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

Decision by the Central Licensing Board in 259^th meeting:
The Board considered and endorsed the change of management from old to new management of M/s A.H Pharmaceuticals, Faisalabad under DML No. 000630 by way of Formulation as per Form-29 as under ;

Current Management	Retiring Management	New Management
Mr. Muhammad Asif S/o Muhammad Yousaf CNIC No.33100-9084622-5. Mr. Ehsan Ahmad S/o Bukhtiar Ahmad CNIC No. 33100-5517783-1.	Mr. Muhammad Asif S/o Muhammad Yousaf CNIC No.33100-9084622-5. Mr. Ehsan Ahmad S/o Bukhtiar Ahmad CNIC No. 33100-5517783-1.	Mr.Zahid Iqbal S/o Jamal ud Din CNIC No.36502-8234419-5. Mr. Asif Jabbar S/o Haji Abdul Jabbar CNIC No. 33100-6423811-9.

Case No. 20. M/S EG PHARMACEUTICALS, 13-A, INDUSTRIAL TRIANGLE, KAHUTA ROAD, ISLAMABAD – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.

Case Background

M/s EG Pharmaceuticals, 13-A, Industrial Triangle, Kahuta Road, Islamabad wherein the firm has submitted the application for change of technical staff (Production Incharge) dated 17-11-2015.

After evaluation of the change of technical staff application of the firm, a letter for completion of application for change of technical staff was issued for following shortcomings: -

1. 
   Clear readable and attested copy of CNIC of appointee.
   
2. 
   Job acceptance letter by the appointee.
   
3. 
   Approval letter of earlier approved Production Manager.
   
4. 
   Resignation letter of the previous approved Production Manager.
   
5. 
   Undertaking as whole time employee from the Firm’s higher authority.
   
6. 
   Detail experience of 10 years for Production Manager according to the Section (16) of Drugs Licensing Registering & Advertising Rules, 1976.
   

The firm submitted reply but the same was incomplete and reminder was issued to the firm with following shortcomings:-

1. 
   Job acceptance letter by the appointee.
   
2. 
   Approval letter of earlier approved Production Manager.
   
3. 
   Resignation letter of the previous approved Production Manager.
   
4. 
   Undertaking as whole time employee from the Firm.
   
5. 
   Detail experience certificate as under Drugs Licensing Registering & Advertising Rules, 1976 (not less then 10 years).
   
6. 
   All documents attested as per check list.
   

The firm submitted reply but the same was incomplete and final reminder was issued to the firm with following shortcoming;

1. 
   Relevant experience of proposed Production Incharge is less than 10 years.
   

As per record of Licensing Division, no reply has been received from the firm in response to above mentioned final reminder. It is also submitted that the proposed Production Incharge has resigned from the firm dated 30-11-2017 and firm has not submitted documents for approval of new Production Incharge.

Proceedings and Decision of Central Licensing Board in 257^thmeeting

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 DML No. 000752 by way of formulation of M/s EG Pharmaceuticals, 13-A, Industrial Triangle, Kahuta Road, Islamabad may not be rejected by Central Licensing Board or their 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 26^th February, 2018 was issued to the M/s M/s EG Pharmaceuticals, 13-A, Industrial Triangle, Kahuta Road, Islamabad.

In reply to the Show Cause notice firm has submitted the deficient documents and application for renewal of DML in now complete.
A letter of Personal hearing has been issued on 20^th March, 2018.
Proceedings and Decision of Central Licensing Board in 259^thmeeting

Mr. Shoukat Hayat Khan, Chief Executive of the firm appeared before the Board and contended that he has completed the all codal formalities for renewal of Drug Manufacturing Licence therefore, ShowCause Notice issued to him may be withdran. The Board considering the facts decided to revoke the Showcause Notice issued to the firm and also issue warning the firm should be careful in future for compliance of the law.

