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MINUTES OF 259th MEETING OF CENTRAL LICENSING BOARD HELD ON 29TH & 30TH MARCH , 2018

*=*=*=*=*259th meeting of the Central Licensing Board (CLB) was held on 29 th & 30th March, 2018 in the

Committee Room, Drug Regulatory Authority of Pakistan, 4 th 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. Dr. Hafsa Karam EllahiRepresentative Director (QA/LT), DRAP, Islamabad

Member

2.Mr. Munawar Hayat, Chief Drug Controller, Primary and Secondary Health Care Department, Govt. of Punjab, Lahore

Member

3. Dr.Ikram-ul-Haque , Expert inQC/QA of drugs. Member

4. Prof. Dr. Abdullah Dayo, Dean, Faculty of Pharmacy, University of Sindh, Jamshoro

Member

5. Prof. Dr. Mohammad Usman, Expert in manufacturing of drugs Member

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

Member

7.Mr. Muhammad Israr Additional Draftsman Ministry of Law, Justice and Human Rights, Islamabad.

Member

8.Syed Qalb e HassanChief Drug Inspector, Health Department, Government of Sindh, Karachi

Member

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

Secretary/Member

10. Mr. Nawaz Ahmed and Mr. Arshad Mehmood Malik, Representative of PPMA Observer

11. Mr. Kamran Anwar, Representative of PCDA. 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, Deputy Director (QC), Mr. Zeeshan Nazir, Deputy Director (QA), Dr.

Muhammad Yaqoob AD (Lic.), and Dr. Zunaira Farayad, Assistant Director, DRAP Islamabad

assisted the Secretary Central Licensing Board in presenting the agenda.

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Item-I CONFIRMATION OF THE MINUTES OF 258 th MEETING

The Central Licensing Board (CLB) formally confirmed the minutes of its 258 th meeting held on

January 8, 2018. The Board also decided that in future contents of the agenda may be made part of

the final minutes especially item at Agenda item II, III and IV for background of the case and

further clarity in decisions.

A. DRUG LICENSING DIVISION

Item-II: GRANT OF NEW DRUG MANUFACTURING LICENSES.

The Board considered the following cases of grant of new drug manufacturing licenses in the light

of recommendations of respective panel of experts/inspectors and decided as under:

S # Name of the firmDate of

Inspection / Type of License

Ranking/ Evaluation Inspection Panel Members

1 M/s Parkar Pharma, Plot No. 0/7-A, S.I.T.E Area Kotri Sindh

Sections 03

1. Tablet (General) Section

2. Capsule (General) Section

3. Liquid Syrup (General) Section.

07-02-2018 Good 1. Prof. Abdullah Dayo, Dean Pharmacy Sindh University, Jamshoro.

2. Mr. Syed Muzaffar Ali Jafri, Director DTL (Sindh).

3. Dr. Najam-us-Saquib, Additional Director (E&M), Karachi

4. Dr. Obaid Ali, Federal Inspector of Drugs.

Recommendations of the panel: -

Based on the areas inspected, the people met and the documents reviewed and considering the

findings of the inspection and vision of the management for exports, Panel recommends the

grant of the Drug Manufacturing License by way of formulation of above mentioned sections.

Decision by the Central Licensing Board in 259th meeting

The Board considered and approved the grant of Drug Manufacturing Licence by way of

formulation in the name of M/s Parkar Pharma, Plot No. 0/7-A, S.I.T.E Area Kotri Sindh

with following sections:

Sections 03

1. Tablet (General) Section2. Capsule (General) Section3. Liquid Syrup (General) Section.

2 M/s Effort 23-02-2018 Good 1. Dr. Farzana Chaudhary,

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Pharmaceuticals (Pvt) Ltd, 28-km, Ferozepur Road, Lahore.

Sections 02



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

Director (E&M), DRAP, Lahore.

3. Mr. Anjum Pervez, Consultant (R&L), PDCU, Lahore.

4. Hafiz Muhammad Jawad Ali, Area FID, Lahore.

5. Dr. Zunaira Faryad, Assistant Director (Lic), DRAP, Islamabad.


Keeping in view of the above all, the Panel recommends the grant of grant of the Drug

Manufacturing License by way of formulation of above mentioned sections.



formulation in the name of M/s Effort Pharmaceuticals (Pvt) Ltd, 28-km, Ferozepur Road,

Lahore with following sections:

Sections 02

1. Tablet (General) Section2. Capsule (General) Section

3 M/s Fahmir Pharma (Pvt) Ltd., Main Mandiwala Stop, 26-km, Lahore Road, Sharaqpur, District Sheikhupura.

Sections 03



3. Sachet (General) Section.

09-03-2018 Good 1. Dr. Farzana Chaudhary, Director UVAS, Lahore.

2. Mr. Asim Rauf, Additional Director (E&M), DRAP, Lahore.

3. Mrs. Majida Mujahid, Federal Inspector of Drugs, Lahore.

4. Mr. Anjum Pervaiz, Consultant Registration & Licensing, Provincial Drug Control Unit, Lahore.


Keeping in view the manufacturing facilities present in the unit the members of the panel

recommends the grant of new Drug Manufacturing License to M/s Fahmir Pharma (Pvt)

Ltd., Main Mandiwala Stop, 26-km, Lahore Jaranwala Road, Sharaqpur, District

Sheikhupura as per layout plan approved by DRAP for above mentioned sections by way of

Formulation.

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formulation in the name of M/s Fahmir Pharma (Pvt) Ltd., Main Mandiwala Stop, 26-km,

Lahore Road, Sharaqpur, District Sheikhupura with following sections:

Sections 03

1. Tablet (General) Section2. Capsule (General) Section3. Sachet (General) Section.

4 M/s Liven Pharmaceuticals (Pvt) Ltd,Sray Road, 49-Km, Multan Road,Phool Nagar, Districr Kasur.

Section (05)1. Tablet (General)

Section.

2. Capsule (General)

Section.

3. Oral Dry Powder Sachet

(General) Section.

4. Liquid Injectable

Ampoule (General)

Section.

5. Liquid Injectable Vial

(General) Section.

6. Liquid Injectable

(Psychotropic) Section.

16-03-2018 Good 1. Dr. Farzana Chaudhary, Director Pharmacy Department, UVAS, Lahore.

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

3. Mr. Anjum Pervaiz, Consultant Health Department, Punjab.

4. Mr. Ajmal Sohail Asif, Federal Inspector of Drugs. Lahore.

Recommendations of the panel: -The panel of inspectors recommends the grant of Drug Manufacturing License by way of

formulation in respect of above mentioned sections to M/s Liven Pharmaceuticals (Pvt)

Ltd, 49-Km, Multan Road, Lahore.



formulation in the name of M/s Liven Pharmaceuticals (Pvt) Ltd, 49-Km, Multan Road,

Lahore with following sections:

Section (05)

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1. Tablet (General) Section.

2. Capsule (General) Section.

3. Oral Dry Powder Sachet (General) Section.

4. Liquid Injectable Ampoule (General) Section.

5. Liquid Injectable Vial (General) Section.

6. Liquid Injectable (Psychotropic) Section.

5 M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-1, RCCI Industrial Estate, Rawat.

Section (04)1. Capsule (Cephalosporin)

Section.

2. Dry Suspension (Cephalosporin) Section.

3. Dry Vial Injection (Cephalosporin) Section.

4. Sachet (Cephalosporin) Section.

09-03-2018 &

20-03-2018

Good 1. Dr. Muhammad Fakkharuddin Aamir, Additional Director-II (QA&LT), DRAP, Islamabad.

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

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

4. Mr. Muhammad Yaqoob, Assistant Director (Lic), DRAP Islamabad.


The panel of inspectors recommends the grant of Drug Manufacturing License by way of

formulation in respect of above mentioned sections to M/s Liven Pharmaceuticals (Pvt)

Ltd, 49-Km, Multan Road, Lahore.



formulation in the name of M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-1, RCCI

Industrial Estate, Rawat with following sections:

Section (04)1. Capsule (Cephalosporin) Section.

2. Dry Suspension (Cephalosporin) Section.

3. Dry Vial Injection (Cephalosporin) Section.

4. Sachet (Cephalosporin) Section.

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

The Board considered following cases of Grant of Additional Sections & Expansion/Amendments

of already licensed units in the light of recommendations by respective panel of experts/inspectors

and decided as under: -

S # Name of the firmDate of

Inspection Ranking/

EvaluationInspection Panel Members

1. M/s OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, S.I.T.E, Karachi.

DML No. 000012 (Formulation)

Section (03)

1. Capsule Section (General) in place of R&D Lab (Amendment)

2. Microbiology Labs(Amendment) First Floor

3. New Product Development Lab (Amendment)

09-01-2018 Good 1. Syed Muied Ahmed, Expert in Drugs Production.

2. Mr. Kalb-e-Hassan, Chief Drug Inspector, Sindh, Karachi

3. Dr. Saif-ur-Rehman Khattak, Director, CDL, DRAP, Karachi.

4. Mr. Shoaib Ahmed, Federal Inspector of Drugs, DRAP, Karachi.


1. Panel recommends the grant of additional sections and amendments in Capsule Section (General) in place of R&D Lab, Microbiology Lab and new Product development Lab.

2. The grant / amendments in the Capsule Section (Hormone / Soft Gelatin) in place of Capsule Section (General / Soft Gelatin) have not been recommends due to the GMP deficiencies.


The Board approved the grant of following additional sections /amendment in the name of M/s

OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, S.I.T.E, Karachi on the recommendations of

the panel od experts:-

Section (03)

1. Capsule Section (General) in place of R&D Lab (Amendment)2. Microbiology Labs(Amendment) First Floor3. New Product Development Lab (Amendment)

Moreover, the Board did not approve on the recommendations of the panel of experts in the name of M/s OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, S.I.T.E, Karachi for the following Section.

1. Capsule Section (Hormone / Soft Gelatin) in place of Capsule Section (General / Soft Gelatin)

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2. M/s Medisure Laboratories Pakistan

(Pvt) Ltd, Plot No. A-115, S.I.T.E-

II, Super Highway, Karachi

DML No. 000503 (Formulation)Section (03)1. Capsule (Cephalosporin) Section 2. Dry Powder Suspension

(Cephalosporin) Section.3. Dry Powder Injection

(Cephalosporin) Section

22-01-2018 Good 1. Syed Muied Ahmed, Member Central Licensing Board.

2. Mr. Abdul Rasool Shaikh, Federal Inspector of Drug, DRAP, Karachi.

3. Ms. Ume Laila, Assistant Director, DRAP, Karachi

4. Chief Drug Inspector Sindh (Vacant Seat)


Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for international certificates, panel recommends the grant of additional sections as mentioned above.



Medisure Laboratories Pakistan (Pvt) Ltd, Plot No. A-115, S.I.T.E-II, Super Highway, Karachi

on the recommendations of the panel of experts:-

Section (03)1. Capsule (Cephalosporin) Section 2. Dry Powder Suspension (Cephalosporin) Section.3. Dry Powder Injection (Cephalosporin) Section

3. M/s Winthrox Laboratories (Pvt) Ltd, Plot No. K-219-A, S.I.T.E, Super Highway, Karachi.


Section (04)1. Sterile Dry Powder Injection

(Cephalosporin) Section.2. Capsule (Cephalosporin) Section.3. Dry Powder Suspension

(Cephalosporin).4. Liquid Injectable (General)

Section.

09-03-2018 Good 1. Prof. Dr. Ghulam Sarwar, Member Central Licensing Board.

2. Dr. Najam-us-Squib, Additional Director (E&M), DRAP, Karachi.


Recommendations of the panel: -The panel unanimously concluded to recommend the grant of additional sections as mentioned above.



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Winthrox Laboratories (Pvt) Ltd, Plot No. K-219-A, S.I.T.E, Super Highway, Karachi on the

recommendations of the panel od experts:-

Section (04)1. Sterile Dry Powder Injection (Cephalosporin) Section.2. Capsule (Cephalosporin) Section.3. Dry Powder Suspension (Cephalosporin).4. Liquid Injectable (General) Section.

4. M/s Ferozsons Laboratories Ltd, Amangarh, Nowshera, Khyber Pakhtunkwa.DML No. 000038 (Formulation)

Sections (03)1. Quality control Laboratory

(Amended).2. Quality Assurance (New).3. Product Development (New).

24-01-2018 Good 1. Prof. Dr. Muhammad Saeed, Peshawar University, Peshawar.

2. Director DTL KPK, Peshawar.

3. Area Federal Inspector of Drugs, DRAP, Peshawar.

Recommendations of the panel: -As per facilities checked, record and people interviewed the panel unanimously recommend the grant of aforesaid additional/amended Sections;



Ferozsons Laboratories Ltd, Amangarh, Nowshera, Khyber Pakhtunkwa on the

recommendations of the panel od experts:-

Sections (03)1. Quality control Laboratory (Amended).2. Quality Assurance (New).3. Product Development (New).

5. M/s Max Pharmaceuticals, Plot No. 12, Street No. N-7, National Industrial Zone, Rawat, Rawalpindi.

DML No.000671 (Formulation)Sections (01)1. Dry Powder for Injection

(Cephalosporin).

13-03-2018 Good 1. Prof. Dr. Muhammad Usman, Member Central Licensing Board.

2. Prof. Dr. Gul Majeed, Dean Faculty of Pharmacy , QAU, Islamabad.

3. Mr. Khalid Mahmood, Federal Inspector of Drugs-II, DRAP, Islamabad.

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

by the company, the panel recommends M/s Max Pharmaceuticals, Plot No. 12, Street No. N-7,

National Industrial Zone, Rawat, Rawalpindi for the grant Additional Section namely Dry

Powder for injection (Cephalosporin) (Formulations) for the aforesaid Section.

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Max Pharmaceuticals, Plot No. 12, Street No. N-7, National Industrial Zone, Rawat, Rawalpindi

on the recommendations of the panel od experts:-

Sections (01)1. Dry Powder for Injection (Cephalosporin).

6 M/s Neutro Pharma (Pvt) Ltd, 9.5-Km, Sheikhupura Road, Lahore.

DML No. 000576 (Formulation)Section (03)1. Tablet (Psychotropic) Section

(Revised).2. Capsule (Psychotropic) Section

(Revised). 3. 3. Cream/ Ointment (General)

Section (Revised)

16-03-2018 Good 1. Dr. Ikram-ul-Haq, Member CLB.

2. Mrs. Aisha Irfan, Deputy Director, DRAP, Lahore.

3. Mr. Abdul Rashid Shaikh, Federal Inspector of Drugs.


Keeping in view the facilities like building , HVAC, system, machinery and equipment,

personal, documents and Quality Control Testing facilities the panel of inspectors is of the

opinion to recommend the grant of above mentioned revised additional sections to M/s Neutro

Pharma (Pvt) Ltd, Lahore situated at 9.5-km, Sheikhupura Road, Lahore.



Neutro Pharma (Pvt) Ltd, 9.5-Km, Sheikhupura Road, Lahore on the recommendations of the

panel of experts:-

Section (03)1. Tablet (Psychotropic) Section (Revised).2. Capsule (Psychotropic) Section (Revised). 3. Cream/ Ointment (General) Section (Revised)

7 M/s Hudson Pharma (Pvt) Ltd, Plot 21-03-2018 Good 1. Dr. Ikram-ul-Haq, Member of 150

D-93, North Western Industrial Zone, Port Qasim, Karachi.

DML No. 000842 (Formulation)Section (01)1. Eye/Ear & Nasal Drops

(General) Section.

CLB.2. Dr. Najam-us-Saquib,

Additional Director (E&M), DRAP, Karachi.

3. Dr. Mehwish Tanveer, Federal Inspector of Drugs.

The Central Licensing Board in its 257th meeting held on 24-25th January, 2018 decided as under:-The Board approved the grant of following additional sections:-

Sections (02).1. Ointment/Cream/Lotion/Gel (General) Section.2. Capsule (General) Section.The Board did not approve the grant of following additional section and as and when the section will be ready for inspection, the firm may apply for constitution of panel:-Eye/Ear & Nasal Drops (General) Section.

The firm requested for constitution of panel to re-inspection for grant of Eye/Ear & Nasal Drops (General) Section and following panel was constituted:-

1. Dr. Ikram-ul-Haq, Member CLB.2. Dr. Najam-us-Saquib, Additional Director (E&M), DRAP, Karachi. 3. Dr. Mehwish Tanveer, Federal Inspector of Drugs.

Remarks and Recommendations of the panel: -During the inspection, panel observed that the firm has almost attended all the observations notices by the panel during last inspection. However, firm is maintaining sterilization (autoclave) facility in the separate areas observed by the panel during last visit. M oreover, firm has conducted sterilization process validation and qualification including porous load cycle study and trolly with laminarhas been provided for shifting of sterilized itemsfrom sterlizer to aseptic area, under multiple wrappings. Sterlization process now seems to be satisfactory to maintain sterility of the items being sterilized. However, firm has given commitment/ undertaking to shift autoclave to the section within six monthsfor which the firm is agreed to submit the lay out planto DRAP authorities for shifting of autoclave to the section within three months.

Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for international certificates in near future and commitment of the firm, panel recommends the grant of above mentioned additional section.Decision by the Central Licensing Board in 259th meeting

The Board approved the grant of following additional sections /amendment in the name of M/s Hudson Pharma (Pvt) Ltd, Plot D-93, North Western Industrial Zone, Port Qasim, Karachi on the recommendations of the panel of experts:- Section (01)

1. Eye/Ear & Nasal Drops (General) Section.However, as per commitment, the firm will submit lay out plan within three months and install Autoclave /sterlizerin this section within six months.

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8M/s Platinum Pharmaceuticals (Pvt) Ltd, A-20, North Western Industrial Zone, Bin Qasim, Karachi.


Section (03)

1. Tablet (Hormone) Section.2. Capsule (Hormone) Section.3. Extension of FG Warehouse

21-03-2018 Good 1. Mr. Syed Muied Ahmed, Member CLB.

2. Mr. Muzaffar Jaffery, Director DTL, Sindh.

3. Dr. Mehwish Tanveer, Federal Inspector of Drugs.



findings of the inspection and vision of the management for export, panel recommends the

amendments / expansion of aforesaid sections.



Platinum Pharmaceuticals (Pvt) Ltd, A-20, North Western Industrial Zone, Bin Qasim, Karachi

on the recommendations of the panel od experts:-

Section (03)

1. Tablet (Hormone) Section.2. Capsule (Hormone) Section.3. Extension of FG Warehouse

9 M/s Bosch Pharmaceuticals (Pvt) Ltd, Plot No. 209, Sector-23, Korangi Industrial Area, Karachi.DML No. 00 (Formulation)Section (01)

1. Penicillin (Injectable) Section.

12-03-2018 Good 1. Mr. Syed Muied Ahmed, Member CLB.

2. Dr. Saif-ur-Rehman Khattak, Director, CDL, Karachi

3. Dr. Najam-us-Saquib, Federal Inspector of Drugs.


Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for international certifications, panel recommends the grant of additional section of aforesaid sections.Decision by the Central Licensing Board in 259th meeting


Bosch Pharmaceuticals (Pvt) Ltd, Plot No. 209, Sector-23, Korangi Industrial Area, Karachi on

the recommendations of the panel od experts:-

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Section (01)

1. Penicillin (Injectable) Section.

10 M/s Radiant Pharma (Pvt) Ltd,

43-E, Sundar Industrial Estate,

Lahore.


Section (01)1. Dry Powder Injection

(General) Section.

09-03-2018 Good 1. Dr. Farzana Chaudhary, Director Pharmacy Department, UVAS, Lahore.

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

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


Keeping in view the facilities like building , HVAC, system, machinery and equipment,

personal, documents and Quality Control Testing facilities the panel of inspectors is of the

opinion to recommend the grant of above mentioned section of M/s Radiant Pharma (Pvt) Ltd,

43-E, Sundar Industrial Estate, Lahore.


The Board approved the grant of following additional section /amendment in the name of M/s

Radiant Pharma (Pvt) Ltd, 43-E, Sundar Industrial Estate, Lahore on the recommendations of

the panel of experts:-

Section (01)1. Dry Powder Injection (General) Section.

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

The Board considered the following cases of grant of Renewal of Drug Manufacturing Licenses in

the light of recommendations by panel of experts/inspectors subject to confirmation of deposition of

CRF as admissible under the rules and decided as under: -

S # Name of the firm Date of Inspection

Ranking/ Evaluation

Inspection Panel Members

1 M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. A-46, S.I.T.E, North Karachi, Karachi DML No. 000490 (Formulation)

Period: 01-01-2017 to 31-12-2022

18-01-2018 Good 1. Mr. Syed Muzaffar Hussain Jaffery, Director DTL, Sindh.

2. Prof. Dr. Ghulam Sarwar, Member DRB.


4. Mr. Abdul Waheed, Assistant Director, CDL, Karachi.


The Panel thoroughly inspected & reviewed in detail their QA system, Production system, QC

Lab, Stores, utilities & respective documents and found an optimal level of compliance &

based on the above stated observation the panel unanimously recommends the grant of

renewal of DML No. 000490 (Formulation) for the next five years commencing on 01-01-

2017 and ending on 31-12-2022.


The Board approved the renewal of Drug Manufacturing Licence No. 000490 (Formulation)

in the name of M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. A-46, S.I.T.E, North

Karachi, on the recommendations of the panel of experts for the further period of five years

commencing on 01-01-2017 and ending on 31-12-2022.

2 M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. L-4/1 A&B, Block-21, Federal-B Industrial area, Karachi DML No. 000040 (Formulation)

11-01-2018 Good 1. Dr. Abdullah Dayo, Dean, Faculty of Pharmacy, University of Sindh, Karachi.

2. Mr. Syed Muzaffar Hussain Jaffery, Director DTL, Sindh.

3. Mr. Kirshan, Federal Inspector of Drug, DRAP, Karachi.

4. Mr. Farman Ali, Assistant Director, DRAP, Karachi.

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Period:30-05-2015 to 29-05-2020 Recommendations of the panel: -

The Panel reviewed in detail the critical documents relating to manufacturing, QA, QC,

Supply chain and utilities and found at good level of compliance. The panel further observed

that all above mentioned sections are given as per approved layout plan were inspected

keeping in view the existing GMP conditions, suitability of equipments/machineries and

capabilities of management and working personnel towards compliance, the panel

unanimously recommends the grant of renewal DML No. 000040 (Formulation) for the next

tenure.



in the name of M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. L-4/1 A&B, Block-

21, Federal-B Industrial area, Karachi on the recommendations of the panel of experts for

the further period of five years commencing on 30-05-2015 and ending on 29-05-2020

3 M/s Evergreen Pharmaceuticals, 20-Km, Ferozepur Road, Lahore.


Period; 01-08-2017 to 31-07-2022.

07-11-2017 Good 1. Dr. Ikrarm-ul-Haq, Member CLB.

2. Dr. Zaka-ur-Rehman, Chief Pharmacist / Drug Controller Children Hospital.

3. Mr. Ajmal Sohail Asif, Federal Inspector of Drug, DRAP, Lahore.

Recommendations of the panel: -Panel has thoroughly inspected the unit also evaluated the various documents in connection

with Production, Quality Control and Quality Assurance. Panel also discussed various

technical aspects at length. Keeping in view of the above all, panel decided to recommend

the renewal of Drug Manufacturing License No. 000736 of M/s Evergreen Pharma, 20-

Km, Ferozepur Road, Lahore.


The Board approved the renewal of Drug Manufacturing Licence No. 000736 (Formulation) in the name of M/s Evergreen Pharma, 20-Km, Ferozepur Road, Lahore on the recommendations of the panel of experts for the further period of five years commencing on 01-08-2017 and ending on 31-07-2022.

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4 M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. B-10, Block-B, S.I.T.E, North Karachi , Karachi DML No. 000626 (Formulation)

Period: 05-10-2017 to 04-10-2022

01-02-2018 Good 1. Prof. Dr. G. Razzak Shahwani, Chairman Department of Pharmaceutics, Balochistan University Quetta.

2. S. Muzaffar Ali Jafery, Director DTL, Karachi.

3. Prof. Dr. Ghulam Sarwar, Member, DRB, Islamabad.



During a detailed inspection the Panel thoroughly inspected their QA system, Production

system, Practices in QC Lab & Stores, the Panel also reviewed several documents with

respect to training, validation, OOS, Failures, Complaints, recalls, vendor selection, Change

Management & utilities. A Good level of compliance was noted at the end. Keeping in view

the above stated facts and based on the attitude of the management towards continuous

improvements, the panel concluded to recommends the grant of renewal of DML No.

000626 (Formulation) for the next five years.



in the name of M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. B-10, Block-B,

S.I.T.E, North Karachi , Karachi on the recommendations of the panel of experts for the

further period of five years commencing on 05-10-2017 and ending on 04-10-2022.

5 M/s Medisure Laboratories

Pakistan (Pvt) Ltd, Plot No. A-

115, S.I.T.E-II, Super Highway,

Karachi


Period; 06-10-2017 to 05-10-2022

22-01-2018 Good 1. Syed Muied Ahmed, Member Central Licensing Board.


3. Ms. Ume Laila, Assistant Director, DRAP, Karachi.

4. Chief Drug Inspector Sindh (Vacant Seat)



findings of the inspection and vision of the management for international certificates, panel

recommends the grant of renewal of the Drug Manufacturing License by way of formulation.

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in the name of M/s Medisure Laboratories Pakistan (Pvt) Ltd, Plot No. A-115, S.I.T.E-II,

Super Highway, Karachi on the recommendations of the panel of experts for the further

period of five years commencing on 06-10-2017 and ending on 05-10-2022.

6 M/s WnsFeild Pharmaceuticals, Plot No.122, Block-A, Phase-V, Industrial Estate, Hattar.


Period;13-04-2017 to 12-04-2022

18-01-2018 Good 1. Prof. Dr. Jamshed Ali Khan, Faculty of Pharmacy, Peshawar University, Peshawar.

2. Additional Director (E&M), DRAP, Peshawar.

3. Area Federal Inspector of Drugs, DRAP, Peshawar.

4. Area Assistant Director (Lic), DRAP, Islamabad.

Recommendations of the panel: -The panel recommended the grant of renewal of Drug Manufacturing License No.000610 by way of Formulation.



in the name of M/s WnsFeild Pharmaceuticals, Plot No.122, Block-A, Phase-V, Industrial

Estate, Hattar on the recommendations of the panel of experts for the further period of five

years commencing on 13-04-2017 and ending on 12-04-2022

7 M/s D-Maarson Pharmaceuticals, Plot No.17, SS-2, RCCI, Rawat, Rawalpindi. DML No. 000744 (Formulation)Period:16-08-2017 to 15-08-2022

14-12-2017 Good 1. Dr. Muhammad Tanveer Alam, Additional Director (PS), DRAP, Islamabad.

2. Mr. Manzoor Ali Bozdar, Additional Director (Licensing), DRAP, ISlambad.


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


1. In view of facts, detailed visit of facility and supporting documents provided by the company, the panel unanimously recommended M/s D-Maarson Pharmaceutical, Plot No.17,

SS-2, RCCI, Rawat, Rawalpindi for the renewal Drug Manufacturing License No. 000744 of 150

(Formulation).2. During the scrutiny of records it was observed that the products

i. LOX-20 Registration No. 063514ii. CLAUMOX-28 Powder Registration No. 072682iii. MOXIBAC-C Powder Registration No. 062175

3. Aforementioned products contain penicillin/amoxicillin which should be manufactured in dedicated section. The case may be referred to Drug Registration Board for decision. The production of aforementioned products has been halted voluntarily by the management of the firm.



in the name of M/s D-Maarson Pharmaceutical, Plot No.17, SS-2, RCCI, Rawat, Rawalpindi

on the recommendations of the panel of experts for the further period of five years

commencing on 16-08-2017 and ending on 15-08-2022. Moreover, the Central Licening

Board referred the following drugs to the Drug Registration Board for consideration as the

firm does not possess Penicillin Section for the said drugs.

i. LOX-20 Registration No. 063514ii. CLAUMOX-28 Powder Registration No. 072682

iii. MOXIBAC-C Powder Registration No. 062175

8 M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, National Industrial Zone, Rawat.

DML No. 000750 (Formulation)Period:16-08-2017 to 15-08-2022

02-02-2018 &

07-02-2018

Good 1. Dr. Abdur Rashid, Additional Director (H&OTC), DRAP, Islamabad.

2. Dr. Zunaira Faryad, AD (Lic), 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 Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, National Industrial Zone, Rawat, Rawalpindi for the renewal of Drug Manufacturing License No. 000750 (Formulation).


The Board approved the renewal of Drug Manufacturing Licence No. 000750 (Formulation) in the name of M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, National Industrial Zone, Rawat, Rawalpindi on the recommendations of the panel of experts for the further period of five years commencing on 16-08-2017 and ending on 15-08-2022.

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9 M/s Siam Pharmaceuticals, Plot No. 217, Industrial Triangle, Kahuta Road, Islamabad.

DML No. 000711 (Formulation)Period:13-06-20016 to 12-06-2021.

