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MINUTES OF 261st MEETING OF CENTRAL LICENSING BOARD HELD ON 2nd MAY, 2018

*=*=*=*=*261st meeting of the Central Licensing Board (CLB) was held on 2nd May, 2018 in the Committee

Room, Drug Regulatory Authority of Pakistan, 4th Floor, T.F. Complex, G-9/4, Islamabad under the

Chairmanship of Mr. Ghulam Rasool Dutani, Director Drug Licensing, Drug Regulatory Authority

of Pakistan, Islamabad.

Following members attended the meeting: -

S. No. Name & Designation Status

1.Mr. Muhammad Israr Additional Draftsman/Joint Secretary (Ex-officio), Ministry of Law and Justice, Islamabad.

Member

2. Dr.Ikram-ul-Haque, Expert inQC/QA of drugs. Member3. Syed Muied Ahmed, Expert in manufacturing of drugs Member4. Prof. Dr. Mohammad Usman, Expert in manufacturing of drugs Member

5.Prof .Dr. Jamshaid Ali Khan, Department of Pharmacy, University of Peshawar, Peshawar.

Member

6. Dr. Abbas Khan, Chief Drug Inspector, Health Department, KPK. Member

7.Syed Saleem Shah, Chief Drug Inspector, Department of Health, Govt. of Balochistan, Quetta.

Member

8.Dr. Hafsa Karam EllahiRepresentative Director (QA/LT), DRAP, Islamabad

Member

9.Mr. Manzoor Ali Bozdar, Additional Director (Lic.), DRAP, Islamabad.

Secretary/Member

10. Mr. Nadeem Alamgir, Representative of Pharma Bureau Observer11. Mr. Kamran Anwar, Representative of PCDA. Observer12. Mr. Saboor Ahmed Sheikh, Representative of PPMA. Observer

The meeting started with the recitation of verses from the Holy Qura’an. The Chairman Central

Licensing Board welcomed the honorable members and participants of the meeting. He stated that

all the legal and codal formalities would be taken into account for disposal of cases and respective

Divisions shall be responsible for the contents, errors and omissions of agenda and minutes. Mr.

Abdul Sattar Sohrani, Mr. Zeeshan Nazir, Deputy Director (QA), Dr. Muhammad Yaqoob AD

(Lic.), and Dr. Zunaira Farayad, Assistant Director (Lic), DRAP Islamabad assisted the Secretary

Central Licensing Board in presenting the agenda.

Item-I CONFIRMATION OF THE MINUTES OF 260 th MEETING

The Central Licensing Board (CLB) formally confirmed the minutes of its 260 meeting held on 16th

April, 2018.

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A. DRUG LICENSING DIVISION

Item-I: GRANT OF ADDITIONAL SECTIONS/EXPANSION/AMENDMENTS ETC.

Following cases have been forwarded by the respective panel of experts for grant of additional

sections. The same are placed before the Board for its consideration/decision, please.

S # Name of the firmDate of

Inspection Ranking/

EvaluationInspection Panel Members

1. M/s Tagma (Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore

DML No. 000414 (Formulation)

Section (02)1. Tablet (Psychotropic /

Narcotic) Section2. Capsule (Psychotropic /

Narcotic) Section

29-04-2015 ---- 1. Dr. Sheikh Akhter Hussain, DDG (E&M), DRAP, Lahore.

2. Mr. Syed Zia Husnain, Federal Inspector of Drugs, DRAP, Lahore.

3. Dr. Akbar Ali, Assistant Drugs Controller.

Recommendations of the panel: -Panel has thoroughly visited the firm and evaluated the documents. Firm has shown lot of

improvement with regard to previous inspections and complied the advises given.

Cephalosporin, Ointment and Sachet sections have ample capacity at present however; said

capacity is underutilized as observed. Panel therefore recommended that in case of

applications of the firm for registration in respective sections, Registration Board may

consider the applications of the Registration under the law and as per policy so that capacity

may be utilize. Panel also recommended for consideration of inspection conducted by the

panel on 06-04-2011 with reference Ministry’s letter no.F.1-8/94 dated 27-11-2010 for grant

of additional sections of Psychotropic / Narcotic (Tablet & Capsules) by Board considered

under Drug Act 1976.

Decision by the Central Licensing Board in 261st meeting

The Board considered and approved the grant of following additional sections in the name of M/s Tagma Pharma (Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore on the recommendations of the panel of experts:- Section (02)

1. Tablet (Psychotropic / Narcotic) Section2. Capsule (Psychotropic / Narcotic) Section

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2 M/s Reliance Pharma, Plot No. 08, S-08, RCCI, Rawat.

Section.

i. Quality Control Lab. (Approval for revised Layout Plan-First Floor).

ii. Ointment and Creams (General) (Regularization).

iii. Gel Section (General) (Regularization).

27-04-2018 Good 1. Mr. Manzoor Ali Bozdar, Additional Director (Licensing), DRAP, ISlambad.

2. Mr. Babar Khan, Dy. Director (PE&R), DRAP, Islamabad.

3. Dr. Hassan Afzaal, FID-III, DRAP, Islamabad.

4. Dr. Muhammad Usman, Assistant Director (Licensing), DRAP, Islamabad.

Recommendations of the panel: -

Keeping in view the above facts, detailed visit of facility and supporting documents provided by the company, the panel unanimously recommended M/s Reliance Pharmaceutical, Plot No. 08, S-08, RCCI, Rawat, Rawalpindi for approval of Revised Layout Plan and regularization of Lay out plan for the following sections as under;

i. Ointment and Creams (General) (Regularization).ii. Gel Section (General) (Regularization).iii. Quality Control Lab. (Approval for revised Layout Plan-First Floor).


The Board considered and approved the following amendments and regularization of sections in the name of M/s Reliance Pharma, Plot No. 08, S-08, RCCI, Rawat on the recommendations of the panel of experts:-

Section (03)i. Ointment and Creams (General) (Regularization).ii. Gel Section (General) (Regularization).iii. Quality Control Lab. (Approval for revised Layout Plan-First Floor).

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Item-II: GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE.

Following cases have been forwarded by the respective panel of experts for grant of Renewal of

Drug Manufacturing Licenses. The same are placed before the Board for its consideration/decision,

please.

S # Name of the firm Date of Inspection

Ranking/ Evaluation

Inspection Panel Members

1 M/s Daneen Pharmaceuticals (Pvt) Ltd[Formerly Kings Pharmaceuticals], Plot No. 27 Sunder Industrial Estate, Lahore


Period: commencing on 21-06-2015 and ending on 20-06-2020

06-02-2018 Nil 1. Dr. Ikram-ul-Haq, Member CLB.

2. Mr. Asim Rauf, Additional Director, DRAP, Lahore.

3. Mr. Imran, Drugs Inspector Industrial, Punjab, Lahore.

4. Ms. Ufaq Tanveer, Federal Inspector of Drugs, Lahore


Keeping in view the facilities like building, HVAC system, machinery and equipment, Instruments, personnel, documentation, Quality Control, testing facilities, panel of inspectors is of the opinion to recommend the renewal of Drug Manufacturing License to M/s Daneen Pharmaceuticals (Pvt) Ltd[Formerly Kings Pharmaceuticals], 27 Sunder Industrial Estate, Lahore for the following

sections.

However, the firm was advised to develop IPQC in general tablet area and improve overall flooring.


The Board considered and approved the renewal of Drug Manufacturing Licence No. 000688

(Formulation) in the name of M/s Daneen Pharmaceuticals (Pvt) Ltd [Formerly Kings

Pharmaceuticals], Plot No. 27 Sunder Industrial Estate, Lahore, on the recommendations of the

panel of experts for the further period of five years commencing on 21-06-2015 and ending on 20-

06-2020. The Board also decided that Federal Inspector of Drugs shall ensure and verify the

compliance of the advises of the panel of experts / inspectors.

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S # Name of the firm Date of Inspection

Ranking/ Evaluation

Inspection Panel Members

2 M/s Reliance Pharma, Plot No. 08, S-08, RCCI, Rawat.


Period:

20-06-2016 to 19-06-2021.

27-04-2018 Good 1. Mr. Manzoor Ali Bozdar, Additional Director (Licensing), DRAP, ISlambad.

2. Mr. Babar Khan, Dy. Director (PE&R), DRAP, Islamabad.

3. Dr. Hassan Afzaal, FID-III, DRAP, Islamabad.

4. Dr. Muhammad Usman, Assistant Director (Licensing), DRAP, Islamabad.


Keeping in view the above facts, detailed visit of facility and supporting documents provided

by the company, the panel unanimously recommended M/s Reliance Pharmaceutical, Plot

No. 08, S-08, RCCI, Rawat, Rawalpindi for renewal of Drug Manufacturing License No.

000724 (Formulation)


The Board approved the renewal of Drug Manufacturing Licence No. 000724 (Formulation) in the

name of M/s Reliance Pharma, Plot No. 08, S-08, RCCI, Rawat, on the recommendations of the

panel of experts for the further period of five years commencing on 20-06-2016 and ending on 19-

06-2021

Item-III: MISCELLANEOUS CASES

CASE NO. 1 CHANGE OF MANAGEMENT OF M/S SATURN PHARMACEUTICALS (PVT) LTD, LAHORE

M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore under DML No.

000734 by way of formulation has submitted request for change in management of the firm as per

Form-29 with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as

under;

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Current Management as per Form-29

Retiring Management Proposed Management as per Form-29

1. Mr. Ahmad Sattar S/o Abdul Sattar Bajwa CNIC No. 35202-1679293-1.2. Mr. Abdul Sattar Bajwa S/o Muhammad Hussian Bajwa CNIC No. 35202-3354188-5.3. Mr. Zafar Ullah S/o Muhammad Siddque CNIC No. 34603-5597479-9.4. Mr. Harron Ali S/o Muhammad Ali CNIC No. 34603-9421872-7.5. Ms. Nasreen Akhtar W/o Abdul Sattar Bajwa CNIC No. 35202-1126689-4.6. Mr. Junaid Asif S/o Muhammad Asif CNIC No. 34603-6936703-1.


1. Mr. Ghulam Yasin Paracha S/o Muhammad Siddiq CNIC No. 35202-8164982-1.2. Ms. Iram Yasin

Paracha W/o Ghulam Yasin Paracha CNIC No. 35202-06118274-2.

Decision by the Central Licensing Board in 261 st meeting:

The Board considered and endorsed the change of management from old to new management of

M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore, under DML No.

000734 by way of formulation as per Form-29 as under;

Current Management as per Form-29

Retiring Management New Management as per Form-29



1. Mr. Ghulam Yasin Paracha S/o Muhammad Siddiq CNIC No. 35202-8164982-1.2. Ms. Iram Yasin

Paracha W/o Ghulam Yasin Paracha CNIC No. 35202-06118274-2.

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CASE NO. 2 CHANGE OF MANAGEMENT OF M/S QINTAR PHARMACEUTICALS, SARGODHA

M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha under

DML No. 000520 by way of formulation has submitted request for change in management of the

firm as per partnership deed with prescribed Fee Challan of Rs.50,000/-. The detail of

management of the firm is as under;

Existing Management as per Form-1A & Partnership deed

Retiring Management

Proposed Management as per Partnership deed page

1. Mr. Muhammad Riaz Masood S/o Dost Muhammad CNIC No. 38403-1866608-1

2. Mr. Muhammad Azhar Mahmood S/o Dost Muhammad

3. Mr. Sarfaraz Ahmad S/o Abdul Hameed CNIC No. 38403-0302356-9.



2. Mr. Irshad-ul-Haq S/o Mukhtar Ahmad CNIC No. 38403-2129300-7.




M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha, under

DML No. 000520 by way of basic manufacture as per Form-29 as under;

Current Management Partnership deed

Retiring Management

New Management as per Partnership deed






2. Mr. Irshad-ul-Haq S/o Mukhtar Ahmad CNIC No. 38403-2129300-7.


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CASE NO. 3 CHANGE OF MANAGEMENT OF M/S PULSE PHARMACEUTICALS (PVT) LTD, LAHORE

M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore

under DML No. 000564 by way of formulation has submitted request for change in management of

the firm as per Form-29 with prescribed Fee Challan of Rs.50,000/-. The detail of management of

the firm is as under;

Previous Management as per Form-1A

Retiring Management

Proposed Management as per Form-29

1. Mr. Muhammad Hussain Mehdi.2. Ms. Maryam Hussain

Mehdi. 3. Dr. Ambreen Javed. 4. Ms. Fatima Hussain

Mehdi. 5. Mrs. Naghmana Javed.6. Mr. Khawaja Nadeem

Akbar.

1. Mrs. Naghmana Javed.2. Mr. Khawaja

Nadeem Akbar.

1. Mr. Muhammad Hussain Mehdi S/o Hussain Mehdi CNIC No. 44107-2040792-9.2. Ms. Mariam Hussain Mehdi D/o

Hussain Mehdi CNIC No. 44107-4563314-2.3. Dr. Ambreen Javed W/o Javed Iqbal

Butt CNIC No. 35202-3660452-8.4. Ms. Fatima Hussain Mehdi D/o

Hussain Mehdi CNIC No. 44107-1985141-8.5. Javaid Iqbal S/o Muhammad Iqbal

CNIC No. 35202-9644985-9.



M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore,

under DML No. 000564 by way of basic manufacture as per Form-29 as under;

Current Management Retiring Management

New Management as per Form-29

1. Mr. Muhammad Hussain Mehdi.2. Ms. Maryam Hussain

Mehdi. 3. Dr. Ambreen Javed. 4. Ms. Fatima Hussain

Mehdi. 5. Mrs. Naghmana Javed.6. Mr. Khawaja Nadeem

Akbar.

1. Mrs. Naghmana Javed.2. Mr. Khawaja

Nadeem Akbar.

1. Mr. Muhammad Hussain Mehdi S/o Hussain Mehdi CNIC No. 44107-2040792-9.2. Ms. Mariam Hussain Mehdi D/o

Hussain Mehdi CNIC No. 44107-4563314-2.3. Dr. Ambreen Javed W/o Javed Iqbal

Butt CNIC No. 35202-3660452-8.4. Ms. Fatima Hussain Mehdi D/o

Hussain Mehdi CNIC No. 44107-1985141-8.5. Javaid Iqbal S/o Muhammad Iqbal

CNIC No. 35202-9644985-9.

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CASE NO. 4 CHANGE OF MANAGEMENT OF M/S CITI PARMA (PVT) LTD, DISTRICT KASUR

M/s Citi Parma (Pvt) Ltd. 3.5 km, Head Baloki Road, Bhai Bheru Distt. Kasur under DML No.

000512 by way of formulation has submitted request for change in management of the firm as per

Form-29 with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as

under;

Previous Management as per Form-29

Retiring Management

Proposed Management

1. Mr. Muhammad Naeem S/o Shar Muhammad CNIC No. 35202-2835907-9.2. Mr. Naveed Amjad S/o Shar Muhammad CNIC No. 35202-2835402-7.3. Mr. Rizwan Ahmad S/o Shar Muhammad CNIC No. 35202-6462958-5.

