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SRO.649(I)/2023: MRP fixation of Cardiac Stents

Asad Ullah Medical Devices, Notifications, SROs

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:-

Notification-of-Fixation-of-MRP-of-04-Cardiac-Stents-02.06.2023Download

Updated Database of Pharmaceutical and Biological Drug Product

Asad Ullah Drugs, Regulatory Updates

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.

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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.

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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.

Decisions of 57th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

Asad Ullah Medical Devices Board

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 57th 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.

Deferred-letters-of-57th-Meeting-of-MDB-12-04-2023Download

Recall Alert: Medical Devices; Aquavent Neonatal Breathing Circuits by M/s. Armstrong Medical Limited, Ireland

Asad Ullah Medical Devices, Recall Alerts

Recall Alert

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DRAP Alert NoNo I/V/05-23-23
Action Date17th 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.