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Month: April 2025

Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

Ahsan Hafiz Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/04-25-36
Action Date15th April, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

Product Batch No Manufacturer Name
(as per label) 		Remarks
GABICA CAPSULE

Each capsule contains:
Pregabalin……300mg		399C27M/s Getz Pharma (Pvt) Ltd.,
29-30/27 , Korangi Industrial Area, Karachi.		‘Substandard’ with regards to Assay and Dissolution, ‘Spurious’ as per Section 3(z-b) (ii)and ‘Adulterated’ as per Section 3(a)(v) of Drugs Act, 1976.

Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products 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.

Recall Alert: SUBSTANDARD PRODUCTS DECLARED BY PROVINCIAL DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/04-25-35
Action Date07th April, 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured byTest Results
Amekoran Injection

 
Reg. No. 053627		Each 2mL contains:
Amikacin (as Sulphate).…250mg		BK-019M/s Ameer Pharma (Pvt) Ltd,
23-Km, Sheikhupura Road, Lahore.		‘Substandard’ on the basis of visible particulates.
Ortizin Tablet

 
Reg. No. 025405		Each film coated tablet contains:
Cetirizine dihydrochloride.…10mg		24I268M/s. Obsons Pharmaceuticals,
209-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.		‘Substandard’ with regards to impurities.
AQUA-P Injection

 
Reg. No. 034290		Sterile water for Injection 5mlP-669M/s. IPRAM International,
Plot No. 26, St # S.S-3, National Industrial Zone,  Rawat.		‘Substandard’ on the basis of visible particulate matter. 
Injection Dorcip 100ml


Reg. No. 046086		Ciprofloxacin as lactate….2mg/mlDC-121M/s. Trigon Pharmaceuticals (Pvt) Ltd. 8-Km, Thokar Raiwind Road, Lahore.  ‘Substandard’ with regards to visible particulates in injection and Sterility Test.
Meclomine Tablet 500mcg

Reg. No.  042601		Each film coated tablet contains:
Mecobalamine…500mcg		8482M/s Alfalah Pharma (PVT) Ltd.,
12-Km, Sheikhupura Road, Lahore.		‘Adulterated’ as per section 3(a)(iv) of Drugs Act, 1976.
Meclomine Tablet 500mcg


Reg. No. 042601		Each film coated tablet contains:
Mecobalamine…500mcg		8440M/s Alfalah Pharma (PVT) Ltd.,
12-Km, Sheikhupura Road, Lahore.		‘Substandard’ on the basis ofPhysical Description & Assay Testand ‘Adulterated’ as per section 3(a)(iv) of Drugs Act, 1976.
Injection Neocobal

Reg. No. 042601		Mecobalamine 0.5mg/mlS-2455M/s Pulse Pharmaceuticals (Pvt.) Ltd.,
Sua Aasil, Raiwind Road, Lahore.		‘Substandard’ on the basis ofAssay Testand ‘Adulterated’ as per Drugs Act, 1976.
Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.
– All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

–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 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 ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 these 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 product.

-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.

    Decisions of the Medical Device Board from 75-85th Meetings

    Muhammad Ayub Naveed Medical Devices Board

    The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan, in its 75-85th meetings, has decided on the following applications for registration/enlistment of medical devices. The applicants, where applicable, are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The details are provided in the below attachments.

    Decisions of the 75th Meeting of the Medical Device Board

    Decisions of the 76th Meeting of the Medical Device Board

    Decisions of the 77th Meeting of the Medical Device Board

    Decisions of the 79th Meeting of the Medical Device Board

    Decisions of the 80th Meeting of the Medical Device Board

    Decisions of the 81st Meeting of the Medical Device Board

    Decisions of the 82nd Meeting of the Medical Device Board

    Decisions of the 83rd Meeting of the Medical Device Board

    Decisions of the 84th Meeting of the Medical Device Board

    Apply for Membership of the Central Licensing Board, DRAP

    Abdul Qadir Careers