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.
Improvements to general performance and bug fixes released as part of this major update in new version of Med Safety Mobile Application.
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.
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.
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)
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 professionalscan report suspected side effects to the National Pharmacovigilance Centre, DRAP. You can submit a report in many ways:
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
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.
On 28th September, 2022; The meeting of Core Team of National Task Force for Eradication of Spurious and Unregistered Therapeutic Goods held on 28th September, 2022 at DRAP, HQ Islamabad. The Chief Executive Officer (CEO) of Drug Regulatory Authority of Pakistan (DRAP) chaired the meeting of Core Team for the National Task Force in light of the recommendation of Senate’s Standing Committee on Ministry of National Health Service, Regulation & Coordination (M/o NHSR&C) today at the DRAP Head Quarters, Islamabad. The Director of Quality Assurance & Lab Testing, DRAP, Director of Licensing, DRAP and All the Chiefs of Drug Inspectorates from across the Pakistan attended the meeting. The CEO, DRAP emphasized on enhancing the collaboration among federal and provincial inspectorate of drugs for market surveillance, ensuring the availability of life saving medicines and mitigation of shortage of medicines. The CEO, DRAP further added the measures to control overpricing and particularly the products for public health emergencies should be focused upon. Rapid Alert System for immediate eradication of substandard and falsified product posing high level threats and effective recalls of defective therapeutic goods were deliberated upon in details. Finally, the communication mechanism for National Task Force was discussed in detail and agreed upon by the participants.
An official delegate from Department of Drug Administration (DDA), Ministry of Health & Population, Government of Nepal under the leadership of Mr. Bharat Bhattarai, Director General, DDA visited DRAP HQ, Islamabad on Tuesday, August 23, 2022. Mr. Asim Rauf, CEO DRAP warmly welcomed the Mr. Bhattarai and other senior officials from DDA and MoH, Nepal.
Directors of Division of Pharmaceutical Evaluation & Regisatrion (PE&R), Medical Devices and Medicated Cosmetics (MDMC), and Health & OTC Products (H&OTC) demonstrated their respective presentations on the various regulatory functions of DRAP. The delegates shows keen interest in the journey of Pakistan toward successful implementation of WHO/ICH Common Technical Document (CTD) format for registration of pharmaceutical and biological drugs in Pakistan, and praises the IT Systems establish by DRAP for integrated regulatory data management in the country.
The officials of the international Health Partner, United States Pharmacopeia- Prompting Quality of Medicine Plus, from Nepal and Pakistan, were also present in these meetings.
The Drug Regulatory Authority of Pakistan (DRAP) and Islamia University of Bahawalpur (IUB) undergoes in a Memorandum of Understanding on August 19, 2022. A brief ceremony was organized at DRAP HQ, Islamabad where Mr. Asim Rauf, CEO, DRAP and Dr. Athar Mahboob, Vice Chancellor, IUB signed the MoU on behalf of their respective institutions. Senior members of both organizations were also present on this occasion.
Both organizations, Under this MoU has agreed to facilitate cooperation in academic research to fosters collective efforts in facilitating scientific progress through exchange of knowledge and expertise. It will open new opportunities for academic, research, trainings and mutual collaborations.
Drug Regulatory Authority of Pakistan (DRAP) , in pursuance to the enactment of Pharmacovigilance Rules, 2022 has notified the National Pharmacovigilance Centre, with the aim to further enhance the Pharmacovigilance activities includes collecting, analyzing, monitoring, and preventing adverse effects in the therapeutic goods.
DRAP also encourages all healthcare professionals to establish the practices of pharmacovigilance in the country as they have pivotal role in monitoring the safety and efficacy of therapeutic goods, particularly for newly-marketed product.
The Authority, under Rule 3(1) read with Rule 3 (2) of the Pharmacovigilance Rules, 2022, notified the National Pharmacovigilance Centre under the Division of Pharmacy Services, DRAP.
The safe use of drugs, vaccines, medical devices and other therapeutic goods medicines is the most important criteria for DRAP to protect the public health and integrity of national healthcare system. Pharmacovigilance is the mechanisms to map and ensure the safety of therapeutic goods throughout their life span – from clinical trials to patient or consumer.
The importance of Pharmacovigilance is increased further in the current era due to arrival of novel of biopharmaceutical products and innovative technologies in healthcare practices.
National Pharmacovigilance Center (NPC) is working at DRAP and Pakistan is a full member of the WHO Programme for International Drug Monitoring.
Two Provincial Pharmacovigilance Centres in Punjab and Islamabad are also working in addition to a Centre of EPI (immunization programme), collecting ADR data and collaborating with the National Centre. National Pharmacovigilance Centre (NPC) has also established a Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
NPC is Coordinating with other provinces/administrative territories, PHPs for establishment of their PV centers and also communicating with manufacture and importers of therapeutic goods for establishment of their pharmacovigilance system and reporting of ADRs to DRAP.
NPC has also published various documents and Guidelines for Stakeholders on pharmacovigilance activities, including :-
Pakistan National Pharmacovigilance Guidelines
Good Vigilance Practice Guidelines for Pharmaceutical Companies
Pharmacovigilance Guidelines for Healthcare Professionals
Pharmacovigilance Guidelines for Patients Pharmacovigilance
Mr. Asim Rauf, CEO DRAP met with WHO Country Representative for Pakistan, Dr Palitha Gunarathna Mahipala on Monday 25th April, 2022 at WHO Country Office, Islamabad, to discuss the bilateral cooperation among WHO and Drug Regulatory Authority of Pakistan.
Dr. Mahipala appreciated the efforts of DRAP and Ministry of National Health Services, Regulation & Coordination for strengthening the national regulatory framework to ensure and enhance the access of quality assured, safe and efficacious therapeutic goods in the country for better health of the people of Pakistan. Mr. Asim Rauf, acknowledged the role of WHO and country office’ team for extending assistance in various health programs which are improving the access of Pakistani citizen to quality assured therapeutic goods.
The meeting ended with the reiteration of the commitment from WHO and DRAP for strengthening the bilateral cooperation and to take all possible measure for protecting the health of the people of Pakistan.