NEW DELHI, April 16 – India’s top drug regulator has ordered state and union territory authorities to immediately halt the manufacture, sale, and distribution of 35 fixed-dose combination (FDC) drugs found to be unapproved and potentially unsafe, including commonly used painkillers, nutrition supplements and anti-diabetics.
The Central Drugs Standard Control Organisation (CDSCO) issued the directive in a letter dated April 11, citing violations of drug safety norms and warning of public health risks. The order follows findings that licenses for the affected FDCs were granted by state authorities without prior evaluation of their safety and efficacy by the Drugs Controller General of India (DCGI), in breach of regulatory procedures.
“It has come to the notice of this directorate that certain FDC drugs have been licensed… without prior evaluation of safety and efficacy as per the provisions of NDCT Rules 2019,” the DCGI, Dr. Rajeev Raghuvanshi, wrote in the communication. “This poses a serious risk to public health and safety.”
FDCs contain a combination of two or more active pharmaceutical ingredients (APIs) in fixed ratios and are regulated as “new drugs” under Indian law, requiring DCGI approval before state authorities can issue licenses.
The CDSCO warned that such unauthorized approvals undermine uniform enforcement of drug safety laws, and may lead to adverse drug reactions or harmful interactions due to a lack of scientific validation. The regulator cited repeated violations dating back more than a decade, despite multiple warnings. The latest letter references a similar notice from January 2013 and the most recent reminder from February 2025.
Manufacturers who received show-cause notices argued that their licenses were granted by state licensing authorities and thus did not breach regulations, according to the CDSCO. However, the DCGI said such actions compromise patient safety and demanded greater oversight from local regulators.
“All State and Union Territory drug controllers are requested to review their approval process for such FDCs and ensure strict compliance of the provisions of the act and rules,” the letter stated.
The communication included a list of the 35 unapproved FDCs, which were either cancelled by the respective licensing authorities or voluntarily surrendered by the manufacturers following regulatory scrutiny. India is among the world’s largest producers of generic medicines, and the latest crackdown underscores the country’s ongoing efforts to tighten oversight of pharmaceutical approvals in the wake of global concerns over drug quality and safety.
