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Spike in fake drug seizures: Govt presents action plan in Parl

New Delhi: The government has recently noted an increasing trend in the number of spurious and substandard drug samples detected in India over the last five years, with more than 1.16 lakh drug samples being tested in 2024-25 alone.

The term “counterfeit medicines” does not appear in a technical definition under Indian drug law. The government, however, assured that instances of spurious, adulterated, and misbranded drugs are being actively monitored and prosecuted under the Drugs and Cosmetics Act, 1940.

In response to an unstarred question asked by the Trinamool Congress Lok Sabha member Deepak Adhikari (Dev), Minister of State for Health and Family Welfare, Anupriya Patel, recently informed the House that more than 3,100 samples were of non-standard quality (NSQ) in the ongoing financial year, out of which 245 were spurious or adulterated, leading to 961 prosecutions initiated against violators.

“Although the Act does not explicitly define ‘counterfeit medicines’,” Patel explained, “it certainly encompasses classes such as spurious, misbranded and adulterated drugs, and appropriate action is taken accordingly.”

The statistics reflect a steady rise in the count of drug samples analysed year after year, from 84,874 in 2020-21 to more than 1.16 lakh in 2024-25. In the same timeframe, the detection of spurious and adulterated drugs has varied, with 424 cases being detected in 2022-23, before dropping marginally to 245 in the ongoing fiscal year.

As a part of its quality monitoring regime, the Central Drugs Standard Control Organisation (CDSCO) issues monthly drug alerts regularly, putting up the details of NSQ drugs on its website to provide transparency and make the public aware. “Whenever a drug is found to be not of standard quality, CDSCO immediately instructs the concerned manufacturers to recall such products and discontinue further distribution,” informed Patel.

She also clarified that after investigations, the licensing authorities of States and Union Territories are authorised to impose tough measures such as production suspensions, suspension of testing, cancellation of licenses, warning letters, and show-cause notices.

The Centre’s response indicates increasing questioning of pharmaceutical production processes in the face of increasing anxiety over drug safety and regulatory compliance, with the CDSCO remaining as the nodal agency for enforcement.

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