MINUTES OF 257th MEETING OF CENTRAL LICENSING BOARD HELD ON JANUARY 24-25, 2018 *=*=*=*=*

257th meeting of the Central Licensing Board (CLB) was held on January 24-25, 2018 in the Committee Room, Drug Regulatory Authority of Pakistan, 4th Floor, T.F. Complex, G-9/4, Islamabad under the Chairmanship of Mr. Ghulam Rasool Dutani, Director Drug Licensing, Drug Regulatory Authority of Pakistan, Islamabad. Following members attended the meeting: - S. No. Name & Designation Status 1. Dr. Sheikh Akhter Hussain. Member Director (QA/LT), DRAP, Islamabad

Mr. Munawar Hayat, Member 2. Chief Drug Controller, Primary and Secondary Health Care Department, Govt. of Punjab, Lahore Syed Welayat Shah, Member 3. Chief Drug Inspector, Department of Health, Govt. of Khyber Pakhtunkhwa, Peshawar Syed Saleem Shah, Member 4. Chief Drug Inspector, Department of Health, Govt. of Balochistan, Quetta 5. Syed Muied Ahmed, Expert in manufacturing of drugs. Member 6. Dr.Ikram-ul-Haque , Expert inQC/QA of drugs. Member

7. Prof. Dr. Abdullah Dayo, Dean, Faculty of Pharmacy, University of Member Sindh, Jamshoro 8. Prof. Dr. Mohammad Usman, Expert in manufacturing of drugs Member

9. Prof Dr. Jamshaid Ali Khan, Department of Pharmacy, University of Member Peshawar, Peshawar Mr. KhurramShahzad Mughal, Member 10. Consultant M/o Law, Justice and Human Rights, as representative of M/o Law and Justice, Islamabad. 11. Mr. Manzoor Ali Bozdar, Additional Director (Lic.), DRAP, Secretary/Member Islamabad. 12. Mr Sabooor Ahmed Sheikh and Mr. Arshad Mehmood as Observer Representatives of PPMA 13. Mr. Nadeem Alamgir, Representative of Pharma Bureau. Observer 14. 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. Zeeshan Nazir, Deputy Director (QA/QC), Mr. Abdul Sattar Sohrani, Deputy Director (QC) Dr. Muhammad Usman AD (Lic.), Dr. Muhammad Ashfaq AD (Lic) and Dr. Zunaira Farayad, AD (Lic) DRAP Islamabad assisted the Secretary Central Licensing Board in presenting the agenda.

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The Board also appreciated the services of Mr. Faqeer Muhammad Shaikh, ex-Chairman, Central Licensing Board for his inclusive approach of conduct of the business of the Board.

Item-I CONFIRMATION OF THE MINUTES OF 256thMEETING

The Central Licensing Board (CLB) formally confirmed the minutes of its 256thmeeting held on November 9-10, 2017. The Board also approved the corrections of the following items which were decided in previous meetings.

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Case NO. 1 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. 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”.

Proceedings and Decision of Central Licensing Board in 256thmeeting 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. 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. Proceedings and Decision of Central Licensing Board in 257th meeting 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.” Page 3 of 116

Case NO. 2 GRANT OF ADDITIONAL SECTIONS OF M/S THERAMED PHARMACEUTICAL (PVT) LTD, 45-KM, MULTAN ROAD, LAHORE .

M/s Theramed Pharmaceutical 10-10-2017 The Board approved the grant of following (Pvt) Ltd, 45-Km, Multan Road, additional sections /amendment as under:- Lahore DML No. 000696 Section (06) (Formulation) 1. Oral Liquid (General) Section. 2. Dry Powder Suspension (General) Section. 3. Capsule (General) Section. 4. Tablet (General) Section. 5. Tablet (Psychotropic) Section (New). 6. Capsule (Psychotropic) Section (New).

Proceedings of Licensing Division in compliance to the decision of Central Licensing Board: The following sections were mistakenly written in Minutes of 256th meeting of Central Licensing Board of the firm M/s Theramed Pharmaceutical (Pvt) Ltd, Lahore regarding grant of additional sections. 1. Oral Liquid (General) Section. 2. Dry Powder Suspension (General) Section. 3. Capsule (General) Section. 4. Tablet (General) Section. However, the firm already possess the aforesaid sections and Tablet (Psychotropic) Section (New) & Capsule (Psychotropic) Section (New) are new sections. Proceedings and Decision of Central Licensing Board in 257th meeting 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 approved the grant of following additional sections /amendment as under:- Section (02) 1. Tablet (Psychotropic) Section (New). 2. Capsule (Psychotropic) Section (New).” Case No. 3 GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE M/S AIMS PHARMACEUTICALS, PLOT NO. 291, INDUSTRIAL TRIANGLE KAHUTA ROAD, ISLAMABAD.

Case Background The Case for grant of renewal of DML of M/s Aims Pharmaceuticals, Plot No. 291, Industrial Triangle Kahuta Road, Islamabad for the period of 21-03-2017 to 20-03-2020 was placed in 256th meeting of Central Licensing Board held on 9th and 10th November, 2017 and board decided as under:- “The Board approved the renewal of Drug Manufacturing License for the further period w.e.f 21-03-2017 to 20-03-2022.

It is submitted that the recommendations of the panel were as under:- “Keeping in view the above said observations, people met on site, documents reviewed; the panel unanimously recommended not to grant renewal of DML to M/s Aims Page 4 of 116

Pharmaceuticals till the rectification of the shortcomings pointed out by the panel and verification of compliance of these by the same panel.”

Due to typographical mistake the words board approved the renewal were inadvertently mentioned in minutes. Proceedings and Decision of Central Licensing Board in 257th meeting 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 considered the case and did not approve the renewal of Drug Manufacturing Licence. The Board further decided that the licensee shall rectify the shortcomings noted by the panel within a period not less than one month under Rule, 13 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 from the date of issuance of decision of the Board. The licensee shall inform regarding rectifications made and accordingly panel would be constituted to verify the improvements made. Manufacturing in the premises shall remain suspended till decision by the Board. The Central Licening Board will take a decision on the recommendations of the panel either to grant renewal of licence or reject the application and inform the licencee accordingly.”

Case No.4 CHANGE OF MANAGEMENT OF M/S MARTIN DOW LTD, KARACHI

M/s Martin Dow Ltd, Karachi License No. 000267 by way of formulation has submitted request for change in management of the firm as per Form -29 with prescribed Fee Challan of 50,000/- as under; Previous Management Interim Management New Management

1. Mr. Muhammad Jawed Akhai 1. Mr. Muhammad 1. Mr. Muhammad Jawed S/o A. Sattar Akhai CNIC Jawed Akhai S/o A. Akhai S/o A. Sattar Akhai No.42000-1658201-1. Sattar Akhai CNIC CNIC No.42000-1658201-1 2. Mr. Muqtadir M.A Jawad S/o No.42000-1658201-1. 2. Mr. Muqtadir M.A Jawad S/o Shafiq Ahmed CNIC 2. Mr. Muqtadir M.A Shafiq Ahmed CNIC No.42201-5392112-5, Jawad S/o Shafiq No.42201-5392112-5. 3. Mr. Muhammad Hanif S/o Ahmed CNIC 3. Syed Dawood S/o Syed Abdul Sattar CNIC No. No.42201-5392112-5. Fasih Uddin Ahmed, LB- 42006-8272276-9. 3. Rizwan Omar S/o 0060600

4. Mr. Ali Akhai S/o Omar A Muhamamd Muhammad Jawed Akhai CNIC No. 42201- CNIC No. 42006-3326327-5. 3609527-7. 5. Mr. Jawed Ghulam Mohammad S/o Ghulam Mohammad CNIC No. 42201-0556944-9.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Inshal Pharmaceuticals Industries, Rawat, Islamabad by way of formulation as per partnership deed as under: Previous Management / as per Interim Management as New Management as per Form-29 per Form-29 Form-29 1. Mr. Muhammad Jawed 1. Mr. Muhammad 1. Mr. Muhammad Jawed Akhai S/o A. Sattar Akhai Jawed Akhai S/o A. Akhai S/o A. Sattar Akhai CNIC No.42000-1658201-1. Sattar Akhai CNIC CNIC No.42000-1658201-1 2. Mr. Muqtadir M.A Jawad No.42000-1658201-1. 2. Mr. Muqtadir M.A Jawad S/o Shafiq Ahmed CNIC 2. Mr. Muqtadir M.A S/o Shafiq Ahmed CNIC No.42201-5392112-5, Jawad S/o Shafiq No.42201-5392112-5. 3. Mr. Muhammad Hanif S/o Ahmed CNIC 3. Mr. Syed Dawood S/o Mr. Page 5 of 116

Abdul Sattar CNIC No. No.42201-5392112-5. Syed Fasih Uddin Ahmed, 42006-8272276-9. 3. Rizwan Omar S/o LB-0060600

4. Mr. Ali Akhai S/o Omar A Muhamamd Muhammad Jawed Akhai CNIC No. 42201- CNIC No. 42006-3326327- 3609527-7. 5. 5. Mr. Jawed Ghulam Mohammad S/o Ghulam Mohammad CNIC No. 42201-0556944-9.

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 Inshal Pharmaceuticals Industries, Rawat, Islamabad Instead of M/s Martin Dow Ltd, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi under Drug Manufacturing Licence No. 000267 by way of formulation. Proceedings and Decision of Central Licensing Board in 257th meeting 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 considered and endorsed the change of management from old to new management of M/s Martin Dow Ltd, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi by way of formulation as per Form-29 as under:

Previous Management / as per Interim Management as New Management as per Form-29 per Form-29 Form-29 1. Mr. Muhammad Jawed Akhai 1. Mr. Muhammad 1. Mr. Muhammad Jawed S/o A. Sattar Akhai CNIC Jawed Akhai S/o A. Akhai S/o A. Sattar Akhai No.42000-1658201-1. Sattar Akhai CNIC CNIC No.42000-1658201-1, 2. Mr. Muqtadir M.A Jawad S/o No.42000-1658201-1. CEO. Shafiq Ahmed CNIC No.42201- 2. Mr. Muqtadir M.A 2. Mr. Muqtadir M.A Jawad 5392112-5, Jawad S/o Shafiq S/o Shafiq Ahmed CNIC 3. Mr. Muhammad Hanif S/o Ahmed CNIC No.42201-5392112-5. Abdul Sattar CNIC No. 42006- No.42201-5392112-5. 3. Mr. Syed Dawood S/o Mr. 8272276-9. 3. Rizwan Omar S/o Syed Fasih Uddin Ahmed, 4. Mr. Ali Akhai S/o Muhammad Omar A Muhamamd LB-0060600, Director Jawed Akhai CNIC No. 42006- CNIC No. 42201- 3326327-5. 3609527-7. 5. Mr. Jawed Ghulam Mohammad S/o Ghulam Mohammad CNIC No. 42201- 0556944-9. Case No. 05 CHANGE OF MANAGEMENT OF M/S CKD PHARMACEUTICALS PAKISTAN (PVT) LTD, 50/28, KORANGI INDUSTRIAL AREA, KARACHI.

M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi, DML No. 000144 by way of formulation has submitted request for change in management of the firm as per Form-29 from S.E.C.P along with prescribed Fee Challan of 50,000/- as under:- Existing Management as per sale Retiring Management Proposed Management as deed and Form-29 per Form-29

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1. Mr. Ahsan Sultan Ahmed S/o 1. Mr. Ahsan Sultan Ahmed 1. Mr. Syed Mustafa Sultan Ahmed CNIC No. S/o Sultan Ahmed CNIC Hussain Kazmi S/o 42201-3110080-9. No. 42201-3110080-9. Syed Abrar Hussain

2. Mr. Shahab Ahmed S/o 2. Mr. Shahab Ahmed S/o Kazmi CNIC No. Muhammad Ahmed CNIC Muhammad Ahmed CNIC 42201-0716021-7. No. 42301-0887778-3. No. 42301-0887778-3. 3. Mr. Anas Sultan Ahmed 3. Mr. Anas Sultan Ahmed S/o S/o Sultan Ahmed CNIC Sultan Ahmed CNIC No. No. 42201-0775491-9. 42201-0775491-9.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi, DML No. 000144 by way of formulation as per Form 29 of SECPas under;

Existing Management as per sale Retiring Management New Management as per deed and Form-29 Form-29 1. Mr. Ahsan Sultan Ahmed S/o 1.Mr. Ahsan Sultan Ahmed 1. Mr. Syed Mustafa Sultan Ahmed CNIC No. S/o Sultan Ahmed CNIC Hussain Kazmi S/o Syed 42201-3110080-9. No. 42201-3110080-9. Abrar Hussain Kazmi 2. Mr. Shahab Ahmed S/o 2.Mr. Shahab Ahmed S/o CNIC No. 42201- Muhammad Ahmed CNIC No. Muhammad Ahmed CNIC 0716021-7. 42301-0887778-3. No. 42301-0887778-3. 3.Mr. Anas Sultan Ahmed S/o 3. Mr. Anas Sultan Ahmed S/o Sultan Ahmed CNIC No. Sultan Ahmed CNIC No. 42201-0775491-9. 42201-0775491-9.

Proceedings of Licensing Division in compliance to the decision of Central Licensing Board: In the aforesaid minutes of Central Licensing Board the name of one director i.e. Mrs. Naureen Liaqat W/o Liaqat Ali CNIC No. 42000-0451927-2 was inadvertently not mentioned while preparation of agenda and accordingly minutes were approved. Now M/s CKD Pharmaceutical Pakistan (Pvt) Ltd., Karachi has intimated in writing that the correction may be made as per Form-29 and name of the said director may be included. Accordingly, following proposal is made;

Existing Management as per sale Retiring Management Proposed Management as deed and Form-29 per Form-29

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1. Mr. Ahsan Sultan Ahmed S/o 1.Mr. Ahsan Sultan Ahmed 1. Mr. Syed Mustafa Hussain Sultan Ahmed CNIC No. S/o Sultan Ahmed CNIC Kazmi S/o Syed Abrar 42201-3110080-9. No. 42201-3110080-9. Hussain Kazmi CNIC No. 2. Mr. Shahab Ahmed S/o 2.Mr. Shahab Ahmed S/o 42201-0716021-7.

Muhammad Ahmed CNIC No. Muhammad Ahmed CNIC 2. Mrs. Naureen Liaqat W/o 42301-0887778-3. No. 42301-0887778-3. Liaqat Ali CNIC No. 3.Mr. Anas Sultan Ahmed S/o 42000-0451927-2 3. Mr. Anas Sultan Ahmed S/o Sultan Ahmed CNIC No. Sultan Ahmed CNIC No. 42201-0775491-9. 42201-0775491-9.

Proceedings and Decision of Central Licensing Board in 257th meeting The Board approved the correction in decision of the 255th meeting of the Central Licensing Board and decision may be read as under: “The Board considered and endorsed the change of management from old to new management of M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi, DML No. 000144 by way of formulation as per Form 29 of SECPas under

Existing Management as per sale Retiring Management Proposed Management as per deed and Form-29 Form-29 4. Mr. Ahsan Sultan Ahmed S/o 4.Mr. Ahsan Sultan Ahmed 3. Mr. Syed Mustafa Hussain Sultan Ahmed CNIC No. S/o Sultan Ahmed CNIC No. Kazmi S/o Syed Abrar 42201-3110080-9. 42201-3110080-9. Hussain Kazmi CNIC No. 5.Mr. Shahab Ahmed S/o 42201-0716021-7. 5. Mr. Shahab Ahmed S/o

Muhammad Ahmed CNIC No. Muhammad Ahmed CNIC 4. Mrs. Naureen Liaqat W/o 42301-0887778-3. No. 42301-0887778-3. Liaqat Ali CNIC No. 6.Mr. Anas Sultan Ahmed S/o 42000-0451927-2 6. Mr. Anas Sultan Ahmed S/o Sultan Ahmed CNIC No. Sultan Ahmed CNIC No. 42201-0775491-9. 42201-0775491-9.

.” Case No. 06 GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S ROGEN PHARMACEUTICALS, PLOT NO. 30-, S-4, NATIONAL INDUSTRIAL ZONE, RAWAT, ISLAMABAD.

Case Background The Case for grant of renewal of DML of M/s Rogen Pharmaceuticals, Plot No. 30-, S-4, National Industrial Zone, Rawat, Islamabad was placed in 256th meeting of Central Licensing Board held on 9th and 10th November, 2017 and board decided as under:- “The Board approved the renewal of Drug Manufacturing License for the further period w.e.f 02-04-2014 to 01-04-2019”.

It is submitted that the period of DML Renewal was inadvertently mentioned as 02-04-2014 to 01-04- 2019 instead of the correct period i.e 19-07-2015 to 18-07-2020. Proceedings and Decision of Central Licensing Board in 257th meeting Page 8 of 116

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 approved the renewal of Drug Manufacturing License for the further period w.e.f 19-07- 2015 to 18-07-2020”

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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: Date of Inspection S# Name of the firm Decision of CLB / Type of License 1. M/s Winlet Pharmaceuticals 12-10-2017 & The Board approved the grant of Drug (Pvt) Ltd, 30-Km, Sargodha 12-12-2017 Manufacturing Licence by way of Lahore Road, Sargodha. (Formulation) formulation with following sections:

Sections 04:

1. Tablet (General) Section 2. Capsule (General) Section 3. Oral Dry Powder Suspension (General) Section. 4. Liquid Syrup (General) Section.

2. M/s Relizon 05-12-2017 The Board approved the grant of Drug Pharmaceuticals, Plot No. Formulation Manufacturing Licence by way of 118, Sunder Industrial Estate, Raiwind Road, formulation with following sections: Lahore Sections (03):

1. Tablet (General) Section 2. Capsule (General) Section 3. Dry Powder Suspension (General) Section. 3. M/s Multicaps, Plot No. A- 13-01-2018 The Board approved the grant of Drug 92, S.I.T.E, Super Highway Semi-Basic Manufacturing Licence by way of Semi- Industrial Area, Karachi. Basic Manufacture with following sections: Section (01):

1. Empty Hard Gelatin Capsules for the sizes including (00, 0, 1, 2, 3 & 4). 4. M/s Neutro Pharma (Pvt) 02-01-2018 The Board approved the grant of Drug Ltd., 9.5-Km, Sheikhupura Semi-Basic Manufacturing Licence by way of Semi- Road, Lahore. Basic Manufacture for the pellatization only for the following Active Pharmaceutical Ingredients; 1. Duloxetine 2. Dexlansoperazole 3. Esomeprazole Magnesium Dihydrate 4. Fluconazole 5. Orlistat 6. Pantoprazole 7. Ciprofloxacin 8. Lansoperazole+Domperidone 9. Itraconazole 10. Indomethacin 11. Diclofenac Potassium Page 10 of 116

12. Esomeprazole 13. Galanthamine Hydrobromide 14. Ferrous Fumarate 15. Folic Acid 16. Clarithromycin 17. Azithromycin 18. Diclofenac Sodium 19. Tizanidine 20. Omeprazole 21. Theophylline 22. Flurbiprofen 23. Tamsulin 24. Esomeprazole Magnesium Hydrate 5 M/s MeDPharm Research 12-01-2018 The Board approved the grant of Drug Lab, 28-Km, Ferozepur Formulation Manufacturing Licence by way of Road, Lahore formulation with following sections: Sections (07): 1. Tablet (General) Section 2. Capsule (General) Section 3. Dry Powder for Suspension (General) Section. 4. Sachet (General) Section. 5. Capsule (Cephalosporin) Section. 6. Dry Power for Suspension (Cephalosporin) Section. 7. Dry Powder for Injection (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: - Date of S# Name of the firm / DML No. Decision of CLB Inspection 1 M/s Novartana 21-11-2017 The Board did not approve the grant of Pharmaceuticals, 87-B, Sunder following additional section and as and Industrial Estate, Lahore. when the section will be ready for DML No. 000738 inspection, the firm may apply for (Formulation) constitution of panel:- Section (01) 1. Liquid Injectable Ampoule / Vial (General) Section. 2 M/s GlaxoSmithKline Pakistan 31-10-2017 The Board approved the grant of & Ltd, Plot No. 5, Sector 21, following additional sections 21-12-2017 Korangi Industrial Area, /amendment:- Karachi Section (03) 1. Liquid Injection Section (Revised). DML No. 000248 2. Tablet (General) Section (Revised). (Formulation) 3. Eye Drop Section (New).

3 M/s Citi Pharma (Pvt) Ltd, 3.5- 4-12-2017 The Board did not approve the grant of Km, Head Balloki Road, Phool following Additional APIs and as and Nagar, District Kasur. when the area will be ready for inspection, the firm may apply for DML No. 000429 constitution of panel:-:- (Semi Basic) APIs (03) 1. Cephradin. 2. Cephalexin. 3. Cefixime. 4 M/s Pacific Pharmaceuticals, 16-08-2017 The Board approved the grant of 06-11-2017 Ltd, 30-Km, Multan Road, following additional sections:- 07-11-2017 Lahore. Sections (03) 1. Tablet (Psychotropic / Narcotic) DML No. 000295 (New) (Formulation) 2. Capsule (Psychotropic / Narcotic) (New) 3. Tablet (Hormone) (New) However, Board did not approve Section for Anti T.B drugs till improvements are made. Moreover, the area FID will werify the working of HVAC system befor the firm starts the production activity. Page 12 of 116

5 M/s PharmEvo (Pvt) Ltd, Plot 02-01-2018 The Board approved the grant of No. A-29, North Western amendments in following sections Industrial Zone, Port Qasim, except packaging warehouse:- Karachi. Amendments in Sections (06) 1. Tablet (General) Section (Revised) DML No. 000504 (Formulation) 2. Capsule (General) Section (Revised) 3. Ointment / Cream (General) Section (Revised) 4. Sachet (General) Section (Revised) 5. Oral Liquid (General) Section (Revised) 6. Relocation of in process lab. (Revised) The Board advised the firm to submit Layout plan for approval where changes are reported by the panel being made. 6 M/s Kanel Pharma, Plot No. 6, 20-12-2017 The Board approved the grant of Street No. SS-3, National following additional sections:- Industrial Zone, Rawat. Sections (05). DML No. 000758 1. Cream / Ointment Section (General) (Formulation). (New). 2. Topical Lotion Section (General) (New). 3. Capsule Section (Ceph). 4. Dry Suspension Section (Ceph) (New). 5. Dry Vial Injection (Ceph) (New). 7 M/s Pharmagen Ltd, Kot Nabi 08-12-2017 The Board approved the grant of Wala, 34-Km, Ferozepur following APIs:- Road, Lahore Through Semi Basic Manufacture (Alternate Method in addition to existing Method) DML No. 000325 1. Amoxycillin Trihydrate (Semi Basic) 2. Ampicillin Trihydrate

3. Cephalexin Hydrate 4. Cefaclor 5. Cefadroxil Through Semi Basic Manufacture 1. Ledipasvir 2. Daclatasvir Dihydrochloride 3. Velpatasvir

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4. Vildagliptin

8 M/s Honig Pharmaceutical 21-12-2017 The Board approved the grant of Laboratories, 14 KM Adyala following additional sections:- Road, Rawalpindi DML No. 000550 Sections (02). (Formulation). 1. Oral Dry Powder Suspension (General). 2. Capsule (General). 9 M/s Innvotek Pharmaceutical, 30-11-2017 The Board approved the grant of Plot No. 35, Industrial following additional sections Triangle, Kahuta Road, Islamabad. /amendment:- DML No. 000487 Section (02). (Formulation). 1. Tablet Section General (Revised). 2. Capsule Section General (Revised)

10 M/s Sayyed Pharmaceutical 05-01-2018 The Board approved the grant of Industries (Pvt) Ltd, Plot No. following additional sections:- 67/2, Phase-3, Industrial Sections (03). Estate, Hattar 1. Dry Powder Injection DML No. 000697 (Cephalosporin) Section. (Formulation). 2. Sachet (General) Section.

3. Stores (Finished Goods, Packing material, Liquid and Product recall) 11 M/s Tas Pharmaceuticals (Pvt) 03-01-2018 The Board did not approve the grant of Ltd., Plot No. 209, Industrial following additional section Triangle, Kahuta Road, /amendment and as and when the Islamabad sections will be ready for inspection, the firm may apply for constitution of DML No. 000375 panel:- (Formulation). Sections (04).

1. Tablet Section (Psychotropic)Page 14– of 116

New. 2. Tablet General – Amended / Revised. 3. Packing Hall in place of Syrup Section. 4. Regularization of Cream / Ointment Section General. 12 M/s Skims Pharmaceuticals, 19-01-2018 The Board approved the grant of 10-B, Value Addition City following additional sections:- Khurrianwala, Faisalabad. Sections (04).

