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

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

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



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 258thMEETING

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


  1. Tablet (General) Section

  2. Capsule (General) Section

  3. Liquid Syrup (General) Section.

07-02-2018


Good

  1. Prof. Abdullah Dayo, Dean Pharmacy Sindh University, Jamshoro.

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

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

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




Recommendations of the panel: -
Based on the areas inspected, the people met and the documents reviewed and considering the findings of the inspection and vision of the management for exports, Panel recommends the grant of the Drug Manufacturing License by way of formulation of above mentioned sections.

Decision by the Central Licensing Board in 259th meeting

The Board considered and approved the grant of Drug Manufacturing Licence by way of formulation in the name of M/s Parkar Pharma, Plot No. 0/7-A, S.I.T.E Area Kotri Sindh with following sections:



Sections 03


  1. Tablet (General) Section

  2. Capsule (General) Section

  3. Liquid Syrup (General) Section.




2

M/s Effort Pharmaceuticals (Pvt) Ltd, 28-km, Ferozepur Road, Lahore.
Sections 02


  1. Tablet (General) Section

  2. Capsule (General) Section

23-02-2018


Good

  1. Dr. Farzana Chaudhary, Director UVAS, Lahore.

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

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

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

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




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 259th 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


  1. Tablet (General) Section

  2. Capsule (General) Section

3

M/s Fahmir Pharma (Pvt) Ltd., Main Mandiwala Stop, 26-km, Lahore Road, Sharaqpur, District Sheikhupura.
Sections 03


  1. Tablet (General) Section

  2. Capsule (General) Section

  3. Sachet (General) Section.

09-03-2018


Good

  1. Dr. Farzana Chaudhary, Director UVAS, Lahore.

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

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

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




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 259th 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


  1. Tablet (General) Section

  2. Capsule (General) Section

  3. Sachet (General) Section.




4

M/s Liven Pharmaceuticals (Pvt) Ltd,Sray Road, 49-Km, Multan Road,Phool Nagar, Districr Kasur.
Section (05)

1. Tablet (General) Section.

2. Capsule (General) Section.

3. Oral Dry Powder Sachet (General) Section.

4. Liquid Injectable Ampoule (General) Section.

5. Liquid Injectable Vial (General) Section.

6. Liquid Injectable (Psychotropic) Section.


16-03-2018

Good

  1. Dr. Farzana Chaudhary, Director Pharmacy Department, UVAS, Lahore.




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




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




  1. 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 259th 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)

  1. Capsule (Cephalosporin) Section.

  2. Dry Suspension (Cephalosporin) Section.

  3. Dry Vial Injection (Cephalosporin) Section.

  4. Sachet (Cephalosporin) Section.

09-03-2018 &

20-03-2018

Good

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

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

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

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

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 259th 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)

  1. Capsule (Cephalosporin) Section.

  2. Dry Suspension (Cephalosporin) Section.

  3. Dry Vial Injection (Cephalosporin) Section.

  4. Sachet (Cephalosporin) Section.


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