Health Ministry bans high-dose Nimesulide oral drugs citing health concerns
The government noted that safer alternatives are readily available, making the continued availability of high-strength formulations unnecessary and against public interest.
PTC News Desk: The central government has announced a significant move concerning nimesulide, a widely used non-steroidal anti-inflammatory drug (NSAID) prescribed for pain, fever and inflammation. In the interest of public health, it has banned the manufacture, sale and distribution of oral nimesulide formulations containing more than 100 mg, with immediate effect, across the country.
As stated in the official notification, higher-dose oral preparations of nimesulide have been prohibited due to potential risks to human health. The government noted that safer alternatives are readily available, making the continued availability of high-strength formulations unnecessary and against public interest.
The ban has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, which authorises the Centre to restrict or prohibit drugs deemed unsafe. The decision followed consultations with the Drugs Technical Advisory Board (DTAB), the apex body that advises the government on technical issues related to drugs and cosmetics.
Nimesulide has long faced scrutiny over safety concerns, particularly its links to liver toxicity. The World Health Organization has excluded the drug from its Model List of Essential Medicines, reflecting international caution. Several countries have either limited or withdrawn its use due to reports of hepatic injury. In India, the Central Drugs Standard Control Organisation (CDSCO) has repeatedly reviewed its risk–benefit profile. Medical experts have also highlighted that commonly used alternatives such as paracetamol and ibuprofen, when taken at recommended doses, have a more established safety record, supported by evidence from bodies like the Indian Council of Medical Research (ICMR).
The order makes clear that the restriction takes effect immediately and applies uniformly across all states and Union Territories.
By prohibiting high-dose oral nimesulide, the government has taken a key step towards strengthening drug safety regulation in India, aiming to minimise preventable health risks while promoting the use of safer, well-studied options for managing pain and fever.