16-02-2018 Good 1. Dr. Muhammad Tanveer Alam, Additional Director (PS), DRAP, Islamabad.

2. Mr. Muhammad Fakharuddin Aamir, Additional Director (QA&LT), DRAP, Islamabad..

3. Mr. Arslan Tariq, FID-I, DRAP, Islamabad.

4. Dr. Nafees Ur Rehman, Assistant Director (PS), DRAP, Islamabad.


“Keeping in view the above facts on record, the panel unanimously recommended the grant of Renewal of Drug Manufacturing License No. 000711 (Formulation) for approved Tablet Section General and Capsule Section General to M/s Siam Pharmaceuticals, Plot No. 217, Industrial Estate, Triangle Kahuta Road, Islamabad.”


The Board approved the renewal of Drug Manufacturing Licence No. 000711 (Formulation) in the name of M/s Siam Pharmaceuticals, Plot No. 217, Industrial Estate, Triangle Kahuta Road, Islamabad on the recommendations of the panel of experts for the further period of five years commencing on 13-06-20016 and ending on 12-06-2021

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ITEM – V MISC CASES

Case No. 1. CHANGE OF MANAGEMENT OF M/S ALKEMY PHARMACEUTICAL LABORATORIES (PVT) LTD, HYDERABAD

M/s Alkemy Pharmaceutical Laboratories (Pvt) Ltd, P/9, S.I.T.E, Hyderabad, DML No. 000131 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

Current management as per

Form-29

1. Mr. Nazir Ahmad Shaikh CNIC No. 42201-7375233-7.

2. Ms. Rukhsana Shaikh W/o Nazir Ahmad Shaikh CNIC No. 42201-3524178-4.

3. Muhammad Ayoob Jamal S/o Jamal Ahmad Jamal CNIC No. 42101-5885999-7.


1. Mr. Faraz Ahmad Shaikh S/o Nazir Ahmad Shaikh CNIC No. 42201-9270370-1.



Decision by the Central Licensing Board in 259 th meeting:

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

M/s Alkemy Pharmaceutical Laboratories (Pvt) Ltd, P/9, S.I.T.E, Hyderabad, DML No. 000131 by

way of Formulation as per Form-29 as under ;

Previous management Retiring Management New Management





1. Mr. Faraz Ahmad Shaikh S/o Nazir Ahmad Shaikh CNIC No. 42201-9270370-1.



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Case No. 2. CHANGE OF MANAGEMENT OF M/S MEDICURE LABORATORIES, KARACHI

M/s Medicure Laboratories, F/109, S.I.T.E, Hub River Road, Karachi, DML No. 000034 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 Partnership

deed

Retiring

Management


Partnership deed

1. Mr. Shah Mir Hussain S/o Qalandar Shah CNIC No. 42201-0988780-5.

2. Mr. Shabbir Hussain Shah S/o Shah Mir Hussain CNIC No. 42201-5104958-5.

3. Ms. Naushaba Qaisar W/o Qaisar Kamal CNIC No. 42101-2230486-0.






M/s Medicure Laboratories, F/109, S.I.T.E, Hub River Road, Karachi, DML No. 000034 by way of

(Formulation) as per partnership deed as under ;

Previous management Retiring

Management

New Management







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Case No. 3. CHANGE OF MANAGEMENT OF M/S PHARMEVO (PVT) LTD, KARACHI

M/s PharmEvo (Pvt) Ltd, A-29, North Western Industrial Zone, Port Qasim, Karachi, DML No. 000504 by way of formulation has submitted request for change in management of the firm as per Form-29 & Form-A with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as under;

Previous management as per Form-29 of S.E.C.P.

Retiring Management

Current management as per Form-29 of S.E.C.P.

1. Mr. Muhammad Haroon Qassim S/o Ebrahim Qassim CNIC No. 42201-5924502-1.

2. Mr. Muhammad Salman Qassim S/o Ebrahim Qassim CNIC No. 42201-1451584-7.

3. Mr. Zamiruddin Ahmed S/o Amiruddin Ahmed CNIC No. 42201-0567744-1.

4. Mr. Derek Alan Evans S/o William Baden Passport No. 016319260




3. Mr. Derek Alan Evans S/o William Baden Passport No. 016319260.



M/s PharmEvo (Pvt) Ltd, A-29, North Western Industrial Zone, Port Qasim, Karachi, DML No.

000504 by way of (Formulation) as per Form-29 as under ;

Previous management Retiring Management

New Management




4. Mr. Derek Alan Evans S/o William Baden Passport No. 016319260




3. Mr. Derek Alan Evans S/o William Baden Passport No. 016319260.

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Case No. 4. CHANGE OF MANAGEMENT OF M/S ELITE PHARMA (PVT) LTD, LAHORE.

M/s Elite Pharma (Pvt) Ltd,9.5 Km Sheikhupura Road, Lahore DML No. 000455 by way of formulation has submitted request for change in management of the firm as per Form-29 & Form-A with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as under;

Management at the time of Previous Renewal of DML

As per Form-1-A

Interim Management as per Form-29 of SECP

Proposed ManagementAs per Form-29 of SECP

1. Mr. Tahir Mahmood S/o Muhammad Ayub, CNIC No. 35202-2864862-7

2. Mr. Abid Mahmood S/o Muhammad Ayub, CNIC No. 35201-1594803-5

3. Mst. Romila Hamid D/o Hamid Mahmood, CNIC No. 35201-7835331-8

4. Mahwish Hamid D/o Hamid Mahmood CNIC No. 35201-7930236-8



3. Mr. Hmaid Mahmood S/o Muhammad Ayub CNIC No. 35201-7010464-9



2. Mr. Bilal Mahmood S/o Abid Mahmood, CNIC No. 35201-2114366-7



Decision by the Central Licensing Board in 259 th meeting: The Board considered and endorsed the change of management from old to new management of M/s Elite Pharma (Pvt) Ltd,9.5 Km Sheikhupura Road, Lahore DML No. 000455 by way of (Formulation) as per Form-29 as under ;

Management at the time of Previous Renewal of DML

As per Form-1-A

Interim Management as per Form-29 of SECP

Proposed ManagementAs per Form-29 of SECP



3. Mst. Romila Hamid D/o Hamid Mahmood, CNIC No. 35201-7835331-8







2. Mr. Bilal Mahmood S/o Abid Mahmood, CNIC No. 35201-2114366-7



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Case No. 5. CHANGE OF MANAGEMENT OF M/S ZENITH CHEMICAL INDUSTRIES (PVT) LTD, LAHORE.

M/s Zenith Chemical Industries (Pvt) Ltd, Moza Dondey Jia Baga Raiwind Road, Lahore DML No.

000733 by way of semi basic manufacture has submitted request for change in management of the

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

firm is as under;

Previous management as per Article of Association at the

time of Grant of DML

Retiring Management Proposed management as per Form-A issued by S.E.C.P.

1. Mr. Mir Irfan Sallahuddin.2. Mr. Ehtisham Ul Haq.3. Mr. Muhammad Asif

Hafeez.4. Mr. Muhammad Tauseef.5. Mr. Mohammad Temoor

Asif.

1. Mr. Muhammad Asif Hafeez.

2. Mr. Muhammad Tauseef.

3. Mr. Mohammad Temoor Asif.

1. Mr. Mir Irfan Sallahuddin

S/o Mir Salah Ud Din CNIC

No. 61101-1424596-3.

2. Mr. Ehtisham Ul Haq S/o

Muhammad Shamas ul Haq

CNIC No. 35202-4809628-3.



M/s Zenith Chemical Industries (Pvt) Ltd, Moza Dondey Jia Baga Raiwind Road, Lahore DML No.

000733 by way of semi basic as per Form-29 as under ;

Previous management as per Article of Association at the

time of Grant of DML

Retiring Management Proposed management as per Form-A issued by S.E.C.P.

1. Mr. Mir Irfan Sallahuddin.2. Mr. Ehtisham Ul Haq.3. Mr. Muhammad Asif

Hafeez.4. Mr. Muhammad Tauseef.5. Mr. Mohammad Temoor

Asif.

1. Mr. Muhammad Asif Hafeez.

2. Mr. Muhammad Tauseef.

3. Mr. Mohammad Temoor Asif.

1. Mr. Mir Irfan Sallahuddin

S/o Mir Salah Ud Din CNIC

No. 61101-1424596-3.

2. Mr. Ehtisham Ul Haq S/o

Muhammad Shamas ul Haq

CNIC No. 35202-4809628-3.

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Case No. 6 CHANGE OF TITLE OF M/S MERCK PHARMACEUTICAL (PVT) LTD, KARACHI

M/s Merck Pharmaceutical (Pvt) Ltd, F-126, S.I.T.E, Karachi under DML No. 000043 by way of

formulation has submitted request for change of title of the firm as per Form-29 with prescribed

Fee Challan of Rs.50,000/- as under;

Title and legal status of the firm at previous renewal of DML as per Form-1A

Title and legal status of the firm at Current renewal of DML

as per Form-29 M/s Merck Pharmaceutical (Pvt) Ltd, F-126, S.I.T.E, Karachi.

M/s Martin Dow Marker Ltd, F-126, S.I.T.E, Karachi.


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

management of M/s Merck Pharmaceutical (Pvt) Ltd, F-126, S.I.T.E, Karachi under DML No. 000043 by

way of (Formulation) as under ;

Previous Title New Title

M/s Merck Pharmaceutical (Pvt) Ltd, F-126, S.I.T.E, Karachi.

M/s Martin Dow Marker Ltd, F-126, S.I.T.E, Karachi.

Case No. 7. CHANGE OF MANAGEMENT OF M/S MERCK PHARMACEUTICAL (PVT) LTD, KARACHI


formulation has submitted request for change in management of the firm as per Form-29 & Form-

A with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as under;

Previous management as per

Form-29 of S.E.C.P.

Retiring

Management


Form-29 of S.E.C.P.

1. Syed Anis Ahmed Shah S/o Syed Fazal Hussain Shah CNIC No.42301-4602118-1.

2. Mr. Ali Aamir S/o Abid Ali CNIC No.42301-0740467-9.

3. Mohammad Amjad S/o Mohammad Yousaf CNIC No. 42301-9382243-7.

1.Mohammad Amjad S/o Mohammad Yousaf CNIC No. 42301-9382243-7.



3. Syed Dawood S/o Syed Fasih-uddin Ahmed passport No. LB0060600.

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(Formulation) as per Form-29 as under ;

Previous management Retiring Management New management







3. Syed Dawood S/o Syed Fasih-uddin Ahmed passport No. LB0060600.

Case No. 8 CHANGE OF TITLE OF M/S KINGS PHARMACEUTICALS, LAHORE

M/s Kings Pharmaceuticals, 27 Sunder Industrial Estate, Raiwind Road, Lahore under DML No.

000688 by way of formulation has submitted request for change of title of the firm as per Form-29

with prescribed Fee Challan of Rs.50,000/-. The detail is as under;

Previous Title/legal status of firm as per Form-2

Proposed title/ legal status of Firm as per Certificate of incorporation of

S.E.C.P

M/s Kings Pharmaceuticals, , 27 Sunder Industrial Estate, Raiwind Road, Lahore

M/s Daneen Pharma (Private) Limited, , 27 Sunder Industrial Estate, Raiwind Road,

Lahore


The Board considered and approved the change of title/ name of the firm /company from old to new

management of M/s Kings Pharmaceuticals, 27 Sunder Industrial Estate, Raiwind Road, Lahore

under DML No. 000688 by way of (Formulation) as per Form-29 as under ;

Previous Title/legal status of firm New title/ legal status of Firm

M/s Kings Pharmaceuticals, , 27 Sunder Industrial Estate, Raiwind Road, Lahore

M/s Daneen Pharma (Private) Limited, , 27 Sunder Industrial Estate, Raiwind

Road, Lahore

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CASE NO. 9. CHANGE OF MANAGEMENT OF M/S KINGS PHARMACEUTICALS, LAHORE


000688 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 Partnership deed.

Retiring Management Current management as per Form-29 of S.E.C.P.

1. Mr. Faisal Yousaf S/o Muhammad yousafCNIC 35404-7775046-1

2. Mr. Amjad Hussain Cheema S/o Ghulam haider cheema CNIC 34101-2695410-1.

1. Mr. Faisal Yousaf S/o Muhammad yousafCNIC 35404-7775046-1

2. Mr. Amjad Hussain Cheema S/o Ghulam haider cheema CNIC No. 34101-2695410-1.

1. Mr. Ch. Muhammad Israr Sharif S/o Muhammad Sharif

CNIC No. 42301-7794286-72. Muhammad Shahbaz Babar

S/o Chaudhryf Muhammad Sharif CNIC No. 42301-4073982-3




000688 by way of Formulation as per Form-29 as under ;

Previous management Retiring Management Current management

1. Mr. Faisal Yousaf S/o Muhammad yousaf CNIC 35404-7775046-1

2. Mr. Amjad Hussain Cheema S/o Ghulam haider cheema CNIC 34101-2695410-1.

1. Mr. Faisal Yousaf S/o Muhammad yousaf CNIC 35404-7775046-1

2. Mr. Amjad Hussain Cheema S/o Ghulam haider cheema CNIC No. 34101-2695410-1.

1. Mr. Ch. Muhammad Israr Sharif S/o Muhammad Sharif CNIC No. 42301-7794286-7

2. Muhammad Shahbaz Babar S/o Chaudhry Muhammad Sharif CNIC No. 42301-4073982-3

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Case No. 10 CHANGE OF MANAGEMENT OF M/S HEALER LABORATORIES (PVT) LTD, 96/102-C, S.I.E, KOHAT ROAD, PESHAWAR.

M/s Healer Laboratories (Pvt) Ltd, Peshawar DML No. 000303 by way of formulation has

submitted request for change in management of the firm as per Form-29 of SECP alongwith

prescribed Fee Challan of Rs.50,000/- as under;

Previous Management as per Form 29

Retiring Management as per Form 29

New Management as per Form 29

1. Mr. Sajjad Hussain S/o Pir Baksh CNIC No.17301-2138068-7

2. Miss Rubina Yasmin D/o Pir Baksh CNIC No.17301-2910868-8



1. Mr. Mustafa Bashir S/o Muhammad Bashir CNIC No. 61101-7725236-5

2. Mr. Mujtaba Bashir S/o Muhammad Bashir CNIC No. 17301-0564104-3

3. Mr. Muhammad Faisal Bashir S/o Bashir Ahmad CNIC No. 17301-1645469-5



M/s Healer Laboratories (Pvt) Ltd, Peshawar DML No. 000303 by way of Formulation as per

Form-29 as under ;

Previous Management Retiring Management New Management





1. Mr. Mustafa Bashir S/o Muhammad Bashir CNIC No. 61101-7725236-5

2. Mr. Mujtaba Bashir S/o Muhammad Bashir CNIC No. 17301-0564104-3

3. Mr. Muhammad Faisal Bashir S/o Bashir Ahmad CNIC No. 17301-1645469-5

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Case No. 11 CHANGE OF MANAGEMENT OF M/S WINBRAINS RESEARCH LABORATORIES, PLOT NO. 69/1 BLOCK B, PHASE I-II, INDUSTRIAL ESTATE, HATTAR.

M/s Winbrains Research Laboratories, Hattar, DML No.000725 has submitted request for change in

management of the firm as per Partnership Deed alongwith prescribed Fee Challan of Rs.50,000/-

as under;

Previous Management as per Partnership Deed

Interim Management as per Dissolution Deed

New Management as per Partnership Deed

1. Mr. Arshad Mehmood S/o Khushi Muhammad CNIC No. 61101-6927558-3

2. Mr. Muhammad Rafiq S/o Taj Din CNIC No. 37405-6644802-1

3. Mr. Ejaz Khawar S/o Khawaja Muhammad Ramzan CNIC No. 904060-145498-1

4. Mr. Munir Ahmed S/o Mian Maula Bakhsh CNIC No. 37405-0607688-3

5. Mr. Asghar Ali S/o Allah Ditta CNIC No. 34101-2574786-1








M/s Winbrains Research Laboratories, Hattar, DML No.000725 by way of Formulation as per

Partnership deed as under ;

Previous Management Interim Management New Management 1. Mr. Arshad Mehmood S/o

Khushi Muhammad CNIC No. 61101-6927558-3

2. Mr. Muhammad Rafiq S/o Taj Din CNIC No. 37405-6644802-1

3. Mr. Ejaz Khawar S/o Khawaja Muhammad Ramzan CNIC No. 904060-145498-1








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Case No. 12. CHANGE OF MANAGEMENT OF M/S JINNAH PHARMACEUTICALS (PVT) LTD, LAHORE

M/s Jinnah Pharmaceuticals (Pvt) Ltd, 13-Km, Lahore Road, Multan under DML No. 000578 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 Retiring Management

New Management

1. Mr. Taimoor Fazil S/o Muhammad Fazil, CNIC No. 36302-0507065-9.

2. Dr. Atta Muhammad Malik S/o Khuda Baksh, CNIC No. 38302-6000280-5.

3. Mr. Abdul Hameed S/o Muhammad Ramzan CNIC No. 32303-4616584-3.



2. Mr. Manzoor Hammed S/o Mahmood Khan, CNIC No. 32102-8468313-1.




M/s Jinnah Pharmaceuticals (Pvt) Ltd, 13-Km, Lahore Road, Multan under DML No. 000578 by

way of (Formulation) as per Form-29 as under ;

Previous Management Retiring Management

New Management






2. Mr. Manzoor Hameed S/o Mahmood Khan, CNIC No. 32102-8468313-1.


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Case No. 13. CHANGE OF MANAGEMENT OF M/S SAPIENT PHARMA, LAHORE

M/s Sapient Pharma, 123-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore under DML No.

000207 by way of formulation has submitted request for change in management of the firm as per

Form-1A and Partnership deed with prescribed Fee Challan of Rs.50,000/-. The detail of

management of the firm is as under;

Previous Management as per Partnership deed

Adding Management

Current Management as per Partnership deed

1. Mr. Zahir Ahmad Mirza S/o Dr. Manzoor Ahmad Mirza CNIC No. 35202-5774190-5.

2. Ms. Mirza Hassan Zahir S/o Mr. Zahir Ahmad Mirza CNIC No. 35200-1461958-9.

1. Mirza Ali Zahir


2. Mr. Mirza Hassan Zahir S/o Mr. Zahir Ahmad Mirza CNIC No. 35200-1461958-9.

3. Mr.Mirza Ali Zahir S/o Mr. Zahir Ahmad Mirza.



M/s Sapient Pharma, 123-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore under DML No.

000207 by way of (Formulation) as per Partnership deed as under ;

Previous Management Adding Management

New Management


2. Ms. Mirza Hassan Zahir S/o Mr. Zahir Ahmad Mirza CNIC No. 35200-1461958-9.

1. Mirza Ali Zahir


2. Mr. Mirza Hassan Zahir S/o Mr. Zahir Ahmad Mirza CNIC No. 35200-1461958-9.

3. Mr.Mirza Ali Zahir S/o Mr. Zahir Ahmad Mirza.

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Case No. 14. CHANGE OF MANAGEMENT OF M/S TAYYAB LABORATORIES PVT (LTD)., ISLAMABAD.

M/s Tayyab Laboratories Pvt (Ltd)., Islamabad by way of (Formulation) has submitted request for change in management of the firm as per Form 29 along with prescribed Fee Challan of 50,000/- as under:-PREVIOUS MANAGEMENT AS

PER FORM 29 DATED 21-10-2016.

RETIRING MANAGEMENT AS PER FORM 29 DATED 21-02-

2017.

CURRENT MANAGEMENT AS PER FORM 29 DATED 09-10-

2017.1. Mr. Haroon Sajjad S/o Sajjad

Hussain CNIC # 17301-7396211-5.

2. Mr. Sajjad Hussain S/o Pir Bakhsh CNIC # 17301-2138068-7.

3. Mr. Taimur Sajjad S/o Sajjad Hussain CNIC # 17301-4648381-7.

1. Mr. Haroon Sajjad S/o Sajjad Hussain CNIC # 17301-7396211-5.





M/s Tayyab Laboratories Pvt (Ltd)., Islamabad by way of (Formulation) as per Partnership deed as

under ;

PREVIOUS MANAGEMENT RETIRING MANAGEMENT

New MANAGEMENT







Case No. 15 CHANGE OF TITLE OF M/S WYETH PAKISTAN LIMITED, KARACHI

M/s Wyeth Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E. Karachi under DML No. 000006 by way of formulation has submitted request for change of title of the firm as per Form-29 with prescribed Fee Challan of Rs.50,000/- as under;

Previous Title and Owners/Management New Title and Owners/Management as per form-29 from S.E.C.P

Wyeth Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E. Karachi

ICI Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E. Karachi

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The Board considered and approved the change of title/name management from old to new title of

M/s Wyeth Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E. Karachi under DML No. 000006 by

way of Formulation as per Form-29 as under ;

Previous Title New Title as per form-29 from S.E.C.PWyeth Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E. Karachi

ICI Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E. Karachi

Case No. 16. CHANGE OF MANAGEMENT OF M/S WYETH PAKISTAN LIMITED, KARACHI

M/s Wyeth Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E. Karachi under DML No. 000006 by way of formulation has submitted request for change in management of the firm as per Form-29 & Form-A 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 Current Management as per form-29

1. S.M.Wajeehuddin S/o Mohammad Faseehuddin CNIC No. 42201-4564592-3.

2. Mr. Iqbal Bengali S/o Haji Mohammad Bengali CNIC No.42301-4806528-5.

3. Husain Lawai S/o Haji Moosa NIC No. 914000-140464-5.

4. Farid Khan S/o Tahir Ghulam Nasir Khan CNIC#42301-1048442-7

5. Iftikhar Soomro S/o Haji Moula Baksh Soomro CNIC # 42301-9144337-7

6. Badarddin F. Vellani S/o Fatehali Walimuhamma D Vellani CNIC# 42301-0918221-7

7. M.Z. Moin Mohajir S/o M.Abdullah Mohajir CNIC # 42301-8664878-1

1. S.M.Wajeehuddin S/o Mohammad Faseehuddin CNIC No. 42201-4564592-3







1. Asif Jooma S/o Umer Wali Jooma CNIC No.42301-3175078-7.

2. Kamal A Chinoy S/o Amir S Chinoy CNIC No.42301-1401852-5.

3. Muhammad Abid Ganat S/o Moosa Ganatra CNIC No.42201-5355492-7.

4. Muhammad Sohail Tabba S/o Muhammad Yunus Tabba CNIC No.42000-0568372-5

5. Muhammad Ali Tabba S/o Abdul Razzak Tabba CINC No.42201-6464247-3

6. Jawed Yunus Tabba S/o Muhammad Yunus CNIC No.42201-2111104-7

7. Amina Abdul Aziz Bawany W/o Abdul Aziz Bawany CNIC No.42000-3004991-0.

8. Khawaja Iqbal Hassan S/o Khawaja Zafar Hassan CNIC No.42301-8986425-7

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M/s Wyeth Pakistan Limited, S-33, Hawkes Bay Road, S.I.T.E. Karachi under DML No. 000006 by

way of (Formulation) as per Form-29 as under:

Previous Management Retiring Management Current Management

1. S.M.Wajeehuddin S/o Mohammad Faseehuddin CNIC No. 42201-4564592-3.







1. S.M.Wajeehuddin S/o Mohammad Faseehuddin CNIC No. 42201-4564592-3







1. Asif Jooma S/o Umer Wali Jooma CNIC No.42301-3175078-7.

2. Kamal A Chinoy S/o Amir S Chinoy CNIC No.42301-1401852-5.

3. Muhammad Abid Ganat S/o Moosa Ganatra CNIC No.42201-5355492-7.

4. Muhammad Sohail Tabba S/o Muhammad Yunus Tabba CNIC No.42000-0568372-5

5. Muhammad Ali Tabba S/o Abdul Razzak Tabba CINC No.42201-6464247-3

6. Jawed Yunus Tabba S/o Muhammad Yunus CNIC No.42201-2111104-7

7. Amina Abdul Aziz Bawany W/o Abdul Aziz Bawany CNIC No.42000-3004991-0.

8. Khawaja Iqbal Hassan S/o Khawaja Zafar Hassan CNIC No.42301-8986425-7

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Case No. 17. CHANGE OF MANAGEMENT OF M/S MORENO IGLISIAS RESEARCH LABORATORIES (PVT) LTD, LAHORE.

M/s Moreno Iglisias Research Laboratories (Pvt) Ltd, Lahore by way of Formulation has submitted

request for change in management of the firm as per Form 29 along with prescribed Fee Challan of

50,000/- as under:-

Previous Management as per Form-A & Form-29 at the time of previous renewal

Retiring Management Current Management as per Form-29 & Form-A of SECP

1. Mr.Saleh MahmoodS/o Sharif Hussain. CNICNo. 35201-9102579-9.

2. Mr. Riaz Ahmad S/oHabib-ur-Rehman CNIC No. 34603-2285414-3

1. Mr. Riaz Ahmad S/o Habib-ur-RehmanCNIC No. 34603-2285414-3

1. Mr. Saleh Mahmood S/o Sharif Hussain.CNIC No. 35201 9102579-9.

2. Ms. Rahsida Malik W/o Saleh Mahmood,CNIC No. 35201-6205152-0.



M/s Moreno Iglisias Research Laboratories (Pvt) Ltd, Lahore by way of Formulation as per Form-

29 & Form-A as under ;

Previous Management Retiring Management New Management

1. Mr.Saleh MahmoodS/o Sharif Hussain. CNIC No. 35201-9102579-9.

2. Mr. Riaz Ahmad S/oHabib-ur-Rehman CNIC No. 34603-2285414-3

1. Mr. Riaz Ahmad S/o Habib-ur-RehmanCNIC No. 34603-2285414-3

1. Mr. Saleh Mahmood S/o Sharif Hussain.CNIC No. 35201 9102579-9.

2. Ms. Rahsida Malik W/o Saleh Mahmood,CNIC No. 35201-6205152-0.

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Case No. 18 CHANGE OF TITLE OF M/S A.H PHARMACEUTICALS, FAISALABAD.

M/s A.H Pharmaceuticals, Faisalabad under DML No. 000630 by way of formulation has

submitted request for change of title of the firm as per Form-29 with prescribed Fee Challan of

Rs.50,000/-. The detail is as under;

Current Title and legal status as per Form-2 (page 135/Corr)

Proposed Title and legal status as per Form-A and Form-29 (Pages

399-401/Corr)M/s A.H Pharmaceuticals. M/s A.H Pharmaceuticals (Pvt) Ltd.



M/s A.H Pharmaceuticals, Faisalabad under DML No. 000630 by way of (Formulation) as per

Form-29 as under ;

Current Title / Name New Title / NameM/s A.H Pharmaceuticals. M/s A.H Pharmaceuticals (Pvt) Ltd.

Case No. 19. CHANGE OF MANAGEMENT OF M/S A.H PHARMACEUTICALS, FAISALABAD.

M/s A.H Pharmaceuticals, Faisalabad under DML No. 000630 by way of Formulation has submitted request for change in management of the firm as per Form 29 along with prescribed Fee Challan of 50,000/- as under:-

Current Management as per Form-29 from SECP (Page

237/Corr

Retiring Management Proposed Management as per Form-A and Form-29 (Pages

399-401/Corr)1) Mr. Muhammad Asif S/o

Muhammad Yousaf CNIC No.33100-9084622-5.

2) Mr. Ehsan Ahmad S/o Bukhtiar Ahmad CNIC No. 33100-5517783-1.

1) Mr. Muhammad Asif S/o Muhammad Yousaf CNIC No.33100-9084622-5.

2) Mr. Ehsan Ahmad S/o Bukhtiar Ahmad CNIC No. 33100-5517783-1.

1) Mr.ZAhid Iqbal S/o Jamal ud Din CNIC No.36502-8234419-5.

2) Mr. Asif Jabbar S/o Haji Abdul Jabbar CNIC No. 33100-6423811-9.

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M/s A.H Pharmaceuticals, Faisalabad under DML No. 000630 by way of Formulation as per Form-

29 as under ;

Current Management Retiring Management New Management

1. Mr. Muhammad Asif S/o Muhammad Yousaf CNIC No.33100-9084622-5.

2. Mr. Ehsan Ahmad S/o Bukhtiar Ahmad CNIC No. 33100-5517783-1.

1. Mr. Muhammad Asif S/o Muhammad Yousaf CNIC No.33100-9084622-5.

2. Mr. Ehsan Ahmad S/o Bukhtiar Ahmad CNIC No. 33100-5517783-1.

1. Mr.Zahid Iqbal S/o Jamal ud Din CNIC No.36502-8234419-5.

2. Mr. Asif Jabbar S/o Haji Abdul Jabbar CNIC No. 33100-6423811-9.

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Case No. 20. M/S EG PHARMACEUTICALS, 13-A, INDUSTRIAL TRIANGLE, KAHUTA ROAD, ISLAMABAD – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.

