GMP Non-compliance case (new)
Case No. 1. M/S Usman Enterprises, Karachi
Background of the case:
Mr. Abdul Rasool Shaikh, Area FID, Karachi conducted inspection of the firm M/s Usman Enterprises, Karachi on 26.12.2017. The FID noticed following observations:-
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During inspection, overall sanitation & hygiene conditions were noted compromised and inappropriate. Proper tools and steps for cleaning of the areas were advised to be in place. HVAC installation work was seen underway in first aid bandage section, during the active production.
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QC lab was seen under renovation and only two physical quality tests were seen carried out on finished products only.
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Poor record keeping was observed during inspection.
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QA system was seen a bit compromised needed to be improved as per prevailing guidelines. In-process testing is to be carried out properly.
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Stores have to be well defined and properly maintained.
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Poor documentation and retrieval level was observed during the inspection.
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The firm was still noted deficient of technical persons, especially in stores and in QA.
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The FID further concluded that “all the observations discussed with the management of the firm and they agreed to voluntarily halt the production of first aid bandages till the attainment of better level of compliance. All the observations were also to be attended within one month of time. They were advised to submit a time bound plan in this regard. Keeping in view the type and class of medical devises they produce and attitude of the management towards better level of compliance, their overall level of compliance was noted satisfactory.”
Action taken by DRAP: Accordingly showcause notice / suspension of production order was served to the firm M/s Usman Enterprises, Karachi on 06.02.2018.
Reply by the firm: The firm vides letter Ref. No. U18-10102 dated 16.02.2018 submitted reply of the showcause notice / suspension of production order and informed that we had voluntarily suspended the manufacturing activity of our first aid bandage section and also informed the FID due to renovation work being carried out in production area. During the month of Dec / Jan we have carried out some renovations and up-gradation of their facilities with the purpose of improving the facilities of GMP compliance, the area was being upgraded; which may have caused some issues as cleaning and maintenance work was going on at the time of inspection. The CEO of the firm M/s Usman Enterprises, Karachi requested to withdraw the show case notice, Suspension of production order and requested for personnel hearing.
Proceedings of the 259th Meeting of CLB
Mr. Ilyas Khan, Plant Manager of the firm M/s. Usman Enterprises, Karachi appeared before the Board for personal hearing. Mr. Ilyas Khan informed to the Board that the observations noted by the FID in its inspection conducted on 26.12.2017 have been rectified.
Decision of 259th Meeting of CLB
After thorough discussion / deliberations, considering all the pros and cons of the case and compliance report of the firm, the Central Licensing Board decided to:-
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Re-inspect the firm M/s Usman Enterprises, Karachi by following panel of experts,
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Prof. Dr. Abdullah Dayo, Member, CLB
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Area Federal Inspector of Drugs, Karachi
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Chief Drug Inspector, Sindh
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The panel shall submit the detailed inspection report on approved Schedule B-II format. The panel shall also submit rectification status of the observations noted by the FID, in First Aid Bandages Section, in its report dated 26.12.2017, in tabulated form with clear and candid recommendations.
QUALITY CONTROL CASES
Case No.01 Seizure of Illegally Manufactured Drugs of M/s. Everest Pharmaceuticals, Pvt (Ltd), Islamabad recovered from Pharma Net Karachi .
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That Muneeza Khan, FID Karachi alongwith Mr. Abdul Rasool Shaikh, FID, and Dr. Shoaib Ahmed FID, Karachi raided M/s. PharmaNet, godown situated at Plot No. B-161, B-162 sector GF Mehran Town Korangi, Karachi on 06-03-2018.
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That FID recovered suspected unregistered 14 drugs and seized on Form-2 under Section 18 (1) (f) of Drugs Act, 1976/schedule-V of DRAP Act 2012 and Rules framed thereunder.
