The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 64th meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.
Important Notice to INGOs, NGOs, Hospitals and Government Programs/Departments Importers of Donated Drugs in Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) and the Pakistan Single Window (PSW) have implemented an automated clearance system for the importation of donated drugs in Pakistan. This system aims to optimize and expedite the efficiency of the pharmaceutical supply chain in Pakistan and ensure a seamless and transparent delivery of donated drugs.
PSW Subscription Required for Donated Drugs Importation in Pakistan
To participate in this system, all registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs importation need to acquire their PSW Subscription promptly.
The PSW Subscription is a pivotal step in ensuring a smooth and sustainable pharmaceutical supply chain in Pakistan. Your subscription significantly contributes to the optimization of drug distribution, allowing us to collectively make a more substantial impact on public health.
How to Subscribe in 6 Easy Steps:
- Visit the PSW website to access detailed instructions, user manuals, and demo videos.
- Follow the straightforward subscription process and complete your subscription efficiently.
- If you have any questions or require assistance during the subscription process, contact the PSW Support team at 021-111-111-779 or reach out via email at support∂psw.gov.pk.
Prequalification of companies/ firms/ suppliers for supply of chemicals and glassware etc. to CDL Karachi
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 2022 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
DRAP invites all interested parties, including sponsors, investigators, ethics committees, contract research organizations, and other relevant entities, to provide their comments and inputs on the revision of the guideline. 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.
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.babar∂dra.gov.pk with copy to mahvash.ansari∂dra.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.lic∂dra.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 info∂dra.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.
Rapid Alert: Falsified Products identified and Confiscated by the Regulatory Field Force of Punjab
Rapid Alert
| DRAP Alert No | No I/S/02-24-07 |
| Action Date | 16th Feb, 2024 |
| Target Audience | 1. Regulatory Field Force. 2. Therapeutic Goods industry 3. Manufactures of Oral liquid preparations 4. Healthcare professionals |
| Problem Statement | The regulatory field force of Punjab has identified suspected samples of the following product in the market and sent them for analysis in the Drug Testing Laboratories. The Government Analyst has reported that these three products are falsified/spurious. The labelled stated manufacturer has informed that these samples are not manufactured and supplied by themselves in the market. |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No | Manufacturer (as per label) | |
| Duphaston 10mg Tablet | Dydrogesterone 10mg | 223298 | M/s. Highnoon Laboratories Ltd, 17-Km Multan Road, Lahore. |
| Femara 2.5mg Tablet | Letrozole 2.5mg | TTT60 | M/s. Novartis Pharma Stein AG SCHAFFHAUSERSTRASSE |
| Oxidil 1g Inj | Ceftriaxone 1g | 050K | M/s Healthtek Pvt Ltd, Karachi |
| Threat to Public Health | The use of these falsified products will result in the ineffective treatment of patients. Moreover, the safety and quality of the falsified products referenced in this alert are also unknown. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. 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 to halt the distribution/supply of this product. Information related to the supplier of these product’s batches should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 not use products bearing these batches and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product, 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. |
Tender for supply of chemicals, glassware, equipment and reference standards for National Control Laboratory for Biologicals (Retender)
Rapid Alert: Contaminated Propylne Glycol (Batch # 1P03-202308194) Allegedly Produced By M/s. Shinghwa Amperex Technology (Dongying), China.
Rapid Alert
| DRAP Alert No | No I/S/02-24-06 |
| Action Date | 13th Feb, 2024 |
| Target Audience | 1. Regulatory Field Force. 2. Therapeutic Goods industry 3. Manufactures of Oral liquid preparations 4. Healthcare professionals |
| Problem Statement | Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. RM-1-24-000027 dated 31-01-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by M/s. Biolabs (Pvt.) Ltd., Islamabad in compliance to letter vide No. 03-41/2023-QC dated 01-12-2023. Details of test/analysis report are given as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No | Mfg Date | Exp. Date | Manufacturer (as per label) | Remarks |
| Propylene Glycol (Raw Material) | 1P03-202308194 | 26-08-2023 | 25-08-2025 | M/s. Shinghwa Amperex Technology (Dongying) Co. Ltd., China. | The sample is declared substandard for unacceptable levels of Ethylene Glycol (EG) and Diethylene Glycol. |
| Risk Statement | Di-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences. |
| Action Initiated | The Regulatory Field Force has directed to take necessary action on above mentioned contaminated batch of Propylene Glycol and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market. |
| Advice for Therapeutic Goods Manufacturers | Manufacturers of therapeutic goods are required to follow these instructions: 1. Recall Products: If any batch was manufactured using the same lot (1P03-202308194) of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled. 2. Hold Other Batches: All finished products manufactured from any other lot of propylene glycol of M/s. Shinghwa Amperex Technology (Dongying) Co. Ltd., China should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain. 3. Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. 4. Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination. 5. Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. 6. Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products. Before their release into the market, all finished products should be analyzed for EG/DEG contamination. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and 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. |