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.
Author: Ijaz Mustafa
114th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 114th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 26-27 January, 2023. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
115th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 115th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23 February 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.
Career Opportunities: Applications are invited for various positions.
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.
| Position Name and Scale** | No. of vacancies | Division / Office / Cadre | Max. Age Limit* | Qualification/Experience |
|---|---|---|---|---|
| Director (RO-15) | 1 | Budget & Accounts Division | 47 Years | View Advertisement View Corrigendum |
| Director (RO-15) | 1 | Legal Affairs Division | 47 Years | |
| Director (RO-15) | 1 | Technical Cadre | 47 Years | |
| Director (RO-15) | 1 | Administration / HR & Logistic Division | 47 Years | |
| Assistant Director (RO-12) | 1 | Management Information System Division | 30 years | |
| Assistant Director (RO-12) | 4 | Legal Affairs Division | 30 years | |
| Assistant Director (RO-12) | 50 | Technical Cadre | 30 years | |
| Assistant Bacteriologist / Assistant Microbiologist (RO-11) | 2 | CDL Karachi | 30 years | |
| Stenotypist (RO-10) | 4 | DRAP, Islamabad | 30 years | |
| Data Entry Operator (RO-09) | 8 | DRAP, Islamabad | 25 years | |
| Electrician (RO-05) | 1 | CDL Karachi | 30 years | |
| * Max Age Limit Relaxation will be applicable as per Federal Government Policy. **RO: Regulatory Officer |
||||
How to Apply:-
-Please visit the following link: http://etc.hec.gov.pk for online registration.
-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 Fee is to be deposited via 1Link/1Bill Invoice participating Banks/ATM/Internet Banking/Mobile Banking/Easypaisa/JazzCash/Upaisa.
The detail of the fee is as under:-
| Position | Test Fee (PKR) |
|---|---|
| Director (RO-15) | 2500/- |
| Assistant Director (RO-12) | 1500/- |
| Assistant Bacteriologist / Assistant Microbiologist (RO-11) | 1000/- |
| Stenotypist (RO-10) | 1000/- |
| Data Entry Operator (RO-09) | 1000/- |
| Electrician (RO-06) | 600/- |
-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.
Notification: Applications for Registration of Multiple Strength and Volume Drugs (Pharmaceutical) on Form-5F
Drug Regulatory Authority of Pakistan, on the recommendations of the Registration Board has issued guidance for submitting applications for registration of pharmaceutical product with multiple strengths and different fill volumes. The Notification issued in this regard is as under:-
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:-
Minutes of the meetings of Clinical Studies Committee (CSC) conducted in the light of Bio Study Rules 2017
Minutes of 1st Meeting of CSC
Minutes of 2nd Meeting of CSC
Minutes of 3rd Meeting of CSC
Minutes of 4th Meeting of CSC
Minutes of 5th Meeting of CSC
Minutes of 6th Meeting of CSC
Minutes of 1st Meeting of CSC
Minutes of 8th Meeting of CSC
Minutes of 9th Meeting of CSC
Minutes of 10th Meeting of CSC
Minutes of 11th Meeting of CSC
Minutes of 12th Meeting of CSC
Minutes of 13th Meeting of CSC
Minutes of 14th Meeting of CSC
Minutes of 15th Meeting of CSC
Minutes of 16th Meeting of CSC
Minutes of 17th Meeting of CSC
Minutes of 18th Meeting of CSC
Minutes of 19th Meeting of CSC
Minutes of 20th Meeting of CSC
Minutes of 21st Meeting of CSC
Minutes of 22nd Meeting of CSC
Minutes of 23rd Meeting of CSC
Minutes of 24th Meeting of CSC
Minutes of 25th Meeting of CSC
Minutes of 26th Meeting of CSC
Minutes of 27th Meeting of CSC
Minutes of 28th Meeting of CSC
Minutes of 29th Meeting of CSC
Minutes of 30th Meeting of CSC
Minutes of 31st Meeting of CSC
Minutes of 32ndMeeting of CSC
Minutes of 33rd Meeting of CSC
Minutes of 34th Meeting of CSC
Minutes of 35th Meeting of CSC
Minutes of 36th Meeting of CSC
Minutes of 37thMeeting of CSC
Minutes of 38th Meeting of CSC
Minutes of 39th Meeting of CSC
Minutes of 40th Meeting of CSC
Minutes of 41st Meeting of CSC
Minutes of 42nd Meeting of CSC