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



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03. The FID further informed that the above mentioned were recovered and seized in the presence of Mr. Sajjad, Proprietor present (CNIC No. 35202-2654857-7) and Ms. Alia Aroosa, Qualified person present (CNIC No. 35201-8259479-7). The witnesses were also recorded on the seizure Form.



Permission for safe custody

05. The FID requested the competent authority to grant permission for safe custody of seized drug as mentioned above till decision of the case


Decision of the Case:-

Permission for safe custody of the seized stocks of therapeutic goods/drugs was allowed to the FID till the finalization of the case”.
Case No.09 Raid On Office Of M/s. Everest Pharmaceutical Situated at Office No. 13, 3rd Floor, Gohar Centre, Wahdat Road, Lahore.
Mr. Ajmal Sohail Asif, FID Lahore vide letter No.F.5-27/2018-FID (IV)/3258 dated 07th March, 2018 wherein FID informed that on directions of Additional Director, Lahore, he alongwith Mr. Muhammad Usman Iftikhar, Inspector of FIA, Lahore and Ms. Uffaq Tanvir AD, DRAP, Lahore visited the head office of M/s. Everest Pharmaceutical, situated at Office No. 13, 3rd floor, Wahdat Road, Lahore on 06-03-2018. The FID informed that he was directed to inspect the said office and confiscate/ seize any un-registered drugs of the firm stocked/ stored in the office with reference to DRAP, Islamabad′s letter No.F.4-5/2018-QC dated 06-03-2018.

02. The FID further informed that he reached at the said office along with other team members at about 12:15 pm. The office was closed, the door seemed to be locked, door was knocked many times but there was no response. The FID contacted the management of the building and Mr. Sajjad Hussain (Supervisor of the building management) came at the premises. He informed that the office belongs to Mr. Muhmmad Usman of M/s. Everest Pharmaceutical and usually is opened on weekdays. He further informed that today he has not seen any of the employees of the office.

03. The FID also informed that in such circumstances, it was not possible to inspect the office, therefore, the office was sealed under Section 18 (1) (j) of the Drugs Act, 1976 without inspection and a notice was pasted on the door wherein the firm was directed to attend the office of the FID for conducting inspection.

04. The premises was sealed in the presence of Mr. Muhammad Usman Iftikhar, Inspector FIA and Mr. Sajjad Hussain, Supervisor of the building, witnesses were recorded on the notice and the case is under investigation.

05. The FID has requested to grant permission to keep the premises sealed till the premises is inspected in the presence of management of firm and all illegal drugs are seized under the law.
Decision of the Case:-

The Central Licensing Board granted extension of further 90 days in the sealing period of the premises.”
Case No.10 MANUFACTURE AND SALE OF SPURIOUS, UN-REGISTERED, AND SUBSTANDARD DRUGS MENTIONED BELOW BY M/S. EVEREST PHARMACEUTICALS 124, IDUSTRIAL TRIANGLE, KAHUTA ROAD ISLAMABAD.
On the direction of Honorable Supreme Court of Pakistan Islamabad, during the hearing dated 06.03.2018 in connection with Human Rights Case No.5845 and 3923-G of 2018, DRAP inspection team alongwith FIA and NAB teams conducted the inspection of M/s. Everest Pharmaceuticals 124, Industrial Triangle, Kahuta Road Islamabad. Undersigned recovered and sealed the following nine (09) samples of suspected un-registered, sub-standard and spurious drugs for test analysis purpose under Section 18(1)(c)of the Drugs Act, 1976 on prescribed Form-3 in the presence of witnesses. Copy of Form 3 is enclosed the detail thereof is as under:
2. Muhammad Usman Ch. s/o Mr. Zaheer Ahmed Ch. CNIC No.35202-8457717-1 owner/production incharge of the firm resident of Flat No.13, 3rd Floor Ghoar Center Muslim Town Waris
Road Lahore refused to sign and receive the sealed portion of the samples of the drugs and copy of Form-3 required under Section (3)(c) of Schedule-V (Procedure for Inspectors) of DRAP Act 2012 read with section 19(3) of Drugs Act 1976 and rules framed thereunder hence violated Section-3 of Schedule-III (OFFENCE) of DRAP Act 2012 read with Section 27 (3) of Drug Act 1976 (disobeys the lawful authority of any Inspector) and rules framed there under.

