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Author: Ijaz Mustafa

Recall Alert; Drug Product: Sterile Water for Injection (Batch # 739 and 751) by M/s. Zafa Pharmaceutical Laboratories (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts

Recall Alert

DRAP Alert NoNoI/S/07-22-18
Action Date25th July, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Sterile Water for Injection,
Company: M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi.
Batch No. 739 and 751
Manufacturing Date: February-2022,
Expiry Date: February-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Sterile Water for Injection bearing Batch No. 739 and 751 and declared it as Adulterated and Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the company.

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

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of 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) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Sterile-Water-for-Injetion-Zafa-Recall-Alert-18Download

Recall Alert; Drug Product: Phenerzine Elixir (Batch # 037) by M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts

Recall Alert

DRAP Alert NoNoII/S/07-22-20
Action Date2nd August, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions
3. General Public
Product(s) Affected Phenerzine Elixir,
Company: M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi
Batch No. 037
Manufacturing Date: March-2022,
Expiry Date: March-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Phenerzine Elixir bearing Batch No. 037 and declared it as Adulterated and Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the company.

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

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of 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) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Phenerzine-Elixir-Recall-Alert-20Download

Recall Alert; Drug Product: Faasgablin 75mg Capsules (Batch # 2210C001) by M/s FAAS Pharmaceuticals (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts

Recall Alert

DRAP Alert NoNoII/S/07-22-19
Action Date28th July, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions
3. General Public
Product(s) Affected Faasgablin 75mg capsules,
Company: M/s FAAS Pharmaceuticals (Pvt) Ltd., Karachi
Batch No. 2210C001
Manufacturing Date: January-2022,
Expiry Date: January-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Faasgablin 75mg capsules bearing Batch No. 2210C001 and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch(s) of product to the company.

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

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of 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) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Faasgablin-capsules-Recall-Alert-19Download

Draft amendments in rules framed under Drug Act 1976 (for comments within 7 days of publication of SRO).

Ijaz Mustafa SROs

S.R.O 1084(I)/2022 (Amendments in drugs (Appellate Board) rules 1976)

S.R.O_1084_of_2022Download

S.R.O 1085(I)/2022 (Amendments in drugs (Import and Export) rules 1976)

S.R.O_1085_of_2022Download

S.R.O 1086(I)2022 (Amendments in drugs (Federal Inspectors, Federal Drug Laboratory, Federal Government Analysts)) rules 1976

S.R.O_1086_of_2022Download

S.R.O 1087(I)/2022(Amendments in drugs (Licensing, Registering, Advertising) rules 1976)

S.R.O_1087_of_2022Download

DRAP invites comments of stakeholders on the draft Guidelines on Good Distribution Practices for Pharmaceutical and Biological Products

Ijaz Mustafa Drugs, Publications, Regulatory Updates ,

Distribution of drug products includes all activities consisting of procuring, storage / holding, supplying, importing, and / or exporting of products. Such activities are carried out by the marketing authorization /registration holder including manufacturers/importers or their authorized distributors, which supply products to the pharmacies/licensed drug sale outlets and healthcare institutions which are entitled to dispense drug products.

Good Distribution Practice (GDP) is the set of standards of quality assurance for sourcing, handling, storage, and transportation of pharmaceutical and biological drug products under appropriate conditions, as required by the marketing authorization (MA) / registrant, or product specifications. To maintain the quality of pharmaceutical and biological products, every activity in the supply chain and distribution network should be carried out according to the principles of Good Distribution and Storage Practices.

These guidelines are drafted to provide appropriate systems and structures to assist manufacturers, distributors and wholesalers in fulfilling their responsibilities of planning and conducting various activities in the distribution and supply chain, which will be helpful in prevention of proliferation of unauthorized/unregistered, substandard and falsified products in the market.

This draft guideline is uploaded on the official website of DRAP dated 28th May, 2022, 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 prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at akbar.ali∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click to view the draft Guidelines-on-Good-Distribution-PracticesDownload