News & Updates
National Control Laboratories for Biologicals, DRAP issued Guidelines for Lot Release of Biological Products
The regulation of lot release is an integral regulatory control to ensure the quality and safety of biological products. Its purpose is to verify that each batch/lot of the product meets the stipulated standards of manufacturing and quality control. The National Control Laboratory for Biologicals (NCLB), Islamabad assumes the responsibility of overseeing lot release function through reviewing the manufacturer’s protocol, analytical methods and summary protocol, and also conduct analytical testing if necessary. This is aimed at assuring that every product batch/lot that enters the market adheres to the approved specifications at the time of registration, including any post-registration modifications or variations. The primary objective is to safeguard the public from substandard product batches/lot.
The National Control Laboratories for Biologicals, DRAP has published guideline on the procedural requirement for lot release of biological products. This guidance document was drafted and uploaded in May 2023 seeking comments from stakeholders. It provides an overview of the lot release process how the procedure is established and what products are covered under the lot release system.
Shanghai Cooperation Organization (SCO) Pharmaceutical Development Conference; CEO DRAP emphasis cooperation to ensure drug safety and advancing research in the pharmaceutical field
2nd SCO Conference on Pharmaceutical Cooperation
September 25, 2023, Suzhou
The SCO conference on the development of medical and pharmaceutical cooperation was held in Suzhou, China on September 25, 2023. The conference was attended by representatives from the public and private healthcare sectors of the Islamic Republic of Iran, the Republic of Kazakhstan, the People’s Republic of China, the Kyrgyz Republic, the Islamic Republic of Pakistan, the Russian Federation, and the Republic of Uzbekistan.
Mr. Asim Rauf, appreciated the organization of this significant event, which plays a crucial role in promoting regional cooperation and development in the pharmaceutical sector. He added that the SCO region holds immense potential for enhancing pharmaceutical collaboration, and we are committed to contributing to this shared vision. The platform of SCO offers an excellent opportunity to share insights, learn from each other’s experiences, and work collectively towards a safer, more accessible, and sustainable pharmaceutical landscape.
The pharmaceutical industry in Pakistan is evolving from its modest beginnings to become a significant contributor to our national economy as well as meeting around 80 % of domestic needs. Pakistan is eager to collaborate with our fellow SCO member states to harness the full potential of the pharmaceutical sector.
DRAP finalized the 2nd Edition of Guidelines on Post-Registration Variation of Drug Products
DRAP has finalized the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle.
This guidelines are intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.
These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.
These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. The draft guidelines were uploaded on the website in July 2023 seeking comments of stakeholders on the contents of document.
The Guidelines have been finalized keeping in view the comments and suggestions of the Stakeholders. Please navigate to the Publications on the DRAP website for latest guidelines by DRAP.
116th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 116th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23rd May, 2023. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
FIFO Applications List for the Provisional Enlistment of Alternative Medicines and Health Products
The Division of Health & OTC (non-drugs) is responsible for performing the enlistment of manufacturers, importers and their products under the Alternative Medicines and Health Product (Enlistment) Rules 2014.
The Division of Health & OTC, DRAP has published FIFO lists of applications received for the provisional enlistment of various categories of alternative medicines and health products. These lists contain the details of the applicants, the proposed name of the products and date of submission of application.
These lists are intended to provide transparency and accountability to the stakeholders and the public regarding the processing of the applications. It also aims to facilitate the applicants to follow up on their applications.
The list of pending applications can be accessed from the following link:
The National Pharmacovigilance Center, DRAP urge the manufacturers and importers to nominate Pharmacovigilance Officer to ensure safe use of drugs.
Pharmacovigilance is the science and practice of monitoring the safety and efficacy of drugs, both before and after they are marketed. It is a vital aspect of ensuring public health and patient safety, as well as complying with regulatory requirements and ethical standards.
Pharmacovigilance officers are professionals who are responsible for collecting, analyzing, and reporting data on adverse drug reactions, drug interactions, and other potential safety issues. They also conduct risk assessments, implement risk management plans, and communicate with health authorities, health professionals, and patients.
The National Pharmacovigilance Centre at Drug Regulatory Authority of Pakistan urges the pharma industry to nominate or appoint pharmacovigilance officers for their products, as this will ensure the highest standards of quality and safety for their customers and patients. Pharmacovigilance is not only a legal obligation but also a social responsibility. Focusing on pharmacovigilance can enhance reputation, credibility, and competitiveness of a product in the global market.
