General
DRAP’s Pharmacovigilance Newsletter (December, 2023 ; Issue-II)
The Pharmacovigilance Newsletter is a quarterly publication that aims to inform and educate the healthcare professionals and the public about the importance of pharmacovigilance and adverse drug reaction reporting. It also showcases the activities of the National Pharmacovigilance Centre (NPC) and initiatives taken by the NPC for monitoring and evaluating the safety of medicines in Pakistan.
We are pleased to announce that the second issue of the Pharmacovigilance Newsletter (Dec-2023) is now available for download from our website. This issue covers the latest updates on the safety of medicinal products and regulatory actions taken by the Drug Regulatory Authority of Pakistan (DRAP) and other international authorities.
We hope that you will find the newsletter informative and useful. We welcome your feedback and suggestions for improvement. You can contact us at npc∂drap.gov.pk or call us at +92-51-9255980. Thank you for your interest and support in pharmacovigilance.
Together, we can ensure the safe and effective use of medicines in Pakistan.
DRAP invites Comments on Draft Guideline for Storage and Destruction of Substandard-Falsified (SF )and recalled Therapeutic Goods
The Drug Regulatory Authority of Pakistan (DRAP) has drafted a guideline on the storage and destruction of recalled therapeutic goods, which are medicines, medical devices, and health products that do not meet the quality standards or are deliberately misrepresented. The guideline aims to provide a framework for the safe and effective management of such goods, from their identification and reporting to their disposal and documentation.
The draft guideline covers the following aspects:
- The roles and responsibilities of different stakeholders, such as manufacturers, importers, distributors, health care providers, and regulators, in handling substandard and falsified as well as recalled therapeutic goods.
- The criteria for selecting suitable storage facilities and methods for defective therapeutic goods.
- The methods for destroying in an environmentally sound manner.
- The records and reports that need to be maintained and submitted.
The draft guideline is available on the DRAP website on 27th October, 2023 for public consultation. DRAP invites comments and feedback from all stakeholders, including the pharmaceutical industry, health professionals, civil society organizations, and the general public. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at sanaullah.babar∂dra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
DRAP appreciates the cooperation and participation of all stakeholders in ensuring the quality, safety, and efficacy of therapeutic goods in Pakistan.
National Hazardous Waste Management Policy 2022
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.
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.”
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.
Draft Format for Submission of Data under the Ethical Marketing to Healthcare Professionals Rules 2021.
The Ethical Marketing to Healthcare Professionals Rules have been notified vide SRO 1472(I)/2021 on the 12th of November 2021 by the Drug Regulatory Authority of Pakistan. These rules have been promulgated to make the interaction between companies and healthcare professionals transparent, free from corrupt practices and to facilitate medical decisions making in the best interest of the patient.
The aforementioned rules require therapeutic goods companies to submit marketing expenditure details under rule 14(2) and annual compliance certificate under rule 13(h). Subsequent to the notification of these rules, DRAP has drafted an implementation strategy which requires systematic data submission.
The implementation strategy is aimed at harmonized data submissions by stakeholders in a systemic manner, we have drafted followings formats for data submission:-
Comments from therapeutic goods companies, healthcare professionals and relevant stakeholders are invited on the draft documents within 15 days. These comments along with justification are to be submitted using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to drap.pharmacy∂gmail.com, copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Islamabad.
Notification: Application on Form-5F (CTD) for Extension in the Contract Manufacturing Permission of Drugs.
Drug Regulatory Authority of Pakistan on the recommendation of the Registration Board has revised the data requirement for submitting applications for extension in the contract manufacturing permission of the drugs for those product where CTD dossiers has already been submitted and approved by the Registration Board. The Notification issued in this regard is as under:-