Minutes of 259th meeting of central licensing board held on 29th & 30
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- Bu səhifədəki naviqasiya:
- Mr. Matee Ur Rehman (Salesman) S/o Tanvir Ahmed, Resident of House No. 254-C, Sabza Zar Scheme, Lahore.
- The accused persons are involved in contraventions of the provision of schedule-II and schedule-III of the DRAP Act 2012 as under
- The offence is punishable under section 1 (a) and para (4) (contraventions of rules) of schedule-III of DRAP Act 2012.
- Sr. No. Name Of Products/ Batch No. Date Of Mfg. Date Of Exp.
- M/s Mehmood Pharmacy through Mr. Arjumand maqsood.
- Ms. Anem Saeed Qualified person, R/o House No.92 Street No.117, Nisbat Road, Lahore
- The offence is punishable under section 1 (a) and para (4) (contraventions of rules) of schedule-III of DRAP Act 2012. Case No.16
- Decision of the Case:- The Central Licensing Board decided that the keys of the said premises shall be handed over to the area FID. Case No.17
- Proceedings of the case Inspection report of M/s Standard Drug Company Hyderabad conducted by Appellate panel of experts comprising of following
- Syed Muied Ahmed, (Expert in manufacturing) conducted on 11th December 2017 was placed before the CLB. Decision of the Case
The Central Licensing Board examined/evaluated the facts of the case in the light of investigations conducted by the FIDs and Quality Assurance Division and decided to grant permission for registration of FIR against the following accused persons:-
The accused persons are involved in contraventions of the provision of schedule-II and schedule-III of the DRAP Act 2012 as under:-
The offence is punishable under section 1 (a) and para (4) (contraventions of rules) of schedule-III of DRAP Act 2012. Case No. 15 Illegal/ Unauthorized Sale of Un-registered/ Alternative Medicine Raid on M/s. Mehmood Pharmacy, Property No. S-36-R-2(D),/2, Chowk Mayo Hospital, Lahore. FID Lahore-V, Mrs. Aisha Irfan visited the premises of M/s. Mehmood Pharmacy, Property No. S-36-R-2(D),/2,Chowk Mayo Hospital, Lahore on 30-01-2017 alongwith Mr. Abdul Rashid Sheikh, Federal Inspector Of Drugs, Lahore-I and Rana Ihsan ul Haq Athar, Assistant Drugs Controller, DRAP, Lahore and send the case vide letter No.1548/2017-DRAP (L-V) dated 31-01-2017. 02. FID informed that she seized the products at Sr. No. 01 being unregistered/ smuggled and the products at Sr. No. 02-05 are being sold without enlistment on Form-7 in violation to SRO 412(1)/2014, of Schedule-II of DRAP Act, 2012 and sections 23 and 27 of Drugs Act, 1976. Qualified person was also not present at the time of inspection. The Drugs were seized in the presence of Mr. Saqib Maqsood, (preson present)/ Incharge Mehmood Pharmacy, chowk Mayo Hospital, Lahore.
03. The FID requested to grant the permission to keep the seized stock in safe custody of drugs mentioned on Form-2 till decision of the case under Section 19(5) of the Drug Act, 1976. The permission for safe custody has been granted on 17th February, 2017. 04. FID Lahore-V, Mrs. Aisha Irfan forwarded the complete case vide reference letter No.5533/2017-DRAP (L-V) dated 26th April, 2017. 05. Findings: FID recommended that the sale of Un-registered drugs prohibited under Section 23 of the Drugs Act, 1976 read with section A(1) (a) (vii) of Schedule-II of the DRAP Act, 2012 which is punishable under Section 27 of the Drugs Act, 1976 read with section (1) (a) of Schedule-III of the DRAP Act, 2012, therefore the case may be placed before the central Licensing Board. 06. Permission For FIR against the following accused persons may be granted to the FID Lahore For selling un registered drugs in violation to the Drug Act 1976 and DRAP Act 2012:-
ii. Muhammad Arjumand Maqsood R/o House No.92, Army Housing Society, Defense, Lahore. iii. Ms. Anem Saeed Qualified person, R/o House No.92 Street No.117, Nisbat Road, Lahore. “Decision of the Case:- The Central Licensing Board examined/evaluated the facts of the case in the light of investigations conducted by the FIDs and Quality Assurance Division and decided to grant permission for registration of FIR against the following accused persons:-
ii. Muhammad Arjumand Maqsood R/o House No.92, Army Housing Society, Defense, Lahore.