According to the Pharmacovigilance Rules, 2022, notified by the Drug Regulatory Authority of Pakistan (DRAP), it is the legal obligation of the pharma industry to nominate or appoint a pharmacovigilance officer for products registered under the DRAP Act, 2012. The pharmacovigilance officer is required to perform the following duties:
- To collect, record, and report adverse events and other safety data related to the product to the National Pharmacovigilance Centre (NPC) within the specified time frame.
- To conduct periodic safety update reports (PSURs) and risk-benefit assessments of the product and submit them to the NPC.
- To implement risk management plans (RMPs) and risk minimization measures (RMMs) for the product as per the NPC’s recommendations.
- To ensure compliance with the pharmacovigilance rules and guidelines issued by the NPC and DRAP.
- To maintain pharmacovigilance records and documentation for at least 10 years.
“The NPC was established by DRAP in July 2022 under the Pharmacovigilance Rules, 2022, with the aim to enhance the pharmacovigilance activities in the country . The NPC is responsible for collecting, analyzing, monitoring, and preventing adverse effects of therapeutic goods, as well as reviewing and assessing safety data, conducting risk evaluations, and communicating with health authorities, health professionals, and patients. The NPC also provides training, guidance, and support to the provincial or regional pharmacovigilance centres, public health programs, and product registration holders.”
Training on Pakistan Single Window for DRAP Module
Pakistan Single Window-PSW is working on the automation of trade-related business processes of the Drug Regulatory Authority of Pakistan (DRAP). The existing business processes of issuance of License, Permits, Certificates and Others (LPCOs) by DRAP has been mapped in consultation with DRAP._
In this context, Pakistan Single Window-PSW would like to invite you for a hybrid Training Session for the Drug Regulatory Authority of Pakistan-DRAP Module. In this session our Domain and System Experts will provide you the walkthrough of filling Entity Registration, License Registration (DML), Product Registration and SECP Verification.
The meeting is scheduled for Friday, 25th August 2023 from 03:30 PM till 04:30 PM. Manufacturers/DML holders working in Karachi are requested to join us physically at Main Conference Room, Fifth Floor, Bahria Complex-1, M.T Khan Road, Karachi.
Interested members are requested to register themselves by clicking below:
Registration Link: https://us06web.zoom.us/webinar/register/WN_42ArK1qtS1Sf9Xm2bcTi9g
Relevant members of Pharma Industry and associations are encouraged to get themselves register for this session for better understanding of new module. Pease note, only registered members will be allowed to attend this training session.
Relocation of Manufacturing Units from Residential Area to Industrial Area
DRAP issued directions to the manufacturers vide No.F.1-78/2018-DD(H&OTC)(Pt) dated 2nd September, 2019 for those whose manufacturing units were situated in the residential area to relocate their manufacturing sites to the industrial areas to ensure the environmental safety and protection of public health. Following DRAP guidelines, another large manufacturer of alternative medicines has relocated its facility from a residential to an industrial area. Consequently, EEC has cancelled previous enlistment certificates (Form-6 and Form-7) and issued revised enlistment certificate for the new manufacturing site in the residential area.
Developing National Medicine Policy; Meeting of Technical Working Group on 1-2 August 2023 at Islamabad
National Medicine Policy is a high-level guiding document that outlines the national perspective and strategies to promote health sector for enhancing national capacities with the aim to increase access to and rational use of high quality and affordable medicines and health products in the country.
DRAP has significance role in the development and implementation of National Medicine Policy. As a country, we need to undertake measures to make drugs accessible to our populations and future generations through ensuring high-tech manufacturing capabilities, their proper distribution and having trained professional workforce to prescribe and administer these drugs. With the growing population, our needs for essential drugs are also growing for treating various diseases. To meet the objective, a holistic approach is needed in which all the stakeholders work for ensuring that patients get access to quality assured, safe and effective drugs.
TWG Meeting on National Medicine Policy, 1-2 Aug, 2023 at Islamabad
A National Medicine Policy is a crucial framework which provides strategic directions and guidelines for safe, effective, and accessible use of drugs within a country. It has huge significance as it impacts the public health directly. A well-developed NMP ensures equitable access to essential medicines and contributes to disease management and control.
