.

iii) A panel inspection of the firm will be conducted for verification of the improvements in existing premises to verify the conditions of Drug Manufacturing License including GMP under Schedule B-II of Drugs (Licensing, Registering & Advertising) Rules, 1976 framed under, Drugs Act, 1976.

of 78

iv) The production will remain stopped till the final decision by Central Licensing Board after fulfillment of all legal pre-requisites.

Item No. 6 (New Case):- M/s N.B.S Pharma, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production dated 25.03.2013. The case was placed before CLB in its 232nd meeting and Sheikh Shahzad Nabi, Proprietor appeared before the Board wherein he informed that the panel has been constituted to re-inspect the firm but due to non-availability of one member of the panel, the inspection is still lying pending.


Decision of CLBi) The Board directed the QA Section of DRAP to send a

reminder to the panel to conduct the inspection at the earliest with the advice to FID to coordinate with the panel.

ii) The Central Licensing Board deferred the case till receipt of inspection report.

iii) The production of the firm will remain stopped till the final decision by Central Licensing Board.

iv) The Board also took serious notice and showed its deep concern on casual behavior/response of the field offices/FIDs in conducting inspections for the purpose of GMP compliance and for panel inspections for various purposes under the Drugs Act 1976 and rules framed there under which causes un necessary delay in performing their duties.

Item No. 7 (New Case):- M/s Marvi Pharmaceuticals (Pvt) Ltd, Karachi

Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs (Licensing, Registering & Advertising) Rules, 1976 and gross violations of GMP as laid down under Schedule B-II of Drugs

of 78

(Licensing, Registering & Advertising) Rules, 1976 framed under Drugs Act, 1976. Details of violations are given as per relevant agenda item.

Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 23.04.2013. The case was placed before CLB in its 232nd meeting. Mr. Faznani, (Father of the owner of the firm) along with Mr. Abbas Hairder Jafari, Attorney of the firm appeared before the Board. They informed the Board that they do not manufacture herbal products and allopathic products/medicines in one premises but they have two separate premises adjacent to each other, one for herbal products and other is licensed premises having Drug Manufacturing Licensing No.000148. He also claimed that the Central Licensing Board has granted renewal of their Drug Manufacturing License No.000148 (By way of formulation) but they have not yet received the grant of renewal of DML certificate.


Decision of CLB The Board after hearing the views of the firm, taking in to account the case back ground as given in the agenda and detailed deliberations by the members, decided as under:-i) Direction to the Licensing Section shall be sent to verify

the status of validity of license and its renewal status in light of the claim of the firm.

ii) A larger panel inspection will be conducted to check/verify the claim of the firm about two different premises and to check overall GMP conditions of the firm as per Schedule B-II of Drugs (L.R.A) Rules 1976 framed under the Drugs Act 1976 within 30 days.

iii) The claim of the firm regarding false inspection report was set aside by Central Licensing Board as the firm confirmed/admitted before the Board stating that they mis quoted about the said report and informed that the FID had conducted inspection of their unit on 08.03.2013 which was produced before the Board. The firm however was yet on the point that their DML +was still valid.

iv) The Central Licensing Board directed to take/verify the status of the Registrations of products of M/s Marvi Pharmaceuticals (Pvt) Ltd, Karachi from Registration Division as the area FID in his report had mentioned that most of the registrations of Drugs had been expired..

v) The production will remain stopped till the final approval by Central Licensing Board on receipt of the inspection

of 78

report of the firm by the larger panel of experts as mentioned above.

Item No.8 (New Case):- M/s Perfect Pharmaceuticals (Pvt.) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 24.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Abdur Razzaq, Chief Executive appeared before the Board wherein he requested for the resumption of production based on the recommendation of panel of experts vide inspection report dated 04.06.2013


Decision of CLB The Board after taking into consideration, the recommendation of panel comprising of Dr. Sheikh Akhter Hussain, Incharge DRAP Punjab, Mr. Muazzam Ali Khan, Secretary PQCB Punjab, Mr. Asim Rauf, DDG (E&M), Lahore/FID Lahore, and Ms. Qurratulain Rana, ADC Lahore vide its inspection report dated 04.06.2013 hearing the views of the firm and keeping in view the relevant legal provisions/codal formalities and through deliberations of the honorable members decided as under:-i) The Board on the recommendations of the panel allowed

the provisional resumption of production.Ii) The Board also decided to conduct the broad based

inspection on approved audit Performa under Schedule B-II of Drugs (Licensing, Registering and Advertising) Rules 1976 framed under Drugs Act, 1976 for verifying/checking the GMP compliance and conditions of DML by the larger panel within 30 days after resumption of production.

