More than 3,000 drug samples tested across India in 2024–25 failed to meet quality standards, Union Health Minister J P Nadda informed the Lok Sabha, highlighting persistent concerns over substandard and spurious medicines in the country. Of the 1.16 lakh samples analysed during the year, 3,104 were declared “not of standard quality” (NSQ), while 245 were categorised as spurious or adulterated.
Sharing year-on-year data, Nadda said that in 2023–24, regulators tested 1.06 lakh samples, of which 2,988 were found NSQ and 282 classified as spurious or adulterated. In 2022–23, out of 96,173 samples, 3,053 failed quality standards and 424 were labelled spurious, underlining that the problem of poor-quality drugs has remained significant over the past three years despite increased regulatory scrutiny.
To tighten oversight, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with state regulators, launched risk-based inspections of drug manufacturing and testing units in December 2022. Firms are prioritised for inspection based on risk criteria, including the number of NSQ drugs, complaints and product criticality. Since then, more than 960 premises have been inspected and over 860 regulatory actions taken, including show-cause notices, warning letters, stop-production orders and licence cancellations under the Drugs Rules, 1945.
Nadda also stated that details of drugs declared NSQ, spurious or adulterated by central drug testing laboratories are regularly published on the CDSCO website under the ‘Drug Alert’ section, along with the actions initiated under the Drugs and Cosmetics Act, 1940 and allied rules. This public disclosure is aimed at improving transparency and enabling healthcare professionals and patients to stay informed about regulatory findings.
To strengthen the regulatory ecosystem, the Ministry of Health and Family Welfare is implementing the centrally sponsored scheme “Strengthening of States’ Drug Regulatory System” (SSDRS). Under the programme, Rs 756 crore has been released to states and Union Territories as central support, leading to the construction of 17 new drug testing laboratories and upgradation of 24 existing labs and state drug control offices across the country, in a bid to enhance testing capacity and enforcement capability.