1. Tablet Section (General). DML No. 000830 2. Capsule (General) Section. (Formulation). 3. Oral Dry Powder Suspension (General) Section. 4. Oral Dry Powder Sachet (General) Section.

13 M/s Grand Pharma (Pvt) Ltd., 09-01-2018 The Board approved the grant of Plot No. 5-A, Street No. N-5, following additional sections:- National Industrial Zone, Section (01). Rawat, Rawalpindi 1. New Ware House for storage of

eggs at Veterinary Biological DML No. 000680 Facility. (Formulation). 14 M/s Hudson Pharma (Pvt) 19-01-2018 The Board approved the grant of Ltd., Plot No. D-93, North following additional sections:- Western Industrial Zone, Port Sections (02). Qasim, Karachi. 1. Ointment/Cream/Lotion/Gel

(General) Section. DML No. 000842 (Formulation). 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:- 1. Eye/Ear & Nasal Drops (General) Section 15 M/s Chemiworld (Pvt) Ltd., 18-01-2018 The Board approved the grant of Plot No.97-J, Industrial Estate, following additional API:- Hayatabad, Peshawar. API (01). 1. Iron Polysaccharide Complex DML No. 000579 (Basic The Board did not approve the grant of Manufacture) following additional APIs and as and when the area will be ready for inspection, the firm may apply for constitution of panel:- APIs (02). 1. Iron Sucrose Complex 2. Iron Protein Succinylate 16 M/s Saakh Pharma (Pvt) Ltd., 16-10-2017 The Board did not approve the grant of C-7/1, North Western following additional API and as and Insustrial Zone, Page 15 of 116

Karachi when the section will be ready for

insection, the firm may apply for DML No. 000588 (Semi Basic) constitution of panel:- Additional APIs (03): 1. Paracetamol 2. Ciprofloxacin HCL 3. Sulphamethoxazole

Page 16 of 116

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 Decision of CLB No Type of License Inspection 1. M/s General Pharma, Farm 04-10-2017 The Board approved the renewal of Road, 03-Km, G.T. Road, Drug Manufacturing Licence for the Manhes (Kotli Wagha) Komoke. further period w.e.f 20-07-2015 to

19-07-2020. DML No. 000689 (Formulation)

2. M/s Healthtek (Pvt) Ltd, Plot 02-11-2017 The Board approved the renewal of No. 14, Sector 19, Korangi Drug Manufacturing Licence for the Industrial Area, Karachi. further period w.e.f 18-07-2017 to

17-07-2022 DML No. 000618 (Formulation) 3. M/s Safe Pharmaceuticals 05-10-2017 The Board considered the case and did (Pvt), Ltd, Plot No. C-1-20, not approve the renewal of Drug Sector 6-B,North Karachi Manufacturing Licence on Industrial Area, Karachi recommendations of the panel. The 06-02-2015 to 05-02-2020. Board further decided that the licensee DML No. 000349 shall rectify the shortcomings noted by (Formulation) the panel within a period not less than one month under Rule, 13 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 from the date of issuance of decision of the Board. The licensee shall inform regarding rectifications made and accordingly panel would be constituted to verify the improvements made. Manufacturing in the premises shall remain suspended till decision by the Board. The Central Licening Board will take a decision on the recommendations of the panel either to grant renewal of licence or reject the application and inform the licencee accordingly. 4. M/s Albro Pharmaceuticals 25-09-2017 The Board considered the case and (Pvt) Ltd, 340-S, Quaid-e- decided to defer the case till next Azam Industrial Estate, Kot Lakhpat, Lahore. meeting of the Board for want of 14-06-2015 to 13-06-2020. personal hearing regarding update from DML No. 000175 (Formulation) the licensee on the decision of the

Central Licencing Board for purchase of

plot and completion of facility. Page 17 of 116

5. M/s GlaxoSmithKline Pakistan 31-10-2017 The Board approved the renewal of & Ltd, Plot No. 5, Sector 21, Drug Manufacturing Licence for the 21-12-2017 Korangi Industrial Area, further period w.e.f 12-08-2015 to Karachi 11-08-2020 DML No. 000248 (Formulation) 6. M/s PharmEvo (Pvt) Ltd, Plot 02-01-2018 The Board approved the renewal of No. A-29, North Western Drug Manufacturing Licence for the Industrial Zone, Port Qasim, further period w.e.f 05-10-2017 to Karachi. 04-10-2022. DML No. 000504 (Formulation) 7. M/s Innvotek Pharmaceutical, 30-11-2017 The Board approved the renewal of Plot No. 35, Industrial Drug Manufacturing Licence for the Triangle, Kahuta Road, Islamabad. further period w.e.f 05-05-2016 to DML No. 000487 04-05-2021. (Formulation).

8. M/s Pfizer Pakistan Ltd, B-2, 30-10-2017 The Board approved the renewal of

S.I.T.E, Karachi Drug Manufacturing Licence for the further period w.e.f 22-06-2015 to DML No. 000025 21-06-2020. However it was advised the (Formulation) firm must have separate facility for

manufacturing of their only registered corticosteroid product while they have already allocated dedicated compression Cubical and packing line. The matter may also be referred to Drug Registeration Board for their consideration. It was also decided that the firm may be advised to file application for regularization of capsule (General) section which is already mentioned in the their layout. 9. M/s Kanel Pharma, Plot No. 6, 20-12-2017 The Board approved the renewal of Street No. SS-3, National Drug Manufacturing Licence for the Industrial Zone, Rawat. further period w.e.f 04-10-2017 to DML No. 000758 03-10-2022. (Formulation).

Page 18 of 116

10. M/s Ethical Laboratories (Pvt) 21-11-2017 The Board approved the renewal of Ltd, 14-Km, Link Katar Bund Drug Manufacturing Licence for the Road, Thokar Niaz Baig, Lahore. further period w.e.f 14-05-2014 to

13-05-2019 for following sections.

DML No. 000100 1. Tablet (General) Section. (Formulation) 2. Eye Drops (Non-Steroidal) Section. 3. Eye Drops (Steroidal) Section. The Board considered the case and did not approve the renewal of Oral Liquid Section (General) and Capsule Section (General). The Board further decided that the licensee shall rectify the shortcomings noted by the panel within a period not less than one month under Rule, 13 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 from the date of issuance of decision of the Board. The licensee shall inform regarding rectifications made in Oral Liquid Section (General) and Capsule Section (General) and accordingly panel would be constituted to verify the improvements made. Manufacturing in the premises shall remain suspended till decision by the Board. The Central Licening Board will take a decision on the recommendations of the panel either to grant renewal of Oral Liquid Section (General) and Capsule Section (General) or reject the application and inform the licencee accordingly. 11. M/s Medisynth 05-10-2017 The Board approved the renewal of Pharmaceuticals, Plot No. 55, Drug Manufacturing Licence for the Street No. S-5, National Industrial Zone, Rawat. further period w.e.f 14-06-2016 to DML No. 000718 13-06-2021 (Formulation).

Page 19 of 116

12. M/s Honig Pharmaceutical 21-12-2017 The Board approved the renewal of Laboratories, 14 KM Adyala Drug Manufacturing Licence for the Road, Rawalpindi further period w.e.f 28-08-2014 to DML No. 000550 27-08-2019 (Formulation)

13. M/s Tas Pharmaceuticals (Pvt) 03-01-2018 The Board considered the case and did Ltd., Plot No. 209, Industrial not approve the renewal of Drug Triangle, Kahuta Road, Islamabad Manufacturing Licence. The Board DML No. 000375 further decided that the licensee shall (Formulation). rectify the shortcomings noted by the 16-11-2015 to 15-11-2020. panel within a period not less than one month under Rule, 13 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 from the date of issuance of decision of the Board. The licensee shall inform regarding rectifications made and accordingly panel would be constituted to verify the improvements made. Manufacturing in the premises shall remain suspended till decision by the Board. The Central Licening Board will take a decision on the recommendations of the panel either to grant renewal of licence or reject the application and inform the licencee accordingly. 14. M/s Aptcure (Pvt) Ltd.,8- 24-11-2017 The Board approved the renewal of Pharmacity, 30-Km, Multan Drug Manufacturing Licence w.e.f Road, Lahore DML No. 000648 24-10-2013 to 23-10-2018 (Formulation). 1M/s Munawar Pharma (Pvt) 07-11-2017 The Board approved the renewal of 1Ltd., 31-Km, Ferozpur Road, Drug Manufacturing Licence for the 15. Lahore. further period w.e.f 12-01-2014 to DML No. 000379 11-01-2019. (Formulation).

Page 20 of 116

16. M/s SPL Pharmaceuticals, 04-01-2018 The Board approved the renewal of Phase-III, Industrial Estate, Drug Manufacturing Licence for the Hattar. further period w.e.f 19-02-2017 to DML No. 000605 18-02-2022 (Formulation)

17. M/s Ottoman Pharma, 10-Km, 19-12-2017 The Board approved the renewal of Raiwind Road, Lahore. Drug Manufacturing Licence for the

DML No. 000502 further period w.e.f 05-08-2017 to (Formulation) 04-08-2022

18. M/s Werrick Pharmaceuticals, 19-01-2018 The Board approved the renewal of 216-217, I-10/3, Industrial Drug Manufacturing Licence for the Area, Islamabad further period w.e.f 31-10-2016 to DML No. 000489 (Semi 30-10- 2021 Basic).

19. M/s Medipharm (Pvt) Ltd., 07-12-2017 The Board approved the renewal of 108, Kot Lakhpat, Industrial Drug Manufacturing Licence for the Estate, Lahore. further period w.e.f 18-11-2014 to 17-11-2019 DML No. 000243 The Board considered the case and did (Formulation). not approve the renewal of Psychotropic section. The Board further decided that the licensee shall rectify the shortcomings noted by the panel within a period not less than one month under Rule, 13 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 from the date of issuance of decision of the Board. The licensee shall inform regarding rectifications made and accordingly panel would be constituted to verify the improvements made. Manufacturing in the Psychotropic section shall remain suspended till decision by the Board. The Central Licening Board will take a decision on the recommendations of the panel either to grant renewal of Psychotropic section or reject the application and inform the licencee accordingly. 20. M/s Medisave 11-12-2017 The Board approved the renewal of Pharmaceuticals, Plot No. 578- & Drug Manufacturing Licence for the 579,Sunder Industrial Estate, 10-01-2018 Lahore further period w.e.f 26-01-2015 to

25-01-2020. DML No. 000681 (Formulation).

Page 21 of 116

21. M/s Medicraft Pharmaceuticals 22-01-2018 The Board approved the renewal of the (Pvt) Ltd., 126-B, Industrial following previously defferd section; Estate, Hayatabad, Peshawar. Section (01): DML No. 000390 1. Syrup Section (General) (Formulation). 22. M/s Saakh Pharma (Pvt) Ltd., 16-10-2017 The Board approved the renewal of C-7/1, North Western Drug Manufacturing Licence for the Insustrial Zone, Karachi further period w.e.f 29-03-2016 to

28-03-2021.

DML No. 000588 (Semi Basic)

Page 22 of 116

Item No. V MISCELLANEOUS CASES. Case No. 1 CHANGE OF MANAGEMENT OF M/S HONIG PHARMACEUTICAL LABORATORIES, 14 KM, ADYALA ROAD, RAWALPINDI.

M/s Honig Pharmaceutical Laboratories, 14 KM, Adyala Road, Rawalpindi, DML No. 000550 by way of (Formulation)has submitted request for change in management of the firm as per partnership deed along with prescribed Fee Challan of 50,000/- as under:- Previous Management Retiring Management New Management 1. Muhammad Maskeen Bhatti S/o 1. Muhammad Maskeen Bhatti 1. Iftkhar Ahmed S/o Imtiaz Haji Khuda Buksh S/o Haji Khuda Buksh CNIC # Ahmad CNIC # 37405-5553312-3. 37405-5553312-3. CNIC # 37405-6039992-3. 2. Muhammad Rizwan Baig S/o 2. Muhammad Rizwan Baig S/o 2. Muhammad Faisal Latif S/o Muhammad Yaqoob Baig Muhammad Yaqoob Baig Ch. Muhammad Latif CNIC # 37405-2183954-1. CNIC # 37405-2183954-1. CNIC # 37405-5664181-3. 3. Muhammad Saleem Bhatti S/o 3. Muhammad Saleem Bhatti S/o Nuhammad Maskeen Bhatti Nuhammad Maskeen Bhatti CNIC # 37405-5961906-9. CNIC # 37405-5961906-9. 4. Tanveer Akhtar Bhatti S/o 4. Tanveer Akhtar Bhatti S/o Muhammad Maskeen Bhatti Muhammad Maskeen Bhatti CNIC # 37405-6851774-7. CNIC # 37405-6851774-7. 5. Tahir Mehmood S/o Ch. 5. Tahir Mehmood S/o Ch. Muhammad Yousaf Muhammad Yousaf CNIC # 37405-0330867-1. CNIC # 37405-0330867- 6. Abu Bakkar S/o Abdul Rasheed 6. Abu Bakkar S/o Abdul CNIC # 35202-2206953-5. Rasheed CNIC # 35202-2206953-5.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Honig Pharmaceutical Laboratories, 14 KM, Adyala Road, Rawalpindi, DML No. 000550 by way of (Formulation) as per partnership deed as under ; Previous Management Retiring Management New Management 1. Muhammad Maskeen Bhatti S/o 1. Muhammad Maskeen Bhatti 1. Iftkhar Ahmed S/o Imtiaz Haji Khuda Buksh S/o Haji Khuda Buksh Ahmad CNIC # 37405-5553312-3. CNIC # 37405-5553312-3. CNIC # 37405-6039992-3. 2. Muhammad Rizwan Baig S/o 2. Muhammad Rizwan Baig S/o 2. Muhammad Faisal Latif S/o Muhammad Yaqoob Baig Muhammad Yaqoob Baig Ch. Muhammad Latif CNIC # 37405-2183954-1. CNIC # 37405-2183954-1. CNIC # 37405-5664181-3. 3. Muhammad Saleem Bhatti S/o 3. Muhammad Saleem Bhatti S/o Nuhammad Maskeen Bhatti Nuhammad Maskeen Bhatti CNIC # 37405-5961906-9. CNIC # 37405-5961906-9. 4. Tanveer Akhtar Bhatti S/o 4. Tanveer Akhtar Bhatti S/o Muhammad Maskeen Bhatti Muhammad Maskeen Bhatti CNIC # 37405-6851774-7. CNIC # 37405-6851774-7. 5. Tahir Mehmood S/o Ch. 5. Tahir Mehmood S/o Ch. Muhammad Yousaf Muhammad Yousaf CNIC # 37405-0330867-1. CNIC # 37405-0330867- 6. Abu Bakkar S/o Abdul Rasheed 6. Abu Bakkar S/o Abdul CNIC # 35202-2206953-5. Rasheed CNIC # 35202-2206953-5.

Page 23 of 116

Case No. 2. CHANGE OF MANAGEMENT OF M/S SHAIGAN PHARMACEUTICALS (PVT) LTD, ISLAMABAD. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Islamabad, DML No. 000333 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 Retiring Management New Management 1. Mr. Waheed Ahmed S/o Rashid Ahmed 1. Mrs. Qamar-un-Nisa W/o 1. Mr. Waheed Ahmed S/o CNIC # 37405-4456480-7. Rashid Ahmed Rashid Ahmed 2. Mrs. Mahrukh Waheed D/o Waheed CNIC # 210-36-056283. CNIC # 37405-4456480-7. Ahmed 2. Mrs. Mahrukh Waheed D/o CNIC # 37405-1101276-6. Waheed Ahmed 3. Mrs. Qamar-un-Nisa W/o Rashid CNIC # 37405-1101276-6. Ahmed 3. Mr. Basil Ahmed S/o CNIC # 210-36-056283. Washeed Ahamed CNIC # 37405-6039509-3.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Shaigan Pharmaceuticals (Pvt) Ltd, Islamabad, DML No. 000333 by way of (Formulation) as per Form 29 as under: Previous Management Retiring Management New Management 1. Mr. Waheed Ahmed S/o Rashid 1. Mrs. Qamar-un-Nisa W/o 1. Mr. Waheed Ahmed S/o Ahmed Rashid Ahmed Rashid Ahmed CNIC # 37405-4456480-7. CNIC # 210-36-056283. CNIC # 37405-4456480-7. 2. Mrs. Mahrukh Waheed D/o Waheed 2. Mrs. Mahrukh Waheed Ahmed D/o Waheed Ahmed CNIC # 37405-1101276-6. CNIC # 37405-1101276-6. 3. Mrs. Qamar-un-Nisa W/o Rashid 3. Mr. Basil Ahmed S/o Ahmed Washeed Ahamed CNIC # 210-36-056283. CNIC # 37405-6039509-3.

Case No. 3. CHANGE OF MANAGEMENT OF M/S GULF PHARMACEUTICALS, PLOT NO. 49, STREET NO. S-5, RAWALPINDI INDUSTRIAL ZONE (RIZ), ISLAMABAD.

M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, Rawalpindi Industrial Zone (RIZ), Islamabad, DML No. 750 by way of (Formulation) has submitted request for change in management of the firm as per partnership deed along with prescribed Fee Challan of 50,000/- as under:- Previous Management Incoming Management New Management 1. Mr. Muhammad Munawar Khan S/o 1. Mr. Muhammad Wassi Shan S/o 1. Mr. Muhammad Munawar Muhammad Ashfaq Muhammad Inyat Ullah Khan S/o Muhammad Ashfaq CNIC No. 37405-5834516-9. CNIC No. 37405-2288811-1. CNIC No. 37405-5834516-9. 2. Mr. Muhammad Wassi Shan S/o Muhammad Inyat Ullah CNIC No. 37405-2288811-1.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, Rawalpindi Industrial Zone (RIZ), Islamabad, DML No. 750 by way of (Formulation) as per partnership deed as under: Previous Management Incoming Management New Management 1. Mr. Muhammad Munawar Khan S/o 1. Mr. Muhammad Wassi Shan S/o 1. Mr. Muhammad Munawar Muhammad Ashfaq Muhammad Inyat Ullah Khan S/o Muhammad Ashfaq CNIC No. 37405-5834516-9. CNIC No. 37405-2288811-1. CNIC No. 37405-5834516-9. 2. Mr. Muhammad Wassi Shan S/o Muhammad Inyat Ullah CNIC No. 37405-Page2288811 24 of- 1.116

Case No. 4. CHANGE OF MANAGEMENT OF M/S UNIMARK PHARMACEUTICALS, PLOT NO. 7-A, NATIONAL INDUSTRIAL ZONE, RAWAT, ISLAMABAD.

M/s UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad DML No. 000557 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 Incoming Management New Management (Sole Proprietor). 1. Talat Munir Baig S/o Sadiq Hussain 1. Zarqa W/o Riaz Ahmed 1. Talat Munir Baig S/o Sadiq Baig CNIC # 16202-5656628-0. Hussain Baig CNIC # 37405-1017139-3. CNIC # 37405-1017139-3. 2. Zarqa W/o Riaz Ahmed CNIC # 16202-5656628-0.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad DML No. 000557 by way of (Formulation) as per Form-29 as under: Previous Management Incoming Management New Management (Sole Proprietor). 1. Talat Munir Baig S/o Sadiq Hussain 1. Zarqa W/o Riaz Ahmed 1. Talat Munir Baig S/o Sadiq Baig CNIC # 16202-5656628-0. Hussain Baig CNIC # 37405-1017139-3. CNIC # 37405-1017139-3. 2. Zarqa W/o Riaz Ahmed CNIC # 16202-5656628-0.

Case No. 5. CHANGE OF TITLE OF M/S UNIMARK PHARMACEUTICALS, PLOT NO. 7- A, NATIONAL INDUSTRIAL ZONE, RAWAT, ISLAMABAD.

M/s UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad, has submitted request for change of Title of the firm along with prescribed Fee Challan of 50,000/- as under:-

Previous Title of the firm Current Title of the firm as per Form 29 (Sole Proprietor). UniMark Pharmaceuticals, Plot No. 7-A, National UniMark Pharmaceuticals (Pvt) Ltd, Plot No. 7- Industrial Zone, Rawat, Islamabad. A, National Industrial Zone, Rawat, Islamabad.

Decision of CLB: The Board considered and approved the change of title of M/s UniMark Pharmaceuticals, Plot No. 7- A, National Industrial Zone, Rawat, Islamabad DML No. 000557 by way of (Formulation) as per Form-29 as under: Previous Title of the firm Current Title of the firm as per Form 29 (Sole Proprietor). UniMark Pharmaceuticals, Plot No. 7-A, National UniMark Pharmaceuticals (Pvt) Ltd, Plot No. 7- Industrial Zone, Rawat, Islamabad. A, National Industrial Zone, Rawat, Islamabad.

Page 25 of 116

Case No. 6 CHANGE OF MANAGEMENT OF M/S CALIPH PHARMACEUTICALS (PVT) LTD., PLOT NO.17, SPECIAL INDUSTRIAL ZONE (EPZ), RISALPUR.

M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur No. 000748 by way of formulation has submitted request for change in management of the firm as per Form-A of SECP alongwith prescribed Fee Challan of Rs.50,000/- as under; Previous management Retiring management New management 1. Mr. Mumtaz Ali S/o Naeem 1. Mr. Mumtaz Ali S/o Naeem 1. Mr. Muhammad Azmat Shah Shah Ali S/o Fazal Mannan CNIC. No. 16101-3653393-9 CNIC. No. 16101-3653393-9 CNIC No. 17301- 2. Mr. Hameed ur Rehman 2. Mr. Hameed ur Rehman 3861340-1 CNIC. No. 16101-5527602-9 CNIC. No. 16101-5527602-9 2. Mr. Amjad Ali Zeb S/o 3. Mr. Muhammad Saleem S/o 3. Mr. Muhammad Saleem S/o Muhammad Aurangzeb Feroz Bakht, Feroz Bakht, CNIC No. 42201- CNIC. No. 21103-4249119-3 CNIC. No. 21103-4249119-3 3056252-3 4. Mr. Abdul Haq S/o Rehmat 4. Mr. Abdul Haq S/o Rehmat Khan, Khan, CNIC. No. 15303-1202154-1 CNIC. No. 15303-1202154-1

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur DML No. 000748 by way of (Formulation) as per Form-A of SECP as under: Previous management Retiring management New management 1. Mr. Mumtaz Ali S/o 1. Mr. Mumtaz Ali S/o 1. Mr. Muhammad Azmat Ali Naeem Shah Naeem Shah S/o Fazal Mannan CNIC. No. 16101- CNIC. No. 16101- CNIC No. 17301-3861340-1 3653393-9 3653393-9 2. Mr. Amjad Ali Zeb S/o

2. Mr. Hameed ur Rehman 2. Mr. Hameed ur Rehman Muhammad Aurangzeb CNIC. No. 16101- CNIC. No. 16101- CNIC No. 42201-3056252-3 5527602-9 5527602-9 3. Mr. Muhammad Saleem 3. Mr. Muhammad Saleem S/o Feroz Bakht, S/o Feroz Bakht, CNIC. No. 21103- CNIC. No. 21103- 4249119-3 4249119-3 4. Mr. Abdul Haq S/o 4. Mr. Abdul Haq S/o Rehmat Rehmat Khan, Khan, CNIC. No. 15303- CNIC. No. 15303- 1202154-1 1202154-1

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Case No. 7 CHANGE OF MANAGEMENT OF M/S MED ASIA PHARMACEUTICALS (PVT) LTD., PLOT NO.7, NOWSHERA INDUSTRIAL ESTATE, RISALPUR.

