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Rapid Alert: Falsified Propylene Glycol in Supply Chain Market

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo  II/S/08-24-29
Action Date22nd August 2024
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control Administrations
2. Therapeutic Goods Manufacturers
Problem StatementDow Chemical’s Singapore and the Incidents and Substandard/Falsified Medical Products (ISF) Regulation and Safety Unit, World Health Organization have informed DRAP that some miscreants are supplying falsified batches of Propylene Glycol with counterfeit Dow Chemical labelling in the supply chain market in Pakistan. The quality and safety of this material cannot be assured, and it should not be used in the manufacture of medical products.

Details of identified falsified batches are as under:_

Material Batch/Lot No.Manufacturer (as stated on the label)Mfg. DateExp. Date
Propylene Glycol USP/EPF9600L7PPA4Dow Europe GmbH18-10-202318-10-2025
Propylene Glycol US/EPF8900L8PPD6Dow Europe GmbHFeb-2023Feb-2025
USP PropyleneSS8900B3PPD5The Dow Chemical Company18/May/2023-Nil-
Please see the attached alert for pictures of falsified containers of Propylene Glycol
Risk Statement:Diethylene 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 taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1.      Recall Products: If any batch of finished product has been manufactured using the same batch of the propylene glycol that has been identified as contaminated, the retained sample should be immediately analysed and these finished products should be recalled from local and export markets if found contaminated.


2       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.

3.     Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

4.    Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

5.     Follow Guidelines: Adhere to the pharmacopeial 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 DEG/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.

DRAP Switched Over to Pakistan Single Window (PSW) for Regulatory Controls on Crossborder Trade at Karachi Custom Stations

Asad Ullah Drugs, General

The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce that, effective August 15, 2024, we have successfully transitioned from the Online Import Export System (OIES) to the Pakistan Single Window (PSW) for processing applications related to the clearance of commercial imports of raw materials and finished drug products at Karachi Seaport and Airport customs stations.

Pakistan Single Window (PSW) is an electronic portal enabling cross-border trade using standardized information and documents through a single entry point for all import, export, and transit-related regulatory requirements. The information is transmitted electronically, and individual data elements for clearance and regulatory approvals need only be submitted once. Authorized users who have completed the subscription process can access the PSW to perform cross-border procedures, including online payment/fees.

Key Highlights of the Transition:

  • Single Declaration Release: DRAP officers are now electronically issuing Release Orders through a Single Declaration (SD) system, streamlining the import/export process for pharmaceutical products.
  • Trade Automation: The new system allows for 24/7 electronic submission of cross-border trade applications, including online payment of fees and controlled data processing by authorized users.
  • Single Entry Point: Users can now submit standardized information and documents just once, simplifying the application process.
  • Clear Visibility and Application Tracking: The PSW system provides clear visibility of actions on applications, eliminating the need for physical visits for application follow-ups. It also allows for electronic calls on documents for any shortcomings.

DRAP Operations at PSW Include:

  • Entity Registration: Onboarding of existing Drug Manufacturing Licenses (DMLs), product registrations, and importers with existing drug sale licenses.
  • Raw Materials & Finished Drugs: Processing of drug import licenses (Form 5), clearance certificates for the import of raw materials, finished drugs, and controlled drugs.
  • Clinical Trials, Tests & Analysis: Issuance of drug import licenses for test analysis (Form 6) and clearance certificates for the import of drugs/medicines for clinical trials.
  • Hospital/Institutional Use & Donations: Import permits for unregistered/unavailable drugs and clearance certificates for donation medicines.

Additional Information:

  • DRAP Notification: DRAP has issued a notification regarding this transition to ensure all stakeholders are informed and prepared for the new process.
  • PSW User Manual: PSW has issued a comprehensive user manual to guide users through the new system, ensuring a smooth and efficient transition.

For further assistance, please contact us at 021-111-111-779 or email support∂psw.gov.pk.

