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


A letter of Personal hearing has been issued on 20



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

Mr. Nazar Talib, Managing Director of the company appeared before the Board. He contended that lay out plan was approved by the Division of Licensing for first floor accordingly construction was being done. Roof of the newly built room was collapsed and incident happened. He argued that there was no un-authorised construction as reported by the Federal Inspector of Drugs. He also submitted approval letter from Licensing Division for layout plan approval for said section. He also argued that Sindh Building Control Authority has initially sealed the premises and de-sealed it after investigations. He also informed that production is also carried out on the ground floor. The Board after hearing the representative of the firm and facts on record decided to revoke the show cause notice issued to the firm. The Board directed area federal Inspector of firm to submit updated report on premises with status as per Lay Out Plan.



Case No. 30 RENEWAL OF DRUG MANUFACTURING LICENSE NO. (000684) (FORMULATION) OF M/S BRAND PHARMA INTERNATIONAL, K-105, PHASE-II, S.I.T.E, SUPER HIGHWAY, KARACHI
M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi was issued the License No. 000684 (Formulation) on 10-05-2010 and due date of renewal of License was 09-05-2015. It is pertinent to mention that Rule 5 (6) of Drug (L, R & A) Rule, 1976 states “if an application of renewal is made after the expiry of the period of validity of License but within 60 days of expiry, the License shall continue in force on payment of additional surcharge of Rs. 5,000/- per day the application is delayed and thereafter until orders are passed on such application”. But in this case the application for renewal of DML for the period 10-05-2015 to 09-05-2020 has not been received till date. Therefore, DML No. 000684 (Formulation) M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi is no more valid.
Proceedings and Decision of Central Licensing Board in 257th 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, 5 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why DML No. 000684 by way of formulation of M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi may not be declared cancelled.


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

The Show Cause notice dated 27th February, 2018 was issued to the M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi.

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

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

No person appeared on behalf of the firm. The Board deferred the case for want of report from Federal Inspector of Drugs and service of showcause notice to the firm through Federal Inspector of drugs.



Case No.31 M/S GENERA PHARMACEUTICALS, PLOT NO. 244, STREET NO. 8, I-9/2, INDUSTRIAL AREA, ISLAMABAD – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A) RULES, 1976.

Case Background

M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad submitted the application for renewal of DML No. 000448 by way of (Formulation) on 27-04-2015 for the period of 29-04-2015 to 28-04-2020, as due date of renewal of said DML was 28-04-2015.


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. Form “C” from registrar of firm.

  2. Partnership deed attested, copies of CNICs of all partners.

  3. Declaration regarding change of management from last renewal.

  4. Proof of sections approved by the Central Licensing Board.

  5. Approved copy of layout plan.

  6. Nothing due certificate regarding CRF from STO.

  7. documents should be attested as per check list.

With reference to above letter, the firm submitted following documents;



  1. Partnership deed attested, copies of CNICs of all partners un-attested.

Upon evaluation of firm’s reply, a shortcoming still deficient regarding renewal of DML application. Final reminder was issued to the firm with following shortcomings:-





  1. Form “C” from registrar of firm.

  2. Partnership deed attested, copies of CNICs of all partners.

  3. Declaration regarding change of management from last renewal.

  4. Proof of sections approved by the Central Licensing Board.

  5. Approved copy of layout plan.

  6. Nothing due certificate regarding CRF from STO.

  7. Documents of proposed Quality Control Incharge (Mr. Hashim)

With reference to above letter, it is mentioned that as per available record of Licensing Division, no correspondence received in respect to shortcomings in application for renewal of DML of the firm.



Proceedings and Decision of Central Licensing Board in 257th 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. 000448 by way of formulation of M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, 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 26th February, 2018 was issued to the M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad.


No reply is received from the firm yet.

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

Proceedings and Decision of Central Licensing Board in 259thmeeting

Mr. Waseem Butt , Chief Executive of the firm appeared before the Board. He argued that he was in process of acquiring land to meet his plan for establishment of firm. He also argued that GMP compliance at existing premises is not possible therefore he had closed the unit three years ago. The Board after hearing the representative of the firm and considering the facts on the record and after thread bare deliberation decided to cancel the Drug Manufacturing Licence No. 000448 by way of formulation issued in the name of M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad, Drug Manufacturing Licence No. 000448 by way of (Formulation) 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.




