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Introducing Centralized Case Management System for Enhanced Efficiency and Transparency

Asad Ullah General, Notifications, Press Releases

The Drug Regulatory Authority of Pakistan (DRAP) has introduced a centralized case management system, aimed at boosting operational efficiency and ease of doing business processes for the therapeutic goods industry. This system is designed to monitor the processing of applications and to enable applicants to track their regulatory submissions and furnish additional details as required, marking as a significant step towards enhancing transparency and efficiency.

All licensed / applicant of therapeutic goods manufacturers/importers/exporters/ clinical trial sites/ CROs etc can access this system on eAPP module (www.eapp.dra.gov.pk) of DRAP through their existing secured account credentials, effective from 29th May, 2024. This module ensures that submissions are forwarded to the Director of the concerned Divisions with visibility for applicants to track their cases and receive timely responses, under monitoring by the DRAP’s higher management.

We are hopeful that implementation of this new system will significantly improve the visibility of application processing and streamline regulatory operations.

Stakeholders-Task-ManagementDownload

Combating Substandard and Falsified Products : Public Alert Reporting

Asad Ullah Press Releases

Islamabad, 4th April, 2024 —  The Drug Regulatory Authority of Pakistan (DRAP) is aiming for effective communication and public awareness on combating Substandard and Falsified (SF) products to protect public health; hence the frequency of public alerts is likely to increase, and media communication of key messages represents an important mediator of the behaviour of individuals in response to public health countermeasures. Since culpability is commonly used as a tool to influence public behaviour, it is important to keep the public informed while avoiding panic due to misinformation/disinformation,

In a recent event, DRAP issued an alert No I/S/03-24-15 regarding the presence of falsified Risek 40mg injections in the market. This alert was intended to caution healthcare providers and the public about the presence of counterfeit products in the market and to procure the product from authorized sources only. Unfortunately, some misinterpretations of the alert have led to widespread misinformation.

DRAP is committed to ensuring the safety and well-being of the public and calls for responsible reporting. We are working diligently to remove the falsified products from the market and to hold those responsible, accountable.

Press Release: Toxic Impurities Found In Raw Material; DRAP Directs Oral Liquid Manufacturers To Ensure Testing Of Raw Material For Imurties

Asad Ullah Press Releases

Islamabad, January 11, 2024 — The Drug Regulatory Authority of Pakistan (DRAP) has issued a warning to the therapeutic goods industry about a batch of propylene glycol raw material that has been found to be contaminated with ethylene glycol, a toxic substance that can cause serious health problems and even death.

The report of Federal Government Analyst at Central Drug Laboratory, Karachi has revealed ethylene glycol contamination in the said batch of propylene glycol, in an amount much higher than the acceptable limit. The contaminated batch (C815N3OR41) was claimed to be manufactured by Dow Chemicals, Thailand. Initial investigations suggest that the integrity of the supply chain of the raw material may have been compromised.

Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations in the pharmaceutical and alternative medicines industry. In the past two years, there have been international reports related to the adulteration of these raw materials with Diethylene glycol (DEG) and Ethylene glycol (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.  

DRAP has directed the pharmaceutical companies to immediately recall finished products from local and export markets that were manufactured using the mentioned batch of propylene glycol. The Regulatory Field Force has been instructed to confiscate the contaminated batch of propylene glycol, seize all oral preparations that were manufactured using the same batch of propylene glycol and submit the report within 24 hours. DRAP has also directed the therapeutic goods industry to hold finished products manufactured from any other lot of propylene glycol claimed to be manufactured by Dow Chemicals, Thailand and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.

The Central Drug Laboratory in Karachi is currently conducting analysis of both raw materials and finished products against the pharmacopoeial monograph and WHO guidelines for testing of EG/DEG in oral liquid preparations, respectively, as a part of the ongoing investigation.

In December 2023, DRAP issued its third advisory to the pharmaceutical industry, requiring companies to screen raw materials for contamination with EG and DEG before using them in the manufacturing of oral liquid preparations. Additionally, all finished products must be analyzed for EG/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.

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

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DRAP Participating in International Med Safety Week 2023 Social Media Campaign

Asad Ullah Pharmacovigilance, Press Releases

From 6 to 12 November, Drug Regulatory Authority of Pakistan (DRAP) will take part in the global #MedSafetyWeek campaign, a collaboration involving more than 80 medicines regulatory agencies and several non-governmental organizations, to raise awareness about the importance of reporting side effects of medicines. With the theme ‘Who can report?’, this year’s campaign will focus on the key role of every patient, doctor, nurse, and pharmacist who reports a side effect and contributes to using medicines safely.

