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

(4) i.e. contravention of rules:- subject to the provisions of clause (1) (2) and (3) whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees or with both.

(6), Penalty for violating the prohibitions: whoever himself or by any other person on his behalf violates any prohibitions specified in schedule-II shall be punished with imprisonment for a term upto five years and with fine up to five hundred thousand rupees.


Case No.06 Manufacture & Sale of Un-Registered Drug Reap 2.5mg Tablet Batch No. 188, Reg. No. 068804 Manufactured By M/s. Everest Pharmaceutical Pvt. Ltd., Islamabad.

1. That Pharmaceutical Evaluation & Registration Division reported that M/s. Everest Pharmaceutical, Islamabad is involved in manufacturing of certain Un-registered products with fake registration numbers which are not approved by the Pharmaceutical Evaluation & Registration Division.

02. The matter was circulated to the field offices of DRAP vide letter of even no dated 03^rd December, 2015 for necessary action under the law.

03. That FID Karachi inspected the business premises of M/s Aqmar Pharma first floor 36-Block BSMCH Karachi on 02-02-2016 and seized capsule Reap 2.5mg B. No. 188 purported to be Mfg. by M/s. Everest Pharma, Islamabad on Form-2 which was duly signed by Mr. Mohd. Farooq sheikh Proprietor the firm FID also took sample on Form-3 for the purpose of test/ analysis.

04. The FID Karachi also seized cap Reap 2.5 mg B.No.188 purported to be manufactured by M/s Everest Pharma Islamabad on Form-2 from M/s Bright Pharma Karachi on 01-02-2016 duly signed by Mr. Mohd. Rafique, proprietor.

05. That M/s Bright Pharma, Karachi sale record was also obtained by the FID Karachi which proved that M/s. Bright Pharma, Karachi sold the said product in the market of Karachi, in addition to other Un-registered products manufactured by M/s. Everest Pharma, Islamabad.

06. M/s Bright Pharma, Karachi submitted invoice warranty issued by M/s Aqmar Pharma Karachi vide invoice No. AKPH-B 24 dated 14-01-2016.

07. That M/s. Aqmar Pharma submitted invoice warranty having number 411672, dated 29-12-2015 and number 12575, dated 29-01-2016 of Capsules Reap 2.5mg as a source of purchased from M/s. Tainzy International 15 Qauyum Block Mustafa town Wahdat Road Lahore. M/s Bright Pharma also submitted delivery challan of Aqmar Pharma dated 01-02-2016 for the purchased of 60 packs of Reap 2.5mg Capsules of the same batch, as a source of purchased of M/s. Aqmar Pharma from Tainzy international Lahore.

08. M/s. Aqmar Pharma, Karachi also submitted agreement for supply of drugs with M/s Tainzy International Lahore duly signed and stamp by Mr. Zafarullah Wattoo, CEO of M/s Tainzy International and Mr. Farooq Sahikh, MD of M/s Aqmar Pharma signed on 05^th May 2014 for the supply of Reap 2.5 mg Capsules.

09. FID Karachi asked M/s Tainzy International Lahore to verify the invoice warranty and purchased record of the said capsules from the manufacture.

10. It is pertinent to mention that these invoices issued by M/s. Tainzy International, Lahore the sale record proved following Un-registered drugs in addition to Reap 2.5 mg Capsules supplied by M/s Everest Pharmaceutical Islamabad:

1. 
   Capsule RP-XIME 400mg B. No. 115 at Rs.276.25_____________ 1720 packs
   
2. 
   MOON-B suspension vials B.No.599 at Rs. 170.00______________1000 vials
   

11. M/s. Tainzy International submitted invoices a source of purchase of Reap 2.5mg Capsules vide invoice No. EPO/864 dated 27-11-2015 and invoice No. EPO/ 829 dated 09-10-2015, signed and issued by M/s. Everest Pharmaceutical, Islamabad.

12. That AD Import & Export vide letter No. F.3-6/2017(I&E)/QA/LT 2018 dated 01^st March 2018 confirmed that M/s Everest Pharmaceuticals Islamabad did not obtained clearance of Raw Material of the above mentioned products nor obtained import license mandatory for the import of active pharmaceutical ingredients under the DRAP Act 2012 and rules framed thereunder.

