Minutes of 259th meeting of central licensing board held on 29th & 30

Item-III: GRANT OF ADDITIONAL SECTIONS/EXPANSION/AMENDMENTS ETC.
The Board considered following cases of Grant of Additional Sections & Expansion/Amendments of already licensed units in the light of recommendations by respective panel of experts/inspectors and decided as under: -

S #	Name of the firm	Date of Inspection		Ranking/ Evaluation		Inspection Panel Members
1.	M/s OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, S.I.T.E, Karachi. DML No. 000012 (Formulation) Section (03) Capsule Section (General) in place of R&D Lab (Amendment) Microbiology Labs(Amendment) First Floor New Product Development Lab (Amendment)	09-01-2018		Good		Syed Muied Ahmed, Expert in Drugs Production. Mr. Kalb-e-Hassan, Chief Drug Inspector, Sindh, Karachi Dr. Saif-ur-Rehman Khattak, Director, CDL, DRAP, Karachi. Mr. Shoaib Ahmed, Federal Inspector of Drugs, DRAP, Karachi.
	Recommendations of the panel: - Panel recommends the grant of additional sections and amendments in Capsule Section (General) in place of R&D Lab, Microbiology Lab and new Product development Lab. The grant / amendments in the Capsule Section (Hormone / Soft Gelatin) in place of Capsule Section (General / Soft Gelatin) have not been recommends due to the GMP deficiencies. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, S.I.T.E, Karachi on the recommendations of the panel od experts:- Section (03) Capsule Section (General) in place of R&D Lab (Amendment) Microbiology Labs(Amendment) First Floor New Product Development Lab (Amendment) Moreover, the Board did not approve on the recommendations of the panel of experts in the name of M/s OBS Pakistan (Pvt) Ltd, C-14, Manghopir Road, S.I.T.E, Karachi for the following Section. Capsule Section (Hormone / Soft Gelatin) in place of Capsule Section (General / Soft Gelatin)
2.	M/s Medisure Laboratories Pakistan (Pvt) Ltd, Plot No. A-115, S.I.T.E-II, Super Highway, Karachi DML No. 000503 (Formulation) Section (03) Capsule (Cephalosporin) Section Dry Powder Suspension (Cephalosporin) Section. Dry Powder Injection (Cephalosporin) Section		22-01-2018		Good		Syed Muied Ahmed, Member Central Licensing Board. Mr. Abdul Rasool Shaikh, Federal Inspector of Drug, DRAP, Karachi. Ms. Ume Laila, Assistant Director, DRAP, Karachi Chief Drug Inspector Sindh (Vacant Seat)
	Recommendations of the panel: - Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for international certificates, panel recommends the grant of additional sections as mentioned above. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s Medisure Laboratories Pakistan (Pvt) Ltd, Plot No. A-115, S.I.T.E-II, Super Highway, Karachi on the recommendations of the panel of experts:- Section (03) Capsule (Cephalosporin) Section Dry Powder Suspension (Cephalosporin) Section. Dry Powder Injection (Cephalosporin) Section
3.	M/s Winthrox Laboratories (Pvt) Ltd, Plot No. K-219-A, S.I.T.E, Super Highway, Karachi. DML No. 000807 (Formulation) Section (04) Sterile Dry Powder Injection (Cephalosporin) Section. Capsule (Cephalosporin) Section. Dry Powder Suspension (Cephalosporin). Liquid Injectable (General) Section.		09-03-2018		Good		Prof. Dr. Ghulam Sarwar, Member Central Licensing Board. Dr. Najam-us-Squib, Additional Director (E&M), DRAP, Karachi. Mr. Abdul Rasool Shaikh, Federal Inspector of Drug, DRAP, Karachi.
	Recommendations of the panel: - The panel unanimously concluded to recommend the grant of additional sections as mentioned above. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s Winthrox Laboratories (Pvt) Ltd, Plot No. K-219-A, S.I.T.E, Super Highway, Karachi on the recommendations of the panel od experts:- Section (04) Sterile Dry Powder Injection (Cephalosporin) Section. Capsule (Cephalosporin) Section. Dry Powder Suspension (Cephalosporin). Liquid Injectable (General) Section.
4.	M/s Ferozsons Laboratories Ltd, Amangarh, Nowshera, Khyber Pakhtunkwa. DML No. 000038 (Formulation) Sections (03) Quality control Laboratory (Amended). Quality Assurance (New). Product Development (New).		24-01-2018		Good		Prof. Dr. Muhammad Saeed, Peshawar University, Peshawar. Director DTL KPK, Peshawar. Area Federal Inspector of Drugs, DRAP, Peshawar.
	Recommendations of the panel: - As per facilities checked, record and people interviewed the panel unanimously recommend the grant of aforesaid additional/amended Sections; Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s Ferozsons Laboratories Ltd, Amangarh, Nowshera, Khyber Pakhtunkwa on the recommendations of the panel od experts:- Sections (03) Quality control Laboratory (Amended). Quality Assurance (New). Product Development (New).
5.	M/s Max Pharmaceuticals, Plot No. 12, Street No. N-7, National Industrial Zone, Rawat, Rawalpindi. DML No.000671 (Formulation) Sections (01) Dry Powder for Injection (Cephalosporin).		13-03-2018		Good	Prof. Dr. Muhammad Usman, Member Central Licensing Board. Prof. Dr. Gul Majeed, Dean Faculty of Pharmacy , QAU, Islamabad. Mr. Khalid Mahmood, Federal Inspector of Drugs-II, DRAP, Islamabad.
	Recommendations: “Keeping in view the above facts, detailed visit of facility and supporting documents provided by the company, the panel recommends M/s Max Pharmaceuticals, Plot No. 12, Street No. N-7, National Industrial Zone, Rawat, Rawalpindi for the grant Additional Section namely Dry Powder for injection (Cephalosporin) (Formulations) for the aforesaid Section. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s Max Pharmaceuticals, Plot No. 12, Street No. N-7, National Industrial Zone, Rawat, Rawalpindi on the recommendations of the panel od experts:- Sections (01) Dry Powder for Injection (Cephalosporin).
6	M/s Neutro Pharma (Pvt) Ltd, 9.5-Km, Sheikhupura Road, Lahore. DML No. 000576 (Formulation) Section (03) Tablet (Psychotropic) Section (Revised). Capsule (Psychotropic) Section (Revised). 3. Cream/ Ointment (General) Section (Revised)		16-03-2018		Good		Dr. Ikram-ul-Haq, Member CLB. Mrs. Aisha Irfan, Deputy Director, DRAP, Lahore. Mr. Abdul Rashid Shaikh, Federal Inspector of Drugs.
	Recommendations of the panel: - Keeping in view the facilities like building , HVAC, system, machinery and equipment, personal, documents and Quality Control Testing facilities the panel of inspectors is of the opinion to recommend the grant of above mentioned revised additional sections to M/s Neutro Pharma (Pvt) Ltd, Lahore situated at 9.5-km, Sheikhupura Road, Lahore. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s Neutro Pharma (Pvt) Ltd, 9.5-Km, Sheikhupura Road, Lahore on the recommendations of the panel of experts:- Section (03) Tablet (Psychotropic) Section (Revised). Capsule (Psychotropic) Section (Revised). Cream/ Ointment (General) Section (Revised)