3. A sealed sample of each drug was sent under Section (3)(a) of Schedule-V (Procedure for Inspectors) read with section 19(3)(i) of Drugs Act, 1976 to the Federal Government Analyst, Central Drugs Laboratory Karachi on prescribed Form-4 for test & analysis purpose on 7th March, 2018 and one portion of sealed sample of each drug was forwarded to Secretary Registration Board, Drug Regulatory Authority of Pakistan required under Section (3)(b) of Schedule-V (Procedure for Inspectors) read with section 19(3)(ii) of Drugs Act, 1976 excluding the sealed portion of samples of said drug of the firm.




  1. The Division of Pharmaceuticals Evaluation and Registration (PE&R) was also requested to verify the status of registrations of the drugs mentioned at para [1]. The Division of PE & R has informed that all the drugs mentioned on Form-3 are un-registered as per their official record.




  1. The Federal Government Analyst, Central Drugs Laboratory Karachi, under section 22 (2) of the Drugs Act, 1976 and rules framed there under sent the test reports of the drugs mentioned on Form-3 as below:-




Sample. No

Name of Drug & Batch No.

Manufacturer

Remarks on the test report with its number, Date

Violations

01-FID-I/2018

Ever Strong Tablets

Batch No. 055

Reg. No. 070250

Mfg. Date: Nil

Exp. Date 02/20


M/s. Everest Pharmaceuticals, Plot No. 124, Industrial triangle, Kahuta Road, Islamabad..

Un-Registered Drug Product”

R.IP.30/2018

Dated 22nd March 2018

Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under.

02-FID-I/2018

Levonag Tablets.

Batch No. 301

Reg No. 032726

Mfg. Date: Nil

Exp. Date: 09/19


-do-

Un-Registered Drug Product”

R.IP.31/2018

Dated 20th March 2018


Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under.

03-FID-I/2018

Imcob Tablets.

Batch No. 421

Reg No. 072015

Mfg. Date: Nil

Exp. Date: 11/19


-do-

Un-Registered Drug Product”

R.IP.32/2018

Dated 20th March 2018

Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under.


04-FID-I/2018


EverFlox Suspension

Batch No. 064

Reg No. 070150

Mfg. Date: 2/18

Exp. Date: 02/20


-do-


Un-Registered Drug Product”

R.IP.33/2018

Dated 20th March 2018



Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under.

05-FID-I/2018

Cardol Tablets.

Batch No. 054

Reg No. 072074

Mfg. Date: Nil

Exp. Date: 02/20


-do-

Un-Registered & Spurious Drug Product”

R.IP.34/2018

Dated 21st March 2018


Schedule-II A(1)(a)(vii) and A(1)(a)(i) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) and (1)(a)(i) of Drugs Act, 1976 and rules framed there under.

06-FID-I/2018

Biotriol Oral Solution.

Batch No. 444

Reg No. 070078

Mfg. Date: 12/16

Exp. Date: 12/18


-do-

Un-Registered Drug Product”

R.IP.35/2018

Dated 22nd March 2018



Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under

07-FID-I/2018

M Plus Tablets.

Batch No. 332

Reg No. 068787

Mfg. Date: Nil

Exp. Date: 10/19


-do-

Un-Registered Drug Product”

R.IP.36/2018

Dated 22nd March 2018



Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under

08-FID-I/2018

Everchol Tablets.

Batch No. 062

Reg No. 063289

Mfg. Date: Nil

Exp. Date: 2/20


-do-

Un-Registered & Sub-Standard Drug Product”

R.IP.37/2018

Dated 21st March 2018




Schedule-II A (1)(a)(vii) and (v) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) and (v) of Drugs Act, 1976 and rules framed there under

09-FID-I/2018

Lexidex-M Tablets.

