The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 55th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.
Regulatory Updates
Decisions of 54th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)
The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 54th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.
Important Notice to Pharmaceutical / Biological Manufacturers and Importers
DRAP has deployed an online application management system namely, Pakistan Integrated Regulatory Information Management System (PIRIMS) for processing of regulatory information related to licensing, registration and inspections of pharmaceutical and biological drugs.
All the Registration Holders of pharmaceutical and biological drug products are directed to update the finished product specifications and validated testing procedures i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification, in the corresponding product profile / details in the PIRIMS at http://pirims.dra.gov.pk. The portal to perform the above-said activity will remain accessible for thirty days after publication of this notice and afterwards, no request shall be entertained. It is further clarified that after the lapse of the due time for above-said activity, necessary regulatory fee may apply.
For further information and queries, Registration holders may contact Data Management Cell (DMC) of Pharmaceutical Evaluation & Registration Division through email (dmc∂dra.gov.pk) with regards to guidance for procedures and requirements etc.
Pakistan Integrated Regulatory Information Management System (PIRIMS)
PIRIMS enable the regulators and industry to communicate electronically for processing regulatory information related to licensing, registration, inspections procedures for pharmaceutical and biological drugs.
Med Safety App Updates; Mobile Application for Reporting of Adverse Drug Reaction is Updated and Improved
Dear Med Safety App User!
DRAP would like to request all Med Safety Application Users to update the “Med Safety App” from the respective application store to install the latest features, improvements and bug fixes.
The developer of the app Medicines and Health Regulatory Agency (MHRA) UK has announced a significant update to the Med Safety App which is available from both Android and Apple app stores from Thursday 2nd March 2023. This update supports new features in the reporting form and allows us (National Pharmacovigilance Centre DRAP) to ask specific questions relating to a patient’s report based on the information provided. The update will also enable requests for further information to be displayed within the app and for user responses to be sent back to us.
Improvements to general performance and bug fixes released as part of this major update in new version of Med Safety Mobile Application.
Safety Alert: WHO Global Alert on Tetracycline Hydrochloride Ophthalmic Ointment USP 1%
Safety Alert
Update from WHO Global Surveillance and Monitoring System
| Date: | 28th February 2023 |
| Target Audience: | · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. · International travelers/General Public · NGO’s/Supply Donations/Humanitarian Medicines |
| Problem or Issue | World Health Organization (WHO) issued Medical Product Alert No. N°2/2023 dated 22nd February 2023 which refers to the batches of Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, manufactured by Galentic Pharma (India) Pvt. Ltd, located at R-673, T.T.C. MIDC Rabale, Thane- Belapur Road, Navi Mumbai – 400701, Maharashtra, India Supplied in various countries under various labels. Visual examination of random samples had shown a range of quality issues with the random samples of the product batches e.g. particles ranging in color, size and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation. DRAP has never authorized sale of any products from Galentic Pharma (India) Pvt. Ltd (Thane Belapur Road, Navi Mumbai, India). These products are neither registered nor available on Pakistan market, however these may have been carried for personal use while visiting other countries. The manufacturer has initiated a voluntary recall for several batches. The manufacturer has indicated that other batches may be included in the voluntary recall |
| Potential Hazards: | There is currently no established evidence of any adverse events from the affected batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%. Redness and swollen eyes are common reactions to general use of tetracycline eye ointment. There is currently no indication that the above-mentioned quality issues may give rise to adverse events that are not listed in the product labelling. The affected TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% is supplied in bulk and as a component of various medical kits supplied by some international organizations providing humanitarian assistance. |
| Advice for healthcare professionals: | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this affected batch of product. Adverse reactions or quality problems experienced with the use of any product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for patients: | Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan/ National Pharmacovigilance Centre. |
All therapeutic goods must be obtained from the licensed pharmacies, and other authorized retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professional in case of any doubt.
SRO 224(I)/2023: Notification of Amendment in the Medical Devices Rules, 2017 dated 27th February, 2023
Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Research) Rules, 1978
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.
Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Licensing, Registering & Advertising) Rules 1976 and the Medical Device Rules, 2017
The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976 and the Medical Device Rules, 2017. These draft amendments are herby notified seeking comments from stakeholder.
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.
Lists of Applications for Provisional Enlistment of Alternative Medicines and Health Products
Following is the provisional list of applications are received for provisional enlistment of products with the Division of Health & OTC, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. Applicant firm are requested to furnish comments with respect to submitted applications within 30 days of the uploading of this list, if any. The comments received within 30 days of the publication of this list will be given due consideration, after which a final list will be uploaded on the website. Comments received after due date shall not be entertained. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application
These lists are prepared according to types of products and categories of applicant’ firms, as under:-
2021_-_Date_wise_Provisional_List_of_Application_for_Provisional_Enlistment_of_Homeopathic_productsDownload
Cancellation of Enlistment Certificates (Form-6 and Form-7) of two alternative products manufacturers’ for non-compliance to minimum regulatory requirements.
Enlistment Evaluation Committee (EEC) has cancelled the provisional enlistment certificates of two (02) alternative products manufacturing companies for non compliance to minimum manufacturing requirement as per applicable rules. The Committee also cancelled / revoked all the product enlistment certificates issued on the name of these two firms. The cancellation letters have been issued by the Division of Health & OTC to the all concerned authorities.