Case Background

M/s EG Pharmaceuticals, 13-A, Industrial Triangle, Kahuta Road, Islamabad wherein the firm has

submitted the application for change of technical staff (Production Incharge) dated 17-11-2015.

After evaluation of the change of technical staff application of the firm, a letter for completion of

application for change of technical staff was issued for following shortcomings: -

1. Clear readable and attested copy of CNIC of appointee.2. Job acceptance letter by the appointee.3. Approval letter of earlier approved Production Manager.4. Resignation letter of the previous approved Production Manager.5. Undertaking as whole time employee from the Firm’s higher authority.6. Detail experience of 10 years for Production Manager according to the Section

(16) of Drugs Licensing Registering & Advertising Rules, 1976.

The firm submitted reply but the same was incomplete and reminder was issued to the firm with

following shortcomings:-

1. Job acceptance letter by the appointee.2. Approval letter of earlier approved Production Manager.3. Resignation letter of the previous approved Production Manager.4. Undertaking as whole time employee from the Firm.5. Detail experience certificate as under Drugs Licensing Registering & Advertising

Rules, 1976 (not less then 10 years).6. All documents attested as per check list.

The firm submitted reply but the same was incomplete and final reminder was issued to the firm with following shortcoming;

1. Relevant experience of proposed Production Incharge is less than 10 years. As per record of Licensing Division, no reply has been received from the firm in response to above mentioned final reminder. It is also submitted that the proposed Production Incharge has resigned from the firm dated 30-11-2017 and firm has not submitted documents for approval of new Production Incharge.Proceedings and Decision of Central Licensing Board in 257thmeeting

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

why the application for renewal of DML No. 000752 by way of formulation of M/s EG

Pharmaceuticals, 13-A, Industrial Triangle, Kahuta Road, Islamabad may not be rejected by

Central Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled

by Central Licensing Board.

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

The Show Cause notice dated 26th February, 2018 was issued to the M/s M/s EG Pharmaceuticals,

13-A, Industrial Triangle, Kahuta Road, Islamabad.

In reply to the Show Cause notice firm has submitted the deficient documents and application for

renewal of DML in now complete.

A letter of Personal hearing has been issued on 20th March, 2018.

Proceedings and Decision of Central Licensing Board in 259 th meeting

Mr. Shoukat Hayat Khan, Chief Executive of the firm appeared before the Board and contended

that he has completed the all codal formalities for renewal of Drug Manufacturing Licence

therefore, ShowCause Notice issued to him may be withdran. The Board considering the facts

decided to revoke the Showcause Notice issued to the firm and also issue warning the firm should

be careful in future for compliance of the law.

Case No. 21. M/S CALIPH PHARMACEUTICALS (PVT) LTD., PLOT NO.17, SPECIAL INDUSTRIAL ZONE (EPZ), RISALPUR – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.

M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur submitted the application for renewal of

DML No. 000748 by way of formulation on 17-07-2017 for the period of 13-08-2017 to 12-08-

2022, which was well on time. After evaluation of the renewal application of the firm, a letter for

completion of application for renewal of DML was issued for following shortcomings: -

i. Fee of Rs.50,000/- alongwith requisite documents for approval of change in management, but the management seems to have been changed as under;Previous Management as per Memorandum and Article of Association (Page 33/Corr –

main file)

Current Management as per Form-1A (Page 8/Corr) dated

14-07-2017

i. Mr. Mumtaz Ali ii. Mrs. Lal Zari

iii. Mr. Farman Ali

i. Mr. Muhammad Azmat Ali ii. Mr. Amjad Ali Zeb

ii. Attested copy of approval letter(s) of all the approved section(s) has not been attached

Proposed QC Incharge (Mr. Naseer Ahmed).

iii. Complete set of attested documents as per check list.iv. Fee challan of Rs.5,000/- for approval of change of QC Incharge.

With reference to above letter, the firm submitted some shortcoming documents. Upon

evaluation, Licensing Division issued final reminder with following shortcomings;

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i. Attested copy of Form-29 and Form-A of SECP showing the detail of previous management, has not been attached.

ii. Approval letter(s) of all licensed section(s), has not been attached.iii. Resignation letter of previously appointed QC Incharge.

With reference to above final reminder, the firm submitted some shortcoming documents.

Upon evaluation, following shortcoming has still been observed;

i. Attested copy of section approval letter(s) has not been provided.

Proceedings and Decision of Central Licensing Board in 257thmeeting




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

application for renewal of DML No. 000748 by way of formulation of M/s Caliph Pharmaceuticals

(Pvt) Ltd. Risalpur not be rejected by Central Licensing Board.


The Show Cause notice dated 26th February, 2018 was issued to the M/s of M/s Caliph

Pharmaceuticals (Pvt) Ltd. Risalpur.

In reply to the Show Cause notice firm has submitted the short documents and application for




Mr. Adnan Khan, Manager Finance of the firm appeared before the Board and contended that he

has completed the all codal formalities for renewal of Drug Manufacturing Licence therefore,

ShowCause Notice issued to him may be withdran. The Board considering the facts decided to

revoke the Showcause Notice issued to thr firm and also issue warning the firm should be careful in

future for compliance of the law.

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Case No. 22 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S SYMANS PHARMACEUTICALS (PVT) LTD, 10-KM, SHEIKHUPURA ROAD, LAHORE

M/s Symans Pharmaceuticals (Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore had

applied for renewal of DML No. 000323 by way of formulation on 16-09-2015 for the period of 19-

10-2015 to 18-10-2020.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 26-07-2016 under Rule

5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. Form 29- from S.E.C.P along with copies of CNIC and any change in

management / Directors / Owners

2. Approval Layout plan of premises (Copy)

3. Proof of licensed sections from CLB

4. Approval letter of technical staff

5. Nothing due certificate for CRF

The firm submitted documents on 11-08-2016 but following documents were still

deficient /short and same were conveyed to the firm Reminder-I letter issued on 28-12-2016.

1. Attested documents of renewal as per form 1A.2. Proposed technical staff documents as per check list.3. Approval Layout plan of premises (Copy).4. Proof of licensed sections from CLB.5. All documents should be duly attested.

The firm submitted documents on 30-01-2017 in reply to Reminder-I but following

documents were still deficient /short and Final Reminder was issued on 06-02-2017 to the firm with

following shortcomings: -

1. Attested documents of renewal as per form 1A.2. Proposed technical staff documents as per check list.3. Approval Layout plan of premises (Copy).4. Proof of licensed sections from CLB.5. All documents should be duly attested.

The firm submitted documents on 28-02-2017 in reply to Final Reminder. Upon

Evaluation following shortcoming has been observed and application for renewal of DML is still

incomplete

1. Approval letter of proposed Quality Control Incharge, if any change then provide set of documents for Proposed Quality Control Incharge (as per check list) along with prescribe fee.

2. Approved master Layout plan of premises (Copy).3. Proof of licensed sections from CLB.

4. Updated nothing due certificate regarding CRF from STO.5. All documents should be duly attested.

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why the application for renewal of DML No. 000323 by way of formulation of M/s Symans

Pharmaceuticals (Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore may not be rejected by Central

Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled by

Central Licensing Board.


The Show Cause notice dated 26th February, 2018 was issued to the M/s Symans Pharmaceuticals

(Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore. No reply of the show cause notice is received from

the firm. However, the firm has filed application of Mr. Talat Ahmad Anjum for approval as

Quality Control Incharge but documents submitted by the firm were incomplete and un-attested and

same was conveyed to the firm.



Dr. Syed Saleem Hyder, Managing Director of the firm appeared before the Board and presented

documented which were evaluated by the Board and found complete. He further contended that he


ShowCause Notice issued to him may be withdrawn. The Board considering the facts decided to



Case No. 23 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SHAFI TEXTILE CORPORATION, 608-B, SMALL INDUSTRIAL ESTATE, SARGODHA ROAD, FAISALABAD

M/s Shafi Textile Corporation, 608-B, Small Industrial Estate, Sargodha Road, Faisalabad had

applied for renewal of DML No. 000436 by way of formulation on 22-10-2014 for the period of 07-

09-2014 to 06-09-2019.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 16-02-2017 under Rule


1. Renewal application is 45 days late according to Rule 6 of drugs (L, R&A) rule 1976 the additional surcharge 5,000/- each day, deposit fee of Rs. 225000/- = (45x5000).

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2. There is change in management of the firm, so proper application along with challan fee of Rs. 50,000/-.

3. Proof of licensed section from CLB /Approved layout plan.4. Updated nothing due certificate regarding CRF from STO.5. All documents should be duly attested.

The firm did not submit their reply. Final Reminder was issued on 08-06-2017 to the firm

with following shortcomings: -

1. Renewal application is 45 days late according to Rule 6 of drugs (L, R&A) rule 1976 the additional surcharge 5,000/- each day, deposit fee of Rs. 225000/- = (45x5000).

2. There is change in management of the firm, so proper application along with challan fee of Rs. 50,000/-.

3. Proof of licensed section from CLB /Approved layout plan.4. Updated nothing due certificate regarding CRF from STO.5. All documents should be duly attested.

The firm has not submitted the above mentioned documents till date and application for

renewal of DML is still incomplete

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why the application for renewal of DML No. 000436 by way of formulation of M/s Shafi Textile

Corporation, 608-B, Small Industrial Estate, Sargodha Road, Faisalabad may not be rejected by

Central Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled

by Central Licensing Board.


The Show Cause notice dated 26th February, 2018 was issued to the M/s Shafi Textile Corporation,

608-B, Small Industrial Estate, Sargodha Road, Faisalabad

No reply of the show cause notice is received from the firm till date.



Mr. Muhammad Zeeshan, General Manager of the firm appeared before the Board and could not

satisfy the Board. The Board considering the facts on the record and after thread bare deliberation

decided to suspend the Drug Manufacturing Licence No. 000436 by way of formulation issued in

the name of M/s Shafi Textile Corporation, 608-B, Small Industrial Estate, Sargodha Road,

Faisalabad till settelemnt of codal formalities 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. If the

firm completes the codal formalities, the Chairman Central Licensing Board shall pass an order for

revocation of suspension. However, case would be brought before Central Licensing Board in

forthcoming meeting for endorsement of decision taken by the Chairman.

Case No. 24 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S TAGMA PHARMA (PVT) LTD, 12.5-KM, RAIWIND ROAD, LAHORE

M/s Tagma Pharma (Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore had applied for

renewal of DML No. 000414 by way of formulation on 14-07-2015 for the period of 06-08-2015 to

05-08-2020.The application for the renewal of DML of the firm was evaluated and a letter for

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following shortcomings / deficiencies was issued to the firm on 03-09-2015 under Rule 5{2A} of

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

1. Duly attested details of management.2. Form-29.3. Proof of all sections.4. CNIC copies of management.5. Attested details of qualified persons.6. Undertaking regarding correct details.


deficient /short and Final Reminder was issued on 21-07-2017 to the firm with following

shortcomings: -

1. Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of management at the time of previous renewal and now at present renewal.

2. Nothing due certificate regarding CRF from STO (Updated).3. Detail of Premises with Proof of CLB approved sections.4. Approval letter of Production Incharge and Quality Control Incharge, if any

change then provide set of documents for proposed Production Incharge and Quality Control (as per check list) along with prescribe fee of Rs. 10,000/-

5. All Documents should be duly attested.

The firm submitted documents on 01-08-2017 in reply to Final Reminder. Upon Evaluation

following shortcoming has been observed and application for renewal of DML is still incomplete


2. Nothing due certificate regarding CRF from STO (Updated).3. Detail of Premises with Proof of CLB approved sections.4. All Documents should be duly attested.

Now the Division of Budget and Account has forwarded Nothing due certificate regarding CRF

from STO (Updated) and following documents shortcomings:


2. Detail of Premises with Proof of CLB approved sections.3. All Documents should be duly attested.

Proceedings and Decision of Central Licensing Board in 257th meeting





why the application for renewal of DML No. 000414 by way of formulation of M/s Tagma Pharma

(Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore may not be rejected by Central Licensing Board or their

Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.


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The Show Cause notice dated 26th February, 2018 was issued to the M/s M/s Tagma Pharma (Pvt)

Ltd, 12.5-Km, Raiwind Road, Lahore.

The firm replied to the show cause notice but application for renewal of DML is still short of

following documents:

i. Prescribed fee of Rs. 50,000/- as there seems to be change in management of the firm. The detail of management is as under:-

Pervious Management as per Form-29 Year 2014

Retiring Management Current Management as per Form-A Year 2017

1. Mr. Abdul Aleem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-1691245-9.

2. Mr. Naeem Shami S/o Abdul Ishfaq Shami CNIC No.35202-4717733-9.

3. Mr. Shahid Nadeem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-8856537-1.

1. Mr. Abdul Aleem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-1691245-9

2. Mr. Naeem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-4717733-9

1. Mr. Shahid Nadeem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-8856537-1

2. Ms. Saima Nadeem W/o Shahid Nadeem Shami CNIC No. 35202-274539-2

ii. Latest Form-29 duly attested from S.E.C.P. iii. Detail of Premises with Proof of CLB approved sections



Mr. Nadeem Shami, Managing Director of the firm appeared before the Board and presented

documented which were evaluated by the Board and found complete. He further contended that he


ShowCause Notice issued to him may be withdrawn. The Board considering the facts decided to



Case No. 25 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S MASFA INDUSTRIES (PVT) LTD, 17-KM, SHEIKHUPURA ROAD, LAHORE

M/s Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore had applied for



following shortcomings / deficiencies was issued to the firm on 19-09-2016:-

1. The application of renewal of DML is 30 days late. of 150

2. Detail of management ate previous renewal of DML and latest management at present renewal of DML.

3. Proof of sections approved by CLB.4. Approval letter of Production Incharge and Quality Control Incharge.5. Updated Nothing due certificate for CRF from STO (R&D) DRAP, Islamabad.


deficient /short and Final Reminder was issued to the firm on 10-07-2017 for completion of

application.

1. You were asked to submit late surcharge fee for DML renewal i.e.30*5,000=150,000/- However Statistical Officer of DRAP endorsed for Rs.134, 970/- you are required to submit remaining Rs. 15,030/- in DRAP account.

2. Attested Form-29 from S.E.C.P. (Latest 2017 and at time of grant of DML (2011) if any change in management then fee for change in management/Director.

3. Nothing due certificate of C.R.F. from S.T.O DRAP.

The firm submitted documents on 28-08 -2017 in reply to Final Reminder but

application for renewal of DML is short of following documents as of today:

1. Nothing due certificate of C.R.F. from S.T.O DRAP.




Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the DML No. 000713 by

way of formulation of M/s Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore may not

be suspended under Rule 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 till

settlement of Central Research Fund.


The Show Cause notice dated 26th February, 2018 was issued to the M/s Masfa Industries (Pvt) Ltd,

17-km, Sheikhupura road, Lahore.

In reply to the Show Cause notice firm has submitted the short documents and application for




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No person on behalf of the firm appeared before the Board. However, the Board considering the

facts on record decided to revoke the Showcause Notice issued to the firm and also issue warning to

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

Case No. 26 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S DOSACO LABORATORIES, 9.2-KM, SHEIKHUPURA ROAD, LAHORE.

M/s Dosaco Laboratories, 9.2-Km, Sheikhupura Road, Lahore. had applied for



following shortcomings / deficiencies was issued to the firm on 04-10-2016:-

1. Classes of Drugs

2. Dosage forms of drugs

3. Detail of management previous renewal of DML and lattes management present

renewal of DML.

4. Proof of Section from CLB

5. Approval letter of Production Incharge and QC Incharge

6. Noting due certificate regarding CRF from STO.

The firm submitted documents of Mr. Yasir Khan for approval as Production Incharge on 13-12-

2016 but did not respond to shortcomings to Licensing Division’s letter issued on 04-10-2016.

Application for approval of Production Incharge was evaluated and firm was communicated

following deficient documents in the application vide letter issued on 28-12-2016:-

1. Job acceptance letter by the appointee

2. Experience Certificate as under Drugs (Licensing, Registering and Advertising)

Rules, 1976 (Not less than 10 year).

3. Resignation / retirement of earlier Production Incharge.

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

letter / transfer letter from the same firm.

5. Undertaking as whole time employee

6. All documents should be duly attested.

The firm did not submitted documents and Final Reminder was issued to the firm on

19-06-2017 for completion of application.

1. Classes of Drugs

2. Dosage forms of drugs

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3. Detail of management previous renewal of DML and lattes management present

renewal of DML.

4. Proof of Section from CLB

5. Approval letter of QC Incharge

6. Noting due certificate regarding CRF from STO (Updated).

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

8. Experience Certificate as under Drugs (Licensing, Registering and Advertising)

Rules, 1976 of Production Incharge (Not less than 10 year).

9. Resignation / retirement of earlier Production Incharge.

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

letter / transfer letter from the same firm (Production Incharge).

11. Undertaking as whole time employee on stamp paper (Production Incharge)


The firm submitted documents on 13-09-2017 in reply to Final Reminder for renewal

of DML. Upon evaluation following shortcomings has been observed in the application for

renewal of DML is still incomplete:

i. Nothing due certificate regarding CRF form STO, DRAP, Islamabad (Update).

ii. Proof of sections approved by Central Licensing Board.iii. CNIC copy, academic degrees and Registration Certificate of appointee

are not duly attested.iv. Resignation/ retirement letter of earlier Production Incharge is not

provided.v. Experience certificates is less than 10 years as per submitted documents

of the firm. Total experience of Proposed Production Incharge is approximately 9 years and 03 months.

vi. There is change in management of the firm. The detail of which is as under:

Management as per Form-1A at the time of renewal of DML for tenure 19-04-2006 to 18-04-2011



Current Status

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i. Mr. Muhammad Firdous.

ii. Mr. Muhammad Yaqoob Butt and Others.

Not Provided i. Mr. Nadeem Firdous.

ii. Mr. Abu Obaida Butt & Others.

i. Mr. Nadeem Firdous.

ii. Mr. Umar Butt






why the application for renewal of DML No. 000094 by way of formulation of M/s Dosaco

Laboratories, 9.2-Km, Sheikhupura Road, Lahore may not be rejected by Central Licensing Board

or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing

Board.


The Show Cause notice dated 26th February, 2018 was issued to the M/s Dosaco Laboratories, 9.2-

Km, Sheikhupura Road, Lahore




Mr. Yasir Khan appeared before the Board. He contested that certificate regarriding CRF is recived

and presented before the Board. The Board after hearing the representative of the firm and

considering the facts on the record and after thread bare deliberation decided to suspend the Drug

Manufacturing Licence No. 000094 by way of formulation issued in the name of M/s Dosaco

Laboratories, 9.2-Km, Sheikhupura Road, Lahore till settelemnt of codal formalities 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 and Rule, 5(2A) of the Drugs (Licensing,

Registering and Advertising) Rules, 1976. If the firm completes the codal formalities, the Chairman

Central Licensing Board shall pass an order for revocation of suspension. However, case would be

brought before Central Licensing Board in forthcoming meeting for endorsement of decision taken

by the Chairman.

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Case No. 27 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ALBRO PHARMACEUTICALS (PVT) LTD, 340-S, QUAID-E-AZAM INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE.

Background of the caseMr. Abdul Rashid Shaikh, FID and Mrs. Saira Naeem, area ADC, Lahore conducted inspection of the firm M/s Albro Pharmaceutical, Lahore on 12.06.2015, to verify the GMP compliance and production activities. Following critical observations were noticed by the panel during their visit:-

General Information

Land of the firm does not fulfill the requirements of SRO. 470 (1)/98 dated 15.05.1998 Schedule-B to the Drugs (Licensing, Registration & Advertisement) Rules, 1976. It is advised to shift the manufacturing facility to appropriate area to fulfill the requirement of above said SRO till then; the management is directed to strictly maintain the cGMP requirements for the manufacturing of registered drugs.

Workers Entrance:

It is advised to improve the workers entrance.

Oral Liquid Section:

The firm was advised to replace the drains with GMP drains in the section.

The firm was advised to replace the cooking vessel for the syrup manufacturing.

The firm was advised to conceal the lights of areas.

Raw Material Store:

The firm was advised to ensure the availability of closed trolleys for the transportation of dispensed materials from store to production floor.

The firm was advised to affix the proper labeling with relevant colours on the quarantine materials released or rejected

The firm was advised to improve the storage condition of liquid materials by keeping in view the safety measures.

The firm was advised to review and upgrade the dispensing SOPs.

Tablet Section:

The firm was directed to ensure availability of the Double Cone Mixer.

The firm was directed to ensure the availability of separate bags for each product for Fluid-bed dryer.

The firm was directed to review the manufacturing SOPs as far as batch size is concerned.

The firm was directed to ensure the batch size as per available manufacturing capacity.

Quality Control Laboratory:

The firm was advised to ensure the FTIR, KARL Fischer and Automatic Polarimeter.

The firm was advised to upgrade the SOPs for testing methods as per current pharmacopoeia requirements.

The firm was advised to develop separate and independent Quality Assurance Department under the supervision of senior technical person without fail.

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The firm was advised to get internal and external audit and then its CAPA, and the report be submitted to the office of FID.

The firm was advised to ensure to make the stability chamber functional, conduct stability of the products and maintain their record as per guidance of stability study.

The FID further directed the management to:-

Remove the shortcomings at the earliest. The re-inspection will be conducted accordingly.

Action Taken by DRAP:- After receiving inspection report, a show cause notice was issued to the firm on 10.11.2015.Reply of the firm:- In response of the show cause notice, the firm vide letter No. Nil dated 23.11.2015 informed that many of the observations has been resolved and improved.Proceedings of the 246 th Meeting of CLB Mr. Waseem Ahmad Bari, Director and Mr. Sibtul Hassan Abaas, Production Manager of the firm

M/s Albro Pharma, Lahore appeared before the Board for personnel hearing. Mr. Waseem Ahmad

Bari informed to the Board that the existing plot is about 2.5 Kanal and assured that he will

purchase the new plot of 4 kanal (size) in next six months. He has submitted an undertaking stating

that the facility will be developed in four years. He further informed that all the observations

identified by FID have been rectified and are ready for inspection for verification of the

rectification.

Decision of the 246 th Meeting of CLB After thorough discussion/deliberations, considering all the pros and cons of the case, keeping in view the available record and request of Director of the firm M/s Albro Pharma, Lahore, the Board decided to conduct panel cGMP inspection of the firm on approved format under Schedule B-II of Drugs (LR&A) Rules, 1976 by the following members.

i. Dr. Zaka ur Rehman, Member, CLB

ii. Mr. Abdul Rashid Sheikh, FID, Lahore

iii. Mr. Zia Husnain, FID, Lahore

The Board further decided to ask the panel to also submit the report in tabulated form identifying the previous observations and the current status of the observations noted by the panel in its inspection conducted on 12.06.2015.

To purchase the plot of 4 kanals in 06 months and complete the facility within a period of 2 years


The Board considered the case and decided to defer the renewal of DML till next

meeting of the Board for want of personal hearing regarding update from the licensee on the

decision of the Central Licensing Board for purchase of plot and completion of facility.


A letter of Personal hearing has been issued on 20th March, 2018. of 150


Mr. Waseem Bari, Owner of the firm appeared before the Board. He contested that firm possess

three sections, land at new site has been purchased and application for site verification has already

been filed. He further contended that considerable time may be allowed to shift to new premises.

The Board after hearing the representative of the firm and considering the facts on the record and

after thread bare deliberation decided to defer the case for the sake of shifting of the premises to

new site within a period of one years. The firm shall get site approval within one month and lay out

approval within one month and will apply for grant of licence within a period of one year. The firm

shall also submit progress report quarterly. If firm fails to comply at any stage the Central Licenisng

Board shall start proccedings as per law.

Case No. 28 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S T.G PHARMA, KARACHI

M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi had applied for renewal of

DML No. 000547 by way of formulation for the period of 24-07-2014 to 23-07-2019 on 23-07-

2014.

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 23rd February, 2016 and 2nd March, 2017

under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

i) Proper application on Form-IA on firm’s letter head dully signed / stamp by CEO of firm.

ii) No Objection Certificate for Central Research Fund (CRF) (updated) issued by Statistical Officer DRAP, Islamabad

iii) Legal status of the firm along with details of ownership, attested copies of CNIC’s.

iv) List of total section of the firm and their letters of approval which were issued by Central Licensing Board.

v) Approval letter of QC Incharge and Production Incharge if (not available) then provide complete documents of technical persons i.e QC Incharge and Production Incharge according to checklist (enclosed).

Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 10th July,

2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following

shortcomings.

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i) Proper application on Form-IA on firm’s letter head dully signed / stamp by CEO of

firm.

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

iii) Legal status of the firm along with details of ownership, attested copies of CNIC’s. .

iv) Approval letters of sections issued by the Central Licensing Board

v) Approval letter of proposed Quality Control Incharge and Production Incharge, if any

change then provide set of duly attested documents for Proposed Quality Control

Incharge and Production Incharge (as per check list) along with prescribe fee.

vi) Documents should be duly attested.





Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to

why their application for renewal of M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area,

Karachi Drug Manufacturing Licence No. 000547 by way of formulation may not be rejected or

Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.


The Show Cause notice dated 05th January, 2018 was issued to the M/s T.G Pharma, E-30, Sector

15, Korangi Industrial Area, Karachi.

No reply of the show cause notice is received from the firm.

A letter of Personal hearing has been issued on 17th January, 2018


No person appeared on behalf of the firm. The Board decided to defer the case for giving one more

opportunity and service of notice through Federal Inspector of Drugs.


Firm submitted documents on 2nd February, 2018 in reply to personal hearing letter dated 17 th

January, 2018 but following documents are still deficient /short and application for renewal of DML

is still incomplete.

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

ii) Legal status of the firm either Sole proprietor / Partnership firm at this renewal and at

time of previous renewal alongwith attested CNIC copies of all partners / owners.

iii) Approval letter of all section issued by CLB or if not available then submitted layout

plan for regularization.

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iv) Approval letter of proposed Quality Control Incharge and Production Incharge, if any

change then provide complete set of duly attested documents for Proposed Quality

Control Incharge and Production Incharge (as per check list) along with prescribe fee.

A letter of Personal hearing has been issued


Dr. Waseem Siddiqui appeared before the Board. He contested that documents regarding CRF is

submitted with concerned Division. However, he could not satisfy the Board regarding the deficient

documents. The Board after hearing the representative of the firm and considering the facts on the

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

000547 by way of formulation issued in the name of M/s T.G Pharma, E-30, Sector 15, Korangi

Industrial Area, Karachi 000547 till settlement of codal formalities 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, 5(2A) of the Drugs (Licensing,

Registering and Advertising) Rules, 1976. If the firm completes the codal formalities, the Chairman

Central Licensing Board shall pass an order for revocation of suspension. However, case would be

brought before Central Licensing Board in forthcoming meeting for endorsement of decision taken

by the Chairman.

Case NO. 29 RESTRUCTURING OF LICENSED PREMISES WITHOUT PRIOR APPROVAL FROM DRAP OF M/S LISKO PAKISTAN (PVT) LTD, KARACHI

A copy of letter is received from Mr. Kirshan, Assistant Director / Federal Inspector

of Drugs, Karachi addressed to the Director M/s Lisko Pakistan (Pvt) Ltd, Karachi, wherein he has

stated that as follow:-

“I am directed to inform you that the undersigned visited the premises (Lisko Pakistan (Private) Limited, L-10/D, Block-21, Federal "B" Industrial Area) on dated 26-10-2017 regarding the subject matter and as per telephonic discussion with you that the construction work for bottle store was undergoing on the first floor of the building without approval intimation to Area FID.2. As per your statement, during the course of construction work, the roof of the floor fallen down due to overload on dated 24-10-2017 and eventually one of the labors died and the four injured.3. During the visit the undersigned found the factory premises were sealed by Sindh Building Control Authority (SBCA) (annexure attached). 4. You are hereby directed to explain that why the permission was not taken from DRAP.

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5. You are further directed that explain your position within 7 days of receipt of this office letter and intimate the DRAP for approval before resuming the activities in factory premises”.





Rule, 19 and Rule 20 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why

their Drug Manufacturing Licence No. 000520 of M/s Qintar Pharmaceuticals (Pvt) Ltd, 14-A,

Punjab Small Industrial Estate, Lahore Road, Sargodha by way of formulation may not be

suspended or cancelled by Central Licensing Board.

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

In the aforesaid minutes of Central Licensing Board the name of the firm was inadvertently typed as

M/s Qintar Pharmaceuticals (Pvt) Ltd, 14-A, Punjab Small Industrial Estate, Lahore Road,

Sargodha under Drug Manufacturing Licence No. 000520 by way of formulation Instead of M/s

Lisko Pakistan (Pvt) Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi under Drug

Manufacturing Licence No. 000110 by way of formulation.


The Board approved the correction in decision of the 256th meeting of the Central Licensing Board

and decision may be read as under:

“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, 19 and Rule 20 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their Drug Manufacturing Licence No. 000110, M/s Lisko Pakistan (Pvt) Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi by way of formulation may not be suspended or cancelled by Central Licensing Board.”