M/s Med Asia Pharmaceuticals (Pvt) Ltd. Risalpur has submitted request for change in management of the firm as per Form-A of SECP alongwith prescribed Fee Challan of Rs.50,000/- as under; Previous management Retiring management New management 1. Mr. Sher Muhammad S/o 1. Mr. Sher Muhammad S/o 1. Col. (R) Anwar Ul Haq Muhammad Akram, Muhammad Akram, S/o Ch. Muhammad Shafi CNIC No.17301-3889455-1 CNIC No.17301-3889455-1 CNIC No. 61101- 2. Mr. Muhammad Yousaf 2. Mr. Muhammad Yousaf 1920315-5 Khalil S/o Malik Nusa Khan, Khalil S/o Malik Nusa Khan, 2. Mr. Mujeeb Alam S/o CNIC No.17301-1490031-5 CNIC No.17301-1490031-5 Shah Jehan, CNIC

3. Mr. Kashif Khan S/o 3. Mr. Kashif Khan S/o No. 17301-1457033-9 Muhammad Hayat, Muhammad Hayat, 3. Mr. Shabeer Ahmad S/o CNIC No.17301-1347227-1 CNIC No.17301-1347227-1 Faraz Ullah, CNIC

4. Mr. Muhammad Tahir S/o 4. Mr. Muhammad Tahir S/o No. 17101-0277504-1 Sahib Gul, CNIIC No.16101- Sahib Gul, CNIIC No.16101- 9356882-3 9356882-3 5. Mr. Muhammad Fayaz S/o 5. Mr. Muhammad Fayaz S/o Kachkol, CNIC No.17101- Kachkol, CNIC No.17101- 7193842-7 7193842-7

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Med Asia Pharmaceuticals (Pvt) Ltd. Risalpur by way of (Formulation) as per Form-A of SECP as under: Previous management Retiring management New management 1. Mr. Sher Muhammad S/o 1. Mr. Sher Muhammad S/o 1. Col. (R) Anwar Ul Haq S/o Muhammad Akram, Muhammad Akram, Ch. Muhammad Shafi CNIC No.17301-3889455-1 CNIC No.17301-3889455-1 CNIC No. 61101-1920315-5

2. Mr. Muhammad Yousaf 2. Mr. Muhammad Yousaf 2. Mr. Mujeeb Alam S/o Shah Khalil S/o Malik Nusa Khalil S/o Malik Nusa Jehan, Khan, Khan, CNIC No. 17301-1457033-9 CNIC No.17301-1490031-5 CNIC No.17301-1490031-5 3. Mr. Shabeer Ahmad S/o

3. Mr. Kashif Khan S/o 3. Mr. Kashif Khan S/o Faraz Ullah, Muhammad Hayat, Muhammad Hayat, CNIC No. 17101-0277504-1 CNIC No.17301-1347227-1 CNIC No.17301-1347227-1 4. Mr. Muhammad Tahir S/o 4. Mr. Muhammad Tahir S/o Sahib Gul, CNIIC Sahib Gul, CNIC No.16101-9356882-3 No.16101-9356882-3 5. Mr. Muhammad Fayaz S/o 5. Mr. Muhammad Fayaz S/o Kachkol, CNIC No.17101- Kachkol, CNIC No.17101- 7193842-7 7193842-7

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Case No. 8 CHANGE OF MANAGEMENT OF M/S POPULAR CHEMICAL WORKS (PVT) LTD, LAHORE UNDER DML NO. 000076 (FORMULATION)

M/s Popular Chemical Works (Pvt) Ltd, 9-Km, Lahore Sheikhupura Road, Lahore, License No. 000076 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 Retiring Management Current Management as per per Form-1A Form-29 from SECP

1. Mr. Mian Asad Shuja-ur- 1. Mr. Mian Tariq Rehman. 1. Mr. Mian Misbah-Ur-Rehman Rehman S/o Shuja-Ur- S/o Mian Ghulam Qadir Rehman CNIC No. 35201- CNIC No. 35202-2773300-3. 0587490-1. 2. Mr. Abdul Hameed Piracha 2. Mr. Mian Tariq Rehman. S/o Mian Abdul Raheem Piracha CNIC No. 35202-2910398-7. 3. Mr. Mian Omer Rehman S/o Mian Misbah-Ur-Rehman CNIC No. 35202-7045808-3. 4. Mr. Mian Asad Shuja-ur- Rehman S/o Shuja-Ur- Rehman CNIC No. 35201-0587490-1.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Popular Chemical Works (Pvt) Ltd, 9-Km, Lahore Sheikhupura Road, Lahore License No. 000076 by way of (Formulation) as per Form-A of SECP as under: Previous Management as Retiring Management Current Management as per per Form-1A Form-29 from SECP

1. Mr. Mian Asad Shuja-ur- 1. Mr. Mian Tariq Rehman. 1. Mr. Mian Misbah-Ur-Rehman Rehman S/o Shuja-Ur- S/o Mian Ghulam Qadir Rehman CNIC No. 35201- CNIC No. 35202-2773300-3. 0587490-1. 2. Mr. Abdul Hameed Piracha 2. Mr. Mian Tariq Rehman. S/o Mian Abdul Raheem Piracha CNIC No. 35202- 2910398-7. 3. Mr. Mian Omer Rehman S/o Mian Misbah-Ur-Rehman CNIC No. 35202-7045808-3. 4. Mr. Mian Asad Shuja-ur- Rehman S/o Shuja-Ur- Rehman CNIC No. 35201- 0587490-1.

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Case No. 9 CHANGE OF MANAGEMENT OF M/S ZAKFAS PHARMACEUTICALS (PVT) LTD, MULTAN

M/s Zakfas Pharmaceuticals (Pvt) Ltd, Multan, License No. 000603 by way of formulation hasSubmitted 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 Retiring Management Current Management as per Form-1A Form-29 from SECP 1. Mr. Malik Noor Samad 1.Mr. Malik Noor Samad 1.Mr. Malik Kashif Kamran Awan S/o Malik Ghulam Awan S/o Malik Awan S/o Malik Noor Samad Hyder Awan CNIC Ghulam Hyder Awan Awan CNIC No. 36302- No.36302-8840665-3. CNIC No.36302- 8850165-3. 2. Mr. Malik Kashif Kamran 8840665-3. Awan S/o Malik Noor Samad 2.Mr. Malik Atif Adnan Awan Awan CNIC No. 36302- S/o Malik Noor Samad Awan 8850165-3. CNIC No. 36302-5044246-9. 3. Mr. Malik Atif Adnan Awan S/o Malik Noor Samad Awan 3.Mr. Faisal Faizan Awan S/o CNIC No. 36302-5044246-9. Malik Noor Samad Awan 4. 4. Mr. Faisal Faizan Awan CNIC No. 36302-5301868-7. S/o Malik Noor Samad Awan CNIC No. 36302-5301868-7.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Zakfas Pharmaceuticals (Pvt) Ltd, Multan, License No. 000603 by way of (Formulation) as per Form- 29 of SECP as under: Previous Management as per Retiring Management Current Management as per Form-1A Form-29 from SECP

1.Mr. Malik Noor Samad Awan 1.Mr. Malik Noor Samad 1. Mr. Malik Kashif Kamran S/o Malik Ghulam Hyder Awan S/o Malik Awan S/o Malik Noor Samad Awan CNIC No.36302- Ghulam Hyder Awan Awan CNIC No. 36302- 8840665-3. CNIC No.36302- 8850165-3. 2.Mr. Malik Kashif Kamran 8840665-3. Awan S/o Malik Noor Samad 2. Mr. Malik Atif Adnan Awan Awan CNIC No. 36302- S/o Malik Noor Samad Awan 8850165-3. CNIC No. 36302-5044246-9. 3.Mr. Malik Atif Adnan Awan S/o Malik Noor Samad Awan 3. Mr. Faisal Faizan Awan S/o CNIC No. 36302-5044246-9. Malik Noor Samad Awan 4.4. Mr. Faisal Faizan Awan CNIC No. 36302-5301868-7. S/o Malik Noor Samad Awan CNIC No. 36302-5301868-7.

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Case No. 10 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;

Title and legal status of the firm at previous Title and legal status of the firm at renewal of DML as per Form-1A Current renewal of DML as per Form-1A & Form-29 M/s Pakheim Pharma, 28-Km, Ferozepur Road, M/s Pakheim International Pharma (Pvt) Ltd, Lahore. (Partnership firm) 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: Title and legal status of the firm at previous Title and legal status of the firm at Current renewal of DML as per Form-1A renewal of DML as per Form-1A & Form-29 M/s Pakheim Pharma, 28-Km, Ferozepur Road, M/s Pakheim International Pharma (Pvt) Ltd, Lahore. (Partnership firm) 28-Km, Ferozepur Road, Lahore. (Private Limited firm)

Case No. 11. CHANGE OF MANAGEMENT OF M/S CURATECH PHARMA (PVT) LTD, 35- KM, MULTAN ROAD, LAHORE

M/s Curatech Pharma (Pvt) Ltd, 35-Km, Multan Road, Lahore under DML No. 000619 by way of formulation has submitted request for change of 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 Retiring Management Current Management as per Form-1A & Form-29 from Form-29 from SECP SECP 1. Mr. Sajid Ijaz Shah 1. Mr. Sajid Ijaz Shah 1. Mr. Muhammad Asher S/o Ijaz Hussain S/o Ijaz Hussain Khurram S/o M.I. Iftikhar CNIC No. 33104-8350132-9 CNIC No. 33104-8350132-9 CNIC No.35202-1650603-9 2. Mr. Iftikhar Ahmad 2. Mr. Iftikhar Ahmad 2. Mr. Muhammad Imran Siddiqui S/o Abdul Rasheed Siddiqui S/o Abdul Rasheed Khurram S/o M.I. Iftikhar CNIC No. 61101-3310031-7 CNIC No. 61101-3310031-7 CNIC No 35202-5323653-1 3. Mr. Bashir Ahmad Qureshi 3. Mr. Bashir Ahmad Qureshi 3. Mr. M.I. Khurram S/o Haji S/o Ijaz Ahmad S/o Ijaz Ahmad BArkat Ali CNIC No. 35202-7995621-1 CNIC No. 35202-7995621-1 CNIC No. 35202-2013319-7

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Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Curatech Pharma (Pvt) Ltd, 35-Km, Multan Road, Lahore under DML No. 000619 by way of (Formulation) as per Form-29 of SECP as under:

Previous Management as per Retiring Management Current Management as per Form-1A & Form-29 from Form-29 from SECP SECP 1. Mr. Sajid Ijaz Shah 1. Mr. Sajid Ijaz Shah 1. Mr. Muhammad Asher S/o Ijaz Hussain S/o Ijaz Hussain Khurram S/o M.I. Khurram CNIC No. 33104-8350132-9 CNIC No. 33104-8350132-9 CNIC No.35202-1650603-9 2. Mr. Iftikhar Ahmad Siddiqui 2. Mr. Iftikhar Ahmad S/o Abdul Rasheed Siddiqui S/o Abdul Rasheed 2. Mr. Muhammad Imran CNIC No. 61101-3310031-7 CNIC No. 61101-3310031-7 Khurram S/o M.I. Khurram 3. Mr. Bashir Ahmad Qureshi 3. Mr. Bashir Ahmad Qureshi CNIC No 35202-5323653-1 S/o Ijaz Ahmad S/o Ijaz Ahmad CNIC No. 35202-7995621-1 CNIC No. 35202-7995621-1 3. Mr. M.I. Khurram S/o Haji Barkat Ali CNIC No. 35202-2013319-7

Case No.12 CHANGE OF TITLE OF M/S WINTHROX LABORATORIES, K-129-A, PHASE-II, S.I.T.E, SUPER HIGHWAY, KARACHI.

M/s Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E, Super Highway, Karachi under DML No. 000807 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 Legal Status and Title as per Proposed Legal Status and Title as per Partnership Deed of The Firm Form-29 of The Firm Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E, Winthrox Laboratories (Pvt) Ltd, K-129-A, Super Highway, Karachi. Phase-II, S.I.T.E, Super Highway, Karachi. 1. Rizwan Umer Sheikh, Partner. 1. Rizwan Umer Sheikh, Director. 2. Tabassum Tariq, Partner. 2. Tabassum Tariq, Director.

Decision of CLB: The Board considered and approved the change of title of M/s Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E, Super Highway, Karachi under DML No. 000807 by way of (Formulation) as per Form-29 of SECP as under: Previous Legal Status and Title as per Proposed Legal Status and Title as per Partnership Deed of The Firm Form-29 of The Firm Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E, Winthrox Laboratories (Pvt) Ltd, K-129-A, Super Highway, Karachi. Phase-II, S.I.T.E, Super Highway, Karachi. 3. Rizwan Umer Sheikh, Partner. 3. Rizwan Umer Sheikh, Director. 4. Tabassum Tariq, Partner. 4. Tabassum Tariq, Director.

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Case No. 13 CHANGE OF MANAGEMENT OF M/S SAMI PHARMACEUTICALS (PVT) LTD, F-95, OFF HUB RIVER ROAD, S.I.T.E, KARACHI

M/s Sami Pharmaceuticals (Pvt) Ltd, F-95, Off Hub River Road, S.I.T.E, Karachi under DML No. 000072 by way of formulation has submitted request for change of 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 Retiring Management Current Management as per Form-29 from SECP Form-29 from SECP

1. Mr. Shamim Ahmed S/o 1. Ms. Nafees Yasin 1. Mr. Shamim Ahmed S/o S.M. S.M. Rafi CNIC No. W/o Muhamamd Rafi CNIC No. 42201-0709868- 42201-0709868-7. Yasin CNIC No. 7. 2. Ms. Nafees Yasin W/o 42301-4246934-6. 2. Mr. Muhammad Yasin Malik S/o Muhamamd Yasin CNIC Hameed Eid Muhammad CNIC No. 42301-4246934-6. No. 42301-0668555-7. 3. Ovais Shamim S/o Shamim 3. Ovais Shamim S/o Shamim Ahmed CNIC No. 42201- Ahmed CNIC No. 42201- 0709876-5. 0709876-5. 4. Mr. Zubair Shamim S/o 4. Mr. Zubair Shamim S/o Shamim Ahmed CNIC No. Shamim Ahmed CNIC No. 42201-0709872-3. 42201-0709872-3. 5. Mr. Shoaib Shamim S/o 5. Mr. Shoaib Shamim S/o Shamim Ahmed CNIC No. Shamim Ahmed CNIC No. 42201-0709871-7. 42201-0709871-7. 6. Mr. Junaid Shamim S/o 6. Mr. Junaid Shamim S/o Shamim Shamim Ahmed CNIC No. Ahmed CNIC No. 42201- 42201-0709876-3. 0709876-3. 7. Mr. Abdul Salam S/o Zik- 7. Mr. Abdul Salam S/o Zik-ur- ur-Rehman CNIC No. Rehman CNIC No. 42201- 42201-6555398-5. 6555398-5.

Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Sami Pharmaceuticals (Pvt) Ltd, F-95, Off Hub River Road, S.I.T.E, Karachi under DML No. 000072 by way of (Formulation) as per Form-29 of SECP as under:

Previous Management as per Retiring Management Current Management as per Form-29 from SECP Form-29 from SECP

1. Mr. Shamim Ahmed S/o 1. Ms. Nafees Yasin 1. Mr. Shamim Ahmed S/o S.M. S.M. Rafi CNIC No. 42201- W/o Muhamamd Rafi CNIC No. 42201-0709868- 0709868-7. Yasin CNIC No. 7. 2. Ms. Nafees Yasin W/o 42301-4246934-6. 2. Mr. Muhammad Yasin Malik S/o Muhamamd Yasin CNIC No. Hameed Eid Muhammad CNIC 42301-4246934-6. No. 42301-0668555-7. 3. Ovais Shamim S/o Shamim 3. Mr. Ovais Shamim S/o Shamim Ahmed CNIC No. 42201- Ahmed CNIC No. 42201- 0709876-5. 0709876-5. 4. Mr. Zubair Shamim S/o 4. Mr. Zubair Shamim S/o Shamim Ahmed CNIC No. Shamim Ahmed CNIC No. Page 32 of 116

42201-0709872-3. 42201-0709872-3. 5. Mr. Shoaib Shamim S/o 5. Mr. Shoaib Shamim S/o Shamim Ahmed CNIC No. Shamim Ahmed CNIC No. 42201-0709871-7. 42201-0709871-7. 6. Mr. Junaid Shamim S/o 6. Mr. Junaid Shamim S/o Shamim Shamim Ahmed CNIC No. Ahmed CNIC No. 42201- 42201-0709876-3. 0709876-3. 7. Mr. Abdul Salam S/o Zik-ur- 7. Mr. Abdul Salam S/o Zik-ur- Rehman CNIC No. 42201- Rehman CNIC No. 42201- 6555398-5. 6555398-5.

Case No. 14 CHANGE OF MANAGEMENT OF M/S MAPLE PHARMACEUTICALS (PVT) LTD, PLOT NO. 147, SECTOR 23, KORANGI INDUSTRIAL AREA, KARACHI

M/S Maple Pharmaceuticals (Pvt) Ltd, Plot No. 147, Sector 23, Korangi Industrial Area, Karachi under DML No. 000620 by way of formulation has submitted request for change of 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 Retiring Management Current Management as per Form-29 from SECP Form-29 from SECP 1. Mr. Mehtabuddin Feroz S/o 1.Mr. Mehtabuddin Feroz 1. Mr. Shafiuddin Feroz S/o Ferozuddin CNIC No. 42201- S/o Ferozuddin CNIC No. Ferozuddin CNIC No. 1613369-5. 42201-1613369-5. 42201-2816202-7. 2. Mr. Shafiuddin Feroz S/o Ferozuddin CNIC No. 42201- 2.Mr. Taufiq Feroz S/o 2. Mr. Mohsin Shafi Feroz 2816202-7. Ferozuddin CNIC No. S/o Shafiuddin Feroze 3. Mr. Taufiq Feroz S/o 42201-3557318-9. CNIC No. 42201- Ferozuddin CNIC No. 42201- 1967477-1. 3557318-9. 3.Mr. Sohail Feroz S/o 4. Mr. Sohail Feroze S/o Ferozuddin CNIC No. 3. Mr. Ahsan Feroz S/o Ferozuddin CNIC No. 42201- 42201-0841143-9. Shafiuddin Feroze CNIC 0841143-9. No. 42201-7653450-7. 5. Mr. Mohsin Shafi Feroz S/o Shafiuddin Feroze CNIC 4. Mr. Tehseen Feroz S/o No. 42201-1967477-1. Shafiuddin Feroze CNIC 6. Mr. Ahsan Feroz S/o No. 42201-0721036-1. Shafiuddin Feroze CNIC No. 42201-7653450-7. 5. 5. Mr. Raheel Shafi S/o 7. Mr. Tehsin Feroz S/o Shafiuddin Feroz CNIC Shafiuddin Feroze CNIC No. No. 42201-9232879-3. 42201-0721036-1. 8. Mr. Raheel Shafi S/o Shafiuddin Feroz CNIC No. 42201-9232879-3.

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Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/S Maple Pharmaceuticals (Pvt) Ltd, Plot No. 147, Sector 23, Korangi Industrial Area, Karachi under DML No. 000620 by way of (Formulation) as per Form-29 of SECP as under: Previous Management as per Retiring Management Current Management as per Form-29 from SECP Form-29 from SECP 1. Mr. Mehtabuddin Feroz S/o 1. Mr. Mehtabuddin Feroz S/o 1. Mr. Shafiuddin Feroz S/o Ferozuddin CNIC No. 42201- Ferozuddin CNIC No. Ferozuddin CNIC No. 42201- 1613369-5. 42201-1613369-5. 2816202-7. 2. Mr. Shafiuddin Feroz S/o Ferozuddin CNIC No. 42201- 2. Mr. Taufiq Feroz S/o 2. Mr. Mohsin Shafi Feroz S/o 2816202-7. Ferozuddin CNIC No. Shafiuddin Feroze CNIC No. 3. Mr. Taufiq Feroz S/o Ferozuddin 42201-3557318-9. 42201-1967477-1. CNIC No. 42201-3557318-9. 4. Mr. Sohail Feroz S/o Ferozuddin 3. Mr. Sohail Feroz S/o 3. Mr. Ahsan Feroz S/o CNIC No. 42201-0841143-9. Ferozuddin CNIC No. Shafiuddin Feroze CNIC No. 5. Mr. Mohsin Shafi Feroz S/o 42201-0841143-9. 42201-7653450-7. Shafiuddin Feroze CNIC No. 42201-1967477-1. 4. Mr. Tehseen Feroz S/o 6. Mr. Ahsan Feroz S/o Shafiuddin Shafiuddin Feroze CNIC No. Feroze CNIC No. 42201- 42201-0721036-1. 7653450-7. 7. Mr. Tehsin Feroz S/o Shafiuddin 5. Mr. Raheel Shafi S/o Feroze CNIC No. 42201- Shafiuddin Feroze CNIC No. 0721036-1. 42201-9232879-3. 8. Mr. Raheel Shafi S/o Shafiuddin Feroze CNIC No. 42201- 9232879-3.

Case No. 15 CHANGE OF MANAGEMENT OF M/S HUMAYUN INTERNATIONAL PHARMA (PVT) LTD, 20-KM, SATIANA ROAD, FAISALABAD

M/s Humayun International Pharma (Pvt) Ltd, 20-Km, Satiana Road, Faisalabad under DML No. 000443 by way of formulation has submitted request for change of 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 Retiring Management Current Management as per Form-29 from SECP Form-29 from SECP 1. Mr. Humayun Chaudhry S/o 1. Mr. Humayun 1. Mr. Tahir Humayun Chaudhry Imam-udDin C.E.O / Chaudhry S/o S/o Humayun Chaudhry Director. Chaudhry Imam-ud- Director CNIC No. 33100- 2. Mr. Tahir Humayun S/o Humayun Din C.E.O / Director 4362414-1 Chaudhry Director CNIC No. 2. Ms. Saima Tahir 33100-4362414-1. W/o Tahir Humayun 3. Ms. Saima Tahir W/o Tahir Director Humayun Director CNIC No. CNIC No. 33100- 8987772-6. 33100-8987772-6

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Decision of CLB: The Board considered and endorsed the change of management from old to new management of M/s Humayun International Pharma (Pvt) Ltd, 20-Km, Satiana Road, Faisalabad under DML No. 000443 by way of (Formulation) as per Form-29 of SECP as under: Previous Management as per Retiring Management Current Management as per Form-29 from SECP Form-29 from SECP 1. Mr. Humayun Chaudhry S/o 1.Mr. Humayun Chaudhry 1. Mr. Tahir Humayun Chaudhry Imam-udDin C.E.O / S/o Chaudhry Imam-ud- S/o Humayun Chaudhry Director. Din C.E.O / Director Director CNIC No. 33100- 2. Mr. Tahir Humayun S/o Humayun 4362414-1 Chaudhry Director CNIC No. 2. Ms. Saima Tahir W/o Tahir 33100-4362414-1. Humayun Director 3. Ms. Saima Tahir W/o Tahir CNIC No. 33100- 8987772-6. Humayun Director CNIC No. 33100-8987772-6

Case No.16 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; 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.

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.

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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).

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. Page 36 of 116

In the light of para 7-11/N, Licensing Division may proceed to take necessary action under relevant rules and regulation, please”. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to 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 cancelled by Central Licensing Board. 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. Proceedings and Decision of Central Licensing Board in 257thmeeting 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.

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Case No. 17 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ZEB LABORATOIRES (PVT) LTD, LAHORE

M/s Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital, Lahore had applied for renewal of DML No. 000122 by way of formulation for the period of 22-09-13 to 21-09-2018 on 20-09-2013. 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 21st July, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- 1. Attested Detail of management at the time of previous renewal of DML and latest management at renewal of DML along with CNIC copies of all Director / Partners. 2. Attested Nothing due certificate regarding CRF from STO (updated). 3. 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/-. 4. Approved Master Layout Plan / Proof of licensed section from CLB. 5. All documents should be duly attested. The firm submitted their reply on 21st August, 2017 After evaluation of the submitted documents, final reminder was issued on 15th September, 2017 to the firm with following shortcomings: - 1. Form 29 for year 2016-17 duly attested by S.E.C.P. 2. Nothing due certificate regarding CRF from STO (Valid upto 31-12-2017). 3. Detail of premises including approved sections from CLB. 4. Section wise detail of machinery for manufacture. 5. Detail of machinery for Quality Control Lab. 6. Copy of CNIC of appointee (Production Incharge and Quality Control Incharge). 7. Registration certificate from Pharmacy Council (Production Incharge). 8. Experience Certificate of Production Incharge as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years in relevant field of Production). 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). 11. Undertaking as whole time employee (Production Incharge and Quality Control Incharge). 12. All Documents should be duly attested. Firm submitted documents on 29th September, 2017in reply to Final Reminder but following documents are still deficient /short and application for renewal of DML is still incomplete. i. Nothing due certificate regarding CRF from STO. ii. Form 29 for year 2016-2017 duly attested from S.E.C.P. iii. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules, 1976 for proposed Production Incharge (Not less than 10 years). iv. Resignation or termination letter of Quality Control Incharge from the previous firm / promotion letter / transfer letter from the same firm. Page 38 of 116

As per available record, there seems to be change of management of the firm. The detail of which is as under: Change of management from last renewal Previous Management as Retiring Current Management per Form-1A Management as per Form-29 (Page- (Page-21/Corr) 400-401/Corr)

1. Mr. Fateh-Ullah Khan 1. Mr. Asad-Ullah 1. Mr. Fateh-Ullah Khan S/o Zafar-Ullah Khan. Khan S/o Zafar- S/o Zafar-Ullah 2. Mr. Asad-Ullah Khan S/o Ullah Khan. Khan. Zafar-Ullah Khan. 2. Mr. Khair- Ullah 2. Mr. Kaleem-Ullah 3. Mr. Khair- Ullah Khan Khan S/o Zafar- Khan S/o Fateh-Ullah S/o Zafar-Ullah Khan. Ullah Khan. Khan. 4. Mr. Kaleem-Ullah Khan 3. Mr. Saif-Ullah Khan S/o Fateh-Ullah Khan. S/o Fateh-Ullah 5. Mr. Saif-Ullah Khan S/o Khan. Fateh-Ullah Khan.

Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital, Lahore. A letter of Personal hearing has been issued on 17th January, 2018. Meanwhile a letter is receive from the firm, wherein the firm has stated that they had stopped production of common generic drugs due to some business decisions. The firm is, therefore, surrendering their Drug Manufacturing License No. 000122 (Formulation) in the name of M/s Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital, Lahore Proceedings and Decision of Central Licensing Board in 257th meeting Mr. Fatehullah Khan, Chief Executive of the firm appeared before the Board. He apprised the Board that they intend to surrender the Drug Manufacturing Licence by way of formulation for the purpose of utilizing the premises for HOTC products. The Board considering the facts on the record and after thread bare deliberation decided to cancel the Drug Manufacturing Licence No. 000122 by way of formulation issued in the name of M/s Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital, Lahore on the request of the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976

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Case No. 18 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S DR. SETHI PHARMA INDUSTRIES, CHICHAWATNI.

M/s Dr. Sethi Pharma Industries, 3-Burewala Road, Chichawatni had applied for renewal of DML No. 000293 by way of formulation for the period of 22-07-2015 to 21-07-2020 on 10-07-2015 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 1st November, 2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- 1. Details of management / proprietor / director alone with copies of CNIC attested. 2. Legal status of firm, Partnership deed, Form”C”, which one is applicable. 3. Affidavit that whether there is any change in management and provided information is correct. 4. L.O.P of firm. 5. Proof of approval of licensed sections from CLB. 6. Registration of earlier Q.C Incharge 7. Complete experience certificates dully attested for 10 years. 8. Registration of appointee from previous firm. 9. Fee challan for approval. The firm submitted their reply on 23th November, 2016 After evaluation of the submitted documents, Final Reminder was issued on 11th July, 2017 to the firm with following shortcomings: - 1. Approved copy of L.O.P and Section approval letters for section from Licensing Board. 2. Attested copies of experience letter for 10 years for proposed Q.C Incharge. 3. Resignation of earlier Q.C Incharge and present nominee.

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The firm submitted their reply on 25th July, 2017 to Final Reminder and following documents are still deficient /short and application for renewal of DML is still incomplete.

1. Approved copy of L.O.P and Section approval letters for section from Licensing Board. 2. Attested copies of experience letter for 10 years for proposed Q.C Incharge. 3. Resignation of earlier Q.C Incharge and present nominee. 4. Affidavit as sole proprietor on stamp paper. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Dr. Sethi Pharma Industries, 3-Burewala Road, Chichawatni Drug Manufacturing Licence No000293 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Dr. Sethi Pharma Industries, 3- Burewala Road, Chichawatni Reply of the show cause is received from the firm and documents were evaluated. Firm has submitted all the required documents for renewal of DML No. 000293 (Formulation) and application for renewal of DML is complete. The firm has been called for personal hearing vide Licensing Division letter dated 17th January, 2018. Proceedings and Decision of Central Licensing Board in 257thmeeting Mr. Mehmood Durrani , Production Manager of the firm appeared before the Central Licensing Board and contented that requirements has been completed by him and showcuase issued to him may be recalled. The Borad after hearing the representative of the firm advised him to comply the legal requirements in time in future and decided to cease the operation of the showcause notice issued to the firm with immediate effect.

Case No. 19 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S PULSE PHARMACEUTICALS (PVT) LTD, LAHORE.

M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore had applied for renewal of DML No. 000564 by way of formulation for the period of 31-12-2014 to 30-12- 2019 on 15-12-2014. 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 30th March, 2015 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- 1. To provide approval letters of Capsule (Antibiotic) and Oral Dry Powder suspension (Antibiotic) which are mentioned in last inspection report of renewal of DML but in licensing Division, there is no proof for grant of these sections. Page 41 of 116

2. To furnish latest Form-29 issued by Security Exchange Commission of Pakistan (S.E.C.P) and CNIC photocopies of all Directors. 3. To furnish documents / information of proposed Technical Expert with respect to Rule 16 of the Drug (L, R & A) Rules 1976 after promulgation of SRO 1134(1)/2014. The technical experts shall possess minimum 10 years experience after academic qualification. The firm submitted their reply on 04th May, 2015.After evaluation of the submitted documents, Final Reminder was issued on 17th September, 2016 to the firm with following shortcomings: - 1. As per Form-29, there seems change in management, if change then the requisite fee. 2. Job acceptance letter of Q.C Incharge. 3. Resignation letter of earlier Q.C Incharge. 4. Prescribe fee of Rs. 5000/ for approval of technical staff.

Firm did not submit their reply to Final Reminder and following documents are still deficient /short and application for renewal of DML was incomplete. i. As per Form 29, there seems change in management, if change then the prescribe fee alongwith CNIC copies of all Directors. ii. Form-29 duly attested from S.E.C.P. iii. Nothing due certificate regarding CRF from STO (Updated). iv. Duly attested Appointment letter (Q.C Incharge). v. Duly attested Copy of academic degrees (Q.C Incharge). vi. Duly attested copy of experience certificates (Q.C Incharge). vii. Undertaking as whole time employee on stamp paper. viii. Duly attested resignation letter of appointee from previous firm (Q.C Incharge). ix. Job acceptance letter of Q.C Incharge. x. Resignation letter of earlier Q.C Incharge. xi. Prescribe fee of Rs. 10.000/ for approval of technical staff. xii. Duly attested copy of experience certificates (Production Incharge). Accordingly, case was placed before the Board in its 256th meeting held on 9-10th November, 2017. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore Drug Manufacturing Licence No000564 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore A letter of Personal hearing has been issued on 17th January, 2018.

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Firm has replied to show cause notice on 22-01-2018. Application for renewal of DML is still short of following documents; 1. Form-29 duly attested from SECP. 2. Up-to-date Nothing Due Certificate (CRF) from STO, DRAP. 3. Resignation/retirement of earlier Production Incharge duly attested.

Proceedings and Decision of Central Licensing Board in 257thmeeting Mr. Umar Mehmood, Executive of the firm appeared before the Central Licensing Board and presented documents which were considered and found complete. He also contended that that requirements has been completed and showcuase issued to him may be recalled. The Borad after hearing the representative of the firm advised him to comply the legal requirements in time in future and decided to cease the operation of the showcause notice issued to the firm with immediate effect.

Case No. 20 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S DRUGPHARM (PVT) LTD, LAHORE

M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore had applied for renewal of DML No. 000366 by way of formulation for the period of 24-04-2016 to 23-04-2021 on 15-04-2016. The application for the renewal of DML of the firm was evaluated and a letter for following shortcomings / deficiencies was issued to the firm on 23th August, 2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- 1. Classes of Drugs. 2. Dosage forms of drugs. 3. Change (s) in name of proprietor / directors / partners. 4. Detail of premises including approved layout plan of the factory / proof of section from CLB. 5. Copy of approval production and QC Incharge 6. Noting due certificate regarding CRF from STO. 7. Form-29 from S.E.C.P and CNIC of partners The firm submitted their reply on 8th September, 2016 After evaluation of the submitted documents, a letter was issued on 30th January, 2017 to the firm with following shortcomings: - 1. Attested Form-29 from S.E.C.P along with copies of CNIC of all directors. 2. Any change in directors from last renewal along with Form-29 at previous renewal. 3. N.O.C for C.R.F (attested up to 2015). 4. Approved copy of Layout Plan. 5. Approved of technical staff or application / documents. 6. All documents should be duly attested. The firm submitted their reply on 23th February, 2017 After evaluation of the submitted documents, Final Reminder was issued on 19th June, 2017 to the firm with following shortcomings: - 1. Attested Form-29 from S.E.C.P along with copies of CNIC of all directors. 2. Any change in directors from last renewal along with Form-29 at previous renewal. 3. N.O.C for C.R.F (attested up to 2016). 4. Approved copy of Layout Plan. 5. Approved of technical staff or application / documents. 6. All documents should be duly attested. Page 43 of 116

Firm did not submit their reply to Final Reminder and following documents are still deficient /short and application for renewal of DML is still incomplete. 1. Attested Form-29 from S.E.C.P along with copies of CNIC of all directors. 2. Any change in directors from last renewal along with Form-29 at previous renewal. 3. N.O.C for C.R.F (attested up to 2016). 4. Approved copy of Layout Plan. 5. Approved of technical staff or application / documents. 6. All documents should be duly attested. Moreover, The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is stated that a case No. 37/17 is filed before Hon’ble Drug Court, Quetta in respect of M/s DrugPharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore. Accused are not appearing before the Court despite issuance of Non bailable warrants repeatedly. Therefore, Chairman Drug Court, Balochistan, Quetta has ordered to cancel the Drug Manufacturing Licence of said firm and report in this regard may be forwarded to Chairman Drug Court, Balochistan, Quetta. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore Drug Manufacturing Licence No. 000366 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore A letter of Personal hearing has been issued on 17th January,2018. Proceedings and Decision of Central Licensing Board in 257thmeeting No representative of the of the firm appeared before the Board. The Board considering the facts on the record and after thread bare deliberation decided to cancel Drug Manufacturing Licence No. 000366 by way of formulation issued in the name of M/s Drugpharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore on the orders of the Court 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. Case No. 21 CANCELLATION OF DRUG MANUFACTURING LICNCE OF M/S FRIENDS PHARMA (PVT) LTD, 31-KM, FEROZEPUR ROAD, LAHORE

The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is stated that a case No. 42/16 is filed before Hon’ble Drug Court, Quetta in respect of M/s Friends Pharma (Pvt) Ltd, 31-Km, Ferozepur Road, Lahore. Accused are not appearing before the Court despite issuance of Non Page 44 of 116 bailable warrants repeatedly. Therefore, Chairman Drug Court, Balochistan, Quetta has ordered to cancel the Drug Manufacturing Licence of said firm and report in this regard may be forwarded to Chairman Drug Court, Balochistan, Quetta. Proceedings and Decision of Central Licensing Board in 256thmeeting 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 cancellation of Drug Manufacturing Licence. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Friends Pharma (Pvt) Ltd, 31- Km, Ferozepur Road, Lahore. A letter of Personal hearing has been issued on 17th January, 2018. Proceedings and Decision of Central Licensing Board in 257thmeeting Mr. Nadeem Zafar, chief Executive of the company appeared before the Board and submitted orders of the Honourbale High Court, Balochistan, Quetta. Honourbale High Court, Balochistan, Quetta has suspended the ordes of the Drug Court, Balochistan, Quetta, dated 10th November, 2017 and 30th December, 2017 to the extent of the issuance of warrant of arrest and for initiating proceedings against the company. Keeping in view the facts and verbal assurance by the chief Executive of the company for appearance before the Drug Court, Balochistan, the Board decided to cease the operation of showcause notice and report shall be submitted to the Drug Court, Balochistan, Quetta. Case NO. 22 M/S HELICON PHARMACEUTEK PAKISTAN (PVT) LTD., MODEL TOWN ROAD, FAISALABAD – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.

M/s Helicon Pharmaceutek Pakistan (Pvt) Ltd, Faisalabad had submitted application dated 06-11-2015 for the renewal of DML No. 000117. 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 28-12-2016: - i. Details of management/Form-29 from S.E.C.P. Previous Form-29 and any change in management, CNIC copies of all Directors. ii. Details of premises including approved L.O.P iii. Approval of technical staff or proposed documents for technical staff as per check list iv. Proof of all licensed sections. v. N.O.C for C.R.F 2. Firm did not submit the reply of the above shortcoming letter; accordingly a final reminder was issued by Secretary CLB dated 17-02-2017.Firm submitted reply alongwith deficient documents against the final reminder for the completion of their DML renewal application as under: i. Unattested form-29 from SECP ii. Copy of L.O.P iii. Nothing Due certificate UPTO 31-12-2005 iv. Mr. Rafaqat Ali , production Incharge v. Miss ZahidaMaqsood, Q.C Incharge Page 45 of 116

3. Following documents /information is still deficient /short; i. Firm submitted the name of Miss ZahidaMaqsood as Q.C. Incharge, However it is revealed from record that she had resigned from her post on 2-1-2009 and her resignation was accepted by the management of firm. According Mr. Muhammad Rafiq Khan S/o Sultan Jan Khan was approved as Q.C. Incharge vide this office letter of even Number dated 21-07-2009 Firm did not reply for approval of approved of Q.C. Incharge Miss ZahidaMaqsood to this office was submitted resignation of Mr. Muhammad Rafiq Khan till to date as per available record of licensing Division. ii. Firm submitted form-29 (un-attested) and seems change in management, however fee Challan for change of management is not provided iii. Letter of approved Section from CCB is not provided. iv. Latest nothing due certificate for C.R.F from S.T.) is not provided. Firm submitted certificate up to 2015.

Proceedings and Decision of Central Licensing Board in 254th meeting. 4. 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. 000117 by way of formulation ofM/s Helicon Pharmaceutek Pakistan (Pvt.) Ltd, Faisalabad may not be rejected by Central Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. 5. The Show Cause notice dated 21st July, 2017 was issued to the M/s Helicon Pharmaceutek Pakistan (Pvt.) Ltd, Faisalabad.Reply of the show cause is received from the firm which is as under:- “This show cause notice is seem to be a result of misreading/ non reading of our reply received on dated 20.03.2017 and reply to your letter dated 28.12.2016 and 17.02.2017.We were required to provide following five information's/ queries i. Detail of management form-29 duly attested from S.E.C.P. previous Form-29 and any change in management. CNIC copies of all direction. ii. Detail of premises including approved layout plan. iii. Proof of all licensed sections. iv. Approval of technical staff or proposed documents for technical person as per check list. v. Nothing due Certificate for CR.F. We have already thoroughly replied all these queries/ observations by providing all requisite information and by attaching the requisite documents. We reproduce for your kind information along with the extract of requisite reply para wise as below. Which proves that this show cause/notice is unwarranted and liable to withdrawn forth with Query 1. Detail of management form-29 duly attested previous Form-29 and from S.E.C.P.

any change in management. CNIC copies of all directors. Page 46 of 116

Reply: Form 29 duly certified on 06 August 2016 diary no. 918622 from joint registrar S. E.C.P. Faisalabad elaborating he following information of all the directors. Query 2. Detail of premises including approved layout plan. Reply: The detail of premises including layout plan is attached here with again. This factory was licensed in 1962 and then under Drug Act 1976 and since then continuing at this premises duly inspected and approved and renewed as per layout plan. Query 3.Proof of all licensed sections. Reply: The license sections have been duly inspected while granting the registrations and while renewing the drug manufacturing license. This is the sufficient proof of licensed section. More over all our registrations are current and renewed.

Query 4. Approval of technical staff proposed documents for technical person as per check list. Reply: The following approved technical staff is working continuously without any interruptions After fulfillment of all requisite qualifications. As under Sr. No Name Job assigned Qualification 1. Mr. Rafaqat Ali Production Manager B. Pharmacy 2. Ms. ZahidaMaqsood Quality Control Manager B. Pharmacy copy of approval letter of Ministry of Health is attached for ready reference. Query 5. Nothing due certificate for C.R.F, Reply: Letter dated 20th March 2015 issued by the statistical officer DRAP Islamabad narrating this "Nothing due certificate is valid up to 31.12.2015" copy attached. We are amongst the pioneer manufacturing units serving the country. In the recent past we have donated 50% of our registered drugs to a charity. Thus we are not working for profit. it is not out of place to mention that in line with the suggestions of the inspection panels, we have closed down few sections and are intending to shift the production to a third party arrangement till such time that we have alternative manufacturing facility to under take these by our self for which we have made positive arrangements. We have sufficiently replied to your queries on the basis of which we were issued this un warranted show cause notice. We therefore request personal hearing to clarify our stance for ends of justice as poor patients are likely to suffer incase of any adverse consequences arising out of misreading's We may be accorded some convenient date with sufficient lead time for personal hearing as well”. Observations of the Licensing Division 6. Observations of the Licensing Division are as under: Query 1. Detail of management form-29 duly attested previous Form-29 and from S.E.C.P. any change in management. CNIC copies of all directors. Page 47 of 116

Observation: The firm has submitted copy of form-29 which is not duly attested from S.E.C.P. and not provided CNIC copies of all directors. Query 2. Detail of premises including approved layout plan. Observation: The firm did not submit approved layout plan. Query 3.Proof of all licensed sections. Observation: Not provided by the firm Query 4. Approval of technical staff proposed documents for technical person as per check list. Observation: It is revealed from the record that Ms. ZahidaMaqsood (approved Quality Control Incharge) had resigned from her post on 02-01-2009 and her resignation was accepted by the management of firm (page 56/Corr). Accordingly Mr. Muhammad Rafiq Khan S/o Sultan Jan Khan was approved as Quality Control Incharge vide this office letter of even number date 21-07-2009 (page 69/Corr). Afterwards, the firm neither applied for approval of Ms. Zahida Maqsood as Quality Control Incharge nor submitted resignation of Mr. Muhammad Rafiq Khan till date to Licensing Division. Query 5. Nothing due certificate for C.R.F, Observation: The Nothing due certificate for C.R.F. is valid upto 31-12-2015. The firm has been called for personal hearing Proceedings and Decision of Central Licensing Board in 255thmeeting No person appeared before the Board. Letter issued to the firm for personal hearing is received undelivered. The Board therefore, decided to defer the case till next meeting of the Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. A letter of Personal hearing has been issued on 1st November, 2017. The firm has replied in the response of Personal hearing letter and informed that due to paucity of time, they could not properly prepared for the personal hearing and their technical person is on leave for medical reasons. The firm, therefore, requested that the personal hearing may kindly be adjourned to the forthcoming meeting of Central Licensing Board. Proceedings and Decision of Central Licensing Board in 256th meeting. Mr. Tariq Mahmood Accounts Manager appeared on behalf of the firm the Board. He contended that their technical person is on leave for medical reasons therefore, time may be granted for next hearing to defend the case. The Board, therefore, decided to provided one opportunity for personal appearance before the Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. A letter of Personal hearing has been issued on 17th January,2018. Proceedings and Decision of Central Licensing Board in 257th meeting. Mr. Tariq Mahmood, Accounts Manager appeared on behalf of the firm before the Board. He contended that he may be given time of two weeks to complete the application. The Board considering Page 48 of 116 the facts on the record and after thread bare deliberation decided to suspend Drug Manufacturing Licence No. 000117 by way of formulation in the name of M/s Helicon Pharmaceutek Pakistan (Pvt.) Ltd, Faisalabad till completion of requirements as per Schedule B and 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.

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Case No. 23. INSPECTION REPORT OF M/S HIMONT PHARMACEUTUCALS, LAHORE. A panel inspection report pertaining to M/s Himont Pharmaceuticals (Pvt) Ltd, 17-Km, Ferozepur Road, Lahore forwarded vide letter No. F. No. 1-59/2017-FID IV dated 21st June, 2017, on the subject cited above. The panel observed that in Cephalosporin Section approved change room was not being used and it has been converted into washing area. The firm was using another room for entrance which was not provided with proper change over facility for workers. It was observed that the workers in the section were just wearing a coat over their street cloths. The panel was of the opinion that in this sensitive area of manufacturing the workers should wear proper uniform to avoid any chance of cross contamination, additionally it may pose a greater risk on workers and others safety due to exposure to the Cephalosporin powders sticking on the cloths. The panel advised the firm to provide proper change over facility for the workers. In the Capsule (General) Section, the firm has provided only manual Capsule filling machines, which seems not to be appropriate to meet the latest GMP requirements. The Panel recommended the renewal Drug Manufacturing License to all approved sections except Capsule (General) and Cephalosporin (injectable, oral dry powder suspension & capsule) section. The case was accordingly placed before the Central Licensing Board in its 255th meeting held on 16-17th August, 2017. The Central Licensing Board considered the facts of the case, legal provisions and decided as under; “The Board decided to issue 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 suspension or cancellation for Capsule (General) and Cephalosporin (injectable, oral dry powder suspension & capsule) section on the recommendations of the panel of experts”. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board: The Show Cause notice dated 12th January, 2018 was issued to the M/s Himont Pharmaceuticals (Pvt) Ltd, 17-Km, Ferozepur Road, Lahore. Reply of the show cause is received from the firm which is as under:- Sr. Observations Status No 1 General Capsule Area  Complied semi- automatic machine  It was noted that in the general capsule section the firm installed has provided only manual capsule filling machine which seemed not to be appropriate to meet  Complied. Capsule polisher and metal  The latest GMP requirement Capsule polisher and detector installed. metal detector to be installed. 2 Capsule Area (Cephalosporin)  Complied. Change over Capsule was neat and clean provided with the required facility provided machine and equipment. HVAC system was installed and  Complied, Capsule functional. It was note provided with proper change over just polisher and metal wearing a coat over their street cloths addition to cross detector installed. Page 50 of 116

contamination may also pose a greater risk on workers own and others safety due to exposure to the Cephalosporin powders sticking on the cloths. The firm was also advised to provide capsule polisher and metal detector in the section. 3 Oral Dry Powder Suspension(Cephalosporin )  Complied, Change Metal was neat and clean provide with the require machine and over facility provided equipment. HVAC system was installed and functional. It was not provided with proper change over facility for workers. The workers in the section were just wearing a coat over their street cloths which in addition to cross contamination may also pose a greater risk on workers and others safety due to exposure Cephalosporin powders sticking on the cloths. 4 Dry Powder Injectable (Cephalosporin)  Complied, Change Section was neat and clean provided with the require machine over facility provided and equipment. HVAC system was installed and functional. It was noted that entrance to this section was not provided with proper change over facility for workers. The workers in section were just wearing a coat over their street cloths which in addition to cross contamination may also pose a greater risk on workers own and others safety due to exposure to the Cephalosporin powders sticking on the cloths. 5 Quality Control  FTIR has been sent for In quality department the firm possesses necessary equipment diagnosis and to carry out the testing / analysis for the products being rectification of problem manufactured quality control equipment were installed and to Perkin Elmer calibrated. Among the major instruments the firm possesses Company. the HPLC, UV spectrophotometer. Karl Fisher, TOC, and liquid particle analyzer etc. The microbiology lab was also equipped. However, it was noted that FTIR was out of order; the firm was advised to make it functional at earliest.

The firm has been called for personal hearing vide Licensing Division letter dated 17th January, 2018. Proceedings and Decision of Central Licensing Board in 257th meeting. Dr. Maqsood Ahmed, Head Quality Operations appeared before the Board and contended that all rectifications have been made as per advice of the panel of experts. He further requested that panel of experts may be constituted for verification of the improvemengts made in Capsule (General) and Cephalosporin (injectable, oral dry powder suspension & capsule) section. The Board after hearing the represenetative of the firm decided to constitute same panel for verification of improvements made. The Board also authorized that Chief Drug Controller may be replaced with Mr. Anjum Pervaiz in the panel. Page 51 of 116

Case No. 24. INSPECTION REPORT OF M/S REKO PHARMACAL, LAHORE.

A panel inspection report pertaining to M/s M/s Reko Pharmacal (Pvt) Ltd., 13-KM, Multan Road, Lahore forwarded vide letter No. F. No. 1-21/2012-FID (F) dated 12th June, 2017, on the subject cited above. The panel observed that Liquid Injectable (General) Section was neat and clean. HVAC system was installed and functional. However, it was noted that firm has not provided appropriate vial filling machine and hence did not possess proper vial manufacturing facility. The firm has provided the necessary equipment and instrument for test / analysis of products except the liquid injectable dosage forms. It was noted the firm has not provided TOC and liquid particle analyzer, required for conducting test / analysis of liquid injectable dosage forms. Hence the firm did not possess the Quality Control facility for liquid injectable. The case was accordingly placed before the Central Licensing Board in its 254th meeting held on 15th June, 2017. The Central Licensing Board considered the facts of the case, legal provisions and decided as under; “The Board decided to issue 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 suspension / cancellation of Liquid Injectable Section on the recommendations of the Panel of Inspectors till the provision of proper manufacturing and testing facilities”. The Show Cause notice dated 26th October, 2017 was issued to the M/s Reko Pharmacal (Pvt) Ltd., 13 KM, Multan Road, Lahore. Now the firm has replied to Show Cause notice the observations of panel and reply of the firm is as under:

Observations of panel Reply of the firm Liquid Injectable (General) Section was neat In respect to the specific observation of the panel and clean. HVAC system was installed and regarding manual vial machine in the vial filling functional. However, it was noted that firm section, we are in the process of upgrading the has not provided appropriate vial filling vial section and have ordered the new automatic machine and hence did not possess proper vial filling machine (quotation is attached) which vial manufacturing facility will replace the manual vial filling machine. The firm has provided the necessary equipment As per instruction / observations of panel and instrument for test / analysis of products inspection report pertaining to M/s Reko except the liquid injectable dosage forms. It Pharmacal (Pvt) Ltd, we have upgraded our was noted the firm has not provided TOC testing facilities of liquid injectable dosage and liquid particle analyzer, required for forms. We have purchased and installed the TOC conducting test / analysis of liquid injectable analyzer and liquid particle counter and all tests dosage forms. Hence the firm did not possess for injectable dosage form are being conducted the Quality Control facility for liquid on these instruments (copies of invoices of TOC injectable. analyzer and liquid particle counter attached )

Furthermore, the firm has requested that they would highly appreciate if the CLB note the required change and withdraw the whole cause and renew their injectable section.

