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.
Regulatory Updates
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.
Stakeholders Comments are invited on Draft Guidelines for Post-Registration Variation of Drugs
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.
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:-
SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017
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:-
SRO.649(I)/2023: MRP fixation of Cardiac Stents
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:-
Updated Database of Pharmaceutical and Biological Drug Product
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.
Related News
- DRAP invites Comments on Draft Guideline for Storage and Destruction of Substandard-Falsified (SF )and recalled Therapeutic Goods
- DRAP Added New eService for Online Data Submission for Registration of Pharmaceutical and Biological Product
- National Control Laboratories for Biologicals, DRAP issued Guidelines for Lot Release of Biological Products
- DRAP finalized the 2nd Edition of Guidelines on Post-Registration Variation of Drug Products
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.
Recall Alert: Medical Devices; Aquavent Neonatal Breathing Circuits by M/s. Armstrong Medical Limited, Ireland
Recall Alert
| DRAP Alert No | No I/V/05-23-23 |
| Action Date | 17th May 2023 |
| Target Audience | -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 this link. -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. |
DRAP invites Comments on Draft Guidance Document for Submission of Application on Form 5F (CTD) for Registration of Biological Drug Products for Human Use
This guidance is developed to assist manufacturers and importers in developing their applications for registration of human biological drug products. Drug Regulatory Authority of Pakistan (DRAP) has adapted CTD format for registration of all such drugs vide SRO-713(l)/2018 dated 8th June 2018. Detailed guidance regarding the data requirement for CTD format has been provided in ICH M-4 guidelines. Since the DRAP is introducing the CTD in a progressive manner, therefore, initial guidance to applicants would be helpful for harmonization and appropriate data submission to achieve consistency and uniformity of application.
The guideline is intended to provide data requirements of Form-5F (CTD) for registration / market authorization of biological products of all types including New drug products, and Biosimilars. This document provides guidance for importers and local manufacturers of human biological products on how to obtain market authorization / registration in the territory of Pakistan.
This draft guideline is uploaded on the official website of DRAP dated on 9th May, 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, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to a ahmad.ansari∂dra.gov.pk copying at ahsan.hafiz∂dra.gov.pk , or can be posted at mailing address, Director, Biological Drugs, Drug Regulatory Authority of Pakistan, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.