13. That the accused persons given below have violated the provisions of Schedule-II, of DRAP Act 2012 and hence, committed offences as under:-

a. A (1)(a)(i), i.e. Export Import are manufacture for sale or sell any spurious therapeutic good;

b. A. (1)(a)(vii) i.e. export, import are manufacture for sale or sell any therapeutic goods which is not registered or is not in accordance with conditions of registration as disclosed in the registration dossier and that has undergone pharmaceuticals evaluation;

c. A. (1)(a)(x) i.e. export, import are manufacture for sale or sell any therapeutic good in contravention of any of the provision of this Act are rules made thereunder;

d. A. (1)(b), manufacture for sale any theraputice goods except under and in accordance with the condition of a license issued under this Act and;

e. (1)(e), Import or export any therapeutic goods drugs for the import or export of which a license is required except under , and in accordance with the conditions of such license.

14. The Prohibitions mentioned in para 5 are offences and punishable under schedule III of DRAP Act 2012

1. 
   (1)(a), exports, imports, manufacturers for sale or sells any spurious therapeutic goods or any therapeutic good which is not registered.
   
2. 
   (1)(c), Imports without license any therapeutic goods for the import of which a license is required.
   
3. 
   (2)(b) gives to the purchaser a false warranty in respect of any therapeutic goods sold by him that the therapeutic goods does not is any way contravene the provisions of schedule II and is not able to prove that, when gave the warranty , he had good and sufficient reason to believe the same to be true.
   
4. 
   (4) i.e. contravention of rules:- subject to the provisions of clause (1) (2) and (3) whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees or with both.
   
5. 
   (6), Penalty for violating the prohibitions: whoever himself or by any other person on his behalf violates any prohibitions specified in schedule-II shall be punished with imprisonment for a term upto five years and with fine up to five hundred thousand rupees
   

15. Permission For Safe Custody of the Seized stock

The FID Karachi has requested to necessary permission for safe custody of sized stock was granted by the Director QA/LT on behalf of CLB till the decision of the case.

16. Permission for Lodging of FIR

The FID Karachi has requested to grant the permission of lodging of FIR of 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
   
7. 
   Mr. Khuram Naeem warrantor for M/s Everest Pharmaceuticals Islamabad who signed and issued above mentioned false warranties on behalf of M/s Everest Pharmaceuticasl Islamabad.
   
8. 
   Mr. Zafarullah Watto Chief Executive Tanzy International Ground Floor 15, Qayum block Mustafa Town Wahdat Road Lahore.
   

“Decision of the Case:-

1. 
   Permission for safe custody of the seized stocks of therapeutic goods/drugs was allowed to the FID till the finalization of the case.
   

2. 
   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. 
   Muhammad Arshad, Production In charge, M/s Everest Pharmaceuticals Islamabad
   
6. 
   Mian Istiaq Ahmed Assistant QC Incharge, M/s Everest Pharmaceuticals Islamabad
   
7. 
   Mr. imtiaz Ahmed Quality Control manager of Everest Pharmaceuticasl
   
8. 
   Mr. Khuram Naeem warrantor for M/s Everest Pharmaceuticals Islamabad who signed and issued above mentioned false warranties on behalf of M/s Everest Pharmaceuticasl Islamabad.
   
9. 
   Mr. Zafarullah Watto Chief Executive Tanzy International Ground Floor 15, Qayum block Mustafa Town Wahdat Road Lahore.
   

3. 
   The FID shall lodge FIR under schedule- IV of the DRAP Act 2012 and resubmit the complete case to the CLB after completion of investigations under the law.
   
4. 
   That the accused have violated the provisions of Schedule-II, of DRAP Act 2012 and hence, committed offences as under:-
   

a. A. (1)(a)(vii) i.e. export, import or manufacture for sale or sell any therapeutic goods which is not registered or is not in accordance with conditions of registration as disclosed in the registration dossier and that has undergone pharmaceuticals evaluation;

c. A. (1)(a)(x) i.e. export, import or manufacture for sale or sell any therapeutic good in contravention of any of the provision of this Act are rules made thereunder;

d. A. (1)(b), manufacture for sale any therapeutic goods except under and in accordance with the condition of a license issued under this Act and;

e. (1)(e), Import or export any therapeutic goods drugs for the import or export of which a license is required except under , and in accordance with the conditions of such license.