Item No. 9 (New Case):- M/s Shafi Textile Faisalabad

Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs (Licensing, Registering & Advertising) Rules, 1976 and gross

of 78

violations of GMP as laid down under Schedule B-II of Drugs (Licensing, Registering & Advertising) Rules, 1976 framed under Drugs Act, 1976. Details of violations are given as per relevant agenda item.

Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production dated 23.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Muhammad Abdullah, Owner of the firm appeared before the Board wherein he informed that he has only government orders and market supply is not in practice due to which the firm remains closed mostly. He requested the Board that he has supply order from Pakistan Defense Forces. Almost half of the supply order has been done so he may be allowed to complete this supply order. He also informed that a panel has been constituted with reference to renewal of his premises but the inspection has not been conducted by the panel yet. Moreover, the firm submitted an undertaking to the Board that he (firm) will purchase land for new premises by December, 2013 and also fulfill the codal formalities like site verification, approval of layout plan etc.


Decision of CLB i) After hearing the views and request of the firm, the Board

decided that the Licensing Section may be asked to expedite the inspection for renewal of DML immediately and this case will be considered in the light of report of panel inspection for renewal of DML.

ii) The production will remain stopped till the final decision by Central Licensing Board and in the light of report for renewal of Drugs Manufacturing License by Licensing Section.

Item No. 10 (New Case):- M/s Aptcure (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production dated 23.04.2013. The case was placed before CLB in its 232nd meeting and Mr.

of 78

Muhammad Masood, Chief Executive and Raja Muhammad Farooq, Director appeared before the Board wherein they informed that their panel inspection has been conducted on 16.07.2013. The report is awaited.


Decision of CLB The Board decided as under:-i) The Central Licensing Board deferred the case till panel

report is presented before Central Licensing Board to enable Board to take the decision in the light of report.

ii) The production will remain stopped till the final approval by Central Licensing Board.

Item No. 11 (New Case):- M/s 3S Pharmaceuticals (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 23.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Naveed Ahmad Sindhu, Director of the firm appeared before the Board wherein he has requested for the resumption of their production based on the recommendation of panel in its inspection report dated 27.06.2013.


Decision of CLB: The Board after taking into consideration, the recommendation of panel comprising of Dr. Sheikh Akhter Hussain, Incharge DRAP Punjab, Mr. Asim Rauf, DDG (E&M)/FID, Lahore, Mr. Moazzam Ali Khan, Secretary PQCB Punjab and Ms. Qurratulain Jamil Rana, ADC Lahore vide its inspection report dated 27.06.2013, hearing the views of the firm and keeping in view the relevant

of 78

legal provisions/codal formalities and through deliberations of the honorable members decided as under:-i) The Board on the recommendations of the panel allowed

the provisional resumption of production.ii) The firm shall be re-inspected in working condition by a

larger panel within 30 days time period after the resumption of production as per provision of Schedule B-II of Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under Drugs Act, 1976 specially containing provision for GMP compliance.

Item No. 12 (New Case):- M/s Prime Laboratories (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 23.04.2013. The case was placed before CLB in its 232nd meeting wherein Sheikh Zubair Iqbal, Director of the firm appeared before the Board along with Mr Bashir Ahmad Advocate, Legal Advisor of the firm wherein they informed that their panel inspection has been conducted but QA Section informed the Board that they had not received report till the date of Board’s meeting. During proceedings Sheikh Zubair Iqbal used very harsh words for the Board and exhibited very unethical and unprofessional attitude for which all the members took serious notice and demonstrated their immense displeasure.


Decision of CLB i) The Board decided to defer the case and that production

of the firm will remain stopped till rectification of shortcomings verified by the panel.

ii) The Board desired that the decision shall be taken in light of report of panel which will be presented in upcoming meeting of Central Licensing Board.

iii) Board also took extremely serious notice of the harsh, unethical and unprofessional attitude of Sheikh Zubair Iqbal, Director of the firm towards the Board during its

of 78

proceedings and decided to issue warning to him to refrain from such attitude before the Board and be careful in future.

iv) The Board also directed the representatives of PPMA and Pharma Bureau to communicate, the serious concern and displeasure of all the Board members regarding the un professional, un ethical and harsh attitude of Sheikh Zubair Iqbal, Director of the firm, to all their member companies in general and the firm under reference in particular under intimation to the Central Licensing Board.

Item No. 13(New Case):- M/s Crest Pharmaceuticals, Islamabad


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 23.04.2013. The case was placed before CLB in its 232nd meeting Mr. Tariq Mahmood, Chief Executive of the firm called for personal hearing but he did not appear before the CLB inspite of the fact he came for the purpose but he left the meeting before his case be heard.