1. Mr. Muhammad Naeem S/o Shar Muhammad CNIC No. 35202-2835907-9.

2. Mr. Naveed Amjad S/o Shar Muhammad CNIC No. 352025-060989-7.3. Mr. Rizwan Ahmad S/o Shar Muhammad CNIC No. 35202-6462958-5.



M/s Citi Parma (Pvt) Ltd. 3.5 km, Head Baloki Road, Bhai Bheru Distt. Kasur , under DML No.

000512 by way of basic manufacture as per Form-29 as under;

Previous Management as per Form-29

Retiring Management

Proposed Management

1. Mr. Muhammad Naeem S/o Shar Muhammad CNIC No. 35202-2835907-9.2. Mr. Naveed Amjad S/o Shar Muhammad CNIC No. 35202-2835402-7.3. Mr. Rizwan Ahmad S/o Shar Muhammad CNIC No. 35202-6462958-5.

1. Mr. Muhammad Naeem S/o Shar Muhammad CNIC No. 35202-2835907-9.

2. Mr. Naveed Amjad S/o Shar Muhammad CNIC No. 352025-060989-7.3. Mr. Rizwan Ahmad S/o Shar Muhammad CNIC No. 35202-6462958-5.

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CASE NO. 5 CHANGE OF MANAGEMENT OF M/S DOSACO LABORATORIES, LAHORE

M/s Dosaco Laboratories , Lahore under DML No. 000094 by way of formulation has submitted

request for change in management of the firm as per Partnership deed with prescribed Fee Challan

of Rs.50,000/-. The detail of management of the firm is as under;

Previous Management as per Form-1A

Added Management Proposed Management as per Partnership deed

1. Mr. Nadeem Firdous.2. Mr. Umar Firdous

1. Mr. Abu Obaida Butt S/o Muhammad Yaqoob Butt.

1. Mr. Nadeem Firdous S/o Muhammad Firdous.2. Mr. Abu Obaida Butt S/o

Muhammad Yaqoob Butt.3. Mr. Umar Firdous S/o Muhammad

Firdous.



M/s Dosaco Laboratories , Lahore, under DML No. 000094 by way of basic manufacture as per

Form-29 as under

Current Management Incoming Management

New Management as per Partnership deed

1. Mr. Nadeem Firdous.2. Mr. Umar Firdous

1. Mr. Abu Obaida Butt S/o Muhammad Yaqoob Butt.

1. Mr. Nadeem Firdous S/o Muhammad Firdous.2. Mr. Abu Obaida Butt S/o

Muhammad Yaqoob Butt.3. Mr. Umar Firdous S/o Muhammad

Firdous.

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Case No. 6 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ZENITH CHEMICAL INDUSTRIES (PVT) LTD, LAHORE.

M/s Zenith Chemical Industries (Pvt) Ltd, Moza Dondey Jai Baga Raiwind Road, Lahore had

applied for renewal of DML No. 000733 by way of Semi Basic manufacture for the period of 15-

06-2016 to 14-06-2021 on 22-03-2016.

The application for the renewal of DML of the firm was evaluated and a letter for following

shortcomings / deficiencies was issued to the firm on 8 thJune, 2016 under Rule 5{2A} of Drugs

(Licensing, Registering, Advertising) Rules, 1976:-

1. Change(s) in name of proprietor / directors / partners (if any)2. Copy of 29 attested by SECP3. List of approved API4. Firm has appalled for the approval of proposed production Incharge Mr. Hasham

Khalid who is BSC Chemical engineering who does not full fill requirements of the Rule16 drugs (LR&A Rule1976)

5. Noting due certificate regarding CRF from STO.6. Resignation or termination letter of appointee from the previous firm / promotion

letter / transfer letter from the same firm QC Incharge7. Undertaking as whole time employee I QC Incharge8. Resignation / retirement of earlier QC Incharge.9. Fee of 10000. Production Incharge and QC Incharge.

The firm replied to this letter on 01-07-2016 alongwith application for approval of proposed Production Incharge. A letter dated 18th November, 2016 was issued to the firm for submission of following documents:

1. Undertaking as whole time employee for Production Incharge2. Nothing due certificate 3. Experience Certificate as under Drugs (Licensing, Registering and

Advertising) Rules, 1976. (not less than 10 years)4. Undertaking as whole time employee for QC Incharge5. All documents should be dully attested.

The firm submitted the shortcoming documents and a Reminder letter was issued on 2nd March,

2017 of following shortcomings.

1. Updated Nothing due certificate regarding CRF from STO.2. Copy of CNIC of appointee (Proposed Production Incharge and QC

Incharge).3. Job acceptance letter by the appointee (Proposed Production Incharge).4. Resignation / retirement of earlier Production Incharge.5. Undertaking as whole time employee (QC Incharge Mr. Muhammad

Omer Kaleem).6. All documents should be duly attested.

The firm submitted documents in reply to Reminder but following shortcomings were still present

in the application for renewal of DML.

1. Changes in name of proprietors / directors / partners (if any). of 63

2. CNIC copies of all directors / Partners.3. Copy of Form-29 (Updated)4. Nothing due certificate regarding CRF from STO (Updated).5. Proposed Production Incharge does not fulfills the requirements of Rule 16 of Drugs (L,

R, &A) rules 1976 in terms of qualification.6. Complete Set of documents for proposed Production Incharge as (per check list).7. Appointment letter (Quality Control Incharge).8. Job acceptance letter by the appointee (Quality Control Incharge).9. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules,

1976 (Not less than 10 years).10. Resignation / retirement of earlier Quality Control Incharge.11. Resignation or termination letter of appointee from the previous firm / promotion letter /

transfer letter from the same firm.12. All documents should be duly attested.

Final Reminder dated 31st July, 2017 under Rule 5 (2A) was issued to the firm for submission of following documents:

1. Changes in name of proprietors / directors / partners (if any).2. CNIC copies of all directors / Partners.3. Copy of Form-29 (Updated)4. Nothing due certificate regarding CRF from STO (Updated).5. Proposed Production Incharge does not fulfill the requirements of Rule 16 of Drugs (L,

R, &A) Rules 1976 in terms of experience ,submit complete set of documents of Production Incharge as per requirements of Rule 16 of Drugs (L, R, &A) Rules 1976.

6. Appointment letter (Quality Control Incharge).7. Job acceptance letter by the appointee (Quality Control Incharge).8. Experience Certificate of Quality Control Incharge as under Drugs (Licensing,

Registering and Advertising) Rules, 1976 (Not less than 10 years in relevant t field of Quality Control).

9. Resignation / retirement of earlier Quality Control Incharge.10. Resignation or termination letter of appointee from the previous firm / promotion letter /

transfer letter from the same firm (Quality Control Incharge and Production Incharge).11. All documents should be duly attested.

The firm replied to Final Reminder but application for renewal of DML is still incomplete with

following shortcoming.

1. Nothing due certificate regarding CRF from STO (Updated).

Proceedings and Decision of Central Licensing Board in 259 th meeting

The Board considering the facts on the record and after thread bare deliberation decided to serve

Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the

Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of

Rule, 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their

application for renewal of M/s Zenith Chemical Industries (Pvt) Ltd, Moza Dondey Jai Baga

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Raiwind Road, Lahore, Drug Manufacturing Licence No. 000733 by way of semi basic may not be

suspended till settlement of Central Research Fund.

Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.

The Show Cause notice dated 26th April, 2018 was issued to the M/s Zenith Chemical Industries

(Pvt) Ltd, Moza Dondey Jai Baga Raiwind Road, Lahore.

Nothing Due Certificate of CRF M/s Zenith Chemical Industries (Pvt) Ltd, , Lahore valid upto 31-

12-2018 has been received from Division of (B&A), DRAP and application for renewal of DML in

now complete.

Proceedings and Decision of Central Licensing Board in 261 st meeting

The Board considering the facts on the record and after thread bare deliberation decided to revoke

the operation of Show Cause Notice dated 26th April, 2018 issued in the name of M/s Zenith

Chemical Industries (Pvt) Ltd, Moza Dondey Jai Baga Raiwind Road, Lahore, Drug Manufacturing

Licence No. 000733 by way of semi basic manufacture. The Board also decided to issue warning to

the firm to be careful in future for compliance of the law.

Case No. 7 APPLICATION FOR APPROVAL OF PRODUCTION INCHARGE & QUALITY CONTROL INCHARGE OF M/S AVANT PHARMACEUTICAL (PVT) LTD, BALOCHISTAN.

M/s Avant Pharmaceutical (Pvt) Ltd, Plot No. M-28, Hub Industrial Estate, Balochistan had applied

on 1th September, 2017 for approval of Mr. Gul Muhammad Jamali as Production Incharge and Mr.

IqrarHussain as Quality Control Incharge after resignation of earlier Production Incharge w.e.f 11-

01-2017.

Application was evaluated and letter of following shortcomings was issued to the firm on 10 th

October, 2017.

1. Prescribe fee of Rs. 10,000/- for change of proposed Production Incharge and

Quality Control Incharge.

2. Job acceptance letter by the appointee (Production Incharge).

3. Resignation / retirement of earlier Production Incharge and Quality Control

Incharge.

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4. Resignation or termination letter of appointee from the previous firm / promotion

letter / transfer letter from the same firm (Production Incharge and Quality Control

Incharge).

5. Undertaking as whole time employee on stamp paper (Production Incharge and

Quality Control Incharge).

6. All documents should be duly attested.

Meanwhile, copy of resignation letter of Mr. Gul Muhammad Jamali was received on 24th October,

2017.The firm replied to aforementioned letter of shortcomings on 11th November, 2017 and

submitted deficient documents of Quality Control Incharge and filed new application for approval

of Mr. Muhammad Arif Khan as Production Incharge. Again a letter of following shortcomings was

issued to the firm on 24th November, 2017 for completion of application:

1. Complete set of duly attested documents for Proposed Production Incharge (as per

check list).

2. Appointment letter (Quality Control Incharge).

3. Job acceptance letter by the appointee (Quality Control Incharge).

4. Resignation / retirement of earlier QC Incharge.




The firm submitted documents on 26th December, 2017 in reply to Licensing Division’s letter and

submitted deficient documents of Quality Control Incharge and new application of Mr. Muhammad

Aslam. Upon evaluation, the following shortcomings were observed in the application and firm was

served with Final Reminder dated 2nd February, 2018:

1. Complete set of duly attested documents for Proposed Production Incharge and

Quality Control Incharge (as per check list).

2. Resignation / retirement of earlier QC Incharge and Production Incharge.




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The firm replied to Final Reminder but application for approval of technical staff is still incomplete

with following shortcomings.

1. Complete set of duly attested documents for Proposed Production Incharge and

Quality Control Incharge (as per check list).

2. Resignation / retirement of earlier QC Incharge and Production Incharge.








Rule 16 and Rule 19 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why

DML No. 000786 by way of Formulation in the name of M/s Avant Pharmaceutical (Pvt) Ltd, Plot

No. M-28, Hub Industrial Estate, Balochistan may not be suspended or cancelled by Central

Licensing Board.

Case No.8 CANCELLATION LICENSE OF M/S FLORENCE FARMACEUTICS (PVT) LTD, ISLAMABAD UNDER DRUG MANUFACTURING LICENSE NO. 000635 (FORMULATION)

Letter received from Mr. Awais Ahmed, Assistant Director (QA-IV), DRAP, Islamabad wherein he

has submitted inspection report of M/s Florence Pharmaceutics (Pvt) Ltd., Plot No. 266, Industrial

Triangle, Kahuta Road, Islamabad. The conclusion of inspection report is as under:-

“Mr. Arslan Tariq, FID-I Islamabad visited the firm M/s Florence Pharmaceutics

(Pvt) Ltd., Plot No. 266, Industrial Triangle, Kahuta Road, Islamabad on 12-01-

2018 to see the progress regarding the rectification of observations pointed out

during last inspection dated 15-11-2017, the firm was order to stop the production

by the Division of QA&LT till the rectification and verification of the observations.

However upon visit, the factory was found locked and chowkidar (Mr. Saleem) was

present on the site. In the presence of Driver & Mr. Shehzad Ahmed (Witness), that of 63

all the machinery has been moved to an unknown place by the owner of M/s

Florence Pharmaceutics (Pvt) Ltd., the chowkidar also stated that there is no

existence of M/s Florence Pharmaceutics as the real owner of land and building

(Mr. Farooq Khilji) has withdrawn / cancelled the lease / rental with the

management of M/s Florence Pharmaceutics.

FID confirmed the same telephonically from Mr. Farooq Khilji on Cell No. 0306-

5393900. He also informed that he had already submitted an application for the

cancellation of license to Mr. ManzoorBozdar, Additional Director (Lic), DRAP,

Islamabad”.

Meanwhile Mrs. Shahida Bano W/o Late Muhammad Sadqeen owner of Plot No. 266, Industrial

Triangle, Kahuta Road, Islamabad has informed that lease agreement was ended on October, 2016

and mutual understanding Florence Pharmaceutics Director Saif-ud-Din has withdrawn their Plot on

15th November, 2017. She has also informed that they are not interested for further agreement with

Florence Pharmaceutics (Pvt) Ltd.

Proceedings and Decision of Central Licensing Board in 259 th meeting




Rule, 5(2A), Rule 16 and Rule 19 of the Drugs (Licensing, Registering and Advertising) Rules,

1976 as to why their application for renewal of M/s Florence Pharmaceutics (Pvt) Ltd., Plot No.

266, Industrial Triangle, Kahuta Road, Islamabad Drug Manufacturing Licence No. 000635 by way

of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or

cancelled by Central Licensing Board.

Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.

The Show Cause notice dated 19th April, 2018 was issued to the of M/s Florence Pharmaceutics

(Pvt) Ltd., Plot No. 266, Industrial Triangle, Kahuta Road, Islamabad.

A letter of personal hearing has been issued to the firm on 24th April, 2018.


Mr. Tahir ul Wudood Lahooti appeared before the Board. He contended that he is the legal owner /

partner and CEO of the firm according to the available record of S.E.C.P and DRAP. He also

disclosed that the firm is under possession of illegal persons / trespassers against whom he has

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gotten registered a case of theft & encroachment as all the machinery and equipments have been

illegally removed without the consent / permission of the legal owners. He requested the Board to

suspend the DML and further disclosed that in future he intends to get the products manufactured

through contract / toll manufacturing. When asked he affirmed that presently premises are not in

position that manufacturing of drugs could be carried out. The Board considering the facts on the

record and after thread bare deliberation decided to cancel the Drug Manufacturing Licence No.

000635 by way of formulation in the name of M/s Florence Pharmaceutics (Pvt) Ltd., Plot No. 266,

Industrial Triangle, Kahuta Road, Islamabad with immediate effect under Section 41 of the Drugs

Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for

not complying the provision of Rule, 16 Rule 19 and Rule 20 of the Drugs (Licensing, Registering

and Advertising) Rules, 1976.