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M/s Pharma Net Karachi provided bill warranties No. EPO/897 dated 20-02-2018, EPO/860 dated 10-02-2018, EPO/909 dated 26-02-2018, EPO/703 dated 18-12-2017, EPO/637 dated 28-11-2017 duly signed and issued by the M/s Everest pharmaceuticals Islamabad. They also submitted copies of purchase return (without invoice) against the purchase of seized drugs of M/s. Everest Pharmaceuticals situated at 124 Industrial Triangle Kahutta Road, Islamabad.
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The details of the unregistered drugs are as under:
Sr. No.
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Product
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Registration Status as on date:
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Mfg. Date
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Exp. Date
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Quantity
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Purported To Be Manufactured By
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01.
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Diaflext Tab.
020
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Fake Registration numbers were applied on the labels of un registered drugs
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01-2017
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01-2019
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71 Packs of 30 Tablets each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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02.
|
DutPlus Tab.
009
|
-do-
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01-2018
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01-2020
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45 Packs of 20 tabs. each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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03.
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DutPlus Tab.
094
|
-do-
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03-2017
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03-2019
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18 Packs of 20 Tablets each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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04.
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EverLong 60 mg Tab.
374
|
-do-
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Not given
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11-2019
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774 Packs of 10 Tablets each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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05.
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Evertam Tab.
285
|
-do-
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08-2016
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08-2018
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90 Packs of 20 Tabs. each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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06.
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Maintain Tab.
217
|
-do-
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06-2017
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06-2019
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01 Pack of 20 tablets
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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07.
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Maintain Tab.
362
|
-do-
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10-2017
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10-2019
|
218 Packs of 20 Tablets each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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08.
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Rabzol-D Tab.
347
|
-do-
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10-2017
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10-2019
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712 Packs of 14 Tabs. each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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09.
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Sumat N Tab.
089
|
-do-
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03-2017
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03-2019
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81 Packs of 10 Tabs. each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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10.
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Zerodol Tab.
371
|
-do-
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11-2017
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11-2019
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223 Packs of 20 Tabs. Each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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11.
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Zycin 250 mg Tab.
006
|
-do-
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01-2018
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01-2020
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31 Packs of 10 Tabs. Each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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12.
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Zycin 250 mg Tab.
059
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-do-
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02-2017
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02-2019
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70 Packs of 10 Tab. each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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13.
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Zycin 500 mg Tab.
028
|
-do-
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01-2018
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01-2020
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490 Packs of 10 Tabs. each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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14.
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Zycin 500 mg Tab.
207
|
-do-
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06-2017
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06-2019
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56 Packs of 10 Tabs. each
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M/s. Everest Pharmaceuticals 124-Industrial Triangle, Islamabad.
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05. 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.
6. The Prohibitions mentioned in para 5 are offences and punishable under schedule III of DRAP Act 2012
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(1)(a), exports, imports, manufacturers for sale or sells any spurious therapeutic goods or any therapeutic good which is not registered.
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(1)(c), Imports without license any therapeutic goods for the import of which a license is required.
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(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.
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(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.
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(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
07. 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.
08. Permission for Lodging of FIR
The FID Karachi has requested to grant the permission of lodging of FIR of the following accused persons:-
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M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.
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Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabad
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Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad
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Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad
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Ch. Muhammad Usman, Production In charge, M/s Everest Pharmaceuticals Islamabad
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Muhammad Istiaq QC Incharge, M/s Everest Pharmaceuticals Islamabad
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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:-
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 as under:-
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Permission for safe custody of the seized stocks of therapeutic goods/drugs was allowed to the FID till the finalization of the case.
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Permission for registration of FIR was granted against the following accused persons.
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M/s Everest Pharmaceuticals Islamabad. Through owner, Ch. Muhammad Usman.
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Ch. Muhammad Usman (owner), M/s Everest Pharmaceuticals Islamabad
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Dr. Kamran Izhar (Partner), M/s Everest Pharmaceuticals Islamabad
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Noor Muhammad Mahar (Partner), M/s Everest Pharmaceuticals Islamabad
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Ch. Muhammad Usman, Production In charge, M/s Everest Pharmaceuticals Islamabad
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Mian Istiaq Ahmed QC In-charge, M/s Everest Pharmaceuticals Islamabad
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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.
