Minutes of 259th meeting of central licensing board held on 29th & 30
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Case No. 37 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SATURN PHARMACEUTICALS (PVT) LTD, LAHORE M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore had applied for renewal of DML No. 000734 by way of formulation for the period of 15-06-2016 to 14-06-2021 on 9-05-2016. The application for the renewal of DML of the firm was evaluated and a letter for following shortcomings / deficiencies was issued to the firm on 16th June, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-
The firm submitted their reply on 31st July, 2017 After evaluation of the submitted documents, final reminder was issued on 15th August, 2017 to the firm with following shortcomings: -
Firm replied on 13-09-2017 to Final Reminder by stating that they have already submitted documents but unfortunately these documents were not duly attested. Now it is our humble request in your honor that duly attested copies will be provided in your office within few days. Following documents are still deficient /short and application for renewal of DML is incomplete.
Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore Drug Manufacturing Licence No. 000734 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore Reply of show cause notice The firm has submitted the documents in reply of the show cause notice. Upon evaluation following documents are found to be deficient;
A letter of Personal hearing has been issued on 17th January, 2018. Proceedings and Decision of Central Licensing Board in 257th meeting Mr. Ghulam Yasin Paracha , Chief Executive of the firm appeared before the Board and contended that they have applied for nothing due certificate on 12-01-2018 and no production is being carried out in the premises. The Board considering the facts on the record and after thread bare deliberation decided to suspend the Drug Manufacturing Licence No. 000734 by way of formulation issued in the name of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore till settlement of CRF and other codal formalities under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The suspension order dated 5th March, 2018 was issued to the M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore In reply to the suspension order firm has submitted the short documents and application for renewal of DML in now complete. Proceedings and Decision of Central Licensing Board in 259thmeeting The Board considering the facts on the record and after thread bare deliberation decided that order of suspension of Licence of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore DML No. 000734 may be revoked for further period and also decided to resume the production of the firm. Case No. 38 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ALFALAH PHARMA (PVT) LTD, 12-KM, SHEIKHUPURA ROAD, LAHORE M/s Alfalah Pharma (Pvt) Ltd, 12-Km, Sheikhupura Road, Lahore had applied for renewal of DML No. 000461 by way of formulation on 30-08-2017 for the period of 05-08-2017 to 04-08-2022.The application for the renewal of DML of the firm was evaluated and a letter for following shortcomings / deficiencies was issued to the firm on 19th October, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-
The firm submitted documents on 07th November, 2017 but following documents were still deficient /short and Final Reminder was issued on 12th January, 2018 to the firm with following shortcomings: -
Incharge.
The firm submitted documents on 26th January, 2018 in reply to Final Reminder. Upon Evaluation following shortcoming has been observed and application for renewal of DML is still incomplete
Proceedings and Decision of Central Licensing Board in 259thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A), Rule 16 and Rule 19 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Alfalah Pharma (Pvt) Ltd, 12-Km, Sheikhupura Road, Lahore, Drug Manufacturing Licence No. 000461 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Case NO. 39 M/S HAFIZ PHARMA INDUSTRY , 44-KM, (GHANIYA)KAMOKE, DISTRICT GUJRANWALA – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976. M/s Hafiz Pharma Industry, Kamoke had submitted application dated 04-07-2016 for the renewal of their Drug Manufactuing Licence period from 07-07-2016 to 06-07-2021. After evaluation of the renewal application of the firm, a letter for completion of application for renewal of DML was issued for following shortcomings/attested documents dated 23-08-2016:
(iv) No Objection Certificate for Central Research Fund (CRF) updated issued by Statistical Officer DRAP, Islamabad. 2. Firm did not submit the reply of the above shortcoming letter, however firm had applied for the approval of Production Incharge, which was approved. Accordingly a final reminder was issued for the completion of DML renewal application dated 20-04-2017 for following shortcomings;
3. Firm has submitted following documents /copies in reply to above final reminder ;
4. Following documents/information is still short/deficient.
Proceedings and Decision of Central Licensing Board in 254th meeting. 5. The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the application for renewal of M/s Hafiz Pharma Industry, 44-KM, (Ghaniya) Kamoke, District Gujranwalaby way of formulation may not be rejected by Central Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board 6. Reference Para 113/N, Central Licensing Board in its 254th meeting held on 15th June, 2017 decided to serve show cause notice to the firm for violation of Rule 16 and Rule 5(2A) and accordingly show cause notice was issued to the firm dated 24-07-17. 7. Firm has submitted reply to show cause notice but firm has not submitted the following required documents for renewal of DML No 000595(Formulation) and application for renewal of DML is still incomplete.
