Substandard quality in 3,104 drugs, 245 found spurious in FY25: JP Nadda

Since December 2022, the Central Drugs Standard Control Organisation (CDSCO) has inspected 905 drug manufacturing and testing units, resulting in 694 regulatory actions, Nadda said

Between April 2024 and March 2025, a total of 3,104 drug samples were declared not of standard quality, while 245 were found to be spurious or adulterated, the government informed the Rajya Sabha on Tuesday. These results came from 1,16,323 drug samples tested across the country during the period.

 

The data was shared by Union Health Minister Jagat Prakash Nadda in response to a question on the prevalence of substandard and spurious drugs in the country.

 

Nadda also stated that between April 2023 and March 2024, a total of 1,06,150 drug samples were tested, out of which 2,988 were found to be not of standard quality and 282 were identified as spurious.

 

“Isolated cases regarding spurious/adulterated/sub-standard drugs are received from time to time,” Nadda said in the statement. 

 

Risk-based inspections and regulatory action 

Since December 2022, the Central Drugs Standard Control Organisation (CDSCO) has inspected 905 drug manufacturing and testing units, resulting in 694 regulatory actions, including stop production or testing orders, licence suspensions or cancellations, warning letters, and show-cause notices, Nadda said.

 

He further added that manufacturers whose drugs fail quality checks are required to immediately recall and halt further distribution of those batches.

 

As for whether the government plans to publish a list of compliant drug manufacturers to rebuild public trust, Nadda said that CDSCO already uploads alerts about drugs declared not of standard quality, spurious, misbranded or adulterated on its website under the ‘Drug Alert’ section.

 

Funding and policy initiatives 

To address broader challenges in drug quality, the government is implementing the Strengthening of Pharmaceutical Industry (SPI) scheme, which includes support for common facilities, technology upgrades for small and medium enterprises, and promotion of research and knowledge-sharing.

 

The ministry of health and family welfare is also running a centrally sponsored scheme - Strengthening of States’ Drug Regulatory System (SSDRS) - with an approved outlay of ₹850 crore, Nadda said, adding that the funding has supported the construction of 17 new drug testing labs and the upgradation of 24 existing labs.