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Month: May 2023

Minutes of the meetings of Clinical Studies Committee (CSC) conducted in the light of Bio Study Rules 2017

Ijaz Mustafa Clinical Studies Committee

Minutes of 1st Meeting of CSC

1-CSC07-02-2019Download

Minutes of 2nd Meeting of CSC

2-CSC09-05-2019Download

Minutes of 3rd Meeting of CSC

3-CSC16-05-2019Download

Minutes of 4th Meeting of CSC

4-CSC17-07-2019Download

Minutes of 5th Meeting of CSC

5-CSC08-08-2019Download

Minutes of 6th Meeting of CSC

6-CSC20-01-2020Download

Minutes of 1st Meeting of CSC

7-CSC18-02-2020Download

Minutes of 8th Meeting of CSC

8-CSC0000Download

Minutes of 9th Meeting of CSC

9-CSC08-04-2020Download

Minutes of 10th Meeting of CSC

10-CSC28-04-2020Download

Minutes of 11th Meeting of CSC

11-CSC20-05-2020Download

Minutes of 12th Meeting of CSC

12-CSC22-06-2020Download

Minutes of 13th Meeting of CSC

13-CSC11-08-2020Download

Minutes of 14th Meeting of CSC

14-CSC21-09-2020Download

Minutes of 15th Meeting of CSC

15-CSC12-10-2020Download

Minutes of 16th Meeting of CSC

16-CSC27-11-2020Download

Minutes of 17th Meeting of CSC

17-CSC22-12-2020Download

Minutes of 18th Meeting of CSC

18-CSC26-12-2020Download

Minutes of 19th Meeting of CSC

19-CSC12-02-2021Download

Minutes of 20th Meeting of CSC

20-CSC10-03-2021Download

Minutes of 21st Meeting of CSC

21-CSC22-03-2021Download

Minutes of 22nd Meeting of CSC

22-CSC23-03-2021Download

Minutes of 23rd Meeting of CSC

23-CSC03-04-2021Download

Minutes of 24th Meeting of CSC

24-CSC07-04-2021Download

Minutes of 25th Meeting of CSC

25-CSC28-04-2021Download

Minutes of 26th Meeting of CSC

26-CSC31-05-2021Download

Minutes of 27th Meeting of CSC

27-CSC24-06-2021Download

Minutes of 28th Meeting of CSC

28-CSC29-06-2021Download

Minutes of 29th Meeting of CSC

29-CSC05-08-2021Download

Minutes of 30th Meeting of CSC

30-CSC12-08-2021Download

Minutes of 31st Meeting of CSC

31-CSC26-08-2021Download

Minutes of 32ndMeeting of CSC

32-CSC12-10-2021Download

Minutes of 33rd Meeting of CSC

33-CSC11-11-2021Download

Minutes of 34th Meeting of CSC

34-CSC13-01-2022Download

Minutes of 35th Meeting of CSC

35-CSC13-10-2022Download

Minutes of 36th Meeting of CSC

36-CSC21-11-2022Download

Minutes of 37thMeeting of CSC

37-CSC06-12-2022Download

Minutes of 38th Meeting of CSC

38-CSC08-02-2023Download

Minutes of 39th Meeting of CSC

39-CSC28-02-2023Download

Minutes of 40th Meeting of CSC

40-CSC17-03-2023Download

Minutes of 41st Meeting of CSC

41-CSC10-04-2023Download

Minutes of 42nd Meeting of CSC

42-CSC03-05-2023Download

DRAP issued a Draft of Guidelines on the Lot Release of Biological Drugs

Asad Ullah Drugs, General

The lot release of biological products is a part of the regulation of biological products. It involves the independent assessment of each lot of a licensed biological product before it is released in the market. In addition to manufacturing, the complexity inherent to biological products, proper storage conditions and efficient supply chain management must be ensured to preserve these products’ sensitivity and limited shelf life properties. For the reasons stipulated above, a careful independent review of manufacturing and quality control data on every lot of product as stated is, therefore, necessary before use. Lot release program enables National Regulatory Authority (NRA) to ascertain the safety, quality, and effectiveness of every lot of these products.

This draft guideline is uploaded on the official website of DRAP dated 5th May 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format, (further information on comments submission can access at this link. Comments and suggestions can be forwarded via email to ayub.naveed∂dra.gov.pk, copied at director∂nclb.dra.gov.pk, or can be posted at the mailing address, The Director, National Control Laboratory for Biologicals, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Chak Shehzad, Islamabad.

final-draft-guideline-for-lot-release-NCLB-dated-3-5-2023Download

Recall Alert: Drug Product; Fluorazine 1mg Tablet (Batch # T-2065) CKD Pharmaceuticals Pak (Pvt) Ltd, Karachi

Asad Ullah Recall Alerts

Recall Alert

DRAP Alert NoNoI/S/04-23-20
Action Date11th April 2023
Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Fluorazine 1mg Tablets
Composition: Trifluoperazine HCl
Manufactured by: M/s. CKD Pharmaceutical, Karachi
Batch No. 2040006
Problem / Issue Provincial Drug Inspector, Karachi took the sample of Fluorazine 1mg Tablet. Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. T-2065 of the product as of substandard quality.
Action Initiated-The manufacturing company/registration holder has been directed to immediately recall the defective product batch from the market.

-All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this product batch. The remaining stock should be quarantined and returned to the supplier/company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return this product’s defective batch(es) to the importer/company.

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to taking or using this product.

-All drug products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.
    Fluorazine-1mg-Recall-alertDownload