Spurious batch of Telma H flagged, 103 other drugs fail CDSCO tests

Telma H is manufactured by Glenmark Pharmaceuticals and is prescribed for controlling high blood pressure, particularly in individuals prone to water retention or heart failure

The country’s apex drug regulator has labelled 103 drugs and formulations as Not of Standard Quality (NSQ) while flagging a batch of popular hypertension medicine Telma H as spurious.

 

The Central Drug Standards Control Organisation (CDSCO), in its monthly quality review for February, has named the brand for which they found spurious samples, however, it has not named the drugmakers.

 

“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 said.

 

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.

 

And of the 103 drug samples, 47 were identified by central drug laboratories while 56 were checked at state laboratories. 

 

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

 

Some combination medication samples include FDC syrups used to treat cough, cold and deficiency of B vitamins. 

 

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.