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



Yüklə 1,12 Mb.
səhifə17/17
tarix17.01.2019
ölçüsü1,12 Mb.
#99263
1   ...   9   10   11   12   13   14   15   16   17

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:-

  1. M/s Mehmood Pharmacy, through Mr. Muhammad Zeeshan (Proprietor) S/o Muhammad Arjumand Mahmood, M/s. Mehmood Pharmacy, Inside Metro Habib Cash and Carry, Thokar Niaz Baig, Multan road, Lahore. Resident of house No.92 army Housing Scheme Defence, Lahore.



  1. Mr. Muhammad Zeeshan (Proprietor) S/o Muhammad Arjumand Mahmood, M/s. Mehmood Pharmacy, Inside Metro Habib Cash and Carry, Thokar Niaz Baig, Multan road, Lahore. Resident of house No.92 army Housing Scheme Defence, Lahore.




  1. Mr. Matee Ur Rehman (Salesman) S/o Tanvir Ahmed, Resident of House No. 254-C, Sabza Zar Scheme, Lahore.




  1. Mr. Haseeb Ahmed (person present at the time of raid) 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:-


  1. Sale of un registered drugs

  2. Sale of drugs without warranty.

  3. Manufacturing/import without authorization from the DRAP.



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.


Sr. No.

Name Of Products/ Batch No.

Date Of Mfg.

Date Of Exp.

Manufactured By

Quantity

01.

MyDacla 60 (Daclatasavir Dihydrochloride) Tablets 60 mg/ MYDA 16020

09-2016

08-2018

M/s Natco Pharma Limited Kokjhar, Mirza Garru Bazar, District Kamrup Guwahati India.


28 Tablets

02.


Alopia 004

02-2016

03-2020

Nil

11 Packs

03.

Alopia Hair Food 004


02-2016

Use Within 03 Years

Nil

07 Packs

04.

Alopia Hair Food Plus 004


02-2016

Use Within 03 Years

Nil

02 Packs

05.

Alopia Hair Loss Solution 002

03-2016

Use Within 03 Years

M/s Primose 293 A-1, Gulberg-III, Lahore.

05 Packs

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:-


  1. M/s Mehmood Pharmacy through Mr. Arjumand maqsood.

  2. Mr. Saqib Maqsood, person present/ incharge Mehmood Pharmacy, R/O House No.07, street No.98, Kocha Mehar Faizan Main Bazar Mozang, Lahore.

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:-

  1. M/s Mehmood Pharmacy through Mr. Arjumand maqsood.

  2. Mr. Saqib Maqsood, person present/ incharge Mehmood Pharmacy, R/O House No.07, street No.98, Kocha Mehar Faizan Main Bazar Mozang, Lahore.

ii. Muhammad Arjumand Maqsood R/o House No.92, Army Housing Society, Defense, Lahore.

  1. Ms. Anem Saeed Qualified person, R/o House No.92 Street No.117, Nisbat Road, Lahore


The accused persons are involved in contraventions of the provision of schedule-II and schedule-III of the DRAP Act 2012 as under:-


  1. Sale of un registered drugs/therapeutic goods

  2. Sale of drugs without warranty.

  3. Manufacturing/import without authorization from the DRAP.



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:

S.No.

Name of the Product Batch No. & M/s

Remarks

Decision of DRB in its 255th meeting held on 17-18th December 2015

1.

Netrozole (Metronidazole) Suspension Batch No.NZ10-A M/s Standard Drug Company Hyderabad (Reg. No. 057829 )

Substandard (CDL/NIH)

“The Board decided to Cancel the registration of Netrozol Suspension Batch No. NZ 10-A Reg. No. 057829 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as many samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

2.

Netrozole (Metrinidazole) Suspension Batch No.NZ.08-A M/s Standard Drug Company Hyderabad (Reg. No. 057829)

Substandard (CDL/NIH)

“The Board decided to Cancel the registration of Netrozol Suspension Batch No. 08-A Reg. No. 057829 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad


3.

Staifaminc(Mefanimic Acid) Suspension Batch No.SF.07A M/s Standard Drug Company Hyderabad (Reg. No. 057826)

Substandard (CDL/NIH)

“The Board decided to Cancel the registration of Staifaminc Suspension Reg. No. 057826 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad


6.

Rheudic-50 Tablets (Diclofenic Sodium) Batch No.RD.04-A M/s Standard Drug Company Hyderabad Reg. No.066939

Substandard (CDL/NIH)

“The Board decided to Cancel the registration of Rheudic-50 Tablets Reg. No.066939 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad



7.

Sodamint Tablets (Sodium Bicarbonate) Batch No. SM.09-A M/s Standard Drug Company Hyderabad (Reg. No.008879)

Substandard (CDL/NIH)

“The Board decided to Cancel the registration of Sodamint Tablets Reg. No.008879 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad


8.

Staiflic Tablets (Folic Acid) Batch No.SF.03-A M/s Standard Drug Company Hyderabad Reg. No.57828

Substandard (CDL/NIH)

The Board decided to Cancel the registration of Staiflic Tablets (Folic Acid) Reg. No.57828 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad


9.

Montilu 10mg Tablets (Montilukast Sodium) Batch No.B01A M/s Standard Drug Company Hyderabad Reg. No.067688

Substandard (CDL/NIH)

The Board decided to Cancel the registration of Montilu 10 mg Tablets (Mountelukast Sodium) Reg. No.067688 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad




10.

Stabru Suspension (Ibuprofen) Batch No.SB.22A M/s Standard Drug Company Hyderabad Reg. No.057827

Substandard (CDL/NIH)

The Board decided to Cancel the registration of Stabru Suspension Ibuprofen Reg. No.057827 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad


11.

Stamelox 15mg Tablets (Meloxicam) Batch No.SA01-A M/s Standard Drug Company Hyderabad Reg. No.067648

Substandard (CDL/NIH)

The Board decided to Cancel the registration of Stamelox 15 mg Tablets (Meloxicam) Reg. No.067648 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad




12.

Standlo 500mg Tablets (Levofloxacine) Batch No.SO-03-A M/s Standard Drug Company Hyderabad Reg. No.066934

Substandard (CDL/NIH)

“The Board decided to Cancel the registration of Standlo 500mg Tablets (Levofloxicine) Reg. No.066934 and decided to recommended the Central Licensing Board for Cancellation of DML of the Firm as 12 samples of the firm has been declared substandard by both the Labs i.e. CDL Karachi and Appellate NIH Islamabad

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:
Personal hearing letters were issued to the accused persons of the firm but no person appeared before the board. The board was informed that the letter has been received from the Managing Director of the firm; Mr. Imtiaz Ahmad dated 14th March, 2017. He submitted that He is unable to attend the meeting as He is suffering from high fever due to which doctor had suggested him to take complete bed rest and not to travel somewhere with this condition. He requested to call him for personal hearing in next meeting of the Board.

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


  1. Dr. Kifayatullah CDC Gilgit Baltistan,




  1. Professor Dr. Maqsood Ahmed Rifah International university Lahore and




  1. Syed Muied Ahmed, (Expert in manufacturing) conducted on 11th December 2017 was placed before the CLB.


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:
1   ...   9   10   11   12   13   14   15   16   17




Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©muhaz.org 2022
rəhbərliyinə müraciət

    Ana səhifə