Month: May 2025
Minutes of 302nd Meeting of the Central Licensing Board held on 20th November, 2024
Tender Notice for Supply & Installation of Air Conditioners, Led Tv, Multimedia Screens and Projector in DRAP HQ
Recall Alert: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES
Recall Alert
| DRAP Alert No | No I/S/04-25-40 |
| Action Date | 22nd April, 2025. |
| Target Audience | – National Regulatory Field Force of DRAP and Provincial Drug Control Departments – Healthcare Professionals – Veterinarians – Farmers/consumers |
| Problem / Issue | Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by | Test Results |
|---|---|---|---|---|
| Atopin Injection For Veterinary use only Reg. No. 062122 | Each ml contains: Atropine Sulphate..…..1mg (50mL) | 376.ATP | M/s Symans Pharmaceuticals (Pvt) Ltd., 10Km, Sheikhupura Road, Lahore. | ‘Substandard’ on the basis of Bacterial Endotoxin Test. |
| Risk Statement: | Failure of the Bacterial Endotoxin Test (BET) for an injectable product may result in the release of a product with pyrogenic contamination. This may pose a significant risk of febrile reactions, endotoxic shock, or other serious adverse effects in animals. |
| Action Initiated | The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batch of the product from the market. |
| Advice for Veterinarians | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link. |
| Advice for Farmers/Consumers | Farmers/consumers should not use this product. They shall contact their veterinarians or healthcare provider(s) if the animal experienced any problem that may be related to using this product. |
Recall Alert: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES
Recall Alert
| DRAP Alert No | No I/S/04-25-39 |
| Action Date | 29th April, 2025. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by | Test Results |
|---|---|---|---|---|
| Ame-pin Injection Reg. No. 065943 | Each 2ml contains: Tramadol hydrochloride.…100mg | TD-039 | M/s. Ameer Pharma (Pvt) Ltd, 23 Km, Sheikhupura Road, Lahore. | ‘Substandard’ on the basis of visible particles as per BP. |
| GEE-Sol RL 1000mL Infusion Reg. No. 081437 | Compound Sodium Lactate | 25B097 | M/s Gallop Water Sciences, 404-Sundar Industrial Estate, Lahore. | ‘Substandard’ on the basis of Bacterial Endotoxin Test. |
| Rudazole Infusion Reg. No. 076911 | Each 100ml vial contains: Metronidazole….500mg | RD-044 | M/s Rukha Pharmaceutical & Laboratories (Pvt) Ltd., 537-D&E, Sundar Industrial Estate, Lahore. | ‘Substandard’ on the basis of Bacterial Endotoxin Test. |
| Risk Statement: | The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population. |
| Action Initiated | – The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –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 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 to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 these 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 using this product. -All therapeutic 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. |
Minutes of the 345th Meeting of the Registration Board Held on 19th to 21st February, 2025
The Drug Registration Board convened its 345th meeting on 19th to 21st February, 2025 in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.