Batch No. 060

Reg No. 068872

Mfg. Date: Nil

Exp. Date: 2/20


-do-

Un-Registered Drug Product”

R.IP.38/2018

Dated 20th March 2018




Schedule-II A (1)(a)(vii) of DRAP Act, 2012 read with Section 23 (1)(a)(vii) of Drugs Act, 1976 and rules framed there under

6. Keeping in view of the test reports of Federal Government Analyst, Central Drugs Laboratory, Karachi the M/s Everest Pharmaceuticals, Islamabad have been found involved in manufacturing/selling of spurious, un-registered & sub-standered drugs and violated Schedule-II A (1)(a)(i), (v) and (vii) of DRAP Act, 2012 read with Section 23 (1)(a) (i), (v) and (vii) of Drugs Act, 1976 and rules framed there under and also volited Schedule-III (OFFENCE) Section -3 of DRAP Act 2012 read with Section 27 (3) of Drug Act 1976 (disobeys the lawful authority of any Inspector) and rules framed there under.


7. Dr. Hafsa Karam Elhi Additional Director QA< requested for launching FIR, the competient Authority i.e Director QA< DRAP-Islamabad granted the permission to launch FIR aganist following accused persons of M/s. Everest Pharmaceuticals 124, Indstrial Triangle, Kahuta Road islamabad responsible for manufacturing and selling of un-registered drugs and import/smuggling of active pharmaceutical ingredients without import license and clearance from DRAP, Islamabad.:

  1. Ch. Muhammad Usman,

  2. Dr. Kamran Izhaar,

  3. Noor Muhammad Mehr,

  4. Ch. Muhammad Usman, Production In-Charge and

  5. Muhammad Ishtiaq QC Incharge and other



  1. That the FGA declared the samples as unregistered, Spurious and substandard vide test/analysis reports as per details below. The actives of the products are also mentioned:



Sr. No

Name of brand product

Name of drug

Batch no.

Manufacturer name

Report number

Remarks

1

Cardol tablet

Calcium and carbonate

054

M/s Everest Pharmaceuticals, Islamabad.

R.IP.34/2018

dated: 21st March, 2018



Un-registered and spurious

2

Levonag 250mg tablets

Levofloxacin

301

M/s Everest Pharmaceuticals, Islamabad.

R.IP.31/2018 dated: 20th March, 2018

Un-registered

3

Imcob 1000mcg tablets

Mecobalamin

421

M/s Everest Pharmaceuticals, Islamabad.

R.IP.32/2018

dated: 20th March, 2018



Un-registered

4.

Everflox suspension

Levofloxacin and Metronidazole benzoate

064

M/s Everest Pharmaceuticals, Islamabad.

R.IP.33/2018 dated: 20th March, 2018

Un-registered

5.

Lexidex-M tablets

Montelukast sodium and Loratadine

060

M/s Everest Pharmaceuticals, Islamabad.

R.IP.38/2018 dated: 20th March, 2018

Un-registered

6.

Everchol Tablets

Mecobalamin and Cholcalciferol

062

M/s Everest Pharmaceuticals, Islamabad.

R.IP.37/2018 dated: 21st March, 2018

Un-registered and Substandard

07.

M Plus tablets

Montelukast

332

M/s Everest Pharmaceuticals, Islamabad

R.IP.36/2018 dated: 22nd March, 2018

Un-registered and Substandard

08.

Everestrong Tablets

Calcium Carbonate

055

M/s Everest Pharmaceuticals, Islamabad

R.IP.30/2018 dated: 22nd March, 2018

Un-registered and Substandard

09.