The firm has been called for personal hearing vide Licensing Division letter dated 17th January,Page 52 2018. of 116

Proceedings and Decision of Central Licensing Board in 257th meeting. Ms. Seemal Khalid, Director and Mr. Sameer Iftikhar appeared before the Board and contended that all rectifications have been made as per advice of the panel of experts. She further requested that panel of experts may be constituted for verification of the improvemengts made in Liquid Injectable Section. The Board after hearing the represenetative of the firm decided to constitute same panel for verification of improvements made and installation of liquid injectable filling machine.. Case No. 25 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. 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 16th June, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- 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. 3. Nothing due certificate regarding CRF from STO (Updated). 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: - 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. 3. Nothing due certificate regarding CRF from STO (Updated). 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. All Documents should be duly attested. 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 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.

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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. 3. Nothing due certificate regarding CRF from STO (Updated). 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. All Documents should be duly attested. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to 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 rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 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. Proceedings and Decision of Central Licensing Board in 257th meeting 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 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

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Case No. 26 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S CHISHTI PHARMACEUTICAL INDUSTRIES, CHICHAWATNI

M/s Chishti Pharmaceutical Industries, Chichawatni had applied for renewal of DML No. 000483 by way of formulation for the period of 19-12-2015 to 18-12-2020 on 15-12-2015 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 1st November, 2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- 1. Details of management at the time grant of DML and previous renewal of DML and present renewal of DML. 2. Details of premises including layout plan / proof of section from Central Licensing Board. 3. All documents should be duly attested. The firm submitted their reply on 26th December, 2016 After evaluation of the submitted documents, Final Reminder was issued on 19th August, 2017 to the firm with following shortcomings: - 1. Proposed Change in management agreement i.e revised deed from previous to present management alongwith attested copies of CNIC’s. 2. Requisite fee Rs. 50,000/- for change of management. 3. Form-D from registrar of firms. 4. Complete set of documents for QC Incharge (as per check list) along with prescribe fee Rs. 5,000/-. 5. Nothing due certificate regarding CRF from STO (Updated). 6. All documents should be duly attested. Firm submitted documents on 25th September, 2017 in reply to Final Reminder but following documents are still deficient /short and application for renewal of DML is still incomplete. 1. There seems to be Change in management, revised Partnership deed alongwith attested copies of CNIC’s of partners. 2. Requisite fee Rs. 50,000/- for change of management. 3. Form-D from registrar of firms. 4. Complete set of documents for QC Incharge (as per check list) along with prescribe fee Rs. 5,000/-. 5. Nothing due certificate regarding CRF from STO (Updated). 6. All documents should be duly attested. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their Page 55 of 116 application for renewal of M/s Chishti Pharmaceutical Industries, Chichawatni Drug Manufacturing Licence No000483 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Chishti Pharmaceutical Industries, Chichawatni A letter of Personal hearing has been issued on 17th January, 2018. The firm has replied to show cause notice and documents submitted by the firm are evaluated and application is found to be deficient of following documents; 1. Complete set of duly attested documents for approval of Quality Control Incharge alongwith requisite fee of Rs. 5000/-. Proceedings and Decision of Central Licensing Board in 257thmeeting Mr. Muhammad Arshad Chisti, Chief Executive of the firm appeared before the Central Licensing Board and submitted documents which have been perused found as per requirement. The Borad after hearing the representative of the firm advised him to comply the legal requirements in time in future and decided to cease the operation of the showcause notice issued to the firm with immediate effect. Case No.27 HIRRA PHARMACEUTICAL LABORATORIES (PVT) LTD, LAHORE

M/s Hirra Pharmaceutical Laboratories, 1.3-Km, Asli Raiwind Road (Ladhaky Bhula). Lahore-Cantt had applied for renewal of DML No. 000449 by way of formulation for the period of 1-08-2015 to 31- 07-2020 on 30-07-2015. 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 20th October, 2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- 1. Form 29 from S.E.C.P. newly details of management along with CNIC copies & any change in management 2. Section wise details of machinery 3. Name & qualification along with documents for QC Incharge & Production Incharge 4. Noting due certificate regarding CRF from STO. 5. Proof of all licensed Sections. The firm did not submit their reply and Final Reminder was issued on 19th June, 2017 to the firm with following shortcomings: - 1. Form 29 from S.E.C.P. newly details of management along with CNIC copies & any change in management 2. Section wise details of machinery 3. Name & qualification along with documents for QC Incharge & Production Incharge 4. Noting due certificate regarding CRF from STO. 5. Proof of all licensed Sections.

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Firm submitted documents on 13th July, 2017 in reply to Final Reminder but following documents are still deficient /short and application for renewal of DML is still incomplete. 1. Form-29 duly attested from S.E.C.P alongwith CNIC copies of all directors. 2. Duly attested document for approval of proposed QC Incharge & Production Incharge alongwith prescribe fee. 3. Proof of all licensed Sections approved by Central Licensing Board. 4. Prescribe fee of 50,000/- for change of management. 5. Prescribe fee of 50,000/- for change of Legal Status from M/s Hirra Pharmaceutical Laboratories to Hirra Pharmaceutical Laboratories (Pvt) Ltd. 6. All document should be duly attested. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Hirra Pharmaceutical Laboratories, 1.3-Km, Asli Raiwind Road (Ladhaky Bhula). Lahore-Cantt Drug Manufacturing Licence No. 000449 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Hirra Pharmaceutical Laboratories, 1.3-Km, Asli Raiwind Road (Ladhaky Bhula). Lahore-Cantt A letter of Personal hearing has been issued on 17th January,2018. Proceedings and Decision of Central Licensing Board in 257th meeting Dr. Kamran Ahmed, Director of the firm appeared before the Central Licensing Board and submitted documents which have been perused found as per requirement. The Borad after hearing the representative of the firm advised him to comply the legal requirements in time in future and decided to cease the operation of the showcause notice issued to the firm with immediate effect. Case No. 28 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S QINTAR PHARMACEUTICALS, 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. 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 22-10-2013 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

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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 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

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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. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to 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. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. 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. Proceedings and Decision of Central Licensing Board in 257thmeeting 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 Page 59 of 116 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. Case No. 29 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.

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.

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Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) 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. Proceedings of Licensing Division in compliance to the decision of 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 Proceedings and Decision of Central Licensing Board in 257thmeeting 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. Case No. 30 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SULTAN COTTON & BANDAGES, MIRPURKHAS. M/s Sultan Cotton & Bandages, Plot No. 145-146, Sindh Small Industrial Estate, Mirwah Road, Mirpurkhas Karachi, had applied for renewal of DML No. 000585 by way of formulation for the period of 08-11-2015 to 07-11-2020 on 27-10-2015. 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 07-11-2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

i. Latest Form-29 from S.E.C.P. dully attested alongwith CNIC copies of management at the time of previous renewal and now at present renewal. ii. Latest N.O.C. of CRF. iii. Detail of Premises with Proof of approved sections. iv. Job Acceptance letter of QC incharge/Production incharge. v. Required Fee for change of QC incharge/Production incharge. vi. Experience certificates of at least 10 years of proposed Production Incharge/QC Incharge. vii. Resignation letter of proposed Production Incharge/QC Incharge from previous firm. viii. Registration certificate from Pharmacy Council of proposed Production Incharge dully attested.

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Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 26th July, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of 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 approved sections. 4. Job Acceptance letter of QC Incharge and Production Incharge. 5. Required Fee of Rs 10,000/- for change of QC Incharge and Production Incharge. 6. Experience certificates of at least 10 years of proposed Production Incharge and QC Incharge. 7. Resignation letter of proposed Production Incharge and QC Incharge from previous firm. 8. Registration certificate from Pharmacy Council of proposed Production Incharge dully attested. 9. Documents should be duly attested.

Firm submitted documents on 7th August, 2017in reply to Final Reminder but following documents are still deficient /short and application for renewal of DML is still incomplete. 1. Attested Photocopy of Partnership deed (Latest) and CNIC copies of Both Partners. 2. Attested Approval letters of all sections issued by the Central Licensing Board.

3. Copy of academic degrees, as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Production Incharge and Quality Control Incharge).

4. Attested Experience Certificate of Production Incharge and Quality Control Incharge as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years in relent field). Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Sultan Cotton & Bandages, Plot No. 145-146, Sindh Small Industrial Estate, Mirwah Road, Mirpurkhas Drug Manufacturing Licence No. 000585 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 5th January, 2018 was issued to the M/s Sultan Cotton & Bandages, Plot No. 145-146, Sindh Small Industrial Estate, Mirwah Road, Mirpurkhas . Reply of the show cause notice is received from the firm on 19th January, 2018 which is evaluated and application for renewal of DML of firm is now found to be complete. A letter of Personal hearing has been issued on 17th January, 2018 Page 62 of 116

Proceedings and Decision of Central Licensing Board in 257th meeting Dr. Muhammad Saleem apeared before the Central Licensing Board and contented that requirements has been completed by him and showcuase issued to him may be recalled. The Borad after hearing the representative of the firm advised him to comply the legal requirements in time in future and decided to cease the operation of the showcause notice issued to the firm with immediate effect. Case No. 31 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S KAILGON AGRO INDUSTRIES (Pvt) Ltd, HUB.

M/s Kailgon Agro Industries (Pvt) Ltd , Hub, Balochistan had submitted application dated 10-02-2016 for the renewal of DML No. 000277 for the tenure 11-02-2016 to 10-02-2021 . 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 09-09-2016: - i. Fee for change of management/Directors. ii. Proof of all licensed sections issued from Central Licensing Board. iii. N.O.C for C.R.F. 2. Firm did not submit the reply of the above shortcoming letter; accordingly a reminder was issued by Secretary CLB dated 09-03-2017 to submit documents for renewal of DML .Firm did not submit reply along with deficient documents against the reminder for the completion of their DML renewal application. In the meanwhile firm also applied for change of both technical personsand letter dated: 27-03-2017of shortcomings was issued to the firm to submitdocuments for approval of Production Incharge & Q.C. incharge. 3. A Final Reminder dated 16-06-2017 was issued to the firm to submit following documents for renewal of DML& for approval of technical staff(Production Incharge & Q.C. Incharge): i. Attested form-29 along with Form -A from SECP(Updated). ii. Approval letters of sections issued from CLB. iii. Nothing Due certificate(Updated) iv. Prescribed fee of Rs.50,000 for change of management. v. N.O.C from previous management to new management. vi. Prescribed fee of Rs.5000 for change of Q.C. Incharge vii. Attested academic certificates of Q.C. Incharge. viii. Resignation of Production Incharge & QC incharge from previous firm. ix. Attested CNIC copy of QC incharge. x. Resignation of earlier appointed Production Inchage. 4. Firm submitted documents on 29-06-2017 in reply to Final Reminder but following documents are still deficient /short; i. Attested form-29 along with Form -A from SECP(Updated). ii. Prescribed fee of Rs.50,000 for change of management. iii. Resignation of earlier appointed Production Incharge. iv. Relevant Experience certificates of Production Incharge & QC Incharge. Page 63 of 116

v. Prescribed fee of Rs.5000 for change of Q.C. Incharge vi. Attested academic certificates of Q.C. Incharge. vii. Resignation of Production Incharge & QC incharge from previous firm. viii. Attested CNIC copy of QC incharge. Proceedings and Decision of Central Licensing Board in 255th meeting. The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the application for renewal of DML No. 000277 by way of formulation of M/s Kailgon agro industries(Pvt) Ltd , Hub, Balochistan may not be rejected by Central Licensing Board or the Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 26th September, 2017 was issued to the M/s Kailgon Agro Industries(Pvt) Ltd , Hub, Balochistan In reply to show cause notice firm has submitted the required documents for renewal of DML but upon evaluation following documents are still found deficient. i. Proposed Quality Control Incharge does not fulfill the requirement of Rule 16 (e) of (L,R&A) Rules 1976 in term of Qualification. ii. Attested Form-29 for year 2017 from S.E.C.P. iii. Resignation of earlier appointed Production Incharge. iv. Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm (Production Incharge). v. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years in relevant field) of proposed Production Incharge Mr. Muhammad Akhtar. The firm has been called for personal hearing vide Licensing Division letter date 1st November, 2017.

Proceedings and Decision of Central Licensing Board in 256th meeting. No person appeared on behalf of the firm the Board, therefore, decided to provide one opportunity for personal appearance before the Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. A letter of Personal hearing has been issued on 17th January,2018. Proceedings and Decision of Central Licensing Board in 257th meeting. Mr. Shahab Hashmi, Director of the firm appeared before the Board and contended that mail at company address is not reaching in time and therefore they are facing difficulty for submitting reply in time. He further contended that they have applied for change in management at SECP office Quetta but due to law and order situation he is unable to travel to Quetta as soon as he get certificate regarding updated management he would submit accordingly. The Board considering the facts on the record and after thread bare deliberation decided to suspend Drug Manufacturing Licence No. 000277 Page 64 of 116 by way of formulation in the name of M/s Kailgon Agro Industries (Pvt) Ltd , Hub, Balochistan till completion 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. Case No. 32 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S WYETH PAKISTAN LTD, KARACHI. M/s Wyeth Pakistan Ltd, S-33, Hawkes Bay Road, SITE, Karachi, had applied for renewal of DML No. 000006 by way of formulation for the period of 31-03-2015 to 30-03-2020 on 02-03-2015. 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 23-02-2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

i) Detail management on firm letter head, Form-29, attested copies of CNIC’s. ii) Approval letter of QC Incharge and Production Incharge if not then provide complete documents of technical persons i.e QC Incharge and Production Incharge as per checklist (enclosed). iii) List of total section of the firm and their letters of grant which were approved in meetings of Central Licensing Board. iv) No Objection Certificate for Central Research Fund (CRF) by Statistical Officer DRAP, Islamabad

Firm did not submit the shortcoming documents and a Reminder-I letter was issued on 15th February, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following shortcomings.

i) Detail management on firm letter head, Form-29, attested copies of CNIC’s. ii) Approval letter of QC Incharge and Production Incharge if not then provide complete documents of technical persons i.e QC Incharge and Production Incharge as per checklist (enclosed). iii) List of total section of the firm and their letters of grant which were approved in meetings of Central Licensing Board. iv) No Objection Certificate for Central Research Fund (CRF) by Statistical Officer DRAP, Islamabad

Firm submitted documents on 27th February, 2017 and a Final Reminder letter was issued on 29th March, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following shortcomings. 1. Detail of premises including approved layout plan / Proof of Sections from CLB. 2. Prescribed fee of Rs. 50,000/- for change of management / directors as it seems like management is changed from last renewal till at present renewal. 3. Set of documents for Proposed Quality Control Incharge and Production Incharge as per check list.

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4. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years for proposed Quality Control Incharge and Production Incharge). 5. All documents should be duly attested. Firm submitted documents on 28th April, 2017 in reply to Final Reminder but following documents are still deficient /short and application for renewal of DML is still incomplete. 1. Updated Form-29 and Form-A duly attested from S.E.C.P alongwith CNIC copies of all Director. 2. Set of documents for Proposed Production Incharge as per check list with relevant Qualification and Experience. 3. Appointment letter (Quality Control Incharge). 4. Job acceptance letter by the appointee (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. All documents should be duly attested. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Wyeth Pakistan Ltd, S-33, Hawkes Bay Road, SITE, Karachi, Drug Manufacturing Licence No. 000006 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 5th January, 2018 was issued to the M/s Wyeth Pakistan Ltd, S-33, Hawkes Bay Road, SITE, Karachi. In reply to the showcause notice firm has submitted the shortcoming documents and application for renewal of DML in now complete. A letter of Personal hearing has been issued on 17th January, 2018 Proceedings and Decision of Central Licensing Board in 257thmeeting Dr. Sadia, Head of Regulatory Affairs and Mr. Rashid, Director Production apeared before the Central Licensing Board and contented that requirements has been completed by him and showcuase issued to him may be recalled. The Borad after hearing the representative of the firm advised him to comply the legal requirements in time in future and decided to cease the operation of the showcause notice issued to the firm with immediate effect.

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Case No. 33 RENEWAL OF DRUG MANUFACTURING LICENCE M/S GABA PHARMACEUTICAL LABORATORIES, KARACHI.

M/s Gaba Pharmaceutical Laboratories, S-76, S.I.T.E, Maripur Road, Karachi, has applied for renewal of DML No. 000168 by way of formulation for the period of 29-06-2015 to 28-06-2020 on 15th May, 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 9th September, 2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- i. Legal status of firm i.e. sole proprietor, partnership, private limited or public limited company. ii. Detail of management / partners /directoralong with CNIC copies and relevant Form i.e. Form-C,D or Form-29 (whichever is applicable). iii. Form-1A duly signed / stamped by Authorized person. iv. Detail of premises including layout plan. v. NOC of CRF issued from statistical officer of DRAP (Updated). vi. Resignation / retirement of earlier Production Incharge. vii. Complete set of attested documents (as per check list) of proposed QC Incharge previous approved QC Incharge in B.Sc. and Current requirement is M.Sc. viii. Complete set of attested documents for 10 year experience.

Later on with reference to above shortcomings / deficiencies a reminder letter was issued on 7thFebruary, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976. i. Complete set of attested documents of proposed QC Incharge holding degree in M.S.C. (Chemistry) or Pharmacy and with relevant experience. ii. Latest NOC of CRF. iii. Approval letter of sections issued from CLB along with copy of approved L.O.P. iv. Attested experience certificate of 10 years of proposed Production Incharge according to Drugs (L,R&A) Rules, 1976. v. Resignation letter of previously appointed Production Incharge. vi. Resignation letter of Production Incharge Mr. RiazHusain from previous firm. vii. Attested CNIC copy of proposed Production Incharge. viii. Attested Appointment letter and Joining Report of Production Incharge. ix. Undertaking by Production Incharge. x. Prescribed Fee for change of Production Incharge Mr. Riaz Husain.

Later on with reference to above shortcomings / deficiencies a final reminder letter was issued on 27th March, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976.

i. Detail of premises including approved layout plan / Proof of Section from CLB. ii. Nothing due certificate regarding CRF from STO (Updated). iii. Fee of Rs. 5,000/- for proposed Quality Control Incharge. iv. Fee challan should be retained by STO (R&D), DRAP, Islamabad (Production Incharge). v. Provide name of approved Quality Control Incharge and Production Incharge. In case of new nominees, provide complete set of documents for Proposed Quality Control Incharge and Production Incharge with names as per check list. vi. All documents should be duly attested.

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The firm has submitted their reply on 23rd February, 2017 and 10th April, 2017 which is evaluated and still found following shortcomings / deficiencies:-

i. Detail of premises including approved layout plan / Proof of Section from CLB. ii. Nothing due certificate regarding CRF from STO (Updated). iii. Fee of Rs. 5,000/- for proposed Quality Control Incharge. iv. Complete Set of documents of proposed Quality Control Incharge and production Incharge (as per check list) Decision of Central Licensing Board in 254th meeting. The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the application for renewal of DML No. 000168 by way of formulation of M/s Gaba Pharmaceutical Laboratories, S-76, S.I.T.E, Maripur Road, Karachi, may not be rejected by Central Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 22nd June, 2017 was issued to the M/s Gaba Pharmaceutical Laboratories, S-76, S.I.T.E, Maripur Road, Karachi. A letter of Personal hearing has been issued on 17th January, 2018. The reply of the firm is received on 24-01-2018 which is as under; I would like to inform you that entire business of Gaba Pharmaceuical Laboratories has been shut down/closed completely due to certain family issues among the partners. It is not out of place to mention here that some litigation are also pending in the courts of law. Under these circumstances, we are unabale to attend your scheduled meeting. It is therefore requested to grant minimum three months time for personal appearance before the central licensing board. Your cooperation in this regard is highly appreciated. Decision of Central Licensing Board in 257th meeting. The Board considering the facts on the record and after thread bare deliberation decided to suspend Drug Manufacturing Licence No. 000168 by way of formulation in the name of M/s Gaba Pharmaceutical Laboratories, S-76, S.I.T.E, Maripur Road, Karachi 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 till settlement of codal formalities.

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Case No. 34. M/S DANAS PHARMACEUTICALS (PVT) LTD., 312 INDUSTRIAL TRIANGLE KAHUTA RAOD, ISLAMABAD CHANGE OF MANGEMENT – VIOLATION OF SECTION 34 OF DRUGS ACT, 1976 THEREOF.

M/s Danas Pharmaceuticals (Pvt) Ltd., 312 Industrial Triangle Kahuta Raod, Islamabad Licence No. 000569 by way of formulation was granted licence in 2005. The company/ firm informed for change of Chief Executive vide letter No. Danas /L&A/2014 dated 08-07-2014. Some observations were noted and conveyed to firm on 26th December, 2014 and reminder to this effect was issued on 12January, 2015. The observations which were conveyed to the firm are as under: i) It seems that management of the firm has been changed number of times without intimation to Central Licensing Board. It is not clear that who has purchased the licensed premises of M/S Danas Pharmaceuticals (Pvt) Ltd, DML No.000569 (Formulation) located at Plot # 312, Industrial Estate, Kahuta Triangle, Islamabad from Mr. Ansar Farooq, who was Chief Executive Officer of the firm according to available record of Licensing Division, DRAP, Islamabad. ii) With respect to the deed of sale dated 09-09-2011 submitted by your firm, it has been observed that one of the present Directors of your firm i.e Mr. Imran Khan S/o Muhammad Khan holding CNIC # 3602-0489641-7 has purchased this licensed unit from Mr. Rizwan Khan S/O Muhammad Khan holding CNIC # 36302-5064463-5. Mr. Rizwan Khan was not the Director of the firm as per available record of Licensing Division DRAP Islamabad and in any of Form 29 provided by your firm. Therefore you are required to submit sale deed / agreement made between Mr. Ansar Farooq, previous CEO of the firm & Mr. Rizwan Khan and to also submit copy of Form 29 issued and attested by SECP wherein Mr. Rizwan Khan was appointed as Director of the firm and also for retirement / resignation from directorship of the firm. iii) You are also required to submit attested photocopy of Form-29 issued by SECP wherein Mr. Usma Lahooti was appointed as director of the firm.

2. The firm replied that we are still waiting for the fresh Form—29 and annual return i.e Form-A for the year 2014-15 from SECP, which is expected to receive with fortnight. Meanwhile Anti Narcotics Force, Rawalpindi has also issued a letter on 26th October, 2015 wherein they referred to FIR 40/2011 ANF Police Station, Rawalpindi and directed to not to accept Form-A and 29 till finalization of said case in Supreme Court of Pakistan. 3. Danas Pharmaceuticals, Islamabad has filled writ petition through Mr. Mohammad Mustafa purported Chief Executive in the Islamabad High Court, Islamabad vide writ petition No. 1174/2016, wherein above referred letter of ANF has been contested. The court has not yet granted any relief to petitioner.Moreover, firm has been concealing information and changing their management time and again without seeking approval from the Board as under:

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DETAILS OF THE DIRECTOR OF THE FIRM FROM THE TIME OF GRANT OF DML TO TILL DATE

At time of grant of At the time of Form 29 issued Form 29 Form 29 issued Form 29 first DML in year submission of on 30-12-2012 issued on 31- on 16-04-2014 issued on 2005. The name of renewal of (Page 50- 10-2013 (Page 48- 02-07- the Directors of the DML of the 52/Corr.) (Page 53- 49/Corr.) 2014 firm on prescribed firm dated 29- 54/Corr.) (Page 45- Form 1 for 03-2011 47/Corr.) application for grant of DML (Page 87/Corr.) of main volume 1. Mr. Ansar Mr. Ansar 1. Imran Tariq Haneef 1. Mudasir Muhamm Farooq Farooq CEO of Ahmed Sole Farooq- ad 2. Mr. Muhammad the firm. Khan – proprietor of Appointed Mustafa Naveed Akhtar Appointed Tariq Hanif 2. Kaleem has been 3. Mrs. Azra 2. Usman and Co. Arshad - appointed Parveen Bashir - Chartered Appointed by Board 4. Mr. Nadeem Appointed Accountant- 3. Usama of Ahmed Khan 3. Najam-ul- re-appointed` Lahooti - Director 5. Mrs. Mehreen Ghafar- Resigned as Chief Nadeem Appointed 4. Fawad Executiv 6. Mrs. Tahira 4. Tariq Rasheed- e Officer Tasneem Haneef Sole Retirement upto the proprietor conclusio of Tariq n of Hanif and AGM in Co. 2015. Chartered Accountant- Retired

4. In the circumstance mentioned above, section 34 of the Drugs Act, 1976 and Rule 5(6) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 is not being complied. Any contravention / illegality committed by M/s Danas Pharmaceuticals (Pvt) Ltd., 312 Industrial Triangle Kahuta Raod, Islamabad would create trouble for the DRAP to nominate accused in the case. DECISION. 5. The Board deliberated on the case matter in detail in the light of steps taken by the Licensing Division and facts of the case decided to show-cause the company under Section 41 of the Drugs Act, 1976 and Rule 12 of the Drug (Licensing, Registering and Advertising) Rules,1976 as to why their Drug manufacturing Licence may not be cancelled or suspended for violation of Section 34 of the Drugs Act, 1976 and Rule 5 (6) of the Drug (Licensing, Registering and Advertising) Rules,1976. Action by Licensing Division 6. Accordingly, show cause notice was served to the firm through Chief Executive (claimant) and Director (claimant).