Case No. 9 COMMITTEE ON EVALUATION OF LAYOUT PLAN

The Central Licensing Board with the permission of Chair, deliberated on the subject matter and

decided to constitute following Committee to develop guidelines within a period of 45 days or

earlier for evaluation of layout plan on uniform basis:

1. Dr. Ikram-ul-Haque, Member Central Licensing Board.

2. Syed Muied Ahmed, Member Central Licensing Board.

3. Additional Director (Licensing), DRAP, Islamabad.

4. Deputy Director (Licensing), DRAP, Islamabad.

5. All Assistant Directors (Licensing), DRAP, Islamabad.

6. One Representative from Parma Bureau.

7. One Representative from PPMA.

Additional Director(Licensing) shall perform the functions of Secretary of the committee.

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QUALITY ASSURANCE CASES (GMP NON-COMPLIANCE)

Item No. I Resumption of Production

Case No. i. M/S HARMANN PHARMACEUTICAL LABORATORIES (PVT) LIMITED, LAHORE

Background of the case:

Mr. Ajmal Sohail, FID conducted inspection of firm on 3rd and 4th October, 2013 to check the GMP compliance of the firm. The FID reported that the firm was operating at unsatisfactory level of compliance with GMP guidelines as per the Drugs Act, 1976 and rules framed thereunder and recommended that the firm may be directed to stop all kinds of manufacturing activities till rectification of the shortcomings and improvement of GMP compliance level. Accordingly, show cause notice was issued to the firm and directed to stop manufacturing of drugs in all sections immediately.

2. The firm in response, instead of replying to the Show Cause Notice issued by CLB, preferred to file a writ petition in Honorable Islamabad High Court Islamabad. The Honorable Court in its order dated 26.11.2013 suspended the show cause notice to the extent to stop manufacturing of drugs till next date of hearing. The Honorable Court while hearing the case on 11.01.2017 constituted a team to be headed by Chairman, CLB (Official in attendance) consisting of Area Federal Inspector of Drugs Lahore, Additional Director Quality Assurance, Islamabad and Dr. Ikram ul Haq Ex-Director of Drugs Testing Laboratory/Ex- Member of CLB and directed to visit the premises of the petitioner and submit report.

3. It is also worthwhile to mention here that renewal of Drug Manufacturing License (DML) of the firm is also due w.e.f. 09.01.2011. A panel was constituted on 24.01.2013 but the firm showed some reservations on panel members and applied for reconstitution of panel. Another panel was constituted by competent authority on 26.11.2014 but the firm raised reservations on panel members and gave a legal notice to Licensing Division . Another letter was issued for renewal of DML of the firm on 31.07.2015, but the firm again sent a legal notice to Licensing Division. Hence, inspection of firm for renewal of DML could not be conducted yet.

Observations of the panel:

The team visited the firm on 24.01.2017 at about 12:30 PM. At the time of visit a person namely Mr. Luqman Ali, who introduced himself as production manager of the firm, was present. A lady, who introduced herself as QC Incharge of the firm, was also present but left the premises before inspection was started.

Mr. Luqman, production incharge was informed that the team has to conduct inspection of firm on the directions of Honorable Court. He told the team that none of owners/Directors of the firm was present at premises and Mr. Haseeb Khan, director of the firm had left just 10 minutes before the arrival of team. He was asked to call Mr. Haseeb Khan, Director and request him to come back so that inspection may be conducted in his presence. Accordingly, Mr. Luqman contacted him on his mobile phone and area FID (Ajmal Sohail Asif) also talked to him and informed about the purpose of inspection and requested him to be present during the course of inspection. Mr. Haseeb Khan told that he was coming, so the team decided to wait for his arrival.

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Upon inquiring about production status; Mr. Luqman told the team that at that time two batches of syrups namely “No–All and Ammo Plus” were under manufacturing in oral liquid section. He further told that firm was also under maintenance and paint work was being done. Team noted that paint work was being done on the outer side of the building.

While waiting in the lobby of production areas (outside the executive entrance) team saw through the glass door that the workers were walking/running in the production corridor. After about 10 minutes, Mr. Luqman informed the team that Mr. Haseeb Khan, Director/owner of the firm has directed him not to allow the team to visit the firm.

While standing in the lawn of the firm team noted that the workers of the firm were leaving the premises. In the meanwhile, a person namely Mr. Asif Khan, who told himself to be the security guard/supervisor (without any uniform), also conveyed the team that Mr. Haseeb Khan Director/owner has directed that team may not be allowed to inspect the firm and asked the team to leave the premises (it is worth mentioning here that he had a naked pistol (without holster) in his hand while talking to the team and moving here and there – there was no need to exhibit weapon in their own premises .

Team asked Mr. Luqman that he being production manager is a responsible person for manufacturing and he should let the team to inspect the firm as he is bound under section 20 of the Drugs Act, 1976 which is read as:

“20. Persons bound to disclose place where drugs are manufactured or kept:

Every person for the time being in charge of any premises whereon any drug is being manufactured or is kept for sale or distribution shall, on being required by an Inspector so to do, disclose to the Inspector the place where the drug is being manufactured or is kept, as the case may be.”

But he refused and told that as per owner’s direction he could not allow the team to inspect the premises. However, considering the persistent denial of the firm regarding inspection, the team suspecting the possibility of GMP violations (that may endanger the public health) decided to enter the production areas to fulfill the duty in compliance to Honorable Court’s orders and as empowered by the Drugs Act, 1976 and rules framed thereunder.

Team then entered the production area along with Mr. Luqman, Production manager and noted that the firm has locked many of the rooms such as raw materials store, finished goods store, packing materials store and entrance doors leading to first floor (injection section/cream ointment section/capsule section & quality control/microbiology laboratory). Team of inspectors asked Mr. Luqman to open the locks of all the manufacturing sections but he denied and told that the person with keys has left the premises. Only areas open/accessible were tablet section, oral liquid section and workers change rooms. Thus, the team could only inspect the open areas with the help of mobile phone flash lights as the firm also shut down the electricity supply few minutes after the team entered the production areas. The observations were as follows:

i. Change rooms:The firm has provided separate change rooms for male and female workers. Separate entrance for executives was provided.

The change rooms were not neat and clean. The cabinets were dirty and rusty. The fixtures for tube lights were not properly affixed and were loose producing recesses and staying area for dust and dirt. There was water seepage on walls. The change rooms were stinking; no means of fresh air/air conditioning was provided.

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ii. Oral liquid section, it was comprised of:a. A room for solution preparation containing storage and manufacturing vessels of different sizes and mixers. The room was not neat and clean. A small room connected to this room was very dirty, having seepage on walls, the sanitary conditions of this room were very unhygienic.The team noted that firm was involved in active manufacturing in this section at the time of inspection and it was evident that the firm after arrival of the inspection team let the workers to leave the premises and the batches of drugs under manufacturing were left as they were. It was noted that a batch of syrup namely “Ammo Plus, Batch No.3481, batch size 1000 liter” was present in a manufacturing tank. On the window of the room a label “Line Clearance Certificate” was fixed by adhesive tape showing that area was being used for manufacturing of Ammo Plus, Batch No. 3481 on 24.01.2017. A container was containing some liquid material bearing a label “Zofen Tab, Coating material” showing that this syrup manufacturing area was also being used for other purposes such as for preparation of coating solutions for tablets, which is also a severe GMP non-compliance and may lead to cross-contamination.

b. A room for oral liquid filling having two filling machines and an attached small room having a bottle blowing machine. Liquid filling room was connected to packing room through conveyor belt. This area was not provided with HVAC system which is required for environmental control and to avoid cross-contaminations.Team noted that a batch of syrup No-All, Batch No. 3480 was being packed and some quantity of packed/unpacked filled bottles were left on the packing table when the workers left the premises.

iii. Tablet Section, it was comprised of:a. A room for dry and wet granulation, drying & final mixing. This room was not neat and

clean. There was powder and dust on floor, walls, and electrical panels. The fluidized bed dryer in section was very dirty. It was rusty and its bottom air duct for supply of hot air was full of powder. Even cobwebs were seen in the airway.There were about 9 drums full of different tablets of different colours in polythene bags of different sizes and powder/granules of some unidentified materials. Some of the bags were labeled with marker, whereas, majority were unidentified. Storage/stocking of these different loose tablets and powder/granules in this manufacturing area could not be justified by the production manager. Presence of such different unidentified tablets/powder/granules is a serious violation of GMP as it has potential for cross-contamination and mix-ups.

b. A compression room, accessed through a buffer that opened into a lobby having three cubicles with compression machines. The compression cubicles were provided with HVAC. The lobby was not provided with HVAC, suggesting that it was not possible to maintain the negative pressure of compression cubicles that may pose a great risk of cross contamination. The doors and cubicles of this area were made of aluminum and glass and were not properly maintained. There were open drainage holes in the compression cubicles.c. A coating room having entry through a buffer and a solution preparation room was provided. This area was not provided with HVAC. There was water seepage on walls. There was no equipment for preparation of coating solution.d. A blistering room; this room was not provided with HVAC. The room was dirty. Open electrical wires were hanging, filled with dust and powder at the connection point of ceiling fan.

iv. Capsule section: could not be inspected because entrance door to this section was locked by the firm and was not opened even when asked.v. Ointment/Cream/Gel section: could not be inspected because entrance door to this section was locked by the firm and was not opened even when asked.

vi. Injectable section: could not be inspected because entrance door to this section was locked by the firm and was not opened even when asked.

vii. Raw material store: could not be inspected because entrance door was locked by the firm and was not opened even when asked.

viii. Packing material store: could not be inspected because entrance door was locked by the firm and was not opened even when asked.

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ix. Finished goods store: could not be inspected because entrance door was locked by the firm and was not opened even when asked.x. Quality Control: could not be inspected because entrance door was locked by the firm and was not opened even when asked.

Conclusion:

Based on the areas inspected, and considering the findings of the inspection, the team of inspectors was of the opinion that M/s Harmann Pharmaceutical Laboratories (Pvt) Limited, situated at 16 Km, Multan Road, Lahore was Not Complying with GMP requirements as per Schedule B-II required under Rule 20 of the Drugs (Licensing, Registering & Advertising) Rules, 1976.

The team of inspectors also observed that the firm was Not Complying with the conditions of license as required under Rule 16, 19 & 20 of Drugs (Licensing, Registering & Advertising) Rules, 1976.

The management of the firm created resistance and obstruction in the inspection of the team by shutting down the electricity and not opening the locked areas as mentioned above, which is a clear violation of Rule 19(8) of the Drugs (Licensing, Registering & Advertising) Rules, 1976 which is read as:

“19. Conditions of licence to manufacture, by way of basic manufacture, semi-basic manufacture formulation and repacking of drugs:

(8) The licensee shall allow any member of the Central Licensing Board or of a Provincial Quality Control Board or an Inspector to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture & the means employed in standardising and testing the drugs and to take samples for test and analysis.”

And is also an offence under Schedule III of the DRAP Act, 2012, which is read as:

“(3) Obstruction of Inspector - Whoever obstructs an Inspector in the exercise of any power conferred upon him by or under this Act, or disobeys the lawful authority of any Inspector, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one lakh rupees, or with both.”

Recommendations:

Keeping in view the findings of the inspection and conclusion, the team of inspectors recommends that:

i. The firm may be directed to stop all kinds of manufacturing activities immediately, because of GMP non-compliance, in greater public interest.

ii. The Drug Manufacturing License of the firm may be cancelled for not complying with the licensing conditions.iii. Legal action may be taken against the firm for obstructing the lawful authority of inspectors.

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Decision of Islamabad High Court, Islamabad:

The case was fixed to be heard on 14.02.2017 in the Honorable Justice Islamabad High Court, Islamabad. Wherein the Honorable Justice dismissed the Writ Petition No. 4328/2013 and directed the respondents to perform their statutory obligations without fear and favor and must take all the steps which fall within the ambit of applicable law. The respondents are at liberty to proceed in the matter in requirement of law. The respondents shall submit report through learned registrar of this court for perusal in chamber.

Reply by the firm: The firm vide letter dated 03.03.2017 submitted reply of showcause notice dated 12.11.2013 and requested for the personal hearing and constitution of panel of experts to inspect the production and Quality Control section.

Proceedings of the 252 nd Meeting of CLB

The Board was informed that Mr. Ajmal Sohail Asif, FID, Lahore conducted routine GMP inspection of the firm on 03-04.10.2013 and noticed gross violations in the GMP compliance. The FID informed that firm is operating at unsatisfactory level of compliance with GMP guidelines. The FID directed to stop manufacturing activities. Accordingly QA&LT Division issued showcause notice and suspension of production activities to the firm on 12.11.2013. The firm filed a writ petition in Honorable Islamabad High Court, Islamabad, whereby showcause notice and suspension of production order was challenged. The Honorable Court in its order dated 26.11.2013 suspended the showcause notice / suspension of production order till next date of hearing. The case was heard on 11.01.2017 and the Honorable, Islamabad High Court, Islamabad vacated the stay order and constituted following panel of experts to conduct the inspection of the firm:-

i. Mr. Faqeer Muhammad Shaikh, Chairman CLBii. Dr. Abdur Rashid, Additional Director (QA&LT)iii. Dr. Ikram-ul-Haq Member CLBiv. Area FID, Lahore

The panel inspected the firm on 24.01.2017 and concluded as under:-

a. “ Based on the areas inspected, and considering the findings of the inspection, the team of inspectors was of the opinion that M/s Harmann Pharmaceutical Laboratories (Pvt) Limited, situated at 16 Km, Multan Road, Lahore was Not Complying with GMP requirements as per Schedule B-II required under Rule 20 of the Drugs (Licensing, Registering & Advertising) Rules, 1976.

b. The team of inspectors also observed that the firm was Not Complying with the conditions of license as required under Rule 16, 19 & 20 of Drugs (Licensing, Registering & Advertising) Rules, 1976.

c. The management of the firm created resistance and obstruction in the inspection of the team by shutting down the electricity and not opening the locked areas as mentioned above, which is a clear violation of Rule 19(8) of the Drugs (Licensing, Registering & Advertising) Rules, 1976.”

