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MINUTES of 229Th MEETING of CENTRAL LICENSING BOARD

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MINUTES of 229Th MEETING of CENTRAL LICENSING BOARD 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. Page 1 of 116 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. Page 2 of 116 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.
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