The Drugs Controller General of India (DCGI) has directed the recall of 49 medicines from the market after they were found to be “not of standard quality” (NSQ) following routine quality checks. The decision, announced on October 25, 2024, was part of the regulator’s monthly quality control exercise, which identified both NSQ and spurious drugs. Legal action has also been initiated against the makers of four spurious drugs.
According to DCGI Rajeev Singh Raghuvanshi, the spurious drugs were produced by unauthorized manufacturers and traced back to unsanctioned sellers. He emphasized that the affected products did not necessarily pose a life-threatening risk, but certain batches failed to meet the required efficacy standards set under the Drugs and Cosmetics Act, 1940. NSQ drugs refer to those that do not adhere to quality standards, impacting their potency, composition, or performance.
Out of nearly 3,000 samples tested, 49 drugs were flagged for recall, constituting about 1.5% of the total. “The identification of NSQ drugs does not imply that these medicines are counterfeit or harmful,” Dr. Raghuvanshi explained. He stressed that only specific batches of the drugs have failed the tests, requiring a targeted recall of those batches. Not all units of the brand are affected, and manufacturers must promptly remove the failed batches from circulation.
Among the recalled medicines are painkillers, antifungal drugs, and diabetes treatments. Notable products flagged for quality issues include:
Metronidazole tablets I.P. 400 mg, produced by Hindustan Antibiotics Ltd., used to treat infections.
Oxytocin injection I.P. 5 IU/1 ml, manufactured by Pushkar Pharma, a synthetic hormone used during childbirth.
Metformin hydrochloride 500 mg, manufactured by Swiss Biotech Parenterals, used to regulate blood glucose levels in diabetes patients.
Diclofenac sodium tablets, a pain reliever by Hindustan Antibiotics Ltd.
Nimesulide and paracetamol tablets, produced by Innova Captab Ltd.
Pantoprazole gastro-resistant tablets, manufactured by Alkem Health.
Cefpodoxime tablets by Aristo Pharmaceuticals Pvt. Ltd.
Amoxicillin and potassium clavulanate tablets, manufactured by Alkem Health.
Ciprofloxacin tablets, produced by Cadila Pharmaceuticals Ltd.
The DCGI’s monthly testing process involves screening between 2,000 to 3,000 drug samples from the market. If any discrepancies in quality are detected, a recall is initiated immediately. Dr. Raghuvanshi noted that investigations begin with the seller and extend along the entire supply chain to identify the origin of any spurious product.
For spurious drugs, prosecution or administrative action is taken depending on the severity of the violation. In the case of NSQ medicines, immediate steps are taken to inform manufacturers and ensure the withdrawal of problematic batches from pharmacies and healthcare facilities.
The findings have been published on the official DCGI website, following routine practice. The regulator has assured the public that corrective measures are being implemented and that market monitoring will continue to prevent the recurrence of such issues.
The recall and action against unauthorized manufacturers underscore the importance of compliance with safety standards to maintain public trust in pharmaceuticals.
(Input from various sources)
(Rehash/Ankur Deka/MSM)