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Letter for personal hearing was issued to the firm on 08.03.2017. Mr. Haseeb Khan, Director and Prof. Dr. Hafeez Khan of the firm M/s Harmann Pharmaceutical, Lahore appeared before the Board for personal hearing. Mr. Haseeb Khan informed the Board that reply of the show cause notice dated 12.11.2013 has been submitted in the QA&LT Division on 03.03.2017, in compliance to the orders of the Honorable, Islamabad High Court, Islamabad dated 14.02.2017. He added that request for panel inspection to verify the GMP and constitution of panel of experts was also submitted on 03.03.2017. He also added that observations noted during the inspection conducted on 03 & 04.10.2013 and 24.01.2017 has been rectified and the firm is ready for the inspection. The Board enquired regarding status of the production activities of the firm. Director of the firm informed that the production has been suspended after decision of the Honorable, Islamabad High Court. The Board also enquired regarding approval of layout plan in connection with the approved products. Director of the firm informed to the Board that new layout plan in accordance with the registered products shall be submitted in the Licensing Division for necessary approval. Decision of the 252 nd Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the Federal Inspector of Drugs in its inspection dated 03 & 04.10.2013, poor compliance of the firm towards GMP compliance and orders of the Honorable Islamabad High Court, Islamabad in its Writ Petition No. 4328/2013 dated 14.02.2017, the Board decided to:-

i. Suspend the Drug Manufacturing License of the firm M/s Harmann Pharmaceutical Laboratories (Pvt) Ltd, Lahore for a period of (06) six months, under Section 41 of the Drugs Act, 1976 read with Rule 12 (1) of the Drugs (L, R&A) Rules, 1976, from the date of issuance of decision of the 252nd meeting of CLB.

i. If the management of the firm wants to continue the manufacturing of registered products, the firm shall submit revised layout plan in accordance with the prevailing law, with respect to the registered products and get approval from the Licensing Division.

ii. Re-inspection shall be conducted after completion of suspension period of DML and approval of revised layout plan from the Licensing Division. The CLB authorized Chairman CLB to constitute panel of experts to verify the rectification status of the observations noted during the inspections dated 03&04.10.2013 and 24.01.2017.

iii. The Panel should submit the report on approved format under Schedule B-II of Drugs (LR&A) Rules, 1976. The panel shall also submit brief report in tabulated form identifying the previous observations and the current status with clear and candid recommendations.

iv. The report shall be presented in the meeting of Central Licensing Board for perusal and approval.

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Decision of the 147 th Meeting of Appellate Board

The firm M/s Harmann Pharma, Lahore files an appeal in the Appellate Board, against decision of the 252nd Meeting of CLB. The Board after hearing arguments of the appellant and defendants decided to remand the appeal back to the CLB and constituted a panel of following experts to inspect the premises of the appellant who shall submit its report within 30 days from communication of this decision :-

Dr. Farzana Chaudhary, UVAS, Lahore Mr. Shahid Nasir Mr. Syed Muid Ahmed, member CLB

Mr. Asim Rauf, Additional director, Lahore

The report of the panel will be placed before the CLB in its forthcoming meeting. Meanwhile the production of the firm will remain suspended till recommendation by the panel for resumption of production and approval thereof by the CLB.

Updated status:-

The panel constituted by the Appellate Board conducted inspection of the firm M/s Harmann Pharma, Lahore on 17.10.2017 and 27.03.2018. The panel submitted detailed inspection report including previous observations and updated status and forwarded following conclusion and recommendation:-

“Based on the finding of the inspection, the panel recommends resumption of production of following sections to M/s Harmann Pharmaceutical Labs, Lahore:-

i. Tablet Section (Genera)ii. Capsule Section (General)iii. Oral Liquid Sectioniv. Cream / Ointment Sectionv. Sterile Section II

Sterile I & III were not ready for inspection.”

Proceedings of the 261 st meeting of the CLB

The case was placed before the board in the light of decision of 147 th meeting of Appellate Board and recommendations of the panel of experts in its report dated 27.03.2018.

Decision of the 261 st Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, recommendation of the panel of experts in its report dated 27.03.2018, the Central Licensing Board decided to:-

I. Revoke the suspension of DML and resume the production activities of the firm M/s Harmann Pharmaceutical Laboratories (Pvt) Limited, Lahore in Tablet Section (General), Capsule Section (General), Oral Liquid Syrup Section, Ointment / Cream Section and Sterile Section II (Steroidal Injection Section).

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II. Production of Sterile Section I (General Injections) and Sterile Section III (Hormonal Injections) shall remain suspended till submission of compliance report by the firm, verification by the panel of experts and subsequent approval from the CLB.

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Item No. II GMP Non-compliance Cases (Old)

Case No. 2:- M/s Mediways International, Lahore

Background:-

M/s Mediways International, Multan Road, Lahore was inspected on 09.02.2015 by Mr. Ajmal Sohail Asif, FID Lahore to see/verify the GMP compliance. During inspection the FID pointed out a number of serious shortcomings and gross violations including the following:-

Change Rooms:

Air curtains were installed but were not functional at the time of inspection. No Separate change room was provided for visitors or executives. Change rooms were very small and need to be reorganized in respect of outside doors. The firm was also advised to provide cabinets in the change rooms for keeping the workers

belongings etc. It was also noticed that at the time of inspection the change rooms were not maintained and

were not neat and clean.Storage Areas:

Quarantine area not properly demarcated and separated from the de-dusting area. The firm has provided a dispensing hood which was placed in the raw material store for

recipients. But it seemed not to be in use, since there were no accessories like balance, scoops etc inside the dispensing booth.

Balances and other accessories for dispensing were available on one of the racks of raw materials.

No separate facility for sampling of the materials was available; the firm was advised to provide proper sampling facility.

The firm was also advised to rearrange the placement of dispensing hood providing separate cabin and proper flow of pre and post dispensed materials

However packing material store was congested the firm was advised to expand the storage area for packing materials.

Production Areas:

HVAC was not functional at the time of inspection due to load shedding as informed by management of the firm.

The firm was advised to partition this room for separation of de-cartooning and bottle blowing functions.

It was also noticed that all the doors in production area were wooden and the firm was advised to replace all the wooden doors.

Quality Control Laboratory:

It was noticed that QC lab was accessed through the de-dusting/ quarantine area of raw material store; the firm was advised to provide some other entrance to QC laboratory in order to avoid unnecessary movements QC of staff in stores.

Quality Assurance:

During the last inspection the firm has presented a QA officer but at the time of this inspection no QA personnel was present.

From ware houses to production and quality control no prevalence/involvement of quality assurance was observed.

The management of the firm was also advised during previous inspection to strengthen the QA department but no improvement was seen in this department.

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Due to lack of QA system, deviations from SOPs, GMP, GSP etc, were observed in stores, manufacturing areas and quality control.

Non existence of an independent check and balance system may result in compromises, by manufacturing and QC personnel, for routine deviations from practices and procedures. Such a situation may pose a great potential of compromises on overall quality of the products being manufactured.

Sanitation and Hygiene:

The equipments in QA laboratory and different gauges, matters and equipment in manufacturing areas were not calibrated.

There was no system for qualification and validation of machines, procedures and practices. The firm has no procedures for cleaning validation and was advised to develop.Products Recalls:

The firm was advised to assign a separate area for recall products and demark it wellSelf Inspection and Quality Audit:

No record was available for any audit.Personnel:

However, there was no technical person to look after the QA. The firm was advised to establish proper QA department and to hire appropriate personnel to

strengthen the QATraining:

However, It was not being implemented as no record was availableEquipment & Machinery:

However, the firm was advised to upgrade the syrup filling machine. The machines/equipments were not properly labeled regarding the status. However, the firm was advised to purchase the FTIR on priority basis.Materials:

The firm was advised to purchase the materials from manufacturers or authorized suppliers. The firm was also advised to conduct vendor qualification. The firm has not developed a proper material management system. The materials were not properly labeled. The firm was advised to affix the label on each and every container / bag of a lot of material. The firm was also advised to develop and implement the procedures for safety and security

of the workers/personnel handling the materials in stores and also to mark the racks and allocate locations of the materials.

In packing materials store the firm was advised for safe storage of printed materials and unit cartons under lock and key.

Documentation:

It was found that some of the SOPs and BMRs needed review, improvement and updating regarding the actual practices.

The log books for QC equipment were not maintained. The firm was advised to prepare procedure for OOS, cleaning validation etc.Good Practices in Production:

In general the practices were observed not to be in accordance with the prescribed procedures.

The firm was asked to present the BMR for the last batch of a product namely “Antizile Syrup” but the management failed to produce any documentation.

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Good Practices in Quality Control:

There were procedures for QC analysis but they needed to be updated. The log books for instruments and equipments were not maintained. In general the practices were observed not to be in accordance with the prescribed

procedures.Utilities

Water Purification System:

The firm was advised to install transfer pipes for supply of purified water to manufacturing area to minimize the exposure to external environment during manual transfer.

HVAC System:

The firm was advised to repair the manometer so that the pressure gradients in buffer and manufacturing areas may be checked.

The FID further concluded that: The non compliant behavior of the firm towards advises made during previous panel inspection; the firm was considered to be operating at unsatisfactory level of the compliance with GMP guidelines as per Drugs Act, 1976 and rules framed there under.

Action Taken by DRAP: - Accordingly, a show cause notice and suspension of production order in all section was issued to the firm on 20.03.2015 with immediate effect.

Reply of the firm: - In response to show cause notice the firm vide letter No. Nil dated 15.06.2015 submitted their reply and requested to verify the shortcomings through area FID.

Proceedings of 245 th meeting of CLB held on 30.12.2015

Mr. Jamil Ahmad, CEO of the firm appears before the Board. He informed that the observations given by the FID were given attention and most of the observations have been rectified and compliance report was also submitted. The firm is ready for inspection.

Decision of 245 th meeting of CLB held on 30.12.2015

The case was placed before the Central Licensing Board for consideration. The Board after thorough discussion, keeping in view the available record, compliance report and request from CEO of the firm, decided to conduct panel cGMP inspection of the firm, on approved Schedule B-II cGMP format and panel will also submit report in tabulated form identifying the previous observations and the current status, by the following members:-

i. Dr. Ikram ul Haq, Member, CLBii. Dr. Zaka ur Rehman, Member, CLBiii. Mr. Ajmal Sohail Asif, Area FID.

Accordingly decision of 245th meeting of CLB was conveyed to the firm on 10.02.2016

Letter of Secretary PQCB, Lahore:-

Mr. Abid Saeed Baig, Secretary, Provincial Quality Control Board, Punjab informed that Deputy Drug Controller Allama Iqbal Town Lahore alongwith other members inspected the premises on 16.06.2016. The team observed that:-

i. Manufacturing of Drugs was being carried out under unhygienic conditions.ii. Improper storage of drugs (at 40 degree Centigrade).

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iii. Illegal or unauthorized import of raw materials without label (misbranded).

The case was placed in 249th meeting of CLB held on 29.08.2016.

Proceedings of the 249 th meeting of CLB

The Board was informed that Mr. Ajmal Sohail Asif, FID conducted inspection of the firm on 09.02.2015. The firm was issued order for suspension of production activities and issued showcause notice / Suspension of production order No.F.4-4/2001-QA on 20.03.2015. Accordingly, the case was discussed in 245th Meeting of CLB, wherein the CLB had constituted following panel of experts to verify the improvements:-

a. Dr. Ikram ul Haqb. Dr. Zaka ur Rehmanc. Mr. Ajmal Sohail Asif

Inspection report of the firm is still awaited. The Board also discussed and evaluated the reports / cases forwarded by the Secretary, PQCB, Punjab, Lahore and Chief Drug Controller, Punjab for cancellation / suspension of DML of the firm M/s Mediways, Lahore. The Board also consider sub Rule 3 of Rule 5 of Punjab Drugs Rules, 2007 which categorically stated that “The provincial and district Board shall examine a case referred to it by an inspector and shall , if an action is proposed to be taken against a person under the Act or the rule, issue a showcause notice to the personal and provide him an opportunity for hearing before taking the action about the prosecution of the person or recommending suspension or cancellation of his license to the licensing authority.”

Decision of the 249 th Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, keeping in view the available record, the Board considered the recommendations of the Secretary, PQCB, Punjab and took a serious notice on illegal / unauthorized manufacturing and violation of the orders of the DRAP’s letter No. No.F.4-4/2001-QA dated 20.03.2015. The Board decided to issue a showcause notice to the firm M/s Mediways, Lahore on illegal / unauthorized production activities and disobeying the orders of DRAP.

Accordingly showcause notice was issued to the firm on 03.10.2016.

Proceedings of the 250 th Meeting of CLB

Mr. Jamil Ahmed, Chief Executive of the firm M/s Mediways International, Lahore appeared before the Board for personal hearing. He informed that the production is suspended since March, 2015, as per direction of the Division of QA&LT. The provincial government during the raid sealed the premises, which was later on de-sealed on the order of the Drug Court, Lahore. He also informed that inspection book is also in the custody of provincial drug inspector, which has not been handed over to him till date, despite number of requests. Dr. Ikram ul Haq, Member CLB informed the Board that he along-with other members of the panel visited the firm, in compliance to decision of 245th Meeting of CLB, but the firm was found closed and the inspection could not be carried out.

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Decision of the 250 th Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, keeping in view the available record, non serious and non-professional attitude of the firm, , the Board decided to:-

i. Suspend the Drug Manufacturing License of the firm M/s Mediways International, Lahore for a period of six months under Section 41 of the Drugs Act, 1976 read with Rule 12 (1) of the Drugs (LR&A) Rules, 1976.

ii. Direct the area FID to visit the firm on alternate months to verify the suspension of production and submit report.

iii. Resumption of production shall only be allowed after completion of suspension of DML period, verification by the panel of experts and subsequent approval from the Competent Authority.

Updated status:-

The panel constituted by the Director QA&LT conducted inspection of the firm on

26.12.2017 (received on 17.04.2018). The panel submitted detailed inspection report including

previous observations and updated status on Schedule B-II format and recommended as under:-

“Based on the areas inspected, the people met and the documents reviewed, and considering the finding of the inspection in comparison with the observations of the previous inspection, the panel of inspectors does not consider the firm to be at a satisfactory level of compliance with GMP guidelines as per Drugs Act, 1976 and rules framed there under. The plot size is smaller than the prescribed requirement. However, CLB in its 241st meeting held on 15.5.2015 decide “to allow two years time for shifting of unit / enhancement of plot size according to rules”; and that two years period. Therefore, the panel of inspectors does not recommend M/s Mediways International, 16KM Multan Road, Lahore, for resumption of production. The report is forwarded herewith for further consideration and necessary action”.

Proceedings of the 261 st meeting of the CLB

The case was placed before the board for appraisal in the light of recommendations of the panel of experts in its report dated 26.12.2017.

Decision of the 261 st Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, recommendation of the panel of experts in its report dated 26.12.2017, the Central Licensing Board decided to:-

i. Further extend Suspension of DML period for next six months from the date of issuance of decision of 261st meeting of CLB.

ii. The Licensing Division Shall place the case in forthcoming meeting of CLB in the light of decision of 241st meeting of CLB.

