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

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.04:- Manufacture and sale of un registered drug product Ever long tablet 60mg B. No. 131 Mfg date 05-17, Exp date 05-19 Mfg by Everst Pharmaceutical Islamabad

FID Lahore

Mr. Abdul Rashid Shaikh along with Mr. Ajmal Sohail Asif FID, DRAP Lahore and Mr. Usman Ghani Deputy Drugs Controller Shah Rukan-e Alam Town, Multan, inspected the following two pharmaceuticals distributors at multan which were reportedly the distributors for the said un registered drugs

1. 
   Madina Medicine Co, 300 Shamsbad Colony near Ladies Park Multan.
   
2. 
   M/s Pharma Distributors 286 Shamsabad Colony Multan.
   

2. M/s Pharma Distributors Multan on 29-09-2017 for the purpose of test analysis one portion of the sample was returned to the Distributor along with copy of the Form-3 at the spot.

3. One sealed potion of sample was sent to FGA, CDL Karachi on 02-10-2017 on Form-4. Invoice/warranty bearing No. EVM/527, dated 26-09-2017 was provided by M/s Pharma Distributors Multan issued by M/s Everest Pharma Islamabad. The third sealed portion was sent to the warrantor accordingly on 09-10-2017 but the same was receive back undelivered with the postal authorities

4. Meanwhile on the next day the firms representative Mr. Haroon Yousuf provided in this office a copy of the Court orders which were self explanatory. The same along with report in this regard were communicated to the Additional Director DRAP Lahore too. Later on a Notice was also received from the Honorable Court of Mr. iftikhar Ahmed Additional Session Judge Lahore regarding contempt of Court application filed by the manufacturer

5. The Director/FGA Karachi informed that the registration holder had not yet submitted the approved specification to CDL for the referred formulation which is violation of prescribed conditions of registration of Drug product and amongst other advised to ensure availability of complete specifications in time to proceed the test analysis. The Director CDL/FGA issued the test report of the samples with the following remarks:-

Remarks:-

Other tests could not be performed due to non receipt of method of testing and reference standard. Request has already been made vide this Laboratory letter no. F.5-3(LHR)/2017-CDL/S-2703, dated 20^th October 2017 reminder-I No. F.5-3(LHR)/2017-2880 dated 17^th November 2017 and reminder-II No. F.5-3(LHR)/2017-2950 dated 30^th November 2017.

6. Another Test report No. LHR257/2017 dated 06-02-2018 has also been received from the FGA CDL Karachi with following remakrs:

1. 
   The lable claims Each tablet contains Dapoxetine HCL eq. to Dapoxetine 60mg (Everst Specs)
   
2. 
   As per decision of the Registration Board communicated to this lab vide DRAP Islamabad letter No. F.8-8/2016-Reg-III (M-263) dated 11^th January 2017 everlong tablet were neither presented in any agenda of RB not its registration was approved by it. The above mentioned letter states as Registration Board in 263^rd meeting held on 29^th and 30^th November 2016 considered subject mentioned case pertaining to unlawful and fraudulently issuance of Ever long tablet 60mg registration letter. The board declared that the application for registration of Everlong tablet was neither presented in any agenda of Registration Board nor its registration was approved by it. The Board therefore based on the current legal scenario decided to declare that the purported registration letter of the Everlong which was obtained through unlawful manner is considered as vide as inittio, since it was issued fraudulently as it was got issued without approval of RB.
   
3. 
   In the light of decision of RB the sample Everlong 60mg tablets is declared unregistered Drug Product under the Drugs Act 1976.
   

8. 
   The explanation letter along with a copy of the above Test Report No. LHR.257/2017 dated 06-02-2018 has been sent to the manufacturer M/s Everest Pharma Islamabad, a copy whereof along with of the Test Report No. LHR 257/2017 dated 06-02-2018 is also endorsed to M/s Pharma Distributors with the directions to recall the drugs and stop distribution of un registered drug Everelong 60mg tablets and also indicate the stock position as on 19-02-2018 but not response has been received in this regard so far
   
9. 
   That M/s Pharma Distributors Multan provided appointment letter as distributor of M/s Everest Pharmaceuticasl dated 01-07-2015, invoice No. EVM/527 dated 26-09-2017 showing the source of purchase of Everlong Tablet B.No. 131 in addition to tablet Rabazol D B.No. 412 and Tablet Dutolus B.No.094 duly signed and issued by Mr. Haroon Yousuf as warrantor . M/s Pharma Distributor also provided invoice No. EPO/787 dated 19-01-2018 for the purchase of four other unregistered drugs i.e. Zicine 250 table Zicine 500 tablets, Dut plus table and Everetame tablets they also submitted invoice No. EPO 785 dated 18-01-2018 and EPO/719 dated 01-01-2018 for the purchase of Everelong 60mg tablet B.No.374.
   
10. 
    The M/s Pharma Distributor also provided copies of pay order /check of UBL 1270 LMQ Road Branch Multan for payment of one million rupees dated 30-10-2017 to M/e Everest Pharmaceuticals. They also submitted another pay orders of rupees 07 Laks to M/s Everest Pharmaceuticasl on 25-01-2018.
    