Decision of CLB i) The Board considering the facts of the case decided to

constitute a larger panel to inspect the firm on audit performa for evaluation of GMP as laid down under Schedule B-II of Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under of Drugs Act, 1976.

ii) The production will remain stopped till the final approval by Central Licensing Board as the panel inspection is still to be conducted for verification of rectification of shortcomings indentified by area FID in his report. The case shall be presented before next meeting of Central Licensing Board after the receipt of panel inspection report.

of 78

Item No. 14 (New Case):- M/s Xenon Pharmaceutical (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 23.04.2013. The case was placed before CLB in its 232nd meeting and Dr. Zulfiqar Malik, Chief Executive of the firm appeared before the Board wherein he requested the Board to allow the firm to resume production in all sections including Steroid syrup section as the product being manufactured in this area is short in the country.


Decision of CLB The Board after taking into consideration, the recommendation of panel comprising of Mr. Asim Rauf, DDG (E&M), Lahore, Mr. Moazzam Ali Khan, Secretary PQCB Punjab and Mrs. Aisha Khalil, FID Lahore vide its inspection report dated 11-06-2013, hearing the views of the firm and keeping in view the relevant legal provisions/codal formalities and through deliberations of the honorable members decided as under:-

The Board after hearing the views and request of the firm decided as under:-

i) The Board allowed the firm to resume production provisionally in all their sections except in steroidal sections as recommended by the panel.

ii) The production of steroidal sections will remain stopped till the provision/approval of dedicated facilities and subsequent approval by the Central Licensing Board.

iii) The Board also decided to conduct the inspection of the firm by a larger panel on audit perform as laid down under Schedule B-II in order to check/verify the GMP compliance of the firm in working condition within 30 days after resumption of production.

of 78

Item No. 15 (New Case):- M/s Ambro Pharma (Pvt) Ltd, Islamabad


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 23.05.2013. The case was placed before CLB in its 232nd meeting but no one from the firm appeared before the Board. However, the firm in its reply to show cause notice requested that they are upgrading/renovating their unit and more time is required to complete this project/task.


Decision of CLB i) The Board decided to defer the case till next meeting of

Central Licensing Board. ii) The production will remain stopped till the final decision

by Central Licensing Board as the panel inspection is still to be conducted for verification of rectification of shortcomings indentified by area FID in its report. The case shall be presented before next meeting of Central Licensing Board after the receipt of panel inspection report.

Item No. 16 (New Case):- M/s Avicenna Laboratories (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production dated 26.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Muhammad Shafiq, Production Manager appeared before the Board wherein he informed that they have made improvements as suggested by the FID and are ready for inspection.

of 78


Decision of CLB The Board decided the following:-i) The Board took serious notice that without prior approval

from or intimation to Central Licensing Board (Licensing Section) how the firm involved in renovation of vaccine production area for which the firm should be asked for clarification by QA Section.

ii) The Board further decided to direct the firm to establish a self contained/dedicated facility for production of Penicillin containing products/drugs and no production activity of penicillin containing products shall be conducted till provision of dedicated/self contained facility as per requirement of relevant rules and same approval by the CLB.

iii) The Central Licensing Board decided that the production will remain stopped till the final approval of Central Licensing Board.

iv) The Central Licensing Board also decided for a broad based inspection of unit by a panel as per audit Performa devised as per Schedule B-II of Drugs (Licensing, Registering and Advertising) Rules 1976 framed under Drugs Act, 1976 in order to check/verify the GMP compliance level of the firm.

Item No. 17 (New Case):- M/s Dosaco Laboratories (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 29.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Muhammad Azeem, Quality Control In charge and Mr. Humayoun Rashid, Production In charge appeared before the Board wherein they requested the Board that they need more time of approx 6 months as the renovation/upgradation work was under process. The firm submitted an undertaking in this regard to the Board.

of 78


Decision of CLBi) After hearing the views and request of the firm, the Board

acceded to the request of the firm regarding extension in time period for renovation/upgradation work for a period of 6 months. However, the production of the firm will remain stopped till final decision of CLB.

ii) The Central Licensing Board also desired that instruction/information should be issued/conveyed to all FIDs and all provincial Chief Drug Inspectors (Punjab, KPK, Sindh, Baluchistan, Gilgit-Baltistan, ICT) regarding stoppage of production of the firm w.e.f. 29.04.2013 with the advise to ensure that a market/institutional survey should be conducted to check the availability of Drugs of M/s Dosaco Laboratories (Pvt) Ltd, Lahore manufactured after 29.04.2013, and for any action taken under the law/rules shall be presented before the Board.

iii) The Board further decided to ask the firm to get layout plan of the building approved for eye drops, penicillin (dedicated) and steroidal products/drugs as required under rules.

iv) The Registration Board/Directorate of Registration will also be appraised about the decision of CLB regarding suspension of products/drugs i.e. eye drops, penicillin and steroids containing products manufactured in these sections for immediate action and compliance at their end as firm does not possess manufacturing facilities/areas for these products as required under the rules.

