DRAP Alert No: I/S/08-25-56
Date of Action: 20th August 2025
Intended Audience:
Regulatory Field Force of DRAP and Provincial Drug Control Departments
Healthcare Professionals
Pharmacies and Medical Stores
Problem Statement
Provincial Drug Testing Laboratories have notified the Drug Regulatory Authority of Pakistan (DRAP) that the following products have been declared “Spurious”. The details are provided below.
Therapeutic Goods Affected
Brexin Tablet
Composition: Each tablet contains Piroxicam-β-Cyclodextrine (Lyophilized) equivalent to Piroxicam 20 mg
Batch No.: 1192087
Purported Manufacturer: Under license of Chiesi Pharmaceutical S.P.A., Parma-Italy. Marketed by: Chiesi Pharmaceuticals Pvt. Ltd., Lahore.
Remarks: Drug Testing Laboratory, Rawalpindi (Punjab) declared the product as “Spurious” under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.
Tablet Zetro 500 mg (Reg. # 053120)
Composition: Each film-coated tablet contains Azithromycin (as dihydrate) 500 mg
Batch No.: F18031
Purported Manufacturer: Getz Pharma (Pvt.) Ltd., Plot # 01, Sector 25, Korangi Industrial Area, Karachi (DML# 000933).
Remarks: Declared “Spurious” by Drug Testing Laboratory, Rawalpindi under clause (i) of subsection (z-b).
Tablet Augmentin 625 mg
Composition: Each film-coated tablet contains Amoxicillin (as trihydrate) 500 mg, Clavulanic Acid (as potassium salt) 125 mg
Batch No.: 7F4W
Purported Manufacturer: GlaxoSmithKline Pakistan Ltd., F/268, S.I.T.E., Karachi (DML# 000233).
Remarks: Declared “Spurious” by Drug Testing Laboratory, Multan under clause (i) & (ii) of subsection (z-b).
Tablet Tonoflex-P
Composition: Each film-coated tablet contains Tramadol HCl 37.5 mg, Paracetamol 325 mg
Batch No.: KFM145
Purported Manufacturer: Sami Pharmaceuticals (Pvt.) Ltd., F-95, S.I.T.E., Karachi (DML# 000072).
Remarks: Declared “Spurious” by Drug Testing Laboratory, Rawalpindi under clause (i) & (ii) of subsection (z-b).
Tablet Efaston
Composition: Each film-coated tablet contains Dydrogesterone 10 mg
Batch No.: 41160
Purported Manufacturer: Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., 137-Ferozepur Road, Lahore (DML# 000064).
Remarks: Declared “Spurious” by Drug Testing Laboratory, Rawalpindi under clause (i) & (ii) of subsection (z-b).
Capsule Gabica 300 mg
Composition: Each capsule contains Pregabalin 300 mg
Batch No.: 403C27
Purported Manufacturer: Getz Pharma (Pvt.) Ltd., 29-30/27 Korangi Industrial Area, Karachi (DML# 000284). (Recovered from peddler/hawker)
Remarks: Declared “Spurious” by Drug Testing Laboratory, Multan under clause (i) & (ii) of subsection (z-b).
Imcomox Capsule
Composition: Each capsule contains Amoxicillin trihydrate equivalent to Amoxicillin (USP) 500 mg
Batch No.: 08
Purported Manufacturer: IMCO Pharmaceutical Labs, 73-Industrial Estate, Hayatabad, Peshawar (DML# 000317).
Remarks: Declared “Spurious” by Drug Testing Laboratory, Faisalabad under clause (i) & (ii) of subsection (z-b).
Omnidol NU Tablet
Composition: Each uncoated tablet contains Paracetamol 500 mg, Caffeine 65 mg
Batch No.: 1220
Purported Manufacturer: Olive Laboratories, Plot No. 52-S-6, National Industrial Zone, Rawat, Rawalpindi (DML# 000524).
Remarks: Drug Water & Food Testing Laboratory, Gilgit-Baltistan declared:
For caffeine assay → “Spurious” under clause (i) of subsection (z-b).
For paracetamol assay → “Substandard” under subsection (zz).
Capsule Cefspan 400 mg
Composition: Each capsule contains Cefixime 400 mg
Batch No.: F0580
Purported Manufacturer: Barrett Hodgson Pakistan (Pvt.) Ltd., F/423 S.I.T.E., Karachi (DML# 000457).
Remarks: Declared “Spurious” by Drug Testing Laboratory, Rawalpindi under clause (i) & (ii) of subsection (z-b).
Capsule Icon 100 mg
Composition: Each capsule contains Itraconazole pellets equivalent to Itraconazole 100 mg
Batch No.: 241694
Purported Manufacturer: Ferozsons Laboratories Ltd., Amangarh, Nowshera (DML# 000038).
Remarks: Declared “Spurious” by Drug Testing Laboratory, Rawalpindi under clause (i) & (ii) of subsection (z-b).
Tablet Novidat
Composition: Each film-coated tablet contains Ciprofloxacin Hydrochloride equivalent to Ciprofloxacin 500 mg
Batch No.: FIM147
Purported Manufacturer: Sami Pharmaceuticals (Pvt.) Ltd., F-95, Off Hub River Road, S.I.T.E., Karachi (DML# 000072).
Remarks: Declared “Spurious” by Drug Testing Laboratory, Rawalpindi under clause (i) & (ii) of subsection (z-b).
(Pictorial identification guidelines are available in the official PDF version.)
Risk Statement
All the products listed above are confirmed falsified/spurious because their packaging falsely claims manufacture by licensed companies, whereas they are not. Laboratory results show absence of active pharmaceutical ingredients, meaning no therapeutic effect. Such falsified drugs pose serious public health risks, including treatment failure, disease progression, and life-threatening outcomes—especially for patients depending on these medicines for essential therapy. The public is strongly advised not to use these products and to report any suspicious medicines to DRAP immediately.
Actions Taken
The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned unregistered/falsified products.
Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.
Guidance for Healthcare Professionals
DRAP advises healthcare professionals to remain vigilant in pharmacies, healthcare facilities, and supply chains potentially affected by these products. Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.
Guidance for Consumers
Consumers must avoid these products. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.
Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.
Reference:
Drug Regulatory Authority of Pakistan. (2025, August 20). Rapid alert – Crackdown against falsified / spurious drug products [Webpage]. Drug Regulatory Authority of Pakistan, Ministry of National Health Services, Regulations & Coordination. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/rapid-alert-crackdown-against-falsified-spurious-drug-products/
