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

Case No. 25 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S MASFA INDUSTRIES (PVT) LTD, 17-KM, SHEIKHUPURA ROAD, LAHORE
M/s Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore had applied for renewal of DML No. 000713 by way of formulation on 13-07-2016 for the period of 15-06-2016 to 14-06-2021.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 19-09-2016:-

1. 
   The application of renewal of DML is 30 days late.
   
2. 
   Detail of management ate previous renewal of DML and latest management at present renewal of DML.
   
3. 
   Proof of sections approved by CLB.
   
4. 
   Approval letter of Production Incharge and Quality Control Incharge.
   
5. 
   Updated Nothing due certificate for CRF from STO (R&D) DRAP, Islamabad.
   

The firm submitted documents on 18-10-2016 but following documents were still deficient /short and Final Reminder was issued to the firm on 10-07-2017 for completion of application.

1. 
   You were asked to submit late surcharge fee for DML renewal i.e.30*5,000=150,000/- However Statistical Officer of DRAP endorsed for Rs.134, 970/- you are required to submit remaining Rs. 15,030/- in DRAP account.
   
2. 
   Attested Form-29 from S.E.C.P. (Latest 2017 and at time of grant of DML (2011) if any change in management then fee for change in management/Director.
   
3. 
   Nothing due certificate of C.R.F. from S.T.O DRAP.
   

The firm submitted documents on 28-08 -2017 in reply to Final Reminder but application for renewal of DML is short of following documents as of today:

1. 
   Nothing due certificate of C.R.F. from S.T.O DRAP.
   

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 as to why the DML No. 000713 by way of formulation of M/s Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore may not be suspended under Rule 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 till settlement of Central Research Fund.

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 Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore.

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

No person on behalf of the firm appeared before the Board. However, the Board considering the facts on record decided to revoke the Showcause Notice issued to the firm and also issue warning to the firm to be careful in future for compliance of the law.

Case No. 26 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S DOSACO LABORATORIES, 9.2-KM, SHEIKHUPURA ROAD, LAHORE.
M/s Dosaco Laboratories, 9.2-Km, Sheikhupura Road, Lahore. had applied for renewal of DML No. 000094 by way of formulation on 12-04-2016 for the period of 19-04-2016 to 18-04-2021.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 04-10-2016:-

1. 
   Classes of Drugs
   
2. 
   Dosage forms of drugs
   
3. 
   Detail of management previous renewal of DML and lattes management present renewal of DML.
   
4. 
   Proof of Section from CLB
   
5. 
   Approval letter of Production Incharge and QC Incharge
   
6. 
   Noting due certificate regarding CRF from STO.
   

The firm submitted documents of Mr. Yasir Khan for approval as Production Incharge on 13-12-2016 but did not respond to shortcomings to Licensing Division’s letter issued on 04-10-2016. Application for approval of Production Incharge was evaluated and firm was communicated following deficient documents in the application vide letter issued on 28-12-2016:-

1. 
   Job acceptance letter by the appointee
   
2. 
   Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 year).
   
3. 
   Resignation / retirement of earlier Production Incharge.
   
4. 
   Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm.
   
5. 
   Undertaking as whole time employee
   
6. 
   All documents should be duly attested.
   

The firm did not submitted documents and Final Reminder was issued to the firm on 19-06-2017 for completion of application.

1. 
   Classes of Drugs
   
2. 
   Dosage forms of drugs
   
3. 
   Detail of management previous renewal of DML and lattes management present renewal of DML.
   
4. 
   Proof of Section from CLB
   
5. 
   Approval letter of QC Incharge
   
6. 
   Noting due certificate regarding CRF from STO (Updated).
   
7. 
   Job acceptance letter by the appointee (Production Incharge)
   
8. 
   Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules, 1976 of Production Incharge (Not less than 10 year).
   
9. 
   Resignation / retirement of earlier Production Incharge.
   
10. 
    Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm (Production Incharge).
    