7	M/s Hudson Pharma (Pvt) Ltd, Plot D-93, North Western Industrial Zone, Port Qasim, Karachi. DML No. 000842 (Formulation) Section (01) Eye/Ear & Nasal Drops (General) Section.			21-03-2018		Good		Dr. Ikram-ul-Haq, Member CLB. Dr. Najam-us-Saquib, Additional Director (E&M), DRAP, Karachi. Dr. Mehwish Tanveer, Federal Inspector of Drugs.
	The Central Licensing Board in its 257^th meeting held on 24-25^th January, 2018 decided as under:- The Board approved the grant of following additional sections:- Sections (02). Ointment/Cream/Lotion/Gel (General) Section. Capsule (General) Section. The Board did not approve the grant of following additional section and as and when the section will be ready for inspection, the firm may apply for constitution of panel:- Eye/Ear & Nasal Drops (General) Section. The firm requested for constitution of panel to re-inspection for grant of Eye/Ear & Nasal Drops (General) Section and following panel was constituted:- Dr. Ikram-ul-Haq, Member CLB. Dr. Najam-us-Saquib, Additional Director (E&M), DRAP, Karachi. Dr. Mehwish Tanveer, Federal Inspector of Drugs. Remarks and Recommendations of the panel: - During the inspection, panel observed that the firm has almost attended all the observations notices by the panel during last inspection. However, firm is maintaining sterilization (autoclave) facility in the separate areas observed by the panel during last visit. M oreover, firm has conducted sterilization process validation and qualification including porous load cycle study and trolly with laminarhas been provided for shifting of sterilized itemsfrom sterlizer to aseptic area, under multiple wrappings. Sterlization process now seems to be satisfactory to maintain sterility of the items being sterilized. However, firm has given commitment/ undertaking to shift autoclave to the section within six monthsfor which the firm is agreed to submit the lay out planto DRAP authorities for shifting of autoclave to the section within three months. Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for international certificates in near future and commitment of the firm, panel recommends the grant of above mentioned additional section. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s Hudson Pharma (Pvt) Ltd, Plot D-93, North Western Industrial Zone, Port Qasim, Karachi on the recommendations of the panel of experts:- Section (01) Eye/Ear & Nasal Drops (General) Section. However, as per commitment, the firm will submit lay out plan within three months and install Autoclave /sterlizerin this section within six months.
8	M/s Platinum Pharmaceuticals (Pvt) Ltd, A-20, North Western Industrial Zone, Bin Qasim, Karachi. DML No. 000415 (Formulation) Section (03) Tablet (Hormone) Section. Capsule (Hormone) Section. Extension of FG Warehouse			21-03-2018		Good			Mr. Syed Muied Ahmed, Member CLB. Mr. Muzaffar Jaffery, Director DTL, Sindh. Dr. Mehwish Tanveer, Federal Inspector of Drugs.
	Recommendations of the panel: - Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for export, panel recommends the amendments / expansion of aforesaid sections. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s Platinum Pharmaceuticals (Pvt) Ltd, A-20, North Western Industrial Zone, Bin Qasim, Karachi on the recommendations of the panel od experts:- Section (03) Tablet (Hormone) Section. Capsule (Hormone) Section. Extension of FG Warehouse
9	M/s Bosch Pharmaceuticals (Pvt) Ltd, Plot No. 209, Sector-23, Korangi Industrial Area, Karachi. DML No. 00 (Formulation) Section (01) Penicillin (Injectable) Section.	12-03-2018				Good			Mr. Syed Muied Ahmed, Member CLB. Dr. Saif-ur-Rehman Khattak, Director, CDL, Karachi Dr. Najam-us-Saquib, Federal Inspector of Drugs.
	Recommendations of the panel: - Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for international certifications, panel recommends the grant of additional section of aforesaid sections. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional sections /amendment in the name of M/s Bosch Pharmaceuticals (Pvt) Ltd, Plot No. 209, Sector-23, Korangi Industrial Area, Karachi on the recommendations of the panel od experts:- Section (01) Penicillin (Injectable) Section.
10	M/s Radiant Pharma (Pvt) Ltd, 43-E, Sundar Industrial Estate, Lahore. DML No. 000776 (Formulation) Section (01) Dry Powder Injection (General) Section.		09-03-2018		Good		Dr. Farzana Chaudhary, Director Pharmacy Department, UVAS, Lahore. Mr. Asim Rauf, Additional Director, DRAP, Lahore Ms. Ufaq Tanveer, Federal Inspector of Drugs. Lahore.
	Recommendations of the panel: - Keeping in view the facilities like building , HVAC, system, machinery and equipment, personal, documents and Quality Control Testing facilities the panel of inspectors is of the opinion to recommend the grant of above mentioned section of M/s Radiant Pharma (Pvt) Ltd, 43-E, Sundar Industrial Estate, Lahore. Decision by the Central Licensing Board in 259^th meeting The Board approved the grant of following additional section /amendment in the name of M/s Radiant Pharma (Pvt) Ltd, 43-E, Sundar Industrial Estate, Lahore on the recommendations of the panel of experts:- Section (01) Dry Powder Injection (General) Section.

