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.
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.”
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.
The supply chain of Time and Temperature Sensitive Drug Products (TTSDPs) requires constant maintenance of temperature so that the cold chain remains integral to ensure that the product quality is not compromised. Registration holders of TTSDPs including manufacturers, Importers and exporters along with their authorized distributors, are required to provide suitable storage conditions throughout the life cycle of the product under the Drugs (Licensing, Registering & Advertising) Rules, 1976. Similarly, Pharmacies, Medical stores and other authorized sale outlets, and healthcare institutions are also required to provide suitable storage and distribution while dispensing TTSDPs under relevant provincial drug sale rules.
DRAP has drafted this guidelines to set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSDPs). These guidelines intended to emphasize the increased importance of pharmaceutical cold chain management as a result of changing product environment, the requirements for Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring system.
This draft guideline is uploaded on the official website of DRAP dated on 27th March, 2023, for seeking comments and suggestions from stakeholders on the draft document. 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 akbar.ali∂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.
The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Research) Rules, 1978. These draft amendments are herby notified seeking comments from stakeholders.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Additional 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.
Registration Board in its 323rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.”
Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under:
“The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”
Accordingly, the decision of Registration Board is circulated for information and compliance by relevant stakeholders / manufacturers.
Registration Board of DRAP has issued a Guidance document for applicants on submission of application on form 5-F (CTD) for registration of pharmaceutical drug products for human use. Submission of data of pharmaceutical equivalence and Comparative Dissolution Profile (CDP) is required under section 3.2.P.2.2.1 (Formulation Development) of Form 5F (CTD).
In order to further harmonize the submission of such data and ensure data integrity, Registration Board in its 322nd meeting held on 8th & 10th November, 2022 decided as under:
“Firm shall submit the image/picture/snapshot of the innovator/reference/comparator pack against which Pharmaceutical equivalence / Comparative Dissolution Profile studies have been performed and shall reveal the details of brand name, manufacturer, batch# and expiry date of the innovator/reference/comparator product in the section 3.2.P.2.2.1 (Formulation development) of Form 5F.“
Accordingly, above decision of Registration Board is hereby notified and circulated for information and compliance by relevant stakeholders / applicants.