DRAP invited Stakeholders Comments on revision of Guidelines on Recall of Defective Therapeutic Goods

The Drug Regulatory Authority of Pakistan (DRAP) is revising the Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods, which were first published in 2021. The revision is based on the feedback from stakeholders and the recommendations from the World Health Organization (WHO).

The guidelines provide a comprehensive framework for reporting, investigating, and recalling suspected defective therapeutic goods products and applies to the therapeutic goods industry and supply chain, healthcare professionals, patients, sponsors of clinical trials, and regulatory staff. The guidelines aim to provide recommendations and explain the procedures to be adopted by the DRAP and the Pharmaceutical Industry for the effective removal of defective therapeutic goods from the market that may cause harm to the consumer and to safeguard public health.

By adhering to these guidelines, the licensees and the DRAP can ensure a timely, coordinated, and transparent response to any defective therapeutic goods incidents, and thus protect the health and safety of the public and the animals.

The main objectives of the revision are to:

  • Update the procedures for recalls and related actions for defective therapeutic goods
  • Adopt a uniform and consistent approach to conducting recalls in Pakistan
  • Incorporate the best practices and lessons learned from the consultative workshop on recalls and rapid alerts held by DRAP
  • Enhance the communication and coordination among the manufacturers, importers, suppliers, and DRAP in conducting recalls
  • Strengthen the monitoring and evaluation of the recall outcomes and follow-up actions

We invite all stakeholders to review the draft revised guidelines and provide us with your comments and suggestions . This draft guideline is available for comments from 21-02-2024. 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 sanaullah.babardra.gov.pk with copy to mahvash.ansaridra.gov.pk or can be posted at following mailing address: Deputy Director, Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Stakeholders are invited to submit their comments on Draft Guidance on Establishment of Pharmaceutical Unit and Post License Changes (2nd edition)

The Drug Regulatory Authority of Pakistan (DRAP) is inviting stakeholder comments on the revised guidance document: “Establishment of Pharmaceutical Unit and Post License Changes”. This document aims to simplify and clarify the regulatory procedures for applicants and firms seeking to acquire, renew, or modify their Drug Manufacturing Licenses (DMLs).

Features of Revised Edition of the Guidance Document

This document provides a clear and concise overview of the entire licensing process, from initial application to post-license modifications.

The guidance document outlines the steps involved in obtaining a DML, including site selection, application forms, fee payment, and inspections. This aims to make the process more efficient and transparent for applicants.

Who Benefits

Applicants: This guideline serves as a valuable resource for pharmaceutical companies, entrepreneurs, and individuals seeking to establish or expand their drug manufacturing operations in Pakistan.

Firms: Existing DML holders can utilize this document to understand their responsibilities and procedures for post-license changes and renewals.

Investors: The streamlined process outlined in the guideline can create a more attractive investment climate for the pharmaceutical industry in Pakistan.

To access the full DRAP guidance document, please Click on “Establishment of Pharmaceutical Unit and Post License Changes”.

The revised guidelines are open for public comments until March 7, 2024. DRAP invites all the relevant stakeholders, such as pharmaceutical companies 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 dir.licdra.gov.pk or can be posted at mailing address, Director, Division of Drug Licensing, 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.

DRAP added New features in eAPP system enabling Online Submission for all types of Registration Applications of Drug Products

The Drug Regulatory Authority of Pakistan (DRAP) added a new e-service for online regulatory data submission for registration/marketing authorization of human drugs for local manufacturing, import and export. This e-service complements the existing one for licensing operations of all pharmaceutical and biological manufacturers, which are both accessible through the same platform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan, which aims to ensure the quality, safety and efficacy of therapeutic goods in Pakistan.

The e-service requires applicants to submit their data in a standardized format, as specified in the following type of submission:

  • Registration of Drugs on Form-5F for human Use.
  • Registration of Drugs on Form-5 & Form 5A for Veterinary Use.
  • Application for Post Registration Variations.
  • Renewal for Registration of Drugs

The new e-service allows applicants to submit their data electronically through the eAPP portal, which can be accessed after registering an account with DRAP. The e-service offers several benefits, such as:

  • Faster and easier data submission and processing
  • Reduced paper work and redundancy
  • Increased transparency and visibility

This new e-service will facilitate the licensing and registration process and improve the regulatory system in Pakistan. DRAP will reach out to applicants in assisting application submission on this new eService.

We welcome your feedback and suggestions on how to improve our services. Please contact us at infodra.gov.pk or +92 51 9260 500 for any queries or assistance.

We hope that these new features will further enhance the efficiency and convenience of our e-service and facilitate the development and availability of quality therapeutic goods in Pakistan.

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

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 February 22, 2024. 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.hussaindra.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.


Warning To Therapeutic Goods Manufactures on DEG/EG Impurities in Raw Materials: A Serious Threat to Therapeutic Goods Quality and Safety

The Drug Regulatory Authority of Pakistan (DRAP) has issued a warning to the therapeutic goods industry about the use of raw material contaminated with diethylene glycol (DEG) and ethylene glycol (EG) impurities, which can pose serious health risks to consumers.

What is the issue?

The Central Drugs Laboratory Karachi has declared another sample of raw material i.e. propylene glycol (PG) as substandard sent for test/analysis due to unacceptable levels of ethylene glycol.

Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations in the pharmaceutical and alternative medicines industry. When used in oral liquid preparations, these solvents can lead to serious health risks due to DEG and EG toxicity. When ingested, DEG and EG are metabolized into toxic metabolites that can affect the central nervous system, heart, and can cause kidney damage, which can be fatal.

In the past two years, there have been international reports related to the adulteration of these raw materials with DEG and EG causing kidney damage and death of children in Gambia, Uzbekistan, and Indonesia. Industrial grade DEG and EG are used for various applications (solvents, antifreeze agent) in other industries.

Earlier, several cases of substandard raw materials including PG and finished goods contaminated with DEG and EG have been reported from various part where investigations have suggested that the main problem lies with the integrity of supply chain of raw material which appears to be compromised. Consequently, action has been initiated against the culprits involved.

What are the actions taken by DRAP?

Despite repeated warnings and instructions, many therapeutic goods manufacturers have neglected to verify the quality and safety of their raw materials from authorized vendors. The Central Drug Laboratory, Karachi is currently analyzing both raw materials and finished products for EG and DEG contamination, following the pharmacopoeial standards and WHO guidelines for testing of EG and DEG in oral liquid preparations. To ensure the quality and safety of their products, manufacturers should test their raw materials for EG and DEG contamination before using them in their production processes to prohibit potential influx of contaminated products in the market.

In view of the criticality of the matter and potential for untold human tragedy, the therapeutic goods industry is once again warned to screen raw materials (propylene glycol, glycerin and sorbitol) for contamination with EG and DEG before using these materials in the manufacturing of oral liquid preparations. Additionally, all finished products must be analyzed for EG and DEG contamination before their release into the market. DRAP also issued directives to nutraceutical and alternative medicine companies to ensure compliance and safeguard public health from contaminated products. Additionally, the industry is diected to recall any finished products that were manufactured using the contaminated lot/batch of propylene glycol, hold the affected batches of finished products and ensure testing of finished products for EG and DEG contamination before releasing them into the supply chain.

DRAP urge pharma industry to take measures to prevent utilization of contaminated raw material in the manufacturing of liquid preparation including following:-

  • Implement a supplier qualification and verify the compliance of the suppliers with the relevant standards and regulations.
  • Verify traceability and authenticity of the raw material using unique identifiers such as barcodes or RFID tags to track their movement and origin throughout the supply chain.
  • Conduct regular risk assessments and monitor the performance of the suppliers, and take corrective actions if any issues are detected.
  • Educate and train the staff and the suppliers on the importance of preventing EG and DEG contamination, and the potential consequences of using contaminated solvents.
  • Verify the features that indicate the authenticity of the product, such as holograms, serial numbers, watermarks, or special packaging. The products should also be checked for any signs of poor printing, misspellings, inconsistent logos, tamper-evident seals or sturdy wrapping materials.

DRAP is committed to ensure the safety and quality of therapeutic goods in Pakistan, and protecting the public from substandard and falsified products.

