The Ministry of Health and Family Welfare (MoHFW) has banned the manufacture, sale and distribution of oral formulations containing Nimesulide above 100 mg in immediate-release dosage form, citing potential risks to human health. The decision was notified on December 29 and is effective immediately.
Nimesulide is a widely used non-steroidal anti-inflammatory drug (NSAID) prescribed for pain, inflammation and fever in adults. It is commonly sold in India under popular brand names such as Nise, Nimulid, Nicip, and several fixed-dose combinations.
What exactly has been banned?
According to the official notification, the prohibition applies to:
- All oral formulations containing Nimesulide above 100 mg
- Immediate-release dosage forms only
- For human use
This is not a blanket ban on Nimesulide. Lower-dose formulations (100 mg or less) and other permitted forms are not covered under this notification.
Why did the government ban high-dose Nimesulide?
The MoHFW stated that it is “satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate-release dosage form are likely to involve risk to human beings” and that safer alternatives are available.
The decision follows recommendations from the Drugs Technical Advisory Board (DTAB) and has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the Centre to prohibit drugs in public interest.
Health authorities have long flagged concerns around hepatotoxicity (liver toxicity) linked to Nimesulide, especially at higher doses.
Previous restrictions on Nimesulide
This is not the first regulatory action against the drug:
- Use in children below 12 years was already banned earlier, citing higher susceptibility to liver toxicity.
- In February this year, the government also prohibited Nimesulide and its formulations for animal use.
The latest move extends safety restrictions to high-dose adult formulations.
Impact on pharmaceutical companies
Nimesulide is manufactured and marketed by several Indian drugmakers, either as standalone tablets or in combination therapies. Companies with exposure include:
- Dr Reddy’s Laboratories
- Cipla
- Sun Pharmaceutical Industries
- Abbott India
- Alkem Laboratories
- Torrent Pharmaceuticals
- Lupin
- Intas Pharmaceuticals
The ban may require companies to withdraw or reformulate high-dose products, while continuing lower-dose alternatives where permitted.
What should patients do?
Health authorities have advised that:
- Patients should not stop medication abruptly
- Those currently using higher-dose formulations should consult their doctors
- Physicians may prescribe safer alternative pain-relief or anti-inflammatory drugs
Big picture
The move reflects the government’s continued focus on drug safety and risk-benefit evaluation, especially for widely used medicines. By restricting high-dose immediate-release Nimesulide, regulators aim to reduce potential liver-related adverse effects while ensuring that safer treatment options remain available.
Patients and healthcare providers are expected to gradually shift toward alternative therapies as the ban comes into force nationwide.