Item-IV: GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE.
The Board considered the following cases of grant of Renewal of Drug Manufacturing Licenses in the light of recommendations by panel of experts/inspectors subject to confirmation of deposition of CRF as admissible under the rules and decided as under: -

S #	Name of the firm	Date of Inspection		Ranking/ Evaluation				Inspection Panel Members
1	M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. A-46, S.I.T.E, North Karachi, Karachi DML No. 000490 (Formulation) Period: 01-01-2017 to 31-12-2022	18-01-2018		Good				Mr. Syed Muzaffar Hussain Jaffery, Director DTL, Sindh. Prof. Dr. Ghulam Sarwar, Member DRB. Mr. Abdul Rasool Shaikh, Federal Inspector of Drug, DRAP, Karachi. Mr. Abdul Waheed, Assistant Director, CDL, Karachi.
	Recommendations of the panel: - The Panel thoroughly inspected & reviewed in detail their QA system, Production system, QC Lab, Stores, utilities & respective documents and found an optimal level of compliance & based on the above stated observation the panel unanimously recommends the grant of renewal of DML No. 000490 (Formulation) for the next five years commencing on 01-01-2017 and ending on 31-12-2022. Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000490 (Formulation) in the name of M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. A-46, S.I.T.E, North Karachi, on the recommendations of the panel of experts for the further period of five years commencing on 01-01-2017 and ending on 31-12-2022.
2	M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. L-4/1 A&B, Block-21, Federal-B Industrial area, Karachi DML No. 000040 (Formulation) Period:30-05-2015 to 29-05-2020	11-01-2018		Good		Dr. Abdullah Dayo, Dean, Faculty of Pharmacy, University of Sindh, Karachi. Mr. Syed Muzaffar Hussain Jaffery, Director DTL, Sindh. Mr. Kirshan, Federal Inspector of Drug, DRAP, Karachi. Mr. Farman Ali, Assistant Director, DRAP, Karachi.
	Recommendations of the panel: - The Panel reviewed in detail the critical documents relating to manufacturing, QA, QC, Supply chain and utilities and found at good level of compliance. The panel further observed that all above mentioned sections are given as per approved layout plan were inspected keeping in view the existing GMP conditions, suitability of equipments/machineries and capabilities of management and working personnel towards compliance, the panel unanimously recommends the grant of renewal DML No. 000040 (Formulation) for the next tenure. Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000040 (Formulation) in the name of M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. L-4/1 A&B, Block-21, Federal-B Industrial area, Karachi on the recommendations of the panel of experts for the further period of five years commencing on 30-05-2015 and ending on 29-05-2020
3	M/s Evergreen Pharmaceuticals, 20-Km, Ferozepur Road, Lahore. DML No. 000736 (Formulation) Period; 01-08-2017 to 31-07-2022.		07-11-2017		Good		Dr. Ikrarm-ul-Haq, Member CLB. Dr. Zaka-ur-Rehman, Chief Pharmacist / Drug Controller Children Hospital. Mr. Ajmal Sohail Asif, Federal Inspector of Drug, DRAP, Lahore.
	Recommendations of the panel: - Panel has thoroughly inspected the unit also evaluated the various documents in connection with Production, Quality Control and Quality Assurance. Panel also discussed various technical aspects at length. Keeping in view of the above all, panel decided to recommend the renewal of Drug Manufacturing License No. 000736 of M/s Evergreen Pharma, 20-Km, Ferozepur Road, Lahore. Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000736 (Formulation) in the name of M/s Evergreen Pharma, 20-Km, Ferozepur Road, Lahore on the recommendations of the panel of experts for the further period of five years commencing on 01-08-2017 and ending on 31-07-2022.