Case No. 32 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S MEDICURE LABORATORIES, KARACHI
M/s Medicure Laboratories, F/109, S.I.T.E, Hub River Road, Karachi, had applied for renewal of DML No. 000034 by way of formulation for the period of 30-04-2015 to 29-04-2020 on 05-05-2015.
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 23rd February, 2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-


  1. To submit late fee for submission of DML renewal application i.e. Rs.5,000/- per day for 06 days = Rs.5,000x6=Rs.30,000/-.

  2. No objection certificate for Central Research Fund (CRF) 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 grant which were approved in meetings of Central Licensing Board.

  5. Complete documents of technical persons i.e QC Incharge and Production Incharge according to Performa (enclosed).

The firm submitted their reply on 4th March, 2016. After evaluation of the submitted documents, Final reminder was issued on 7th December, 2017 to the firm with following shortcomings: -




  1. Prescribed fee of Rs. 50,000/- for change of management / directors.

  2. Detail of all partners / Directors of firm’s letter head alongwith CNIC copies.

  3. Approval / Grant letters of all repacking drugs for which renewal of DML is applied alongwith fee of Rs, 5,000/- per drug / product.

  4. Complete set of duly attested documents for Proposed Production Incharge and Quality Control Incharge (as per check list).

  5. Nothing due certificate regarding CRF from STO (Updated).

  6. Approval letters of sections issued by the Central Licensing Board and if not available then submit master layout plan for Regularization of manufacturing facility.

  7. All documents should be duly attested.

Firm submitted documents on 22nd December, 2017 in reply to Final Reminder 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. Approval letters alongwith prescribe fee of Rs. 5,000/- per product for re-packing item / Products.

  3. Complete set of duly attested documents for Proposed Production Incharge Ms. Zubia Kawal as her total post qualification experience is less than 10 years which does not fulfill the requirements of Rule 16 of Drugs (Licensing, Registering and Advertising) Rules 1976 in term of relevant experience.

  4. Resignation / retirement of earlier Quality Control Incharge.

  5. Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm (Quality Control Incharge).

  6. Job acceptance letter by the appointee (Quality Control Incharge).

  7. Undertaking as whole time employee on stamp paper (Quality Control Incharge).

  8. Prescribed fee of 10,000/- for Production Incharge and Quality Control Incharge.


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 Medicure Laboratories, F/109, S.I.T.E, Hub River Road, Karachi, Drug Manufacturing Licence No000034 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.


Case No. 33 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S EROS PHARMA, KARACHI
M/s Eros Pharma, Plot No. 94-95, Sector 23, Korangi Industrial Area, Karachi, had applied for renewal of DML No. 000147 by way of formulation for the period of 21-08-2015 to 20-08-2020 on 03-08-2015. 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 5th June, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-


  1. Form-29 alongwith Form-A duly attested from S.E.C.P (Updated year 2017).

  2. Form-29 duly attested from S.E.C.P (for year 2010).

  3. Detail of management at the time of pervious renewal of DML and present renewal of DML along with CNIC copies of all directors.

  4. Approved Master Layout Plan / Proof of licensed section from CLB.

  5. Nothing due certificate regarding CRF from STO (Updated).

  6. Prescribed fee of Rs. 50,000/- for change of management / directors.

  7. Prescribe fee of Rs. 10,000/- for change of proposed Production Incharge and Quality Control Incharge.

  8. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years for proposed Production Incharge and Quality Control).

  9. Resignation / retirement of earlier Production Incharge and Quality Control Incharge.

  10. Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm (Production Incharge and Quality Control Incharge).

  11. All documents should be duly attested.

The firm submitted their reply on 12th October, 2017. After evaluation of the submitted documents, Final reminder was issued on 5th December, 2017 to the firm with following shortcomings: -



  1. Form-29 along with Form-A duly attested from S.E.C.P (Updated year 2017).

  2. Form-29 duly attested from S.E.C.P (for year 2010).

  3. Attested CNIC copies of all directors at present renewal and at last renewal.

  4. Approval letters of sections issued by the Central Licensing Board or if not available

then submit master layout plan for Regularization.

  1. Section wise detail of machinery for manufacture.

  2. Section wise detail of machinery for Quality Control Lab.

  3. Nothing due certificate regarding CRF from STO (Updated).

  4. Prescribed fee of Rs. 50,000/- for change of management / directors.

  5. Prescribe fee of Rs. 5,000/- (original challan retained by STO (R&D)) for change of proposed Quality Control Incharge alongwith complete set of attested documents of Mr. Ahmed Raza.