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Reply by Mr. Muhammad Mustufa, Managing Director & Chief Executive

7. Reply of Mr. Muhammad Mustufa

1. With due respects and apologies, aggrieved and resented with the observations given and further issuance of show cause notice dt.02-03-2017 acknowledged by us dt.07-03-2017 in the above referred meeting . In replying to show cause notice would like to bring the following points for your kind consideration that justify if dully considered, will remove all the ambiguities and issuance of un-warranted show-cause notice should be vacated . i. That first of all, present management took the control of the company in 2014 by purchasing shares at a juncture when it was at a “Crash situation” ii. That with the restructuring, the present management team set a goal to reinvigorate the image and business of the company which was tarnished / spoiled by the misdeeds of erstwhile members. Through dedication and fairness the company is gaining confidence in the business community and today IMS Data ranks it at #123 (listing of 2016). We are not just stopping here , rather we have set target to be within top 100 companies by the end of current year. iii. That currently, we are also proud to be one of the companies,chosen by the KPK Government in its campaign to purchase quality drugs from the Market at competitive prices. iv. That with the staff strength of 50 peoples and revenue generation of forty millions, In 2016 we are looking with 185 people and revenue generations two hundred Eighty five Million plus per annum. v. That is discussed earlier, In th transitional period of 2014,we took control of the management/the undersigned being Chief Executive office of the Company appointed in July 2014, and upon receipt of certified copy of Form-29 from SECP, intimated the licensing Division vide letter No. Danas L/A/2014 dated 08-07-2014, 18-11-2014 and 24-11-2014 including the paid free Challan of Rs.50,000/- dt.18- 11-2014 for change of management (copy of letter enclosed herewith as Annexure- A,B&C.) vi. That besides, the share Holders and management Team, as mentioned in preceding para, no change has been brought in the formation of the company , but re-elected till 2019.Therefore, there exists no element of concealment from the licensing Division, Whatsoever, on the part of the present Management has dully submitted to your good office vide our letter dt.10-01-2017 dully acknowledged by you dt.10- 01-2017(Attached herewith certified copies of Form-29 and Form-A for the year 2016 for your kind perusal as Annexure-D) vii. That the above fact clearly revealed that at the part of the present management there is no concealment at all from the Licensing Division . viii. That it is also pertinent to mention here that , we did queried the then Licensing Division officer that since Januray,2014 we were continuously observing the name of Mr. Imran Ahmed Khan the then C.E.O of the company not only signatory on all documents related to Ministry /DRAP, but specifically with the Licensing Division for submission of details of technical staff, layout plan, etc, for which we have seen due acknowledgements from Licensing Division, including but not limited to dealing with Area FID, DDG(E&M)/ Chairman QC for CGMP inspections, imports of material (API’s) but no objection was ever raised upon the same. Therefore, we requested the then Licensing Division to recheck/verify the record for change of

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management .However, despite assurance to do the needful, we had no reply or response. ix. That in view of our aforesaid observation, it is once again requested to re-check this aspect as the same is needed to be rectified being an act done by the erstwhile Management While dealing with the then members of Licensing Division. x. It is also stated that if some illegality ,irregularity or concealment has been committed by the previous Management between the period of 2011 up to july - 2014, the same is not attributable to us we have already submitted that we took control of the affairs of the company in July 2014. xi. That however, being the present custodian of the affairs of the company for the last three years, we are extremely apologetic for the same and are ready to rectify any error done / caused by the previous Management with the hope that the error caused previously and prior to our inclusion in the Company may be condoned. xii. That in edition to the aforesaid, through the subject Meeting, it has also been observed by the Board that we promised to submit the certified copies of Form-29 for 2014 and 2015 but remained silent about the submission. It is submitted that the same has been furnished to the licensing Division vide our letter No.L&A/DANAS/SECP/01 & DANAS/L&A/2014.(copy of letters enclosed herewith as Annexure-E) xiii. That apart from above submission, your attention is also drawn towards our meeting with the then Honourable Secretary Licensing Board Mr. Abdullah dt.22- 03-2016. In result of that meeting a detailed and elaborated /comprehensive letter/reply explaining all the happenings/events and objections /observations in chronological order since our inclusion in the affairs of the company in the year 2014 annexed with all necessary supportive documents including mentioned at aforesaid para was re-submitted to your good office vide our letter dt.24-03-2016 duly acknowledged by the Licensing Division dt.25-03-2016 (copy of letter along with all annexure enclosed herewith for your ready reference as Annexure-F) xiv. That however, about the pending certified copies of Form-A (of present management) for the year 2014 and 2015 have been dully submitted vide letter dt.08-08-2016 acknowldged by your good office on dated 09-08-2016. (Copy of letter enclosed herewith as Annexure-G). xv. That regarding ANF’s letter dt. 26-10-2015 is concerned, it was about directions (in our opinion beyond their legal scope) to our two main regulators i.e SECP and DRAP i.e not to issue certified copies of Form-A and Form-29 for the year 2014 and 2015 for SECP and not to entertain the same by DRAP respectively. xvi. That initially the issuance of certified copies of Forms A and 29 for the year 2014 and 2015 were g egretted by the SECP while acting upon the direction of the ANF. That we have approached and explained our stance to SECP vide our letter dated 19-11-2015. (Copy of letter enclosed herewith as Annexure-H). xvii. That in this connection, we also approached and explained our stance to ANF Authorities as well vide our letter dated 11-12-2015 and a copy of the same was also submitted to the license Division vide our letter No.CEO/DP/01 dated 25-12- 2015. However, the ANF Authorities did not reply that letter. (Copy of letter enclosed herewith as Annexure-I). xviii. That to contest our statuary rights vis a vis management of the Company, we were constrained to approach the Court of Law and filed a Constitutional Petition bearing No. 1174/2015, titled “M/s Danas Pharmaceuticals (Pvt) Ltd. etc. Vs. Page 72 of 116

Federation of Pakistan etc”, pending adjudication before the Honourable Islamabad High Court, Islamabad. xix. That the above scenario has also been brought to your kind notice vide our letter No. dated 13-04-2016 dully acknowledged by your good office dated 14-04-2016 (copy of letter enclosed herewith as Annexure-I). xx. That after initial few hearings and arguments raised in the above refereed case, The SECP admitted / felt their wrong footings on acting upon the directions of ANF’s letter. xxi. That therefore, during the pendency of the case, SECP has issued all the pending certified copies of Form-A and Form-29 i.e for the year 2014, 2015 and later for the year 2016. xxii. That the same have been dully submitted to the licensing Division vide our letter dated 08-08-2016 acknowledged by your good office dated 09-08-2016 and for the year 2016 vide our letter dated 10-01-2017 dully acknowledged by you dated 10-01-2017 (Attached herewith copies of letters alongwith certified copies of Form-A and Form-29 enclosed herewith as Annexure-K and L). xxiii. That although the same impugned letter in question contained direction for you as well, but it is appreciated by saluting your wisdom that the Authority has not aided any illegality on the Directions of ANF. We also appreciate this very fact that the Authority has trusted in our words and acts and confided us. Therefore, keeping in view of the stance, the Drug Regulatory Authority has been arrayed as Proforma Respondent, as no relief has been sought against the Authority. xxiv. Therefore, the undersigned while acting for and on behalf of the Company and rest of the Sharre Holders / Management assures you that ever since our inclusion, no illegality has ever been committed. However, the concerns raised by the Board in the Meeting can only be attributable to the past Management. xxv. That in the light of foregoing, we at present believe have no issues with our main regulators i.e SECP or your good office. Further the main relief we were looking for have already obtained.

2. That in the light of above submission, it would be crystal clealr that the present management haven’s concealed anything from the competent authority, the main argument of that licensing board meeting. Hence, otherwise, all other formalities are being fully complied by us So, at this juncture, we can fairly say that there is no justification and plausible reason to serve us a Show Cause Notice and it needs earnest reconciliation and revocation. Therefore your early response to safeguard our valuable interests are dire needed, and the same shall also be highly appreciated. Your precious time is also sought in furthereance of this communication for a personal hearing and we hope to hear from you soon in this regard at your earliest convenience. 3. He has also written an other letter where in he has made submission that we further would like to inform you that in response to ANF’s letter No. dated 02-03-2017 a comprehensive and well elaborated reply vide our letter dated 06-03-2017 has been dully submitted to ANF Authorities. Acknowledgement to our above refered letter ANF authorities is enclosed herewith for your kind perusal. We are looking forward to receive their appropriate reply with in fortnight inshAllah. We are very much hopeful through that expected replyPage 73 / letterof 116 our last issue pertaining to the directions given to SECP and your good office will also be resolved amicably. You are also aware of the fact that regarding issue of management and shares holding, we have already submitted up-to-date Form-A and Form-29 for the year 2016- 2019. 4. He has further responded through legal consel M/S AJURIS, Advocates & Corporate Counsel, Islamabad, Where it is stated :- i. We have been instructed by M/S Danas Pharmaceuticals (Pvt) Limited (company ) and act for and on behalf of the Compnay and Mr.Mustafa/Chief Exective Officer of the Company (Clients). This response is with refrence to Show Cause Noted 02-03-2017 issued in the name of M/s Danas Pharmaceuticals (Pvt) Limited . ii. The Show Cause Notes alleges that the company has been concealing information and changing their management without approval of Central Licensing Borad in violation of section 34 of the Drugs Act,1976 read with Rule 5(6) of the Drugs (L,R&A.) Rule,1976.Our client have been required to show cause in writing within 15 days of issuance of the Show Cause Notes as to why the Compnay’s Drug Manufacturing License No.000569 should not be cancelled or suspended . iii. You will appreciate that our Clients have filed Writ Petition No.1174/2016 titled ‘M/s. Danas Pharmaceutics (Pvt.) Limited etc. vs. Federation of Pakistan etc.’ (“Petition”) before the Honorable Islamabad High Court in which notices have been served to the Drug Regulatory Authority of Pakistan (“DRAP”). You will further appreciate that in the Petition our Clients have impugned all letters of the Anti Narcotics Force that form the foundation of the baseless allegations leveled against the Clients. Our Clients have also filed an application for interim relief in the Petition, which is pending adjudication before the Honorable Islamabad High Court. iv. It is emphasized that during the pendency of the application for interim relief, any adverse action against the Clients would be tantamount to interference with the proceedings of the Honorable Islamabad High Court. In this regard, reliance is placed on the case of Saifur Rehman Vs. Muhammad Ayub and 2 others (1998 CLC 1872) which states “Needless to point out that there is sound logic behind the proposition that a party to the proceedings cannot, while an application for interim relief is bona fide pending, blatantly so act as to pre-empt its lawful disposal because that, in given set of circumstances, may amount to doing things calculated “to interfere with or obstruct or interrupt or prejudice the process of law or the Page 74 of 116

due course of a judicial proceeding” and thus fell within the mischief of section 3 of the Contempt of Court Act, 1976.” Reliance is also placed on the case of Arif Khan and 7 others Vs. Federation of Pakistan and others (2002 CLC 601) which states that “There appears to be prima facie force in the contention of Mr. K.M. Nadeem that while notices of a lis are issued to the other side, the latter is expected to maintain a status guo.” v. The basis of the SCN is a matter in dispute pending adjudication which is ripe for final arguments and strong likelihood of success exists in favour of the Clients. Any continuation of proceedings in pursuance of the SCN while the Petition is pending may not only cause serious prejudice and loss to the Clients it may also tantamount to interference with pending proceedings before the Hononorable Islamabad High Court.

In view of the facts as stated and the law on the subject, you are requested to desist from taking any coercive action against our Clients in relation to matters pending adjudication before the Honorable Islamabad High Court. Your cooperation in this regard shall be highly appreciated. Reply by Mr. Usma Lahoti, Director.

8. Reply of Mr Usama Lahooti is as under:

1. It is submitted that I hold 66666.66 shares in Danas Pharmaceuticals (Pvt) Ltd. Since 2012, which previously were held by Tahir-ul-Wadood Lahoti (my father) since 2007. I alongwith shareholding was also the Director of the company, the title which I still hold as per the record of Security Exchange commission of Pakistan (SECP), till date. Meanwhile a case was registered against the company by ANF with regard to allotment of ephedrine to the company. During the period 2012 to 2014 due to hectic commitment in the case and subsequently the health issue of my father, which resulted into his CABG procedure, I remained mostly busy there. During 2012, the then Chief Executive, illegally prepared Form 29 against me for removal from the Board of Director and submitted the same to the SECP. The same was turned down by the SECP by declaring it as an illegal document prepared contrary to the relevant rules spelled out in the Companies Ordinace 1984. After this I was re- elected as director in 2013 by the company and my name was endorsed in the Form 29 of 2013. 2. During July, 2014, Mr. Imran Ahmad Khan resigned from the post of Chief Exeuctive and Mr. Muhammad Mustafa, on the same date took over as Chief Executive. This act was a gross irregularity of the companies Ordinance, 1984. I was neither informed nor asked to vote, as per rights authorized to me by the Companies Ordinance, 1984.

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3. During the stay of my father in the company, he had loan an amount approximately around 40 Million to the company at various stages, for various activities, from his personal account. During last quarter of 2013 when the company was asked to pay back the loan, they hesitated in one form or the other, saying that financial position of the company at this point is not in a condition to pay back such a heavy loan. Since we were in dire need of the money so the company was requested for grant of loan from the personal accounts of any of the shareholder. This request was acceded to and a resolution was passed during the Board of Director meeting held on 30th January, 2014, wherein Mr. Muhammad Mustafa and Mr. Mudassar Farooq agreed to give the loan amounting to 30.25 Millions against pledging of my shares. For which as a guarantee I had given blank dated shares deed and resignation signed and submitted the same to the company for keeping it as a pledged record. Contrary to the agreement, Mr. Muhammad Mustafa fraudulently submitted my these documents to the SECP for transfer of shares in his name. On getting this information about of his this malafide act I immediately approached SECP for non transfer of my shares in anyone name without my personal appearance. 4. Meanwhile, ANF had also frozen the shares of mine and my family through a letter to SECP during December, 2012, February, 2015 and October, 2016. In the light of these letters, SECP, paid no heed to fraudulently submitted documents for transfer of shares. After having the knowledge about this act of Mr. Muhammad Mustafa, I initiated a correspondence with the SECP mentioning about the irregularities taking place in the company, also highlighted the illegal occupation of Mr. Muhammad Mustafa as Chief Executive of the company. In response to my letter SECP gave me a comprehensive reply in February, 2016 mentioning therein that statutory documents of the company are frozen at the time of 2011 and also clarified that Form 26 submitted by the company against me stands null and void after being withdrawn by the company. Thereby confirming me back to the status of Director of the company till date. 5. After having received detail reply from the SECP about the status of self declared chief Executive by Mr. Muhammad Mustafa, I approached Drug Regulatory Authority’s (DRAP), staring from Federal Inspector of Drugs, Chairman Quality Control, Director Licensing, Director Quality Assurance and the Chief Executive Officer of the DRAP through nth numbers of time. Similarly I had been corresponding through normal letters as well as through legal notices with Mr. Muhammad Mustafa and Mudassar Farooq cautioning them about all the illegalities being performed by them as per DRAP lay as well as, as per Companies Ordinance, 1984 but unfortuneately nothing could put them right. Finally as a result of my various personal meetings with Licensing Directorate Officials in DRAP resulted in taking this case in the board meeting.

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6. To summarize the present management sitting in the company and corresponding with DRAP is totally illegal and unauthorized. As per the record of SECP according to the directions of ANF about freezing of assets. The only authorize Director is myself which has been confirmed by the SECP through their letter of February, 2016. Since the present management could not g et any headway from SECP through a marathon correspondence by their counsel and even putting all kind of pressure on the Regulators of SECP, finally they filed a writ petition No. 1174/2016 in Islamabad High Court, Islamabad. In this petition, Mr. Muhammad Mustafa and party has made ANF, SECP and DRAP as the respondents but have not made me or Ansar Farooq Ch. As respondents in the same petition. The concern of the petitioners is evident from the court record that for the past more than 4 months, the petitioner’s counsel is seeking adjournment for the one reson or the other. Moreover, the Honourable Islamabad High Court, Islamabad has not passed any restraining / supporting order in favour of petitioner. The respondents ANF as well as SECP have submitted their replies to the Islamabad High Court, Islamabad wherein they have clearly mentioned their legal position about freezing of shares and making the same non transfereable in the SECP. 7. Just for record and for demand of justice, I am attaching copies of all letters sent to SECP and their reply to me, letters / legal notices sent to Mr. Muhammad Mustafa and Mudassar Farooq and copies of letter sent to FIDm CQC, DD Licensing, Director Licensing and the CEO of DRAP, Going through these letters will give a clear idea that how much effort I have put in to stand beside the law and knock each door to get the justice. The copies of reply by ANF and SECP as respondents to the Islamabad High Court, Islamabad. 8. Keeping in view, the above brief history and seeing my efforts through correspondence with Mr. Muhammad Mustafa, SECP and DRAP, I have no doubt in conformingly mentoning that the management is illegal therefore, they should not be entertained in seeking any approval, sanctions and any other facility from the DRAP. If the company has to proceed on a legal way then all the correspondence reaching DRAP should have my signature since I am the only legitimate director as per law. It is also submitted that as per Drug Act relevant rules quoted in your show cause notice, I am being legitimate Director be authorized to take on as Chief Executive of the company. 9. In response to para 3 of your show cause notice dated 02-03-2017, I hereby confirm that Mr. Tahir-ul-Wadood Lahoti will like to be heard by the Central Licensing Board on the date of its assembly in person. You are requested to intimate about the date and venue of Board Meeting at Cell No. 0332-5555532 and 0316-5555532

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Proceedings Central Licensing Board in 254th meeting 9. Mr. Osama Lahooti, Director (claimant) or his representative could not appear before the Board. 10. Mr. Muhammad Mustafa, Chief Executive (Claimant), Mr. Muhammad Mudassir and Ahmad Junaid Advocate appeared before the Board. They pleaded their case reiterated the facts already submitted in reply to the Showcause Notice and set of documents presented before the Board. During the pleadings they apprised the Board that till March, 2016 Security and Exchange Commission of Pakistan has been issuing Form-29 and has been refusing to issue Shareholdings. They also apprised the Board that they have signed a “Sale Deed” with Mr Osama Lahooti while “Transfer Deed” is signed without date of execution. They also apprised the Board that they have contested against the letter of the ANF in the Islamabad High Court, Islamabad through Constitutional Petition bearing No. 1174/2015 whereby Drug regulatory Authority of Pakistan was directed not to accept Form-A and Form 29. A number of hearings has been held and no relief to the plaintiff has been awarded by the Honourable Court and no restraining orders are passed by the Honourable High Court. Decision of the Central Licensing Board in 254th meeting 11. The Board after hearing the one party decided to defer the case for giving final opportunity of personal hearing to the Mr. Osama Lahooti in the next meeting of the Board. 12. After 254th meeting of the Central Licenisng Board Mr. Muhammad Mustafa through his legal counsel M/s Ahmed Junaid Advocate addressed to Secretary Central Licensing Board has alleged as under: i. that he have acted on for and on behalf of M/s Danas Pharmaceuticals (Pvt) Limited (the Company) and this refers to the hearing dated 15-06-2017, under Show Cause Notice dated 02-03-2017. With regard to the same, you are being conveyed utmost disappointment on behalf of the Company, as serious observations and concerns causing grievance to the Company have been made/found during the course of the subject Meeting. It has been explicitly observed/witnessed that, you had deliberately kept the Respectable Members of CLB in dark, regarding certain aspects of our case, which are validly and legally favoring the Renewal of License. Further, in a deliberate and blatant manner, you have concealed from the minutes of CLB meeting the very aspect/fact that the present management (those who are reflecting from the updated/later/recent Form-29 issued from the SECP) are the legitimate sole owners of total 200,000 shares of the Company out of which 133,334 (66.67%) shareholding (an absolute majority) in the company holds PERFECT TITLE, and only 66,666 (33.33%) shares with the freezing status by ANF Authorities. The said aspect was supported by documentary evidences/facts as has been submitted by the Company from time to time in your good office.You have not only deliberately concealed from the respectable members of the CLB but also from the minutes of CLB meeting the fact that the company has been submitting

Page 78 of 116 all forms A and Forms 29 since 2014, which do not reflect Mr. Lahooti as Director of the company. ii. You have also deliberately concealed from the respectable members of the CLB, but also not recorded in the minutes of CLB meeting the contents of letter dated 10-01- 2017, wherein you were informed by the company that as per relevant provisions of governing law i.e. companies ordinance, 1984, through elections in the AGM of the company, as was due in October, 2016, the present Management has been elected for the period of next three years i.e. for the term 2016-2019, which do not reflect Mr. Lahooti as Director of the Company for the said term. iii The company and its present Management in therefore highly indignant and in deep dejection, which further observing the unacceptable/unwarranted biasness on the part of the Secretary Licensing Board, as it has been witnessed beyond and shadow of doubt that you have reflected a mindset to deteriorate the very interests of the company, as you have brushed aside the contents of reply to the show cause Notice, which was mainly rebutting the alleged concealment of change of Management. Through the said reply it has been maintained that it was committed/ mis-doing of the then Management, however you only discussed, to our understanding supported mostly the allegations leveled by Mr. Usama Lahoti against the present management of the company. iv Therefore, being the stake holders of the situations, they therefore, hold right to query us with expectations of an immediate/without any delay response from your side. Needless to state that you and us are fortified by the provisions of the Drugs Act, 1976 and Drugs (Licensing, Registration and Advertising) Rules, 1976, for the purpose of renewal of license. Without prejudice, it seems to us that we have sat to argue/defend the so-called and irrelevant concerns of an outgoing share holder and previous director of the company i.e. Mr. Lahooti. Therefore, in view of the same, please clarify that haven’t you created a norm/history that the Central Licensing Board is also authorized to turn its ears to any complaint, if raised and agitated regarding the title of share holdings or any dispute, if raised thereon? Or you are broadening the scope of the aforesaid legislations by acting as a Judge of your own cause? Please, write to us that which provision of the said laws warrants you to travel beyond the scope of your permitted authority. v To the best of their knowledge and understanding, if you could prove otherwise, our perusal of the aforesaid laws reveals that renewal of license of a company is only dependent to what is required under Rule-5 thereof and also disclosure of mandatory information i.e. name of management only, as required to be placed through Form-1-A. Therefore, if you are privy to any other piece of legislation, which does warrant you to arbitrate and adjudicate any correspondence/complaint as a judge, whereby a previous share holder has