11. 
    Undertaking as whole time employee on stamp paper (Production Incharge)
    
12. 
    All documents should be duly attested.
    

The firm submitted documents on 13-09-2017 in reply to Final Reminder for renewal of DML. Upon evaluation following shortcomings has been observed in the application for renewal of DML is still incomplete:

1. 
   Nothing due certificate regarding CRF form STO, DRAP, Islamabad (Update).
   
2. 
   Proof of sections approved by Central Licensing Board.
   
3. 
   CNIC copy, academic degrees and Registration Certificate of appointee are not duly attested.
   
4. 
   Resignation/ retirement letter of earlier Production Incharge is not provided.
   
5. 
   Experience certificates is less than 10 years as per submitted documents of the firm. Total experience of Proposed Production Incharge is approximately 9 years and 03 months.
   
6. 
   There is change in management of the firm. The detail of which is as under:
   

Management as per Form-1A at the time of renewal of DML for tenure 19-04-2006 to 18-04-2011	Management as per Form-1A at the time of renewal of DML for tenure 19-04-2011 to 18-04-2016	Management as per Form-1A at the time of renewal of DML for tenure 19-04-2016 to 18-04-2021	Current Status
Mr. Muhammad Firdous. Mr. Muhammad Yaqoob Butt and Others.	Not Provided	Mr. Nadeem Firdous. Mr. Abu Obaida Butt & Others.	Mr. Nadeem Firdous. Mr. Umar Butt

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. 000094 by way of formulation of M/s Dosaco Laboratories, 9.2-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 Dosaco Laboratories, 9.2-Km, Sheikhupura Road, Lahore

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. Yasir Khan appeared before the Board. He contested that certificate regarriding CRF is recived and presented before the Board. The Board after hearing the representative of the firm and considering the facts on the record and after thread bare deliberation decided to suspend the Drug Manufacturing Licence No. 000094 by way of formulation issued in the name of M/s Dosaco Laboratories, 9.2-Km, Sheikhupura Road, Lahore 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 16 and 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. 27 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ALBRO PHARMACEUTICALS (PVT) LTD, 340-S, QUAID-E-AZAM INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE.

Background of the case

Mr. Abdul Rashid Shaikh, FID and Mrs. Saira Naeem, area ADC, Lahore conducted inspection of the firm M/s Albro Pharmaceutical, Lahore on 12.06.2015, to verify the GMP compliance and production activities. Following critical observations were noticed by the panel during their visit:-

General Information

• 
  Land of the firm does not fulfill the requirements of SRO. 470 (1)/98 dated 15.05.1998 Schedule-B to the Drugs (Licensing, Registration & Advertisement) Rules, 1976. It is advised to shift the manufacturing facility to appropriate area to fulfill the requirement of above said SRO till then; the management is directed to strictly maintain the cGMP requirements for the manufacturing of registered drugs.
  

Workers Entrance:

• 
  It is advised to improve the workers entrance.
  

Oral Liquid Section:

• 
  The firm was advised to replace the drains with GMP drains in the section.
  
• 
  The firm was advised to replace the cooking vessel for the syrup manufacturing.
  
• 
  The firm was advised to conceal the lights of areas.
  

Raw Material Store:

• 
  The firm was advised to ensure the availability of closed trolleys for the transportation of dispensed materials from store to production floor.
  
• 
  The firm was advised to affix the proper labeling with relevant colours on the quarantine materials released or rejected
  
• 
  The firm was advised to improve the storage condition of liquid materials by keeping in view the safety measures.
  
• 
  The firm was advised to review and upgrade the dispensing SOPs.
  

Tablet Section:

• 
  The firm was directed to ensure availability of the Double Cone Mixer.
  
• 
  The firm was directed to ensure the availability of separate bags for each product for Fluid-bed dryer.
  
• 
  The firm was directed to review the manufacturing SOPs as far as batch size is concerned.
  
• 
  The firm was directed to ensure the batch size as per available manufacturing capacity.
  

Quality Control Laboratory:

• 
  The firm was advised to ensure the FTIR, KARL Fischer and Automatic Polarimeter.
  
• 
  The firm was advised to upgrade the SOPs for testing methods as per current pharmacopoeia requirements.
  
• 
  The firm was advised to develop separate and independent Quality Assurance Department under the supervision of senior technical person without fail.
  
• 
  The firm was advised to get internal and external audit and then its CAPA, and the report be submitted to the office of FID.
  
