India flags 169 substandard drug batches, probes fake Ursodeoxycholic Acid
India’s central drug regulator has flagged 169 medicine samples as ‘Not of Standard Quality’ (NSQ) in April 2025. Among these, one batch of Ursodeoxycholic Acid has been identified as potentially spurious and is now under investigation by authorities. The Central Drugs Standard Control Organisation (CDSCO) detected the issues during a routine nationwide surveillance exercise. State drug testing laboratories found 127 of the NSQ samples, while central laboratories identified the remaining 42. The problematic batches include commonly used medicines like paracetamol, metformin, amoxicillin, and cough syrups.
The potentially spurious Ursodeoxycholic Acid batch was collected from Bihar and produced in August 2024. The company listed on its packaging has denied manufacturing it. Under the Drugs and Cosmetics Act, 1940, a drug is classified as spurious if it falsely uses another product’s name or mimics it deceptively. Authorities have clarified that the findings relate only to these specific batches. The investigation does not suggest broader concerns about other medicines currently available in the market.
The CDSCO continues to examine the Ursodeoxycholic Acid case while monitoring the quality of medicines across the country. The flagged batches remain isolated incidents, with no evidence of wider contamination or systemic issues in the drug supply.