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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.
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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.
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The Prohibitions mentioned above are offences and punishable under schedule III of DRAP Act 2012
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(1)(a), exports, imports, manufacturers for sale or sells any spurious therapeutic goods or any therapeutic good which is not registered.
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(1)(c), Imports without license any therapeutic goods for the import of which a license is required.
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(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.
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(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.
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(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.02 Seizure of Stock under Section 18(1)(f) of the Drugs Act, 1976 From (M/s Fazal Din &Sons (pvt) Ltd 53- Shahrah-e-Quaid-e-Azam, Lahore) i.e. Tab Everlong 60mg Mfg by M/e Everest Pharmaceuticals 124 industiral Triangle Islamabad.
FID Lahore.
Mr. Abdul Rashid Sheikh FID Lahore-VI has forwarded the subject mentioned case. The FID Lahore along with Ms. Uzma barkat, FID Lahore and Ms. Nureen Ramzan, inspector, FIA Lahore visited the premises of M/s Fazal Din & sons (pvt) Ltd on 06-03-2018.
The FID Lahore seized the following unregistered drugs:-
S.No
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Name of drug and Batch No..
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Mfg date
|
Exp date
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Mfg by
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Quantity
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1.
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Everelong 60mg Tablets
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374
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11-17
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11-19
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127 Tablets
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2. The Everlong 60mg tablets were recovered and seized in the presence of Syed Asghar Abbas Zaidi, Branch Manager and Ms. Samia Altaf pharmacist (newly appointed Qualified person). The witnesses were also recorded on the seizure form.
3. The FID referred to the competent authority as required under Drug Act 1976 and Schedule-V to the DRAP Act 2012.
4. The FID further requested to grant permission for safe custody of seized drugs as mentioned above till the decision of the case under provision of the drug Act 1976 and Schedule-V to the DRAP Act 2012.
Permission For Safe Custody:-
“The Case is submitted for grant the permission of safe custody of the seized stock”
“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.03 Seizure of illegally manufactured stocks of M/s Everest pharmaceuticals 124 –Industrial Triangle Islamabad From M/s Al- Karim Medicine Peshawar
FID Peshawar
Mr. Ziaullah FID-III /Assistant Director Peshawar, upon credible information regarding the availability of stocks of the subject mentioned firm at the premises of M/s Al-karim medicine Traders Al-Sham medicine Market Namak Mandi, Peshawar, the FID-III Peshawar along with a team of provincial drug Inspector, conducted raid at the said premises.
2. The FID Peshawar informed that stock of Tab. Eversafe and Dry Suspension Eversafe claimed to be manufactured by M/s Everest pharmaceuticals Islamabad were recovered from the premises. The stocks were seized and took samples for test analysis.
3. That the FID Peshawar referred the sample to the FGA, Karachi for test analysis which were declared un registered as under:-
S.No
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Name of drug and Batch No..
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Mfg date
|
Exp date
|
Test Report No.
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1.
|
Everesafe suspension Batch No.449
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12-17
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12-19
|
R.IP .39/2018, un registered drug product
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2.
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Everesafe Tablets Batch No.373
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11-17
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11-19
|
R.IP .40/2018, un registered drug product
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04. The FID also seized the following stocks on Form-2:-
S.No
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Name of drug and Batch No..
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Mfg date
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Exp date
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Quantity
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1.
|
Everesafe DS Batch No.449
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12-17
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12-19
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80x100
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2.
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Everesafe Tablets Batch No.373
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11-17
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11-19
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12x554
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05. Permission For Safe Custody.
The FID Peshawar has requested for grant the permission of safe custody of the seized stock till the finalization of the case.
“Decision of the Case:-
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