Case No. 21. M/S CALIPH PHARMACEUTICALS (PVT) LTD., PLOT NO.17, SPECIAL INDUSTRIAL ZONE (EPZ), RISALPUR – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.
M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur submitted the application for renewal of DML No. 000748 by way of formulation on 17-07-2017 for the period of 13-08-2017 to 12-08-2022, which was well on time. After evaluation of the renewal application of the firm, a letter for completion of application for renewal of DML was issued for following shortcomings: -

1. 
   Fee of Rs.50,000/- alongwith requisite documents for approval of change in management, but the management seems to have been changed as under;
   

Previous Management as per Memorandum and Article of Association (Page 33/Corr – main file)	Current Management as per Form-1A (Page 8/Corr) dated 14-07-2017
Mr. Mumtaz Ali Mrs. Lal Zari Mr. Farman Ali	Mr. Muhammad Azmat Ali Mr. Amjad Ali Zeb

2. 
   Attested copy of approval letter(s) of all the approved section(s) has not been attached
   

Proposed QC Incharge (Mr. Naseer Ahmed).

3. 
   Complete set of attested documents as per check list.
   
4. 
   Fee challan of Rs.5,000/- for approval of change of QC Incharge.
   

With reference to above letter, the firm submitted some shortcoming documents. Upon evaluation, Licensing Division issued final reminder with following shortcomings;

1. 
   Attested copy of Form-29 and Form-A of SECP showing the detail of previous management, has not been attached.
   
2. 
   Approval letter(s) of all licensed section(s), has not been attached.
   
3. 
   Resignation letter of previously appointed QC Incharge.
   

With reference to above final reminder, the firm submitted some shortcoming documents. Upon evaluation, following shortcoming has still been observed;

1. 
   Attested copy of section approval letter(s) has not been provided.
   

Proceedings and Decision of Central Licensing Board in 257^thmeeting

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) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the application for renewal of DML No. 000748 by way of formulation of M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur not be rejected by Central Licensing Board.

Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.

The Show Cause notice dated 26^th February, 2018 was issued to the M/s of M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur.

In reply to the Show Cause notice firm has submitted the short documents and application for renewal of DML in now complete.
A letter of Personal hearing has been issued on 20^th March, 2018.
Proceedings and Decision of Central Licensing Board in 259^thmeeting

Mr. Adnan Khan, Manager Finance of the firm appeared before the Board and contended that he has completed the all codal formalities for renewal of Drug Manufacturing Licence therefore, ShowCause Notice issued to him may be withdran. The Board considering the facts decided to revoke the Showcause Notice issued to thr firm and also issue warning the firm should be careful in future for compliance of the law.

Case No. 22 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S SYMANS PHARMACEUTICALS (PVT) LTD, 10-KM, SHEIKHUPURA ROAD, LAHORE
M/s Symans Pharmaceuticals (Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore had applied for renewal of DML No. 000323 by way of formulation on 16-09-2015 for the period of 19-10-2015 to 18-10-2020.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 26-07-2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. 
   Form 29- from S.E.C.P along with copies of CNIC and any change in management / Directors / Owners
   
2. 
   Approval Layout plan of premises (Copy)
   
3. 
   Proof of licensed sections from CLB
   
4. 
   Approval letter of technical staff
   
5. 
   Nothing due certificate for CRF
   

The firm submitted documents on 11-08-2016 but following documents were still deficient /short and same were conveyed to the firm Reminder-I letter issued on 28-12-2016.

1. 
   Attested documents of renewal as per form 1A.
   
2. 
   Proposed technical staff documents as per check list.
   
3. 
   Approval Layout plan of premises (Copy).
   
4. 
   Proof of licensed sections from CLB.
   
5. 
   All documents should be duly attested.
   

The firm submitted documents on 30-01-2017 in reply to Reminder-I but following documents were still deficient /short and Final Reminder was issued on 06-02-2017 to the firm with following shortcomings: -

1. 
   Attested documents of renewal as per form 1A.
   
2. 
   Proposed technical staff documents as per check list.
   
3. 
   Approval Layout plan of premises (Copy).
   
4. 
   Proof of licensed sections from CLB.
   
5. 
   All documents should be duly attested.
   

The firm submitted documents on 28-02-2017 in reply to Final Reminder. Upon Evaluation following shortcoming has been observed and application for renewal of DML is still incomplete

1. 
   Approval letter of proposed Quality Control Incharge, if any change then provide set of documents for Proposed Quality Control Incharge (as per check list) along with prescribe fee.
   