Registration Board Direction; Procedure for Capacity Assessment of the Contract Acceptor

Registration Board in its 333rd meeting held on 19th – 20th December, 2023 discussed the subject mentioned case and decided as under: –

1.         Inspection of contract accepter for manufacturing / testing capacity assessment shall be conducted for all those contract manufacturers, who has not been inspected for such purpose with in the last 3 years. The panel shall verify capacity assessment of all those sections, which are approved by the Licensing Division.

2.         Capacity assessment of newly applied facility (Section) shall not be carried out, if any section of that manufacturing facility has already been assessed within last three years.

3.         Following shall be prerequisites for submission of application for contract manufacturing under Rule 20(A) of Contract Manufacturing Policy.

a.         Affidavit on stamp paper (Showing name, designation, CNIC Number of contract giver) stating installed capacity of the contract accepter for contract manufacturing. This affidavit shall only be signed by the CEO / MD of the firm. i.e. contract accepter.

b.         Copy of DML of both firms. i.e. contract giver and contract accepter along with Section (s) approval from Licensing Division.

c.         Valid GMP certificate or GMP inspection report of the contract accepter, conducted within last three years.

d.         Copy of legalized contract between contract giver and contract accepter on stamp paper presenting the capacities of the contract accepter for the manufacturing sections for whom the products have been applied, and

4.         Affidavits submitted by the contract accepter, showing manufacturing / testing capacity, will be verified in the subsequent inspections conducted for GMP / renewal of DML and will be reported accordingly. Chairman, Registration Board may constitute panel of experts to verify capacity assessment, if required.

5.         The capacity verification report will be valid for 3 years.

Guidelines on Standards for Establishment of Hospital Pharmacies is now open for comments.

Drug Regulatory Authority of Pakistan is seeking feedback on proposed guidelines for hospital pharmacies. These standards aim to ensure consistent, high-quality pharmacy services across all hospitals, ultimately benefiting patients and the healthcare system as a whole.

The guidelines cover four key areas:

  1. Hospital Pharmacy Operations which include aspects like organizational structure, staffing, resources, policies, and procedures for managing medications from procurement and storage to dispensing and monitoring.
  2. Medicine Use Management where the focus is on optimizing medication use within the hospital. This involves procedures for medication reconciliation, identifying potential issues, and implementing strategies to improve medication effectiveness and avoid medication-related harm.
  3. Quality Improvement with the believe in continuous improvement! These guidelines outline practices for assessing the effectiveness of hospital pharmacy services, identifying areas for improvement, and implementing corrective actions.
  4. Human Resources Development for ensuring a competent and skilled pharmacy workforce is crucial. The guidelines address training and development programs for all pharmacy personnel, from pharmacists to technicians.

DRAP invites you to review the proposed guidelines and share your thoughts and suggestions. Your input will be invaluable in shaping the final document and ensuring it reflects the needs and expectations of patients, healthcare professionals, and the community.

These guidelines were uploaded on the official website of DRAP on 12th of January, 2024 for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to dir.psdra.gov.pk, copying aqsa.hashmidra.gov.pk, or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP’s Pharmacovigilance Newsletter (December, 2023 ; Issue-II)

The Pharmacovigilance Newsletter is a quarterly publication that aims to inform and educate the healthcare professionals and the public about the importance of pharmacovigilance and adverse drug reaction reporting. It also showcases the activities of the National Pharmacovigilance Centre (NPC) and initiatives taken by the NPC for monitoring and evaluating the safety of medicines in Pakistan.

We are pleased to announce that the second issue of the Pharmacovigilance Newsletter (Dec-2023) is now available for download from our website. This issue covers the latest updates on the safety of medicinal products and regulatory actions taken by the Drug Regulatory Authority of Pakistan (DRAP) and other international authorities.

We hope that you will find the newsletter informative and useful. We welcome your feedback and suggestions for improvement. You can contact us at npcdrap.gov.pk or call us at +92-51-9255980. Thank you for your interest and support in pharmacovigilance.

Together, we can ensure the safe and effective use of medicines in Pakistan.