Drug regulator CDSCO flags 3 drugs as spurious, 56 not of standard quality

CDSCO made the revelation in its monthly update for October; drugs include those used to treat acid reflux, lower cholesterol and reduce risk of heart disease

The Central Drug Standards Control Organisation (CDSCO) on Friday flagged select batches of three drugs as spurious and listed 56 other drugs and formulations as not of standard quality.

 

The drugs flagged as spurious in CDSCO’s recent monthly update for October 2024 include antibiotic Taxim-O 200 (Alkem), antacid Pan D (Alkem), Sun Pharma's Rosuvas 10 tablet, used to lower cholesterol and reduce the risk of heart disease. 

 

While the CDSCO alert has named the brands for which they found spurious samples, the alert, however, does not name 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 product is purported to be spurious, however, the same is subject to the outcome of investigation,” the replies state.

 

The apex drug regulatory body has also listed 56 drugs and formulations, manufactured by 49 companies, as not of standard quality (NSQ). NSQ drugs are those that do not meet the quality standards set by national or international authorities.

 

These drugs include batches of fixed drug combinations (FDCs) such as hypertension medication Antas PRP manufactured by Intas Pharmaceuticals. The list also includes Decitabine for Injection 50 mg per vial, used to treat rare blood cancers which is manufactured by Dr Reddy’s Laboratories (DRL). 

 

DRL and Intas have not responded to the queries mailed by Business Standard. 

 

Most of these units are located in cities such as Ahmedabad, Himachal Pradesh’s Baddi and Uttarakhand’s Haridwar and Roorkee, whereas samples were tested by the central laboratories, including those in Kolkata, Mumbai, Hyderabad, Guwahati, and Chandigarh.

 

The CDSCO also released a state list of 34 drugs, manufactured by 25 companies that were found to be NSQ under various degrees of counts.

 

These include fourteen drugs manufactured out of Himachal Pradesh and six from Kerala, including four drugs manufactured by a company called the Kerala Medical Services Corporation.

 

Nine drugs manufactured by units based in Baddi were also classified as NSQ in the state list.