2. 
   Approved master Layout plan of premises (Copy).
   
3. 
   Proof of licensed sections from CLB.
   
4. 
   Updated nothing due certificate regarding CRF from STO.
   
5. 
   All documents should be duly attested.
   

Proceedings and Decision of Central Licensing Board in 257^thmeeting

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 DML No. 000323 by way of formulation of M/s Symans Pharmaceuticals (Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore may not be rejected by Central Licensing Board or their 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 26^th February, 2018 was issued to the M/s Symans Pharmaceuticals (Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore. No reply of the show cause notice is received from the firm. However, the firm has filed application of Mr. Talat Ahmad Anjum for approval as Quality Control Incharge but documents submitted by the firm were incomplete and un-attested and same was conveyed to the firm.

A letter of Personal hearing has been issued on 20^th March, 2018.
Proceedings and Decision of Central Licensing Board in 259^thmeeting

Dr. Syed Saleem Hyder, Managing Director of the firm appeared before the Board and presented documented which were evaluated by the Board and found complete. He further contended that he has completed the all codal formalities for renewal of Drug Manufacturing Licence therefore, ShowCause Notice issued to him may be withdrawn. The Board considering the facts decided to revoke the Showcause Notice issued to thr firm and also issue warning the firm should be careful in future for compliance of the law.

Case No. 23 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SHAFI TEXTILE CORPORATION, 608-B, SMALL INDUSTRIAL ESTATE, SARGODHA ROAD, FAISALABAD

M/s Shafi Textile Corporation, 608-B, Small Industrial Estate, Sargodha Road, Faisalabad had applied for renewal of DML No. 000436 by way of formulation on 22-10-2014 for the period of 07-09-2014 to 06-09-2019.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 16-02-2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. 
   Renewal application is 45 days late according to Rule 6 of drugs (L, R&A) rule 1976 the additional surcharge 5,000/- each day, deposit fee of Rs. 225000/- = (45x5000).
   
2. 
   There is change in management of the firm, so proper application along with challan fee of Rs. 50,000/-.
   
3. 
   Proof of licensed section from CLB /Approved layout plan.
   
4. 
   Updated nothing due certificate regarding CRF from STO.
   
5. 
   All documents should be duly attested.
   

The firm did not submit their reply. Final Reminder was issued on 08-06-2017 to the firm with following shortcomings: -

1. 
   Renewal application is 45 days late according to Rule 6 of drugs (L, R&A) rule 1976 the additional surcharge 5,000/- each day, deposit fee of Rs. 225000/- = (45x5000).
   
2. 
   There is change in management of the firm, so proper application along with challan fee of Rs. 50,000/-.
   
3. 
   Proof of licensed section from CLB /Approved layout plan.
   
4. 
   Updated nothing due certificate regarding CRF from STO.
   
5. 
   All documents should be duly attested.
   

The firm has not submitted the above mentioned documents till date and application for renewal of DML is still incomplete

Proceedings and Decision of Central Licensing Board in 257^thmeeting

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 DML No. 000436 by way of formulation of M/s Shafi Textile Corporation, 608-B, Small Industrial Estate, Sargodha Road, Faisalabad may not be rejected by Central Licensing Board or their 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 26^th February, 2018 was issued to the M/s Shafi Textile Corporation, 608-B, Small Industrial Estate, Sargodha Road, Faisalabad

No reply of the show cause notice is received from the firm till date.
A letter of Personal hearing has been issued on 20^th March, 2018.
Proceedings and Decision of Central Licensing Board in 259^thmeeting

Mr. Muhammad Zeeshan, General Manager of the firm appeared before the Board and could not satisfy the Board. The Board considering the facts on the record and after thread bare deliberation decided to suspend the Drug Manufacturing Licence No. 000436 by way of formulation issued in the name of M/s Shafi Textile Corporation, 608-B, Small Industrial Estate, Sargodha Road, Faisalabad till settelemnt of 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) of the Drugs (Licensing, Registering and Advertising) Rules, 1976. If the firm completes the codal formalities, the Chairman Central Licensing Board shall pass an order for revocation of suspension. However, case would be brought before Central Licensing Board in forthcoming meeting for endorsement of decision taken by the Chairman.