Firm has been called for personnel hearing to explain its position on the above subject matter. Proceedings and Decision of Central Licensing Board in 255thmeeting 8. Mr. Hafiz Abdur Rehman, owner of the firm and Mr Waheed Akhtar , Manager appeared before the Board. They contended that documents for issuance of NOC for CRF has also been submitted with Budget and Accounts Division. After hearing the representative of the firm and facts on record, the Board decided to suspend the Drug Manufacturing Licence of M/s Hafiz Pharma Industry, 44-KM, (Ghaniya) Kamoke, District Gujranwala DML No000595by way of formulation for the period of three (03) months with immediate effect under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The suspension order dated 09th October, 2017 was issued to the M/s Hafiz Pharma Industry, 44-KM, (Ghaniya) Kamoke, District Gujranwala. In reply to the suspension order firm has submitted the short documents and application for renewal of DML in now complete. Proceedings and Decision of Central Licensing Board in 259thmeeting The Board considering the facts on the record and after thread bare deliberation decided that order of suspension of Licence of M/s Hafiz Pharma Industry, 44-KM, (Ghaniya) Kamoke, District Gujranwala DML No. 000595 may be revoked for further period and also decided to resume the production of the firm. Case No. 40 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S QINTAR PHARMACEUTICALS, SARGODHA M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha, had applied for renewal of DML No. 000520 by way of formulation for the period of 19-06-2013 to 18-06-2018 on 13-06-2013. The application for the renewal of DML of the firm was evaluated and a letter for following shortcomings / deficiencies was issued to the firm on 22-10-2013 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-
Firm submitted documents on 10th February, 2017 and a letter was issued on 8th August, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following shortcomings.
Firm submitted documents on 5th September, 2017 in reply to letter issued on 8th August, 2017 and a letter for following shortcomings / deficiencies was issued to the firm on 18th October, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-
File is received from Budget & Account Division related to CRF issue of M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha with following observations. Extract taken from 2-194/2008-STO (R&D) 13. For issuance of NDC, required documents have been submitted by the licensee M/s Qintar Pharmaceuticals (DML No. 000520 11-A Punjab Small Industrial Estate Lahore), i.e. audited financial statements and income tax returns, for FY 2014, 2015 & 2016 along with original bank receipts on account of CRE. The same were checked as per SOP procedure in vogue, IFRS and IAS, but found basic accounting mistakes in preparation financial statements, that made financial statements suspicious. Therefore, for M/s Qintar was asked to submit duly authenticated attested aforesaid documents in order to proceed further (page 109 /Corr.). But the firm taken it leniently and again submitted the same documents by affixing at rubber stamp. 14. Accordingly to establish authenticity of relevant documents it was decided to approach concerned audit firm M/s. Nasir Absar & Co. to get verify the above said financial statements. Therefore, telephonically contacted to Mr. Rizwan Chartered Accountant on behalf of M/s Nasir Absar & Co. and then he came to this office on 14-05-17 and shown their strong concerns about using their letter head and name were forged as the firm is only dealing with tax matters. Hence, the above financial statements are of fraud. As this office required some written evidence from their side, then M/s Nasir Absar & Co. asked for a letter, therefore with approval of Director (B&A) letter to auditor were issued on 24-05-17 15. In reply, M/s Nasir Absar & Co. vide letter No NCAI/DRAP/001 dated 13-07-17 at page (180/Corr.) has requested to this office ("to take strict action as allowed under the Drugs Act, 1976 and its ancillary rules for forging, falsifying and misleading to this office in this regard)", against M/s Qintar Pharmaceuticals. 