The Show Cause notice dated 27th February, 2018 was issued to the M/s Lisko Pakistan (Pvt) Ltd,

L-10/D, Block-21, Federal "B" Industrial Area, Karachi.




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Mr. Nazar Talib, Managing Director of the company appeared before the Board. He contended that

lay out plan was approved by the Division of Licensing for first floor accordingly construction was

being done. Roof of the newly built room was collapsed and incident happened. He argued that

there was no un-authorised construction as reported by the Federal Inspector of Drugs. He also

submitted approval letter from Licensing Division for layout plan approval for said section. He also

argued that Sindh Building Control Authority has initially sealed the premises and de-sealed it after

investigations. He also informed that production is also carried out on the ground floor. The Board

after hearing the representative of the firm and facts on record decided to revoke the show cause

notice issued to the firm. The Board directed area federal Inspector of firm to submit updated report

on premises with status as per Lay Out Plan.

Case No. 30 RENEWAL OF DRUG MANUFACTURING LICENSE NO. (000684) (FORMULATION) OF M/S BRAND PHARMA INTERNATIONAL, K-105, PHASE-II, S.I.T.E, SUPER HIGHWAY, KARACHI

M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi was issued the

License No. 000684 (Formulation) on 10-05-2010 and due date of renewal of License was 09-05-

2015. It is pertinent to mention that Rule 5 (6) of Drug (L, R & A) Rule, 1976 states “if an

application of renewal is made after the expiry of the period of validity of License but within 60

days of expiry, the License shall continue in force on payment of additional surcharge of Rs. 5,000/-

per day the application is delayed and thereafter until orders are passed on such application”. But

in this case the application for renewal of DML for the period 10-05-2015 to 09-05-2020 has not

been received till date. Therefore, DML No. 000684 (Formulation) M/s Brand Pharma

International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi is no more valid.

Proceedings and Decision of Central Licensing Board in 257th meeting




Rule, 5 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why DML No.

000684 by way of formulation of M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super

Highway, Karachi may not be declared cancelled.


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The Show Cause notice dated 27th February, 2018 was issued to the M/s Brand Pharma

International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi.




No person appeared on behalf of the firm. The Board deferred the case for want of report from

Federal Inspector of Drugs and service of showcause notice to the firm through Federal Inspector of

drugs.

Case No.31 M/S GENERA PHARMACEUTICALS, PLOT NO. 244, STREET NO. 8, I-9/2, INDUSTRIAL AREA, ISLAMABAD – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.

Case Background

M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad submitted the application for renewal of DML No. 000448 by way of (Formulation) on 27-04-2015 for the period of 29-04-2015 to 28-04-2020, as due date of renewal of said DML was 28-04-2015.

After evaluation of the renewal application of the firm, a letter for completion of application for renewal of DML was issued for following shortcomings:-

i. Form “C” from registrar of firm.ii. Partnership deed attested, copies of CNICs of all partners.iii. Declaration regarding change of management from last renewal.iv. Proof of sections approved by the Central Licensing Board.v. Approved copy of layout plan.vi. Nothing due certificate regarding CRF from STO.vii. documents should be attested as per check list.

With reference to above letter, the firm submitted following documents;

i. Partnership deed attested, copies of CNICs of all partners un-attested.

Upon evaluation of firm’s reply, a shortcoming still deficient regarding renewal of DML application. Final reminder was issued to the firm with following shortcomings:-

i. Form “C” from registrar of firm.ii. Partnership deed attested, copies of CNICs of all partners.iii. Declaration regarding change of management from last renewal.iv. Proof of sections approved by the Central Licensing Board.v. Approved copy of layout plan.vi. Nothing due certificate regarding CRF from STO.vii. Documents of proposed Quality Control Incharge (Mr. Hashim)

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With reference to above letter, it is mentioned that as per available record of Licensing Division, no correspondence received in respect to shortcomings in application for renewal of DML of the firm. Proceedings and Decision of Central Licensing Board in 257 th meeting





why the application for renewal of DML No. 000448 by way of formulation of M/s Genera

Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad may not be rejected

by Central Licensing Board or their Drug Manufacturing Licence may not be suspended or

cancelled by Central Licensing Board.


The Show Cause notice dated 26th February, 2018 was issued to the M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad.

No reply is received from the firm yet.



Mr. Waseem Butt , Chief Executive of the firm appeared before the Board. He argued that he was in process of acquiring land to meet his plan for establishment of firm. He also argued that GMP compliance at existing premises is not possible therefore he had closed the unit three years ago. The Board after hearing the representative of the firm and considering the facts on the record and after thread bare deliberation decided to cancel the Drug Manufacturing Licence No. 000448 by way of formulation issued in the name of M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad, Drug Manufacturing Licence No. 000448 by way of (Formulation) 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, 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976.

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Case No. 32 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S MEDICURE LABORATORIES, KARACHI

M/s Medicure Laboratories, F/109, S.I.T.E, Hub River Road, Karachi, had applied for renewal of


2015.


shortcomings / deficiencies was issued to the firm on 23rd February, 2016 under Rule 5{2A} of


i) To submit late fee for submission of DML renewal application i.e. Rs.5,000/- per day for 06 days = Rs.5,000x6=Rs.30,000/-.

ii) No objection certificate for Central Research Fund (CRF) by Statistical Officer DRAP, Islamabad

iii) Legal status of the firm along with details of ownership, attested copies of CNIC’s.

iv) List of total section of the firm and their letters of grant which were approved in meetings of Central Licensing Board.

v) Complete documents of technical persons i.e QC Incharge and Production Incharge according to Performa (enclosed).

The firm submitted their reply on 4th March, 2016. After evaluation of the submitted documents,

Final reminder was issued on 7th December, 2017 to the firm with following shortcomings: -

1. Prescribed fee of Rs. 50,000/- for change of management / directors.2. Detail of all partners / Directors of firm’s letter head alongwith CNIC copies.3. Approval / Grant letters of all repacking drugs for which renewal of DML is applied

alongwith fee of Rs, 5,000/- per drug / product.4. Complete set of duly attested documents for Proposed Production Incharge and Quality

Control Incharge (as per check list).5. Nothing due certificate regarding CRF from STO (Updated).6. Approval letters of sections issued by the Central Licensing Board and if not available

then submit master layout plan for Regularization of manufacturing facility.7. All documents should be duly attested.

Firm submitted documents on 22nd December, 2017 in reply to Final Reminder but following

documents are still deficient /short and application for renewal of DML is still incomplete.

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

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2. Approval letters alongwith prescribe fee of Rs. 5,000/- per product for re-packing item / Products.

3. Complete set of duly attested documents for Proposed Production Incharge Ms. Zubia

Kawal as her total post qualification experience is less than 10 years which does not

fulfill the requirements of Rule 16 of Drugs (Licensing, Registering and Advertising)

Rules 1976 in term of relevant experience.

4. Resignation / retirement of earlier Quality Control Incharge.

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

transfer letter from the same firm (Quality Control Incharge).

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

7. Undertaking as whole time employee on stamp paper (Quality Control Incharge).

8. Prescribed fee of 10,000/- for Production Incharge and Quality Control Incharge.





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 Medicure Laboratories, F/109, S.I.T.E, Hub

River Road, Karachi, Drug Manufacturing Licence No000034 by way of formulation may not be

rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing

Board.

Case No. 33 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S EROS PHARMA, KARACHI

M/s Eros Pharma, Plot No. 94-95, Sector 23, Korangi Industrial Area, Karachi, had applied for

renewal of DML No. 000147 by way of formulation for the period of 21-08-2015 to 20-08-2020 on

03-08-2015. 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 5th June, 2017 under Rule 5{2A} of


1. Form-29 alongwith Form-A duly attested from S.E.C.P (Updated year 2017).2. Form-29 duly attested from S.E.C.P (for year 2010).3. Detail of management at the time of pervious renewal of DML and present renewal

of DML along with CNIC copies of all directors.4. Approved Master Layout Plan / Proof of licensed section from CLB.

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5. Nothing due certificate regarding CRF from STO (Updated).6. Prescribed fee of Rs. 50,000/- for change of management / directors.7. Prescribe fee of Rs. 10,000/- for change of proposed Production Incharge and

Quality Control Incharge.8. Experience Certificate as under Drugs (Licensing, Registering and Advertising)

Rules, 1976 (Not less than 10 years for proposed Production Incharge and Quality Control).

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

10. Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm (Production Incharge and Quality Control Incharge).


The firm submitted their reply on 12th October, 2017. After evaluation of the submitted documents,

Final reminder was issued on 5th December, 2017 to the firm with following shortcomings: -

1. Form-29 along with Form-A duly attested from S.E.C.P (Updated year 2017).2. Form-29 duly attested from S.E.C.P (for year 2010).3. Attested CNIC copies of all directors at present renewal and at last renewal.4. Approval letters of sections issued by the Central Licensing Board or if not available then submit master layout plan for Regularization.5. Section wise detail of machinery for manufacture.6. Section wise detail of machinery for Quality Control Lab.7. Nothing due certificate regarding CRF from STO (Updated).8. Prescribed fee of Rs. 50,000/- for change of management / directors.9. Prescribe fee of Rs. 5,000/- (original challan retained by STO (R&D)) for change of

proposed Quality Control Incharge alongwith complete set of attested documents of Mr. Ahmed Raza.


Firm submitted documents on 6th February, 2018 in reply to Final Reminder but following


1. Form-29 along with Form-A duly attested from S.E.C.P (Updated year 2017).2. Form-29 duly attested from S.E.C.P (for year 2010).3. Prescribed fee of Rs. 50,000/- for change of management / directors if the management

is changed.4. Attested CNIC copies of all directors at present renewal and at last renewal.5. Approval letters of sections issued by the Central Licensing Board or if not available then submit master layout plan for Regularization.6. Nothing due certificate regarding CRF from STO (Updated).7. All documents should be duly attested.




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1976 as to why their application for renewal of M/s Eros Pharma, Plot No. 94-95, Sector 23,

Korangi Industrial Area, Karachi, Drug Manufacturing Licence No. 000147 by way of formulation

may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central

Licensing Board.

Case No. 34 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S RUKHA PHARMACEUTICAL LABORATOIRES (PVT) LTD, LAHORE

M/s Rukha Pharmaceutical Laboratories (Pvt) Ltd, Plot No. 537-D&E, Sunder Industrial Estate,

Raiwind Road, Lahore had applied for renewal of DML No. 000753 by way of formulation for the

period of 12-09-2017 to 11-09-2022 on 30-08-2017.


shortcomings / deficiencies was issued to the firm on 3rd October, 2017 under Rule 5{2A} of Drugs

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

1. Form-29 duly attested from S.E.C.P (Updated)

2. Detail of management at the time of previous renewal of DML and at present Renewal

alongwith copies of CNIC of all Directors.



The firm submitted their reply on 17th October, 2017.After evaluation of the submitted documents,

Final reminder was issued on 08th November, 2017 to the firm with following shortcomings: -

1. Prescribed fee of Rs. 50,000/- for change of management / directors as it seems management is changed from last renewal till at present renewal.

2. Form-29 duly attested from S.E.C.P (Updated) alongwith CNIC copies of all Director.



Firm submitted documents on 21st November, 2017 in reply to Final Reminder but following


I. Nothing due certificate regarding CRF from STO (Updated). of 150

II. Form-29 duly attested from S.E.C.P for year 2017 alongwith CNIC copies of all

Director.

III. Copy of CNIC of appointee (Production Incharge).

IV. Undertaking as whole time employee on stamp paper (Production Incharge).

V. All documents should be duly attested.






1976 as to why their application for renewal of M/s Rukha Pharmaceutical Laboratories (Pvt) Ltd,

Plot No. 537-D&E, Sunder Industrial Estate, Raiwind Road, Drug Manufacturing Licence No.

000753 by way of formulation may not be rejected or Drug Manufacturing Licence may not be

suspended or cancelled by Central Licensing Board.

Case No. 35 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S UMER USMAN COTTON INDUSTRIES, JHANG.

M/s Umer Usman Cotton Industries, Faisalabad Road, Jhang Saddar had applied for renewal of


2015.


shortcomings / deficiencies was issued to the firm on 26 th May, 2016 under Rule 5{2A} of Drugs


1. Name registered drugs approved.2. Detail of premises including Layout plan.3. Detail of management / owner / partners on firm letter head alongwith

declaration regarding any change in management & copies of CNIC (Attested).4. Nothing due certificate regarding CRF (Latest).

Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 17th

May, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of

following shortcomings.

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1. Name(s) of drugs registered / approved.2. Detail of premises including Layout plan.3. Approved Master Layout Plan / Proof of licensed section from CLB.4. Detail of management / owner / partners on firm letter head along with

declaration regarding any change in management & copies of CNIC (Attested).5. Nothing due certificate regarding CRF (Latest).6. Documents should be duly attested.

Firm did not submit their reply to Final Reminder till date and following documents are still

deficient /short and application for renewal of DML is still incomplete.

1. Name(s) of drugs registered / approved.2. Detail of premises including Layout plan.3. Approved Master Layout Plan / Proof of licensed section from CLB.4. Nothing due certificate regarding CRF (Latest).5. Detail of management / owner / partners on firm letter head along with

declaration regarding any change in management & copies of CNIC (Attested) if change, then prescribe fee of Rs. 50,000/-.






1976 as to why their application for renewal of M/s Umer Usman Cotton Industries, Faisalabad

Road, Jhang Saddar, Drug Manufacturing Licence No. 000361 by way of formulation may not be


Board.

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Case No. 36 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.


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


1. Change(s) in name of proprietor / directors / partners (if any) 2. Copy of 29 attested by SECP 3. 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. of 150

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 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.






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.

Case No. 37 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SATURN PHARMACEUTICALS (PVT) LTD, LAHORE

M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore had applied for

renewal of DML No. 000734 by way of formulation for the period of 15-06-2016 to 14-06-2021 on

9-05-2016.


shortcomings / deficiencies was issued to the firm on 16th June, 2017 under Rule 5{2A} of Drugs


1. Duly signed and stamped Form-1A.

2. Detail of management Previous at the time of grant of DML and latest management

present renewal of DML along with CNIC copies of directors.


4. Approval letter / proof of proposed Production Incharge and Quality Control

Incharge if any change then provide complete set of documents for proposed

Production Incharge and Quality Control Incharge (as per check list) along with

prescribe fee.

5. Documents should be duly attested.

The firm submitted their reply on 31st July, 2017 After evaluation of the submitted documents, final

reminder was issued on 15th August, 2017 to the firm with following shortcomings: -








prescribe fee.


Firm replied on 13-09-2017 to Final Reminder by stating that they have already submitted

documents but unfortunately these documents were not duly attested. Now it is our humble request

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in your honor that duly attested copies will be provided in your office within few days. Following

documents are still deficient /short and application for renewal of DML is incomplete.








prescribe fee.







why their application for renewal of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar

Raiwind Road, Lahore Drug Manufacturing Licence No. 000734 by way of formulation may not be


Board.


The Show Cause notice dated 05th January, 2018 was issued to the M/s Saturn Pharmaceuticals

(Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore

Reply of show cause notice

The firm has submitted the documents in reply of the show cause notice. Upon evaluation following

documents are found to be deficient;

1. Duly attested resignation/retirement of earlier Production and Quality Control Incharge.2. Nothing Due Certificate regarding CRF.3. Duly attested appointment and job acceptance letter of QC Incharge.

A letter of Personal hearing has been issued on 17th January, 2018.


Mr. Ghulam Yasin Paracha , Chief Executive of the firm appeared before the Board and contended

that they have applied for nothing due certificate on 12-01-2018 and no production is being carried

out in the premises. The Board considering the facts on the record and after thread bare deliberation of 150

decided to suspend the Drug Manufacturing Licence No. 000734 by way of formulation issued in

the name of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore till

settlement of CRF and other codal formalities 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) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules,

1976


The suspension order dated 5th March, 2018 was issued to the M/s Saturn Pharmaceuticals (Pvt) Ltd,

25-Km, Thokar Raiwind Road, Lahore

In reply to the suspension order firm has submitted the short documents and application for renewal

of DML in now complete.


The Board considering the facts on the record and after thread bare deliberation decided that order

of suspension of Licence of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road,

Lahore DML No. 000734 may be revoked for further period and also decided to resume the

production of the firm.

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Case No. 38 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ALFALAH PHARMA (PVT) LTD, 12-KM, SHEIKHUPURA ROAD, LAHORE

M/s Alfalah Pharma (Pvt) Ltd, 12-Km, Sheikhupura Road, Lahore had applied for



following shortcomings / deficiencies was issued to the firm on 19th October, 2017 under Rule


1. Due date of renewal application is 04-08-2017 and renewal application was received on 30-08-2017 which is 26 days late. According to Rule 6 of drugs (L, R&A) rule 1976 the additional surcharge 5,000/- each day and total Rs. 130,000/- = (26x5000) should be deposited.

2. Nothing due certificate regarding CRF from STO (Updated).3. Approved Master layout plan.4. Approval letters of all sections issued by the Central Licensing Board.5. Complete set of documents for Proposed Production Incharge and Quality

Control Incharge as (per check list) alongwith prescribe fee of Rs. 10,000/- for change of technical staff.

6. Duly attested copy of shares transfer deed.

7. Duly attested CNIC copies of previous directors.

8. Duly attested NOC from previous management.


The firm submitted documents on 07th November, 2017 but following documents

were still deficient /short and Final Reminder was issued on 12th January, 2018 to the firm with

following shortcomings: -

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

2. Form-29 for year 2017 duly attested by S.E.C.P.

3. CNIC copies of all Directors.

4. CNIC copies of Proposed Production Incharge and Quality Control

Incharge.

5. Resignation/ retirement letters of earlier Production Incharge and Quality

Control Incharge.

6. Undertaking as whole time employee on Stamp Paper.


The firm submitted documents on 26th January, 2018 in reply to Final Reminder. Upon

Evaluation following shortcoming has been observed and application for renewal of DML is still

incomplete

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

2. Updated Form-29 for year 2017 duly attested by S.E.C.P.

3. Undertaking as whole time employee on Stamp Paper of proposed

Production Incharge and Quality Control Incharge.






1976 as to why their application for renewal of M/s Alfalah Pharma (Pvt) Ltd, 12-Km, Sheikhupura

Road, Lahore, Drug Manufacturing Licence No. 000461 by way of formulation may not be rejected

or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.

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Case NO. 39 M/S HAFIZ PHARMA INDUSTRY , 44-KM, (GHANIYA)KAMOKE, DISTRICT GUJRANWALA – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.

M/s Hafiz Pharma Industry, Kamoke had submitted application dated 04-07-2016 for the

renewal of their Drug Manufactuing Licence period from 07-07-2016 to 06-07-2021. After

evaluation of the renewal application of the firm, a letter for completion of application for renewal

of DML was issued for following shortcomings/attested documents dated 23-08-2016:

i) Detail of Management / Directors / Partners.

ii) Proof of sections from Central Licensing Board / approved layout plan.

iii) Approval letter of Production and QC Incharge.(iv) No Objection Certificate for Central Research Fund (CRF) updated issued by

Statistical Officer DRAP, Islamabad.

2. Firm did not submit the reply of the above shortcoming letter, however firm had applied for

the approval of Production Incharge, which was approved. Accordingly a final reminder was issued

for the completion of DML renewal application dated 20-04-2017 for following shortcomings;

i) Detail of Management / Directors / Partners.

ii) Proof of sections from Central Licensing Board / approved layout plan.

iii) Approval letter of QC Incharge.

iv) No Objection Certificate for Central Research Fund (CRF) updated issued by Statistical Officer DRAP, Islamabad.

3. Firm has submitted following documents /copies in reply to above final reminder ;

(i) Copy of L.O.P

(ii) Incomplete documents of Quality Control Incharge

(iii) Incomplete documents of C.R.F

(iv) Name of Managing Director.

4. Following documents/information is still short/deficient.

(i) Updated Nothing Due Certificate for C.R.F from S.T.O

(ii) Complete set of attested documents for approval of proposed Q.C Incharge as per check list.

Proceedings and Decision of Central Licensing Board in 254th meeting.

5. 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


why the application for renewal of M/s Hafiz Pharma Industry, 44-KM, (Ghaniya) Kamoke,

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District Gujranwalaby way of formulation may not be rejected by Central Licensing Board or their

Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board

6. Reference Para 113/N, Central Licensing Board in its 254th meeting held on 15th June, 2017

decided to serve show cause notice to the firm for violation of Rule 16 and Rule 5(2A) and

accordingly show cause notice was issued to the firm dated 24-07-17.

7. Firm has submitted reply to show cause notice but firm has not submitted the following

required documents for renewal of DML No 000595(Formulation) and application for renewal of

DML is still incomplete.

i) N.O.C OF CRF (Updated)ii) Complete set of documents of Q.C. Incharge.

Firm has been called for personnel hearing to explain its position on the above subject matter.


8. Mr. Hafiz Abdur Rehman, owner of the firm and Mr Waheed Akhtar , Manager appeared

before the Board. They contended that documents for issuance of NOC for CRF has also been

submitted with Budget and Accounts Division. After hearing the representative of the firm and facts

on record, the Board decided to suspend the Drug Manufacturing Licence of M/s Hafiz Pharma

Industry, 44-KM, (Ghaniya) Kamoke, District Gujranwala DML No000595by way of formulation

for the period of three (03) months 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, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and

Advertising) Rules, 1976.


The suspension order dated 09th October, 2017 was issued to the M/s Hafiz Pharma Industry, 44-

KM, (Ghaniya) Kamoke, District Gujranwala.

In reply to the suspension order firm has submitted the short documents and application for renewal

of DML in now complete.


The Board considering the facts on the record and after thread bare deliberation decided that order of suspension of Licence of M/s Hafiz Pharma Industry, 44-KM, (Ghaniya) Kamoke, District Gujranwala DML No. 000595 may be revoked for further period and also decided to resume the production of the firm.

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Case No. 40 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S QINTARPHARMACEUTICALS, SARGODHA

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

applied for renewal of DML No. 000520 by way of formulation for the period of 19-06-2013 to 18-

06-2018 on 13-06-2013.


shortcomings / deficiencies was issued to the firm on 22-10-2013 under Rule 5{2A} of Drugs


1. Copy of new partnership deed duly attested by office of Registrar of firm as the name of partners as mentioned in your above said application are different than mention in previous application dated 10-06-2008 for the same purpose i.e. grant of renewal of Drug Manufacturing License at that time.

2. Attested copy of Certificate of Registrar of firm duly issued by the office of Registrar of firm’s alongwith attested copies of CNIC of all the present Directors / Partner.

3. No Objection Certificate for Central Research Fund (CRF) by Statistical Officer DRAP, Islamabad till to date.

Firm submitted documents on 10th February, 2017 and a letter was issued on 8th August, 2017 under

Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following

shortcomings.

1. Prescribe fee of Rs. 50,000/- for change of management and original challan retained

by STO (R&D), DRAP, Islamabad.

2. Attested Nothing due certificate regarding CRF from STO (Updated).

Firm submitted documents on 5th September, 2017 in reply to letter issued on 8th August, 2017 and a

letter for following shortcomings / deficiencies was issued to the firm on 18th October, 2017 under

Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. Form-D from Registrar of firms.2. Copy of previous partnership deed.3. NOC from previous partners on stamp paper.4. All documents should be duly attested.

File is received from Budget & Account Division related to CRF issue of M/s Qintar

Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha with following

observations.

Extract taken from 2-194/2008-STO (R&D)

13. For issuance of NDC, required documents have been submitted by the licensee M/s Qintar

Pharmaceuticals (DML No. 000520 11-A Punjab Small Industrial Estate Lahore), i.e. audited

financial statements and income tax returns, for FY 2014, 2015 & 2016 along with original bank

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receipts on account of CRE. The same were checked as per SOP procedure in vogue, IFRS and IAS,

but found basic accounting mistakes in preparation financial statements, that made financial

statements suspicious. Therefore, for M/s Qintar was asked to submit duly authenticated attested

aforesaid documents in order to proceed further (page 109 /Corr.). But the firm taken it leniently

and again submitted the same documents by affixing at rubber stamp.

14. Accordingly to establish authenticity of relevant documents it was decided to approach

concerned audit firm M/s. Nasir Absar & Co. to get verify the above said financial statements.

Therefore, telephonically contacted to Mr. Rizwan Chartered Accountant on behalf of M/s Nasir

Absar & Co. and then he came to this office on 14-05-17 and shown their strong concerns about

using their letter head and name were forged as the firm is only dealing with tax matters. Hence, the

above financial statements are of fraud. As this office required some written evidence from their

side, then M/s Nasir Absar & Co. asked for a letter, therefore with approval of Director (B&A)

letter to auditor were issued on 24-05-17

15. In reply, M/s Nasir Absar & Co. vide letter No NCAI/DRAP/001 dated 13-07-17 at page

(180/Corr.) has requested to this office ("to take strict action as allowed under the Drugs Act,

1976 and its ancillary rules for forging, falsifying and misleading to this office in this

regard)", against M/s Qintar Pharmaceuticals.

16. In the light above it is emerged that M/s Qintar is not contributing towards CRF since 2013

(July 2013) as per rules and also submitted forged, falsified and misleading annual audited financial

statements of outstanding periods i.e. July 2013 to June 2016. This is clear violation of rule 19 sub

rule (14), Chapter II of “The Drugs (Licensing, Registration and Advertising) Rules 1976". The

same also attracts necessary action as mentioned in rule 12 of aforesaid rules because it seems that

the licensee is managing to avoid actual amount of CRF.






why their application for renewal of M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial

Estate, Lahore Road, Sargodha, Drug Manufacturing Licence No. 000520 by way of formulation

may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central

Licensing Board.


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The Show Cause notice dated 05th January, 2018 was issued to the M/s Qintar Pharmaceuticals, 14-

A, Punjab Small Industrial Estate, Lahore Road, Sargodha

A letter of Personal hearing has been issued on 17th January, 2018.

Firm has replied to Show Cause Notice and application of renewal of DML is complete except

following documents:

1. Updated Noting due certificate regarding CRF from STO.

Moreover, firm has stated that in case of CRF, we recruited authorized person Mr. Anwar Ahmed

(Late) for dealing all matters of DRAP including CRF on behalf of Qintar Pharmaceutical.

Unfortunately, he died few months ago, therefore, we could not communicate properly with Budget

and Accounts Department to resolve matters about audited financial statements. We are requesting

to CLB to please give us some time for issuance of NDC from Budget & Accounts Department. We

also make sure that this kind of negligence will not happen again.


Mr. Zeeshan Masood, Managing Director of the firm appeared before the Board. He contested that

representative of the firm is died who used to deal with the subject matter and they have taken up

the matter with the concerned firm for audit of the accounts. He was of the view that matter would

be resolved very soon. The Board apprised him that secretariat for the Central Licening Board only

accepts the nothing due certificate issued from the Division of the Budget and Accounts. The Board

considering the facts on the record and after thread bare deliberation decided to suspend the Drug

Manufacturing Licence No. 000520 by way of formulation issued in the name of M/s Qintar

Pharmaceuticals 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha till settlement of

Central Research Fund 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.


The suspension order dated 5th March, 2018 was issued to the M/s Qintar Pharmaceuticals 14-A,

Punjab Small Industrial Estate, Lahore Road, Sargodha.

In reply to the suspension order firm has submitted the Updated Noting due certificate regarding

CRF from STO and application for renewal of DML in now complete.


The Board considering the facts on the record and after thread bare deliberation decided that order of suspension of Licence of M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha, Drug Manufacturing Licence No. 000520 may be revoked for further period and also decided to resume the production of the firm.

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Case No.41 M/S MEDLEY PHARMACEUTICALS (DML NO. 000237) PLOT NO. 41/A, PUNJAB SMALL INDUSTRIES ESTATE, JHANG BAHTAR ROAD, WAH CANTT.

Case Background.

M/s Medley Pharmaceuticals (DML No. 000237) Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt., submitted the application for renewal of DML No. 000675 by way of formulation on 30-06-2014 for the period of 30-06-2014 to 01-07-2019, as due date of renewal of said DML was 30-06-2014. After evaluation of the renewal application of the firm, a letter for completion of application for renewal of DML was issued for following shortcomings: -

i. Appointment letter, Job acceptance letter, resignation of proposed production Incharge from previous firm, resignation of Production Incharge previously working in your firm, undertaking on letter head of the firm that proposed Production Incharge is whole time employee of the firm.

ii. Appointment letter, Job acceptance letter, resignation of proposed Quality Control Incharge from previous firm, resignation of Quality Control Incharge previously working in your firm, undertaking on letter head of the firm that proposed Quality Control Incharge is whole time employee of the firm.

iii. Nothing Due Certificate issued by Statistical Officer, DRAP, Islamabad regarding deposition of Central Research Fund up 31-12-2014.

