Centre bans oral nimesulide above 100 mg, citing health risks and safer alternatives under Drugs and Cosmetics Act.
The Union Health Ministry has banned the manufacture, sale, and distribution of oral formulations of nimesulide above 100 mg in immediate-release form, citing serious risks to human health. ()
According to an official notification issued earlier this week, the Centre has invoked its powers under Section 26A of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB), to prohibit such formulations with immediate effect.
TOP INSIGHT
The Union Health Ministry has banned the manufacture, sale, and distribution of all oral #Nimesulide formulations above 100mg with immediate effect. Citing health risks and the availability of safer alternatives, the move aims to enhance #patientsafety.
#NSAID #DrugNews #Painkillers #DrugSafety
High-Dose Oral Nimesulide Poses Risk
“The Central Government is satisfied that the use of all oral formulations containing nimesulide above 100 mg in immediate-release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available,” the notification stated.
However, the ban does not apply to strengths below 100 mg, nor does it cover strengths above 100 mg in other dosage forms such as sustained-release or extended-release preparations. Non-oral formulations, including topical gels, creams, and suppositories, are also excluded from the prohibition, a senior Ministry official clarified.
About the Drug Nimesulide
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) used for its pain-relieving, anti-inflammatory, and fever-reducing properties. It is a prescription medicine typically recommended only for short-term and second-line treatment, particularly when other therapies fail, due to long-standing concerns over its potential liver toxicity.
The drug was first approved in Italy in 1985 and later introduced in several countries. In India, the Drug Controller General of India (DCGI) approved nimesulide in 1995. It is currently available in more than 50 countries worldwide.
Study Notes Approved Uses of Nimesulide; Centre Cites Safer Alternatives
According to published scientific literature, including the study “Nimesulide: Critical Appraisal of Safety and Efficacy in Acute Pain”, the drug is approved for use in individuals above 12 years of age for conditions such as acute pain, painful osteoarthritis, primary dysmenorrhea, acute tendinitis, postoperative dental pain, and fever.
The Health Ministry noted that safer therapeutic alternatives are available, making continued use of high-dose immediate-release oral formulations unnecessary. The move aligns with ongoing regulatory efforts to reduce medicine-related adverse effects and improve patient safety.
Fixed-dose and fixed-strength drug combinations, including those involving NSAIDs, have gained popularity due to perceived benefits such as better compliance, improved therapeutic outcomes, and lower overall treatment costs. However, regulators continue to reassess such products to ensure their safety profile outweighs potential risks.
With this latest decision, manufacturers, distributors, and retailers have been directed to immediately halt the production and sale of the banned formulations across the country.
References:
- Nimesulide: Critical Appraisal of Safety and Efficacy in Acute Pain – (https://japi.org/article/japi-73-3-e22)
Source-Medindia