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Stakeholders Comments are invited on revision of Guidelines for Conduct of Clinical Research in Pakistan

Abdul Qadir Clinical Trials, Uncategorized

The Drug Regulatory Authority of Pakistan (DRAP) is revising Guidelines on Conduct of Clinical Trials in Pakistan with the aim to ensure the safety, quality, and efficacy of investigational products in clinical trials, as well as the ethical conduct and oversight of clinical research in Pakistan.

The revised guidelines cover various aspects of clinical trial activities, such as:

  • The regulatory framework and approval process for clinical trials in Pakistan
  • The roles and responsibilities of various stakeholders involved in clinical trial activities, such as DRAP, National Bio Ethics Committee, sponsors, investigators, and pharmaceutical associations
  • The requirements and procedures for obtaining informed consent, protecting the rights and welfare of trial participants, and reporting adverse events and serious adverse events
  • The standards and principles for designing, conducting, monitoring, recording, analyzing, and reporting clinical trials
  • The good clinical practice (GCP) requirements for clinical trial materials and investigational products
  • The data management and quality assurance systems for clinical trial data and documents
  • The post-trial obligations and follow-up measures for clinical trial sponsors and investigators

The revised guidelines are based on the best regulatory practices as per the International Council for Harmonisation (ICH) guidelines, and the World Health Organization (WHO) guidelines.

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 using prescribed format (click here to visit how to submit comments) via email to shafqat.hussain∂dra.gov.pk or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.

DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan.

Draft-Guidelines-to-Conduct-of-Clinical-Research-in-Pakistan-12-05-2025-3rd-Revision-2Download

Rapid Alert: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS

Ahsan Hafiz Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/05-25-41
Action Date13th May, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDirectorate 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		241476M/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		C240712M/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-0023M/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 StatementFalsified 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 InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

Recall Alert: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

Ahsan Hafiz Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/04-25-40
Action Date22nd 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 NamesCompositionBatch DetailsManufactured byTest Results
Atopin Injection

For Veterinary use only
 
Reg. No. 062122		Each ml contains: Atropine Sulphate..…..1mg (50mL)376.ATPM/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 InitiatedThe 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 VeterinariansDRAP 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/ConsumersFarmers/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

    Ahsan Hafiz Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/04-25-39
    Action Date29th 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 NamesCompositionBatch DetailsManufactured byTest Results
    Ame-pin Injection

     
    Reg. No. 065943    		Each 2ml contains: Tramadol hydrochloride.…100mgTD-039M/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 Lactate25B097M/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-044M/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 ProfessionalsDRAP 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

      Muhammad Ayub Naveed Registration Board

      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.

      Minutes-of-345th-Meeting-of-Registration-BoardDownload