DRAP-Phase-1-on-PSWDownload

Stakeholders Comments are invited on Draft Guidelines On Submission of Expenditure Details Under the Ethical Marketing To Healthcare Professionals Rules, 2021

Asad Ullah Advertisements, Drugs, General

The Healthcare Industry, comprising various sectors, is interlinked and highly dependent on frequent interactions, coordination, and supportive activities for a sustainable healthcare environment. Among this industry, therapeutic goods establishments and healthcare professionals are two important stakeholders and their interaction is vital and prone to criticism due to its repercussions on patients and the public.

To ensure innovation, progress, and improvement in healthcare and healthcare products while preserving professional ethics and transparency, the Drug Regulatory Authority of Pakistan (DRAP) has taken significant steps in line with the provision of Section 7(q) of the DRAP ACT 2012, which mandated the Authority to monitor and regulate marketing practices to ensure the rational use of drugs and ethical criteria for the promotion of therapeutic goods in line with international practices. In exercising this function, DRAP has notified the “Ethical Marketing to Healthcare Professionals Rules 2021” via S.R.O. 1472(I)/2021 on the 12th of November 2021. These rules outline the major forms of interaction between companies and healthcare professionals.

To facilitate the implementation, DRAP has developed a draft guideline on submitting expenditure details related to marketing activities targeted towards healthcare professionals to provide clarity and ensure compliance with the Ethical Marketing to Healthcare Professionals Rules 2021.

These guidelines are uploaded on the official website of DRAP on the 9th of August, 2024 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on how to submit comments visit the DRAP website or click here. Comments and suggestions can be forwarded via email to aqsa.hashmi∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Chak Shehzad, Islamabad.

DRAFT Guidelines on Data Submission under Ethical Marketing RulesDownload

DRAP Pharmacovigilance Newsletter-August 2024

Asad Ullah Pharmacovigilance

The National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP) is excited to announce the release of the new edition of its Pharmacovigilance Newsletter!

This edition is filled with essential updates and insights for healthcare professionals, regulators, and registration holders. Key highlights include:

  • Launching of VigiMobile App in Urdu 
  • Strengthening Pharmacovigilance Systems in Public Health Programmes 
  • Pharmacovigilance Training Sessions for Healthcare Professionals
  • Highlights from the 4th Meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) 
  • Latest Safety Alerts 

Stay informed and enhance your knowledge of medication safety to help minimize medication harm and ensure better patient outcomes

NPC Newsletter_July24 Final (RS)Download

Webinar on Building Effective Medicine Pricing Policies for Low- and Middle-Income Countries

Asad Ullah Events
Webinar on Building Effective Medicine Pricing Policies for Low- and Middle-Income Countries

The Drug Regulatory Authority of Pakistan held an insightful discussion on “Building Effective Medicine Pricing Policies for Low and Middle-Income Countries on Tuesday July 23, 2024 at 10:00 AM at DRAP HQ, Islamabad. The session was led by Prof. Zaheer-Ud-Din Babar, University of Huddersfield and Editor-in-Chief of the Journal of Pharmaceutical Policy and Practice. Senior management of the DRAP attended the session at DRAP HQ, Islamabad, while more than 100 colleagues from industry and academia participated in the session virtually.

The discussion among participants centered on evidence-based challenges and potential solutions for medicinal pricing policies, tailored to the specific needs of low and middle-income countries. It included an analysis of five distinct pharmaceutical pricing strategies and the primary enablers for developing effective policies.



In case you missed the live session, the webinar recording is available at the following link.

Bioequivalence and Bioavailability of Drug Products

Asad Ullah Drugs

The Drug Regulatory Authority of Pakistan (DRAP) is committed to ensure that all pharmaceutical drug products shall conform to acceptable standards of safety, efficacy and quality. The submission of bioequivalence studies is requirement of Form-5F (Common Technical Document) notified vide SRO 713(1)/2018 dated 08.06.2018.

The Registration Board, in its 338th meeting on July 4, 2024, resolved that the regulatory approval process for the registration of generic drugs in light of the guidelines of international regulatory agencies will include the implementation of Bio-equivalence studies in adherence to WHO guidelines. The decision of the Registration Board is hereby communicated for implementation.

Bioavailability-Bioequivalence-StudiesDownload