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

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

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259^th meeting of the Central Licensing Board (CLB) was held on 29^th & 30^th March, 2018 in the Committee Room, Drug Regulatory Authority of Pakistan, 4^th Floor, T.F. Complex, G-9/4, Islamabad under the Chairmanship of Mr. Ghulam Rasool Dutani, Director Drug Licensing, Drug Regulatory Authority of Pakistan, Islamabad.

Following members attended the meeting: -

S. No.	Name & Designation			Status
		Dr. Hafsa Karam Ellahi Representative Director (QA/LT), DRAP, Islamabad	Member
	Mr. Munawar Hayat, Chief Drug Controller, Primary and Secondary Health Care Department, Govt. of Punjab, Lahore			Member
	Dr.Ikram-ul-Haque , Expert inQC/QA of drugs.			Member
	Prof. Dr. Abdullah Dayo, Dean, Faculty of Pharmacy, University of Sindh, Jamshoro			Member
	Prof. Dr. Mohammad Usman, Expert in manufacturing of drugs			Member
	Prof Dr. Jamshaid Ali Khan, Department of Pharmacy, University of Peshawar, Peshawar			Member
	Mr. Muhammad Israr Additional Draftsman Ministry of Law, Justice and Human Rights, Islamabad.			Member
	Syed Qalb e Hassan Chief Drug Inspector, Health Department, Government of Sindh, Karachi			Member
	Mr. Manzoor Ali Bozdar, Additional Director (Lic.), DRAP, Islamabad.			Secretary/Member
	Mr. Nawaz Ahmed and Mr. Arshad Mehmood Malik, Representative of PPMA			Observer
	Mr. Kamran Anwar, Representative of PCDA.			Observer

The meeting started with the recitation of verses from the Holy Qura’an. The Chairman Central Licensing Board welcomed the honorable members and participants of the meeting. He stated that all the legal and codal formalities would be taken into account for disposal of cases and respective Divisions shall be responsible for the contents, errors and omissions of agenda and minutes. Mr. Abdul Sattar Sohrani, Deputy Director (QC), Mr. Zeeshan Nazir, Deputy Director (QA), Dr. Muhammad Yaqoob AD (Lic.), and Dr. Zunaira Farayad, Assistant Director, DRAP Islamabad assisted the Secretary Central Licensing Board in presenting the agenda.

Item-I CONFIRMATION OF THE MINUTES OF 258^thMEETING

The Central Licensing Board (CLB) formally confirmed the minutes of its 258^th meeting held on January 8, 2018. The Board also decided that in future contents of the agenda may be made part of the final minutes especially item at Agenda item II, III and IV for background of the case and further clarity in decisions.

A. DRUG LICENSING DIVISION
Item-II: GRANT OF NEW DRUG MANUFACTURING LICENSES.
The Board considered the following cases of grant of new drug manufacturing licenses in the light of recommendations of respective panel of experts/inspectors and decided as under:

S #	Name of the firm	Date of Inspection / Type of License	Ranking/ Evaluation	Inspection Panel Members
1	M/s Parkar Pharma, Plot No. 0/7-A, S.I.T.E Area Kotri Sindh Sections 03 Tablet (General) Section Capsule (General) Section Liquid Syrup (General) Section.	07-02-2018	Good	Prof. Abdullah Dayo, Dean Pharmacy Sindh University, Jamshoro. Mr. Syed Muzaffar Ali Jafri, Director DTL (Sindh). Dr. Najam-us-Saquib, Additional Director (E&M), Karachi Dr. Obaid Ali, Federal Inspector of Drugs.
	Recommendations of the panel: - Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for exports, Panel recommends the grant of the Drug Manufacturing License by way of formulation of above mentioned sections. Decision by the Central Licensing Board in 259^th meeting The Board considered and approved the grant of Drug Manufacturing Licence by way of formulation in the name of M/s Parkar Pharma, Plot No. 0/7-A, S.I.T.E Area Kotri Sindh with following sections: Sections 03 Tablet (General) Section Capsule (General) Section Liquid Syrup (General) Section.

