Comments are invited on revision of Guidelines on Inspection of Good Clinical Practices for Clinical Trials
The Drug Regulatory Authority of Pakistan (DRAP) is planning to revise its guideline for the conduct of Good Clinical Practice (GCP) inspection and reporting. The current guideline was issued in Maech-2024 and provides the procedure and criteria for GCP inspections of clinical trials regulated by DRAP.
The revision aims to update the guideline in accordance with the latest international standards and best practices, as well as to address the feedback and suggestions received from the stakeholders. The revised guideline will cover the following aspects:
- The objectives and scope of GCP inspections
- The preparation and planning of GCP inspections
- The conduct and documentation of GCP inspections
- The follow-up and closure of GCP inspections
The revised guidelines are open for public comments until June 05, 2025. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. 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 shafqat.hussain∂dra.gov.pk with copy to dir.ps∂dra.gov.pk or can be posted at following mailing address: Assistant Director (Clinical Research), Pharmacy Services Division, Drug Regulatory Authority of Pakistan, DRAP-NCLB Building, Prime Minister’s Health Complex, Park Road, Chak Shahzad, Islamabad, Pakistan. DRAP appreciates your participation and contribution to this consultation process. Your comments and inputs will help us to improve the quality and effectiveness of our GCP inspection and reporting system
Minutes of the 346th Meeting of the Registration Board Held on 22nd April, 2025
The Drug Registration Board convened its 346th meeting on 22nd April, 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: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS
Rapid Alert
| DRAP Alert No | No I/S/05-25-41 |
| Action Date | 13th May, 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 Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No | Manufacturer Name (as per label) | Remarks |
| Duphaston Tablet Each film coated tablet contains: Dydrogesterone…10mg | 241476 | M/s Highnoon Laboratories Ltd., 17.5 Km, Multan Road, Lahore. | ‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976. |
| Calamox Tablet Each film coated tablet contains: Amoxicillin Trihydrate eq. to Amoxicillin….875mg Clavulanate potassium eq. to Clavulanic acid…125mg | C240712 | M/s Bosch Pharmaceuticals (Pvt.) Ltd., 221-223, Sector 23, Korangi Industrial Area, Karachi. | ‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976. |
| Zamclo Tablet Each enteric coated tablet contains: Diclofenac sodium…..50mg | ZC-0023 | M/s Zamko Pharmaceuticals (Pvt) Ltd., 641-A, Sundar Industrial Estate, Lahore. | ‘Spurious’ as per Section 3(z-b) (ii)of the Drugs Act, 1976. |
| Risk Statement | Falsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. 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. |
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.
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. |