• 
  The firm was advised to ensure to make the stability chamber functional, conduct stability of the products and maintain their record as per guidance of stability study.
  

The FID further directed the management to:-

• 
  Remove the shortcomings at the earliest. The re-inspection will be conducted accordingly.
  

Action Taken by DRAP:- After receiving inspection report, a show cause notice was issued to the firm on 10.11.2015.

Reply of the firm:- In response of the show cause notice, the firm vide letter No. Nil dated 23.11.2015 informed that many of the observations has been resolved and improved.

Proceedings of the 246^th Meeting of CLB

Mr. Waseem Ahmad Bari, Director and Mr. Sibtul Hassan Abaas, Production Manager of the firm M/s Albro Pharma, Lahore appeared before the Board for personnel hearing. Mr. Waseem Ahmad Bari informed to the Board that the existing plot is about 2.5 Kanal and assured that he will purchase the new plot of 4 kanal (size) in next six months. He has submitted an undertaking stating that the facility will be developed in four years. He further informed that all the observations identified by FID have been rectified and are ready for inspection for verification of the rectification.

Decision of the 246^th Meeting of CLB

After thorough discussion/deliberations, considering all the pros and cons of the case, keeping in view the available record and request of Director of the firm M/s Albro Pharma, Lahore, the Board decided to conduct panel cGMP inspection of the firm on approved format under Schedule B-II of Drugs (LR&A) Rules, 1976 by the following members.

1. 
   Dr. Zaka ur Rehman, Member, CLB
   
2. 
   Mr. Abdul Rashid Sheikh, FID, Lahore
   
3. 
   Mr. Zia Husnain, FID, Lahore
   

The Board further decided to ask the panel to also submit the report in tabulated form identifying the previous observations and the current status of the observations noted by the panel in its inspection conducted on 12.06.2015.
To purchase the plot of 4 kanals in 06 months and complete the facility within a period of 2 years
Proceedings and Decision of Central Licensing Board in 257^th meeting
The Board considered the case and decided to defer the renewal of DML till next meeting of the Board for want of personal hearing regarding update from the licensee on the decision of the Central Licensing Board for purchase of plot and completion of facility.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.

A letter of Personal hearing has been issued on 20^th March, 2018.

Proceedings and Decision of Central Licensing Board in 259^thmeeting

Mr. Waseem Bari, Owner of the firm appeared before the Board. He contested that firm possess three sections, land at new site has been purchased and application for site verification has already been filed. He further contended that considerable time may be allowed to shift to new premises. The Board after hearing the representative of the firm and considering the facts on the record and after thread bare deliberation decided to defer the case for the sake of shifting of the premises to new site within a period of one years. The firm shall get site approval within one month and lay out approval within one month and will apply for grant of licence within a period of one year. The firm shall also submit progress report quarterly. If firm fails to comply at any stage the Central Licenisng Board shall start proccedings as per law.

Case No. 28 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S T.G PHARMA, KARACHI
M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi had applied for renewal of DML No. 000547 by way of formulation for the period of 24-07-2014 to 23-07-2019 on 23-07-2014.

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 23^rd February, 2016 and 2^nd March, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

1. 
   Proper application on Form-IA on firm’s letter head dully signed / stamp by CEO of firm.
   
2. 
   No Objection Certificate for Central Research Fund (CRF) (updated) issued by Statistical Officer DRAP, Islamabad
   
3. 
   Legal status of the firm along with details of ownership, attested copies of CNIC’s.
   
4. 
   List of total section of the firm and their letters of approval which were issued by Central Licensing Board.
   
5. 
   Approval letter of QC Incharge and Production Incharge if (not available) then provide complete documents of technical persons i.e QC Incharge and Production Incharge according to checklist (enclosed).
   

Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 10^th July, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following shortcomings.

1. 
   Proper application on Form-IA on firm’s letter head dully signed / stamp by CEO of firm.
   
2. 
   Nothing due certificate regarding CRF from STO (Updated).
   
3. 
   Legal status of the firm along with details of ownership, attested copies of CNIC’s. .
   
4. 
   Approval letters of sections issued by the Central Licensing Board
   
5. 
   Approval letter of proposed Quality Control Incharge and Production Incharge, if any change then provide set of duly attested documents for Proposed Quality Control Incharge and Production Incharge (as per check list) along with prescribe fee.
   
