New Delhi | Fresh concerns have emerged over drug quality and patient safety in India after the Central Drugs Standard Control Organisation (CDSCO) flagged one batch of a liver-related medicine as “spurious” and identified 169 other drugs and formulations as “Not of Standard Quality” (NSQ) during its routine surveillance exercise for April 2026. The findings have triggered concern across the pharmaceutical industry, hospitals, and healthcare circles.
According to the monthly drug alert report issued by CDSCO, the batch declared spurious involved Ursodeoxycholic Acid tablets, a medicine commonly prescribed for dissolving gallstones and treating liver-related disorders. The regulator said the suspect batch was detected during testing in Bihar.
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While the drug regulator did not disclose the brand name or the identity of the manufacturer, it stated that the company named on the label had informed authorities that the impugned batch had not been manufactured by them. Based on this clarification, the batch was categorised as a spurious or fake drug.
The surveillance report further revealed that a total of 169 drug samples failed to meet prescribed quality standards during April. Of these, 42 samples were tested in central laboratories while 129 were examined in state-run laboratories. Experts clarified that drugs falling under the NSQ category are not necessarily counterfeit, but they fail to comply with the pharmacopoeial standards laid down for safety, potency, or composition. In several cases, the quantity of active ingredients may vary, potentially reducing the effectiveness of treatment.
Healthcare experts warned that substandard medicines could directly impact patient outcomes, particularly in the treatment of critical illnesses involving the liver, heart, infections, and chronic diseases. In some cases, patients may not receive the intended therapeutic benefit, while in others the use of poor-quality medicines could lead to adverse reactions or medical complications.
Industry observers noted that India is one of the world’s largest producers of generic medicines, making stringent quality monitoring even more important. They stressed that tighter surveillance, stronger supply chain tracking systems, and better coordination between central and state drug authorities are necessary to curb the circulation of counterfeit or substandard medicines. Experts also pointed out that fake medicines often enter the market through unauthorised distributors, weak monitoring mechanisms, and informal supply networks.
CDSCO regularly conducts nationwide sampling and testing of medicines available in the market and publishes lists of products that fail quality checks. The exercise is aimed at safeguarding public health and ensuring that pharmaceutical manufacturers comply with mandated quality standards. Regulatory agencies, along with state drug control departments, typically initiate follow-up action to remove suspect batches from circulation and investigate the source of violations.
Medical experts have also advised consumers to avoid purchasing medicines from unregistered pharmacies or unverified online platforms. Patients are encouraged to carefully check batch numbers, expiry dates, packaging details, and manufacturer information before using any medicine. They have also been urged to immediately consult doctors and notify drug control authorities if any unusual side effects or suspected quality issues are observed after consumption.
The latest findings have once again highlighted growing concerns over pharmaceutical supply chain integrity in India. Experts believe the recurring detection of substandard and suspected fake medicines may push regulators to intensify enforcement measures and strengthen oversight mechanisms in the coming months to ensure patient safety and maintain confidence in the healthcare system.
