Last Updated on May 3, 2025 by The Health Master
Nimesulide
The Indian Council of Medical Research (ICMR), the leading body of India for health research, has recommended stricter regulations on the widely and frequently used pain and fever drug, Nimesulide.
Highlighting safety concerns, the ICMR has recommended a ban on the drug for individuals under the age of 18 and those aged 60 and above.
The ICMR has also recommended prohibition of all formulations of Nimesulide exceeding 100 mg across all age groups.
Availability of Nimesulide’s in the Indian Market
Nimesulide is easily available in India under various popular brand names, including Nimulid, Nimtex, and Nicip etc.
Notably, Dr. Reddy’s Laboratories’ brand, Nise, stands as the top-selling Nimesulide drug in the country.
According to data from the market research firm PharmaTrac, the Indian market for Nimesulide is substantial, valued at ₹497 crore and demonstrating an 11% growth rate over the past year.
A History of Concerns Surrounding Nimesulide
The non-steroidal anti-inflammatory drug (NSAID) has been under scrutiny from health experts for a long period of time.
Keeping in view these concerns, the Union Ministry of Health and Family Welfare had previously banned the use of Nimesulide in children below 12 years of age in the year 2011.
More recently, in December 2024, the government further restricted the drug by prohibiting its production, sale, and distribution for veterinary purposes.
ICMR’s Deeper Investigation into Adult Usage
Prior to these latest recommendations, the health ministry tasked the ICMR with conducting a thorough study on the impact of Nimesulide on adults.
This investigation was prompted by growing anxieties that the drug could potentially cause severe liver damage in some patients, with potentially fatal consequences.
Call for a Complete Ban on Higher Dosage Formulations
Now, based on their comprehensive research, the ICMR has formally recommended to the Drugs Technical Advisory Board (DTAB) a complete ban on all Nimesulide formulations exceeding a 100 mg dosage.
Elevated Risks for these Age Groups
The panel of experts involved in the ICMR study reached the conclusion that using Nimesulide by individuals under 18 years of age and those aged 60 and above carries significant risks.
Their findings indicated that elderly patients exhibit a higher incidence of adverse reactions associated with Nimesulide use, particularly concerning gastrointestinal bleeding and perforation, which can prove fatal.
All experts agreed that Nimesulide is contraindicated in individuals aged 60 and above.
Risk on Fertility and Pregnancy
Furthermore, the ICMR’s research revealed a potential link between Nimesulide use and impaired female fertility.
Consequently, the ICMR has advised against the use of Nimesulide in women who are actively trying to conceive.
Black Box Warning Proposed on label
The ICMR experts have strongly recommended that a prominent “black box warning” should be mandatory on the labels of all Nimesulide formulations, whether they are single-ingredient formulations or combination drugs.
Q. What is Nimesulide?
A. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in fever and pain management.
Q. Why is a ban recommended on Nimesulide and for which age groups?
A. The ICMR has recommended a ban on Nimesulide due to some safety issues, e.g. adverse reactions, including gastrointestinal issues and liver damage if used by individuals below 18 years and those aged 60 and above.
Q. Complete ban is proposed for which strength of Nimesulide?
A. The ICMR has recommended a ban on all formulations of Nimesulide exceeding 100 mg for all age groups.
Q. Has Nimesulide been banned before?
A. Yes, the pediatric use of Nimesulide in children below 12 years was banned in India in 2011. Its use in veterinary was prohibited in January 2025.
Q. What are the side effects of Nimesulide?
A. Major side effects of Nimesulide may include liver damage, gastrointestinal problems such as bleeding and perforation, and impact on female fertility.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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