16. In the light above it is emerged that M/s Qintar is not contributing towards CRF since 2013 (July 2013) as per rules and also submitted forged, falsified and misleading annual audited financial statements of outstanding periods i.e. July 2013 to June 2016. This is clear violation of rule 19 sub rule (14), Chapter II of “The Drugs (Licensing, Registration and Advertising) Rules 1976". The same also attracts necessary action as mentioned in rule 12 of aforesaid rules because it seems that the licensee is managing to avoid actual amount of CRF. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha, Drug Manufacturing Licence No. 000520 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The Show Cause notice dated 05th January, 2018 was issued to the M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha A letter of Personal hearing has been issued on 17th January, 2018. Firm has replied to Show Cause Notice and application of renewal of DML is complete except following documents: 1. Updated Noting due certificate regarding CRF from STO. Moreover, firm has stated that in case of CRF, we recruited authorized person Mr. Anwar Ahmed (Late) for dealing all matters of DRAP including CRF on behalf of Qintar Pharmaceutical. Unfortunately, he died few months ago, therefore, we could not communicate properly with Budget and Accounts Department to resolve matters about audited financial statements. We are requesting to CLB to please give us some time for issuance of NDC from Budget & Accounts Department. We also make sure that this kind of negligence will not happen again. Proceedings and Decision of Central Licensing Board in 257thmeeting Mr. Zeeshan Masood, Managing Director of the firm appeared before the Board. He contested that representative of the firm is died who used to deal with the subject matter and they have taken up the matter with the concerned firm for audit of the accounts. He was of the view that matter would be resolved very soon. The Board apprised him that secretariat for the Central Licening Board only accepts the nothing due certificate issued from the Division of the Budget and Accounts. The Board considering the facts on the record and after thread bare deliberation decided to suspend the Drug Manufacturing Licence No. 000520 by way of formulation issued in the name of M/s Qintar Pharmaceuticals 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha till settlement of Central Research Fund under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5 (2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The suspension order dated 5th March, 2018 was issued to the M/s Qintar Pharmaceuticals 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha. In reply to the suspension order firm has submitted the Updated Noting due certificate regarding CRF from STO and application for renewal of DML in now complete. Proceedings and Decision of Central Licensing Board in 259thmeeting The Board considering the facts on the record and after thread bare deliberation decided that order of suspension of Licence of M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha, Drug Manufacturing Licence No. 000520 may be revoked for further period and also decided to resume the production of the firm. Case No.41 M/S MEDLEY PHARMACEUTICALS (DML NO. 000237) PLOT NO. 41/A, PUNJAB SMALL INDUSTRIES ESTATE, JHANG BAHTAR ROAD, WAH CANTT. Case Background. M/s Medley Pharmaceuticals (DML No. 000237) Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt., submitted the application for renewal of DML No. 000675 by way of formulation on 30-06-2014 for the period of 30-06-2014 to 01-07-2019, as due date of renewal of said DML was 30-06-2014. After evaluation of the renewal application of the firm, a letter for completion of application for renewal of DML was issued for following shortcomings: -
With reference to above letter, the firm submitted following documents;
Upon evaluation of firm’s reply, a shortcoming still deficient regarding technical persons. A letter was issued to the firm with following shortcomings:-
In response to letter, the firm has submitted for the approval of new technical staff and upon evaluation of documents following shortcomings have still been observed: For Quality Control Incharge Miss. Nabeela Noor.
For Production Mr. Mohammad Imran.