(Quality Control Cases)

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Case No.01 INSPECTION REPORT OF M/S EVEREST PHARMACEUTICALS, PLOT NO. 124, KAHUTA ROAD, INDUSTRIAL TRIANGLE, ISLAMABAD- PERMISSION FOR PROSECUTION

1. That DRAP inspection team along with FIA and NAB teams reached in front of M/s Everest Pharma, Plot No. 124, Industrial Triangle, Kahuta Road, Islamabad at 11:00 am on the direction of Supreme Court of Pakistan in HRC case No. 5845-G/2018, but the factory was found closed and main door was locked. DRAP team was comprised of following DRAP officers:-

i. Dr. Hafsa Karam Elahi, Additional Director QA&LT-I, Islamabadii. Dr. Obaid Ullah, Director PE&R, DRAP, Islamabadiii. Dr. Muhammad Fakhruddin Aaamir, Additional Director QA/LT-II, Islamabadiv. Mr. Abdul Sattar Sohrani, Deputy Director QCv. Ch. Zeeshan Nazir, Deputy Director, DRAP, Islamabadvi. Dr. Ghazanfar Ali, Deputy Director DRAP, Islamabadvii. Mr. Abdullah, Deputy Director DRAP, Islamabadviii.Mr. Akhtar Abbas Khan, Deputy Director, Islamabadix. Dr. Arslan, FID, Islamabadx. Mr. Hassan Afzaal, FID, Islamabad

2. That Accused Ch. Muhammad Usman asked someone to bring keys. Unknown person brought keys and opened the doors at 11:40 am. Detailed inspection of the manufacturing unit was conducted. A large number of drugs were seized on Form-2 (copy attached). 3. During inspection following contraventions were identified and recorded on prescribed form and owner Ch. Muhammad Usman, Dr. Kamran Izhaar, Noor Muhammad Mahar, Ch. Muhammad Usman, Production In-charge and Muhammad Ishtiaq, QC Incharge of M/s Everest Pharma, Plot No. 124, Kahuta Road, Industrial Triangle, Islamabad and others responsible for manufacturing and selling of unregistered drugs and import / smuggling of active pharmaceutical ingredients without import license and clearance from DRAP. Accused person were involved in:-

i. Manufacturing and sale of unregistered drugs.ii. Manufacturing of Drugs with raw material smuggled / imported without approval of DRAP

and without having import license.iii. Violation of GMP as prescribed under the rules.iv. Manufacturing of government property drugs without valid purchase orders.v. The firm was manufacturing drugs in unhygienic conditions violating the conditions of

license.vi. Manufacturing / storage of drugs without identifiable labels.vii. Keeping Unidentifiable raw materials.viii.Keeping Expired raw materials ix. Without master production record / batch manufacturing record.x. Manufacturing of Drugs without approved technical persons responsible for manufacturing

and testing of drugs.xi. Without Quality Control record and release certificates.

4. That All the recovered un-registered drugs, labels of unregistered and government property drugs, therapeutic goods and available records were listed and inventory was prepared and all these recoveries were witnessed by the followings:-

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i. DRAP Officers mentioned above.

5. That Token samples were seized on Form-2 and rest of the stocks were stored within the premises of the factory and factory was locked and sealed. Huge quantity of sealed unregistered drugs were also recovered. The firm was manufacturing and selling drugs from the active pharmaceutical ingredients and excipient without necessary clearance from the DRAP. The firm did not obtain the import license for most of the raw materials. Critical and major non-conformities of GMP compliance were identified by the inspection team especially in the following areas.

i. Qualified technical personnel involvement in the manufacturing, selling and testing was not visible.

ii. Shelf life of the manufactured products was awarded without support of stability data.

iii. Master production record and batch manufacturing record were not available for the products being manufactured.

iv. Marketing authorization of most of the products were not obtained from the authority as prescribed under the law.

v. Release certificates were not available for the active pharmaceutical ingredients and finished products.

vi. Sanitization and cleanliness conditions of the process areas were poor.vii. Unhygienic conditions were prevailing in the manufacturing unit.viii. There were mixups of raw materials, semi finished and finished products in all areas

like process areas, ware houses, packing areas and raw material stores.ix. Packing material store was established outside the licensed premises in the open

areas covered by ordinary roof.x. Most of the raw materials and semi finished tablets and capsules were packed into

shopping bags without identification labels.xi. Syrup manufacturing areas and ointment cream sections were used as ware house for

semi finished products and raw materials.xii. Expired raw materials available in the working areas of ware house.

6. That FIR was registered at Police Station FIA ACC, Islamabad vide FIR No.05/2018 against accused persons involved heinous crimes. All accused persons were running your business in violations to Drug Act 1976& DRAP Act 2012 and rules framed thereunder. Hence the accused persons have committed offence under Schedule II of DRAP Act, 2012 which is punishable under schedule III of the DRAP, Act, 2012. Manufacturing and selling of unregistered drugs and import of drugs without valid drug import license are cognizable offences under schedule IV of DRAP, Act, 2012.

7. That all accused persons have violated the provisions of Schedule-II, of DRAP Act 2012 as under:-

a. A (1)(a)(vii) i.e. export, import or manufacture for sale or sell any therapeutic goods which is not registered or is not in accordance with conditions of registration as disclosed in the registration dossier and that has undergone pharmaceuticals evaluation;

c. A (1)(a)(x) i.e. export, import or manufacture for sale or sell any therapeutic good in contravention of any of the provision of this Act are rules made thereunder;

d. A (1)(b), manufacture for sale any therapeutic goods except under and in accordance with the condition of a license issued under this Act and;

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e. A (1)(e), Import or export any therapeutic goods drugs for the import or export of which a license is required except under , and in accordance with the conditions of such license.

A. That Prohibitions mentioned above are offences and punishable under schedule III of DRAP Act 2012

a. (1)(a), exports, imports, manufacturers for sale or sells any spurious therapeutic goods or any therapeutic good which is not registered.

b. (1)(c), Imports without license any therapeutic goods for the import of which a license is required.

c. (2)(b) gives to the purchaser a false warranty in respect of any therapeutic goods sold by him that the therapeutic goods does not is any way contravene the provisions of schedule II and is not able to prove that, when gave the warranty , he had good and sufficient reason to believe the same to be true.

d. (4) i.e. contravention of rules:- subject to the provisions of clause (1) (2) and (3) whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees or with both.

e. (6), Penalty for violating the prohibitions: whoever himself or by any other person on his behalf violates any prohibitions specified in schedule-II shall be punished with imprisonment for a term up to five years and with fine up to five hundred thousand rupees

08. FIA has submitted interim Challan dated 16th April 2018 on 24th April 2018 along with copies of the following documents in the said FIR under Section 109PPC, read with Section 23/27 of the Drug Act 1976

a) Statement of witnesses.b) Copy of FIR.c) Complaint.d) Permission For Registration of FIRe) Seizure memof) Drug analysis reportg) Physical and judicial remand application h) Conviction plus

09. Mr. Muhammad Riaz, Inspector FIA stated in the challan that the concerned authorities including DRAP, Registrar of companies (SECP) Islamabad, Registrar of Firms (ICT), Islamabad and Estate Directorate of CDA has been requested for provision of relevant record regarding ownership of M/s Everest Pharma. Plot No.124 Kahutta Road industrial Triangle Islamabad. The requisite information/record is awaited from these quarters. Federal Board of Revenue has been requested to provide the details of raw material imported by the M/s Everest Pharmaceuticals. Keeping in view the above mentioned facts/evidence available so far, the accused Ch. Muhamamd usman, Owner of M/s Everest Pharmaceuticals Islamabad in connivance with others have been found guilty of offences under section 109 PPC r/w sections 23, 27 of Drugs Act 1976. Investigations are in progress. Interim Challan/report U/S 173 Cr. PC is submitted in competent Court through FID Islamabad to start prosecution of the instant case.

10. Keeping in view the facts in FIR and the contents of interim challan dated 16th April 2018 submitted by the Mr. Muhammad Riaz, Inspector FIA Islamabad. It is requested that the case may please be place in forthcoming meeting of CLB and permission for prosecution of following accused persons who committed offence under Schedule II A (1) (a) (vii). A(1)(b) & A (1)(e) of

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DRAP Act 2012 which is punishable under schedule III 1 (a) 1 (c) & 2 (d) of the DRAP Act 2012 and manufacturing/selling of unregistered drugs and import of drugs without valid drug import license which is cognizable under schedule IV of DRAP Act 2012. The FID has requested for the grant of permission for prosecution against the following accused persons:-

a. M/s Everest Pharma Plot No. 124 Industrial Triangle Kahutta Road Islamabad through Ch. Muhammad Usman.

b. Ch. Muhammad usman S/o Zaheer Ahmed Choudhary Owner/ production incharge of M/s Everest Pharma Plot No. 124 Industrial Triangle Kahutta Road Islamabad.

c. Dr. Kamran Izhar Qureshi S/o izhar Ul Haq Qureshi, R/o 201/2 R. Phase -2 Lahore & House No.397-D Phase 5 Defense Housing Society Lahore.

d. Noor Muhammad Mehr Flat No. 17, second floor Abrar Center Wahdat Road Lahore owner of M/s Everest Pharma Plot No. 124 Industrial Triangle Kahutta Road Islamabad, permanent address of the accused Basti Khair Muhammad Mehar near A ar C and factor Sadiqabad Wahid Bakhsh Mehar, District Rahim Yar Khan

e. Mian Ishtiaq Ahmed QC Incharge of M/s Everest Pharma Plot No M/s Everest Pharma Plot No. 124 Industrial Triangle Kahutta Road Islamabad

11. That accused persons were issued show cause notice & personal hearing letter and hereby asked to explain their position about the above said violations which are offence and crimes against the society that why you should not be prosecuted for the above mentioned offences in the Court of competent jurisdiction to award them punishment under the law

12. It was also asked that if they want to be heard in person or through their pleader may appear before the Central Licensing Board on 02-05-2018 at 11:00 am in the committee room of DRAP, Islamabad on the following address

“04th Floor Committee Room, DRAP, Telecom Foundation Complex G/9-4 Mauve Area, Islamabad”

Proceedings:-

Dr. Kamran Izhar appeared before the CLB in its 261st meeting held on 02-05-2018 in person and he claimed that he is neither partner nor beneficiary of the M/s Everest Pharmaceuticals 124 Islamabad. His name has been included in the Form-I of renewal of license filed by M/s Everest Pharmaceuticals Islamabad without his consent. He further contended that he is not partner of the M/s Everest Pharmaceuticals Islamabad in any official document of CDA/SECP, etc. He admittedly confirmed that he appeared before the Drug Registration Board along with Ch. Usman to persue the registration of sofosbuvir 400mg as clinical consultant. He also denied the sale/lease agreement with the land lord owner which was submitted by the Ch Usman in the Licensing Division. The counsel of accused Noor Muhammad Mahar appeared before the CLB and submitted application for adjournment. However, he could not submit any power of Attorney to appear before the Board on his behalf.

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Decision of the Case:-

The Central Licensing Board examined and evaluated following documents material on records and facts presented by the secretariat

i. Complaint filed by the Additional Director/FIDs Islamabad region along with seizure form 2, inspection report dated 6-3-2018, inventory report of raw materials of active pharmaceutical ingredients, evaluations reports of seized registers during inspection.

ii. FIR and interim challan submitted by the FIA IO along with relevant documents.iii. Request of the FID for the grant of permission for prosecution against the accused

persons and show cause notice issued to the accused persons.iv. Records of the Licensing Division in the files of Everest Pharmaceuticals Islamabad; v. Record of QA/LT Division related to M/s Everest Pharmaceuticals Islamabad.vi. Record of PER Division related to M/s Everest Pharmaceuticals Islamabadvii. Record of Legal Affair Division related to M/s Everest Pharmaceuticals Islamabadviii. Inspection reports and writ petitions filed by M/s Everest pharmaceuticals and its

owners/partners/ warrantorsix. Personal hearing of Dr. Kamran Izhar and documents presented by him.x. Request of the counsel Malik Asif Raza Advocate High Court who appeared on behalf

of accused Noor Mahar.xi. None of accused persons submitted reply of show cause notice dated 25 April 2018 and

only Kamran Izhar Qureshi appeared before the CLB in person. xii. No one appeared on behalf of Ch. Usman, owner/production Incharge and Mian

Ishtiaq Ahmed Quality Control Incharge of M/s Everest Pharmaceuticals Islamabad.

The Board after through deliberations and examination of the above mentioned records concluded as under:-

1. The record of the firm available with DRAP confirms that Dr. kamran Izhar Qureshi is Director/partner of the firm on the basis of following grounds:-

a. He has been nominated as Director/partner in the renewal application for the grant of license filed by M/s Everest pharmaceuticals Islamabad on prescribed Form-IA.

b. Dr. Kamran Izhar Qureshi along with Ch. Usman principal accused appeared before the DRB as Director regarding the registration of ledisovir (Sofosbuvir 400mg and ledisovir 90mg) about observations of panel of inspection conducted on 09th December 2015 to verify to genuineness of stability data for Product registration.

c. Lease agreement and Agreement to sell submitted by M/s Everest Pharmaceuticasl Islamabad with the land lord of the property also confirms the partnership of the Dr. Kamran Izhar Qureshi as its partner/ Director.

d. Correspondence of Ch Muhammad Usman also confirmed the partnership of Kamran Izhar Qureshi in M/s Everest Pharmaceuticals Islamabad.

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2. The request filed by the counsel of Noor Muhammad Mahar was rejected on the grounds that it seems malafide on the part of the accused to delay the case for his vested interest. He has failed to defend the allegations conveyed to him through show cause notice. It is also confirmed that Noor Muhammad Mahar on oath submitted in the court that he is owner of M/s Everest Pharmaceuticals Islamabad;

3. The investigations conducted by Additional Director QA/LT/ FID Islamabad/IO of FIA in FIR No. 05/2018 have collected sufficient evidence on the face of record to prove that the following persons are guilty of offences.

a. M/s Everest Pharma Plot No. 124 Industrial Triangle Kahutta Road Islamabad through Ch. Muhammad Usman;

b. Ch. Muhammad Usman S/o Zaheer Ahmed Choudhary Owner/ production incharge of M/s Everest Pharma Plot No. 124 Industrial Triangle Kahutta Road Islamabad. He was operating as owner as well as Production Incharge responsible for manufacturing of illegal and unlawful drugs;

c. Dr. Kamran Izhar Qureshi S/o izhar Ul Haq Qureshi, R/o 201/2 R. Phase -2 Lahore & House No.397-D Phase 5 Defense Housing Society Lahore is M/s Everest Pharmaceuticals Islamabad;

d. Noor Muhammad Mehr Flat No. 17, second floor Abrar Center Wahdat Road Lahore owner of M/s Everest Pharma Plot No. 124 Industrial Triangle Kahutta Road Islamabad, Permanent address of the accused Basti Khair Muhammad Mehar near A ar C and factor Sadiqabad Wahid Bakhsh Mehar, District Rahim Yar Khan. He is also owner /partner of M/s Everest Pharmaceuticals Islamabad;

e. Mian Ishtiaq Ahmed QC Incharge of M/s Everest Pharma Plot No M/s Everest Pharmaceuticals Plot No. 124 Industrial Triangle Kahutta Road Islamabad. He is responsible for the quality control affairs of the M/s Everest Pharmaceuticals Islamabad.