With reference to above letter, the firm submitted following documents;

ii. Appointment letter, Job acceptance letter, resignation of proposed production Incharge from previous firm, resignation of Production Incharge previously working in your firm, undertaking on letter head of the firm that proposed Production Incharge is whole time employee of the firm.

iii. Appointment letter, Job acceptance letter, resignation of proposed Quality Control Incharge from previous firm, resignation of Quality Control Incharge previously working in your firm, undertaking on letter head of the firm that proposed Quality Control Incharge is whole time employee of the firm.

Upon evaluation of firm’s reply, a shortcoming still deficient regarding technical persons. A letter was issued to the firm with following shortcomings:-

i. Attested documents of technical staff (Production & Quality Control Incharge) as per check list.

In response to letter, the firm has submitted for the approval of new technical staff and upon evaluation of documents following shortcomings have still been observed:

For Quality Control Incharge Miss. Nabeela Noor. i. Attested copy of Appointment letter.ii. Attested Copy of CNIC.iii. Attested copy of Job acceptance letter.iv. Attested copy of Experience Certificate (s) covering the period of not less than

10 years. v. Attested copy of Resignation / retirement of earlier Quality Control Manager.vi. Attested copy of Resignation or termination letter of appointee from the previous

firm / promotion letter / transfer letter from the same firm (QC Incharge).

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For Production Mr. Mohammad Imran. i. Attested copy of Appointment letter.ii. Attested copy of Job acceptance letter.iii. Attested copy of Experience Certificate (s) covering the period of not less than

10 years. iv. Attested copy of Resignation / retirement of earlier Production Manager.v. Attested copy of Resignation or termination letter of appointee from the

previous firm / promotion letter / transfer letter from the same firm (Production Incharge).

A file is received from B&A relating to CRF issue of the M/s Medley Pharmaceuticals with following observations:-

Extract at place below taken from File No.2-282/STO(R&D) Para 7-10/N).

“For issuance of NDC, required documents have been submitted by the licensee M/s Medley Pharmaceuticals (DML No. 000237) Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt., i.e audited financial statements and income tax returns, for F.Y 2015 & 2016 alongwith original bank receipts on account of CRF. The same were checked as per SOP’s / procedure in vogue, IFRS and IAS, but found basic accounting mistakes in preparation of financial statements, that made financial statements suspicious. Therefore for M/s Medley was asked to submit duly authenticated / attested aforesaid documents in order to proceed further (Page 81/Corr). But the firm taken it leniently and again submitted the same documents by affixing attested rubber stamp page 91-106/Corr).

Accordingly to establish authenticity of relevant documents, it was decided to approach concerned audit firm M/s Nasir Absar & Co. to get verify the above said financial statements. Therefore, telephonically contacted to Mr. Rizwan Chartered Accountant on behalf of M/s Nasir Absar & Co. and then he came to this office on 14-05-17 and shown their strong concerns about using their letter head and name were forged as the firm is only dealing with tax matters. Hence, the above financial statements are of fraud. As this office required some written evidence from their side, then M/s Nasir Absar & Co. asked for a letter, therefore with approval of Director (B&A) letter to auditor were issued on 24-05-17 at page (110/Corr).

In reply, M/s Nasir Absar & Co. vide letter No.NCAL/DRAP/002 dated 13-0717 at page (112)/Corr). has recommended to this office (“to take strict action as allowed under the Drugs Act, 1976 and its ancillary rules for forging, falsifying and misleading to this office in this regard)” against M/s Medley Pharmaceuticals.

In the light above it is emerged that M/s Medley is not contributing towards CRF since 2014 (July 2014) as per rules and also submitted forged, falsified and misleading annual audited financial statements of outstanding periods i.e July, 2014 to June 2016. This is clear violation of rule 19 sub rule (14), Chapter II of “The Drugs (Licensing, Registration and Advertising) Rules, 1976”. The same also attracts necessary action as mentioned in rule 12 of aforesaid rules because it seems that the licensee is managing to avoid the actual amount of CRF.

In the light of para 7-11/N, Licensing Division may proceed to take necessary action under relevant rules and regulation, please”.


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why their application for renewal of M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small

Industries Estate, Jhang Bahtar Road, Wah Cantt Drug Manufacturing Licence No. 000237 by way

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


Accordingly, show cause notice dated 05-01-2018 and letter of personal hearing dated 17-01-2018

has been issued to the firm.

Reply of the Show Cause Notice.

With this letter we are enclosing our shortcomings for Renewal of License No. 000237 i.e Documents for Production Incharge and Quality Control Incharge. All the necessary documents are attached hereby.

As for the matter of CRF issue as stated in Show Cause Notice, it is stated that our representative person for auditing and CRF of firm Mr. Anwar and CEO Mr. Javied Iqbal Chishti of the firm passed away in 2016 because of which the matter could not be handled properly and lead to some misconceptions. It is humbly requested to you that kindly give us time to dig out the matter more efficiently and come out with authentic audit reports so as to prove ourselves clean in the matter as firm has receive NOC of year 2014 and duly submitted all CRF in time.

Current Status.

The firm has submitted documents of new Production & Quality Control Incharge which are

complete and only shortcoming remaining is up- to-date Nothing Due Certificate.


Mr. Zia , Director of the firm appeared before the Board. He contested that CEO of the firm is died

and they have taken up the matter with the concerned firm for audit of the accounts. He was of the

view that matter would be resolved very soon. The Board apprised him that secretariat for the

Central Licening Board only accepts the nothing due certificate issued from the Division of the

Budget and Accounts. The Board considering the facts on the record and after thread bare

deliberation decided to suspend the Drug Manufacturing Licence No. 000237 by way of

formulation issued in the name of M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small

Industries Estate, Jhang Bahtar Road, Wah Cantt till settelemnt of Central Research Fund 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. of 150


The suspension order dated 5th March, 2018 was issued to the Medley Pharmaceuticals Plot No.

41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt.

In reply to the suspension order firm has submitted the Updated Noting due certificate regarding

CRF from STO and application for renewal of DML in now complete.



of suspension of Licence of M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries

Estate, Jhang Bahtar Road, Wah Cantt Drug Manufacturing Licence No. 000237 may be revoked

for further period and also decided to resume the production of the firm.

Case No.42. WITHDRAWAL OF SACHET (PSYCHOTROPIC) SECTION OF M/S WILSHIRE LABORATORIES (PVT) LTD, LAHORE

M/s Wilshire Laboratories (Pvt) Ltd, 124/1, Quaid-e-Azam Industrial Estate, Kot Lakhpat,

Lahore, has applied for withdrawal of Sachet (Psychotropic) Section and they have informed that

they do not hold registration of any Psychotropic product.


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

the request of M/s Wilshire Laboratories (Pvt) Ltd, 124/1, Quaid-e-Azam Industrial Estate, Kot

Lakhpat, Lahore

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Case No. 43 ADDITION OF THE WORDS (POWDER / PELLETS) WITH OMEPRAZOLE AND ESOMEPRAZOLE IN THE APPROVED LIST OF PRODUCTS MANUFACTURED BY WAY OF SEMI BASIC MANUFACTURE OF M/S PHARMAGEN LTD, LAHORE

The Central Licensing Board in its 236 th meeting held on 27th June, 2014 approved

the grant of Omeprazole and Esomeprazole Magnesium Trihydrate to M/s Pharmagen Ltd, Lahore.

However, the word Powder / Pellets was not mentioned with approved APIs. Now the firm has

requested to change the name of two products Omeprazole and Esomeprazole Magnesium

Trihydrate to omeprazole (Powder / Pellets) and Esomeprazole Magnesium Trihydrate

(Powder / Pellets) as they are manufacturing pellets right from the semi basic route through N-2

stage, they start their process from sulphide compound, get powder first and then pellets, the

product in both cases is in the form of pellets. It was approved during inspection by the Experts

Committee constituted by DRAP for process verifications.


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

the request of M/s Pharmagen Ltd, Lahore.

Case No. 44. M/S ATLANTIC PHARMACEUTICAL LABORATORIES, 89-D, INDUSTRIAL ESTATE, HAYATABAD, PESHAWAR – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.

M/s Atlantic Pharmaceutical Laboratories, Peshawar submitted the application for renewal

of DML No. 000273 by way of formulation on 27-10-2014 for the period of 30-10-2014 to 29-10-

2019, which was well on time. After evaluation of the renewal application of the firm, a letter for

completion of application for renewal of DML was issued for following shortcomings: -

i. Revised partnership deed mentioning change in directors / owners if any.ii. To provide approval letter of Production and QC Incharge if technical persons

are changed then provide documents according to Rule 16 of Drugs (Licensing, Registering & Advertising) Rules, 1976, after promulgation of S.R.O 1134(i)/2014 and submit documents according to checklist (check list enclosed).

iii. No Objection Certificate for Central Research Fund (CRF) by Statistical Officer DRAP, Islamabad.

2. With reference to above letter, it is mentioned that as per available record of Licensing

Division, no correspondence received in respect to shortcomings in application for renewal of DML

of the firm. Licensing Division issued final reminder with the following shortcomings.

i. Partnership Deed(s) mentioning the detail of the previous and current management.

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ii. Attested copy of CNIC’s of all partners.iii. Up-to-date Nothing Due Certificate (CRF) from STO, DRAP, Islamabad.iv. Attested copy of list of section wise equipments.v. Complete set of attested documents of proposed Production Incharge Mr.

Sikandar Sohail as per check list attached.vi. Fee challan of Rs.5000/- for change of technical staff.

3. In response to final reminder, the firm submitted following documents;

i. Copy of partnership deed.ii. Copy of Form-H.

iii. Copies of CNIC’s of Directors.iv. Copy of application for issuance of Nothing Due Certificate (CRF).v. Copy of list of section wise equipments.

vi. Docuemnts of proposed technical staff alongwith fee Challan.

4. After evaluation of the submitted documents, following shortcomings were still observed: -

i. Up-to-date Nothing Due Certificate from STO, DRAP, Islamabad.ii. Proof of all approved sections.

iii. The experience of proposed Production and QC Incharge is less than ten (10) years.

Decision of CLB.

5. 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


why their application for renewal of M/s Atlantic Pharmaceutical Laboratories, 89-D, Industrial

Estate, Hayatabad, PeshawarDML No. 000273by way of formulation may not be rejected or Drug

Manufacturing Licence may not be suspended or cancelled by Central Licensing Board

6 Accordingly, show Cause Notice was served to the firm. No reply from the firm is received

yet. Now, firm has also been called for personal hearing.


Mr. Humayun Khan, Director and Mr. Hameed ur Rehman, Quality Control Manager appeared

before the Board. They contended that they have completed documents for approval of Quality

Control Incharge. They also contended that documents for issuance of NOC for CRF has also been

submitted with Budget and Accounts Division.After hearing the representative of the firm and facts

on record, the Board decided to suspend the Drug Manufacturing Licence of M/s Atlantic

Pharmaceutical Laboratories, 89-D, Industrial Estate, Hayatabad, Peshawar DML No. 000273 by

way of formulationfor the period of three (03) months with immediate effect under Section 41 of

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

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Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing,

Registering and Advertising) Rules, 1976.


The suspension order dated 26th September, 2017 was issued to the M/s Atlantic Pharmaceutical

Laboratories, 89-D, Industrial Estate, Hayatabad, Peshawar.

In reply to the suspension order firm has submitted the deficient documents and application for

renewal of DML in now complete except section approval letter for which the firm has submitted

the layout plan for regularization which is under process at Division level.


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

the suspension of M/s Atlantic Pharmaceutical Laboratories, 89-D, Industrial Estate, Hayatabad,

Peshawar DML No. 000273 for further period and also decided to resume the production of the

firm.


of suspension of Licence of M/s Atlantic Pharmaceutical Laboratories, 89-D, Industrial Estate,

Hayatabad, Peshawar DML No. 000273 may be revoked for further period and also decided to

resume the production of the firm.

Case No.45 M/S BF BIOSCIENCES LIMITED, LAHORE UNDER DRUG MANUFACTURING LICENSE NO. 000655 (FORMULATION)

Case Background

The Central Licensing Board in its 235th meeting held on 15th May, 2014 considered the case of M/s

BF Biosciences Limited, Lahore and decided is as under:-

“Approved the Grant of Renewal of DML The Board was further apprised by Licensing Division that the firm in its renewal application has mentioned that they have registration of Omeprazole at Biotech facility where as panel in the inspection report has mentioned that the firm has dedicated biotech manufacturing facility only.The Board in this regard advised to refer the case of registration of Omera Injection (Omeprazole) with Reg. No. 067967 to Drug Registration Board for its consideration and further necessary action accordingly.”

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This decision was conveyed to Drug Registration Board vide letter issued on 27 th August, 2014 (Page-404/Corr). The Drug Registration Board in its 277th meeting held on 27-29th December, 2017 considered the case of the firm and proceedings of the case are as under:

“Following application now have been submitted on Form 5 along with enclosures on CTD format, details of which are presented here for consideration of Registration Board.

845. Name and address of manufacturer / Applicant

M/s BF Biosciences Ltd., 5-Km, Sundar Raiwind Road, Raiwind.

Brand Name +Dosage Form + Strength

Omera 40mg Infusion (Lyophilized Powder Injection)

For Solution For Intravenous

Composition Each vial contains:Omeprazole (as sodium) …40mg

Diary No. Date of R& I & fee Dy. No.16942; 04-10-2017; Rs.20,000/- (03-10-2017)

Pharmacological Group Proton pump inhibitors

Type of Form Form-5

Finished product Specification Manufacturer specifications

Pack size & Demanded Price 1’s;As per SRO

Approval status of product in Reference Regulatory Authorities.

Approved by MHRA of UK

Me-too status Risek Injection 40mg of M/s Getz Pharma (Reg.#024170)

GMP status Last inspection report 08-09-2017 Panel concludes good level of GMP compliance.

Remarks of the Evaluator. Firm has section approval for Biological parenteral only whereas applied formulation does not fall in this category.

Firm has submitted Enclosures along with form 5 as per CTD format approved in 264th meeting of registration Board.

Firm has submitted reports of accelerated & real time stability studies for three batches.

Decision: Registration Board deferred the case for personal hearing for clarification of firm’s request to manufacture applied formulation in Biological parenteral section.



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Esomega 40mg Infusion(Lyophilized Powder For Solution For Intravenous Injection)

Composition Each vial contains:Esomeprazole (as sodium) …40mg



Type of Form Form-5

Finished product Specification Manufacturer specifications

Pack size & Demanded Price As per SRO



Me-too status X-Prazole 40mg Infusion of M/s Mediate Pharmaceuticals, Karachi (Reg.#057925)






The Proceedings Of 278 th Meeting Of Drug Registration Board

Following cases were presented in 277th meeting of Registration Board, submitted on Form 5 along with enclosures on CTD format. The details of cases & decisions of Board are reproduced as under:



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Omera 40mg Infusion (Lyophilized Powder Injection)

For Solution For Intravenous

Composition Each vial contains:Omeprazole (as sodium) …40mg



Type of Form Form-5Finished product Specification Manufacturer specificationsPack size & Demanded Price 1’s;As per SRO



Me-too status Risek Injection 40mg of M/s Getz Pharma (Reg.#024170)









Esomega 40mg Infusion(Lyophilized Powder For Solution For Intravenous Injection)

Composition Each vial contains:Esomeprazole (as sodium) …40mg



Type of Form Form-5Finished product Specification Manufacturer specifications

Pack size & Demanded Price As per SRO

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Me-too status X-Prazole 40mg Infusion of M/s Mediate Pharmaceuticals, Karachi (Reg.#057925)


Remarks of the Evaluator. Firm has section approval for Biological parenteral

only whereas applied formulation does not fall in this category.




Following details have been submitted of Module 3 (Quality / CMC) for both above cited

applications: Contents of Module: 3 (Quality / CMC)

Module Section Sub- section

Contents Data submitted

3 3.2.S DRUG SUBSTANCE

3.2.S.1General Information Detail submitted for

i. Nomenclatureii. Structure

iii. General properties

3.2.S.2Manufacture Detail submitted for

i. Manufacturer(s)ii. Description of Manufacturing

Process and Process Controls

3.2.S.3Characterization Detail submitted for

i. Elucidation of Structure and other Characteristics

ii. Impurities

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3.2.S.4

Control of Drug Substance

Detail submitted fori. Control of Drug Substance

ii. Specificationiii. Analytical Proceduresiv. Validation of Analytical Proceduresv. Batch Analyses

vi. Justification of Specification

3.2.S.5 Reference Standards or Materials

Detail submitted for Reference Standards

3.2.S.6 Container Closure System

Detail submitted for Container Closure System

3.2.S.7 Stability Detail submitted for Stability. (Protocol & reports have been submitted)

3.2.P DRUG PRODUCT

3.2.P.1Description and Composition of Drug Product

Detail submitted for Composition of Drug Product

3.2.P.2 Pharmaceutical Development

Detail submitted for Components of the Drug Product.

3.2.P.3Manufacture Detail submitted for

i. Manufacturer(s)ii. Batch Formula

iii. Description of Manufacturing Process

and Process Controlsiv. Controls of Critical Steps and

IntermediatesUndertaking has been submitted for Process validation

3.2.P.4

Control of Excipient Detail submitted fori. Specifications

ii. Analytical ProceduresAll excipients used are of Pharmacopoeal grades

3.2.P.5

Control of Drug Product

Detail submitted fori. Specification(s)

ii. Analytical Proceduresiii. Validation of Analytical Procedures

(Protocol & report have been submitted)

3.2.P.6 Reference Standards or Materials

Detail submitted for Reference Standards or Materials

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3.2.P.7 Container Closure System

Detail submitted for Container Closure System

3.2.P.8

Stability Following have been submitted:i. Stability Summary and Conclusions

ii. Post-approval Stability Protocol and Stability Commitment

iii. Stability Data (Only reports have been submitted.)

Now, the firm has requested for personal hearing before the Honourable Drug Registration Board to enable to them to present their case. The representatives of the firm now have been called upon for personal hearing.

Proceedings: Dr. Ajmal Nasir (Director Technical) appeared before the Board and briefed regarding justification for the manufacturing of non- biologicals along with bio-pharmaceuticals at BF Biosciences Ltd as under:“BF Biosciences is manufacturing six products i.e. Interferon Alpha 2a, Interferon Alpha 2b, Pegylated interferon alpha 2a, Erythropoietin, Filgrastim and Terlipressin acetate injections.Drug Substances manufactured using a Biological system using living organisms/cell lines through culturing or Recombinant DNA are termed as BIOLOGICALS, whereas Drug Products manufactured using already produced Biological Drug Substances (which no longer contain living organisms) are termed as Bio-Pharmaceuticals. Dedicated facility is required for the manufacturing of BIOLOGICAL SUBSTANCES and certain other highly sensitizing compounds etc., but not for biopharmaceuticalsAll above-mentioned products manufactured at BF Biosciences are Bio-Pharmaceuticals. These bio-pharmaceutical formulations are peptides that are easily denatured by temperature as well as pH changes, and thus can be eliminated from the facility through cleaning validation between production batches. These do not therefore bear contamination risks carried by penicillin-based antibiotics and other products requiring dedicated manufacturing facilities.Bio-Pharmaceuticals formulation and filling / Lyophilization (if required) is allowed as

per WHO 1, Eudralex 2 and FDA 3 guidelines along with non-Biopharmaceuticals on Campaign basis.At BF Biosciences we intend to avail this allowance to manufacture non-Biologicals along with Bio-Pharmaceuticals on Campaign basis.All required controls and systems are in place and are compliant to requirements for campaign- based manufacturing of biopharmaceuticals and non- biologicals.”REFERENCES

1) Annex 3 WHO good manufacturing practices for biological products Replacement of Annex 1 of WHO Technical Report Series, No. 822 Section 9, 13.

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2) EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Us e Annex 2 Manufacture of Biological active substances and Medicinal Products for Human Use Section 8 g and 9

3) FDA approves BioMarin’s manufacturing facility in Cork, Ireland he FDA has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Cork, Ireland for production of the formulated bulk substance. Niamh Marriott (European Pharmaceutical Review)

It is pertinent to mention that M/s BF Biosciences Ltd. Lahore was previously granted registration for Omega injection (Omeprazole), Reg. No. 067967, in same manufacturing facility vide letter no. F.15-7/2010-Reg-V (M-228) dated 10-12-2010.Later Central Licensing Board in 235th meeting while discussing the case of renewal of DML of M/s BF Bio Sciences, Lahore passed following orders in respect of Omega injection (Omeprazole) , Reg. No. 067967:-“The Board was apprised by licensing division that the firm in its renewal application has mentioned that they have registration of omeprazole at biotech facility where as panel in the inspection report has mentioned that the firm has dedicated biotech manufacturing facility only. The Board in this regard advised to refer the case of registration of Omega injection (Omeprazole), Reg. No. 067967 to Drug Registration Board for its consideration and further necessary action accordingly”.

Registration Board in its 245th meeting held on 29th & 30th September, 2014 decided to issue show cause for cancellation of registration of Omega injection (Omeprazole), Reg. No. 067967, registered in the name of M/s BF Biosciences Ltd. Lahore.

Subsequently Omega injection (Omeprazole), Reg. No. 067967 of M/s BF Biosciences Ltd. Lahore, was de-registered vide letter no. F.15-2/2015-Reg-V (M-247)Decision: Registration Board deliberated the matter in detail and decided to refer the case

to Central Licensing Board for their comments on firm’s request as CLB has granted for Biological parenteral section only”.

Proceedings of Licensing Division

The firm has requested for grant of personal to present their case before the Central Licensing Board.


Dr. Ajmal Nasir, Director Technical and Mr. Baqar Hassan appeared before the Borad on behalf of

the firm and gave detailed presentation on subject matter of compaign manufacture. The Board

considering the facts on the record and after thread bare deliberation decided to defer the case for

detailed working before reaching a conclusive decision.

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Case No.46 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

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. Manzoor Bozdar, 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.


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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


CASE NO. 47 GRANT OF ADDITIONAL SECTIONS/EXPANSION/AMENDMENTS ETC OF M/S HILTONPHARMA (PVT) LTD, KARACHI.

The Central Licensing Board in its 238th meeting held on 19th December, 2014 approved the grant of

amendments/ expansion to M/s Hilton Pharma (Pvt) Ltd, Karachi according to approved layout plan

for following existing sections:

1. Oral Dry Powder Suspension (General).2. Sachet (General)3. Dedicated facilities for blistering & packing.4. Sachet (Enflor)*

*The Board has granted provisional approval of amendments/expansion in already existing Sachet

(Enflor) section. The active ingredient of Sachet Enflor is Sacharomyces Boulardii is probiotic

which is not a drug after the promulgation of the DRAP Act, 2012. Since the firm has registration of

Enflor sachet product, therefore the Board directed to refer the case to Division of Pharmaceutical

Evaluation & Research, DRAP, Islamabad to take review of registration of probiotic (Sachet

Enflor) product of the firm and to inform CLB for necessary action accordingly.

Now Policy Board in its 18 th meeting decided that:-

No nutraceutical product or alternative medicines already registered as drug under the Drugs Act,

1976 shall be allowed for switch over from drug category to alternative medicines or Health & OTC

(non-drug) category. Therefore, those who want to switch for price de-regulation due to such

switching will not arise. (Copy of decision attached)

Meanwhile, Drug Registration Board considered the case of the firm in its 278th meeting held on 29-

31st January, 2018 and referred the matter to Licensing Division for evaluation in light of decision

of DRAP’s authority. Proceedings of the Drug Registration Board’s 278th meeting are as under:

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“CaseNo. 21. RequestforcontractmanufacturingofdrugbyM/s.TabrosPharma(Pvt.)Ltd; Karachi.

M/s. TabrosPhamra(Pvt.)Ltd;Karachiwasgranted the registration offollowingproduct:-

Reg.No. NameofDrug(s) RegistrationHistory Remarks026886 BiflorSachet250mg Init.DateofReg.12-05-2001 Renewal

Each sachetcontains:- Copyof1strenewalapplicationdated confirmationLyophilised 04-02-2006 requiredboulardil……….285mg Copof2ndrenewalapplicationdated from RRR(Correspondingto250mgof 14-04-2011 section.Yeast) Copyof 03rdrenewaldated18-02-2016

Themanagement of the firm hasprovided followingdocuments:-

i. Fee of Rs. 50,000/-forthis purpose.ii. Copyof renewal of registrationandcopies ofrenewalapplications.iii. Contractagreement on stamp paper.iv. Last inspection ofM/s. Hilton Pharma,Karachi dated 19-07-2017.v. Approval of SectionbyCLB ofM/s. Hilton Pharma,Karachi.vi. NOCfrom M/s. Hilton Pharma,Karachi.

M/s.TabrosPharma,Karachihasrequestedtochangetheregistrationstatusofaboveproducttocontractmanufacturing byM/s. Hilton Pharma(Pvt.) Ltd;Plot 13-14, Sector15, Korangi

IndustrialArea,Karachi.ThefirmhasfurtherstatedthattheyareplanningtoestablishProbioticfacility.

M/sHiltonPharma,KarachiwasgrantedSachet(Enflor)Sectionon4.12.2014withfollowingremarks:

“TheCentralLicesingBoardhasgrantedprovisionalapprovalofamendments/expansioninalreadyexistingsachet(Enflor)section.TheactiveingredientofsachetEnflorisSacharomycesBoulardiiisprobioticwhichisnotadrugafterthepromulgationofDRAPAct,2012.SincethefirmhasregistrationofEnflorsachetproduct,thereforetheBoarddirectedtoreferthecasetoDivisonofPharmaceuticalEvaluation&Research,DRAP,Islamabadtotakereviewofregistrationofprobiotic(SachetEnflor)productofthefirmandtoinformCLBfornecessaryactionaccordingly”.

Decision: RegistrationBoardreferredthemattertoLicensingDivisionforevaluationinlight ofdecisionofDRAP’sauthority in thesubjectmatter.”

The firm has requested to remove provisional approval sentence and removal of Enflor from

bracket as they have asked from the Division of Pharmaceutical Evaluation& Research that the

active ingredient of registered Product sachet Enflor is Sacharomyces Boulardil which is probiotic.

Proceedings and Decision of Central Licensing Board in 259 th meeting of 150

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

substitute the words and phrases “Sachet (Enlor)” with the words and phrases Sachet

(Probiotcs)”. However, The Drug Registration Board may decide the matter in the light of the

decision of the DRAP Policy Board. The Board also decided to delete the following phrase

approved earlier in 238th meeting held on 19th December, 2014.

“*The Board has granted provisional approval of amendments/expansion in already existing Sachet (Enflor) section. The active ingredient of Sachet Enflor is Sacharomyces Boulardii is probiotic which is not a drug after the promulgation of the DRAP Act, 2012. Since the firm has registration of Enflor sachet product, therefore the Board directed to refer the case to Division of Pharmaceutical Evaluation & Research, DRAP, Islamabad to take review of registration of probiotic (Sachet Enflor) product of the firm and to inform CLB for necessary action accordingly.”

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Item-VI CORRECTION IN THE MINUTES OF 257 th MEETING

The Central Licensing Board (CLB) formally confirmed the minutes of its 258 th meeting held on

08th March, 2018.

Case No. 1 CHANGE OF TITLE OF M/S PAKHEIM INT’L (PVT) LTD, 28-KM, FEROZEPUR ROAD, LAHORE

M/s Pakheim Int’l (Pvt) Ltd, 28-Km, Ferozepur Road, Lahore under DML No. 000492 by way of

formulation has submitted request for change of title of the firm as per Form-29 with prescribed

Fee Challan of Rs.50,000/- as under;



as per Form-1A & Form-29 M/s Pakheim Pharma, 28-Km, Ferozepur Road, Lahore. (Partnership firm)

M/s Pakheim International Pharma (Pvt) Ltd, 28-Km, Ferozepur Road, Lahore. (Private Limited firm)

Decision of CLB:

The Board considered and approved the change of title of M/s Zakfas Pharmaceuticals (Pvt) Ltd,

Multan, License No. 000603 by way of (Formulation) as per Form-29 of SECP as under:



as per Form-1A & Form-29 M/s Pakheim Pharma, 28-Km, Ferozepur Road, Lahore. (Partnership firm)

M/s Pakheim International Pharma (Pvt) Ltd, 28-Km, Ferozepur Road, Lahore. (Private Limited firm)

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

In the aforesaid minutes of Central Licensing Board the name of the firm was inadvertently typed as

M/s Zakfas Pharmaceuticals (Pvt) Ltd, Multan, License No. 000603 by way of (Formulation)

Instead of M/s Pakheim Int’l (Pvt) Ltd, 28-Km, Ferozepur Road, Lahore under DML No. 000492

by way of formulation.


The Board considering the case and approved the correction.

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QUALITY ASSURANCE CASES

Case No. 1: M/s Eros Pharmaceuticals (Pvt) Ltd, KarachiBackground of the case:

Dr. Abdur Rashid, Additional Director (QA&LT), Dr. Najam-us-Saquib, Area FID, Karachi, Dr. Muhammad Kashif, AD, Karachi and Dr. Krishan, AD, Karachi conducted inspection of the firm M/s Eros Pharma (Pvt) Ltd, Karachi on 04.04.2017 to verify GMP compliance / production activities of the firm. The panel noticed critical observations and rectification. Accordingly show cause notice / suspension of production order was issued to the firm on 01.06.2017.