No.18 (New Case):- M/s Elixir Laboratories (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 06.05.2013. The case was placed before CLB in its 232nd meeting but no reply to show cause notice has been submitted by the firm up till now and no one appeared before the Board for personal hearing.

Proceeding:- The members of the Board were provided with the agenda of QA Section. The brief of case was presented before 232nd meeting of

of 78

Central Licensing Board and Board was apprised about the cases of firms who have violated the conditions of DML, Rules and non compliance of GMP and action taken by the DRAP. The Board after thorough deliberations on all the agenda items including the instant case took the decision accordingly on case to case basis.

Decision of CLB i) The Board observed that the Appellate Board is

constituted under section 9 of Drugs Act, 1976 and rules framed there-under to consider/decide appeals preferred before it by the persons/firms who are aggrieved by any decision of the CLB or the Registration Board etc. The Board felt that the firm may approach to submit its grievances before the said apex forum (Drug Appellate Board) as provided under the Drugs Act, 1976 after communication of decisions of Central Licensing Board.

ii) The Board deferred the case being sub- judice and lying pending before Islamabad High Court, Islamabad.

iii) The Board further decided that the production of the firm will remain stopped as the gross violations of Drug (Licensing, Registering and Advertising) Rules1976 had been committed by the firm.

Item No. 19 (New Case):- M/s Risma Laboratories, Karachi


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 16.05.2013. The case was placed before CLB in its 232nd meeting and Mr. Sohail Riaz, Director/GM of the firm appeared before the Board wherein he informed that the panel has been constituted to re-inspect the firm, but due to Holy month of Ramadan, the inspection is still pending.


Decision of CLBi) The Board deferred the case and decided that production

of the firm will remain stopped till panel inspection and final decision by Central Licensing Board in the light of panel inspection report.

of 78

ii) The Board directed the QA Section to send reminder to panel for conducting the inspection expeditiously.

iii) The Board also took serious notice and showed its deep concern on casual behavior/response of the field offices/FIDs in conducting inspection for the purpose of GMP compliance and for panel inspections for various purposes under the Drugs Act 1976 and rules framed there under which causes un necessary delay in disposing off cases by CLB.

Item No. 20 (New Case):- M/s British Pharma, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 09.05.2013. The case was placed before CLB in its 232nd meeting and Mr. Muhammad Akram, Production In charge appeared before the Board wherein he informed that their panel inspection has been conducted. The report is still awaited.


Decision of CLB i) The Board deferred the case and decided that the

production of the firm will remain stopped till panel inspection and final decision by Central Licensing Board in the light of panel inspection report.

ii) The Board also took serious notice and showed its deep concern on casual behavior/response of the field offices/FIDs in submitting inspection reports for the purpose of GMP compliance and for panel inspections for various purposes under the Drugs Act 1976 and rules framed there under which causes un necessary delay in disposing off cases by CLB.

Item No. 21 (New Case):- M/s Medivet (Pvt) Ltd, Lahore

Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs (Licensing, Registering & Advertising) Rules, 1976 and gross violations of GMP as laid down under Schedule B-II of Drugs

of 78

(Licensing, Registering & Advertising) Rules, 1976 framed under Drugs Act, 1976. Details of violations are given as per relevant agenda item.

Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 09.05.2013. The case was placed before CLB in its 232nd meeting and Mr. Haris Saeed, Managing Director and Mr. Uzair, Production Manager appeared before the Board, wherein they have informed that they made improvements as suggested by the FID and ready for inspection.


Decision of CLB i) The Board decided that the production will remain

stopped till the final decision by Central Licensing Board.ii) The Board also decided to get the firm re-inspected by a

panel to verify the improvements made by the firm in the light of shortcomings indentified by the area FID.

iii) The panel inspection report as and when received will accordingly be presented in the meeting of CLB for further consideration and decision by the Board.

Item No. 22 (New Case):- M/s Oval Pharmaceuticals, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 25.03.2013. The case was placed before CLB in its 232nd meeting and Mr. Muhammad Tahir Mahmood, Director of the firm appeared before the Board, wherein he informed that the panel inspection has been conducted and he submitted the copy of the report dated 17.06.2013 by hand to the Board. The report was read out before the Board and it was observed by the Board that this report was a preliminary report. The panel has reported that most of the shortcomings addressed by the firm and the panel is of opinion to resume/recommend the production activities and the detail report will be sent to the Board concerned.

Proceeding:- The members of the Board were provided with the agenda of QA Section. The brief of case was presented before 232nd meeting of Central Licensing Board and Board was apprised about the cases

of 78

of firms who have violated the conditions of DML, Rules and non compliance of GMP and action taken by the DRAP. The Board after thorough deliberations on all the agenda items including the instant case took the decision accordingly on case to case basis.

