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 678(I)/2023 Amendments in the Drug Pricing Policy-2018.
Rapid Alert; Drug Product: Falsified Phenobar 30mg Tablets identified in the Market
Rapid Alert
Falsified Phenobarbitone 30mg Tablets
| DRAP Alert No | No I/S/06-23-24 |
| Action Date | 5th June 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores 3. General Public |
| Problem Statement | Drug Inspectorate field force including various Provincial Inspector of Drugs took samples of Phenobar 30mg Tablets from the market and asked the manufacturer stated on the label for verification of authenticity. The purported manufacturer i.e. M/s Star Laboratories (Pvt) Ltd., Lahore, has informed that following batches were not manufactured by them. The product detail as mentioned on the label is as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Composition as per label | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | Phenobar Tablets 30mg | Phenobarbitone | QA019, QA025, QA016. | M/s Star Laboratories (Pvt) Ltd .Lahore |
| Risk Statement: | Consequences of use of Spurious/ Falsified Drugs includes but not limited to followings: -Falsified/Spurious drugs may contain toxic and narcotic/psychotropic ingredients in unacceptable doses which may be life threating. -These are manufactured under unhygienic condition without the proper inspection and approval, which are highly injurious to human health. -Poor-quality medicines compromise the treatment of diseases and may intensified the existing condition. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products. -Adverse reactions or quality problems experienced with the use of these product shall 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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |
Minutes of 290th Meeting of Central Licensing Board held on 28th April 2023
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:-
Minutes of 327th meeting of Registration Board held on 13th April, 2023
The Drug Registration Board convened its 327th meeting held on 13th April, 2023 in the Committee Room of the Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
113rd Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 113rd meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 08-December-2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
SRO 620(I)/2023: Fixation of Maximum Retail Price of Cardiac Stents
SRO 595(I)/2023: Maximum Retail Price of Drugs and Biologicals Under CPI.
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
- Disposal of Short Shelf Life Cases
- Draft Guidance Document For Clinical Trials Of Biological Products (Manufacture Locally)
- Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders
- Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)
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.