CDSCO flags 7 drugs as spurious, 167 fail quality tests in Dec 2025

CDSCO has flagged seven drug batches as spurious and listed 167 others as not of standard quality in its December 2025 surveillance, covering common medicines for BP, pain and allergies

The Central Drugs Standard Control Organisation (CDSCO) has flagged select batches of seven drugs as spurious and listed 167 other drugs and formulations as not of standard quality (NSQ) in its routine surveillance for December 2025.

Which drugs were flagged as spurious by CDSCO?

Among the spurious drugs were three batches of Telma-AM and Telma 40, which are used to treat hypertension. The CDSCO also found spurious batches of Montina L, used to treat allergy symptoms such as runny nose, the antacid Pantop D, and two batches of pain reliever Chymoral Forte.

Where were the spurious drug samples detected?

The central drug regulator said that of the seven drug samples found spurious, four were identified from its North Zone jurisdiction, which includes Uttar Pradesh, Uttarakhand, Rajasthan, Punjab, Haryana, Himachal Pradesh, Delhi and Jammu and Kashmir.

 

One spurious sample each was also identified from Bihar, Maharashtra and the CDSCO’s Food and Drug Administration (FDA) laboratory in Ahmedabad.

What did CDSCO say about the manufacturers of spurious drugs?

While the regulator did not disclose the name of the manufacturer of the spurious syrup, 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.

How many drugs failed quality tests in December 2025?

The CDSCO also flagged samples of 167 drugs as NSQ, of which 74 were tested in central laboratories and 93 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.

What does ‘not of standard quality’ mean?

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.