The firm was served letter for personnel hearing in the 255 th Meeting of CLB, wherein Mr. Asif Iqbal, Director, M/s Eros Pharmaceuticals (Pvt) Ltd, Karachi along-with his brother Mr. Abid Iqbal, Director, M/s Eros Pharmaceuticals (Pvt) Ltd, Karachi appeared before the Board for personnel hearing. The Central Licensing Board has decided as under:-

Decision of the 255 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 decided to:-

1. De-seal the firm by Area FID so that the firm can start rectifying the deficiencies pointed out by the panel.

2. The firm will complete all the renovation work within one month time after de-sealing and a panel inspection will be conducted by the following members on approved format under Schedule-B-II of Drugs (LR&A) Rules, 1976.

a. Mr. Syed Muid Ahmed, member CLB

b. Chief Drug Inspector, Sindh

c. Area FID, DRAP, Karachi

3. The panel will also submit report in tabulated form indentifying the previous observations and the current status.

4. The production will remain suspended during this period and orders for resumption of production will be issued by CLB bases upon the findings / recommendations of the inspection panel.

5. Area FID will be asked to submit his reply as to why detailed report and sealing memo was not forwarded in time and inspection report was not signed by one of the members of the panel. Further, CLB will also be intimated about the approval of composition of the panel for conducting said inspection.

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Accordingly decision of the CLB was conveyed to the firm and quarters concerned vide letter No.F.8-4/2017-QA (M-255-CLB) dated 05.10.2017.

Dr. Najam-us-Saquib, Additional Director, DRAP, Karachi vide letter dated 23.01.2018 informed that post of the Chief Drug Inspector, Sindh is vacant at present and requested that further necessary directions may kindly be given for the inspection of the firm. In the meanwhile, Syed Kalbe Hassan has been posted as Chief Drug Inspector, Sindh.

Updated Status

The panel conducted inspection of the firm on 26.03.2018 and concluded as

“M/s Eros Pharmaceuticals (Pvt) Ltd, situated at plot No. 94-95/23, Korangi Industrial area Karachi, was inspection by the panel as constituted vide DRAP letter No.F.8-4/2017-QA (M-255-CLB) dated 05.10.2017 for observing the improvements made and up-gradation carried out by the firm after the inspection of the firm by the panel conducted on 06.04.2017, wherein the firm was sealed then after central licensing board in its 255th meeting ordered to de-seal the premises and allowed the firm to rectify the deficiencies pointed out by the panel.

Based on the observation made, documents reviewed and the finding of inspection, panel is of opinion that M/s Eros Pharmaceuticals, Karachi has attended almost all the shortcomings as noticed by the panel during last inspection (dated 04.04.2017) and up-graded the facility by providing the HVAC system, epoxy flooring and segregating the ware-housing facility for raw materials, packaging materials and finished goods and premises observed maintained at a good level of sanitation and hygiene.

Keeping in view the above stated fats panel recommends the resumption of the production in the following sections:

Tablet (General)

Capsule (General)

Syrup Oral (General)

Ointment / Cream “

Proceeding of the 259 th meeting of the CLB

The case was placed before the board in the light of the decision of 255 th meeting of

CLB and recommendations of the panel of experts in its report dated 26.03.2018.


After thorough discussion/deliberations, considering all the pros and cons of the

case, recommendation of the panel of experts its report dated 26.03.2018, the Central

Licensing Board decided to resume the production activities of the firm M/s Eros Pharma

(Pvt) Ltd, Karachi in Tablet Section (General), Capsule Section (General), Syrup Oral

Section (General) and Ointment / Cream Section.

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CASE NO. 2: M/S REX PHARMA, KARACHI

CHANGE OF PANEL DUE TO DEATH OF ONE OF THE HONORABLE MEMBER DR. KIFAYAT ULLAH, CDC, GILGIT, BALTISTAN

Background of the caseInspection of the firm M/s Rex Pharmaceutical Pakistan, Karachi was conducted on

06.03.2013 by Mr. Abdul Rasool Sheikh, FID, Karachi. During inspection the FID pointed

out a number of serious/critical shortcomings in all sections. Accordingly showcause

notice/stop production order was issued on 23.04.2013. The case was presented before

CLB in its 232nd meeting held on 29&30th July 2013. The Board had decided as under:-

i) The case was deferred by Central Licensing Board till its next meeting as per your request that the Director of the firm had gone to Saudi Arabia for performing Umrah and requested to defer the case till next meeting of CLB.

ii) The production will remain stopped / suspended till the final approval for resumption of production by the Central Licensing Board.

2. The case was again presented before the 233rd Meeting of CLB, wherein the CLB

had decided as under:-

“After thorough discussion and deliberations, considering the background of the case and facts on record, Board unanimously decided to suspend the DML of the firm for period of three months under Rule 13 of Drugs (Licensing, Registering and Advertising) Rules, 1976. The Board further decided to issue show cause notice and personal hearing to the firm and advised for market survey of production manufactured by firm.”

3. The decision of the CLB was conveyed to the firm on 24.02.2014.The firm vide letter No. Nil dated 02.04.2014 replied that they have removed all the shortcomings and ready for inspection. The Area FID visited the firm on 18.11.2014 and recommended for cancellation of DML. The case was placed before the CLB in its 245 th Meeting held on 30.12.2015.

Proceedings of the 245th Meeting of CLB: The firm was provided opportunity of personal hearing before the Board, but no

representative appeared before the CLB, on behalf of firm. The Board showed displeasure on such non serious attitude of the company.

Decision of 245th Meeting of CLB: The Board after thorough discussion, keeping in view the available record, observations of the FID in its inspection conducted on 06.03.2013, track record and non serious attitude of the firm, and report of the FID dated 18.11.2014 which categorically stated that “The DML

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of the firm may be cancelled in larger public interest”, has decided to suspend the DML of the firm M/s Rex Pharmaceuticals Pakistan, Karachi for a period of 06 months, under Rule 12 of the Drugs (LR&A) Rules, 1976.

4. The decision of the CLB was conveyed to the firm on 09.02.2016.

Inspection conducted by Area FID, Karachi on 06.01.2017

Mr. Abdul Rasool Shaikh, FID, Karachi vide letter dated 24.01.2017 informed that the firm was inspected on 06.01.2017 and found non-operational, no one was there except watchman who told that factory is closed since 2011 and owners are reported to be living in USA now days. Based on the current conditions of the firm it is recommended that their DML by way of formulation may be cancelled in larger public interest.

Proceedings of the 252 nd Meeting of CLB

The Board was informed by the Deputy Director (QA) that the firm was served letter for personal hearing on 08.03.2017 and the area FID was also informed to send the letter to the firm. But no representative of the firm appeared before the Board for personal hearing under section 41 under the Drug Act 1976, read with rule 12 of the Drugs (L, R & A) Rules 1976.

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 letter dated 24.01.2017, in which the FID recommended to cancel the DML of the firm in the larger public interest, casual attitude of the firm towards GMP compliance, track record of the firm and nonappearance of representatives of the firm before the Board to defend the case, the Board decided to cancel the Drug Manufacturing License of the firm M/s Rex Pharmaceutical Pakistan, Karachi, under Section 41 of the Drugs Act, 1976 read with Rule 12 of the Drugs (L,R&A) Rules, 1976, from the date of issuance of decision of the 252 nd

meeting of CLB.

5. Decision of the CLB was conveyed to the firm and quarter concerned on 15.03.2017.

Decision of Appellate Board in its 147 th Meeting M/s Rex Pharmaceutical Pakistan, Karachi filed an appeal against the decision of

the CLB regarding cancellation of DML. The case was considered in 147 th meeting of the Appellate Board held on 28.08.2017, wherein the appellate board decided to suspend the operation of impugned order of CLB dated 15.03.2017 communicated on 24.04.2017 and remand the appeal back to the CLB. The appellate board constituted a panel of following panel to inspect the premises of the appellant who shall submit its report within 30 days from the date of communication:-

a. Dr. Kifayat Ullah, CDC, Gilgit, Baltistanb. Prof. Dr. Maqsood Ahmed, Ripah International University, Lahorec. Syed Muied Ahmed, Expert in Manufacturing, Karachi

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 recommendations by the panel for the resumption of production and approval thereof by the CLB.

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Panel inspection on the decision of the Appellate Board:-The panel inspected the firm on 12.12.2017 and noticed following observation

which still needs rectification:-

General:- Layout of the facility was approved by DRAP in 1997. Panel noticed number of

changes in the facility as compared to the approved layout of 1997.Dry Powder injectables (Cephalosporin)

There was not status labeling for clean down quarantine and passed material storage areas

There was not air conditioning in cold store area. No temperature monitoring or recording in raw material stores area No designated area for material sampling. No provision of HVAC in change room and main corridor of ceph manufacturing

area No HVAC in vial washing room Plain water, deionized water and distilled water lines were provided in the vial

washing room but no status labeling on these lines. No provision was seen for water for injection loop in vial washing room Dry heat sterilizer and autoclave installed in washing room were very old and no

evidence was available for their qualification / validation Magenhelic gauge outside the sterile vial filling area showed zero pressure,

meaning there was no pressure differential in the room. Dry powder vial filling line was very old and no evidence of qualification / validation. No temperature monitoring in finished goods store area.

Liquid injectables (ampoule) section Common change room for liquid injectable and cephalosporin dry powder injectable

sections. Male and female staff enter and come out of both the above sections through the same change room.

No proper change room for ampoule washing room No proper HVAC in ampoule washing room Ampoule washing machine was very old and almost manual. No clarity on quality of water used for ampoule washing. No provision was seen for

water injection loop in ampoule filling machine. No manometer installed to demonstrate air pressure differential in ampoule filling

room. No connection of water for injection loop in ampoule manufacturing area. No mixer

for making solutions. No means for pressure filtration of solutions. Autoclave for filled ampoule sterilization was very old and no evidence of

qualification / validation. No provision for ampoule leak testing.

Veterinary injectables section Clean down and quarantine area is common No temperature control in raw material store. No sampling and dispensing booth No status label on water lines No filter assembly was available for filtration of injectable solutions. No laminar flow on injectable filling machine No HVAC in sterile cool down area and vial washing area. No autoclave was available in veterinary injectable area

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Eye drop section: No proper change facility for sterile eye drop section No HVAC in washing area No status labeling on water lines No filter assembly for eye drop solution filtration. One old filling machine was installed in a room, without any provision for stopper

inserting and capping. No laminar flow on filling machine.Eye ointment section

There was no equipment in ointment manufacturing No service lines or drain lines in the room There was not any room for ointment filling and no filling machine was available.

Dry powder (cephalosporin) No status labeling in stores No HVAC in change room HVAC was not working in powder mixing room Cephalosporin powder filling room is next to non-cephalosporin tablet compression

room and non-ceph tablet coating room with a door in between. Chances of cross contamination were evident.

No provision of bottle cleaning No dust control or extraction in powder filling area. A blister cutting and a strip cutting machine were lying in a small room. Both were

very old and looking out of order. An old capsule filling machine was lying in a small room in cephalosporin area.

Oral liquids section HVAC supply and return duct were on the same wall of the liquid filling room.

Therefore chances of quality air not reaching to the other end of the room No transfer pump or filtration assembly seen in the liquid manufacturing room.

Tablet section No positive or negative air pressure differential in tablet compression rooms. Entry to one table compression room is through another tablet compression room;

therefore chances of cross contamination. Solvent coating is carried out in open pans. No exhaust system for solvent vapors. No proper HVAC ducting. Supply and return on the same wall. Granulation area very noisy due to air coming from the air supply duct. Seems

problem in air balancing. No positive or negative air pressure differential in granulation room.Veterinary oral liquid & powder section.

No proper manufacturing vessel in liquid manufacturing area. No proper liquid filling machine. Powder blender was available in one room but not powder filling machine. No exhaust system or air pressure differential were available.

The panel further concluded and recommended that:-

The panel observed a number of shortcomings in building, production machinery, HVAC system, documentation etc. Therefore, based on the areas inspected, the people met and documents reviewed and considering the findings of inspection the panel recommends that the Drug Manufacturing License may be granted to M/s Rex Pharmaceuticals Pakistan, Karachi, for two sections only namely Oral Liquids and Tablet (after addressing the observations in this report).

Decision of 257 th Meeting of CLB:- of 150

The case was placed before the Central Licensing Board in its 257 th Meeting held on 24-25 Jan, 2018 and decided as under:-

“After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 12.12.2017 decided to

i. Re-inspect the firm M/s Rex Pharmaceutical Pakistan, Karachi by following panel of experts, constituted by the Appellate Board in its 147 th Meeting:-

a. Dr. Kifayat Ullah, CDC, Gilgit, Baltistanb. Prof. Dr. Maqsood Ahmed, Ripah International University, Lahorec. Syed Muied Ahmed, Expert in Manufacturing, Karachi

ii. The panel shall submit the detailed report alongwith rectification status of the observations in the Tablet Section and Liquid Syrup Section noted by the panel in the report dated 12.12.2017. Further more the panel will also submit detailed report regarding the quality control laboratory and storage facilities of the firm. The report shall be placed in the forthcoming meeting of Central Licensing Board for consideration.

The Decision of the 257th meeting of CLB was conveyed to the firm and quarters concerned on

06.03.2018.

Updated status:-

The firm vide letter No. Nil dated 20.03.2018 received on 27.03.2018 informed that they have

rectified the observations recommended by the panel. In the meanwhile one of the respected panel

member Dr. Kifayat Ullah, CDC, Gilgit passed away.

Proceedings of the 259 th meeting of the CLB

The case was placed before the board in the light of request of the firm M/s. Rex Pharmaceutical

Pakistan, Karachi regarding death of one of worthy panel member Dr. Kifayatullah, Chief Drug

Controller, Gilgit Baltistan.


After thorough discussion / deliberations, considering all the pros and cons of the case and

intimation of the firm regarding death of the worthy panel member Dr. Kifayatullah, Chief Drug

Controller, Gilgit Baltistan, the Central Licensing Board decided to replace name of deceased

member Dr. Kifayatullah, Chief Drug Controller, Gilgit Baltistan with Additional Director, Karachi,

other members of the panel shall remain same.

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GMP Non-compliance case (new)

Case No. 1. M/S Usman Enterprises, Karachi

Background of the case:

Mr. Abdul Rasool Shaikh, Area FID, Karachi conducted inspection of the firm M/s Usman Enterprises, Karachi on 26.12.2017. The FID noticed following observations:-

i) During inspection, overall sanitation & hygiene conditions were noted compromised and inappropriate. Proper tools and steps for cleaning of the areas were advised to be in place. HVAC installation work was seen underway in first aid bandage section, during the active production.

ii) QC lab was seen under renovation and only two physical quality tests were seen carried out on finished products only.

iii) Poor record keeping was observed during inspection.iv) QA system was seen a bit compromised needed to be improved as per prevailing guidelines.

In-process testing is to be carried out properly.v) Stores have to be well defined and properly maintained.vi) Poor documentation and retrieval level was observed during the inspection.vii) The firm was still noted deficient of technical persons, especially in stores and in QA.viii) The FID further concluded that “all the observations discussed with the management of the

firm and they agreed to voluntarily halt the production of first aid bandages till the attainment of better level of compliance. All the observations were also to be attended within one month of time. They were advised to submit a time bound plan in this regard. Keeping in view the type and class of medical devises they produce and attitude of the management towards better level of compliance, their overall level of compliance was noted satisfactory.”

Action taken by DRAP: Accordingly showcause notice / suspension of production order was served to the firm M/s Usman Enterprises, Karachi on 06.02.2018.

Reply by the firm: The firm vides letter Ref. No. U18-10102 dated 16.02.2018 submitted reply of the showcause notice / suspension of production order and informed that we had voluntarily suspended the manufacturing activity of our first aid bandage section and also informed the FID due to renovation work being carried out in production area. During the month of Dec / Jan we have carried out some renovations and up-gradation of their facilities with the purpose of improving the facilities of GMP compliance, the area was being upgraded; which may have caused some issues as cleaning and maintenance work was going on at the time of inspection. The CEO of the firm M/s Usman Enterprises, Karachi requested to withdraw the show case notice, Suspension of production order and requested for personnel hearing.

Proceedings of the 259 th Meeting of CLB

Mr. Ilyas Khan, Plant Manager of the firm M/s. Usman Enterprises, Karachi appeared before the Board for personal hearing. Mr. Ilyas Khan informed to the Board that the observations noted by the FID in its inspection conducted on 26.12.2017 have been rectified.

Decision of 259 th Meeting of CLB of 150

After thorough discussion / deliberations, considering all the pros and cons of the case and compliance report of the firm, the Central Licensing Board decided to:-

i. Re-inspect the firm M/s Usman Enterprises, Karachi by following panel of experts,

a. Prof. Dr. Abdullah Dayo, Member, CLBb. Area Federal Inspector of Drugs, Karachic. Chief Drug Inspector, Sindh

ii. The panel shall submit the detailed inspection report on approved Schedule B-II format. The panel shall also submit rectification status of the observations noted by the FID, in First Aid Bandages Section, in its report dated 26.12.2017, in tabulated form with clear and candid recommendations.

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QUALITY CONTROL CASES

Case No.01 Seizure of Illegally Manufactured Drugs of M/s. Everest Pharmaceuticals, Pvt (Ltd), Islamabad recovered from Pharma Net Karachi .

1. That Muneeza Khan, FID Karachi alongwith Mr. Abdul Rasool Shaikh, FID, and Dr. Shoaib Ahmed FID, Karachi raided M/s. PharmaNet, godown situated at Plot No. B-161, B-162 sector GF Mehran Town Korangi, Karachi on 06-03-2018.

2. That FID recovered suspected unregistered 14 drugs and seized on Form-2 under Section 18 (1) (f) of Drugs Act, 1976/schedule-V of DRAP Act 2012 and Rules framed thereunder.

3. M/s Pharma Net Karachi provided bill warranties No. EPO/897 dated 20-02-2018, EPO/860 dated 10-02-2018, EPO/909 dated 26-02-2018, EPO/703 dated 18-12-2017, EPO/637 dated 28-11-2017 duly signed and issued by the M/s Everest pharmaceuticals Islamabad. They also submitted copies of purchase return (without invoice) against the purchase of seized drugs of M/s. Everest Pharmaceuticals situated at 124 Industrial Triangle Kahutta Road, Islamabad.

4. The details of the unregistered drugs are as under:

Sr. No.

Product Registration Status as on date:

Mfg. Date

Exp. Date

Quantity Purported To Be Manufactured By

01. Diaflext Tab.

020

Fake Registration numbers were applied on the labels of un registered drugs

01-2017

01-2019

71 Packs of 30 Tablets each

M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.

02. DutPlus Tab.

009

-do- 01-2018

01-2020

45 Packs of 20 tabs. each


03. DutPlus Tab.

094

-do- 03-2017

03-2019



04. EverLong 60 mg Tab.

374

-do- Not given

11-2019



05. Evertam Tab.

-do- 08-2016

08-2018

90 Packs of 20

M/s. Everest Pharmaceuticals

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285Tabs. each

124-Industrial Triangle, Islamabad.

06. Maintain Tab.

217

-do- 06-2017

06-2019

01 Pack of 20 tablets


07. Maintain Tab.

362

-do- 10-2017

10-2019



08. Rabzol-D Tab.

347

-do- 10-2017

10-2019

712 Packs of 14 Tabs. each


09. Sumat N Tab.

089

-do- 03-2017

03-2019



10. Zerodol Tab.

371

-do- 11-2017

11-2019

223 Packs of 20 Tabs. Each


11. Zycin 250 mg Tab.

006

-do- 01-2018

01-2020

31 Packs of 10 Tabs. Each



059

-do- 02-2017

02-2019

70 Packs of 10 Tab. each



028

-do- 01-2018

01-2020




207

-do- 06-2017

06-2019



05. 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)(i), i.e. Export Import are manufacture for sale or sell any spurious therapeutic good;

b. 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;

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

e. (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.

6. The Prohibitions mentioned in para 5 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 upto five years and with fine up to five hundred thousand rupees

07. Permission For Safe Custody of the Seized stock

The FID Karachi has requested to necessary permission for safe custody of sized stock till the decision of the case.

08. Permission for Lodging of FIR

The FID Karachi 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. Muhammad Istiaq QC Incharge, M/s Everest Pharmaceuticals Islamabad7. Mr. Haroon Yousuf warrantor for M/s Everest Pharmaceuticals Islamabad who

signed and issued above mentioned false warranties on behalf of M/s Everest Pharmaceuticasl Islamabad.

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“Decision of the Case:-The Central Licensing Board examined/evaluated the facts of the case in the light of investigations conducted by the FIDs and Quality Assurance Division and decided as under:-

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

B. Permission for registration of FIR was granted 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 Islamabad

c. 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 Istiaq Ahmed QC In-charge, M/s Everest Pharmaceuticals

Islamabadg. Mr. Haroon Yousuf warrantor for M/s Everest Pharmaceuticals

Islamabad who signed and issued above mentioned false warranties on behalf of M/s Everest Pharmaceuticasl Islamabad.

C. The FID shall lodge FIR under schedule- IV of the DRAP Act 2012 and resubmit the complete case to the CLB after completion of investigations under the law.

D. That the accused 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 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. The Prohibitions mentioned above are offences and punishable under schedule III of DRAP Act 2012






Case No.02 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.

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4. The FID further requested to grant permission for safe custody of seized drugs as mentioned above till the decision of the case under provision of the drug Act 1976 and Schedule-V to the DRAP Act 2012.

Permission For Safe Custody:-

“The Case is submitted for grant the permission of safe custody of the seized stock”

“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”.

Case No.03 Seizure of illegally manufactured stocks of M/s Everest pharmaceuticals 124 –Industrial Triangle Islamabad From M/s Al- Karim Medicine Peshawar

FID Peshawar

Mr. Ziaullah FID-III /Assistant Director Peshawar, upon credible information regarding the availability of stocks of the subject mentioned firm at the premises of M/s Al-karim medicine Traders Al-Sham medicine Market Namak Mandi, Peshawar, the FID-III Peshawar along with a team of provincial drug Inspector, conducted raid at the said premises.

2. The FID Peshawar informed that stock of Tab. Eversafe and Dry Suspension Eversafe claimed to be manufactured by M/s Everest pharmaceuticals Islamabad were recovered from the premises. The stocks were seized and took samples for test analysis.

3. That the FID Peshawar referred the sample to the FGA, Karachi for test analysis which were declared un registered as under:-


Mfg date

Exp date

Test Report No.

1. Everesafe suspension Batch No.449

12-17 12-19 R.IP .39/2018, un registered drug product

2. Everesafe Tablets Batch No.373

11-17 11-19 R.IP .40/2018, un registered drug product

04. The FID also seized the following stocks on Form-2:-


Mfg date

Exp date

Quantity

1. Everesafe DS Batch No.449

12-17 12-19 80x100

2. Everesafe Tablets Batch No.373

11-17 11-19 12x554

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05. Permission For Safe Custody.

The FID Peshawar has requested for grant the permission of safe custody of the seized stock till the finalization of the case.


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Case No.04:- Manufacture and sale of un registered drug product Ever long tablet 60mg B. No. 131 Mfg date 05-17, Exp date 05-19 Mfg by Everst Pharmaceutical Islamabad

FID Lahore

Mr. Abdul Rashid Shaikh along with Mr. Ajmal Sohail Asif FID, DRAP Lahore and Mr. Usman Ghani Deputy Drugs Controller Shah Rukan-e Alam Town, Multan, inspected the following two pharmaceuticals distributors at multan which were reportedly the distributors for the said un registered drugs

1. Madina Medicine Co, 300 Shamsbad Colony near Ladies Park Multan.2. M/s Pharma Distributors 286 Shamsabad Colony Multan.

2. M/s Pharma Distributors Multan on 29-09-2017 for the purpose of test analysis one portion of the sample was returned to the Distributor along with copy of the Form-3 at the spot.

3. One sealed potion of sample was sent to FGA, CDL Karachi on 02-10-2017 on Form-4. Invoice/warranty bearing No. EVM/527, dated 26-09-2017 was provided by M/s Pharma Distributors Multan issued by M/s Everest Pharma Islamabad. The third sealed portion was sent to the warrantor accordingly on 09-10-2017 but the same was receive back undelivered with the postal authorities

4. Meanwhile on the next day the firms representative Mr. Haroon Yousuf provided in this office a copy of the Court orders which were self explanatory. The same along with report in this regard were communicated to the Additional Director DRAP Lahore too. Later on a Notice was also received from the Honorable Court of Mr. iftikhar Ahmed Additional Session Judge Lahore regarding contempt of Court application filed by the manufacturer

5. The Director/FGA Karachi informed that the registration holder had not yet submitted the approved specification to CDL for the referred formulation which is violation of prescribed conditions of registration of Drug product and amongst other advised to ensure availability of complete specifications in time to proceed the test analysis. The Director CDL/FGA issued the test report of the samples with the following remarks:-

Remarks:-

Other tests could not be performed due to non receipt of method of testing and reference standard. Request has already been made vide this Laboratory letter no. F.5-3(LHR)/2017-CDL/S-2703, dated 20th October 2017 reminder-I No. F.5-3(LHR)/2017-2880 dated 17th November 2017 and reminder-II No. F.5-3(LHR)/2017-2950 dated 30 th

November 2017.

6. Another Test report No. LHR257/2017 dated 06-02-2018 has also been received from the FGA CDL Karachi with following remakrs:

1. The lable claims Each tablet contains Dapoxetine HCL eq. to Dapoxetine 60mg (Everst Specs)

2. As per decision of the Registration Board communicated to this lab vide DRAP Islamabad letter No. F.8-8/2016-Reg-III (M-263) dated 11 th January 2017 everlong tablet were neither presented in any agenda of RB not its registration was approved by it. The above mentioned letter states as Registration Board in 263 rd

meeting held on 29th and 30th November 2016 considered subject mentioned case pertaining to unlawful and fraudulently issuance of Ever long tablet 60mg

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registration letter. The board declared that the application for registration of Everlong tablet was neither presented in any agenda of Registration Board nor its registration was approved by it. The Board therefore based on the current legal scenario decided to declare that the purported registration letter of the Everlong which was obtained through unlawful manner is considered as vide as inittio, since it was issued fraudulently as it was got issued without approval of RB.

3. In the light of decision of RB the sample Everlong 60mg tablets is declared unregistered Drug Product under the Drugs Act 1976.

8. The explanation letter along with a copy of the above Test Report No. LHR.257/2017 dated 06-02-2018 has been sent to the manufacturer M/s Everest Pharma Islamabad, a copy whereof along with of the Test Report No. LHR 257/2017 dated 06-02-2018 is also endorsed to M/s Pharma Distributors with the directions to recall the drugs and stop distribution of un registered drug Everelong 60mg tablets and also indicate the stock position as on 19-02-2018 but not response has been received in this regard so far 9. That M/s Pharma Distributors Multan provided appointment letter as distributor of M/s Everest Pharmaceuticasl dated 01-07-2015, invoice No. EVM/527 dated 26-09-2017 showing the source of purchase of Everlong Tablet B.No. 131 in addition to tablet Rabazol D B.No. 412 and Tablet Dutolus B.No.094 duly signed and issued by Mr. Haroon Yousuf as warrantor . M/s Pharma Distributor also provided invoice No. EPO/787 dated 19-01-2018 for the purchase of four other unregistered drugs i.e. Zicine 250 table Zicine 500 tablets, Dut plus table and Everetame tablets they also submitted invoice No. EPO 785 dated 18-01-2018 and EPO/719 dated 01-01-2018 for the purchase of Everelong 60mg tablet B.No.374. 10. The M/s Pharma Distributor also provided copies of pay order /check of UBL 1270 LMQ Road Branch Multan for payment of one million rupees dated 30-10-2017 to M/e Everest Pharmaceuticals. They also submitted another pay orders of rupees 07 Laks to M/s Everest Pharmaceuticasl on 25-01-2018. 11. In the light of above it is evidently proven that M/s Everest Pharmaceuticals manufactured and sold unregistered drugs to M/s Pharma Distributors Multan as under:-

i. Everlong Tablet B.No. 131.ii. tablet Rabazol D B.No. 412.iii. Tablet Dutolus B.No.094 iv. Zicine 250 table B.No.006v. Zicine 500 tablets, B.No.207vi. Dut plus table B.No.94vii. Everetame tablets B.No. 313viii. Everelong 60mg tablet B.No.374.


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;



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






14. Permission For Safe Custody of the Seized stock)

The FID Karachi has requested to necessary permission for safe custody of sized stock till the decision of the case.




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. Muhammad Istiaq QC Incharge, M/s Everest Pharmaceuticals Islamabad7. Mr. Haroon Yousuf warrantor for M/s Everest Pharmaceuticals Islamabad who


“Decision of the Case:-A. Permission for safe custody of the seized stocks of therapeutic goods/drugs

was allowed to the FID till the finalization of the case.

