India flags 169 substandard medicines, including a potentially fake drug batch
India’s central drug regulator has flagged 169 medicine samples as 'Not of Standard Quality' (NSQ) in April 2025. The findings came from a nationwide surveillance effort involving both central and state testing labs. Among the samples, one was marked as potentially spurious—a batch of Ursodeoxycholic Acid, used to treat gallbladder stones and liver conditions.
The 169 NSQ samples included common medicines like paracetamol, metformin, and amoxicillin-based antibiotics. Of these, 42 were identified by central laboratories, while state drug testing labs detected the remaining 127.
The potentially spurious Ursodeoxycholic Acid batch was collected from Bihar and reportedly manufactured in August 2024. However, the company named on the packaging has denied producing it. Under the Drugs and Cosmetics Act, 1940, a drug is classified as spurious if it falsely uses another product’s name or mimics a different medicine in a misleading way. The Central Drugs Standard Control Organisation (CDSCO) is now investigating the matter. Officials have stressed that the issue is confined to the specific batches tested and does not suggest broader problems with other medicines currently on the market. The identification of NSQ and potentially spurious drugs forms part of a routine surveillance programme conducted with state regulators.
The CDSCO’s investigation into the Ursodeoxycholic Acid batch remains ongoing. Authorities have clarified that the findings relate only to the tested samples and do not reflect wider quality concerns. The regulator continues to monitor drug standards through regular nationwide checks.
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