04. That above mentioned accused persons have committed offences by violating the following provisions Prohibitions of Schedule-II, of DRAP Act 2012:-

a. A (1)(a)(vii) i.e. export, import or manufacture for sale or sell any therapeutic goods which is not registered or is not in accordance with conditions of registration as disclosed in the registration dossier and that has undergone pharmaceuticals evaluation;

b. A (1)(a)(x) i.e. export, import or manufacture for sale or sell any therapeutic good in contravention of any of the provision of this Act or rules made thereunder;

c. A (1)(b), manufacture for sale any therapeutic goods except under and in accordance with the condition of a license issued under this Act and;

d. (1)(e), Import or export any therapeutic goods drugs for the import or export of which a license is required except under , and in accordance with the conditions of such license.

05. That Prohibitions mentioned above are offences and punishable under the following provisions of schedule III of DRAP Act 2012

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e. (6), Penalty for violating the prohibitions: whoever himself or by any other person on his behalf violates any prohibitions specified in schedule-II shall be punished with imprisonment for a term upto five years and with fine up to five hundred thousand rupees

06. Federal Inspector of Drugs Islamabad is allowed for the prosecution before the Drug Court Islamabad against the accused persons mentioned in para 03 who have been proved guilty of offences mentioned in para 4 and which are punishable under the provisions of schedule III of DRAP Act 2012 mentioned in this para.

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Case No.02. INSPECTION REPORT OF M/S ABDUR RAUF & SONS PHARMACY,

GUJRAT HOUSE, SUNNY BANK, MURREE, DISTRICT RAWALPINDI.

Dr. HafsaKaramElahi, Additional Director, QA & LT, DRAP, Islamabad along with the

team included Mr. Hassan Afzal (FID-III), Mr. Arslan Tariq, (FID-I), Mr. HanifUllah (AD-II), Mr.

NoumanYousaf (AD-III), and Mr. Awaisahmed (AD-IV) inspected the premises m/s AbdurRauf&

Sons, Pharmacy, sunny Bank, Murree on 11th April, 2018.

02. The Additional Director, QA & LT, DRAP informed that she visited M/s AbdurRauf&

Sons, Pharmacy, sunny Bank, Murree, the qualified person Ms. RahmaSohail handed over the stock

Voluntarily for seizure on Form-2 along with original warranties issued by M/s Bio Marketing

Services, situated at office no. 54-55, Hathial plaza, Simli Dam Road, Barakahu, Islamabad on

behalf of Tarot Pharmaceutical, Lahore. Tarrot Pharmaceutical had got the stock in question,

manufactured by M/s Everest Pharmaceuticals as per the label claim.

04. The Additional Director, DRAP also informed that following is the detail of voluntarily

handed over stock and the invoice and warranty of the below mentioned products for seizure on

prescribed Form-2 by the qualified person Ms. RahmaSohail of M/s AbdurRauf& Sons Pharmacy,

Gujrat House, Sunny Bank, Murree, District Rawalpindi. The stock was not offered for sale under

lock and key in the expiry/ return; considering the compliant attitude of the qualified person

representing M/s AbdurRauf& Sons, Pharmacy, MsRahmaSohail may be considered as witness in

the proceedings of the case.

Sr. No.

Product Batch

Mfg date Exp date Qty Manufactured by:

01. Levonagtavblet, 250mgReg. no. 032726

301 09/2017 09/2019 10 tablets × 18 Packs

M/s Everest pharmaceuticals.

2. Taroflox tablet,400 mg,Reg. no. 035907

119 04/2017 04/2019 05 tablets × 12 packs

----do----

3. Original invoice and warranty of leaving of Levonag Tablet 250 mg (batch 301), invoice

no. 1075 issued by bio- marketing services, Barakahu, Islamabad.

4. Original invoice and warranty of Taroflox tablet 400 mg (Batch 119), invoice no. 1073

issued by Bio- Marketing services, Barakahu, Islamabad.

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05. The Additional Director, DRAP further informed that subsequent to afore mentioned

inspection and recovery of stock along with warranties, the premises of M/s Bio Marketing Services,

situated at office no. 54-55, Hathial Plaza Simli Dam Road, Barakahu was inspected by Sardar

Shabbier Ahmed, Inspector of Drugs (ICT Islamabad) and Mr. Hassan Afzaal (FID-III) with

intimation to the Additional Director, DRAP, Islamabad. The case is under investigation at the office

of Inspector of Drugs, ICT, Islamabad for identification of responsible persons and launching

prosecution against the responsible persons.

06. The Additional Director requested the Central Licensing Board to grant safe custody of the

seized stock under Section 18(1)(f) of the Drugs Act, 1976 and rules framed thereunder.

Decision of the Central Licensing Board

The Central Licensing Board considered the case and decided to:

1. Allow safe custody to the Federal Inspector of drugs till the finalization of the case.2. Direct FID that he should complete the investigations as soon as possible and submit

complete case for consideration of this Board.

Case No.03 PERMISSION FOR SAFE CUSTODY OF STOCK (UNREGISTERED) SEIZED ON PRESCRIBED FORM- 2 of M/s SILANI TRADERS, SHOP NO. C-3, GATE NO. 2, MADINA CENTER, KARACHI

The FID Syed Hakim Masood, Karachi informed that he along with the officers and officials

conducted the market survey (whole sale) medicine market, Katchi Gali, Karachi on 6 th April, 2018.

During his visit at the premises of M/s Silani Traders, Shop No. C-3, Gate no. 2, Madina center,

Karachi, he along with team recovered suspected stocks of following drug (unregistered/. Spurious)

and seized on prescribed Form-3 under the DRAP Act, 2012 and samples also taken for test/ analysis

purpose on prescribed Form 3. The details are as under:

S. no. Name of

drug

Batch

no.

Mnfg

date.

Exp

date

Qty Mnfd: by

01 Amropyron

Injection

365 9/2017 9-2022 04 vials

of 50 ml

M/s Amros pharmaceutical, A/96, s.i.t.e north Karachi.

02. The FID also informed that the permission for safe custody of seized drug of above seized

drug along with permission for prosecution in drug court may kindly be issued at the earliest.



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1. Allow safe custody to the Federal Inspector of drugs till the finalization of the case.2. Direct FID that he should complete the investigations as soon as possible and submit

complete case for consideration of this Board.

Case No.04 Extension In Period Order Made “Not To Dispose Off” On Form-1 Under The DRAP Act, 2012.Safe Custody Of Stock Seized On prescribed Form-2 Under The DRAP Act, 2012.

The FID Obaid Ali, FID Karachi informed that he alongwith officers of DRAP, Karachi

visited the premises of M/s. Medi Log Services, Civil Hospital Road, Hyderabad on 03 rd April, 2018

wherein he noticed that drug Abhayrab Rabbies vaccine kept in uncontrolled temperature and Ojala

Cotton Wool 400gm are kept on running counter without registration number. Therefore, order was

made “Not to dispose off” on prescribed From-1 under the DRAP Act, 2012 initially for 28 days for

the following drugs:

Sr. No. Name of Drug Batch No. Mfg. By

01. Abhayrab Rabbies Vaccine 18URAB003 M/s. Human Biological Institute,

India.02. Ojala Cotton Wools 400 grams

Declared unregistered vide test report R.KQ.SC.227/2018 dated 25th April 2018

NIL M/s. Tahir Cotton Industries, Okara.

02. The FID requested to extend the period for the order made “Not to dispose off” as per

DRAP Act, 2012 for the drugs mentioned

03. The FID, Karachi also informed that these drugs were seized on prescribes Form-2 under the

DRAP Act, 2012:

Sr. No. Name of Drug Batch No. Quantity Mfg. By

01. Abhayrab Rabbies Vaccine

18URAB003 01 Vial x 01 Pack x 12

M/s. Human Biological Institute, India

Marketed by Cirin Pharmaceuticals,

Hattar.02. Ojala Cotton Wools

400 gramsNIL 79 Rolls M/s. Tahir Cotton

Industries, Okara.03. Rophylac 300

Injection4369600019 01 Injection X 01

Pack X 19CSL Behring Switzerland

04. Human Albumin 50 ml

M3944411A 01 Vial X 01 Pack X 40

CSL Behring Germany

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04. The FID requested to give permission for safe custody of seized and extension in “Not To

Dispose Off period” drugs mentioned above.


The Central Licensing Board considered and decided to:

1. Allow safe custody to the Federal Inspector of drugs till the finalization of the case.2. extend the “not to dispose off” period for further 90 days.3. Direct FID that he should complete the investigations as soon as possible.

Case No.05 Extension In Period Order Made “Not To Dispose Off” On Form-1 Under The DRAP Act, 2012. (M/s. A.J Traders, Shahi Bazar, Sukkar)

The FID Dr Obaid Ali, FID, Karachi informed that he alongwith officers & officials

of DRAP, Karachi visited the premises of M/s. A.J Traders, Shahi Bazar, Sukkar on 05 th April, 2018

wherein FID recovered suspected drugs and order made “Not to dispose off” on prescribed Form-1

for 28 days initially under the DRAP Act, 2012. Details of the drugs are as under:

Sr. No. Name of Drug Batch No. Quantity Mfg. By

01. Burns Aid 0001 25 g X 1 X 255 Packs

Marketed by KS Products

02. Injection B-12 1118 100 X 1ml X 1 X 44 Packs

Ahsons Drug Company

Tandoadam

02. The FID requested to extend the period for the order made “Not to dispose off” as per

DRAP Act, 2012 for the drugs mentioned



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Case No.06 Seizure Of Stock Under Section 18 (1) (f) of the Drugs Act, 1976 From M/s. Cheap Medical Store (Pvt.) Ltd., New Anarkali, Lahore.

The FID L- VI Informed that he alongwith Mr. AsimRauf, Additional Director, DRAP,

Lahore, Mr. AjmalSohail Asif, FID, Lahore, Dr. Akbar Ali, Assistant Director, DRAP, Lahore, Mr.

Ahsan-ul-Haq, Assistant Director, DRAP, Lahore and Mr. Shahrukh Ali, Assistant Director, DRAP,

Lahore visited the premises of M/s. Cheap Medical Store (Pvt) Ltd., 27 New Anarkali, Lahore on

02-04-2018.

02. The FID further informed that at the time of raid proprietor/ qualified person namely Sheikh

Mehmood Ahmed was not present. However, a person namely Sheikh Muhammad Mushtaq S/o.

Sheikh Maqsood Ahmed (told to be nephew of proprietor/ partner) and YousafEjaz S/o. Sheikh Ejaz

(told to be partner, who filed later on during the course of inspection) were present. Store was very

dirty and storage conditions of the medicines were pathetic, there was dust, dirt and cobwebs every

where even inside the shelves and on the medicines. Team found that the premises comprised of a

basement, a ground floor (main medical store), first floor second floor. Basement, first and second

floor were full with raw materials including different active pharmaceutical ingredients, excepients

and other chemicals. It was found that first floor was also being used for repacking of these raw

materials. Team also recovered huge quantities of un-registered/ smuggled drugs of these raw

materials. Team also recovered huge quantities of un-registered/ smuggled drugs from a locked

cupboard on second floor of building.

03. The FID informed that following drugs were seized on Form-2 under section 18 (1) (f) of

the Drugs Act, 1976:

Sr. No. Name of Drug(s)/ Reg. No. Test report by CDL Quantity

01. CPM Raw Material (White

powder purported to be

chlorpheniramine Maleate in

poly bag)

Chlorpheniramine identified

vide test report No.

R.M.SC.25/2018 dated 16th

April 2018

500 gramsx1x2

02. Chloral hydrate (Raw

material China)

Chloral hydrate identified

vide test report No. R.M.

SC.26/2018 dated 16th April

2018

500 gramx1x2

03. Dic/ Pot Raw Material

(White powder purported to

Diclofenac potassium

indentified vide test report

500 gramsx1x2

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be Diclofenac potassium in

poly bag)

No. R.M SC. 27/2018 dated

16th April 2018

04. I.b.u (White powder purport

to be Ibuprofen in poly bag)

Ibuprofen identified vide test

report No. R.M. SC.28/2018

dated 16th April 2018

500 grams x1x2

05. P Raw material (White

powder purported to be

paracetamol in poly bag)

Paracetamol identified vide

test report No. R.M. SC

29/2018 dated 16th April 2018

1000 gramsx1x2

06. Caffine Citrate (Raw

Material)

Caffine Citrate identified vide

test report No. R.M

SC.30/2018 dated 16th April

2018

500 gramx1x2

07. A.C (White powder

purported to be Aspirin)

Aspirin identified vide test

report no. RM SC31/2018


500 gramsx1x2

08. Barium Sulphate (Raw

Material)

Barium and sulphate

identified vide test report No.

RM SC 32/2018 dated 16th

April 2018

200 gramx1x2

09. Aspartame (Raw material

Holland)

Aspartame identified vide test

report No. RM. SC 33/2018


500 gramx1x2

10. Isoniazid (Raw material

China)

500x1x1

11. Mercury Raw 1.5 kgx1x3

12. Atenolol Raw material 200 gramx1

13. Cetrizine 2HCl Raw Material 150 gramx1

14. Piroxicam Raw Material 200 gramx1

15. Testosterone Raw Material 02 gramx1

16. Prednisolone Raw Material 02 grams

(Approx)x1

17. Atropine Sulphate Raw

Material

02 grams

(Approx)x1

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18. StrychineSulphate Raw

Material

05grams (Approx)x1

19. Gentamycin Sulphate Raw

Material

500 grams

(Approx)x1

20. Propanolol Raw Material 500 grams

(Approx)x1

21. OMPR Raw Material (pellets

purported to be omeprazole)

01 kgx1x4

22. Paracetamol Raw Material 25 kgx 2 box

23. Hydroquinine 20 kg x 01 drum

24. Mannitol Raw material 25 kg x 02 drum

25. Tablet Dapson 100 mg 600 (Approx)

26. Inventroy/ stock register 02 Nos.

27. Tablet Duraga 100 mg 150 x 03

28. Tablet Zeytadatic 20 mg 136 x 02

29. TabletnCHrPA 100mg

(Foreign Language)

40 x 04

30. Tablet Dapsone 100 mg 04 x 1000

31. Tablet Cialis 20 mg 01 x 03

32. Tablet Buskopan 300 mg 500 x 10

33. Tablet Rovigon Expired 05 x 10

34. Grucid (Omeprazole

Capsule) 20 mg (Expiry

Date: Oct.2015)

01 strip x 10′s x 400

strips

35. Omepro-D Capsule 1 x 10′s x 60 strips

36. ML-GACID Capsules 1 x 10′s x 5 strips

37. Famotidine Tablets 40 mg 1 x 10′s x 100

Blisters

38. Ceten (Cetrizine

Hydrochloride) Tablets

1 x 10′s x 08 Blisters

04. The FID informed that above mentioned drugs were recovered and seized in the presence of

Sh. Muhammad Mushtaq S/o. Sh. Maqsood Ahmed, Partner (Person present). The witnesses were

recorded on the seizure form.