  6. All documents should be duly attested.

Firm submitted documents on 6th February, 2018 in reply to Final Reminder but following documents are still deficient /short and application for renewal of DML is still incomplete.



  1. Form-29 along with Form-A duly attested from S.E.C.P (Updated year 2017).

  2. Form-29 duly attested from S.E.C.P (for year 2010).

  3. Prescribed fee of Rs. 50,000/- for change of management / directors if the management is changed.

  4. Attested CNIC copies of all directors at present renewal and at last renewal.

  5. Approval letters of sections issued by the Central Licensing Board or if not available

then submit master layout plan for Regularization.

  1. Nothing due certificate regarding CRF from STO (Updated).

  2. All documents should be duly attested.


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 Eros Pharma, Plot No. 94-95, Sector 23, Korangi Industrial Area, Karachi, Drug Manufacturing Licence No. 000147 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.


Case No. 34 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S RUKHA PHARMACEUTICAL LABORATOIRES (PVT) LTD, LAHORE

M/s Rukha Pharmaceutical Laboratories (Pvt) Ltd, Plot No. 537-D&E, Sunder Industrial Estate, Raiwind Road, Lahore had applied for renewal of DML No. 000753 by way of formulation for the period of 12-09-2017 to 11-09-2022 on 30-08-2017.


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 3rd October, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-


  1. Form-29 duly attested from S.E.C.P (Updated)

  2. Detail of management at the time of previous renewal of DML and at present Renewal alongwith copies of CNIC of all Directors.

  3. Nothing due certificate regarding CRF from STO (Updated).

  4. All documents should be duly attested.

The firm submitted their reply on 17th October, 2017.After evaluation of the submitted documents, Final reminder was issued on 08th November, 2017 to the firm with following shortcomings: -




  1. Prescribed fee of Rs. 50,000/- for change of management / directors as it seems management is changed from last renewal till at present renewal.

  2. Form-29 duly attested from S.E.C.P (Updated) alongwith CNIC copies of all Director.

  3. Nothing due certificate regarding CRF from STO (Updated).

  4. All documents should be duly attested.

Firm submitted documents on 21st November, 2017 in reply to Final Reminder 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. Form-29 duly attested from S.E.C.P for year 2017 alongwith CNIC copies of all Director.

  3. Copy of CNIC of appointee (Production Incharge).

  4. Undertaking as whole time employee on stamp paper (Production Incharge).

  5. All documents should be duly attested.


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 Rukha Pharmaceutical Laboratories (Pvt) Ltd, Plot No. 537-D&E, Sunder Industrial Estate, Raiwind Road, Drug Manufacturing Licence No. 000753 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.


Case No. 35 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S UMER USMAN COTTON INDUSTRIES, JHANG.

M/s Umer Usman Cotton Industries, Faisalabad Road, Jhang Saddar had applied for renewal of DML No. 000361 by way of formulation for the period of 18-09-2015 to 17-09-2020 on 10-09-2015.


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 26th May, 2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-


  1. Name registered drugs approved.

  2. Detail of premises including Layout plan.

  3. Detail of management / owner / partners on firm letter head alongwith declaration regarding any change in management & copies of CNIC (Attested).

  4. Nothing due certificate regarding CRF (Latest).

Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 17th May, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following shortcomings.




  1. Name(s) of drugs registered / approved.

  2. Detail of premises including Layout plan.

  3. Approved Master Layout Plan / Proof of licensed section from CLB.

  4. Detail of management / owner / partners on firm letter head along with declaration regarding any change in management & copies of CNIC (Attested).

  5. Nothing due certificate regarding CRF (Latest).

  6. Documents should be duly attested.

Firm did not submit their reply to Final Reminder till date and following documents are still deficient /short and application for renewal of DML is still incomplete.



  1. Name(s) of drugs registered / approved.

  2. Detail of premises including Layout plan.

  3. Approved Master Layout Plan / Proof of licensed section from CLB.

  4. Nothing due certificate regarding CRF (Latest).

  5. Detail of management / owner / partners on firm letter head along with declaration regarding any change in management & copies of CNIC (Attested) if change, then prescribe fee of Rs. 50,000/-.


