DRAP issued Guidelines for Public Health Programs (PHPs) to promote Pharmacovigilance activities and enhancing collaboration with National Pharmacovigilance Centre, DRAP.
Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of drugs, vaccines and other therapeutic goods. Reporting of Adverse Events associated with the use of therapeutic goods exclusively being used by PHPs is essential to a pharmacovigilance system.
The key objectives of pharmacovigilance activities in public health programs are:-
- To improve public health and safety in relation to the use of therapeutic goods in PHPs;
- To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
- To encourage the safe, rational and more effective use of therapeutic goods.
This guideline will assist the Public Health Programs (PHPs) for enhancement of pharmacovigilance activities, and provide a guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.
DRAP published the draft of this guidelines on its website on 23rd April, 2022 inviting the comments of stakeholders on the draft. After through consultation and careful consideration, fist edition of the guidelines on the pharmacovigilance activities in the public health programs are finalized. Nevertheless, anyone can still furnish his/her comments on the guidelines using our comments submissions methods for consideration in the future editions of the document.
Please click to view the document, GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES
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.
Rapid Alert: PRESENCE OF FALSIFIED INJECTION RHOPHYLAC 300MCG, HUMAN ANTI-D IMMUNOGLOBULIN PURPORTEDLY MANUFACTURED BY M/S. CSL BEHRING AG, SWITZERLAND
Rapid Alert
| DRAP Alert No | No I/S/04-25-38 |
| Action Date | 30th April, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Directorate of Drugs Control Punjab (DDCP), vide Alert No. 169/2025, has notified DRAP regarding the presence of falsified Rhophylac 300mcg Injection in the market across Pakistan. Details of the identified product are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No | Purported Manufacturer | Remarks |
| Injection Rhophylac 300, Human Anti-D Immunoglobulin | P100669751 | M/s CSL Behring Switzerland, Wankdorfstrasse 10, CH-3000 Bern 22,Switzerland. | ‘Spurious’ as per Drugs Act 1976, section 3(z-b) (ii) and ‘Substandard’ on the basis of sterility test. |
| Risk Statement | The Anti-D immunoglobulin is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified products. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |