ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has ordered a nationwide recall of various pharmaceutical products – eight for human use and nine veterinary – after lab tests found them substandard, spurious, or falsely labelled, raising serious safety concerns.
According to an alert issued, DRAP stated that various samples tested by provincial drug testing laboratories failed to meet pharmacopoeial standards, and in many cases, the medicines were found to be falsely labelled or lacking active ingredients altogether.
Among the human drugs flagged: 1) Rolekast 10mg tablets, manufactured by M/s Roryan Pharmaceutical Industries (Pvt) Ltd, were found substandard due to failures in dissolution and impurity tests, 2) AME-CLOP Injection, produced by M/s Ameer Pharma (Pvt) Ltd, contained visible particulate contamination, posing serious risks to patients suffering from nausea, vomiting, and gastrointestinal complications, 3) DORCIP Infusion, manufactured by M/s Trigon Pharmaceuticals (Pvt) Ltd, failed multiple tests including sterility, pH, endotoxins, and particulate matter, rendering it unsafe for critically ill patients, 4) Cipotic-D Sterile Eye Drops, purportedly produced by Barrett Hodgson Pakistan (Pvt) Ltd, were declared spurious under Section 3(zb) of the Drugs Act, 1976, and substandard based on sterility and pH testing, 5) Danzen DS tablets, allegedly manufactured by Helix Pharma, 6) Tebisil tablets, claimed to be made by Saffron Pharmaceuticals, 7) Cefspan 400mg capsules, and 8) Brexin tablets, attributed to CHIESI Farmaceutici Italy, were all declared spurious, with DRAP confirming that these products were either mislabelled or had no evidence of having been produced by the claimed manufacturers.
Laboratory testing confirmed that some of these drugs contained no active pharmaceutical ingredients, resulting in a complete loss of therapeutic effect and potentially fatal consequences for patients who relied on them for critical care.
DRAP warned that the use of such falsified medicines may lead to treatment failure, worsening of disease, and life-threatening reactions.
In parallel, DRAP also declared nine veterinary drugs substandard or misbranded after testing found issues such as assay failures, excessive impurities, bacterial endotoxins, and misleading labelling. These include: 1) Micrise-2pc injection by Biorise Pharmaceuticals, 2) Ivozon 2pc by Amazon Pharmaceuticals, 3) IVERMEC 1pc by Grand Pharma, 4) Selmec by Selmore Pharmaceuticals, 5) Ivomek 2pc by Nawal Pharmaceuticals, 6) Ivergen by Symans Pharmaceuticals, 7) Fosphovetz, 8) Oxyvetz 5pc by Vetz Pharmaceutical and 9) Injection OXYZON produced by M/s. Amazon Pharmaceutical
These drugs, widely used in livestock such as cattle, goats, and sheep for parasitic control and infection treatment, were found to pose risks of toxicity, therapeutic failure, and unsafe residues in milk and meat – creating serious public and animal health hazards.
DRAP has directed its regulatory field force, along with provincial health departments, to immediately survey markets and ensure the removal of these products. Pharmacists, chemists, and distributors have been instructed to quarantine affected stocks, halt all supply, and return the products to their source.
Healthcare providers and institutions are advised to enhance vigilance across supply chains and report any suspicious or low-quality batches to DRAP via the designated online reporting system or by email at [email protected].
Consumers are strongly advised to discontinue use of these products if they belong to the identified batches, consult healthcare providers if exposed, and purchase medicines only from licensed pharmacies after verifying product authenticity.
DRAP reiterated that such falsification and manufacturing failures present a grave threat to public safety and called upon all stakeholders to cooperate fully in ensuring the effective recall of all defective medicines from the market.
When contacted Chairman Pakistan Pharmaceutical Manufacturers Association (PPMA), Tauqeer Ul Haq said recall alerts was a normal process regulator use to issue on the reports of the provincial departments.
When he was asked what actions DRAP use to take against in such a situation, Haq said that DRAP further investigate the matter and also the affected company files an appeal against the decision, if, the medicine is found faulty, the whole batch is disposed-off and if there is no problem found during detail investigation, the regulator allows the producer to re-supply the drug in the market.
Copyright Business Recorder, 2025
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