Decision of CLB The Board after thorough discussion decided as follows:-i) The Board observed that the panel report dated

17.06.2013 was not complete to evaluate overall GMP compliance and rectification of shortcomings etc.

ii) The Board decided to defer the case and place the same in the next meeting of the Central Licensing Board in the light of the detailed report submitted by the panel.

Item No. 23 (New Case):- M/s Lahore Pharma, Lahore


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 29.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Muhammad Saeed, Owner of the firm appeared before the Board wherein he submitted the reply of show cause notice to the Board and requested that they have made improvements as suggested by the FID and ready for inspection and also requested to withdraw the show cause notice.


Decision of CLBi) The Board decided that the production will remain

stopped till the final decision by Central Licensing Board. ii) The Board also decided to get the firm re-inspected by a


iii) The panel inspection report will be presented in next meeting of CLB as and when received for further consideration and decision by the Board.

of 78

Item No. 24 (New Case):- M/s Meredoa Company, Karachi


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 23.04.2013. The case was placed before CLB in its 232nd meeting and the owner of the firm informed that he was intending to perform Aitiqaf from the same evening due to which he was unable to travel and appear personally before the Board on 30.07.201, and requested that his case may be deferred for next meeting. The case was placed before the Central Licensing Board.


Decision of CLB i) The Board decided to defer the case till next meeting of

CLB and the production will remain stopped till the final decision by Central Licensing Board.

Item No. 25 (New Case):- M/s Euro Pharma International, Karachi


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 23.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Asif Iqbal, Director of the firm appeared before the Board wherein he requested that they need some more time about 2 months to rectify the shortcomings. As per statement of the representative of firm, the firm has been sealed by the Custom Authorities which will be de-sealed in next month.

Proceeding:- The members of the Board were provided with the agenda of QA Section. The brief of case was presented before 232nd meeting of Central Licensing Board and Board was apprised about the cases of firms who have violated the conditions of DML, Rules and non

of 78

compliance of GMP and action taken by the DRAP. The Board after thorough deliberations on all the agenda items including the instant case took the decision accordingly on case to case basis.

Decision of CLB After hearing the views of the firm and keeping in view the relevant legal provisions/codal formalities and through deliberations of the honorable members decided as under:-

i) The production of firm will remain stopped till the rectification of the shortcomings as identified by the panel on 05.03.2013and final decision by the Central Licensing Board.

ii) The Board decided to constitute a panel to re-inspect the unit in the light of intimation by the firm regarding improvements made and get the firm re-inspected accordingly.

iii) The Board also directed the firm to provide the status of the matter decided by the Custom Authorities to QA Section immediately.

iv) DDG (E&M), Karachi will be directed to coordinate and pursue with Custom Authorities to have update of the matter and inform to QA Section accordingly.

Item No. 26 (New Case):- M/s Shazal’s Pharmaceuticals (Pvt) Ltd, Hattar


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 26.02.2013. The case was placed before CLB in its 232nd meeting and Mr. Muhammad Afzal, Chief Executive and Raja Zahir, Production In charge appeared before the Board and requested for the resumption of production as their panel inspection has been conducted on 06.05.2013 wherein the panel comprising area FID Peshawar, area ADC and area Provincial Drug Inspector, Haripur recommended for resumption of production of the firm..


of 78

Decision of CLB The Board after taking into consideration, the recommendation of panel comprising of area FID Peshawar, area ADC and area Provincial Drug Inspector, Haripur vide its inspection report dated 06.05.2013, hearing the views of the firm and keeping in view the relevant legal provisions/codal formalities and through deliberations of the honorable members decided as under:-i) The Board on the recommendations of the panel allowed

the provisional resumption of production.ii) The Board also decided to conduct the comprehensive

inspection by the larger panel within 30 days after resumption of production.

iii) The persons appeared before the board also committed to complete their application for renewal of DML and furnish complete documents of their technical staff as pointed out by Secretary CLB during the meeting

Item No. 27 (New Case):- M/s Zanctok Pharmaceuticals Laboratory, Hyderabad


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 07.06.2013. The case was placed before CLB in its 232nd meeting and Mr. Feroz Ali Lasi, Director of the firm appeared before the Board wherein he informed that panel inspection has been conducted in which the panel is of opinion that firm has improved their production and quality control facilities and recommended to resume to production. The panel inspection report of the firm with its recommendations for production resumption was however received before meeting.