11. 
    In the light of above it is evidently proven that M/s Everest Pharmaceuticals manufactured and sold unregistered drugs to M/s Pharma Distributors Multan as under:-
    

1. 
   Everlong Tablet B.No. 131.
   
2. 
   tablet Rabazol D B.No. 412.
   
3. 
   Tablet Dutolus B.No.094
   
4. 
   Zicine 250 table B.No.006
   
5. 
   Zicine 500 tablets, B.No.207
   
6. 
   Dut plus table B.No.94
   
7. 
   Everetame tablets B.No. 313
   
8. 
   Everelong 60mg tablet B.No.374.
   

12. 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)(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 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.

13. 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
   

14. Permission For Safe Custody of the Seized stock)

The FID Karachi has requested to necessary permission for safe custody of sized stock till the decision of the case.

15. 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 (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. 
   Muhammad Istiaq QC Incharge, M/s Everest Pharmaceuticals Islamabad
   
7. 
   Mr. Haroon Yousuf warrantor for M/s Everest Pharmaceuticals Islamabad who signed and issued above mentioned false warranties on behalf of M/s Everest Pharmaceuticasl Islamabad.
   

“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. 
   Ch. Muhammad Usman, Production In charge, M/s Everest Pharmaceuticals Islamabad
   
6. 
   Mian Istiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabad
   
7. 
   Mr. Haroon Yousuf warrantor for M/s Everest Pharmaceuticals Islamabad who signed and issued above mentioned false warranties on behalf of M/s Everest Pharmaceuticasl Islamabad.
   

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.05 Seizure on Form-2 Under Section 18(f) of Drugs Act 1976 at Different Medical Stores of Karachi against M/s Everest Pharmaceuticals Islamabad.

FID Karachi

Mr. Abdul Rasool Shaikh FID-VI Karachi along with Dr. Shoaib Ahmed FID inspected,

1. 
   Ali medical store orangabad Karachi and recovered 05 different unregistered drugs on Form-2 on 06-03-2018. M/s Ali medical store provided Cash Memo/invoice having No.1718-1L116505 dated 11-01-2018 issued by M/s pharma net.
   
2. 
   Azeem Sons medical store and recovered Everlong tablets Mfg by Everest pharmaceuticals Islamabad. M/s Azeem and sons provided invoice warranty no. 1718-01 L125273 dated 24-01-2018.
   
3. 
   M/s Khwaja Ghareeb nawaz and recovered Rabzol-D mfg by M/s Everest pharmaceuticals Islamabad on Form-2 the invoice warranty no.1718-0126531 dated 26-01-2018 and 1718-01013355
   

2. Different outlets/pharmacies under the area jurisdiction and found 07suspected un-registered drugs/medicines claimed to be manufactured by M/s Everest pharmaceuticals Islamabad. The FID Karachi seized all the stocks under section 18 (1)(f) of Drug Act 1976 on Form-2. As per information of the FID all the retailers had provided their subsequent purchase records of M/s Pharma Net Karachi the main distributor of M/s Everest Islamabad this distributor was also visited by a team of DRAP Karachi and all the suspected stocks of M/s Everest pharma were seized under the directions and sought necessary related information about the distributed suspected unregistered stocks.

3. M/s Ali Medical Store Aurangabad Karachi, M/s Azim & Sons Nazimabad Karachi and M/s Khawaja Gharib Nawaz Medical store Karachi provided the bill warranties/invoices of M/s Pharma Net Karachi as a proof of their purchase. The M/s Pharma Net Karachi was directed to subsequent bill warranties/invoices in connection with purchase of drugs.

4. The M/s Pharma net Karachi submit the bill warranties/invoices No. EPO/557 dated 03-04-2017, EPO/592 dated 05-10-2018 & EPO/860 dated 10-02-2018 of M/s Everest Pharmaceuticals Islamabad as the proof of their purchase of drugs.

5. The details of the unregistered drugs are as under:-

S.No.	Name of drug	Batch No.	Quantity	Claimed to be manufactured
01	Tab. Rabzol-D From (Khawja Ghareeb Nawaz Medical Store)	111	1x4	M/s Everest Pharmaceuticals
02.	Tab Everlong From (Ali Medical Store)	131	1x10x10	do.
03.	Tab Everlong from (Azeem & Sons)	131	1x10x10	do.
04.	Tab Everlong From (Ali Medical Store)	147	1x10	do.
05.	Tab Maintain From (Ali Medical Store)	362	1x10x2x2	do.
06.	Tab. Zerodol From (Ali Medical Store)	371	1x10x3x1x8	-do-

6. 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.

7. 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
   

08. Permission For Safe Custody of the Seized stock

The FID Karachi requested to necessary permission for safe custody of sized stock till the decision of the case.

09. Permission for Lodging of FIR

The FID Karachi 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. Haroon Yousuf warrantor for M/s Everest Pharmaceuticals Islamabad.
   

“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. 
   Ch. Muhammad Usman, Production In charge, M/s Everest Pharmaceuticals Islamabad
   
6. 
   Mian Istiaq Ahmed QC Incharge, M/s Everest Pharmaceuticals Islamabad
   
7. 
   Mr. Haroon Yousuf warrantor for M/s Everest Pharmaceuticals Islamabad who signed and issued above mentioned false warranties on behalf of M/s Everest Pharmaceuticasl Islamabad.
   

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.