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.
DRAP has rolled out a draft for the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. These Guidelines are intended to assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards. 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. These guidelines retain the essentials of the previously published guidelines and have been extended with new terminology of types of variations and documentation required to support a specific change.
This guideline is 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.
This guidance document is applicable to APIs and excipients manufactured by chemical synthesis or semi-synthetic processes and biological processes and the drug products containing such APIs & excipients.
These draft guidelines on post registration variation were uploaded on the official website of DRAP on 4th July, 2023, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission is available on this link). Comments and suggestions can be forwarded via email to muneeb.cheema∂dra.gov.pk, copying at zeeshan.nazir∂dra.gov.pk, or can post at mailing address Director, Pharmaceutical Evaluation & Registration 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
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:-
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:-
The Drug Regulatory Authority of Pakistan, with the Federal Government’s approval, has made amendments to the Bio-Study Rule 2017. Through this amendments, the Application Form (Form-IIA) for BA/BE Studies has been revised to rationalize the requirement for submission of the reference product’s Certificate of Pharmaceutical Products (CoPP). The Notification issued in this regard is as under:-
Drug Regulatory Authority of Pakistan with approval of the Federal Government, in exercising its powers conferred by subclause (vii) of clause (c) of section 7 of the Drug Regulatory Authority of Pakistan Act2012 (XXI of 2012) readwith section 1 2 of the Drugs Act, 197 6 (XXXI of 197 6) has notified the maximum retail prices of cardiac stents as specified hereunder:-
The Drug Regulatory Authority of Pakistan (DRAP) has updated the database of pharmaceutical and biological drug products. This database is available for public access through DRAP Website and contain information on the drugs registered by the DRAP including the Name of Product (brand/proprietary name), Dosage Form, Composition / Active ingredients, Registration Number, Registration Date, Market Authorization holder and Manufacturing company.
The publicly accessible version of this database is for reference purposes only and is subject to a disclaimer. It provides information on the registered pharmaceutical and biological drug products that can be supplied through authorized establishments (pharmacies/retail outlets or healthcare institutions) in Pakistan.
Note: This database reflects the record of the contents available with the respective Divisions of DRAP. It is not intended to provide any guidance, advice or recommendations on these products.
Unless exempted through special permissions, any pharmaceutical or biological products that is not registered with DRAP cannot be imported or supplied in Pakistan.
For Market Authorization Holders:-
DRAP has transformed manual operation to PIRIMs, marketing authorization holders of pharmaceutical and biological drug products are requested to review and update their finished products Specifications. In this context, a notice was issued and uploaded on the website of DRAP on 13th March, 2023 and 20th April, 2023 (link), with the direction to all Registration Holders of pharmaceutical and Biological drug products to update finished products Specifications. The requisite information must be provided before 09th June, 2023.
-Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses. -Procurement Officers at Hospitals and Healthcare Institutions, -Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
Product(s) Affected
AQUAVENT NEO Neonatal CPAP limb (Ventilator breathing circuit) Manufactured by: Armstrong Medical Limited, Northern Ireland, Distributed by M/s. Elate C.C (Pvt) Ltd. Karachi, Pakistan Batch No. 230123 (230123 as per the list in the Field Safety Notice)
Problem / Issue
Armstrong Medical Limited, Ireland received reports for their Neonatal Breathing Circuits for risk of patient harm as a result of tubing (and a connector attached to the tubing) disconnecting from the elbow within Neonatal Breathing Circuits. Accordingly, the manufacturing company has issued a field safety notice and initiated recall of the defective product from the international market including Pakistan.
Action Initiated
-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.
-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.
-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.
-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals
-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return this product’s defective batch(es) to the importer/company.
-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through thislink.
-Please click here for further information on problem reporting to DRAP.
Advice for Consumers
-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device.
-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.
