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Recall Alert: Drug Product; Water for Injection (Batch #M21421) by M/s. Vision Pharmaceuticals (Pvt.) Ltd., Islamabad.

Asad Ullah Recall Alerts

Recall Alert

DRAP Alert NoN0 I/S/06-22-16
Action Date14th June, 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 Water for Injection,
Company: M/s. Vision Pharmaceuticals (Pvt.) Ltd., Islamabad
Drug Registration No. 081230
Batch No. M21421,
Manufacturing Date: December-2021,
Expiry Date: November-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the Water for injection bearing Batch No. M21421 4A20B27 and declared it as Substandard. The company has been directed to recall the affected batch of product from the market including pharmacies as well as the distribution setups operating in the country.
Action to be takenAll Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of the product(s) to the firm. Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP 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.
Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

If anyone has used this counterfeit product, or if anyone suffers from an adverse reaction/event after having used this product, it is advised to seek immediate medical attention from a qualified healthcare professional, and to report the incident to National Pharmacovigilance Centre, DRAP using this link.

All drug products must be obtained from authorized licensed sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.
Recall Alert for Substandard Water for Injection by M/s Vision Pharmaceutical IslamabadDownload

Decisions of 47th meeting of Medical Device Board Meeting; Deficiency letter

Asad Ullah Medical Devices, Medical Devices Board

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 47th meeting has deferred the 271 applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board, in the below attachment.

List-Deferred-Cases-of-MDB-47-Meeting

Voluntary Recall Alert: Drug Product; Meronem 1g Injection (Batch #4A20B27 and Batch # 4A21D29) by M/S. Pfizer Pakistan Limited, Karachi

Asad Ullah Recall Alerts

Voluntary Recall Alert

DRAP Alert NoN0 I/V/ 15-22-05
Action Date18th May, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Processionals- Physicians, Pharmacists and Nurses at hospitals and clinics
3. General Public
Products Affected Meronem 1g Injection (Intravenous) ,
Batch No. 4A20B27, Expiry Date: August-2022
4A21D29, Expiry Date: December-2023
Problem StatementM/s. Pfizer Pakistan Limited, Karachi has confirmed from their own sources that there is counterfeit Meronem 1gm Injection bearing Batch No. 4A20B27 and 4A21D29, in the market with similar packaging and appearance of their registered product. Due to this, M/s Pfizer Pakistan Limited has initiated a nation wide voluntary recall of 02 batches of their registered product of same batch numbers from the market up to pharmacies and distribution level. Company may be contacted at M/s Pfizer Pakistan Limited, B-2, S.I.T.E, Karachi-75700, Ph +92 (21) 32570621-5
Action to be takenAll Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batches of Meronem 1g injections to the firm, company is also communicating distributors through this letter. Distributors and pharmacies are advised to be vigilant and report any suspected product(s) to the DRAP. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance to ensure the integrity of supply chain.
Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

If anyone has used this counterfeit product, or if anyone suffer an adverse reaction/event having used this product batch, it is advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to Drug Regulatory Authority of Pakistan/National Pharmacovigilance Centre using this link.

All drug products must be obtained from authorized licensed sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.
Meronem-1gm-inj-Recall-Alert-dated-18-05-22Download

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

National Pharmacovigilance Centre, DRAP holds one-day training session for Healthcare Professionals in collaboration with regional centre.

Asad Ullah Events, Uncategorized
National Pharmacovigilance Centre, DRAP holds one-day training session for Healthcare Professionals in collaboration with regional centre.


National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan (DRAP) in collaboration with Islamabad Pharmacovigilance Centre and Shifa
International Hospital, Islamabad conducted a one-day pharmacovigilance training session on 19th of May, 2022. Director and Deputy Director Pharmacy Services Division, Team Lead Vigilance and Focal Persons of National Pharmacovigilance Centre and Islamabad Pharmacovigilance Centre attended the training session.

Pharmacovigilance focal persons of public and private sector hospitals of Islamabad were trained on ADRs reporting as per Pharmacovigilance Rules, 2022. Hands-on training on collecting and filling in ADRs reporting forms and subsequent causality assessment was provided to the participants. The training was concluded with the hope of arranging further such sessions in the future.

Islamabad 19th May, 2022: One-day training session on pharmacovigilance activities for healthcare professional conducted by National Pharmacovigilance Centre, DRAP, Islamabad in collaboration with regional pharmacovigilance centre, Islamabad