5. 
   The Prohibitions mentioned above are offences and punishable under schedule III of DRAP Act 2012
   

1. 
   (1)(a), exports, imports, manufacturers for sale or sells any spurious therapeutic goods or any therapeutic good which is not registered.
   

2. 
   (1)(c), Imports without license any therapeutic goods for the import of which a license is required.
   

3. 
   (2)(b) gives to the purchaser a false warranty in respect of any therapeutic goods sold by him that the therapeutic goods does not is any way contravene the provisions of schedule II and is not able to prove that, when gave the warranty , he had good and sufficient reason to believe the same to be true.
   

4. 
   (4) i.e. contravention of rules:- subject to the provisions of clause (1) (2) and (3) whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to one lakh rupees or with both.
   

5. 
   (6), Penalty for violating the prohibitions: whoever himself or by any other person on his behalf violates any prohibitions specified in schedule-II shall be punished with imprisonment for a term upto five years and with fine up to five hundred thousand rupees
   

Case No.07 Seizure Of Stock Under Section 18 (f) of the Drugs Act, 1976 From (M/s. Clinix Central Pharmacy Franchise of Clinix, Multan Road, Near Shahnoor Studios, Lahore.

Ms. Uzma Barkat, FID, Lahore alongwith Additional Director, DRAP, Lahore and DRAP team alongwith Mr. Ijaz Ahmed, Assistant Director, FIA, Crime Circle, Lahore visited the premises of M/s. Clinix Plus Pharmacy Franchise of Clinix, Multan Road, Near Shahnoor Studios, Lahore on 06-03-2018.

03. The FID further informed that she seized the following drugs on Form-2 under Section 18 (1) of the Drugs Act, 1976 & DRAP Act, 2012.

Sr. No.	Name of Drug (s)	Batch No.	Mfg. Date	Exp. Date	Mfg. by	Quantity
01.	EverLong 60 mg Tablets -do-	374 131	11-17 05-17	11-19 05-19	M/s. Everest Pharmaceuticals 124-Industrial Tiangle, Islamabad	(72 Tablets) 07Packs× 10 Tablets+ 02 Tablets loose (20 Tablets) 02 Packs× 10 Tablets (20 Tablets) 02 Packs× 10 Tablets
02.	Chill Tablets -do-	269 001	08-17 01-18	08-19 01-20	-do- -do-	(70 Tablets) 07 Packs× 10′s (84 Tablets) 08 Packs× 10 Tablets + 04 Tablets loose

04. The FID further informed that the above mentioned were recovered and seized in the presence of Mr. Noor–ur-Rehamn (CNIC No. 35202-5734931-7), Pharmacist, Qualified person. The witnesses were also recorded on the seizure Form.

Permission for safe custody

05. The FID has 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.08 Seizure Of Stock Under Section 18 (f) of the Drugs Act, 1976 From (M/s. Servaid Pharmacy (Pvt.) Ltd. 65-Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.
Ms. Uzma Barkat, Additional Director, DRAP, Lahore and DRAP team alongwith Mr. Muhammad Usman, Inspector, FIA, Crime Circle, Lahore visited the premises of M/s. Servaid Pharmacy (Pvt.) Ltd., 65-Quaid-e-Azam Industrial Estate. Kot Lakhpat, Lahore on 06-03-2018.

02. The FID further informed that she seized the following drugs on Form-2 under Section 18 (1) of the Drugs Act, 1976 & DRAP Act, 2012.

Sr. No.	Name of Drug (s)	Batch No.	Mfg. Date	Exp. Date	Mfg. by	Quantity
01.	EverLong 60 mg Tablets	374	11-17	11-19	M/s. Everest Pharmaceuticals 124-Industrial Tiangle, Islamabad	255 Packs× 10 Tablets
02.	Dyone Tablets	144	05/17	05/19	-do-	07 Packs× 20 Tablets
03.	Sumat-N Tablets	089	03/17	03/19	-do-	04 Packs× 10 Tablets
04.	Zitpro Oral Suspension	17L018	11/17	11/19	-do-	10 Packs×01
05.	Esoval Tablets	365	10/17	10/19	-do-	08 Packs× 14 Tablets