DRAP seek your support to enhance reporting of adverse drug reactions (ADRs) to ensure medicines on the market are acceptably safe.

Reports about side effects can be submitted easily through Med Safety App, DRAP med Vigilance e-reporting system or yellow reporting form.

For detail on how to report visit the link.

#MedSafetyWeek2023

Play your part in medicines safety. Whether you’re a patient, doctor, nurse, or pharmacist, you can help make medicines safer by reporting side effects to National Pharmacovigilance Centre, DRAP.

Through the #MedSafetyWeek campaign more than 80 countries will work together to improve the safety of medicines globally

All medicines agencies operate systems to detect and analyse side effects of medicines. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Constantly collecting and monitoring information from the reports received helps identify risks associated with medicines and take action to minimise harm.

#MedSafetyWeek is an international campaign of Uppsala Monitoring Centre (UMC).

The campaign is supported by WHO and by members of the International Coalition of Medicines Regulatory Authorities (ICMRA)

DRAP emphasizes the importance of reporting side effects through Med Safety App, DRAP med Vigilance e-reporting system or yellow reporting form. All reports made to National Pharmacovigilance Centre (NPC) DRAP will be thoroughly assessed and examined to determine the right steps to be taken to protect the population from harm. Since 2018, NPC DRAP has received and processed over 30,000 reports in which patients, carers, and healthcare professionals have played a key role

“Every report is important in building more knowledge and understanding of the benefits and risks of medicines in clinical use and allows action to be taken to minimise risks.

“Reporting suspected side effects to the NPC DRAP helps to make medicines safer for patients all around the world. In some cases, it can result in better prescribing advice, which can improve patient outcomes.

“If you, or a patient you are supporting, experience a side effect with a medicine, make sure to report it to us promptly.”

Dr.Obaidullah,

National Pharmacovigilance Centre, DRAP, Pakistan

National Hazardous Waste Management Policy 2022

Asad Ullah General, Notifications, Press Releases , , ,

The National Hazardous Waste Management Policy, 2022 of Pakistan is a set of guidelines for the environmentally sound management of solid and hazardous waste in the country. The Ministry of Climate Change has formulated this comprehensive national level policy through consultative process with relevant stakeholders. This Policy is aimed at acting as an umbrella document to address the issue of hazardous waste.

Pharmaceutical Industry being a potential source of generating hazardous material as byproduct of its manufacturing, research and development processes. These involve handling of various chemical compounds which may be toxic, reactive, flammable or otherwise hazardous to human health and environment Therefore, proper management of hazardous waste in pharmaceutical industry is crucial to protect human health and environment.

The Drug Regulatory Authority of Pakistan (DRAP) in 167th meeting directed to upload the National Hazardous Waste Management Policy 2022 on its website for the information and awareness of pharmaceutical industry and other stakeholders.

Annex-IV-National-Hazardous-Waste-Management-Policy-2022Download

Med Safety App Updates; Mobile Application for Reporting of Adverse Drug Reaction is Updated and Improved

Asad Ullah Pharmacovigilance, Press Releases, Regulatory Updates

Dear Med Safety App User!

DRAP would like to request all Med Safety Application Users to update the “Med Safety App” from the respective application store to install the latest features, improvements and bug fixes.

The developer of the app Medicines and Health Regulatory Agency (MHRA) UK has announced a significant update to the Med Safety App which is available from both Android and Apple app stores from Thursday 2nd March 2023. This update supports new features in the reporting form and allows us (National Pharmacovigilance Centre DRAP) to ask specific questions relating to a patient’s report based on the information provided. The update will also enable requests for further information to be displayed within the app and for user responses to be sent back to us. 

Available at Android and Apple Store
Med Safety App

Improvements to general performance and bug fixes released as part of this major update in new version of Med Safety Mobile Application.

Public Awareness: Availability of Drugs

Asad Ullah Press Releases

DRAP works closely with the manufacturing companies to ensure the availability of essential drugs in the market. However, shortages of drugs is a global phenomena and it may occur due to various reasons including the discontinuation of certain products, supply interruptions of materials and manufacturing or quality concerns, etc. DRAP is continuously working to minimize the impact of shortages on general public.

