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Comments are invited on revision of Guidelines on Inspection of Good Clinical Practices for Clinical Trials

Abdul Qadir 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

Draft-GCP-Inspection-Guidelines-3rd-Edition-21-05-25-Download

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.