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RAPID ALERT – CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCTS

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert NoNo I/S/08-25-56
Action Date20th August, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#Product NameBatch No.Purported ManufacturerRemarks
1 Brexin Tablet Each tablet contains: Piroxicam-β-Cyclodextrine (Lyophilized) e.q to Piroxicam……20mg1192087Purported to be manufactured underlicense of Chiesi Farmaceutici S.P.A., PARMA-ITALY Marketed by: Chiesi Pharmaceuticals Pvt. Ltd., Lahore.Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976.
 2Tablet Zetro 500mg (Reg. # 053120)   Each film coated tablet contains: Azithromycin (as dihydrate) ………………….500 mg  F18031Purported to be manufactured underM/s Getz Pharma (Private) Limited.  Plot # 01, Sector 25, Korangi Industrial Area, Karachi (DML# 000933).  Drug Testing Laboratory, Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
3 Tablet Augmentin 625mg   Each film coated tablet contains: Amoxicillin (as trihydrate) …………… 500 mg. Clavulanic Acid (as potassium salt) …… 125mg.  7F4WPurported to be manufactured underM/s GlaxoSmithKline Pakistan Limited, F/268, S.I.T.E. Karachi (DML# 000233).Drug Testing Laboratory, Multan declared the purported drug product as   ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
 4Tablet TONOFLEX-P   Each Film Coated Tablet Contains: Tramadol HCl …… 37.5 mg Paracetamol ……… 325 mg  KFM145Purported to be manufactured underM/s Sami Pharmaceuticals (Pvt.) Ltd. F-95, S.I.T.E. Karachi (DML# 000072).Drug Testing Laboratory, Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
 5Tablet EFASTON   Each film coated tablet contains Dydrogesterone …… 10 mg41160Purported to be manufactured underM/s Lahore Chemical & Pharmaceutical Works (Private) Limited. 137- Ferozepur Road, Lahore (DML# 000064).Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
 6Capsule Gabica 300 mg   Each Capsule contains: Pregabalin ……… 300 mg403C27Purported to be manufactured underM/s Getz Pharma (Private) Limited.  29-30/27 Korangi Industrial Area, Karachi (DML# 000284) (recovered from Peddler / Hawker)Drug testing Laboratory Multan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
 7Imcomox Capsule   Each Capsule Contains: Amoxycillin trihydrate eq. to Amoxycillin (U.S.P) …. 500mg  08Purported to be manufactured underM/s IMCO Pharmaceutical Labs. 73- Industiral Estate, Hayatabad, Peshawar. (DML # 000317)Drug Testing Laboratory, Faisalabad declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
 8Omnidol NU Tablet   Each uncoated tablet contains: Paracetamol …….500mg Caffeine …………….65 mg1220Purported to be manufactured underM/s Olive Laboratories. Plot No.52-S-6 National Industrial Zone Rawat Rawalpindi. (000524)Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as under: – For assay of caffeine, ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 & For assay of Paracetamol,   ‘Substandard’  as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976.
 9CAPSULE CEFSPAN 400 mg   Each capsule contains: Cefixime………400mgF0580Purported to be manufactured underM/s Barrett Hodgson Pakistan (Pvt) Ltd.
F/423 SITE Karachi. (000457)		Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
 10CAPSULE ICON 100 mg Each capsule contains: Itraconazole pellets eq. To itraconazole 100 mg  241694Purported to be manufactured underM/s Ferozsons Laboratories Ltd. Amangarh Nowshera (DML #000038)Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
 11Tablet NOVIDAT Each film coated tablet contains:  Ciprofloxacin Hydrochloride eq. to Ciprofloxacin 500mgFIM147Purported to be manufactured underM/s Sami Pharmaceuticals (Pvt) Ltd. F-95 Off Hub River Road, SITE Karachi. (DML # 000072)Drug Testing Laboratory Rawalpindi declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.

(Please find pictorial guidelines for identification of falsified products in the pdf version to be downloaded from link above)

Risk StatementAll the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company—whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
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.