6. 
   Documents should be duly attested.
   

Proceedings and Decision of Central Licensing Board in 256^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) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi Drug Manufacturing Licence No. 000547 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 05^th January, 2018 was issued to the M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi.

No reply of the show cause notice is received from the firm.

A letter of Personal hearing has been issued on 17^th January, 2018

Proceedings and Decision of Central Licensing Board in 257^thmeeting

No person appeared on behalf of the firm. The Board decided to defer the case for giving one more opportunity and service of notice through Federal Inspector of Drugs.

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

Firm submitted documents on 2^nd February, 2018 in reply to personal hearing letter dated 17^th January, 2018 but following documents are still deficient /short and application for renewal of DML is still incomplete.

1. 
   Nothing due certificate regarding CRF from STO (Updated).
   
2. 
   Legal status of the firm either Sole proprietor / Partnership firm at this renewal and at time of previous renewal alongwith attested CNIC copies of all partners / owners.
   
3. 
   Approval letter of all section issued by CLB or if not available then submitted layout plan for regularization.
   
4. 
   Approval letter of proposed Quality Control Incharge and Production Incharge, if any change then provide complete set of duly attested documents for Proposed Quality Control Incharge and Production Incharge (as per check list) along with prescribe fee.
   

A letter of Personal hearing has been issued
Proceedings and Decision of Central Licensing Board in 259^thmeeting

Dr. Waseem Siddiqui appeared before the Board. He contested that documents regarding CRF is submitted with concerned Division. However, he could not satisfy the Board regarding the deficient documents. The Board after hearing the representative of the firm and considering the facts on the record and after thread bare deliberation decided to suspend the Drug Manufacturing Licence No. 000547 by way of formulation issued in the name of M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi 000547 till settlement 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 16, Rule, 19 and 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. 29 RESTRUCTURING OF LICENSED PREMISES WITHOUT PRIOR APPROVAL FROM DRAP OF M/S LISKO PAKISTAN (PVT) LTD, KARACHI
A copy of letter is received from Mr. Kirshan, Assistant Director / Federal Inspector of Drugs, Karachi addressed to the Director M/s Lisko Pakistan (Pvt) Ltd, Karachi, wherein he has stated that as follow:-

“I am directed to inform you that the undersigned visited the premises (Lisko Pakistan (Private) Limited, L-10/D, Block-21, Federal "B" Industrial Area) on dated 26-10-2017 regarding the subject matter and as per telephonic discussion with you that the construction work for bottle store was undergoing on the first floor of the building without approval intimation to Area FID.

2. As per your statement, during the course of construction work, the roof of the floor fallen down due to overload on dated 24-10-2017 and eventually one of the labors died and the four injured.

3. During the visit the undersigned found the factory premises were sealed by Sindh Building Control Authority (SBCA) (annexure attached).

4. You are hereby directed to explain that why the permission was not taken from DRAP.

5. You are further directed that explain your position within 7 days of receipt of this office letter and intimate the DRAP for approval before resuming the activities in factory premises”.
Proceedings and Decision of Central Licensing Board in 256^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, 19 and Rule 20 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their Drug Manufacturing Licence No. 000520 of M/s Qintar Pharmaceuticals (Pvt) Ltd, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha by way of formulation may not be suspended or cancelled by Central Licensing Board.

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

In the aforesaid minutes of Central Licensing Board the name of the firm was inadvertently typed as M/s Qintar Pharmaceuticals (Pvt) Ltd, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha under Drug Manufacturing Licence No. 000520 by way of formulation Instead of M/s Lisko Pakistan (Pvt) Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi under Drug Manufacturing Licence No. 000110 by way of formulation.

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

The Board approved the correction in decision of the 256^th meeting of the Central Licensing Board and decision may be read as under:

“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, 19 and Rule 20 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their Drug Manufacturing Licence No. 000110, M/s Lisko Pakistan (Pvt) Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi by way of formulation 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 27^th February, 2018 was issued to the M/s Lisko Pakistan (Pvt) Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi.

No reply of the show cause notice is received from the firm till date.