Biotriol Oral Solution




444

M/s Everest Pharmaceuticals, Islamabad

R.IP.35/2018 dated: 22nd March, 2018

Un-registered and Substandard


11. That M/s Everest Pharmaceuticals owners and technical qualified personnel have violated the provisions of schedule II and schedule III by manufacturing unregistered, spurious and substandard drugs. It is also pertinent that some raw materials were imported without import license and clearance from the DRAP as prescribed under the Drug Act 1976, DRAP Act 2012 and drugs import and export rules 1976.
12. The FID has requested for the grant of registration of FIR against the following accused persons:-

  1. M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.

  2. Ch. Muhammad Usman (Chief Executive officer), M/s Everest Pharmaceuticals Islamabad

  3. Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad

  4. Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad

  5. Ch. Muhammad Usman, Production In charge, M/s Everest Pharmaceuticals Islamabad

  6. Muhammad Istiaq QC Incharge, M/s Everest Pharmaceuticals Islamabad


Decision of the Case:-

  1. Permission for registration of FIR was granted against the following accused persons



  1. M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.

  2. Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabad

  3. Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad

  4. Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad

  5. Ch. Muhammad Usman, Production In charge, M/s Everest Pharmaceuticals Islamabad

  6. Mian Ishtiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabad



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



  1. Manufacturing of unregistered drug products.

ii. Manufacturing of spurious drug products.

  1. Manufacturing of substandard drugs.



  1. Import and usage of raw materials without import license and clearance from the DRAP as prescribed under the Drug Act 1976, DRAP Act 2012.



  1. Disobeyed the lawful authority of any Inspector



  1. Drug Import Export Rules 1976.



  1. The FID shall lodge FIR under schedule- IV of the DRAP Act 2012 and resubmit the complete case before the CLB after completion of investigations under the law.


Case No. 11 Manufacture & Sale of Un registered, Adulterated and Sub-Standard Veterinary drugs purported to be manufactured by M/S Honestan Pharma, Karachi. (unlicensed and imported by SALROZ Pharma mfg by Hebei New Century Pharmaceutical ltd China.
FID VII Karachi visited the premises of M/s Al-Azim Medical Store Karachi alongwith Dr. Abdul Rasool Shaikh FID and Dr. Shoaib Ahmed FID on 25th October 2017 and took samples for test analysis and sent to the CDL, Karachi. The following test reports No.R.KQ.593/2017 (initial) dated 10th November 2017, R.KQ.595/2017 (initial) dated 10th November 2017 and KQ. 626/2017 (initial) dated 17th November 2017 from the Federal Government Analyst, CDL, Karachi. Wherein, the Federal Government Analyst has declared samples of;

02. The details of the contraventions and test reports as under:-





Drug Name

Batch No.

Reg. No.

Test result

Manufacturer/importer name

Vitamin AD3E Injection

20170415

Nil

Un registered test report no. RKQ 592/2017 dated 22-12-2017

Imported by SALROZ pharma mfg by Hebei New Century Pharmaceutical ltd China

Oligovit injection

20170414

Nil

Un registered test report R.KQ 594/2017 dated 22-12-2017

-do-

Mouthnil Injection

Mn25

198300

Fake registration no. PE&R Division do not verify this registration no.



Adulterated and substandard test report no. RKQ 595/2017 dated 13th November 2017

Honestan Pharma,

Karachi



not licensed by the DRAP


Diconil-50 plus Injection

Nil


Nil without valid registration

Adulterated and substandard test report RKQ 593/2107 dated 12th December 2017

-do-

Mr. Zaheer Ahmed s/o Muhammad Yaseen proprietor AL-Azim medical store plot No. A12-37 commercial area road No.6 cattle colony landhi Karachi, failed to produce invoice warranties of the above mentioned products despite notices by the area FID.


The FID therefore decalred that mr. Zaheer Ahmed s/o Muhammad yaseen proprietor Al Azim medical store and mehboob ali ismaili s/o Ameer Ali Qualified person are responsible for the offences.

Permission for Lodging of FIR
It is therefore submitted that permission for registration of FIR against the above mentioned accused persons may be granted for manufacturing, importing and selling of unregistered, Adulterated and substandard drugs products without valid manufacturing and import licenses as well as purchasing without valid warranty.
Decision of the Case:-


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