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 Umer Usman Cotton Industries, Faisalabad Road, Jhang Saddar, Drug Manufacturing Licence No. 000361 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.


Case No. 36 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ZENITH CHEMICAL INDUSTRIES (PVT) LTD, LAHORE.
M/s Zenith Chemical Industries (Pvt) Ltd, Moza Dondey Jai Baga Raiwind Road, Lahore had applied for renewal of DML No. 000733 by way of Semi Basic manufacture for the period of 15-06-2016 to 14-06-2021 on 22-03-2016.
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 8th June, 2016 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-

  1. Change(s) in name of proprietor / directors / partners (if any)

  2. Copy of 29 attested by SECP

  3. List of approved API

  4. Firm has appalled for the approval of proposed production Incharge Mr, Hasham Khalid who is BSC Chemical engineering who does not full fill requirements of the Rule16 drugs (LR&A Rule1976)

  5. Noting due certificate regarding CRF from STO.

  6. Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm QC Incharge

  7. Undertaking as whole time employee I QC Incharge

  8. Resignation / retirement of earlier QC Incharge.

  9. Fee of 10000. Production Incharge and QC Incharge.

The firm replied to this letter on 01-07-2016 alongwith application for approval of proposed

Production Incharge. A letter dated 18th November, 2016 was issued to the firm for submission of

following documents:



  1. Undertaking as whole time employee for Production Incharge

  2. Nothing due certificate

  3. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules, 1976. (not less than 10 years)

  4. Undertaking as whole time employee for QC Incharge

  5. All documents should be dully attested.

The firm submitted the shortcoming documents and a Reminder letter was issued on 2nd March, 2017 of following shortcomings.



  1. Updated Nothing due certificate regarding CRF from STO.

  2. Copy of CNIC of appointee (Proposed Production Incharge and QC Incharge).

  3. Job acceptance letter by the appointee (Proposed Production Incharge).

  4. Resignation / retirement of earlier Production Incharge.

  5. Undertaking as whole time employee (QC Incharge Mr. Muhammad Omer Kaleem).

  6. All documents should be duly attested.

The firm submitted documents in reply to Reminder but following shortcomings were still present in the application for renewal of DML.

  1. Changes in name of proprietors / directors / partners (if any).

  2. CNIC copies of all directors / Partners.

  3. Copy of Form-29 (Updated)

  4. Nothing due certificate regarding CRF from STO (Updated).

  5. Proposed Production Incharge does not fulfills the requirements of Rule 16 of Drugs (L, R, &A) rules 1976 in terms of qualification.

  6. Complete Set of documents for proposed Production Incharge as (per check list).

  7. Appointment letter (Quality Control Incharge).

  8. Job acceptance letter by the appointee (Quality Control Incharge).

  9. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years).

  10. Resignation / retirement of earlier Quality Control Incharge.

  11. Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm.

  12. All documents should be duly attested.

Final Reminder dated 31st July, 2017 under Rule 5 (2A) was issued to the firm for submission of following documents:



  1. Changes in name of proprietors / directors / partners (if any).

  2. CNIC copies of all directors / Partners.

  3. Copy of Form-29 (Updated)

  4. Nothing due certificate regarding CRF from STO (Updated).

  5. Proposed Production Incharge does not fulfill the requirements of Rule 16 of Drugs (L, R, &A) Rules 1976 in terms of experience ,submit complete set of documents of Production Incharge as per requirements of Rule 16 of Drugs (L, R, &A) Rules 1976.

  6. Appointment letter (Quality Control Incharge).

  7. Job acceptance letter by the appointee (Quality Control Incharge).

  8. Experience Certificate of Quality Control Incharge as under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years in relevant t field of Quality Control).

  9. Resignation / retirement of earlier Quality Control Incharge.

  10. Resignation or termination letter of appointee from the previous firm / promotion letter / transfer letter from the same firm (Quality Control Incharge and Production Incharge).

  11. All documents should be duly attested.

The firm replied to Final Reminder but application for renewal of DML is still incomplete with following shortcoming.



  1. Nothing due certificate regarding CRF from STO (Updated).


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) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their application for renewal of M/s Zenith Chemical Industries (Pvt) Ltd, Moza Dondey Jai Baga Raiwind Road, Lahore, Drug Manufacturing Licence No. 000733 by way of semi basic may not be suspended till settlement of Central Research Fund.



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