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“Meanwhile sh. Mushtaq Ahmed s/o sh Maqssod Ahmed cheap medical store filed de-

sealing application in Drug Court Lahore. The court vide order dated 16-04-2018 among other

directed CDC to provide assistance to FID Abdul Rashid so that detail inventory is made of all

contravention items in the raided premises which need to be removed for suitable and safe storage.”

Accordingly FID inspected cheap medical store on 30-04-2018 along with Provincial inspector and

DRAP team in the prences of Sh. Muhammad Mushtaq S/o. Sh. Maqsood Ahmed and seized 67

unregistered drug raw materials/articles which were seized on Form-2 and resealed the premises

and referred the case to CLB.

05. The FID also took the samples of some of the drugs on Form-3 for test analysis. The FGA

confirmed the identification of samples of raw materials forwarded by FID for

identification/confirmation of active ingredient 11 test reports from RM SC 25/2018 to RM SC

34/2018. Similarly FGA confirmed the presence of Tadalafail (Tablet Zeytadatic 20 mg) in tablet

Zevtadatic-20 tablets vide test report No.LHR.SC.47/2018 dated 25th April 2018.

06. In view of above detail it is evidently proven that the accused persons are involved in

heinous crimes as under:-

i. Manufacturing and sale of unregistered drugs.

ii. Import/smuggling of unregistered drug products without authorization .

iii. Import/smuggling/storage of raw materials of active pharmaceuticals ingredients

without import license and clearance from the DRAP as prescribed under the Drugs (import and

export) rules Drug Act 1976 and DRAP Act 2012.

iv. Sale/storage of expired drugs.

v. sale and storage of drugs without warranty

07. The FID also informed that after seizure of above mentioned drugs as evidence of crime/

violation, the premises was sealed along with remaining huge quantity of raw materials under section

18 (1) (h) of the Drugs Act, 1976 and sealed keys were handed over to Mr. Mehmood Manzoor,

Proprietor at the spot in the presence of the above witnesses.

08. The FID requested the Competent Authority to grant permission for

i. Extension of sealing period of sealed premises

ii. Safe custody of seized drugs

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ii. Lodging the registration of FIR against the following accused persons

a. The M/s Cheap medical Store Pvt Ltd 27- New Anar Kali Lahore

b. Shiekh. Muhammad Mushtaq S/o. Shiekh. Maqsood Ahmed CNIC 35202-2973889-9 M/s

Cheap medical Store Pvt Ltd 27- New Anar Kali Lahore

c. Yousuf Ejaz S/o Sh. Ejaz Ahmed (Partner) M/s Cheap medical Store Pvt Ltd 27- New Anar

Kali Lahore

d. Sheikh. Mehmood Ahmed CEO and qualified person M/s Cheap medical store pvt ltd M/s

Cheap medical Store Pvt Ltd 27- New Anar Kali Lahore

09. That the accused persons given below have violated the provisions of Schedule-II, of DRAP Act 2012 and hence, committed offences as under:-

a. A. (1)(a)(vii) i.e. export, import are manufacture for sale or sell any therapeutic goods which is not registered or is not in accordance with conditions of registration as disclosed in the registration dossier and that has undergone pharmaceuticals evaluation;

b. A. (1)(a)(x) i.e. export, import are manufacture for sale or sell any therapeutic good in contravention of any of the provision of this Act are rules made thereunder;

c. A (1)(b), manufacture for sale any theraputice goods except under and in accordance with the condition of a license issued under this Act and;

d. A (1)(e), Import or export any therapeutic goods drugs for the import or export of which a license is required except under , and in accordance with the conditions of such license.

e. A (1)(i) sell any therapeutic good without having warranty in the prescribed form bearing the name and tach number of the therapeutic good issued

10. The Prohibitions mentioned in para 9 are offences and punishable under schedule III of DRAP Act 2012


b. (1)(b) Manufactures for sale any therapeutic good without a license. c. (1)(c), Imports without license any therapeutic goods for the import of which a license is

required.d. (4) i.e. contravention of rules:- subject to the provisions of clause (1) (2) and (3) whoever

himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees or with both.


Decision of the case:-

1. The CLB after examination of facts of the case, seizure form, reports of FID and test/

analysis reports of Government Analyst decided as under:-

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i. Extension of sealing period of sealed premises for further 90 days

ii. Allowed Safe custody of seized drugs to the FID till finalization of case

iii. Lodging the registration of FIR against the following accused persons namely

a. The M/s Cheap medical Store Pvt Ltd 27- New Anar Kali Lahore through

Prop Sheikh. Mehmood Ahmed CEO;

b. Shiekh. Muhammad Mushtaq S/o. Shiekh. Maqsood Ahmed CNIC 35202-

2973889-9 M/s Cheap medical Store Pvt Ltd 27- New Anar Kali Lahore ;

c. Yousuf Ejaz S/o Sh. Ejaz Ahmed (Partner) M/s Cheap medical Store Pvt

Ltd 27- New Anar Kali Lahore;

d. Sheikh. Mehmood Ahmed CEO and qualified person M/s Cheap medical

store pvt ltd M/s Cheap medical Store Pvt Ltd 27- New Anar Kali Lahore.


a. A (1)(a)(vii) i.e. export, import are manufacture for sale or sell any therapeutic goods which is not registered or is not in accordance with conditions of registration as disclosed in the registration dossier and that has undergone pharmaceuticals evaluation;

b. A (1)(a)(x) i.e. export, import are manufacture for sale or sell any therapeutic good in contravention of any of the provision of this Act are rules made thereunder;


d. A (1)(e), Import or export any therapeutic goods drugs for the import or export of which a license is required except under , and in accordance with the conditions of such license.

e. A (1)(i) sell any therapeutic good without having warranty in the prescribed form bearing the name and batch number of the therapeutic good issued

03. The Prohibitions mentioned in para 2 of the decision are offences and punishable under schedule III of DRAP Act 2012


b. (1)(b) Manufactures for sale any therapeutic good without a license. c. (1)(c), Imports without license any therapeutic goods for the import of which a license

is required.d. (4) i.e. contravention of rules:- subject to the provisions of clause (1) (2) and (3)

whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees or with both.

e. (6), Penalty for violating the prohibitions: whoever himself or by any other person on his behalf violates any prohibitions specified in schedule-II shall be punished with

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imprisonment for a term upto five years and with fine up to five hundred thousand rupees

04.FID shall register the FIR against the accused person mentioned in para 1 for violation of

prohibitions mentioned in para 2 and punishable under the provisions of schedule III of DRAP

Act 2012 mentioned in para 3

Case No.08 Seizure Of Stock Under Section 18 (1) (h) of the Drugs Act, 1976 From M/s. New Hassan Medical Store, Sialkot.

The FID MajidaMujahid, Lahore informed that she alongwith Dr. Akbar Ali, Assistant

Director, DRAP, Lahore and Mr. Shahrukh Ali, Assistant Director, DRAP, Lahore visited the

premises of M/s. New Hassan Medical Store, LarriAdda, Sialkot on 11-04-2018.

02. The FID further informed that the following drugs seized on Form-2 under section 18 (1) (h)

of the Drugs Act, 1976 & DRAP Act, 2012.

Sr. No. Name of drug/ Reg. No. Manufacturer Quantity

01. Tablet Cobra 150 mg (Sildenafine Citrate)

M/s. Combitic Global 1 X 5s X 8 Packs

02. Tablet Penagra-100 mg M/s. Median Pharmaceutical, India

1 X 4s X 10 Packs

03. Tablet Bigblaster M/s. HAB Pharmaceutical &

Research Ltd., India

1 X 4s X 10 Packs

04. Power Plus Cream M/s. Well Grow Pharma, China

1 X 2 Packs


Mr. Muhammad Ashraf, S/o Ghulam Rasoolself qualified person was present at the time of raid. The

witnesses were also recorded on the seizure form.

04 The FID also informed that after recovering above mentioned materials, among huge quantity

of drugs was sealed in a room of factory under section 18 (1) (h) of the Drugs Act, 1976 and

Schedule V of the DRAP Act, 2012, as evidence of case.

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05. The FID requested the Competent Authority for permission of the Competent Authority for

safe custody of the seized drugs as mentioned above till the decision of the case under prevision of

the Drug Act, 1976 and DRAP Act, 2012.

06. FID also requested the Competent Authority to grant possession to keep the premises

extension sealed till decision of the case.

07. Muhammad Ashraf, S/o Ghulam Rasool proprietor and qualified person of the premises has

contravened the provisions of schedule II and schedule III of DRAP Act 2012 and permission for

lodging the FIR may be allowed against the accused person.



1. Allow safe custody to the Federal Inspector of drugs till the finalization of the case.2. extend the “not to dispose off” period for further 90 days3. allow the permission for registration of FIR against the following accused persons

a. Muhammad Ashraf, S/o Ghulam Rasool proprietor and qualified person of the premises has contravened the provisions of schedule II and schedule III of DRAP Act 2012 and permission for lodging the FIR against the accused person.

Case No.09 Seizure Of Stock Under Section 18 (1) (h) of the Drugs Act, 1976 From M/s. Syed Medical Complex, Sialkot.

The FID MajidaMuhajid Lahore informed that she alongwith Dr. Akbar Ali, Assistant Director, DRAP, Lahore and Mr. Shahrukh Ali, Assistant Director, DRAP, Lahore visited the premises of M/s. Syed Medical Complex, Islamia College Road, Sialkot on 11-04-2018.

03. The FID further informed that the following drugs seized on Form-2 under section 18 (1) (h)

of the Drugs Act, 1976 & DRAP Act, 2012. (Page 05/corr)

Sr. No. Name of drug/ Reg.

No.

Batch No.

Mfg. Date Exp. Date Manufacturer Quantity

01. Wilgesic Forte Tabs.,

Reg. No. 056980

9036 02-2018 02-2020 M/s. Wilson′s Pharmaceuticals,

387-388, 1-9 Industrial Area,

Islamabad.

3 X 100 Tabs.

02. Jaslokan-SR Caps.

Reg. No.

JU 11 12-17 12-19 M/s. Jaskan Pharmaceuticals (Pvt.) Ltd., Plot

5 X 20 Caps.

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078644 No. 50 Sundar Industrial Estate,

Lahore.03. Amarit Plus

Tab.Reg. No. 057257

1572 01-18 01-20 M/s. RekoPharmacal (Pvt.) Ltd., 13-

Km, Multan Road, Lahore.

10 X 30 Tabs.

04. Nulcer Tabs.Reg. No. 015120

18329 11-17 10-19 M/s. Bosch Pharmaceuticals (Pvt.) Ltd., 221,

Sector 23, Korangi

Industrial Area, Karachi.

10 X 10 Tabs.


Mr. ShabbirHussain S/o. GhulamHussain was present at the time of raid and qualified person was

not present. The witnesses were also recorded on the seizure form.

05. The FID requested the Competent Authority for permission of the Competent

Authority for safe custody of the seized drugs as mentioned above till the decision of the case

under prevision of the Drug Act, 1976 and DRAP Act, 2012.

06. The FID also informed that after recovering above mentioned materials, among huge

quantity of drugs was sealed in a room of factory under section 18 (1) (h) of the Drugs Act, 1976 and

Schedule V of the DRAP Act, 2012, as evidence of case.

07. FID also requested the Competent Authority to grant possession to keep the premises

to extension sealed till decision of the case.

08. Mr. ShabbirHussain S/o. GhulamHussain CNIC No.34602-0743658-9 proprietor of the

premises has contravened the provisions of schedule II and schedule III of DRAP Act 2012 and

permission for lodging the FIR may be allowed against the accused person.



1. Allow safe custody to the Federal Inspector of drugs till the finalization of the case.2. extend the “not to dispose off” period for further 90 days.

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Case No.10 Extension in period order made Not to dispose off on Form-I under the DRAP Act 2012.

Mr. Obaid Ali FID Karachi along with officers and officials of DRAP Karachi visited the

premises of DHO Store of Civil Hospital City Thatta on 17th April 2018. The FID found 29

unregistered drugs are stored in the premises. On enquiry management disclosed that they have

received unregistered stock of drugs from WHO warehouse Islamabad. But failed to provide any

permission from DRAP Islamabad to track back. Therefore order made not to dispose off on

prescribed Form-I for 28 days initially under the DRAP Act 2012

Submitted for grant the permission of FID Karachi of Not to dispose of for 28 days of the stocks



Case No.11 PERMISSION TO FILE THE APPEAL AGAINST DE SEALING OF M/S NEW SHIFA PHARMACY JAIL ROAD LAHORE

Mr. Abdul Rashid Shaikh FID Lahore sealed the premises on 22nd March 2018 and 140 unregistered drugs were recovered from the premises. The case was placed before the 260th meeting of CLB held on 16-04-2018 decided as under:-

Decision of the case

1. Allowed safe custody to the Federal Inspector of drugs till the finalization of the case.2. Board allowed permission for Registration of FIR to the FID against the following

accused persons

i. Mr. Mehmood Manzoor, Proprietor (Person Present)

ii. Ms. Iqra Afzal, a newly appointed qualified person (Person Present), as proprietor has applied for change of the qualified person (Person Present),

iii. Mr. Tariq Mehmood, Partner.

3. Sealing period was extended for further 90 days as prescribed under the law

2. The accused person filed desealing application No. 36/2018 in the Drug Court Lahore and the Drug Court Lahore de sealed the premises on the following grounds:-

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i. We understand that this is a licensed premises of the petionter and has been sealed for one month. We note that however the only point of any merite before the this court was fact that if the premises is not de-seal than the legal medicines would deterio as air conditioning is not turned on accordingly we allow the premises deselaed subject to the condition of affidavit that petioner will not contravened the provision of Drug Act 1976 and to provide two sureties in some of rupees five hundred thousand each to the satisfaction of this court:-, further we direct the CDC to carry out or review of Drug Sale license of the New Shifa medical store as it is quite apparent that the premises operating in breach of licensing rules and qualified person was not present at the time of inspection.

3. It is pertinent to mentioned that 140 unregistered drugs products were recovered from the accused and the FIDs issued letter No. 4139/2018 dated 27-03-2018 and 4975/2018 dated 12-04-2018 but they failed to produced invoice warranties of seized drugs accordingly but Drug Court de sealed the premises vide their order dated 24-04-2018. Accordingly the premises was desealed by the FID on 25-04-2018. 4. As there are huge contraventions by the petitioners and Drug Court has also directed CDC to review the Drug Sale license of the New Shifa Pharmacy Lahore it is therefore submitted to the Board for the grant of

a. To file appeal before the High Court against the decision of Drug Court Lahore to restore the sealing of M/s New Shifa Pharmacy Lahore till the finalization of the case, as the CLB has already approved extension of sealing period for further 90 days but the same could not be conveyed to the FID timely, as the minutes were under approval.

b. To allow Additional Director DRAP (E&M) to file appeal against the decisions of the Drug Courts.

c. To recommend CDC Punjab for cancellation of Drug Sale License of M/s New Shifa Pharmacy Lahore as per order of the Drug Court Lahore. FID shall be directed to provide the copy of the decision of the Drug Court along with decision of CLB to CDC Punjab for cancellation of Drug Sale License

Decision of Case

The CLB decided as under:-

a. To file appeal before the High Court against the decision of Drug Court Lahore to restore the sealing of M/s New Shifa Pharmacy Lahore till the finalization of the case, as the CLB has already approved extension of sealing period for further 90 days but the same could not be conveyed to the FID timely, as the minutes were under approval.