Case No. 24 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S TAGMA PHARMA (PVT) LTD, 12.5-KM, RAIWIND ROAD, LAHORE
M/s Tagma Pharma (Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore had applied for renewal of DML No. 000414 by way of formulation on 14-07-2015 for the period of 06-08-2015 to 05-08-2020.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 03-09-2015 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. 
   Duly attested details of management.
   
2. 
   Form-29.
   
3. 
   Proof of all sections.
   
4. 
   CNIC copies of management.
   
5. 
   Attested details of qualified persons.
   
6. 
   Undertaking regarding correct details.
   

The firm submitted documents on 29-09-2015 but following documents were still deficient /short and Final Reminder was issued on 21-07-2017 to the firm with following shortcomings: -

1. 
   Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of management at the time of previous renewal and now at present renewal.
   
2. 
   Nothing due certificate regarding CRF from STO (Updated).
   
3. 
   Detail of Premises with Proof of CLB approved sections.
   
4. 
   Approval letter of Production Incharge and Quality Control Incharge, if any change then provide set of documents for proposed Production Incharge and Quality Control (as per check list) along with prescribe fee of Rs. 10,000/-
   
5. 
   All Documents should be duly attested.
   

The firm submitted documents on 01-08-2017 in reply to Final Reminder. Upon Evaluation following shortcoming has been observed and application for renewal of DML is still incomplete

1. 
   Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of management at the time of previous renewal and now at present renewal.
   
2. 
   Nothing due certificate regarding CRF from STO (Updated).
   
3. 
   Detail of Premises with Proof of CLB approved sections.
   
4. 
   All Documents should be duly attested.
   

Now the Division of Budget and Account has forwarded Nothing due certificate regarding CRF from STO (Updated) and following documents shortcomings:

1. 
   Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of management at the time of previous renewal and now at present renewal.
   
2. 
   Detail of Premises with Proof of CLB approved sections.
   
3. 
   All Documents should be duly attested.
   

Proceedings and Decision of Central Licensing Board in 257^th meeting

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 DML No. 000414 by way of formulation of M/s Tagma Pharma (Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore may not be rejected by Central Licensing Board or their 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 26^th February, 2018 was issued to the M/s M/s Tagma Pharma (Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore.

The firm replied to the show cause notice but application for renewal of DML is still short of following documents:

1. 
   Prescribed fee of Rs. 50,000/- as there seems to be change in management of the firm. The detail of management is as under:-
   

Pervious Management as per Form-29 Year 2014	Retiring Management	Current Management as per Form-A Year 2017
Mr. Abdul Aleem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-1691245-9. Mr. Naeem Shami S/o Abdul Ishfaq Shami CNIC No.35202-4717733-9. Mr. Shahid Nadeem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-8856537-1.	Mr. Abdul Aleem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-1691245-9 Mr. Naeem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-4717733-9	Mr. Shahid Nadeem Shami S/o Abdul Ishfaq Shami CNIC No. 35202-8856537-1 Ms. Saima Nadeem W/o Shahid Nadeem Shami CNIC No. 35202-274539-2

2. 
   Latest Form-29 duly attested from S.E.C.P.
   
3. 
   Detail of Premises with Proof of CLB approved sections
   

A letter of Personal hearing has been issued on 20^th March, 2018.
Proceedings and Decision of Central Licensing Board in 259^thmeeting

Mr. Nadeem Shami, Managing Director of the firm appeared before the Board and presented documented which were evaluated by the Board and found complete. He further contended that he has completed the all codal formalities for renewal of Drug Manufacturing Licence therefore, ShowCause Notice issued to him may be withdrawn. The Board considering the facts decided to revoke the Showcause Notice issued to thr firm and also issue warning the firm should be careful in future for compliance of the law.