2	M/s Effort Pharmaceuticals (Pvt) Ltd, 28-km, Ferozepur Road, Lahore. Sections 02 Tablet (General) Section Capsule (General) Section	23-02-2018	Good	Dr. Farzana Chaudhary, Director UVAS, Lahore. Mr. Asim Rauf, Additional Director (E&M), DRAP, Lahore. Mr. Anjum Pervez, Consultant (R&L), PDCU, Lahore. Hafiz Muhammad Jawad Ali, Area FID, Lahore. Dr. Zunaira Faryad, Assistant Director (Lic), DRAP, Islamabad.
	Recommendations of the panel: - Keeping in view of the above all, the Panel recommends the grant of grant of the Drug Manufacturing License by way of formulation of above mentioned sections. Decision by the Central Licensing Board in 259^th meeting The Board considered and approved the grant of Drug Manufacturing Licence by way of formulation in the name of M/s Effort Pharmaceuticals (Pvt) Ltd, 28-km, Ferozepur Road, Lahore with following sections: Sections 02 Tablet (General) Section Capsule (General) Section
3	M/s Fahmir Pharma (Pvt) Ltd., Main Mandiwala Stop, 26-km, Lahore Road, Sharaqpur, District Sheikhupura. Sections 03 Tablet (General) Section Capsule (General) Section Sachet (General) Section.	09-03-2018	Good	Dr. Farzana Chaudhary, Director UVAS, Lahore. Mr. Asim Rauf, Additional Director (E&M), DRAP, Lahore. Mrs. Majida Mujahid, Federal Inspector of Drugs, Lahore. Mr. Anjum Pervaiz, Consultant Registration & Licensing, Provincial Drug Control Unit, Lahore.
	Recommendations of the panel: - Keeping in view the manufacturing facilities present in the unit the members of the panel recommends the grant of new Drug Manufacturing License to M/s Fahmir Pharma (Pvt) Ltd., Main Mandiwala Stop, 26-km, Lahore Jaranwala Road, Sharaqpur, District Sheikhupura as per layout plan approved by DRAP for above mentioned sections by way of Formulation. Decision by the Central Licensing Board in 259^th meeting The Board considered and approved the grant of Drug Manufacturing Licence by way of formulation in the name of M/s Fahmir Pharma (Pvt) Ltd., Main Mandiwala Stop, 26-km, Lahore Road, Sharaqpur, District Sheikhupura with following sections: Sections 03 Tablet (General) Section Capsule (General) Section Sachet (General) Section.

4	M/s Liven Pharmaceuticals (Pvt) Ltd,Sray Road, 49-Km, Multan Road,Phool Nagar, Districr Kasur. Section (05) 1. Tablet (General) Section. 2. Capsule (General) Section. 3. Oral Dry Powder Sachet (General) Section. 4. Liquid Injectable Ampoule (General) Section. 5. Liquid Injectable Vial (General) Section. 6. Liquid Injectable (Psychotropic) Section.	16-03-2018	Good	Dr. Farzana Chaudhary, Director Pharmacy Department, UVAS, Lahore. Mr. Asim Rauf, Additional Director, DRAP, Lahore. Mr. Anjum Pervaiz, Consultant Health Department, Punjab. Mr. Ajmal Sohail Asif, Federal Inspector of Drugs. Lahore.
	Recommendations of the panel: - The panel of inspectors recommends the grant of Drug Manufacturing License by way of formulation in respect of above mentioned sections to M/s Liven Pharmaceuticals (Pvt) Ltd, 49-Km, Multan Road, Lahore. Decision by the Central Licensing Board in 259^th meeting The Board considered and approved the grant of Drug Manufacturing Licence by way of formulation in the name of M/s Liven Pharmaceuticals (Pvt) Ltd, 49-Km, Multan Road, Lahore with following sections: Section (05) 1. Tablet (General) Section. 2. Capsule (General) Section. 3. Oral Dry Powder Sachet (General) Section. 4. Liquid Injectable Ampoule (General) Section. 5. Liquid Injectable Vial (General) Section. 6. Liquid Injectable (Psychotropic) Section.

5	M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-1, RCCI Industrial Estate, Rawat. Section (04) Capsule (Cephalosporin) Section. Dry Suspension (Cephalosporin) Section. Dry Vial Injection (Cephalosporin) Section. Sachet (Cephalosporin) Section.	09-03-2018 & 20-03-2018	Good	Dr. Muhammad Fakkharuddin Aamir, Additional Director-II (QA<), DRAP, Islamabad. Mr. Manzoor Ali Bozdar, Additional Director (Lic), DRAP, Islamabad. Dr. Hassan Afzaal, FID-III, DRAP, Islamabad. Mr. Muhammad Yaqoob, Assistant Director (Lic), DRAP Islamabad.
	Recommendations of the panel: - The panel of inspectors recommends the grant of Drug Manufacturing License by way of formulation in respect of above mentioned sections to M/s Liven Pharmaceuticals (Pvt) Ltd, 49-Km, Multan Road, Lahore. Decision by the Central Licensing Board in 259^th meeting The Board considered and approved the grant of Drug Manufacturing Licence by way of formulation in the name of M/s Wezen Pharmaceuticals, Plot No. 23 & 24, S-1, RCCI Industrial Estate, Rawat with following sections: Section (04) Capsule (Cephalosporin) Section. Dry Suspension (Cephalosporin) Section. Dry Vial Injection (Cephalosporin) Section. Sachet (Cephalosporin) Section.