Drap issues rapid alert of starting crackdown against unauthorised manufacturers
ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) as a part of its efforts to purge the country of counterfeit, fake and spurious drugs has issued a rapid alert of starting a crackdown against unlicenced/unauthorised manufacturers on receiving various complaints from provincial health authorities.
The pharma sector regulator, in an official communiqué, said the action is being taken against substandard products following official complaints received from the Drug, Water and Food Testing Laboratory, Gilgit-Baltistan (G-B), indicating that the following purported drug products have been declared “spurious” upon analysis and reportedly manufactured by entities not licensed or authorized by Drap. The relevant laboratory findings and product details are as under:
(i) Missron Tablet contains of Dydrogesterone 10mg (used for the treatment of menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions) with batch number 48022 manufactured by M/s Fegga Pharmaceutical, F-21/HPTC, SITE., Karachi. Drug Water and Food Testing Laboratory Gilgit-Baltistan declared the purported drug product as “spurious” as defined under clause (i) and (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
(ii) Quttefol OD tablets contains of L-Methyl-Folate (Folic Acid) 800 mcg, Vitamin B12, 1000 mcg with batch number QL-001 produced by M/s Adcok Pharmaceuticals Factory 3-km Defence Road Off-Raiwind Road, Lahore. Drug Water and Food Testing Laboratory G-B declared the purported drug product as under: – For assay of Vitamin B12, “Spurious” as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 and For assay of Folic Acid, “Substandard” as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976.
(iii) Depasrone Tablets contains of Dydrogesterone 10mg with batch number 2406 produced by M/s Alpine Laboratories, Plot A-41, SITE, Karachi. Drug Water and Food Testing Laboratory G-B declared the purported drug product as ‘Spurious’ as defined under clause (i) and (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
(iv) Dropha Tablets contains of Dydrogesterone 10mg, batch number DRP-0004 produced by M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, Karachi. Drug Water and Food Testing Laboratory G-B declared the purported drug product as “spurious” as defined under clause (i) and (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
All the above-mentioned purported drug products have been confirmed as falsified/spurious, as they are manufactured by entities that are neither licensed nor authorised by the Drap. These products are being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredients in some samples, indicating a complete lack of therapeutic value. The circulation and use of such unregulated products pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to Drap through its official reporting channels.
The Drap, following the information, started a crackdown against all such products and has issued recall alerts directing the National Regulatory Field Force (NRFF), Provincial Drug Control Departments, pharmacists, chemists in distribution, pharmacies/ medical stores, healthcare professionals – physicians, pharmacists, nurses at hospitals/clinics and general public to stop the use of purchase, sale, prescription and use of the drugs.
The manufacturers are directed to immediately recall the defective batches of products from the market. The field force under the administrative control of Drap and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market.
The regulatory field force of DRAP and provincial drug control departments have 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.
Copyright Business Recorder, 2025