The accused persons are involved in contraventions of the provision of schedule-II and schedule-III of the DRAP Act 2012 as under:-
The offence is punishable under section 1 (a) and para (4) (contraventions of rules) of schedule-III of DRAP Act 2012. Case No.16 Handing Over The Keys of Sealed premises of M/s Everest Pharmaceuticasl Plot No. 124 Industrial Triangle Khautta Road Islamabad (Case No.FIR No.05/2018 of FIA ACC Islamabad. Additional Director QA/LT has informed that reference to the decision of the CLB in its 258th meeting held on 08-03-2018, Director FIA Islamabad Zone was requested to indicate to suitable time and date for handing over the keys as per decision. The Director FIA has informed through its correspondence dated 16-03-2018 that power of seizures and sealed are given to the Inspector of Drugs and FID is responsible for the production of case property in the Court. FIA has neither seized the material in question nor seal the premises of M/s Everest Pharmaceuticasl Islamabad. On the directions of district Administration AC rural proper guard of police station Sihala as already been deputed for security on the premises In the light of above the keys of premises of M/s Everest Pharmaceuticals Islamabad be handed over to the concerned FID to produced the seized materials before the competent Court for prosecution “Decision of the Case:- The Central Licensing Board decided that the keys of the said premises shall be handed over to the area FID. Case No.17 Manufacture & Sale of Sub-Standard Drugs by M/S Standard Drug Company, Hyderabad. –Recommendation of Cancellation of Drug Manufacturing License (DML) of 12 Samples of M/S Standard Drug Company, Hyderabad, “Under Section 41 of Drugs Act, 1976”. It is submitted that 12 samples of drugs Manufactured by M/s Standard Drug Company, Hyderabad drawn by FID Hyderabad at Karachi from manufacturing premises on 21st January 2015, were declared Substandard by CDL Karachi. On explanation letter issued by the FID, the firm challenged the CDL reports and requested for Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also declared the 12 samples as Substandard. The 255th meeting of DRB Proceeding: Mr Imtiaz Ahmed (Managing Director/Partner) appeared on the behalf of the firm and defended the case The Case placed before the Central Licensing Board on recommendations of Registration Board in its 255th meeting held on17-18th December 2015 The Registration Board decided to cancel the registration of following twelve (12) products of M/s Standard Drug Company Hyderabad and recommended the Central Licensing Board for cancellation of DML of M/s Standard Drug Company Hyderabad as 12 samples drugs product of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate Lab NIH Islamabad Details of Drugs declared Substandard by Both the Labs:
M/s Standard Drug Company Hyderabad has filed Constitutional Petition No.971 of 2016 (MA 6205/2016) through Mr. Imtiaz Ahmed Vs Federation of Pakistan in the High Court of Sindh, Karachi, Circuit Court, Hyderabad against the decision of the Drug Registration Board in its 255th meeting held on 17-18th December 2015for cancellation of registration of twelve registered products of M/s Standard Drug Company Hyderabad. However no directions for Central Licensing Board have been received from Honorable Sindh High Court Karachi, Circuit Court, Hyderabad. The FID Hyderabad at Karachi vide his letter No.10-02-2016-DRAP(K) dated 01-08-2016 has requested to send the Parawise comments and appointment of Standing Council. Parawise comments and nomination of standing council are under processed/approval in the Division of legal Affairs, DRAP, Islamabad. Decision: The Board after detailed discussion, deliberation, considering the facts and legal provisions decided as under: “The Board decided to issue show cause notice for cancellation of DML of the firm M/s Standard Drug Company Hyderabad as recommended by Registration Board in its 255th meeting held on 17-18th December 2015”. As per decision of the Central Licensing Board in its 250th meeting held on 27th October, 2016 the firm was issued a show cause notice for cancellation of Drug Manufacturing License (DML). The firm has submitted its reply in response to show cause notice regarding cancellation of Drug Manufacturing License (DML) as 12 samples of the said firm has been declared substandard by both the Laboratories. The M/s Standard drug company Hyderabad has filed constitution petition in the High Court of Sindh Circuit Bench at Hyderabad vide C.P. D-971/16 which is graciously being dismissed. The judgment of the Honorable High Court Sindh dated 13-02-2017 is as under:- “the impugned orders are within the jurisdiction as such extraordinary remedy may be pursued/availed by the petitioner. Accordingly, petition is dismissed. Parties shall bear their own costs. However it is clarified that in order to redress his grievance the petitioner may adopt appropriate remedy available to him under the relevant law which shall be dealt with strictly in accordance with law” They have requested for personal hearing before the Central Licensing Board. They have been called for personal hearing. Proceedings:
Decision: The Board after detailed discussion, deliberation and keeping in view the facts of the case including the information provided, the Board decided to cancel the Drug Manufacturing License of the Firm M/s. Standard Drug Company, Hyderabad. The inspection report is attached as Annex. Current Status: It is submitted that M/s Standard Drug Company, Hyderabad filed an appeal against the decision of Registration Board regarding cancellation of Linobex-C Syrup batch No. LC.09-A in its 255th Meeting held on 17th -18th December 2015. Proceedings and decision of 148th Meeting of Appellate Board held on 22-12-2017: (i). The appeal came under discussion during 147th meeting of the Appellate Board held on 28-08-2017. However, at the outset, the appellant requested to adjourn the appeal as he has not received the report of test/ analysis from the Appellate Lab, NIH, Islamabad. The Board accepted the request for adjournment and directed the appellant to submit revised comments after receiving the report of test/ analysis from NIH, Islamabad within 30 days. The decision of the board was communicated to the firm on 22-09-2017. (ii). The Board was informed that the Appellant has submitted a written request to defer the Appeal till next meeting as he has not received the report of test/ analysis from NIH, Islamabad. He further stated that he has written a letter to the Chief (DC&TMD), NIH, Islamabad for issuance of reports of 12 product including Linobex-C syrup and deposited testing fee Rs. 114,480/-. FID, Hyderabad was also requested for provision of said test reports. (iii). The Board accepted the request for adjournment and directed the QA< Division to provide report of NIH, Islamabad to the Appellant within three days to enable the Appellant to submit revised comments in respect of Linobex-C Syrup, registration No. 004077 within 30 days. As per decision of Appellate Board, the NIH test report has been issued to the firm. Then M/s Standard Drug Company Hyderabad filed an appeal against the decision of Central Licensing Board regarding the cancellation of their Drug Manufacturing License on 02-06-2017 (DML. No. 000118). Proceedings and Decision of Appellate Board in its 147th SITTING HELD ON 28-08-2017: A panel was constituted by appellate Board. The panel constituted by the Appellate Board inspected the premises of M/s Standard Drug Company, Hyderabad on 11-12-2017 Their recommendations are as under: “The panel observed a number of critical 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 to continue with the cancellation of drug manufacturing license of Ms Standard Drug Company, Hyderabad”. The inspection report is attached as Annex. “Proceedings of the case Inspection report of M/s Standard Drug Company Hyderabad conducted by Appellate panel of experts comprising of following
Decision of the Case:- “The CLB after deliberation and thread bare discussion decided to issue show cause notice to M/s Standard Drug Company Hyderabad on the basis of short comings/deficiencies identified and forwarded by Appellate Panel in their report (Annex A).” Page of Yüklə 1,12 Mb. Dostları ilə paylaş:
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