CDSCO flags spurious liver drug, 169 others fail quality tests in April

CDSCO flags one batch of a liver drug as spurious and identifies 169 drugs and formulations as not of standard quality during April surveillance

The Central Drugs Standard Control Organisation (CDSCO) has flagged one batch of a drug as spurious and listed 169 other drugs and formulations as not of standard quality (NSQ) in its routine surveillance for April 2026.

 

The spurious batch included ursodeoxycholic acid tablets, which are used to dissolve gallstones and manage liver issues. The CDSCO did not provide the brand name but said the batch was identified in Bihar.

 

While the regulator did not disclose the name of the manufacturer of the spurious tablets, it said the actual manufacturer, as per the label claim, had informed authorities that the impugned batch was not made by them and was therefore a spurious drug.

 

A drug is generally considered spurious when it is manufactured by unauthorised producers using brand names owned by other companies.

 

“The batch sampled for investigation was manufactured by an unauthorised manufacturer using the brand name owned by another company. The matter is under investigation and action will be taken as per the Drugs and Cosmetics Act,” an official familiar with the matter said.

 

The CDSCO also flagged samples of 169 drugs as NSQ, of which 42 were tested in central laboratories and 129 in state laboratories. These include commonly used formulations such as paracetamol, pantoprazole and multivitamin supplements.

 

The list also includes several batches of telmisartan tablets prescribed for high blood pressure, diclofenac-based pain relievers, as well as multiple combinations of levocetirizine and montelukast tablets used to treat allergy symptoms.

 

Drug samples are categorised as NSQ when they fail to meet specified quality parameters such as dissolution, uniformity of weight and assay of active ingredients.

 

“The failure is specific to the drug products of the batch tested by the government laboratory and does not warrant any concerns about other drug products available in the market,” the Union health ministry said in a press note.

 

The ministry added that the identification and removal of NSQ and spurious drugs is a regular, collaborative exercise between central and state regulators. It also clarified that the quality failure is limited to the batches tested and does not raise concerns about other batches of the same drugs available in the market.