For problem related to the drugs availability, DRAP can be reach out at its Toll- Free Number: 0800-03727, or through email at drugshortages∂dra.gov.pk within working hours from Monday to Friday 08:00 AM to 04:00 PM.

DRAP Newsletter: Volume 02-Quarter 01, 2023

Asad Ullah News & Updates, Press Releases, Regulatory Updates

The second volume of quarterly Newsletter of DRAP was issued on 1st January, 2023. This issue highlights the key initiatives and accomplishments of the outgoing year-2022, and welcomes the new year-2023 with reaffirmation to its commitments. DRAP is implementing its Strategic Plan 2022-25 with full zeal and devotion, to protect the public health through effective regulation for availability of safe, quality assured and efficacious therapeutic goods for the people of Pakistan.

DRAP_NewsLtter_Jan23

Medicine Safety Week 2022; DRAP’s Call to Healthcare Professionals and Patients to Report Suspected Adverse Reactions of drugs and vaccines.

Asad Ullah News & Updates, Pharmacovigilance, Press Releases

The seventh annual Social Media Campaign #MedSafetyWeek was launched on the 7th of November, 2022 by the National Pharmacovigilance Centre, DRAP, which was observed until 13th November 2022, to encourage everyone to report suspected side effects of medicines. The International campaign was led by the Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring.

This year’s global campaign involved medicines regulators from 81 countries and focused on the key role of every healthcare professional, patient, and caregivers who reports a suspected side effect and contributes to using medicines safely. This campaign was supported by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA)

#MedSafetyWeek 2022

Every report to the National Pharmacovigilance Centre, DRAP helps to improve the safety of medicines for all patients.

People are encouraged to report suspected side effects of medicines as part of the global #MedSafetyWeek social media campaign

Why Reporting is required?

All medicines may cause side effects in some patients, so there are steps in place to continuously monitor their safety after they are placed on the market. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Regulatory bodies operate systems to detect and analyse those side effects and prevent harm to future patients.

The National Pharmacovigilance Centre, DRAP, collects, organises, and investigates reports of suspected side effects / Adverse effects.

By reporting suspected side effects, you are actively participating in identifying emerging safety issues, so that DRAP can take action when necessary and protect you and others from harm.

Every Report is important for us

Every report made by a patient, a healthcare professional, or a caregiver plays a key role in gaining more knowledge about the benefits and risks of medicines in clinical use and allows action to be taken to minimize risks and can result in better tailored prescribing advice, which can improve patient outcomes.

Patients / care givers and all healthcare professionals can report suspected side effects to the National Pharmacovigilance Centre, DRAP. You can submit a report in many ways:

Are you a Pharmacist?

You are the first person patients go to when they have questions about their medicines.  Please report any new side effects of a medicine via the [Med Safety App & E reporting https://primaryreporting.who-umc.org/PK 

DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

Asad Ullah News & Updates, Press Releases
DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

The Islamabad 11th Nov, 2022; Drug Regulatory Authority of Pakistan signed a memorandum of understanding with the Pakistan Single Window (PSW) in a ceremony held on 11th Nov 2022 at Islamabad. This MoU is aimed at enhancing cooperation among two departments through digital integration of IT System of PSW with the regulatory processed of DRAP. This will enable therapeutic goods industry to utilize an integrated electronic platform for import and export of raw materials and finished products using single entry point.  PSW will support international trade of therapeutic goods by recognizing standardized information and documents on an online platform which will fulfill all import, export, and transit regulatory requirements.

Speaking to the participant at the ceremony, Mr. Asim Rauf, CEO DRAP lauds the efforts and contribution of PSW team and stated that DRAP is continuously transforming its regulatory operations into IT based electronic solutions and various initiatives are underway to revamp drug regulatory system in the country. DRAP is one of the largest organizations in public sector that has fully replaced the manual filling system with an electronic office module for intradepartmental communication and decision making. This MoU will mutually benefit both Regulators and Industry by enabling one window working environment in electronic format which support compliance with all regulatory requirement and processes for cross border trade of therapeutic goods. DRAP and PSW will continue to support each other for provision of more facilitating regulatory environment to industry. In future, DRAP will also integrate licensing and registration systems for therapeutic goods with PSW.