The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 56th 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.
Month: March 2023
Stakeholders Comments are invited on the Draft Guidelines for Good Cold Chain Management Practices for Temperature-Sensitive Drug Products
The supply chain of Time and Temperature Sensitive Drug Products (TTSDPs) requires constant maintenance of temperature so that the cold chain remains integral to ensure that the product quality is not compromised. Registration holders of TTSDPs including manufacturers, Importers and exporters along with their authorized distributors, are required to provide suitable storage conditions throughout the life cycle of the product under the Drugs (Licensing, Registering & Advertising) Rules, 1976. Similarly, Pharmacies, Medical stores and other authorized sale outlets, and healthcare institutions are also required to provide suitable storage and distribution while dispensing TTSDPs under relevant provincial drug sale rules.
DRAP has drafted this guidelines to set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSDPs). These guidelines intended to emphasize the increased importance of pharmaceutical cold chain management as a result of changing product environment, the requirements for Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring system.
This draft guideline is uploaded on the official website of DRAP dated on 27th March, 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. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at akbar.ali∂dra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Decisions of 55th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)
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.
Applications for Registration of Medical Devices for Local Manufacturing
Applications for Registration of Medical Devices for Import
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.
Tender Notice – Security Service
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.
Recall Alert: Drug Product; Opth-Carb Sterile Intraocular Solution (Batch#OP154) by M/s Opth Pharma (Pvt) Ltd., Karachi.
|DRAP Alert No||NoI/S/03-23-16|
|Action Date||9th March 2023|
|Target Audience||1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores|
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
|Product(s) Affected||Ophth-Carb Sterile Intraocular Solution|
Manufactured by: M/s. Ophth Pharma (Pvt.) Ltd., Karachi
Batch No. OP154
Manufacturing Date: 12-2022
Expiry Date: 11-2024
|Problem / Issue||Federal Government Analyst, CDL Karachi has declared the Batch No. OP154 of product “Ophth-Carb Sterile Intraocular Solution” as of substandard quality.|
|Risk Statement||Carbachol is primarily used in the treatment of glaucoma, it is also used during ophthalmic surgery. All ophthalmic products must meet a number of requirements of safety and sterility and if the product is not sterile (free from bacteria or microorganisms), it may lead to serious infection which includes but not limited to redness of eyes, itching in eyes, watery discharge, blurred vision and loss of vision.|
|Action Initiated||-The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market.|
-All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / company.
-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 the defective batch(es) of this product to the importer / company. |
-Adverse reactions or quality problems experienced with the use of 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) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.|
-All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
Conduct of Open E-Kachehri
DRAP will conduct E-Kachehri on 15th March, 2023 at 11:00 am
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%
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.