Decision of CLB The Board after taking into consideration, the recommendation of panel comprising of Mr. Saleem Isharat Hussain, CDI, Sindh, Dr. Muhamad Tanweer Alam, DDG (E&M), Karachi and Dr. Najam-us-Saquid, FID Karachi vide its inspection report dated 23.07.2013, hearing the views of the firm and keeping in view the

of 78

relevant legal provisions/codal formalities and through deliberations of the honorable members decided as under:-i) The Board decided for provisional resumption of

production activities of the firm.ii) The firm shall be re-inspected in working condition by a

larger panel within 30 days time period after the resumption of production as per provision of Schedule B-II of Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under Drugs Act, 1976 specially containing provision for GMP compliance.

Item No. 28 (New Case):- M/s Raymond Pharmaceuticals, Lahor


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 after issuance of show cause notice/ stop production order dated 07.06.2013. The case was placed before CLB in its 232nd meeting and Mr. Muhammad Asif Ch. Proprietor of the firm appeared before the Board wherein he informed that they have made improvements as suggested by the FID and ready for inspection.


Decision of CLB i) The Board decided that the production will remain

stopped till the final decision by Central Licensing Board. ii) The Board also decided to get the firm re-inspected by a


iii) The panel inspection report will be presented in next meeting of CLB as and when received for further consideration and decision by the Board.

Item No. 29 (Old Case):- M/S. ROYAL GROUP & MARION LABORATORIES, KARACHI.

Proceedings- The case of M/s Royal Group and M/s Marion Laboratories (Pvt) Ltd, Karachi was presented in 231st meeting of CLB meeting held on 31.01.2013 wherein following decisions was taken:-

of 78

“The case was placed before the Board in its 231st meeting, wherein M/s Royal Group and M/s Marion Laboratories (Pvt) were called for personnel hearing. After hearing deliberated views of both the firms, the Board directed to both firms to expedite the destruction of substandard batches “Injection Marivell-5 (Dextrose 5%) 500ml manufactured by M/s Marion Laboratories (Pvt) Ltd, Karachi which are lying at port Darussalam and M/s Marion Laboratories (Pvt) Ltd, Karachi had committed to the Board for bearing the expenditures. M/s Marion Laboratories (Pvt) Ltd, Karachi has submitted an undertaking to the Board in this regard”.

Now the Board in its 232nd meeting was apprised about the previous decision of the Board and non compliance of M/s Marion Laboratories (Pvt) Ltd, Karachi on aforesaid decision. The Board took serious notice of casual of approach of M/s Marion Laboratories (Pvt) Ltd, Karachi as on one hand the reported substandard products to pose great threat to public health and on other hand it gave a bad name/fame to Pakistan which may greatly hamper the exports of pharmaceutical industry and tantamount to loss of government exchequer. The Board seriously intended to hear both the parties in order to resolve the matter amicably but unfortunately M/s Marion Laboratories (Pvt) Ltd, Karachi adopted delaying tactics and did not appear before the Board. Even on the direction of Board, DDC (QA) talked telephonically to Mr. Imran Saboor (Son of the Owner/CEO) during the proceedings of the Board to inform M/s Marion Laboratories (Pvt) Ltd, Karachi for personal hearing (as the representative of M/s Marion Lab at Islamabad was not picking the phone) on next day i.e. 30.07.2013 of the Board’s meeting so that their personal hearing be actualized on the evening of same day i.e. 29.07.2013, the Chairman, CLB also talked on telephone to Mr. Imran Saboor to come for personal hearing before the Board on 30.07.2013 as issue was of serious consequences tin hampering exports of pharmaceuticals to the world and African region in particular and causing bad name for the country at large. Despite all out possible efforts even talking on telephone to Mr. Imran Saboor for attending the Board’s meeting even on its next day but he flatly denied to attend the same.

Mrs. Mumtaz Maker, Chairperson of Royal Group appeared before the Board wherein she has presented her matter before the Board in detail regarding the non compliance of M/s Marion Laboratories (Pvt), Karachi and said that the other party did not stand on decision of CLB taken in 231st meeting of the Board. She added that in case M/s Marion Laboratories (Pvt) Ltd, Karachi did not cooperate in destroying substandard batches referred to drug lying at Darussalam port in shortest possible time, it would badly effect not only the exports to whole Africa Region but may also pose serious consequences for the country if matter exploited by other countries, WHO and other international agencies.

After hearing the views of Royal Group, the Board was of serious concern as the repute of the country is at stake and the neighboring countries like India may exploit this issue for generating problems for exports of pharmaceuticals from Pakistan and many such other consequences of serious impact putting repute of the country at stake.

The Board also directed the PPMA representatives of the Board to communicate to their member companies especially M/s Marion Laboratories (Pvt.) Ltd, Karachi for its extremely casual and irresponsible attitude towards this very important issue.

