CDSCO Flags 169 Drug Samples As Substandard, Identifies One Potentially Spurious Medicine Batch

CDSCO Flags 169 Drug Samples As Substandard, Identifies One Potentially Spurious Medicine Batch

India’s central drug regulator flagged 169 medicine samples as Not of Standard Quality during April inspections, while one batch of Ursodeoxycholic Acid was identified as potentially spurious. Authorities said the findings are part of routine nationwide drug surveillance and investigations into the suspicious batch are ongoing.

Amit SrivastavaUpdated: Saturday, May 23, 2026, 09:02 PM IST
CDSCO Flags 169 Drug Samples As Substandard, Identifies One Potentially Spurious Medicine Batch
India’s drug regulator intensified quality surveillance after multiple medicine samples failed laboratory standards during routine nationwide testing | Representational Image

Mumbai, May 23: India’s central drug regulator has flagged 169 drug samples as “Not of Standard Quality” (NSQ) during its routine quality checks conducted in April, while one medicine sample has been identified as potentially spurious.

According to the findings, 42 of the NSQ samples were detected by central laboratories (CDSCO), while state drug testing laboratories identified the remaining 127 samples.

The list includes widely used medicines such as paracetamol, metformin, sitagliptin combination drugs used for diabetes treatment, amoxicillin-based antibiotics, and several cough syrups.

Potentially spurious medicine under investigation

A sample of Ursodeoxycholic Acid, a medicine commonly prescribed for gallbladder stones and liver-related cholestatic disorders, has been marked as spurious.

The batch in question was reportedly collected from Bihar and manufactured in August 2024. The Central Drugs Standard Control Organisation (CDSCO) stated that the company named on the label has denied manufacturing the batch.

Officials said the matter is currently under investigation, and the product will continue to be treated as potentially spurious until the probe is completed.

Under the Drugs and Cosmetics Act, 1940, a drug is considered spurious if it is manufactured under the name of another product or imitates another medicine in a misleading manner that could deceive consumers.

Routine surveillance exercise continues

The Union Health Ministry clarified that the issue is limited to the specific batches tested by government laboratories and does not indicate any wider concern regarding other medicines currently available in the market.

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Authorities said the identification of NSQ and spurious drugs is part of a regular nationwide surveillance exercise carried out jointly with state regulators to ensure such products are removed from circulation.

In the previous reporting cycle for March, regulators had similarly identified 168 drug samples as NSQ and one sample as spurious.

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