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Stakeholders are invited to submit their comments on Draft Guidance on Establishment of Pharmaceutical Unit and Post License Changes (2nd edition)

Mughees Mudassir Drugs, Licensing and Inspections ,

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.

Establishment of pharmaceutical units and post licensure changesDownload

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

Ijaz Mustafa Drugs, General

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.

E-APP-Circular-DRAPDownload

Rapid Alert: Falsified Products identified and Confiscated by the Regulatory Field Force of Punjab

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/02-24-07
Action Date16th Feb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementThe 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:-

ProductBatch NoManufacturer
(as per label)
Duphaston 10mg Tablet
Dydrogesterone 10mg223298M/s. Highnoon Laboratories Ltd, 17-Km Multan Road, Lahore.
Femara 2.5mg TabletLetrozole 2.5mgTTT60M/s. Novartis Pharma Stein AG SCHAFFHAUSERSTRASSE
Oxidil 1g InjCeftriaxone 1g050KM/s Healthtek Pvt Ltd, Karachi
Threat to Public HealthThe 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 InitiatedThe 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 ConsumersConsumers 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.

Rapid Alert: Contaminated Propylne Glycol (Batch # 1P03-202308194) Allegedly Produced By M/s. Shinghwa Amperex Technology (Dongying), China.

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/02-24-06
Action Date13th Feb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementFederal 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:-

ProductBatch NoMfg DateExp. DateManufacturer
(as per label)		Remarks
Propylene Glycol
(Raw Material)		1P03-20230819426-08-202325-08-2025M/s. Shinghwa Amperex Technology
(Dongying) Co. Ltd., China.		The sample is declared substandard
for unacceptable levels of
Ethylene Glycol (EG) and Diethylene Glycol.
Risk StatementDi-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 InitiatedThe 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 ManufacturersManufacturers 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

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

Asad Ullah Clinical Trials, Drugs

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.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-for-Conduct-of-Clinical-Research-in-Pakistan_06_02_24_AmendedDownload

Rapid Alert: Contaminated Glycerin (Batch # 1A2192K) Allegedly Produced By M/S KLM Palm Oleo BHD, Malaysia

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Rapid Alert

DRAP Alert NoNo  I/S/02-24-03
Action Date01stFeb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementMs. Cibex Private Limited Pharmaceuticals, Karachi sent the sample of Glycerin to Central Drugs Laboratory Karachi for test/analysis that was used as a solvent in the manufacturing of oral liquid preparations. The batch was labelled as manufactured by Ms. KLK PALM OLEO SDN BHD, Malaysia. However, on analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of Ethylene Glycol was found. The details of the affected batch are as under:-

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoMfg DateExp. DateManufacturer
(as per label)		Remarks
Glycerin
(Raw Material)		IA2192K06-10-2205-10-24KLK Palm Oleo SDN BHD,
Malaysia		The sample is declared substandard
for unacceptable levels (0.1662%) of
Ethylene Glycol (EG)..
Risk StatementGlycerin contaminated with Ethylene Glycol (EG) when used in oral liquid preparations can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal..
Action InitiatedThe Regulatory Field Force has directed to take necessary action on above mentioned contaminated batch of Glycerin 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 Glycerin. DRAP has directed the therapeutic industry to ensure the testing of this lot or any other lot of raw material prior to use in manufacturing of finished products.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1. Recall Products: If any batch was manufactured using the same lot (1A2192K) of glycerin 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 glycerin of Ms. KLK PALM OLEO SDN BHD, Malaysia should be held. 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.
Advice for Healthcare ProfessionalsDRAP 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 ConsumersConsumers 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.

Recall Alert: Drug Product; Recall of Contaminated Liquid Preparations

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/01-24-05
Action Date30th January 2024
Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
· General Public
Problem / Issue Government Analyst DTL Bahawalpur and DTL Rawalpindi have informed that following products are found to be of “sub-standard” quality due to presence of Ethylene Glycol (EG) impurity at unacceptable levels. Details of affected products is provided in table below.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No ManufacturerTest Results
Asthanil 60ml Syp
Ketotifen 1mg/5ml03-23M/s. Siza International (Pvt.) Ltd
18-Km Ferozpur Road, Lahore.		Ethylene Glycol: 2.896%
Does not comply
Virol Syrup
Ribavirin 5mg/5ml35080M/s. Raazee Therapeutics (Pvt.) Ltd.,
48-Km Lahore-Kasur Road, Lahore.		Ethylene Glycol: 3.31%
Does not comply
Torax DM Syrup
Dextromethorphan HBr 12.5mg & Diphenhydramine HCl 12.5mg110-23M/s. Siza International (Pvt.) Ltd.,
18-Km Ferozpur Road, Lahore.		Ethylene Glycol: 2.14%
Does not comply
Texcol EX Syrup
Acefylline Piperazine 45mg, Diphenhydramine HCl 8mg63833M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore.Ethylene Glycol: 0.985%
Does not comply
Texcol DM Syrup
Dextromethorphan HBr 10mg/5ml09953M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore.Ethylene Glycol: 1.19%
Does not comply
Allerphene Syrup
Chloepheniramine Maleate 2mg/5ml3002M/s. PDH Pharmaceuticals (Pvt.) Ltd., 19-Km Ferozpur Road, Lahore.Ethylene Glycol: 1.417%
Does not comply
Speczine Syrup
Promethazine HCl 5mg/5ml276M/s. Spectrum Laboratories (Pvt.) Ltd., 8-Km Raiwind Road, Lahore.Ethylene Glycol: 2.43%
Does not comply
Bronyl syrup


Nutraceutical cough preparationBL-013M/s. Florex Pharma Pvt Ltd, 25-Km Lahore-Jaranwala Road, Sheikhupura-Lahore.Ethylene Glycol: 0.12%
Does not comply
Action Initiated-All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).

-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 through phone at +92 51 910 73 17, 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 this 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.