Decision of CLB Then the Board in the light of fore going facts/details, decided the case as under:-

of 78

i) The Board upheld its previous decision of destruction of substandard consignments of drugs “Injection Marivell-5 (Dextrose 5%) 500ml lying at Port Darussalam( Tanzania) and Rwanda in a manner as has been devised/agreed upon by both the parties in 231st meeting of CLB.

ii) The Board took serious note as why M/s Marion Laboratories (Pvt) Ltd, Karachi did not comply with the previous order of the Board for destruction of substandard medicines exported from Pakistan. The Board was of the view that sanctity of Pakistan is at risk and strict action under the Drugs Act, 1976 and rules framed there under should be initiated immediately against M/s Marion Laboratories (Pvt) Ltd Karachi for supply of substandard Injection Marivell-5 (Dextrose 5%) 500ml to M/s Royal Group for export purpose to Rwanda.

iii) The Board decided to suspend the Drug Manufacturing License of M/s Marion Laboratories (Pvt) Ltd, Karachi for period of six months for which intimation to Drug Registration Board shall be conveyed accordingly.

iv) The Board also decided to send recommendation to the Registration Board for cancellation/suspension of registration of Injection Marivell-5 (Dextrose 5%) 500ml under section 42 of Drugs Act, 1976 and rules framed there under for manufacturing and supply of substandard drug in the importing country.

v) Resumption of production in the facility will only be allowed by CLB after comprehensive inspection of firm with regard to compliance/ conformity to the conditions of DML and compliance towards the GMP as required under the law/rules.

Item No. 30 (New Case):- M/s Symans Pharmaceuticals (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 29.07.2013 after issuance of stoppage of production order dated 13.03.2013. The case was placed before CLB in its 232nd meeting and Dr. Syed Saleem Haider, Chief Executive of the firm appeared before the Board wherein he requested the Board for resumption of production based on panel inspection conducted on 31.05.2013. During course of hearing he used harsh words before the Board and lost his temper of which the Board took very serious notice and reminded him about his unethical and unprofessional attitude.

of 78

Proceeding: - The members of the Board were provided with the agenda of QA Section. The brief of case was presented before 232nd meeting of Central Licensing Board and Board was apprised about the cases of firms who have violated the conditions of DML, Rules and non compliance of GMP and action taken by the DRAP. The Board after thorough deliberations on all the agenda items including the instant case took the decision accordingly on case to case basis.

.Decision of CLB The Board after taking into consideration, the recommendation of panel comprising of Mr. Asim Rauf, DDG (E&M)/FID, Lahore, Mr. Moazzam Ali Khan, Secretary PQCB Punjab and Mrs. Aisha Khalil, FID Lahore vide its inspection report dated 31.05.2013 hearing the views of the firm and keeping in view the relevant legal provisions/codal formalities and through deliberations of the honorable members decided as under:-i) The Board on the recommendations of the panel allowed

the provisional resumption of production only for non-penicillin products.

ii) The firm shall be re-inspected in working condition by a larger panel within 30 days time period after the resumption of production as per provision of Schedule B-II of Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under Drugs Act, 1976 specially containing provision for GMP compliance.

iii) Production of sections of penicillin containing products shall remain stopped till the provision of self-contained/dedicated facilities by firm after approval of layout plan by Licensing Section and subsequent consideration/decision by CLB.

iv) Board also took extremely serious notice of the harsh, unethical and unprofessional attitude of Dr. Syed Saleem Haider, Chief Executive of the firm towards the Board during its proceedings and decided to issue warning to him to refrain from such attitude before the Board and be careful in future.

v) The Board also directed the representatives of PPMA and Pharma Bureau to communicate, the serious concern and displeasure of all the Board members regarding the un professional, un ethical and harsh attitude of Dr. Syed Saleem Haider, Chief Executive of the firm, to all their member companies in general and the firm under reference in particular under intimation to the Central Licensing Board.

Item No. 31 (New Case):- M/s Alco Chemical (Pvt) Ltd, Lahore

Violations of Rule:- Non fulfillment of conditions of relevant provisions of Drugs (Licensing, Registering & Advertising) Rules, 1976 and gross violations of GMP as laid down under Schedule B-II of Drugs (Licensing, Registering & Advertising) Rules, 1976 framed under

of 78

Drugs Act, 1976. Details of violations are given as per relevant agenda item.

Date of Hearing:- The firm was called for personal hearing on 29.07.2013 after issuance of stoppage of production order dated 14.05.2013. The case was placed before CLB in its 232nd meeting and Dr. Maria H. Arora, Director of the firm appeared before the Board wherein she informed that they have rectified all the shortcomings and their firm was ready for inspection.


Decision of CLB i) The CLB after hearing the views of the firm, decided to

constitute a panel to inspect the firm to check/verify the improvements made by the firm and also check the GMP compliance of the firm in the light of the shortcomings pointed out by the FID.

ii) The Board upheld the decision of stoppage of production till the final approval by Central Licensing Board.