4	M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. B-10, Block-B, S.I.T.E, North Karachi , Karachi DML No. 000626 (Formulation) Period: 05-10-2017 to 04-10-2022	01-02-2018	Good		Prof. Dr. G. Razzak Shahwani, Chairman Department of Pharmaceutics, Balochistan University Quetta. S. Muzaffar Ali Jafery, Director DTL, Karachi. Prof. Dr. Ghulam Sarwar, Member, DRB, Islamabad. Mr. Abdul Rasool Shaikh, Federal Inspector of Drug, DRAP, Karachi.
	Recommendations of the panel: - During a detailed inspection the Panel thoroughly inspected their QA system, Production system, Practices in QC Lab & Stores, the Panel also reviewed several documents with respect to training, validation, OOS, Failures, Complaints, recalls, vendor selection, Change Management & utilities. A Good level of compliance was noted at the end. Keeping in view the above stated facts and based on the attitude of the management towards continuous improvements, the panel concluded to recommends the grant of renewal of DML No. 000626 (Formulation) for the next five years. Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000626 (Formulation) in the name of M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd, Plot No. B-10, Block-B, S.I.T.E, North Karachi , Karachi on the recommendations of the panel of experts for the further period of five years commencing on 05-10-2017 and ending on 04-10-2022.
5	M/s Medisure Laboratories Pakistan (Pvt) Ltd, Plot No. A-115, S.I.T.E-II, Super Highway, Karachi DML No. 000503 (Formulation) Period; 06-10-2017 to 05-10-2022	22-01-2018	Good			Syed Muied Ahmed, Member Central Licensing Board. Mr. Abdul Rasool Shaikh, Federal Inspector of Drug, DRAP, Karachi. Ms. Ume Laila, Assistant Director, DRAP, Karachi. Chief Drug Inspector Sindh (Vacant Seat)
	Recommendations of the panel: - Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for international certificates, panel recommends the grant of renewal of the Drug Manufacturing License by way of formulation. Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000503 (Formulation) in the name of M/s Medisure Laboratories Pakistan (Pvt) Ltd, Plot No. A-115, S.I.T.E-II, Super Highway, Karachi on the recommendations of the panel of experts for the further period of five years commencing on 06-10-2017 and ending on 05-10-2022.
6	M/s WnsFeild Pharmaceuticals, Plot No.122, Block-A, Phase-V, Industrial Estate, Hattar. DML No. 000610 (Formulation) Period; 13-04-2017 to 12-04-2022	18-01-2018	Good				Prof. Dr. Jamshed Ali Khan, Faculty of Pharmacy, Peshawar University, Peshawar. Additional Director (E&M), DRAP, Peshawar. Area Federal Inspector of Drugs, DRAP, Peshawar. Area Assistant Director (Lic), DRAP, Islamabad.
	Recommendations of the panel: - The panel recommended the grant of renewal of Drug Manufacturing License No.000610 by way of Formulation. Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000610 (Formulation) in the name of M/s WnsFeild Pharmaceuticals, Plot No.122, Block-A, Phase-V, Industrial Estate, Hattar on the recommendations of the panel of experts for the further period of five years commencing on 13-04-2017 and ending on 12-04-2022
7	M/s D-Maarson Pharmaceuticals, Plot No.17, SS-2, RCCI, Rawat, Rawalpindi. DML No. 000744 (Formulation) Period: 16-08-2017 to 15-08-2022	14-12-2017	Good	Dr. Muhammad Tanveer Alam, Additional Director (PS), DRAP, Islamabad. Mr. Manzoor Ali Bozdar, Additional Director (Licensing), DRAP, ISlambad. Dr. Hassan Afzaal, FID-III, DRAP, Islamabad. Dr. Muhammad Yaqoob Kakar, Assistant Director (Licensing), DRAP, Islamabad.
	Recommendations of the panel: - 1. In view of facts, detailed visit of facility and supporting documents provided by the company, the panel unanimously recommended M/s D-Maarson Pharmaceutical, Plot No.17, SS-2, RCCI, Rawat, Rawalpindi for the renewal Drug Manufacturing License No. 000744 (Formulation). 2. During the scrutiny of records it was observed that the products i. LOX-20 Registration No. 063514 ii. CLAUMOX-28 Powder Registration No. 072682 iii. MOXIBAC-C Powder Registration No. 062175 3. Aforementioned products contain penicillin/amoxicillin which should be manufactured in dedicated section. The case may be referred to Drug Registration Board for decision. The production of aforementioned products has been halted voluntarily by the management of the firm. Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000744 (Formulation) in the name of M/s D-Maarson Pharmaceutical, Plot No.17, SS-2, RCCI, Rawat, Rawalpindi on the recommendations of the panel of experts for the further period of five years commencing on 16-08-2017 and ending on 15-08-2022. Moreover, the Central Licening Board referred the following drugs to the Drug Registration Board for consideration as the firm does not possess Penicillin Section for the said drugs. LOX-20 Registration No. 063514 CLAUMOX-28 Powder Registration No. 072682 MOXIBAC-C Powder Registration No. 062175
8	M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, National Industrial Zone, Rawat. DML No. 000750 (Formulation) Period: 16-08-2017 to 15-08-2022	02-02-2018 & 07-02-2018	Good	Dr. Abdur Rashid, Additional Director (H&OTC), DRAP, Islamabad. Dr. Zunaira Faryad, AD (Lic), DRAP, Islamabad. Dr. Hassan Afzaal, FID-III, DRAP, Islamabad.
	Recommendations of the panel: - “Keeping in view the above facts, detailed visit of facility and supporting documents provided by the company, the panel unanimously recommended M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, National Industrial Zone, Rawat, Rawalpindi for the renewal of Drug Manufacturing License No. 000750 (Formulation). Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000750 (Formulation) in the name of M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, National Industrial Zone, Rawat, Rawalpindi on the recommendations of the panel of experts for the further period of five years commencing on 16-08-2017 and ending on 15-08-2022.

