Policy Board of the Drug Regulatory Authority of Pakistan (DRAP) has given policy guidelines for inspections of manufacturers keeping in view the suggestions/guidelines of WHO for reliance on other regulatory authorities. Accordingly, the revised “Policy for inspections of manufacturers abroad” as approved by the Policy Board under Section 11 (I) (a) of the DRAP Act, 2012, as under:-
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DRAP notified National Pharmacovigilance Centre (NPC) under the Pharmacovigilance Rules, 2022
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
- Guidelines for Public Health Programmes.
Proposed amendments in the Rules : DRAP invites comments from stakeholders and public on the draft amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976;
The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976. The proposed amendments relates to the minimum area requirement for establishment of a pharmaceutical manufacturing units and adoption of Pharmaceutical Inspection Cooperation / Scheme (PIC/S) Guidelines for Good Manufacturing Practices (GMP), in order to further align more closely with the international standards and best practices, as practiced by many other regulatory authorities around the world.
The DRAP proposes to do so primarily by incorporating the provisos to enable manufactures and regulators to follow principles set by the Pharmaceutical Inspection Cooperation / Scheme (PIC/S) to maintain the quality standards at an acceptable level. PIC/s guidelines provide comprehensive guidance for both industry and regulators on various aspects of Good Manufacturing Practices.
DRAP has the mandate to issue guidelines and to monitor enforcement of licensing of manufacture of therapeutic goods and to implement internationally recognized standards under Section 7(c)(i) & (ix) of the DRAP Act, 2012. Control of environmental conditions for pharmaceutical industry is essential to manufacture quality products. and implementation of Good Manufacturing Practices (GMP) guidelines is critical to ensure the proper design, monitoring, and control of the manufacturing processes and facilities.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification in the official Gazette of Pakistan using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Deputy Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.
SRO 778 (I)/2022 dated 10th June, 2022
S.R.O.559(I)/2022 (Amendments in the Medical Devices Rules, 2017)
DRAP notified the Pharmacovigilance Rules, 2022, for active monitoring of safety of therapeutic goods across the country
The pharmacovigilance Rules, 2022, notified on 22nd April, 2022 , came into effect. This will provide a legal framework to monitor the safety of therapeutic goods throughout their use in the healthcare practice. This legislation details responsibilities of all stakeholders in active supervision of the product’ safety and monitoring, and provides a legal framework to implement and strengthen the pharmacovigilance system across the country. The newly approved rules will have a significant impact to improve pharmacovigilance system in the country, and provides responsibilities to be carried out by the National Pharmacovigilance Centre, Provincial or regional pharmacovigilance Centres, Public Health Programs (PHPs), and as well as, for the products’ registration holders (marketing authorization holders).
The Pharmacovigilance Rules,2022 are aimed at :-
- Establishing the pharmacovigilance system for the collection and monitoring of Adverse Events, and related data on safety of therapeutic goods;
- Review and assessment of safety data for effective regulatory actions to ensure the safe use of drugs, vaccines, medical devices, etc.;
- Encourage reporting of Adverse Events by the Healthcare Professionals, Patients and Consumers of therapeutic goods;
- Better communication and collaborative working among all stakeholders.
To know more about please navigate to “How DRAP Monitor Safety of Therapeutic Goods“, and “How to Report Adverse Events?”
S.R.O. 430(I)/2022 (Notification of Amendments in Form 6A and Form 7A of the Medical Devices Rules, 2017 (18.03.2022))
Promotion and Growth of Active Pharmaceutical Ingredient (API) Industry in Pakistan
Notification No. F. 1-2/2022 -CEO-DRAP, dated 2nd March, 2022.