Item No. 32(New Case):- M/s Ferroza International Pharmaceuticals (Pvt) Ltd, Lahore


Date of Hearing:- The firm was called for personal hearing on 29.07.2013 before CLB in its 232nd meeting and Mr. Usman Khalid, Director of the firm appeared before the Board wherein he informed that they had rectified all the shortcomings pointed out by the FID in his report and requested to inspect the firm within 30 days.


of 78

Decision of CLBi) The Board after hearing the views of the firm decided to

constitute a larger panel to inspect the firm on audit performa schedule B-II in all sections in order to check/verify the GMP compliance.

ii) The production in cephalosporin section will remain stopped till the final decision by Central Licensing Board.

Item No. 33 (New Case):- M/s Eros Pharma (Pvt) Ltd, Karachi


Date of Hearing:- The firm was called for personal hearing on 29.07.2013 after issuance of stoppage of production order dated 26.04.2013. The case was placed before CLB in its 232nd meeting and Mr. Khalid Akhter, Director of the firm appeared before the Board wherein he informed that panel inspection of their unit has been conducted and they requested for the resumption of production in the light of recommendation of the panel by its report dated 08.07.2013.


Decision The Board after taking into consideration, the recommendation of panel comprising of Mr. Saleem Isharat Hussain, CDI, Sindh, Dr. Muhamad Tanweer Alam, DDG (E&M), Karachi and Dr. Shahid Hussain, FID Karachi vide its inspection report dated 08.07.2013 hearing the views of the firm and keeping in view the relevant legal provisions/codal formalities and through deliberations of the honorable members decided as under:-

i) The Board on the recommendations of the panel allowed the provisional resumption of production.

ii) The firm shall be re-inspected in working condition by a larger panel within 30 days time period after the resumption of production as per provision of Schedule B-II of Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under Drugs Act, 1976 specially containing provision for GMP compliance.

of 78

Item No. 34:- (M/s Care Pharmaceuticals, Lahore)


Date of Hearing:- The firm was called for personal hearing on 30.07.2013 and the case was placed before CLB in its 232nd meeting and Mr. Aamir Zulfiqar Ahmad, Director of the firm appeared before the Board wherein he submitted that he is not involved in manufacturing of general product i.e. (sliver sulphadiazine) in steroid section and he also submitted an undertaking to the area FID in this regard.


Decision of CLB i) To stop production of general products in steroid

manufacturing area. ii) The Board also decided that the firm should surrender

registration of the general product i.e. Silver Sulphadiazine and also intimate the CLB accordingly.

iii) The Board also decided to constitute a panel to get the firm re-inspected on audit Performa schedule B-II in all sections in order to check/verify the overall GMP compliance level of the firm in addition to verification of stoppage of production of general products (sliver sulphadiazine) in the steroidal manufacturing area.

Item No. 35:- M/s Pak Risen Pharmaceuticals, Hattar


Date of Hearing:- The firm was called for personal hearing on 29.07.2013 after issuance of show cause notice/ stop production dated 14.09.2012. The case was placed before CLB in its 232nd meeting and Mr. Sabir Khan, Managing Director of the firm appeared before the Board wherein he apologized from the Board that he resumed the production without proper approval from the Board and requested

of 78

that the firm’s production may be allowed to be resumed properly as the panel has recommended and allowed to resume production some months before and subsequently FID has visited and reported GMP compliance level of the firm as good and presented before the Board the copies of inspection reports dated 25-06-2013 and 15-07-2013.


Decision of CLB After hearing the views, request of the firm, and considering the reports of inspections conducted by panel on 05-12-2012, by area FID on 28-01-2013, 25-06-2013 and 15-07-2013, the Board decided as under:-

i) The Board allowed the firm provisionally to resume production of their facility.

ii) The Board also decided to constitute a larger panel to inspect the firm on audit Performa devised as per schedule B-II of Drugs (Licensing, Registration and Advertising) rules 1976 in all sections in order to check/verify the GMP compliance.

iii) Direct the firm to recall all the batches from the market/institutions manufactured after the stoppage of production i.e. 14.09.2012.

iv) The firm apologized for their practice and assured the Board that they will not repeat such practice of resumption of production at their own in future till decision by the CLB. The Board warned the firm to refrain such practice in future.

v) The Board also took serious notice and showed its deep concern on casual behavior/response of the field offices/FIDs in submitting inspection reports for the purpose of GMP compliance and for panel inspections for various purposes under the Drugs Act 1976 and rules framed there under which causes un necessary delay in disposing off cases by CLB.

MEETING ENDED WITH THE VOTE OF THANKS TO THE CHAIR.

************

of 78

minutes of 229th meeting of central licensing ... of... · web viewrana m. maqsood advocate stated...

Documents