A file is received from B&A relating to CRF issue of the M/s Medley Pharmaceuticals with following observations:- Extract at place below taken from File No.2-282/STO(R&D) Para 7-10/N). “For issuance of NDC, required documents have been submitted by the licensee M/s Medley Pharmaceuticals (DML No. 000237) Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt., i.e audited financial statements and income tax returns, for F.Y 2015 & 2016 alongwith original bank receipts on account of CRF. The same were checked as per SOP’s / procedure in vogue, IFRS and IAS, but found basic accounting mistakes in preparation of financial statements, that made financial statements suspicious. Therefore for M/s Medley was asked to submit duly authenticated / attested aforesaid documents in order to proceed further (Page 81/Corr). But the firm taken it leniently and again submitted the same documents by affixing attested rubber stamp page 91-106/Corr). Accordingly to establish authenticity of relevant documents, it was decided to approach concerned audit firm M/s Nasir Absar & Co. to get verify the above said financial statements. Therefore, telephonically contacted to Mr. Rizwan Chartered Accountant on behalf of M/s Nasir Absar & Co. and then he came to this office on 14-05-17 and shown their strong concerns about using their letter head and name were forged as the firm is only dealing with tax matters. Hence, the above financial statements are of fraud. As this office required some written evidence from their side, then M/s Nasir Absar & Co. asked for a letter, therefore with approval of Director (B&A) letter to auditor were issued on 24-05-17 at page (110/Corr). In reply, M/s Nasir Absar & Co. vide letter No.NCAL/DRAP/002 dated 13-0717 at page (112)/Corr). has recommended to this office (“to take strict action as allowed under the Drugs Act, 1976 and its ancillary rules for forging, falsifying and misleading to this office in this regard)” against M/s Medley Pharmaceuticals. In the light above it is emerged that M/s Medley is not contributing towards CRF since 2014 (July 2014) as per rules and also submitted forged, falsified and misleading annual audited financial statements of outstanding periods i.e July, 2014 to June 2016. This is clear violation of rule 19 sub rule (14), Chapter II of “The Drugs (Licensing, Registration and Advertising) Rules, 1976”. The same also attracts necessary action as mentioned in rule 12 of aforesaid rules because it seems that the licensee is managing to avoid the actual amount of CRF. In the light of para 7-11/N, Licensing Division may proceed to take necessary action under relevant rules and regulation, please”. Proceedings and Decision of Central Licensing Board in 256thmeeting The Board considering the facts on the record and after thread bare deliberation decided to serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt Drug Manufacturing Licence No. 000237 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board. Accordingly, show cause notice dated 05-01-2018 and letter of personal hearing dated 17-01-2018 has been issued to the firm.
With this letter we are enclosing our shortcomings for Renewal of License No. 000237 i.e Documents for Production Incharge and Quality Control Incharge. All the necessary documents are attached hereby. As for the matter of CRF issue as stated in Show Cause Notice, it is stated that our representative person for auditing and CRF of firm Mr. Anwar and CEO Mr. Javied Iqbal Chishti of the firm passed away in 2016 because of which the matter could not be handled properly and lead to some misconceptions. It is humbly requested to you that kindly give us time to dig out the matter more efficiently and come out with authentic audit reports so as to prove ourselves clean in the matter as firm has receive NOC of year 2014 and duly submitted all CRF in time. Current Status. The firm has submitted documents of new Production & Quality Control Incharge which are complete and only shortcoming remaining is up- to-date Nothing Due Certificate. Proceedings and Decision of Central Licensing Board in 257thmeeting Mr. Zia , Director of the firm appeared before the Board. He contested that CEO of the firm is died and they have taken up the matter with the concerned firm for audit of the accounts. He was of the view that matter would be resolved very soon. The Board apprised him that secretariat for the Central Licening Board only accepts the nothing due certificate issued from the Division of the Budget and Accounts. The Board considering the facts on the record and after thread bare deliberation decided to suspend the Drug Manufacturing Licence No. 000237 by way of formulation issued in the name of M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt till settelemnt of Central Research Fund under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976. Proceedings of Licensing Division in compliance to the decision of Central Licensing Board. The suspension order dated 5th March, 2018 was issued to the Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt. In reply to the suspension order firm has submitted the Updated Noting due certificate regarding CRF from STO and application for renewal of DML in now complete. Proceedings and Decision of Central Licensing Board in 259thmeeting The Board considering the facts on the record and after thread bare deliberation decided that order of suspension of Licence of M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah Cantt Drug Manufacturing Licence No. 000237 may be revoked for further period and also decided to resume the production of the firm. Yüklə 1,12 Mb. Dostları ilə paylaş:
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