196 Drug Samples Fail CDSCO Tests One Deca-Durabolin Sample Declared Spurious

In a concerning development, 196 drug samples have failed quality tests conducted by the Central Drugs Standard Control Organization (CDSCO), with one sample flagged as spurious. The spurious drug, a Nandrolone Decanoate injection marketed under the name Deca-Durabolin, was found to be manufactured by an unauthorized entity using a brand name owned by another company.

The Union Health Ministry clarified that the sample was collected from Bihar and failed due to issues with its identification and assay parameters. Deca-Durabolin, an anabolic steroid widely used for treating conditions like osteoporosis and anemia, is marketed in India by Zydus Healthcare, following its acquisition of the brand from Merck in 2016.

Of the 196 samples classified as “Not of Standard Quality” (NSQ), 60 were flagged by central laboratories, while 136 samples were identified by state laboratories. These include commonly used drugs such as Nimesulide tablets, Paracetamol tablets, and Cefpodoxime Proxetil tablets, manufactured by various pharmaceutical firms.

The ministry emphasized that these failures are specific to the tested batches and do not indicate risks associated with other batches of the same drug. Regular monthly testing is conducted to ensure substandard or spurious medicines are detected and removed from the market.

According to the Drugs and Cosmetics Act, 1940, a drug is deemed spurious if it is manufactured to deceive or bears the label of another drug. The CDSCO’s continuous monitoring ensures that public safety remains a top priority.