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:
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.
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.
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.
The ISPE Annual Conference & Exhibition, 2023 for Pharmaceutical and biomanufacturing professionals is happening from 23-25 August, 2023 at Suntec, Singapore & online. This conference is aimed at highlighting global and regional best practices in process, technology and innovations. International and Asian manufacturers, regulatory agencies and subject matter experts share knowledge from manufacturing facility design to finished product.
The conference is known as showcasing latest technologies and services, workshops and discussion sessions. This year, participants can join the conference both in-person or virtually.
lSPE Singapore Affiliate Conference & Exhibition, 23-25 August 2023
Free Registration for Regulators, Pharma and Biomanufacturers
The organizers of ISPE Conference and Exhibition, 2022 have offered free registration for regulators and industry professionals who can get register for free to attend the ISPE Singapore conference in august, either online or in person.
Interested applicants are required to fill out the google form provided on the this link or by open the below the link in the browser https://www.cognitoforms.com/ISPESingapore1/ISPESingaporeConferenceExhibition2023ComplimentaryDelegatePass Please note that these complimentary delegate passes are subject to approval by the organizer and may be limited;
National Regulatory Authorities are responsible to ensure that recalls are handled properly and promptly, including alerting the public, classifying the type of drug recall, and safely removing the affected product from the market. DRAP in collaboration with WHO, organized one-day consultative workshop on “Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods” held at DRAP Headquarter in Islamabad on 20th July, 2023. The workshop was aimed at ensuring strong communication skills and knowledge to effectively handle the SF threat and execution of recalls and rapid alerts. Government Analysts from all Quality Control Laboratories (QCLs) working under the DRAP Act 2012 and Drug Act 1976, as well and representatives from drug control administration of all federating units participated in the workshop.
The workshop focused on the following key objectives:
Implementation of effective and integrated Recall and Rapid Alert system in Pakistan.
Emphasizing the need and importance of Recall and Rapid Alert System.
Training and building capacity of all the participants.
Enhancing coordination and communication with provincial governments and related departments.
Safe disposal system of SF products
Improvement in DRAP’s guidelines and harmonization with International best practices.
Risk Communication flow chart for handling SF threats
Core Activities and Topics Covered
1. Introduction and Objectives of Workshop The day began with an overview of current system for rapid alerts and recalls for removing defective therapeutic goods from the market. Director Quality Assurance and Lab Testing, DRAP briefed the participants on the strategies designed to strengthen the collaboration among regulators and QCLs of all federating units. He emphasized the importance of timely and accurate communication to combat the challenge of SF therapeutic goods.
2. Overview of DRAP’s guidelines on Recalls and Rapid Alerts of Defective products This session explained the guidelines of DRAP and action response currently opted by DRAP, highlighting its strengths and limitations. Participants engaged in group discussions to evaluate which methods would be most effective in different scenarios.
3. WHO recommendation on Recalls and Rapid Alerts System in the benchmarking visit Participants were introduced to the WHO GBT indicators, sub-indicators and IDPs, WHO recent visit and their recommendation for the improvement of the current Rapid Alert system. The trainer comprehensively delivered the details, ensuring that the information provided is easily comprehensible and actionable.
4. Harmonization of Terminologies for Defective Products and Role of QCLs in Detection and Disposal of SF products This segment focused on the terminologies being used nationally and their harmonization with WHO recommended terminologies. Later the role of Quality Control Laboratories was emphasized and discussed in group discussion.
5. Best practices for storage and disposal of SF products This session highlighted the current available practices and international practices as recommended by the WHO for safe storage and disposing of the SF products.
6.Effective communication among stakeholders for their removal from the market ;Recall is an effective means of protecting the public from a defective or potentially harmful product, and strong communication among relevant stakeholders is essential for the effective recall of SF Products. It was suggested to utilized modern communication channels by all federating units to ensure in time action on trigger information to safeguard public health. It was agreed by all the participants that prompt and effective communication is very crucial for implementing an proficient Rapid Alert and Recall System to removal of SF product from markets.
7. Practical Exercises The afternoon session involved hands-on practical exercises. Participants were divided into groups and tasked with case studies for different hypothetical scenarios. Case studies and simulations illustrated the effective collaboration between all the relevant stakeholders. This interactive exercise encouraged teamwork and allowed attendees to apply the concepts learned throughout the day.
8. Concluding Remarks and Distribution of Certificates Director Pharmaceutical Evaluation & Registration (PE&R) concluded the workshop with his closing remarks on appreciating the active participation from all regulatory entities and QCLs across Pakistan. The certificates of participation were distributed among the participants at the end of session.
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.
The Drug Regulatory Authority of Pakistan (DRAP) employs over 500 people from a range of educational backgrounds, who have the skills and experience to perform regulatory operational services under the DRAP Act 2012. These include professionals both technical (qualifications in medicine and pharmacy-related sciences, etc.) and non-technical (qualifications in law, information and communication technology, accounts, human resources management, etc.)
DRAP is mandated to provide effective coordination and enforcement of The Drugs Act, 1976, and harmonization of inter-provincial trade and commerce of therapeutic goods. Being the national regulatory body for therapeutic goods, DRAP performs various regulatory functions of therapeutic goods including licensing of establishments, product registrations/marketing authorizations, pharmacovigilance, post-market surveillance and market control, regulatory inspections, laboratory testing, clinical trials oversight and lot release of biologicals.
The recruitment for vacant positions is in line with DRAP Employee Service Regulation 2015 and vacancies are advertised as per posts approved taking into account the needs of the Authority.
Details of Vacant Positions advertised are as below.
-In case of any difficulty during the online registration, please visit onlinehelp.hec.gov.pk or visit HEC Secretariat, or contact HEC regional offices for guidance.
-Application submission comprises two steps; profile completion using the “My Profile” section and application submission using the “Test Name” link on the menu panel in the left-hand sidebar of the online portal.
-Only SUBMITTED applications will be considered for the Test and applications in SAVE or INCOMPLETE mode will not be entertained.
How to Pay Test Fee
-Test Feeis to be deposited via 1Link/1Bill Invoice participating Banks/ATM/Internet Banking/Mobile Banking/Easypaisa/JazzCash/Upaisa.
-Once you have selected 1link 1bill Invoice payment service. Open /sign into your mobile app and click on Bill payment or payment services (as per your mobile banking app options).
-Click on 1Bill Invoice payment services and enter the consumer number generated by the ETC portal. Once you see the details, pay the amount.
-After depositing the fee through 1link 1Bill Invoice, click on Verify Online Payment on ETC Dashboard.
-The test fee is non-refundable and non-transferable.
-The candidates must get their queries/complaints resolved before the closure of the web registration portal. Queries/complaints handling beyond the registration deadline is denied by the system due to logistics/security reasons.
Note: It is Mandatory to bring your Original Roll Number Slip, Original CNIC, Original Passport, and Paid Fee Receipt via 1 link otherwise candidate will not be allowed to sit in the exam.