Page 79 of 116 raised any objection regarding transfer of shares, or his directorship, then you are requested to share the said law with us as well. vi. You are also reminded that during the hearing of show Cause Notice, we have referred to plethora of decisions given by the Central Licensing Board’s Meetings, wherein the Board while renewing the License/Change of management has only resorted to Form-29 of the company which the company has been dully submitting since 2014. We are also keen to know that what made you convinced to contradict and deviate from the previous decisions passed/taken by the Board, whereby the Licenses have been renewed on the basis of the information available through Form-29, issued by the SECP. vii All the aforesaid events and those out of our previous hearing, transpire beyond any shadow of doubt that you have taken steps ahead to facilitate the concern of Mr. Lahooti and that too in such a manner that you forget to follow the law governing your ambit and preview/authority. This is also to state that the Show Cause Notice only levels an allegation of concealment on our part, which we clarified and rebutted through convincing/tangible and reliable evidence. viii Knowingly well that you are not empowered to do so under the law, but to our extreme astonishment, we are unable to understand as to what personal interests/fringe benefits, or simply what urgency was existing on your part that made you to adjudicate upon. We are also unable to understand, what exactly barred you that even you didn’t even bother to make it part of show cause notice or call an explanation/justification/from the company prior to discussion in the CLB, which you are under an obligation to. But rather, you seem completely biased to the Company, whereas it should not be based on personal grievances, rather it is about legal proceedings against a legally licensed company and the company and its present management owe all its rights and reservations, but given your KNOWINGLY/DELIBERATELYRENDERING AN UNJUST JUDGMENT/FAVORITISM/NEPOTISM in favour OF AN ALIEN TO THE PRESENT MANAGEMENT, YOU EVEN have given him another opportunity of hearing to fulfill his suspicious plans. Although Show Cause Notice was very clear and candid that if nobody appears, the decision with made ex-parte. ix As matter of fact, you must understand that this is the licensed company duly licensed under Drugs(Licensing, Registration and Advertising) Rules, 1976, in particular you are dealing with, and not merely the Shareholder of the Company and this is THE COMPNAY which takes full responsibility of th records and documents attached with or contents declared thereof submitted through statuary documents/ forms from time to time dully certified by the SECP, wherein your role is mere an employee and the law applicable on the subject make you a PUBLIC SERVANT, who as the custodian of law, is not only required to maintain the norms

Page 80 of 116 of justice and equity, but is expected to deal with the affairs fo the Companies without any fear, favour or nepotism. x That although you are not in your legal capacity to play the role of an adjudicator under various provisions and sections of the Drugs (Licensing, Registration and Advertising) Rules, 1976 as we have every reason to believe that you have acted in excess of your legal jurisdiction. It was your moral but definitely a legal obligation to first enquire the stand of the Company by sharing the documents/claim submitted by Mr. Lahooti, and in the light of that submissions you should have questioned us or ask any reply after testimonial of the evidences, heard/seen from both end. xi. It is also strange that you have failed to advice Mr. Usama Lahooti that SECP under the preview of various PROVISIONS of Companies Ordinance 1984, i.e. Section-76, Section 152 and Section-290, DRAP is not the competent Authority to adjudicate such matters but only Civil Court has jurisdiction to adjudicate thereon. Further, if any Shareholder is aggrieved of omission of his name from the register of Share Holders, it is only for the Company Judge of High Court to decide and adjudicate the said issue/matter under Section-152 of the Companies Ordinance, 1984. On the contrary by agitating this matter in the CLB, you have rendered him favour, which is highly unbecoming of a man of your stature. xii Even worse than this, you seem to favor/show fidelity to Mr. Usama Lahooti, as YOU deliberately concealed our letters written a year ago dated 21-03-2016 and 24-03-2016 from the CLB in the hearing, wherein we have explicitly explained/clarified/informed your good office that Mr. Lahooti was removed from directorship of the company in year, 2012 and was never re-instate or re-elected by the board of the company, you not only turned a deaf ear to our aforesaid letters, but miserably failed to convey our advice to Mr. Lahooti that DRAP is not competent forum to adjudicate upon his grievance, if any. xiii Further, you have deliberately concealed from the Respectable Members of CLB that the Company has submitted the dully certified Form-29 dated 04-10-2012 issued by SECP wherein Mr. Lahooti having tendered his willful resignation from the said office on 19- 09-2012, in lieu of his forced removal from the directorship through Board Resolution passed by the then management and by the vast majority of the shared holders on 19-09-2012 (copy of the said resolution is re-enclosed for your kind perusal and understanding) the same was duly acknowledged by him on 05-12-2012. Afterwards he was never restored neither re-appointed nor elected by the company since 2012 copy of Form-29 dated 04-10-2012 (Fresh copy of the said Form-29 dated 04-10-2012 re-attested and re-certified on dated 14-07-2017 by SECP is enclosed herewith for your kind perusal and understanding) . xiv We have already reached to the conclusion that having your sympathies for him, Mr. Usama has been knitting a plan against the Company and its Management, and having got your illegal support, while playing a dubious role, you mysteriously portrayed this whole Page 81 of 116 matter suspicious in front of CLB, by referring to a Form-29 dated 31-10-2013, wherein Mr. Usama is shown re-elected as Director till 2016, as becoming a part and parcel of Mr. Lahooti’s intrigue thinking you kept a dreadful and criminal silence at your part of justification, to the fact that the said form-29 is not issued/certified by the SECP. xv We have strong apprehension about accepting/entertaining of the said Form, though knowingly well that the same has no legal sanctity and is a sheer violation of your lawful duty, rather we consider it the mischief/misconduct on your part while acting as the Secretary Licensing Board. The said act of yours in unfathomable and incomprehensible to the company and its management and needs immediate clarification/legal footing, if any, from your side. At the same time, we reserve the right to question the validity of the said Form in the court of law. xvi Further, you have also deliberately concealed from the respectable members of CLB that the company has been submitting all Form A and Forms 29 since 2014, which don not reflect Mr. Lahooti as Director of Company.Let the company make it very clear that the aforesaid on your part is your acts of duality and it further give rise to a simple question about your conduct and your impartiality as The Secretary Licensing Board. xvii. It is hard to understand that, what made you to sit and act as a judge and term Mr. Usama’s so-called complaint a Dispute. This leads to the conclusion that either you are unable to understand the scope of your duties inside the Central Licensing Board, or you are acting in flagrant disregard of the same. Therefore, to justify your part, we shall also await to see, when you will write a letter to Mr. Usama clearly stating therein that he should approach the appropriate forum, if he has any objection of the transactions inside the Company OR OTHERWISE WE SHOULD BE CALLED UPON WHEN HE WILL BE HEARD IN THE UP COMING MEETING OF CLB TO COUNTER HIS CLAIMS/DOCUMENTS. And in case, you fail to do so, it will lead to the conclusion, as drawn aforesaid, that you are acting hands in gloves with Mr. Usama under the garb of his evil designs coupled with your personal interests. xviii You must be already privy to the fact that we have issued a letter dated 21-03- 2016 in the name of Mr. Usama Lahooti to withdraw from his evil designs or at-least approach the Court of law against us to prove the same. You are also therefore, as we consider the same malicious and unproductive attempts and futile efforts on your part, advised to forthwith withdraw your un-lawful objection/arbitration or else, we shall be within our rights to hold you answerable before the Courts of law to prove your legal standings and footings, and in case of your failure to prove the same, you shall also be liable to face our claim of damages. xix. We have also seen that during the hearing of show cause notice you told us that letter dated 26-10-2015 written by ANF has tied your hands and you have expressed your inability to acknowledge the change of Management due to the same, But more Page 82 of 116

surprisingly, for un-known reason you had deliberately concealed from the minutes of CLB in dark about ANF’s letter dated 30-05-2017 in which ANF’s Authorities have shown their inability to respond to their earlier letter dated 26-10-2015, as the matter is prejudice before the Honourable Islamabad High Court, which raises a very serious question that if ANF’s Authorities couldn’t stand to their stance, how you could react to the same? (Copy of the said letter is enclosed herewith for your kind perusal and understanding) xx. But even to settle this issue, when you were asked to give us the same in writing that enable us to place the same before the Honourable Court to get directions thereof, you simply flare up and used abusive language with Representative of the Company, who came to your office for the letter. The company and its management reserve right to place on record of the appropriate forum, the recorded/documented version of your conduct, as you have shown to the company’s representative. xxi. You are further directed, as well as required, through this communication to forthwith and in any case within FIVE DAYS of receipt of the instant letter, do the needful done, as required through preceding paras, failing which we reserve our rights and, therefore, shall be at liberty to initiate legal proceedings against you. In that eventuality, this is to inform you further, that we might feel obligated to divulge to the Court of Law or any other competent forum to secure our rights. Looking forward to hear from you soon. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. 13. Mr. Osama Lahooti has been called for personal hearing. Proceedings and Decision of Central Licensing Board in 255thmeeting 14. The Secretary, Central Licensing Board separated himself from the proceedings of the case in the light of allegations from legal counsel of Mr. Muhammad Mustafa as reproduced at para 12 above and went out of the Committee Room. The honourbale members of the Board brought him back and posed confidence on him being Secretary of the Central Licensing Board. The Board also condemned in stronger terms the contents of the letter written by legal counsel of Mr. Muhammad Mustafa. The Board also reiterated that decision taken and recorded in minutes are taken by the Board and not by any individual and allegations leveled against the Secretary, Central Licensing Board are baseless and of infected mind. The observers on the Board also condemned the contents of the letter written by legal counsel of Mr. Muhammad Mustafa in stronger terms. 15. Col. (R) Tahir ul Wudood Lahooti father of Mr Osama Lahooti appeared before the Board as representative of Mr Osama Lahooti. He contended that: i. I, hold 33% shares of the company till date. ii. I am the legitimate director of the company till date as clarified by the SECP during their letters. iii. All documents submitted by Mr. Muhammad Mustafa to your office against my share holding and directorship are false, fabricated and have been turned down by the SECP, being the regulator of private limited companies as per the Company Ordinance, Page1984. 83 of 116

iv. Since July 2014 onward, every activity took place in the company related to purchases, obtaining sanctions from DRAP related to the active and inactive materials are illegal and also are in total violations of Drug Act. v. All relevant restrictions imposed by the Anti Narcotics Force (ANF) have also been communicated to your office since October, 2015 which clearly directs that sharing capacity of mine cannot be changed. vi. I have been communicating with all relevant offices in the Drug Regulatory Authority, Pakistan starting from FID, CQC, DDG Licensing, Director Licensing and the CEO of DRAP. vii. Mr. Mustafa and party have not been able to prove their legal position in front of all legal Regulators. viii. Restriction imposed by the ANF on transfer of my shares have been communicated to all the concerned regulators since October, 2015. ix. I definitely have apprehension about illegal activities in the company which may harm me, being a director, and not being a part of management physically. x. Drug Act paras quoted in the show cause notice if read and viewed, it allows the board to handover the management to me being the legitimate director in all legal documents. xi. If the DRAP accepts the direction of ANF conveyed then it must accept my shares holding and directorship. Similarly if DRAP and the Licensing Board do not accept the ANF direction then it must be conveyed to me in clear words so as enabling me to approach the appropriate forum regarding this decision of Drugs Licensing Board. The Board after hearing the versions of both Parties, is of the unanimous view that the dispute between the Parties is regarding the share holding of the Company i.e M/s Danas Pharmaceuticals (Pvt) Ltd., 312 Industrial Triangle Kahuta Raod, Islamabad which is purely of civil nature and not within the mandate and jurisdiction of the Board. The Parties therefore, may be advised to have it resolved from the Court of competent jurisdiction. Meanwhile, since the important question before the Board is that who will be responsible for any irregularity / illegality during the time the question of ownership is resolved by the Court. It was resolved that the Secretary Licensing Board, may write a letter to Anti Narcotics Force, in reference to their last received letter stating therein that the Board has received an application from one of the Parties, who has allegedly acquired the major share holding in the Company and same has been endorsed by the Securities and Exchange Commission of Pakistan (SECP), but the Board is unable to process their application due to the impeding instructions issued by the Anti Narcotics Force vide their letter No. F. 2 (132) Assets/ANF/IR/2011-4143 dated 26th October, 2015, F. 2 (132) Assets/ANF/IR/2011-4143 dated 02 March, 2017. Therefore, ANF, may advise the Board the course of action required to be taken in this regard. Compliance of the Licensing Division. In the light of decision of Central Licensing Board in its 255th meeting, a letter dated 2nd October, 2017 was written to Anti Narcotic Force for seeking their advice that the whether the request of Mr. Mohammad Mustafa, Chief Executive (Claimant) may be entertained for change of management.

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Reply of the ANF dated 8th November, 2017. 1. It is intimated that quota was allocated in the name of company which is nominated through its administration in case FIR No.40/2011 PS ANF Rawalpindi.

2. It is further intimated that the matter is sub-judice before the Honourable Islamabad High Court and learned CNS Court, Islamabad. Moreover, proceedings for freezing the shares of Usama Lahoti in CNS Court Islamabad have been initiated in which next date of hearing is 15- 11-2017.

3. Forgoing in view it is advised that no action regarding transfer of shares / change of administration be taken till finalization of above said case, please.

Reply of the ANF dated 13th December, 2017. 1. Assets inquiry of all stakeholders in case FIR No.40/2011, State Vs Ansar Farooq etc. PS ANF Rawalpindi is under process.

2. Apropos, it is requested that any adverse order may not be passed or any such process may not be initiated prejudiced to the right of company / persons to conduct business till finalization of the inquiry, please.

Proceedings and Decision of Central Licensing Board in 257thmeeting The Board considered the replies received from ANF Rawalpindi which is law enforcement agency. ANF Rawalpindi has advised that no action regarding transfer of shares / change of administration be taken till finalization of above said case and any adverse order may not be passed or any such process may not be initiated prejudiced to the right of company / persons to conduct business till finalization of the inquiry. The Board therefore decided to pend the case till decision by the court of the competent jurisdiction on the subject matter. Case No. 35. 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.

Case Background 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 Current Management as per Memorandum and Article of Form-1A (Page 8/Corr) dated Association (Page 33/Corr – 14-07-2017 main file) i. Mr. Mumtaz Ali i. Mr. Muhammad Azmat Ali ii. Mrs. Lal Zari ii. Mr. Amjad Ali Zeb iii. Mr. Farman Ali

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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; 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 The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why 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. Case No.36 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. With reference to above letter, the firm submitted some documents. Upon evaluation, a final reminder with following shortcomings was issued to the firm; 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. Page 86 of 116

vi. Nothing due certificate regarding CRF from STO. vii. Documents of proposed Quality Control Incharge (Mr. Hashim) 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 257th meeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to 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. Case No.37 M/S EG PHARMACEUTICALS, 13-A, INDUSTRIAL TRIANGLE, KAHUTA ROAD, ISLAMABAD – VIOLATION OF RULE 16 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. Page 87 of 116

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. Case No. 38 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 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. The firm submitted documents on 29-09-2015 but following documents were still 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 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. All Documents should be duly attested.

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Now the Division of Budget and Account has forwarded Nothing due certificate regarding CRF from STO (Updated) and following documents 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. 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 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. 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. Case No. 39 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.

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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. 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. 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.

Case No. 40 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 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:- 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 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. 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. Case No. 41 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 renewal of DML No. 000713 by way of formulation on 13-07-2016 for the period of 15-06-2016 to 14-06-2021.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 19-09-2016:- 1. The application of renewal of DML is 30 days late. 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. Page 91 of 116

5. Updated Nothing due certificate for CRF from STO (R&D) DRAP, Islamabad.

The firm submitted documents on 18-10-2016 but following documents were still 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.

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 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. Case No. 42 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S BAXTER PHARMACEUTICALS, KARACHI

M/s Baxter Pharmaceuticals, A-1/A, Scheme No. 33, Phase-II, S.I.T.E, Super Highway, Karachi had applied for renewal of DML No. 000700 by way of formulation on 28-01-2016 for the period of 25-02-2016 to 24-02-2021.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 07-11-2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

i. Form 1-A. ii. Class(es) of Drugs. iii. Dosage form(s) of Drugs. iv. Name of Drug(s) registered. v. Name of Proprietor/Director alongwith attested CNIC copies. vi. Detail of Premises including approved L.O.P. vii. Detail of Section-wise equipments/machinery. viii. Detail of Technical Staff. Page 92 of 116

ix. Latest N.O.C. of C.R.F.

The firm did not submit their reply. A Reminder-I was issued on 24-04-2017 to the firm with following shortcomings: - 1. Form 1-A, 2. Class(es) of Drugs. 3. Dosage form(s) of Drugs. 4. Name of Drug(s) registered. 5. Name of Proprietor / Director along with CNIC copies 6. Detail of premises including approved layout plan / Proof of Sections from CLB. 7. Detail of Section-wise equipments/machinery. 8. Nothing due certificate regarding CRF from STO (Updated). 9. Provide name of approved Quality Control Incharge and Production Incharge. In case of new nominees, provide complete set of documents for Proposed Quality Control Incharge and Production Incharge with names as (per check list) along with prescribe fee. 10. All documents should be duly attested. The firm did not submit their reply. Final Reminder was issued on 19-06-2017 to the firm for above mentioned documents. The firm has submitted the requisite documents. Upon evaluation, following documents are still found to be short and application for renewal of DML is still incomplete; 1. Prescribed fee for change of management. 2. NOC from previous management. Proceedings and Decision of Central Licensing Board in 257th meeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the application for renewal of DML No. 000700 by way of formulation of M/s Baxter Pharmaceuticals, A- 1/A, Scheme No. 33, Phase-II, S.I.T.E, Super Highway, Karachi may not be rejected by Central Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Case No. 43 CANCELLATION OF DRUG MANUFACTURING LICENSE NO. (000663) (FORMULATION) OF M/S AL-AJU COTTON INDUSTRIES MIR PUR KHAS SINDH.

The case was presented before the Board as under:-

The brief background of the case is as under: - Federal Inspector of Drugs Dr. Najam-us-Saquib visited M/s Al-Aju Cotton Industries on 28th June 2013 wherein the FID had reported that there was no production activity underway and premises were found closed. He had further informed that letters and reminders to the firms were issued but no reply from the firm was received. The neighboring person informed that there was no production activity since long and said premises alongwith other surrounding land had been purchased Page 93 of 116 by another person namely Mr. Amjad Memon. On contact to Mr. Amjad Memon he had confirmed that he had purchased the whole land and he did not know about running a pharmaceutical unit, nor he was interested in the same. The FID had recommended for cancellation of Drug Manufacturing License of M/s Al-Aju Cotton Industries, Mirpur Khas, Sindh. Accordingly the case was placed in 233rd meeting of CLB held on 30th & 31st December 2013. Decision of CLB taken in 233rd meeting held on 30-31 December, 2013.

The Board in light of inspection report of area FID and after thorough discussion and deliberations decided to issue Show Cause notice to M/s Al-Aju Cotton Industries, Mirpur Khas, Sindh and called the firm for personal hearing in next meeting before cancellation of DML. Board further decided to collect the DML and Inspection Book through area FID.

Accordingly, Show Cause notice was issued to the firm and the firm was also called for personal hearing in the 234th meeting of CLB. The firm did not respond to the show cause notice. The case was again placed before the Board in its 234th meeting held on 27-02-2014 however firm also failed to appear for personal hearing despite of issuance of letter for the same. Decision of CLB taken in 234th meeting of CLB held on 27-02-2014

The Board after thorough discussion / deliberations and facts on grounds considered and deferred the case for final opportunity of personal hearing and collection of DML and inspection book through Area FID before suspension / cancellation of DML. 3. Accordingly, the decision was conveyed to the firm for final opportunity of personal hearing and a letter was also issued to area FID to collect the DML and inspection book. But no response received from area FID and firm. Accordingly the case was once again presented in 235th meeting of CLB held on 15th May 2014 for consideration/decision. Decision of CLB

The Board after thorough discussion/deliberation and facts on ground decided to defer the case for report of area FID.

No report from area FID. In the light of aforesaid decision is received till date. Proceedings and Decision of Central Licensing Board in 257th meeting The Board considering the facts on the record and after thread bare deliberation decided to give final opportunity to area Federal Inspector of Drugs for updated report for perusal of the Board.

Case No. 44 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 Page 94 of 116 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 The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5 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. Case No. 45 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 renewal of DML No. 000094 by way of formulation on 12-04-2016 for the period of 19-04-2016 to 18-04- 2021.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 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.

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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 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) 12. All documents should be duly attested. The firm submitted documents on 13-09-2017 is 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 Management as Management as Current Status per Form-1A at per Form-1A at per Form-1A at the time of the time of the time of renewal of DML renewal of renewal of DML for tenure 19-04- DML for tenure for tenure 19-04- 2006 to 18-04- 19-04-2011 to 2016 to 18-04- 2011 18-04-2016 2021

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i. Mr. Not Provided i. Mr. Nadeem i. Mr. Nadeem Muhammad Firdous. Firdous. Firdous. ii. Mr. Abu ii. Mr. Umar ii. Mr. Obaida Butt & Butt Muhammad Others. Yaqoob Butt and Others.

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. 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. Case No.46 CANCELLATION OF DRUG MANUFACTURING LICNCE OF M/S MEDIPAK LTD,132/1 INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE.

The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is stated that a case No. 19/2016 is filed before Hon’ble Drug Court, Quetta in respect of M/S Medipak Ltd,132/1 Industrial Estate, Kot Lakhpat, Lahore. Accused are wasting time of Hon’ble Court by adopting delaying tactics.. Therefore, Chairman Drug Court, Balochistan, Quetta has ordered to cancel the Drug Manufacturing Licence of said firm. Meanwhile, M/s Medipak Ltd, 132-Industrial Estate, Kot Lakhpat, Lahore, wherein firm has submitted a copy of orders dated 29-11-2017 of Hon’ble High Court Balochistan, Quetta wherein The Hon’ble High Court suspended the directions of Drug Court, Balochistan Quetta till next date of hearing i.e, 20th December, 2017. Proceedings and Decision of Central Licensing Board in 257thmeeting The Board considering the facts on the record and after thread bare deliberation decided to seek updated status from the firm regarding the case and accordingly communicated to the Honourable Drug Court. Case No. 47. CONSIDERATION OF BIOCHEMISTS FOR APPROVAL AS QUALITY CONTROL INCHARGE.

Case Background Mr. Jehangir Alam was proposed as Quality Control Incharge by the M/s Pak Risen Pharmaceuticals, Hattar but application was rejected by the Licensing Division on the basis that he does not fulfill the requirement of Rule 16(e) of Drugs (L,R&A) Rules, 1976 in terms of qualification as he holds the degree of BS (Hons) in Biochemistry. Page 97 of 116

Now, Mr. Jehangir Alam, Assistant Quality Control Manager, M/s Pak Risen Pharmaceuticals, Hattar has requested to consider Biochemists for approval as Quality Control Incharge as under; “It is stated with great concern that I am a Biochemist and I am associated with Pharmaceutical Industry for about 10 years. I have worked as Quality Control Incharge (DRA approved) for about 04 years. Recently I have applied for the post of Quality Control Incharge from PakRisen Pharmaceuticals but my case was declared rejected as I was found deficient on Rule 16(e) of Drug Act 1976 (i.e degree of Biochemistry was not considered as a branch of chemistry). I have discussed this matter with honorable Dr. Manzoor Bozdar Sahib and Shaikh Faqeer Muhammad Sahib and they both respectable dignities directed me to consult HEC for a clarification note on Biochemistry as a branch of chemistry So, I did accordingly and submitted my application to HEC. The panel of curriculum board immediately responded in positive and declared Bio- chemistry a one of the main five branches of chemistry and more over they (HEC) enquired my need for this clarification so I wrote about the rules of DRAP 16(e). They had gone through my case in detail and released a detail clarification note on “Biochemistry as one of the main branch of chemistry”. (Copy of Declaration note attached) Honorable sir, I am working as assistant quality control manger despite of all my experience of pharmaceutical laboratory. Our biochemist friends of India and Philippines are working as quality control Incharge without any objection in their respective authorities. We request honorable DRAP to consider (Biochemists) for Quality Control Incharge. The course outline of biochemistry suggests that it is the most closest and appropriate branch of chemistry for pharmaceutical laboratory.”

CLARIFICATION BY HEC “It is hereby to inform you that your case was forwarded to our expert for comments/reply. The reply from expert is reproduced below; i. Biochemistry is one of the five branches of Chemistry. ii. Pharmacology is the branch of Biochemistry. iii. Physical Chemistry and two subjects of organic Chemistry were taught compulsory in BS Biochemistry and are evident from the mark sheet of applicant. iv. Subject of analytical techniques was taught in the degree under heading Biochemical Techniques in which Homogenization, Centrifugation, Spectrophotometry, Chromatography, Gas Chromatography, HPLC, IR, Atomic Absorption, Electrophoresis and other chemical techniques are extensively studies using chemical, pharmaceutical and biological samples. v. Other techniques like density, viscosity, pH and titrations and drug quantity determinations are the part of studies in the degree. vi. That BS Biochemistry fulfill the requirement of Rule 16(e) of Drugs (Licensing, Registering and Advertising) Rules, 1976 in terms of qualification.

Therefore, based on the above observations, it is to informed that Biochemistry is a branch of Chemistry and falls in domain of Chemistry under Drugs Rule 1976.” Proceedings and Decision of Central Licensing Board in 257thmeeting Deferred for detailed working regarding the subject being taught in different Universities.

