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



Yüklə 1,12 Mb.
səhifə10/17
tarix17.01.2019
ölçüsü1,12 Mb.
#99263
1   ...   6   7   8   9   10   11   12   13   ...   17

Decision: Registration Board deliberated the matter in detail and decided to refer the case to Central Licensing Board for their comments on firm’s request as CLB has granted for Biological parenteral section only”.




Proceedings of Licensing Division
The firm has requested for grant of personal to present their case before the Central Licensing Board.
Proceedings and Decision of Central Licensing Board in 259thmeeting

Dr. Ajmal Nasir, Director Technical and Mr. Baqar Hassan appeared before the Borad on behalf of the firm and gave detailed presentation on subject matter of compaign manufacture. The Board considering the facts on the record and after thread bare deliberation decided to defer the case for detailed working before reaching a conclusive decision.



Case No.46 CANCELLATION LICENSE OF M/S FLORENCE FARMACEUTICS (PVT) LTD, ISLAMABAD UNDER DRUG MANUFACTURING LICENSE NO. 000635 (FORMULATION)
Letter received from Mr. Awais Ahmed, Assistant Director (QA-IV), DRAP, Islamabad wherein he has submitted inspection report of M/s Florence Pharmaceutics (Pvt) Ltd., Plot No. 266, Industrial Triangle, Kahuta Road, Islamabad. The conclusion of inspection report is as under:-
Mr. Arslan Tariq, FID-I Islamabad visited the firm M/s Florence Pharmaceutics (Pvt) Ltd., Plot No. 266, Industrial Triangle, Kahuta Road, Islamabad on 12-01-2018 to see the progress regarding the rectification of observations pointed out during last inspection dated 15-11-2017, the firm was order to stop the production by the Division of QA< till the rectification and verification of the observations.
However upon visit, the factory was found locked and chowkidar (Mr. Saleem) was present on the site. In the presence of Driver & Mr. Shehzad Ahmed (Witness), that all the machinery has been moved to an unknown place by the owner of M/s Florence Pharmaceutics (Pvt) Ltd., the chowkidar also stated that there is no existence of M/s Florence Pharmaceutics as the real owner of land and building (Mr. Farooq Khilji) has withdrawn / cancelled the lease / rental with the management of M/s Florence Pharmaceutics.
FID confirmed the same telephonically from Mr. Farooq Khilji on Cell No. 0306-5393900. He also informed that he had already submitted an application for the cancellation of license to Mr. Manzoor Bozdar, Additional Director (Lic), DRAP, Islamabad”.

Meanwhile Mrs. Shahida Bano W/o Late Muhammad Sadqeen owner of Plot No. 266, Industrial Triangle, Kahuta Road, Islamabad has informed that lease agreement was ended on October, 2016 and mutual understanding Florence Pharmaceutics Director Saif-ud-Din has withdrawn their Plot on 15th November, 2017. She has also informed that they are not interested for further agreement with Florence Pharmaceutics (Pvt) Ltd.


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 Florence Pharmaceutics (Pvt) Ltd., Plot No. 266, Industrial Triangle, Kahuta Road, Islamabad Drug Manufacturing Licence No. 000635 by way of formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.



CASE NO. 47 GRANT OF ADDITIONAL SECTIONS/EXPANSION/AMENDMENTS ETC OF M/S HILTONPHARMA (PVT) LTD, KARACHI.

The Central Licensing Board in its 238th meeting held on 19th December, 2014 approved the grant of amendments/ expansion to M/s Hilton Pharma (Pvt) Ltd, Karachi according to approved layout plan for following existing sections:



  1. Oral Dry Powder Suspension (General).

  2. Sachet (General)

  3. Dedicated facilities for blistering & packing.

  4. Sachet (Enflor)*

*The Board has granted provisional approval of amendments/expansion in already existing Sachet (Enflor) section. The active ingredient of Sachet Enflor is Sacharomyces Boulardii is probiotic which is not a drug after the promulgation of the DRAP Act, 2012. Since the firm has registration of Enflor sachet product, therefore the Board directed to refer the case to Division of Pharmaceutical Evaluation & Research, DRAP, Islamabad to take review of registration of probiotic (Sachet Enflor) product of the firm and to inform CLB for necessary action accordingly.

Now Policy Board in its 18th meeting decided that:-

No nutraceutical product or alternative medicines already registered as drug under the Drugs Act, 1976 shall be allowed for switch over from drug category to alternative medicines or Health & OTC (non-drug) category. Therefore, those who want to switch for price de-regulation due to such switching will not arise. (Copy of decision attached)

Meanwhile, Drug Registration Board considered the case of the firm in its 278th meeting held on 29-31st January, 2018 and referred the matter to Licensing Division for evaluation in light of decision of DRAP’s authority. Proceedings of the Drug Registration Board’s 278th meeting are as under:

CaseNo. 21. RequestforcontractmanufacturingofdrugbyM/s.TabrosPharma(Pvt.)Ltd; Karachi.



M/s. TabrosPhamra(Pvt.)Ltd;Karachiwasgranted the registration offollowingproduct:-


Reg.No.

NameofDrug(s)

RegistrationHistory

Remarks

026886

BiflorSachet250mg

Init.DateofReg.12-05-2001

Renewal

Each sachetcontains:-

Copyof1strenewalapplicationdated

confirmation

Lyophilised Saccharomyces

04-02-2006

required

boulardil……….285mg

Copof2ndrenewalapplicationdated

from RRR

(Correspondingto250mgof

14-04-2011

section.

Yeast)

Copyof 03rdrenewaldated18-02-2016


Themanagement of the firm hasprovided followingdocuments:-

  1. Fee of Rs. 50,000/-forthis purpose.

  2. Copyof renewal of registrationandcopies ofrenewalapplications.

  3. Contractagreement on stamp paper.

  4. Last inspection ofM/s. Hilton Pharma,Karachi dated 19-07-2017.

  5. Approval of SectionbyCLB ofM/s. Hilton Pharma,Karachi.

  6. NOCfrom M/s. Hilton Pharma,Karachi.


M/s.TabrosPharma,Karachihasrequestedtochangetheregistrationstatusofaboveproducttocontractmanufacturing byM/s. Hilton Pharma(Pvt.) Ltd;Plot 13-14, Sector15, Korangi

IndustrialArea,Karachi.ThefirmhasfurtherstatedthattheyareplanningtoestablishProbioticfacility.

M/sHiltonPharma,KarachiwasgrantedSachet(Enflor)Sectionon4.12.2014withfollowingremarks:

TheCentralLicesingBoardhasgrantedprovisionalapprovalofamendments/expansioninalreadyexistingsachet(Enflor)section.TheactiveingredientofsachetEnflorisSacharomycesBoulardiiisprobioticwhichisnotadrugafterthepromulgationofDRAPAct,2012.SincethefirmhasregistrationofEnflorsachetproduct,thereforetheBoarddirectedtoreferthecasetoDivisonofPharmaceuticalEvaluation&Research,DRAP,Islamabadtotakereviewofregistrationofprobiotic(SachetEnflor)productofthefirmandtoinformCLBfornecessaryactionaccordingly”.




Yüklə 1,12 Mb.

Dostları ilə paylaş:
1   ...   6   7   8   9   10   11   12   13   ...   17




Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©muhaz.org 2022
rəhbərliyinə müraciət

    Ana səhifə