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b. Allowed Additional Director DRAP (E&M), Karachi, Lahore, Peshawar and Islamabad to file appeal against the decisions of the Drug Courts as and when required. CLB also allowed to file appeal in the instant case.

c. Recommended to the CDC Punjab for cancellation of Drug Sale License of M/s New Shifa Pharmacy Lahore as per order of the Drug Court Lahore. FID shall be directed to provide the copy of the decision of the Drug Court along with decision of CLB to CDC Punjab for cancellation of Drug Sale License

Case No.12 Seizure of Stock under Section 18(1)(f) of the Drugs Act, 1976 From (M/s Fazal Din &Sons (pvt) Ltd 53- Shahrah-e-Quaid-e-Azam, Lahore) i.e. Tab Everlong 60mg Mfg by M/e Everest Pharmaceuticals 124 industiral Triangle Islamabad.

FID Lahore.

Mr. Abdul Rashid Sheikh FID Lahore-VI has forwarded the subject mentioned case. The FID Lahore along with Ms. Uzma barkat, FID Lahore and Ms. Nureen Ramzan, inspector, FIA Lahore visited the premises of M/s Fazal Din & sons (pvt) Ltd on 06-03-2018.

The FID Lahore seized the following unregistered drugs:-

S.No Name of drug and Batch No..

Mfg date Exp date Mfg by Quantity

1. Everelong 60mg Tablets

374 11-17 11-19 127 Tablets

2. The Everlong 60mg tablets were recovered and seized in the presence of Syed Asghar Abbas Zaidi, Branch Manager and Ms. Samia Altaf pharmacist (newly appointed Qualified person). The witnesses were also recorded on the seizure form.

3. The FID referred to the competent authority as required under Drug Act 1976 and Schedule-V to the DRAP Act 2012.

4. The permission for safe custody was already allowed by the CLB in its 259 th which is as under:-

“259 Decision of the Case:-

Permission for safe custody of the seized stocks of therapeutic goods/drugs was allowed to the FID

till the finalization of the case”.

5. That Fazal Din and sons Pvt Ltd submitted invoice warranty duly issued by Paris Distributor Lahore

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6. That M/s Paris distributors submitted inovie warranty bearing No. EPO 743 dated 08-01-2018 issued by M/s Everst Pharmaceutical Islamabad.

7. M/s Paris distributors also submitted copies of cheaks to the FID which were given to the manufacturer in return to the price of purchased drugs




c. A. (1)(b), manufacture for sale any theraputice goods except under and in accordance with the condition of a license issued under this Act and;








09. Permission for Lodging of FIR

The FID Lahore has requested to grant the permission of lodging of FIR of the following accused persons:-

1. M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.2. Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabad3. Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad4. Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad5. Ch. Muhammad Usman Production In charge, M/s Everest Pharmaceuticals Islamabad 6. Mian Ishtiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabad

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7. Haroon Yousuf Warrantor M/s Everest Pharmaceuticals Islamabad who signed and issued above mentioned false warranty on behalf of M/s Everest Pharmaceuticals Islamabad.

Decision of the case:-

1. The CLB allowed to the FID for grant the permission for

i. Extension of sealing period of sealed premises for further 90 days

ii. Safe custody of seized drugs was allowed till finalization of the case.

02 The CLB also granted the permission for lodging the registration of FIR against the following accused persons:-

a) M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.b) Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabadc) Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabadd) Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabade) Ch. Muhammad Usman Production In charge, M/s Everest Pharmaceuticals

Islamabad f) Mian Ishtiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabadg) Haroon Yousuf Warrantor M/s Everest Pharmaceuticals Islamabad who signed

and issued above mentioned false warranty on behalf of M/s Everest Pharmaceuticals Islamabad.

03. That the accused persons mentioned above have violated the provisions of Schedule-II, of DRAP Act 2012 and hence, committed offences as under:-



c. A (1)(b), manufacture for sale any theraputice goods except under and in accordance with the condition of a license issued under this Act and;


04. The Prohibitions mentioned in para 3 are offences and punishable under schedule III of DRAP Act 2012 as mentioned below.



c. (2)(b) gives to the purchaser a false warranty in respect of any therapeutic goods sold by him that the therapeutic goods does not is any way contravene the provisions of

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schedule II and is not able to prove that, when gave the warranty , he had good and sufficient reason to believe the same to be true.



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Case No.13 Manufacture and sale of unregistered and spurious drugs by M/s Everest Pharmaceuticals Islamabad samples taken from M/s Pharmanet karachi

Muneeza Khan FID Karachi inspected the business premises of M/s Pharmanet gowdown B-161, P 142 Sector of Mehran Town Karachi and took the samples of the following drugs on Form 3 for test analysis. The detail of seized drugs and their CDL report are as under:-

Sr. No.

Name of Drug (s)

Mfg date. Exp. Date Mfg. by CDL report

1. Everelong 60mg Tablets 374

374 11-17 M/s Everest Pharmaceuticals 124-Industrial Triangle, Islamabad

Unregistered

2. Everelong 60mg Tablets 131

5-17 05-19 -do- Unregistered

3. Rabzol D 347 10-17 10-19 -do- Unregistered 4 Maintain

Tablet 362 10-17 10-19 Do- Unregistered

5. Diaflex tablets 020

1-07 01-19 -do- Unregistered

6. Zerodal Tablets 165

05-17 05-19 Do Spurious/unregistered

07. Sumat-N Tablets 089

03-17 03-19 Do- Substandard/unregistered

08. Zycin 250 mg tablet 059

2-17 02-19 Do- Registered

09. Zycin 250 mg tablet 209


10 Zycin 500 mg tablet 207


2. That M/s Pharmanet Mehran town Karachi provided bill warranty of M/s Everest Pharmaceuticals Islamabad vide invoice no. EP/637 dated 28-11-2017, EPO/860 dated 08-02-2017 and EPO/892 dated 20-02-2018 as a source of their purchase.

3. That FGA declared the 07 seized drugs from s.no. 1-7 as unregistered on the basis of Assistant Director R-III letter No.F.6-2/2015 Reg-III dated 20 th April 2018. Tablet zerodal B. No.165 was declared as unregistered and spurious drug because aceclofenac was not identified vide test report No. KQ.SE237/2018 dated 30th April 2018. Tablet Sumat N B.No.089 was declared as unregistered and substandard drug product vide test report No. KQ.SE.241/2018 dated 30th

April 2018, tablet Rabazol D B.No. 347 was declared vide test report No. KQSC.235/2018 dated 30th April 2018, Maintain Tablet unregistered vide test report No. KQ.SC234/2018 dated 30the April 2018 Everelong B.No.131 was declared unregistered vide test report KQ.SC.233/2018, Everelong B.No.374 was declared unregistered vide test report KQ.SC.232/2018 dated 24th April 2018.

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c. A. (1)(b), manufacture for sale any therapeutic goods except under and in accordance with the condition of a license issued under this Act and;


05. The Prohibitions mentioned herein above are offences and punishable under schedule III of DRAP Act 2012

f. (1)(a), exports, imports, manufacturers for sale or sells any spurious therapeutic goods or any therapeutic good which is not registered.

g. (1)(c), Imports without license any therapeutic goods for the import of which a license is required.

h. (2)(b) gives to the purchaser a false warranty in respect of any therapeutic goods sold by him that the therapeutic goods does not is any way contravene the provisions of schedule II and is not able to prove that, when gave the warranty , he had good and sufficient reason to believe the same to be true.

i. (4) i.e. contravention of rules:- subject to the provisions of clause (1) (2) and (3) whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees or with both.

j. (6), Penalty for violating the prohibitions: whoever himself or by any other person on his behalf violates any prohibitions specified in schedule-II shall be punished with imprisonment for a term upto five years and with fine up to five hundred thousand rupees



1. M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.2. Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabad3. Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad4. Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad5. Ch. Muhammad Usman Production In charge, M/s Everest Pharmaceuticals Islamabad 6. Mian Ishtiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabad7. Haroon Yousuf Warrantor M/s Everest Pharmaceuticals Islamabad who signed and

issued above mentioned false warranty on behalf of M/s Everest Pharmaceuticals Islamabad.


The CLB considered the recored of the case and on the basis of facts decided as under:-

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1. That the accused persons have violated the provisions of Schedule-II, of DRAP Act 2012 and hence, committed offences as under:-





02. The Prohibitions mentioned herein above are offences and punishable under schedule III of DRAP Act 2012

k. (1)(a), exports, imports, manufacturers for sale or sells any spurious therapeutic goods or any therapeutic good which is not registered.

l. (1)(c), Imports without license any therapeutic goods for the import of which a license is required.

m. (2)(b) gives to the purchaser a false warranty in respect of any therapeutic goods sold by him that the therapeutic goods does not is any way contravene the provisions of schedule II and is not able to prove that, when gave the warranty , he had good and sufficient reason to believe the same to be true.

n. (4) i.e. contravention of rules:- subject to the provisions of clause (1) (2) and (3) whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees or with both.

o. (6), Penalty for violating the prohibitions: whoever himself or by any other person on his behalf violates any prohibitions specified in schedule-II shall be punished with imprisonment for a term upto five years and with fine up to five hundred thousand rupees


That CLB also granted the permission of lodging of FIR against the following accused persons for above mentioned violations mentioned in para 1 which are punishable under the provisions of schedule III has mentioned in para 2 against the following accused persons :-

1. M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.2. Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabad3. Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad4. Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad5. Ch. Muhammad Usman Production In charge, M/s Everest Pharmaceuticals

Islamabad 6. Mian Ishtiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabad7. Haroon Yousuf Warrantor M/s Everest Pharmaceuticals Islamabad who signed

and issued above mentioned false warranty on behalf of M/s Everest Pharmaceuticals Islamabad.

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Case No.14 Seizure of Stock manufactured by Everest Pharmacueticals from M/s Servaid Pharmacy Pvt Ltd 65 Quaid-e-Azam Industrial Estate Lahore

Ms. Uzma Barkat, Additional Director, DRAP, Lahore and DRAP team alongwith Mr. Muhammad Usman, Inspector, FIA, Crim Circle, Lahore visited the premises of M/s Servaid Pharmacy (Pvt) Ltd., 65 Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore on 06-03-2018.

02. The FID further informed that she seized the following drugs on Form-2 under section 18 (1) of the Drugs Act, 1976 & DRAP Act 2012.

Sr. No. Name of Drug (s)

Batch No. Mfg. Date Exp. Date Mfg. by Quantity

01. Everelong 60mg Tablets

374 11-17 11-19 M/s Everest Pharmaceuticals 124-Industrial Triangle, Islamabad

255 packs x 10 Tablets

02. Dyone Tablets 144 05/17 05/19 -do- 07 packs x 20 Tablets

03. Sumat-N Tablets

089 03/17 03/19 Do- 04 packs x 10 Tablets

04. Zitpro Oral Suspension

017L018 11/17 11/19 Do- 10 Pakssx01

05. Esoval Tablets 365 10/17 10/19 -do- 08 Packs x14 Tablets

03. The FID further informed that the above mentioned drugs were recovered and seized in the presence of Mr. Sajjad, proprietor present (CNIC No.35202-2654857-7) and Ms. Alia Aroosa, Qualified person present (CNIC No.35201-8259479-7). The witnesses were also recorded on the seizure from.

4. Permission for safe custody of the seized stocks of therapeutic goods/drugs was allowed to the FID till the finalization of the case by the CLB.

5. That M/s Servaid Pharmacy supplied invoice warranty of M/s Alqamar distributor 14-A Asharafia Parka Ferozepur Road Lahroe whereas Al qamar distributor Lahore provided inovice warranty for the product Esoval bearing no. TPO/11909 dated 06-01-2018 issued by Everest Pharmaceuticals Islamabad. M/s Paris distributor who supplied sumat-N tablet B.No. 089 provided inovoice warranty No. EPO/618 dated 31-10-2017 supplied by M/s Everest Pharmaceuticals Islamabad. Similarly M/s Paris Pharmaceuticals supplied invoice warranty No. EPO/906 dated 23-02-2018 issued by M/s Everest Pharmaceuticals Islamabad to the Paris distributors. The product zitrpor oral suspension was incorrectly mentioned mfg Everest Pharmaceuticals actely it is manufacture by M/s ARP Pvt Ltd Rawat and is registered products. FID has requested to corrrect teh name of manfuaturer fo rteh said product. Dyone tablet B.NO. 144 mfg Everest Pharmaceuticals were sold by Saint & Sailor Pharmaceuticals suit No. 13 03rd floor Wahdat Road Lahore vide invoice No. 1759 dated 02-08-2017 to M/s Decent Enterprises Lahore who supplied the same to

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Servaid Pharmacy. It is pertinent to mentioned that the warranty was signed by Mr. Khuram Naeem who is also warrantor of M/s Everest Pharmaceuticals in a number of cases .














1. M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.2. Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabad3. Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad4. Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad5. Ch. Muhammad Usman Production In charge, M/s Everest Pharmaceuticals Islamabad 6. Mian Ishtiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabad7. Khuram Naeem warrantor M/s Saint & Sailor who signed and issued above mentioned

false warranty on behalf of M/s Saint & Sailor Pharmaceuticals.8. Haroon Yousuf Warrantor M/s Everest Pharmaceuticals Islamabad who signed and

issued above mentioned false warranty on behalf of M/s Everest Pharmaceuticals Islamabad.

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The CLB considered the record of the case and on the basis of facts decided as under:-

1. That the accused persons have violated the provisions of Schedule-II, of DRAP Act 2012 and hence, committed offences as under:-












That CLB also granted the permission of lodging of FIR against the following accused persons for above mentioned violations mentioned in para 1 which are punishable under the provisions of schedule III has mentioned in para 2:-

1. M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.2. Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabad3. Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad4. Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad5. Ch. Muhammad Usman Production In charge, M/s Everest Pharmaceuticals

Islamabad 6. Mian Ishtiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabad

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7. Khuram Naeem warrantor M/s Saint & Sailor who signed and issued above mentioned false warranty on behalf of M/s Saint & Sailor Pharmaceuticals.

8. Haroon Yousuf Warrantor M/s Everest Pharmaceuticals Islamabad who signed and issued above mentioned false warranty on behalf of M/s Everest Pharmaceuticals Islamabad.

The meeting ended with the vote of thanks to and by the chair.

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