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Case No.48 APPROVAL OF MASTER LAYOUT PLAN / AUTHENTICATION / REGULARIZATION OF EXISTING FACILITY, DRUG MANUFACTURING LICENSE NO.000379 (FORMULATION) OF M/S MUNAWAR PHARMA (PVT) LTD, LAHORE

M/s Munawar Pharma (Pvt) Ltd, 31-Km, Ferozepur Road, Lahore, DML No. 000379 (Formulation), has applied for regularization of layout plan of running facility for their following existing sections which were licensed before the promulgation of S.R.O. 470/98 dated 15th May 1998 when approval of layout plan was not mandatory: -

Regularization / Authentication / Amendment of Already existing Sections. 1. Tablet (General) Section. 2. Liquid (General) Section. 3. Liquid Injection (General) Section. 4. Capsule (Cephalosporin) Section 5. Oral Dry Powder Suspension 6. Capsule (Penicillin) Section (Cephalosporin) Section 7. Oral Dry Powder Suspension 8. Tablet (Psychotropic) Section (Penicillin) Section 9. Injection (Psychotropic) Section 10. Quality Control Laboratory

Accordingly, layout plan of firm was approved/regularized/authenticated and following panel was constituted to verify the above sections of firm as per approved layout plan.

1. Dr. Ikrarm-ul-Haq, Member Central Licensing Board. 2. Prof. Dr. Muhammad Jamshed, Dean Faculty of Pharmacy, University of Central Punjab, Lahore. 3. Mr. Asim Rauf, Deputy Director General (E&M), DRAP, Lahore. 4. Hafiz Muhammad Jawad Ali, Federal Inspector of Drugs, Lahore-V.

Accordingly, Panel has inspected the premises and verified the above mentioned section.

Recommendations: - The Panel of inspectors endorsed the regularization of the above mentioned section to M/s Munawar Pharma (Pvt) Ltd, 31-Km, Ferozepur Road, Lahore Proceedings and Decision of Central Licensing Board in 257thmeeting The Board approved the regularization of Layout Plan as per recommendations of the members of the panel.

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QUALITY ASSURANCE CASES Item No. I. Resumption of DML

Case No. i. M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad.

Background of the case: Dr. Abdur Rashid, Additional Director (QA<) along-with Syed Hakim Masood, Area FID, Karachi conducted inspection of the firm M/s Alkemy Pharmaceutical, Hyderabad on 16.11.2016 in connection to Quality Control letter dated 27.05.2016, wherein the firm was found in manufacturing and sale of sub-standard drug Azofin suspension, Kemycone suspension and to verify GMP compliance / production activities of the firm.

2. The panel noticed number of critical observations, which need urgent attention and rectification. The observations includes:-

i. No traceability of Raw Materials was available. No proper records were available. No thermometer and hygrometer were found for recording of temperature and humidity in the warehouse. ii. Dispensing Areas needs renovation and additional calibrated weighing balance required. iii. Old silverson mixers are rusted/old and required to be placed with new ones. iv. Storage tanks required to be replaced with new ones. v. Floor, walls and ceiling are cracked/old and needs overall, renovation required. vi. The rodents and insects can enter from drainage in the production of syrup section and so requires better drainage system. vii. Vessels need to be replaced. viii. Liquid filling machine is old and rusty and must be replaced with semi- automatic filling machine with conveyor belt. ix. Water System needs to be upgraded with new one. x. Batch Manufacturing instructions were missing from batch manufacturing records. xi. Iron racks are required to be placed in the warehouse. Iron and plastic pellets maybe further added in the warehouse and wooden pellets should be removed from the area. xii. There are no racks in the finished goods store and medicines are placed on the floor. Few wooden pellets and plastic pellets are also seen in one room. There is a need that iron racks and plastic pellets maybe provided along with hygrometers to monitor the humidity of the finished goods store. Floor walls and ceiling needs renovation paint and up gradation. xiii. Dust can enter from the open exhaust, therefore an exhaust is required. xiv. There is overall need to upgrade the facility in the chemical and microbiological sections of the QC laboratory. No HPLC is available, so one HPLC may be provided. xv. There is lacking of proper log book of the equipments, calibration, and validation of the analytical methods. xvi. Viscometer is no more available to measure the viscosity of suspension. xvii. In microbiological section, autoclave, colony counter and refrigerator are no more available. It is recommended to provide the same.

Page 100 of 116 xviii . The qualified person in chemical and microbiological section needs training and has lack of latest knowledge. It is recommended that the technical personnel may be sent to Karachi for proper training. xix. Qualified persons documents were submitted in 2013, but have not been approved by the concerned division. xx. Packaging materials and labels are not properly stored and documented.

The panel concluded that:- The observations were discussed with the management and the management of the firm voluntarily stopped production in the liquid syrup section for maintenance and renovation. The panel recommended to issue a show cause notice for Liquid Section and personal hearing be given to the representative of the firm for cancellation and suspension of DML.

Action taken by DRAP: Accordingly show cause notice / suspension of production activities in liquid syrup section was issued to the firm on 09.01.2017.

Reply by the firm: The firm vide letter dated 17.01.2017 submitted reply, requested that the facility has been maintained and requested for the constitution of the panel to visit the firm and to provide opportunity for personal hearing.

Proceedings of the 252nd Meeting of CLB The Board was informed by the Deputy Director (QA) that the samples of Azofin Suspension and Kemycone Suspension were declared as of substandard quality by the Central Drugs Laboratory, Karachi. Accordingly the case was placed in 258th meeting of Registration Board held on 25th and 26th April, 2016. The Registration Board constituted panel of experts comprising of Dr. Abdur Rashid, Additional Director (QA<) and Syed Hakim Masood, Area FID to conduct PSI. The panel conducted inspection of the firm on 16.11.2016 and observed gross violations in Liquid syrup Section. Accordingly show cause notice / suspension of production activities in liquid syrup section was issued to the firm on 09.01.2017. The firm was served letter for personal hearing on 08.03.2017. Mr. Faraz Ahad Shaikh, Managing Director and Mr. Asif Najeeb Laghari, QC In-charge appeared before the Board. Managing Director inform the Board that they voluntarily stop the production in liquid section. He added that the observations noted by the panel have been rectified and they are ready for inspection. The Board inquired regarding availability of FTIR, Viscometer and Polarimeter in the Quality Control Lab. The QC In-charge replied in negative. The Board took serious notice of non-availability of most important equipments used for testing of liquid products, in QC Lab.

Decision of the 252nd Meeting of CLB After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 16.11.2016, casual attitude of the firm towards GMP compliance in liquid syrup section, the Board decided to:- i. Suspend the Drug Manufacturing License of liquid syrup section of the firm M/s Alkemy Pharmaceutical Laboratories (Pvt) Ltd, Karachi, for a period of 03 months under section 41 of the Drugs Act, 1976 read with Rule 12 of the Drugs (LR&A) Rules, 1976, from the date of issuance of decision of the 252nd meeting of CLB.

ii. Conduct panel cGMP inspection of the firm on approved format under Schedule B-II of Drugs (LR&A) Rules, 1976, after submission of compliance report by the firm, by the following members:-

 Syed Muid Ahmad, Member CLB  Dr. Abdur Rashid, Additional Director (QA<), Islamabad. Page 101 of 116

 Syed Hakim Masood, Area FID, Hyderabad / Karachi

iii. The Board also decided to direct the panel to submit brief report in tabulated form identifying the previous observations and the current status with clear and candid recommendations.

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

Updated Status: Decision of the 252nd meeting of CLB was conveyed to the firm M/s Alkemy Pharmaceutical, Hyderabad on 24.04.2017 after approval of the minutes of the meeting. Suspension of DML period of the firm has been expired on 23.07.2017. In compliance to decision of 252nd Meeting of CLB the panel conducted inspection of the firm on 26.07.2017 and forward the report to Division of QA< on 14.11.2017. The panel submitted detailed inspection report as under:-

S# Observations noticed on Panel inspection conducted on 26.07.2017 1 No traceability of Raw Materials Firm has initiated record keeping in was available. No proper records respective ledgers. Installed calibrated were available. No thermometer thermometer and hygrometer with available and hygrometer were found for records for previous month and current recording of temperature and month. humidity in the warehouse.

2 Dispensing Areas needs renovation Dispensing area has been upgraded and and additional calibrated weighing calibrated weighing balance is now balance required. provided.

3 Old silverson mixers are rusted/old New silver sons mixer has been installed and required to be placed with new ones.

4 Storage tanks required to be New storage tanks have been installed replaced with new ones.

5 Floor, walls and ceiling are Flooring has been improved with cracked/old and needs overall, preventable backflow drainage sieve. renovation required.

6 The rodents and insects can enter Drainage lines have been improved with from drainage in the production of preventable backflow drainage sieve. syrup section and so requires better drainage system.

7 Vessels need to be replaced. Complied with replacement with new ones

8 Liquid filling machine is old and Filling machine has been repaired and semi rusty and must be replaced with automatic capping machine with the semi- automatic filling machine with conveyor belt has been installed. conveyor belt. 9 Water System needs to be Renovated the water system. Some new upgraded with new one. S.S. Lines has been provided Page where 102 of 116

required. 10 Batch Manufacturing instructions Documentation is found improved were missing from batch management was further advised to adhere manufacturing records. GDP. 11 Iron racks are required to be placed Wooden pallets have been replaced with in the warehouse. Iron and plastic plastic pallets. Racking system is seen in pellets maybe further added in the the raw material store. warehouse and wooden pellets should be removed from the area. 12 xii. There are no racks in the Renovated the area. Plastic pallets have finished goods store and medicines been provided. Racking system is still in are placed on the floor. Few process. wooden pellets and plastic pellets are also seen in one room. There is a need that iron racks and plastic pellets maybe provided along with hygrometers to monitor the humidity of the finished goods store. Floor walls and ceiling needs renovation paint and up gradation. 13 Dust can enter from the open Open exhaust has been closed. HVAC exhaust, therefore an exhaust is system installed in liquid manufacturing area required. which is observed functional. 14 There is overall need to upgrade HPLC seen installed at the time of the facility in the chemical and inspection. QC system seen / observed microbiological sections of the QC upgraded. laboratory. No HPLC is available, so one HPLC may be provided. 15 There is lacking of proper log book Log book / sheets seen implemented. of the equipments, calibration, and validation of the analytical methods. 16 Viscometer is no more available to Viscometer provided measure the viscosity of suspension. 17 In microbiological section, Autoclave, refrigerator have been provided. autoclave, colony counter and Colony counter is in purchase process. refrigerator are no more available. It is recommended to provide the same. 18 The qualified person in chemical Initiated. It is suggested that training and microbiological section needs program should remain continued. training and has lack of latest knowledge. It is recommended that the technical personnel may be sent to Karachi for proper training. 19 Qualified persons documents were Receiving in DRAP regarding approval of submitted in 2013, but have not qualified personnel where presented. been approved by the concerned division. 20 Packaging materials and labels are Packing material inventory is now being not properly stored and managed in this area. documented.

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Recommendations of the panel “The panel appreciated the improvements under taken by the firm. Keeping in view the commitment for continuous improvement, people met and area visited the panel recommends resumption of production in syrup section of the firm M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad”.

Proceedings of the 257th Meeting of CLB The Deputy Director (QA) presented panel report of the firm M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad conducted on 26.07.2017 in compliance to the decision of the 252nd Meeting of CLB.

Decision of the 257th Meeting of CLB After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 26.07.2017 decided to resume the DML of Liquid Syrup Section of the firm M/s Alkemy Pharma, Hyderabad alongwith resumption of production in the Liquid Syrup Section.

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Case No. ii. M/s Rex Pharmaceuticals, Karachi

Background of the case Inspection 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 245th 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 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.

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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 252nd 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 252nd 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 252nd 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 147th 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 147th 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, Baltistan b. Prof. Dr. Maqsood Ahmed, Ripah International University, Lahore c. 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.

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.

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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

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.

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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).

Proceedings of the 257th Meeting of CLB The Deputy Director (QA) presented report of the panel in compliance to decision of 147th Meeting of Appellate Board.

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Decision of the 257th Meeting of CLB 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

1. Re-inspect the firm M/s Rex Pharmaceutical Pakistan, Karachi by following panel of experts, constituted by the Appellate Board in its 147th Meeting:-

a. Dr. Kifayat Ullah, CDC, Gilgit, Baltistan b. Prof. Dr. Maqsood Ahmed, Ripah International University, Lahore c. Syed Muied Ahmed, Expert in Manufacturing, Karachi

2. 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 its 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.

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Quality Control Cases

Case No. 01:

Subject: - Manufacturing and Sale of Unregistered Drug Product-PregEase Tablets Batch No.15021 by M/s Zestech Sciences, Karachi for ICI Pakistan, Karachi F. No. 4- 07/2015- (QC)

The FID-II, Karachi Mrs. Muneeza Khan inspected the premises of M/s ICI Pakistan Limited 5- West Wharf Road Karachi on 19-03-2015 and took the sample of Tab Preg Ease Batch No.15021 manufactured by M/s Zestech Sciences Karachi. The sample was sent to the Federal Government Analyst, CDL Karachi for test/analysis purpose. However, the Federal Government Analyst, CDL, Karachi vide his test report No. KQ.102/2015 dated 13-05-2015 declared the said drug product preg- Ease tablets Batch No.15021 manufactured by M/s Zestech Sciences, Karachi for ICI Pakistan, Karachi as Un-registered drug product under the Drug Act, 1976. The result of CDL test Report Remarks:- “The label of the sample claims “Natural Nutritional Supplement to help calm nausea & jkvomiting of pregnancy (NVP) vitamin B6 and calcium have been identified as allopathic ingredients. Hence, the sample is declared as un Registered Drug product under the Drug Act 1976” 2 The FID-II served the explanation letter on 26th May 2015 to the firm M/s ICI Pakistan Ltd Karachi and M/s Zestech Sciences Karachi to explain their position. In reply to the FID explanation M/s Zestech Sciences Karachi requested for Appellate testing of drug in question under the provision of Drugs Act 1976 on 30th June 2015. The sample was sent to the Appellate Laboratory NIH Islamabad. The Appellate Laboratory has also declared the sample of said drug product as of substandard quality vide its test report No. 027-MNHRS/2015 dated 02nd November 2015 along with remarks mentioning the sample unregistered and unlicensed.

The result of Appellate Laboratory:-

Assay:- Stated Found Limit Percentage Vitamin B6 2mg/tab 1.903mg/tab 90-110% 95.14% Folic Acid 400mcg/tab 415.68mcg/tab 90-110% 103.92% Calcium 124.1mg/tab 11.18mg/tab 90-110% 9.018% Does not comply with manufacturer’s specification.

The FID-II Karachi furnished the names of responsible accused persons in his report are as under:- Mr. Ahsan Feroz Proprietor Page 110 of 116

Mr. Mumtaz Ali Khan Production Incharge Mr. Ejaz Ahmad Paracha QC Manager

Recommendations of FID:-

“Based on the above submission and Lab reports it can easily be concluded that the drug Preg Ease tablets is un registered un-licensed and Sub-Standard product hence sheer violation of Section 23 &27 of Drugs Act 1976 by the manufacturer M/s Zestech Sciences Plot No. 47/23, Korangi Industrial area Karachi based on the violations committed by the firm it is concluded that the contents of case may be kept on the agenda of upcoming meeting of CLB for permission of prosecution against the firm or the contents may be sent to Director OTC & Herbal for his comments in the light of the SRO 412”. The show cause notices were issued to the above named accused persons offering them opportunity of personal hearing before the Central Licensing Board before its 249th meeting held on 29-08-2016. The Firm had submitted the reply of show cause notice. The case was accordingly placed before the CLB in its 249th meeting held 29th August 2016.

Decision of 249th meeting of CLB The Board deferred the case due to paucity of time. The said accused persons were called for personal hearing.

Proceedings:-

Mr. Ahson Feroze appeared before the Central Licensing Board in its 250th meeting held 27th October 2016 and pleaded their case and informed that he is the Managing Director of M/s Zestech Sciences Karachi and M/s Maple Pharmaceuticals Karachi. He was accompanied by Mr. Saeed Khan who informed that he looks the matters of Regulatory affairs of both firms M/s Maple Pharmaceuticals Karachi and M/s Zestech Sciences, Karachi. Mr. Ahson Feroze claimed that their firm (M/s Zestech Sciences Karachi) had not received the copy of test report of Appellate Lab NIH Islamabad and said that the FID had picked three products out of which two were cleared by CDL, Karachi. He informed that their firm has got the enlistment while products were applied to Division of Health & OTC, DRAP, Islamabad.

Decision:-

The Board after detailed discussion, deliberation and keeping in view the facts of the case the Board decided as under:-

1. To direct the concerned FID Karachi, to re investigate the case by including M/s ICI, Karachi from where the samples were picked for test/analysis as the subject drugs were stocked for sale in the premises of M/s ICI Karachi. The Board directed the FID to submit the complete case after fulfilling codal formalities with provisions of law and along with clear and candid recommendations.

2. The Board directed the Quality Control Section to get the status of enlistment of the firm M/s Zestech Science Karachi and product (Tablet Preg Ease) from the Division of Health & OTC, DRAP, Islamabad along with the comments on both laboratories test reports. Page 111 of 116

As per decision of the Central Licensing Board Federal Inspector of Drugs Karachi (Mrs. Muneeza Khan) and Deputy Director Health OTC, DRAP Islamabad was requested to implement the decision of Central Licensing Board.

In compliance of decision of Central Licensing Board:

1. The Deputy Director Health & OTC, DRAP, Islamabad replied vide letter No.F.08-24/2016- DD (Health &OTC) dated 23rd December 2016 wherein he informed that the said firm was enlisted as manufacturer of Softgel capsules Hardgel capsule Tablet, Oral Liquid, Cream Ointment and Sachet dosage forms in 7th meeting of Enlistment Evaluation committee held on 01-02-2016. The products of M/s Zestech Sciences are under evaluation and till to date no product have been enlisted for market authorization.

2. The area FID Karachi vide letter No.MK-33-43/2015-FID-II(K) dated 27th April, 2017, informed that she picked the samples from the premises of ICI Pakistan Limited 5- West Wharf Road Karachi.

She further submitted that based on information and Laboratory reports it can easily be concluded that the drug PregEase is un-registered and substandard drug/ product, hence M/s ICI Pakistan violated the section 23(1)(a)(v) & 23(1)(a)(vii), which is punishable under section 27 of the Drugs Act 1976. She recommended that M/s ICI Pakistan Ltd: may be prosecuted in the drug Court of Sindh Karachi.

Current Status of the Case:

The case was placed before CLB in its 254th meeting held on 15th June 2017. The Board decided the case as under: Decision: “The Board deliberated on the facts presented above and decided to defer the case till completion of all codal formalities including the Showcause Notice is required to be served to M/s ICI Pakistan Limited 5- West Wharf Road Karachi with clear and candid recommendations for the consideration of the board.” As per decision of CLB the show cause notice was issued to the M/S ICI Pakistan Ltd: Karachi dated 07-07-2017, but no response has been received till to date. Proceedings and Decision of 257th Meeting of CLB: Central Licensing Board was informed that M/s. ICI Pakistan failed to respond the show cause notice issued to them. After threadbare evaluation decided that the views/ comments of the Health & OTC Division/ EEC shall be obtained on the subject matter before taking any decision.

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Case No. 02: Subject: Seizure of un registered Drugs under Section 18(1) of the Drug Act 1976. 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 26th August, 2016. The FID forwarded the case to the Director, QA<, DRAP, Islamabad vide letter No.12406/2016-DRAP (L- V) dated 29th August, 2016. 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. The FID Lahore seized the following drugs on form-2 under section 18 (1) (f) of Drug Act, 1976: S. No. Name Of Batch/Lot Mfg Exp. Manufactured Quantity Product(s) No. Data Date by

01. Marevan A520518 11-15 05-18 Mfd By. GSK (13) 5mg (Detail address Thirteen Tablets not mentioned jars in English) 02. Marevan A521058 03-16 09-16 -do- (11) 5mg Eleven Tablets jars 03. Marevan A520917 02-16 08-18 -do- (04) Four 5mg jars Tablets 04. Marevan A520916 02-16 08-18 -do- (15) 5mg Fifteen Tablets jars 05. Marevan A520917 02-16 08-18 -do- (03) 5mg Three Tablets jars 06. Centrum M25939 - Sep-17 Marked by. (03) Silver Pfizer Three Madison, Packs NJ07940 USA 2015 Pfizer Inc Made in Canada 07. Centrum M87735 - Dec-17 2014 Pfizer Inc (02) Two Silver Made in Packs Canada 08. Centrum N43989 - 01-18 2014 Pfizer Inc (02) Two Silver marked by M/s Jars Pfizer Madison, NJ07940 Page 113 of 116

09. Colomycin 11393 10-2014 10-2017 M/s Forest Injection Laboratories 02 UK, Ltd, Packs×10 Whiddon Valley, Vials Branstaple, North Devon Ex 32 8NS, United Kingdom. 10. Viagra MALL Dec- 01-Apr- Mfd by. (03) 100mg 19990544G 2013 2018 Brooklyn, Ne Three Tablets Packed by: Packs× Pfizer Ply Ltd, 06 Australia Tablets 11. Cialis April- Made in USA (02) Two 20mg Control No. - 04/2018 Packs× Tablets 0674654099 03 Tablets 12. Centrum M877733 - Dec-17 Mfd. Pfizer (02) Tablets Inc. Canada Packs 13. Neurobion 213371 12-2015 112017 Mfd. Merck (03) Injection kGaA, Three Darmstadt, Packs Germany 14. Pirfenex BA60218 Dec-15 Nov-17 Mfd. Cipla (01) One 200mg Malpur, Solan Pack Tablets 173205 India

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.

Samples of drugs which were available in sufficient quantities were also sent to Federal Government Analyst for test/ analysis.

The details of test/analysis results of said drugs by Federal Government Analyst, Central Drug Laboratory are as under:-

S.No. Test Report No.& Name of Drug Mfg by Remarks of CDL date with batch No.

1. Test Report No. Marevan 5mg M/s GSK Declared R.LHR.403/2016 dated Tablets Batch Unregistered report 01-11-2016 No.A521058 no.R.LHR.403/2016 dated 01-11-2016

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2. Test Report No. Centrum Sliver M/s Pfizer Declared R.LHR.404/2016 dated Batch Inch, Unregistered report 01-11-2016 No.M30477 Canada no.R.LHR.404/2016 dated 01-11-2016 3. Test Report No. Cialis 20mg M/s GSK Declared R.LHR.405/2016 dated Batch Unregistered test 02-11-2016 No.0674654099 report no. R.LHR.405/2016 dated 02-11-2016 4. Test Report No. Pirfenex Tablets M/s Cipla Drug is not included R.LHR.406/2016 dated Batch Ltd India in any 02-11-2016 No.BA60218 Pharmacopoeia, test report no. R.LHR.406/2016, dated 02-11-2016

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. Permission of safe custody of the stock was granted to the FID on 16th 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.

Recommendations of FID 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 their 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. The Show cause notice was issued to the following accused persons on 25th January 2017. Page 115 of 116

M/s. Mehmood Pharmacy S-77-R/85/C, Mr. Sana Ullah S/O M Suleman Jail road, Opposite Services Hospital, House No. 05, Street No.05 Lahore. Mohellah Amin Park Ravi Road, Lahore

Mr. Atif Ejaz S/O Ejaz Perves R/O67/C Mr. Daud Tareen S/O M Aslam Tareen R/O Punjab Co-Operative Housing Society B-42, GOR-III, Shadman, Lahore Defense Lahore. (Proprietor).

However, the accused persons had not submitted the reply of the show cause notice.

Current Status:

The Names of the accused persons alongwith CNIC nos., contact nos. and copy of Drug Sale License have been received from the FID in response of the decision of 252nd Meeting of the Central Licensing Board. Proceedings and Decision of 257th Meeting of CLB: After detailed evaluation and discussion the Central Licensing Board decided to issue show cause notice to the following accused persons:

i. M/s. Mehmood Pharmacy S-77-R/85/C, Jail Road, Opposite Services Hospital, Lahore through its Proprietor

ii. Mr. Sana Ullah S/O M Suleman House No. 05, Street No.05 Mohellah Amin Park Ravi Road, Lahore.

iii. Mr. Atif Ejaz S/O Ejaz Perves R/O67/C Punjab Co-Operative Housing Society Defense, Lahore.

iv. Mr. Daud Tareen S/O M Aslam Tareen R/O B-42, GOR-III, Shadman, Lahore (Proprietor).

and called for personal hearing in the upcoming meeting of the Central Licensing Board.

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

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