CDSCO flags spurious batch of Telma, 131 other drugs fail quality tests

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The country’s apex drug regulator has labelled 131 drugs and formulations as Not of Standard Quality (NSQ), while flagging a batch of the popular hypertension medicine Telma 40 as spurious.

 

In its monthly quality review for March 2025, the Central Drugs Standard Control Organisation (CDSCO) has named the brands for which it found spurious samples. However, it has not named the drugmakers.

 

One of the popular hypertension medication brands Telma 40 samples were found to be spurious in raids across locations.  

 

The health ministry, in a note, said that the spurious drug sample was identified from West Bengal, adding that it was manufactured by an unauthorised entity using the brand name owned by another company.

 

“The matter is under investigation and action will be taken according to rules,” the ministry note added.

 

Spurious drugs are fake or counterfeit medicines that falsely claim to be genuine, often containing incorrect, contaminated, or no active ingredients—making them ineffective and potentially harmful to patients.

 

“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug,” the CDSCO alert added.

 

Of the 131 drug samples found NSQ, 70 were identified by central drug laboratories, while 61 were tested at state laboratories.

 

The NSQ list includes batches of painkillers containing combinations of paracetamol with diclofenac and aceclofenac, as well as fixed drug combinations (FDCs) prescribed for conditions such as hypertension, heart diseases, acidity, fever and stomach ulcers.

 

Some combination medications also include cough syrups and anti-allergy formulations.

 

A note by the health ministry on the drugs alert stated that the failure is specific to the drug products of the batch tested by government laboratories and does not warrant concerns about other drug products available in the market.

 

As part of continuous regulatory surveillance, the CDSCO picks up drug samples from sales or distribution points, analyses them, and displays a list of spurious drugs on the CDSCO portal on a monthly basis.

 

“The purpose of displaying the spurious drugs list is to make stakeholders aware of the spurious drug batches identified in the market,” the NSQ alert stated.