The government of India has formally banned all oral formulations of nimesulide above 100mg, including nimesulide + paracetamol combination tablets, effective December 29, 2025. The ban covers the manufacture, sale, and distribution of these high‑dose painkillers nationwide after the Drugs Technical Advisory Board (DTAB) found them to be extremely harmful to human health.
The restriction is aimed at immediate-release tablets with more than 100mg of nimesulide and lower dose 100mg formulations can be prescribed. The decision was based on growing evidence that high-dose nimesulide exposure was related to severe adverse effects, said the FDA.
Medical experts say these banned tablets result in liver damage, kidney failure, internal bleeding and even death if not treated promptly. The combination of nimesulide with paracetamol is particularly dangerous as it can trigger drug‑induced liver failure requiring emergency transplant, gastrointestinal ulcers and multi‑organ damage.
Many people have taken high‑dose nimesulide tablets without realizing the risks of mild fever, headache and pain relief for too long. Even casual use of such formulations can have a high risk of irreversible harm, health officials warned.
The ban is likely to curb misuse and self-medication in India in many places. Pharmacies that sell these prohibited tablets will be heavily punished with fines and suspension of licenses and the same is the case for retailers who sell the drugs in pharmacies. Physicians are urging patients to seek medical help with safe substitutes such as paracetamol, ibuprofen, and other approved analgesics.
This is also the very best way for India to be in line with international best practices as several countries had already banned or restricted nimesulide because of its safety. Through the ban the government will be able to boost drug safety and prevent preventable health crises.
We believe the ban on high‑dose nimesulide tablets is the most significant change in the regulation of drugs in India. The government strongly advises against purchasing and using any nimesulide tablets with a dosage of more than 100mg and should consult a doctor for pain and fever management.