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Pharmaceuticals Islamabad f. Mian Istiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals












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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.

Case No.05 Seizure on Form-2 Under Section 18(f) of Drugs Act 1976 at Different Medical Stores of Karachi against M/s Everest Pharmaceuticals Islamabad.

FID Karachi

Mr. Abdul Rasool Shaikh FID-VI Karachi along with Dr. Shoaib Ahmed FID inspected,

i. Ali medical store orangabad Karachi and recovered 05 different unregistered drugs on Form-2 on 06-03-2018. M/s Ali medical store provided Cash Memo/invoice having No.1718-1L116505 dated 11-01-2018 issued by M/s pharma net.

ii. Azeem Sons medical store and recovered Everlong tablets Mfg by Everest pharmaceuticals Islamabad. M/s Azeem and sons provided invoice warranty no. 1718-01 L125273 dated 24-01-2018.

iii. M/s Khwaja Ghareeb nawaz and recovered Rabzol-D mfg by M/s Everest pharmaceuticals Islamabad on Form-2 the invoice warranty no.1718-0126531 dated 26-01-2018 and 1718-01013355

2. Different outlets/pharmacies under the area jurisdiction and found 07suspected un-registered drugs/medicines claimed to be manufactured by M/s Everest pharmaceuticals Islamabad. The FID Karachi seized all the stocks under section 18 (1)(f) of Drug Act 1976 on Form-2. As per information of the FID all the retailers had provided their subsequent purchase records of M/s Pharma Net Karachi the main distributor of M/s Everest Islamabad this distributor was also visited by a team of DRAP Karachi and all the suspected stocks of M/s Everest pharma were seized under the directions and sought necessary related information about the distributed suspected unregistered stocks.

3. M/s Ali Medical Store Aurangabad Karachi, M/s Azim & Sons Nazimabad Karachi and M/s Khawaja Gharib Nawaz Medical store Karachi provided the bill warranties/invoices of M/s Pharma Net Karachi as a proof of their purchase. The M/s Pharma Net Karachi was directed to subsequent bill warranties/invoices in connection with purchase of drugs.

4. The M/s Pharma net Karachi submit the bill warranties/invoices No. EPO/557 dated 03-04-2017, EPO/592 dated 05-10-2018 & EPO/860 dated 10-02-2018 of M/s Everest Pharmaceuticals Islamabad as the proof of their purchase of drugs.

5. The details of the unregistered drugs are as under:- of 150

S.No. Name of drug Batch No.

Quantity Claimed to be manufactured

01 Tab. Rabzol-DFrom (Khawja Ghareeb Nawaz Medical Store)

111 1x4 M/s Everest Pharmaceuticals

02. Tab EverlongFrom (Ali Medical Store)

131 1x10x10 do.

03. Tab Everlong from (Azeem & Sons)

131 1x10x10 do.

04. Tab EverlongFrom (Ali Medical Store)

147 1x10 do.

05. Tab Maintain From (Ali Medical Store)

362 1x10x2x2 do.

06. Tab. Zerodol From (Ali Medical Store)

371 1x10x3x1x8 -do-








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The FID Karachi requested to necessary permission for safe custody of sized stock till the decision of the case.


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


2. Ch. Muhammad Usman (Chief Executive officer), M/s Everest Pharmaceuticals Islamabad

3. 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. Muhammad Istiaq QC Incharge, M/s Everest Pharmaceuticals Islamabad7. Mr. Haroon Yousuf warrantor for M/s Everest Pharmaceuticals Islamabad.






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Pharmaceuticals Islamabad f. Mian Istiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals














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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.

Case No.06 Manufacture & Sale of Un-Registered Drug Reap 2.5mg Tablet Batch No. 188, Reg. No. 068804 Manufactured By M/s. Everest Pharmaceutical Pvt. Ltd., Islamabad.

1. That Pharmaceutical Evaluation & Registration Division reported that M/s. Everest Pharmaceutical, Islamabad is involved in manufacturing of certain Un-registered products with fake registration numbers which are not approved by the Pharmaceutical Evaluation & Registration Division.

02. The matter was circulated to the field offices of DRAP vide letter of even no dated 03rd December, 2015 for necessary action under the law.

03. That FID Karachi inspected the business premises of M/s Aqmar Pharma first floor 36-Block BSMCH Karachi on 02-02-2016 and seized capsule Reap 2.5mg B. No. 188 purported to be Mfg. by M/s. Everest Pharma, Islamabad on Form-2 which was duly signed by Mr. Mohd. Farooq sheikh Proprietor the firm FID also took sample on Form-3 for the purpose of test/ analysis.

04. The FID Karachi also seized cap Reap 2.5 mg B.No.188 purported to be manufactured by M/s Everest Pharma Islamabad on Form-2 from M/s Bright Pharma Karachi on 01-02-2016 duly signed by Mr. Mohd. Rafique, proprietor.

05. That M/s Bright Pharma, Karachi sale record was also obtained by the FID Karachi which proved that M/s. Bright Pharma, Karachi sold the said product in the market of Karachi, in addition to other Un-registered products manufactured by M/s. Everest Pharma, Islamabad.

06. M/s Bright Pharma, Karachi submitted invoice warranty issued by M/s Aqmar Pharma Karachi vide invoice No. AKPH-B 24 dated 14-01-2016.

07. That M/s. Aqmar Pharma submitted invoice warranty having number 411672, dated 29-12-2015 and number 12575, dated 29-01-2016 of Capsules Reap 2.5mg as a source of purchased from M/s. Tainzy International 15 Qauyum Block Mustafa town Wahdat Road Lahore. M/s Bright Pharma also submitted delivery challan of Aqmar Pharma dated 01-02-2016 for the purchased of 60 packs of Reap 2.5mg Capsules of the same batch, as a source of purchased of M/s. Aqmar Pharma from Tainzy international Lahore.

08. M/s. Aqmar Pharma, Karachi also submitted agreement for supply of drugs with M/s Tainzy International Lahore duly signed and stamp by Mr. Zafarullah Wattoo, CEO of M/s Tainzy International and Mr. Farooq Sahikh, MD of M/s Aqmar Pharma signed on 05 th

May 2014 for the supply of Reap 2.5 mg Capsules.

09. FID Karachi asked M/s Tainzy International Lahore to verify the invoice warranty and purchased record of the said capsules from the manufacture.

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10. It is pertinent to mention that these invoices issued by M/s. Tainzy International, Lahore the sale record proved following Un-registered drugs in addition to Reap 2.5 mg Capsules supplied by M/s Everest Pharmaceutical Islamabad:

a) Capsule RP-XIME 400mg B. No. 115 at Rs.276.25_____________ 1720 packsb) MOON-B suspension vials B.No.599 at Rs. 170.00______________1000 vials

11. M/s. Tainzy International submitted invoices a source of purchase of Reap 2.5mg Capsules vide invoice No. EPO/864 dated 27-11-2015 and invoice No. EPO/ 829 dated 09-10-2015, signed and issued by M/s. Everest Pharmaceutical, Islamabad.

12. That AD Import & Export vide letter No. F.3-6/2017(I&E)/QA/LT 2018 dated 01 st

March 2018 confirmed that M/s Everest Pharmaceuticals Islamabad did not obtained clearance of Raw Material of the above mentioned products nor obtained import license mandatory for the import of active pharmaceutical ingredients under the DRAP Act 2012 and rules framed thereunder.












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The FID Karachi has requested to necessary permission for safe custody of sized stock was granted by the Director QA/LT on behalf of CLB till the decision of the case.






Islamabad 6. Muhammad Istiaq QC Incharge, M/s Everest Pharmaceuticals Islamabad7. Mr. Khuram Naeem warrantor for M/s Everest Pharmaceuticals Islamabad who


8. Mr. Zafarullah Watto Chief Executive Tanzy International Ground Floor 15, Qayum block Mustafa Town Wahdat Road Lahore.







Islamabade. Muhammad Arshad, Production In charge, M/s Everest

Pharmaceuticals Islamabad f. Mian Istiaq Ahmed Assistant QC Incharge, M/s Everest

Pharmaceuticals Islamabadg. Mr. imtiaz Ahmed Quality Control manager of Everest Pharmaceuticasl

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h. Mr. Khuram Naeem warrantor for M/s Everest Pharmaceuticals Islamabad who signed and issued above mentioned false warranties on behalf of M/s Everest Pharmaceuticasl Islamabad.

i. Mr. Zafarullah Watto Chief Executive Tanzy International Ground Floor 15, Qayum block Mustafa Town Wahdat Road Lahore.












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Case No.07 Seizure Of Stock Under Section 18 (f) of the Drugs Act, 1976 From (M/s. Clinix Central Pharmacy Franchise of Clinix, Multan Road, Near Shahnoor Studios, Lahore.

Ms. Uzma Barkat, FID, Lahore alongwith Additional Director, DRAP, Lahore and DRAP team alongwith Mr. Ijaz Ahmed, Assistant Director, FIA, Crime Circle, Lahore visited the premises of M/s. Clinix Plus Pharmacy Franchise of Clinix, Multan Road, Near Shahnoor Studios, Lahore on 06-03-2018.

03. 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. EverLong 60 mg Tablets

-do-

374

131

11-17

05-17

11-19

05-19

M/s. Everest Pharmaceuticals 124-Industrial Tiangle, Islamabad

(72 Tablets)07Packs× 10 Tablets+ 02 Tablets loose

(20 Tablets)02 Packs× 10 Tablets

(20 Tablets)02 Packs× 10 Tablets

02. Chill Tablets

-do-

269

001

08-17

01-18

08-19

01-20

-do-

-do-

(70 Tablets)07 Packs× 10′s

(84 Tablets)08 Packs× 10 Tablets +04 Tablets loose

04. The FID further informed that the above mentioned were recovered and seized in the presence of Mr. Noor–ur-Rehamn (CNIC No. 35202-5734931-7), Pharmacist, Qualified person. The witnesses were also recorded on the seizure Form.

Permission for safe custody

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05. The FID has requested the competent authority to grant permission for safe custody of seized drug as mentioned above till decision of the case.


Case No.08 Seizure Of Stock Under Section 18 (f) of the Drugs Act, 1976 From (M/s. Servaid Pharmacy (Pvt.) Ltd. 65-Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.

Ms. Uzma Barkat, Additional Director, DRAP, Lahore and DRAP team alongwith Mr. Muhammad Usman, Inspector, FIA, Crime 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. EverLong 60 mg Tablets

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

255 Packs× 10 Tablets

02. Dyone Tablets

144 05/17 05/19 -do- 07 Packs× 20 Tablets

03. Sumat-N Tablets

089 03/17 03/19 -do- 04 Packs× 10 Tablets

04. Zitpro Oral Suspension

17L018 11/17 11/19 -do- 10 Packs×01

05. Esoval Tablets

365 10/17 10/19 -do- 08 Packs× 14 Tablets

03. The FID further informed that the above mentioned 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 Form.

Permission for safe custody

05. The FID requested the competent authority to grant permission for safe custody of seized drug as mentioned above till decision of the case

“Decision of the Case:- of 150

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

Case No.09 Raid On Office Of M/s. Everest Pharmaceutical Situated at Office No. 13, 3 rd Floor, Gohar Centre, Wahdat Road, Lahore.

Mr. Ajmal Sohail Asif, FID Lahore vide letter No.F.5-27/2018-FID (IV)/3258 dated 07th March, 2018 wherein FID informed that on directions of Additional Director, Lahore, he alongwith Mr. Muhammad Usman Iftikhar, Inspector of FIA, Lahore and Ms. Uffaq Tanvir AD, DRAP, Lahore visited the head office of M/s. Everest Pharmaceutical, situated at Office No. 13, 3rd floor, Wahdat Road, Lahore on 06-03-2018. The FID informed that he was directed to inspect the said office and confiscate/ seize any un-registered drugs of the firm stocked/ stored in the office with reference to DRAP, Islamabad′s letter No.F.4-5/2018-QC dated 06-03-2018.

02. The FID further informed that he reached at the said office along with other team members at about 12:15 pm. The office was closed, the door seemed to be locked, door was knocked many times but there was no response. The FID contacted the management of the building and Mr. Sajjad Hussain (Supervisor of the building management) came at the premises. He informed that the office belongs to Mr. Muhmmad Usman of M/s. Everest Pharmaceutical and usually is opened on weekdays. He further informed that today he has not seen any of the employees of the office.

03. The FID also informed that in such circumstances, it was not possible to inspect the office, therefore, the office was sealed under Section 18 (1) (j) of the Drugs Act, 1976 without inspection and a notice was pasted on the door wherein the firm was directed to attend the office of the FID for conducting inspection.

04. The premises was sealed in the presence of Mr. Muhammad Usman Iftikhar, Inspector FIA and Mr. Sajjad Hussain, Supervisor of the building, witnesses were recorded on the notice and the case is under investigation.

05. The FID has requested to grant permission to keep the premises sealed till the premises is inspected in the presence of management of firm and all illegal drugs are seized under the law.

“Decision of the Case:-The Central Licensing Board granted extension of further 90 days in the sealing period of the premises.”

Case No.10 MANUFACTURE AND SALE OF SPURIOUS, UN-REGISTERED, AND SUBSTANDARD DRUGS MENTIONED BELOW BY M/S. EVEREST PHARMACEUTICALS 124, IDUSTRIAL TRIANGLE, KAHUTA ROAD ISLAMABAD.

On the direction of Honorable Supreme Court of Pakistan Islamabad, during the hearing dated 06.03.2018 in connection with Human Rights Case No.5845 and 3923-G of 2018, DRAP inspection team alongwith FIA and NAB teams conducted the inspection of M/s.

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Everest Pharmaceuticals 124, Industrial Triangle, Kahuta Road Islamabad. Undersigned recovered and sealed the following nine (09) samples of suspected un-registered, sub-standard and spurious drugs for test analysis purpose under Section 18(1)(c)of the Drugs Act, 1976 on prescribed Form-3 in the presence of witnesses. Copy of Form 3 is enclosed the detail thereof is as under:

2. Muhammad Usman Ch. s/o Mr. Zaheer Ahmed Ch. CNIC No.35202-8457717-1 owner/production incharge of the firm resident of Flat No.13, 3 rd Floor Ghoar Center Muslim Town Waris Road Lahore refused to sign and receive the sealed portion of the samples of the drugs and copy of Form-3 required under Section (3)(c) of Schedule-V (Procedure for Inspectors) of DRAP Act 2012 read with section 19(3) of Drugs Act 1976 and rules framed thereunder hence violated Section-3 of Schedule-III (OFFENCE) of DRAP Act 2012 read with Section 27 (3) of Drug Act 1976 (disobeys the lawful authority of any Inspector) and rules framed there under.

3. A sealed sample of each drug was sent under Section (3)(a) of Schedule-V (Procedure for Inspectors) read with section 19(3)(i) of Drugs Act, 1976 to the Federal Government Analyst, Central Drugs Laboratory Karachi on prescribed Form-4 for test & analysis purpose on 7th March, 2018 and one portion of sealed sample of each drug was forwarded to Secretary Registration Board, Drug Regulatory Authority of Pakistan required under Section (3)(b) of Schedule-V (Procedure for Inspectors) read with section 19(3)(ii) of Drugs Act, 1976 excluding the sealed portion of samples of said drug of the firm.

4. The Division of Pharmaceuticals Evaluation and Registration (PE&R) was also requested to verify the status of registrations of the drugs mentioned at para [1]. The Division of PE & R has informed that all the drugs mentioned on Form-3 are un-registered as per their official record.

5. The Federal Government Analyst, Central Drugs Laboratory Karachi, under section 22 (2) of the Drugs Act, 1976 and rules framed there under sent the test reports of the drugs mentioned on Form-3 as below:-

Sample. No

Name of Drug & Batch No.

Manufacturer Remarks on the test report with its number, Date

Violations

01-FID-I/2018

Ever Strong TabletsBatch No. 055Reg. No. 070250Mfg. Date: NilExp. Date 02/20

M/s. Everest Pharmaceuticals, Plot No. 124, Industrial triangle, Kahuta Road, Islamabad..

“Un-Registered Drug Product”R.IP.30/2018Dated 22nd

March 2018

Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under.

02-FID-I/2018

Levonag Tablets.Batch No. 301Reg No. 032726Mfg. Date: Nil

-do- “Un-Registered Drug Product”R.IP.31/2018Dated 20th

March 2018

Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976

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Exp. Date: 09/19

and rules framed there under.

03-FID-I/2018

Imcob Tablets.Batch No. 421Reg No. 072015Mfg. Date: NilExp. Date: 11/19

-do- “Un-Registered Drug Product”R.IP.32/2018Dated 20th

March 2018


04-FID-I/2018

EverFlox SuspensionBatch No. 064Reg No. 070150Mfg. Date: 2/18Exp. Date: 02/20

-do- “Un-Registered Drug Product”R.IP.33/2018Dated 20th March 2018


05-FID-I/2018

Cardol Tablets.Batch No. 054Reg No. 072074Mfg. Date: NilExp. Date: 02/20

-do- “Un-Registered & Spurious Drug Product”R.IP.34/2018Dated 21st

March 2018

Schedule-II A(1)(a)(vii) and A(1)(a)(i) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) and (1)(a)(i) of Drugs Act, 1976 and rules framed there under.

06-FID-I/2018

Biotriol Oral Solution.Batch No. 444Reg No. 070078Mfg. Date: 12/16Exp. Date: 12/18

-do- “Un-Registered Drug Product”R.IP.35/2018Dated 22nd

March 2018

Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under

07-FID-I/2018

M Plus Tablets.Batch No. 332Reg No. 068787Mfg. Date: NilExp. Date: 10/19

-do- “Un-Registered Drug Product”R.IP.36/2018Dated 22nd March 2018


08-FID-I/2018

Everchol Tablets.Batch No. 062Reg No. 063289

-do- “Un-Registered & Sub-Standard Drug Product”R.IP.37/2018Dated 21st

Schedule-II A (1)(a)(vii) and (v) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) and

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Mfg. Date: NilExp. Date: 2/20

March 2018 (v) of Drugs Act, 1976 and rules framed there under

09-FID-I/2018

Lexidex-M Tablets.Batch No. 060Reg No. 068872Mfg. Date: NilExp. Date: 2/20

-do- “Un-Registered Drug Product”R.IP.38/2018Dated 20th March 2018


6. Keeping in view of the test reports of Federal Government Analyst, Central Drugs Laboratory, Karachi the M/s Everest Pharmaceuticals, Islamabad have been found involved in manufacturing/selling of spurious, un-registered & sub-standered drugs and violated Schedule-II A (1)(a)(i), (v) and (vii) of DRAP Act, 2012 read with Section 23 (1)(a) (i), (v) and (vii) of Drugs Act, 1976 and rules framed there under and also volited Schedule-III (OFFENCE) Section -3 of DRAP Act 2012 read with Section 27 (3) of Drug Act 1976 (disobeys the lawful authority of any Inspector) and rules framed there under.

7. Dr. Hafsa Karam Elhi Additional Director QA&LT requested for launching FIR, the competient Authority i.e Director QA&LT DRAP-Islamabad granted the permission to launch FIR aganist following accused persons of M/s. Everest Pharmaceuticals 124, Indstrial Triangle, Kahuta Road islamabad responsible for manufacturing and selling of un-registered drugs and import/smuggling of active pharmaceutical ingredients without import license and clearance from DRAP, Islamabad.:

i. Ch. Muhammad Usman, ii. Dr. Kamran Izhaar, iii. Noor Muhammad Mehr, iv. Ch. Muhammad Usman, Production In-Charge and v. Muhammad Ishtiaq QC Incharge and other

09. That the FGA declared the samples as unregistered, Spurious and substandard vide test/analysis reports as per details below. The actives of the products are also mentioned:

Sr. No

Name of brand product

Name of drug

Batch no.

Manufacturer name

Report number

Remarks

1 Cardol tablet

Calcium and carbonate

054 M/s Everest Pharmaceuticals, Islamabad.

R.IP.34/2018dated: 21st

March, 2018

Un-registered and spurious

2 Levonag 250mg tablets

Levofloxacin 301 M/s Everest Pharmaceuticals, Islamabad.

R.IP.31/2018 dated: 20th

March, 2018

Un-registered

3 Imcob Mecobalamin 421 M/s Everest R.IP.32/201 Un- of 150

1000mcg tablets

Pharmaceuticals, Islamabad.

8dated: 20th

March, 2018

registered

4. Everflox suspension

Levofloxacin and Metronidazole benzoate



March, 2018

Un-registered

5. Lexidex-M tablets

Montelukast sodium and Loratadine



March, 2018

Un-registered

6. Everchol Tablets

Mecobalamin and Cholcalciferol


R.IP.37/2018 dated: 21st

March, 2018

Un-registered and Substandard

07. M Plus tablets

Montelukast 332 M/s Everest Pharmaceuticals, Islamabad

R.IP.36/2018 dated: 22nd

March, 2018


08. Everestrong Tablets

Calcium Carbonate

055 M/s Everest Pharmaceuticals, Islamabad


March, 2018


09. Biotriol Oral Solution

444 M/s Everest Pharmaceuticals, Islamabad


March, 2018


11. That M/s Everest Pharmaceuticals owners and technical qualified personnel have violated the provisions of schedule II and schedule III by manufacturing unregistered, spurious and substandard drugs. It is also pertinent that some raw materials were imported without import license and clearance from the DRAP as prescribed under the Drug Act 1976, DRAP Act 2012 and drugs import and export rules 1976.

12. The FID has requested for the grant of registration of FIR against the following accused persons:-




Islamabad 6. Muhammad Istiaq QC Incharge, M/s Everest Pharmaceuticals Islamabad

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“Decision of the Case:-

A. Permission for registration of FIR was granted against the following accused persons





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

Islamabad

B. The accused persons are involved in contraventions of the provisions of schedule-II and schedule III of DRAP Act 2012 by as under:-

j. Manufacturing of unregistered drug products.

ii. Manufacturing of spurious drug products.

iii. Manufacturing of substandard drugs.

iv. Import and usage of raw materials without import license and clearance from the DRAP as prescribed under the Drug Act 1976, DRAP Act 2012.

v. Disobeyed the lawful authority of any Inspector

vi. Drug Import Export Rules 1976.

C. The FID shall lodge FIR under schedule- IV of the DRAP Act 2012 and resubmit the complete case before the CLB after completion of investigations under the law.

Case No. 11 Manufacture & Sale of Un registered, Adulterated and Sub-Standard Veterinary drugs purported to be manufactured by M/S Honestan Pharma, Karachi. (unlicensed and imported by SALROZ Pharma mfg by Hebei New Century Pharmaceutical ltd China.

FID VII Karachi visited the premises of M/s Al-Azim Medical Store Karachi alongwith Dr. Abdul Rasool Shaikh FID and Dr. Shoaib Ahmed FID on 25 th October 2017 and took samples for test analysis and sent to the CDL, Karachi. The following test reports No.R.KQ.593/2017 (initial) dated 10th November 2017, R.KQ.595/2017 (initial) dated 10th

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November 2017 and KQ. 626/2017 (initial) dated 17 th November 2017 from the Federal Government Analyst, CDL, Karachi. Wherein, the Federal Government Analyst has declared samples of;02. The details of the contraventions and test reports as under:-

Mr. Zaheer Ahmed s/o Muhammad Yaseen proprietor AL-Azim medical store plot No. A12-37 commercial area road No.6 cattle colony landhi Karachi, failed to produce invoice warranties of the above mentioned products despite notices by the area FID.

The FID therefore decalred that mr. Zaheer Ahmed s/o Muhammad yaseen proprietor Al Azim medical store and mehboob ali ismaili s/o Ameer Ali Qualified person are responsible for the offences.

Permission for Lodging of FIR

It is therefore submitted that permission for registration of FIR against the above mentioned accused persons may be granted for manufacturing, importing and selling of unregistered, Adulterated and substandard drugs products without valid manufacturing and import licenses as well as purchasing without valid warranty.


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Drug Name Batch No.

Reg. No. Test result Manufacturer/importer name

Vitamin AD3E Injection

20170415

Nil Un registered test report no. RKQ 592/2017 dated 22-12-2017

Imported by SALROZ pharma mfg by Hebei New Century Pharmaceutical ltd China

Oligovit injection

20170414

Nil Un registered test report R.KQ 594/2017 dated 22-12-2017

-do-

Mouthnil Injection

Mn25 198300Fake registration no. PE&R Division do not verify this registration no.

Adulterated and substandard test report no. RKQ 595/2017 dated 13th November 2017

Honestan Pharma,Karachi not licensed by the

DRAP

Diconil-50 plus Injection

Nil Nil without valid registration

Adulterated and substandard test report RKQ 593/2107 dated 12th December 2017

-do-

A. The Central licensing Board after examination of the facts of the case and investigation report granted the permission for registration of FIR against the following accused persons:-

1. Zaheer Ahmed s/o Muhammad Yaseen proprietor AL-Azim medical store plot No. A12-37 commercial area road No.6 cattle colony landhi Karachi, failed to produce invoice warranties of the above mentioned products despite notices by the area FID.

2. Mehboob Ali Ismaili s/o Ameer Ali Qualified person Al Azim medical store plot No. A12-37 commercial area road No.6 cattle colony landhi Karachi are responsible for the offences.

B. The accused persons have contravened schedule-II prohibitions which are offence under schedule III of DRAP Act 2012.

a. Manufacturing and selling of unregistered drugs.b. Manufacturing and selling of Adulterated and substandard drugs.c. Manufacturing of drugs without DML.d. Import of drugs without valid manufacturing and import

license/clearance.e. Failure to produce warranty as a source of purchase of drugs as

prescribed under the law.

Case No.12. Extension and Sealing period of M/s Everest Pharmaceuticals, Islamabad.

The premises of M/s Everest Pharmaceuticals 124 Islamabad was sealed by Additional Director QA/LT, DRAP, Islamabad on 06-03-2018. The Central licensing Board extended the sealing period upto 90 days in its 258 th meeting held on 09th March 2018. Now the following decisions have also been made by the Central Licensing Board and Drug Registration Board.

1. That manufacturing License of the firm has been cancelled.2. That Product registrations of the firm has been cancelled.3. That huge quantities of raw materials of 167 were also sealed within the

premises.4. A number of FIRs have been registered against the M/s Everest pharmaceutical

Islamabad for manufacturing unregistered, spurious and substandard drugs.It is therefore submitted that sealing period may be extended till the finalization of the case of the firm.

“Decision of the Case:-The Central Licensing Board deferred the case to be discussed in the next meeting of CLB.

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Case No. 13: Seizure of un registered Drugs under Section 18(1) of the Drug Act 1976. Raid on M/s Mahmood Pharmacy S-77-R/85/C, Jail Road, Opposite Services Hospital Lahore.

01. The FID Lahore Mr. Syed Zia Husnain visited the premises of M/s Mahmood Pharmacy S-77-R/85/C, Jail Road, opposite Services Hospital Lahore on 26 th August, 2016. The FID forwarded the case to the Director, QA&LT, DRAP, Islamabad vide letter No.12406/2016-DRAP (L-V) dated 29th August, 2016.

02. At the time of raid Mr. Sana ullah S/o Muhammad Suleman R/o H. No.05 St. No.05, mohallah Amin park Ravi road Lahore who is manger was present. Mr. Atif Ejaz S/o Ejaz pervaz R/o 67/C Punjab Co-operative housing Society, defense Lahore (Qualified person as per drug sale license ) was gone for jumma prayer as informed by the manager Mr. Daud Tareen s/o Muhammad Aslam Tareen R/o B-42, GOR-III Shadman, Lahore (Proprietor) was absent. 03. The FID Lahore seized the following drugs on form-2 under section 18 (1) (f) of Drug Act, 1976:

S. No. Name Of Product(s)

Batch/Lot No.

Mfg Data

Exp. Date

Manufactured by

Quantity

01. Marevan 5mg Tablets

A520518 11-15 05-18 Mfd By. GSK (Detail address not mentioned in English)

(13) Thirteen jars


A521058 03-16 09-16 -do- (11) Eleven jars


A520917 02-16 08-18 -do- (04) Four jars


A520916 02-16 08-18 -do- (15) Fifteen jars


A520917 02-16 08-18 -do- (03) Three jars

06. Centrum Silver

M25939 - Sep-17 Marked by. Pfizer Madison, NJ07940 USA 2015 Pfizer Inc Made in Canada

(03) Three Packs

07. Centrum Silver

M87735 - Dec-17 2014 Pfizer Inc Made in Canada

(02) Two Packs

08. Centrum Silver

N43989 - 01-18 2014 Pfizer Inc marked by M/s Pfizer

(02) Two Jars

of 150

Madison, NJ07940

09. Colomycin Injection

11393 10-2014 10-2017 M/s Forest Laboratories UK, Ltd, Whiddon Valley, Branstaple, North Devon Ex 32 8NS, United Kingdom.