9	M/s Siam Pharmaceuticals, Plot No. 217, Industrial Triangle, Kahuta Road, Islamabad. DML No. 000711 (Formulation) Period: 13-06-20016 to 12-06-2021.	16-02-2018	Good	Dr. Muhammad Tanveer Alam, Additional Director (PS), DRAP, Islamabad. Mr. Muhammad Fakharuddin Aamir, Additional Director (QA<), DRAP, Islamabad.. Mr. Arslan Tariq, FID-I, DRAP, Islamabad. Dr. Nafees Ur Rehman, Assistant Director (PS), DRAP, Islamabad.
	Recommendations of the panel: - “Keeping in view the above facts on record, the panel unanimously recommended the grant of Renewal of Drug Manufacturing License No. 000711 (Formulation) for approved Tablet Section General and Capsule Section General to M/s Siam Pharmaceuticals, Plot No. 217, Industrial Estate, Triangle Kahuta Road, Islamabad.” Decision by the Central Licensing Board in 259^th meeting The Board approved the renewal of Drug Manufacturing Licence No. 000711 (Formulation) in the name of M/s Siam Pharmaceuticals, Plot No. 217, Industrial Estate, Triangle Kahuta Road, Islamabad on the recommendations of the panel of experts for the further period of five years commencing on 13-06-20016 and ending on 12-06-2021

ITEM – V MISC CASES
Case No. 1. CHANGE OF MANAGEMENT OF M/S ALKEMY PHARMACEUTICAL LABORATORIES (PVT) LTD, HYDERABAD
M/s Alkemy Pharmaceutical Laboratories (Pvt) Ltd, P/9, S.I.T.E, Hyderabad, DML No. 000131 by way of formulation has submitted request for change in management of the firm as per Form-29 with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as under;

Previous management as per Form-1A	Retiring Management	Current management as per Form-29
Mr. Nazir Ahmad Shaikh CNIC No. 42201-7375233-7. Ms. Rukhsana Shaikh W/o Nazir Ahmad Shaikh CNIC No. 42201-3524178-4. Muhammad Ayoob Jamal S/o Jamal Ahmad Jamal CNIC No. 42101-5885999-7.	1. Mr. Nazir Ahmad Shaikh CNIC No. 42201-7375233-7.	Mr. Faraz Ahmad Shaikh S/o Nazir Ahmad Shaikh CNIC No. 42201-9270370-1. Ms. Rukhsana Shaikh W/o Nazir Ahmad Shaikh CNIC No. 42201-3524178-4. Muhammad Ayoob Jamal S/o Jamal Ahmad Jamal CNIC No. 42101-5885999-7.

Decision by the Central Licensing Board in 259^th meeting:

The Board considered and endorsed the change of management from old to new management of M/s Alkemy Pharmaceutical Laboratories (Pvt) Ltd, P/9, S.I.T.E, Hyderabad, DML No. 000131 by way of Formulation as per Form-29 as under ;

Previous management	Retiring Management	New Management
Mr. Nazir Ahmad Shaikh CNIC No. 42201-7375233-7. Ms. Rukhsana Shaikh W/o Nazir Ahmad Shaikh CNIC No. 42201-3524178-4. Muhammad Ayoob Jamal S/o Jamal Ahmad Jamal CNIC No. 42101-5885999-7.	1. Mr. Nazir Ahmad Shaikh CNIC No. 42201-7375233-7.	Mr. Faraz Ahmad Shaikh S/o Nazir Ahmad Shaikh CNIC No. 42201-9270370-1. Ms. Rukhsana Shaikh W/o Nazir Ahmad Shaikh CNIC No. 42201-3524178-4. Muhammad Ayoob Jamal S/o Jamal Ahmad Jamal CNIC No. 42101-5885999-7.