02 Packs×10

Vials

10. Viagra 100mg Tablets

MALL 19990544G

Dec-2013

01-Apr-2018

Mfd by. Brooklyn, Ne Packed by: Pfizer Ply Ltd, Australia

(03) Three Packs× 06 Tablets

11. Cialis 20mg Tablets

Control No. 0674654099

-April-04/2018

Made in USA (02) Two Packs× 03 Tablets

12. Centrum Tablets

M877733 - Dec-17 Mfd. Pfizer Inc. Canada

(02) Packs

13. Neurobion Injection

213371 12-2015 112017 Mfd. Merck kGaA, Darmstadt, Germany

(03) Three Packs

14. Pirfenex 200mg Tablets

BA60218 Dec-15 Nov-17 Mfd. Cipla Malpur, Solan 173205 India

(01) One Pack

04. The FID seized these unregistered drugs in contravention to section 23 of Drugs Act, 1976 and also contravention to DRAP Act, 2012 and the room was locked and sealed under section 18 (i) (h) of Drugs Act, 1976.

05. Samples of drugs which were available in sufficient quantities were also sent to Federal Government Analyst for test/ analysis.

06. The details of test/analysis results of said drugs by Federal Government Analyst, Central Drug Laboratory are as under:-

S.No.

Test Report No.& date

Name of Drug with batch No.

Mfg by Remarks of CDL

1. Test Report No. R.LHR.403/2016 dated 01-11-2016

Marevan 5mg Tablets Batch No.A521058

M/s GSK Declared Unregistered report no.R.LHR.403/2016 dated 01-11-2016


Centrum Sliver Batch No.M30477

M/s Pfizer Inch, Canada

Declared Unregistered report

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no.R.LHR.404/2016 dated 01-11-2016


Cialis 20mg Batch No.0674654099

M/s GSK Declared Unregistered test report no. R.LHR.405/2016 dated 02-11-2016


Pirfenex Tablets Batch No.BA60218

M/s Cipla Ltd India

Drug is not included in any Pharmacopoeia, test report no. R.LHR.406/2016, dated 02-11-2016

07. The FID requested to allow to keep the safe custody of the seized drugs mentioned on Form-2 under Section 19(5) of the Drug Act 1976 as the firm is involved in illegal and unregistered manufacturing of drugs.08. Permission of safe custody of the stock was granted to the FID on 16 th September 2016. Meanwhile M/s Mehmood Pharmacy S-77-R/85/C, Jail Road Opposite Services Hospital Lahore filed application in the Drug Court, Lahore in connection with case under reference. On the order of Drug Court Lahore, premises (room) under reference was de-sealed on 17-11-2016.

Findings:-Since the sale and stock of un registered drugs in prohibited under section 23 (1) and section A(1) (a)(vii) of schedule II of Drugs Regulatory Authority of Pakistan Act 2012 which is punishable under section 27(1) (A) of the Drug Act 1976 and schedule III of DRAP Act 2012. Sale of un-registered drug is cognizable offence under section 30(2) of the Drug Act 1976 and schedule IV(1) (a) of Drug regulatory authority of Pakistan Act 2012. As pharmacy is not explaining its position in response to the letters of FID. The FID further informed that all four reports of Federal Government Analyst have also been received, therefore under the explained circumstances mentioned above case is being forwarded under section 19(7) of Drugs Act, 1976 and section 7 of schedule V of Drugs Regulatory Authority of Pakistan Act 2012 to seek further orders of central licensing Board as to action to be taken against the following accused persons in respect of contravention of Drug Act 1976 and Drug Regulatory Authority of Pakistan Act 2012. 09. The Show cause notice was issued to the following accused persons on 25 th

January 2017.

M/s. Mehmood Pharmacy S-77-R/85/C, Jail road, Opposite Services Hospital, Lahore through its proprietor Mr. Daud Khan Tareen S/O M Aslam Tareen R/OB-42, GOR-III, Shadman, Lahore

Mr. Sana Ullah S/O M SulemanHouse No. 05, Street No.05Mohellah Amin Park Ravi Road, Lahore

Mr. Atif Ejaz S/O Ejaz Perves R/O67/C Punjab Co-Operative Housing Society Defense Lahore.

Mr. Daud Tareen S/O M Aslam Tareen R/OB-42, GOR-III, Shadman, Lahore(Proprietor).

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10. Permission For FIR against the following accused persons may be granted to the FID Lahore For selling un registered drugs in violation to the Drug Act 1976 and DRAP Act 2012:-

i. Mr. Sana Ullah S/O M SulemanHouse No. 05, Street No.05Mohellah Amin Park Ravi Road, Lahore.

ii. Mr. Atif Ejaz S/O Ejaz Perves R/O67/CPunjab Co-Operative Housing Society Defense,Lahore.

iii. Mr. Daud Tareen S/O M Aslam Tareen R/OB-42, GOR-III, Shadman, Lahore (Proprietor).

“Decision of the Case:-A. The Central Licensing Board examined/evaluated the facts of the case in the light of investigations conducted by the FIDs and Quality Assurance Division and decided to grant permission for registration of FIR against the following accused persons:-

M/s. Mehmood Pharmacy S-77-R/85/C, Jail road, Opposite Services Hospital, Lahore through its proprietor Mr. Daud Khan Tareen S/O M Aslam Tareen R/O B-42, GOR-III, Shadman, Lahore

Mr. Sana Ullah S/O M SulemanHouse No. 05, Street No.05Mohellah Amin Park Ravi Road, Lahore

Mr. Atif Ejaz S/O Ejaz Perves R/O67/C Punjab Co-Operative Housing Society Defense Lahore.

Mr. Daud Tareen S/O M Aslam Tareen R/O B-42, GOR-III, Shadman, Lahore(Proprietor).

B. The accused persons are involved in contraventions of the provision of schedule-II and schedule-III of the DRAP Act 2012 as under:-

I. Sale of un registered drugs ii. Sale of drugs without warranty.iii. Manufacturing/import without authorization from the DRAP.

C. The offence is punishable under section 1 (a) and para (4) (contraventions of rules) of schedule-III of DRAP Act 2012.

Case No. 14: Seizure of un registered Drugs under Section 18(1) of the Drug Act 1976. Raid on M/s. Mehmood Pharmacy, Metro habib

Cash and Carry, Multan Road, Lahore.

01. That Mr. Ajmal Sohail Asif, FID-Lahore, raided and inspected M/s. Mehmood Pharmacy, Metro habib Cash and Carry, Multan road, Lahore on 03.01.2017 at about

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11:00 am along with FID Miss Ayesha Irfan, FID Mr. Zia Husnain and FID Mr. Abdul Rashid Sheikh.

02. That At the time of raid, Proprietor of the pharmacy namely Muhammad Zeeshan S/o Muhammad Arjumand Mehmood and Qualified Person namely Ms. Amna Riaz D/o Muhammad Riaz were absent. However, a person namely Haseeb Ahmed was present, who told to be the employee of the pharmacy.

03. That During inspection huge quantity of un-registered (smuggled/ unwarranted) drugs including different brands of sexual drugs and many other branded drugs were found at the pharmacy. Some of the quantities of these drugs were seized on form-2, under section 18 (1) (f) of the Drugs Act, 1976 as per following detail:

04. That All of the above drugs were recovered and seized on Form-2 in the presence of

Haseeb Ahmed, employee of the Pharmacy (Person present), Mr. Zia husnain FID, Mr. Abdul Rashid Sheikh FID and Mr. Faraz, Floor manager of Metro-Habib Cash & Carry. The witnesses were recorded on Form-2.

05. That After the seizure of above said drugs the premises comprising a room was sealed under section 18(1) (h) in front of above mentioned witnesses. The Copy of Form-2 along with sealed keys was handed over to Mr. Haseeb Ahmed S/o Tanvir Ahmed (Person present, employee of pharmacy).

06. That the Person present was asked to provide the invoices/warranties of above mentioned drugs or to explain their position by FID that why they were selling these drugs in violation of provisions of the DRAP Act, 2012.But he did not provide any document (invoices/ warranties) and said that owner may have the requisite documents.

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Sr.#

Names of therapeutic goods Quantity

1. Levitra 20mg tablets, Mfd. By Bayer AG Germany 06 packs × 04 tablets2. Viagra tablets 100mg, Mfd. By Pfizer France 01 pack × 04 tablets3. Cialis 20mg tablets, Mfd. By EliLilly UK 15 packs × 02 tablets4. Penegra tablets 100mg, Mfd. By Cadila Healthcare India 05 packs × 04 tablets5. Eltroxin tablets 50 mg, Mfd. By GSK Germany 18 packs6. Eltroxin tablets 100 mg, Mfd. By GSK Germany 06 packs7. Amaryl 03 mg tablets, Mfd. By Sanofi 07 packs × 30 tablets8. Amaryl 02 mg tablets, Mfd. By Sanofi 09 packs × 30 tablets9. Furolin tablets 30 mg, MFD. BY IASIS Pharma Cyprus 02 packs × 30 tablets10. Lipitor 20mg tablets, Mfd. By Pfizer, Istanbul, Turkey 02 packs × 30 tablets11. Lipitor 10mg tablets, Mfd. By Pfizer, Istanbul, Turkey 13 packs × 30 tablets12. Plaquenil 200 mg tablets, Mfd. By Sanofi Istanbul, Turkey 02 packs × 30 tablets13. Roaccutane capsule 20mg, Mfd. By Roche 01 pack × 30 tablets14. CellCept 500 mg capsule, Mfd. By Roche 01 pack × 50

capsules15. Emla Cream 5%, Mfd. By AstraZeneca UK 03 packs × 5 gm16. Centrum Silver tablets (Men), Mfd. By Pfizer Canada 05 packs17. Centrum Silver tablets (Adults), Mfd. By Pfizer USA 06 packs18. Centrum Silver tablets (Women), Mfd. By Pfizer USA 04 packs19. Centrum vlaue tablets (Adults), Mfd. By Pfizer USA 04 packs20. One A Day tablets (Men), Mfd. By Bayer USA 01 packs21. Infacol Oral Suspension, Mfd/Mktd. By Forest Labs UK 10 packs

07. That Accused persons were served a show cause notice vide office letter No. 6-9/2016-FID (F) dated 06-01-2017 and were directed to provide the invoices/ warranties of seized drugs if any and to explain their position that why they were stocking & selling un-registered drugs. They were also directed to attend the office of the FID for recording of statement regarding the case on 13-01-2017, but neither they did not submit any invoice / warranty regarding the seized drugs nor they attended the office of the undersigned. Two reminders were sent by FID dated 23-02-2017 and 28-03-2017 but no reply has been received.

08. That the FID requested to grant permission for safe custody of seized drugs and to keep the premises sealed till the decision of the case. Permission of safe custody of the stock and to keep the premises sealed till decision of the case was granted to the FID on 17th February, 2017. Meanwhile the accused filed a petition in the Honorable Drug Court for de-sealing of the premises. The Honorable Court ordered to de-seal the premises on 11-01-2017, which was accordingly de-sealed on 17-01-2017.

09. Findings:

The FID Lahore requested that either the permission for prosecution of the accused person may be granted or if Honorable Board requires further investigation in the case permission for lodging FIR against the accused persons may be granted as the accused persons have nothing to say in their defense and were involved in the stocking and selling of unregistered/ unwarranted drugs. Since sale and storage of Un- registered/ Unwarranted drugs is prohibited under Section A(1) (a) & A (1) (i) of Schedule-II of the DRAP Act, 2012 read with Section 23 of the Drug Act, 1976 punishable under Schedule-III of the DRAP Act 2012 read with section 27 of the Drug Act, 1976 and is cognizable offence under Section (1)(a) of Schedule-IV of the DRAP Act, 2012 read with Section 30(1)(a) of the Drug Act, 1976 as to the action to be taken in respect of contraventions of the Act as mentioned above.

10. Permission For FIR against the following accused persons may be granted to the FID Lahore For selling un registered drugs in violation to the Drug Act 1976 and DRAP Act 2012:-

i M/s Mehmood Pharmacy, through Mr. Muhammad Zeeshan (Proprietor) S/o Muhammad Arjumand Mahmood, M/s. Mehmood Pharmacy, Inside Metro Habib Cash and Carry, Thokar Niaz Baig, Multan road, Lahore. Resident of house No.92 army Housing Scheme Defence, Lahore.

ii. Mr. Muhammad Zeeshan (Proprietor) S/o Muhammad Arjumand Mahmood, M/s. Mehmood Pharmacy, Inside Metro Habib Cash and Carry, Thokar Niaz Baig, Multan road, Lahore. Resident of house No.92 army Housing Scheme Defence, Lahore.

ii. Mr. Matee Ur Rehman (Salesman) S/o Tanvir Ahmed, Resident of House No. 254-C, Sabza Zar Scheme, Lahore.

iii. Mr. Haseeb Ahmed (person present at the time of raid) S/o Tanvir Ahmed. Resident of House No. 254-C, Sabza Zar Scheme, Lahore.


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The Central Licensing Board examined/evaluated the facts of the case in the light of investigations conducted by the FIDs and Quality Assurance Division and decided to grant permission for registration of FIR against the following accused persons:-

A. M/s Mehmood Pharmacy, through Mr. Muhammad Zeeshan (Proprietor) S/o Muhammad Arjumand Mahmood, M/s. Mehmood Pharmacy, Inside Metro Habib Cash and Carry, Thokar Niaz Baig, Multan road, Lahore. Resident of house No.92 army Housing Scheme Defence, Lahore.

B. Mr. Muhammad Zeeshan (Proprietor) S/o Muhammad Arjumand Mahmood, M/s. Mehmood Pharmacy, Inside Metro Habib Cash and Carry, Thokar Niaz Baig, Multan road, Lahore. Resident of house No.92 army Housing Scheme Defence, Lahore.

C. Mr. Matee Ur Rehman (Salesman) S/o Tanvir Ahmed, Resident of House No. 254-C, Sabza Zar Scheme, Lahore.

D. Mr. Haseeb Ahmed (person present at the time of raid) S/o Tanvir Ahmed. Resident of House No. 254-C, Sabza Zar Scheme, Lahore.

The accused persons are involved in contraventions of the provision of schedule-II and schedule-III of the DRAP Act 2012 as under:-

i. Sale of un registered drugs ii. Sale of drugs without warranty.iii. Manufacturing/import without authorization from the DRAP.

The offence is punishable under section 1 (a) and para (4) (contraventions of rules) of schedule-III of DRAP Act 2012.

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Case No. 15 Illegal/ Unauthorized Sale of Un-registered/ Alternative Medicine Raid on M/s. Mehmood Pharmacy, Property No. S-36-R-2(D),/2, Chowk Mayo Hospital, Lahore.

FID Lahore-V, Mrs. Aisha Irfan visited the premises of M/s. Mehmood Pharmacy,

Property No. S-36-R-2(D),/2,Chowk Mayo Hospital, Lahore on 30-01-2017 alongwith Mr. Abdul Rashid Sheikh, Federal Inspector Of Drugs, Lahore-I and Rana Ihsan ul Haq Athar, Assistant Drugs Controller, DRAP, Lahore and send the case vide letter No.1548/2017-DRAP (L-V) dated 31-01-2017.02. FID informed that she seized the products at Sr. No. 01 being unregistered/ smuggled and the products at Sr. No. 02-05 are being sold without enlistment on Form-7 in violation to SRO 412(1)/2014, of Schedule-II of DRAP Act, 2012 and sections 23 and 27 of Drugs Act, 1976. Qualified person was also not present at the time of inspection. The Drugs were seized in the presence of Mr. Saqib Maqsood, (preson present)/ Incharge Mehmood Pharmacy, chowk Mayo Hospital, Lahore.

Sr. No. Name Of Products/ Batch No.

Date Of Mfg.

Date Of Exp.

Manufactured By

Quantity

01. MyDacla 60 (Daclatasavir Dihydrochloride) Tablets 60 mg/ MYDA 16020

09-2016 08-2018 M/s Natco Pharma Limited Kokjhar, Mirza Garru Bazar, District Kamrup Guwahati India.

28 Tablets

02. Alopia 004 02-2016 03-2020 Nil 11 Packs

03. Alopia Hair Food 004

02-2016 Use Within 03 Years

Nil 07 Packs

04. Alopia Hair Food Plus 004


Nil 02 Packs

05. Alopia Hair Loss Solution 002


M/s Primose 293 A-1, Gulberg-III, Lahore.

05 Packs

03. The FID requested to grant the permission to keep the seized stock in safe custody of drugs mentioned on Form-2 till decision of the case under Section 19(5) of the Drug Act, 1976. The permission for safe custody has been granted on 17th February, 2017.

04. FID Lahore-V, Mrs. Aisha Irfan forwarded the complete case vide reference letter No.5533/2017-DRAP (L-V) dated 26th April, 2017.

05. Findings:FID recommended that the sale of Un-registered drugs prohibited under Section 23 of the Drugs Act, 1976 read with section A(1) (a) (vii) of Schedule-II of the DRAP Act, 2012 which

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is punishable under Section 27 of the Drugs Act, 1976 read with section (1) (a) of Schedule-III of the DRAP Act, 2012, therefore the case may be placed before the central Licensing Board. 06. Permission For FIR against the following accused persons may be granted to the FID Lahore For selling un registered drugs in violation to the Drug Act 1976 and DRAP Act 2012:-

i. M/s Mehmood Pharmacy through Mr. Arjumand maqsood.ii. Mr. Saqib Maqsood, person present/ incharge Mehmood Pharmacy, R/O

House No.07, street No.98, Kocha Mehar Faizan Main Bazar Mozang, Lahore.

ii. Muhammad Arjumand Maqsood R/o House No.92, Army Housing Society, Defense, Lahore.

iii. Ms. Anem Saeed Qualified person, R/o House No.92 Street No.117, Nisbat Road, Lahore.

“Decision of the Case:-The Central Licensing Board examined/evaluated the facts of the case in the light of

investigations conducted by the FIDs and Quality Assurance Division and decided to grant permission for registration of FIR against the following accused persons:-

i. M/s Mehmood Pharmacy through Mr. Arjumand maqsood.ii. Mr. Saqib Maqsood, person present/ incharge Mehmood Pharmacy,

R/O House No.07, street No.98, Kocha Mehar Faizan Main Bazar Mozang, Lahore.

ii. Muhammad Arjumand Maqsood R/o House No.92, Army Housing Society, Defense, Lahore.

iii. Ms. Anem Saeed Qualified person, R/o House No.92 Street No.117, Nisbat Road, Lahore

The accused persons are involved in contraventions of the provision of schedule-II and schedule-III of the DRAP Act 2012 as under:-

i. Sale of un registered drugs/therapeutic goodsii. Sale of drugs without warranty.iii. Manufacturing/import without authorization from the DRAP.

The offence is punishable under section 1 (a) and para (4) (contraventions of rules) of schedule-III of DRAP Act 2012.

Case No.16 Handing Over The Keys of Sealed premises of M/s Everest Pharmaceuticasl Plot No. 124 Industrial Triangle Khautta Road Islamabad (Case No.FIR No.05/2018 of FIA ACC Islamabad.

Additional Director QA/LT has informed that reference to the decision of the CLB in its 258th meeting held on 08-03-2018, Director FIA Islamabad Zone was requested to indicate to suitable time and date for handing over the keys as per decision. The Director FIA has informed through its correspondence dated 16-03-2018 that power of seizures and sealed

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are given to the Inspector of Drugs and FID is responsible for the production of case property in the Court. FIA has neither seized the material in question nor seal the premises of M/s Everest Pharmaceuticasl Islamabad. On the directions of district Administration AC rural proper guard of police station Sihala as already been deputed for security on the premises In the light of above the keys of premises of M/s Everest Pharmaceuticals Islamabad be handed over to the concerned FID to produced the seized materials before the competent Court for prosecution


The Central Licensing Board decided that the keys of the said premises shall be handed over to the area FID.

Case No.17Manufacture & Sale of Sub-Standard Drugs by M/S Standard Drug Company, Hyderabad. –Recommendation of Cancellation of Drug Manufacturing License (DML) of 12 Samples of M/S Standard Drug Company, Hyderabad, “Under Section 41 of Drugs Act, 1976”.

It is submitted that 12 samples of drugs Manufactured by M/s Standard Drug Company, Hyderabad drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, were declared Substandard by CDL Karachi. On explanation letter issued by the FID, the firm challenged the CDL reports and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the 12 samples as Substandard.

The 255th meeting of DRBProceeding:

Mr Imtiaz Ahmed (Managing Director/Partner) appeared on the behalf of the firm and defended the case The Case placed before the Central Licensing Board on recommendations of Registration Board in its 255th meeting held on17-18th December 2015

The Registration Board decided to cancel the registration of following twelve (12) products of M/s Standard Drug Company Hyderabad and recommended the Central Licensing Board for cancellation of DML of M/s Standard Drug Company Hyderabad as 12 samples drugs product of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate Lab NIH Islamabad

Details of Drugs declared Substandard by Both the Labs:S.No. Name of the Product

Batch No. & M/sRemarks Decision of DRB in its

255th meeting held on 17-18th December 2015

1. Netrozole (Metronidazole) Suspension Batch No.NZ10-A M/s

Substandard (CDL/NIH)

“The Board decided to Cancel the registration of Netrozol Suspension Batch No.

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Standard Drug Company Hyderabad (Reg. No. 057829 )

NZ 10-A Reg. No. 057829 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as many samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

2. Netrozole (Metrinidazole) Suspension Batch No.NZ.08-A M/s Standard Drug Company Hyderabad (Reg. No. 057829)


“The Board decided to Cancel the registration of Netrozol Suspension Batch No. 08-A Reg. No. 057829 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

3. Staifaminc(Mefanimic Acid) Suspension Batch No.SF.07A M/s Standard Drug Company Hyderabad (Reg. No. 057826)


“The Board decided to Cancel the registration of Staifaminc Suspension Reg. No. 057826 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

6. Rheudic-50 Tablets (Diclofenic Sodium) Batch No.RD.04-A M/s Standard Drug


“The Board decided to Cancel the registration of Rheudic-50 Tablets Reg. No.066939 and

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Company Hyderabad Reg. No.066939

decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

7. Sodamint Tablets (Sodium Bicarbonate) Batch No. SM.09-A M/s Standard Drug Company Hyderabad (Reg. No.008879)


“The Board decided to Cancel the registration of Sodamint Tablets Reg. No.008879 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

8. Staiflic Tablets (Folic Acid) Batch No.SF.03-A M/s Standard Drug Company Hyderabad Reg. No.57828


The Board decided to Cancel the registration of Staiflic Tablets (Folic Acid) Reg. No.57828 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

9. Montilu 10mg Tablets (Montilukast Sodium) Batch No.B01A M/s Standard Drug Company Hyderabad


The Board decided to Cancel the registration of Montilu 10 mg Tablets (Mountelukast Sodium) Reg. No.067688 and

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Reg. No.067688 decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

10. Stabru Suspension (Ibuprofen) Batch No.SB.22A M/s Standard Drug Company Hyderabad Reg. No.057827


The Board decided to Cancel the registration of Stabru Suspension Ibuprofen Reg. No.057827 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

11. Stamelox 15mg Tablets (Meloxicam) Batch No.SA01-A M/s Standard Drug Company Hyderabad Reg. No.067648

Substandard (CDL/NIH) The Board decided to

Cancel the registration of Stamelox 15 mg Tablets (Meloxicam) Reg. No.067648 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

12. Standlo 500mg Tablets (Levofloxacine) Batch No.SO-03-A M/s Standard Drug Company Hyderabad Reg. No.066934


“The Board decided to Cancel the registration of Standlo 500mg Tablets (Levofloxicine) Reg. No.066934 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the

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Labs i.e. CDL Karachi and Appellate NIH Islamabad

M/s Standard Drug Company Hyderabad has filed Constitutional Petition No.971 of 2016 (MA 6205/2016) through Mr. Imtiaz Ahmed Vs Federation of Pakistan in the High Court of Sindh, Karachi, Circuit Court, Hyderabad against the decision of the Drug Registration Board in its 255th meeting held on 17-18th December 2015for cancellation of registration of twelve registered products of M/s Standard Drug Company Hyderabad. However no directions for Central Licensing Board have been received from Honorable Sindh High Court Karachi, Circuit Court, Hyderabad.

The FID Hyderabad at Karachi vide his letter No.10-02-2016-DRAP(K) dated 01-08-2016 has requested to send the Parawise comments and appointment of Standing Council. Parawise comments and nomination of standing council are under processed/approval in the Division of legal Affairs, DRAP, Islamabad.Decision:

The Board after detailed discussion, deliberation, considering the facts and legal provisions decided as under:“The Board decided to issue show cause notice for cancellation of DML of the firm M/s Standard Drug Company Hyderabad as recommended by Registration Board in its 255th meeting held on 17-18th December 2015”. As per decision of the Central Licensing Board in its 250th meeting held on 27th October, 2016 the firm was issued a show cause notice for cancellation of Drug Manufacturing License (DML). The firm has submitted its reply in response to show cause notice regarding cancellation of Drug Manufacturing License (DML) as 12 samples of the said firm has been declared substandard by both the Laboratories. The M/s Standard drug company Hyderabad has filed constitution petition in the High Court of Sindh Circuit Bench at Hyderabad vide C.P. D-971/16 which is graciously being dismissed. The judgment of the Honorable High Court Sindh dated 13-02-2017 is as under:-

“the impugned orders are within the jurisdiction as such extraordinary remedy may be pursued/availed by the petitioner. Accordingly, petition is dismissed. Parties shall bear their own costs. However it is clarified that in order to redress his grievance the petitioner may adopt appropriate remedy available to him under the relevant law which shall be dealt with strictly in accordance with law”

They have requested for personal hearing before the Central Licensing Board.They have been called for personal hearing.Proceedings:

Personal hearing letters were issued to the accused persons of the firm but no person appeared before the board. The board was informed that the letter has been received from the Managing Director of the firm; Mr. Imtiaz Ahmad dated 14th March, 2017. He submitted that He is unable to attend the meeting as He is suffering from high fever due to which doctor had suggested him to take complete bed rest and not to travel somewhere with this condition. He requested to call him for personal hearing in next meeting of the Board.Decision:

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The Board after detailed discussion, deliberation and keeping in view the facts of the case including the information provided, the Board decided to cancel the Drug Manufacturing License of the Firm M/s. Standard Drug Company, Hyderabad.

The inspection report is attached as Annex.

Current Status:

It is submitted that M/s Standard Drug Company, Hyderabad filed an appeal against the decision of Registration Board regarding cancellation of Linobex-C Syrup batch No. LC.09-A in its 255th Meeting held on 17th -18th December 2015.

Proceedings and decision of 148th Meeting of Appellate Board held on 22-12-2017:

(i). The appeal came under discussion during 147th meeting of the Appellate Board held on 28-08-2017. However, at the outset, the appellant requested to adjourn the appeal as he has not received the report of test/ analysis from the Appellate Lab, NIH, Islamabad. The Board accepted the request for adjournment and directed the appellant to submit revised comments after receiving the report of test/ analysis from NIH, Islamabad within 30 days. The decision of the board was communicated to the firm on 22-09-2017.(ii). The Board was informed that the Appellant has submitted a written request to defer the Appeal till next meeting as he has not received the report of test/ analysis from NIH, Islamabad. He further stated that he has written a letter to the Chief (DC&TMD), NIH, Islamabad for issuance of reports of 12 product including Linobex-C syrup and deposited testing fee Rs. 114,480/-. FID, Hyderabad was also requested for provision of said test reports.

(iii). The Board accepted the request for adjournment and directed the QA&LT Division to provide report of NIH, Islamabad to the Appellant within three days to enable the Appellant to submit revised comments in respect of Linobex-C Syrup, registration No. 004077 within 30 days.As per decision of Appellate Board, the NIH test report has been issued to the firm.

Then M/s Standard Drug Company Hyderabad filed an appeal against the decision of Central Licensing Board regarding the cancellation of their Drug Manufacturing License on 02-06-2017 (DML. No. 000118).Proceedings and Decision of Appellate Board in its 147th SITTING HELD ON 28-08-2017:

A panel was constituted by appellate Board. The panel constituted by the Appellate Board inspected the premises of M/s Standard Drug Company, Hyderabad on 11-12-2017 Their recommendations are as under:

“The panel observed a number of critical shortcomings in building, production machinery, HVAC system, documentation etc. Therefore, based on the areas inspected, the people met and documents reviewed, and considering the findings of inspection the panel recommends to continue with the cancellation of drug manufacturing license of Ms Standard Drug Company, Hyderabad”.The inspection report is attached as Annex.

“Proceedings of the case

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Inspection report of M/s Standard Drug Company Hyderabad conducted by Appellate panel of experts comprising of following

I. Dr. Kifayatullah CDC Gilgit Baltistan,

II. Professor Dr. Maqsood Ahmed Rifah International university Lahore and

III. Syed Muied Ahmed, (Expert in manufacturing) conducted on 11th December 2017 was placed before the CLB.

Decision of the Case:-

“The CLB after deliberation and thread bare discussion decided to issue show cause notice to M/s Standard Drug Company Hyderabad on the basis of short comings/deficiencies identified and forwarded by Appellate Panel in their report (Annex A).”

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