The ministry banned the manufacture, sale and distribution of the oral formulation, citing critical well being dangers. |Photograph courtesy of ANI
The Federal Ministry of Well being has banned oral formulations of nimesulide exceeding 100 mg in immediate-release kind.
“Strengths under 100 mg or above 100 mg in different sorts of releases (gradual launch, prolonged launch, and so on.) usually are not lined by this ban. Parenteral formulations corresponding to topical gels/lotions or suppositories are additionally not prohibited,” mentioned a senior ministry official.
Nimesulide is a nonsteroidal anti-inflammatory drug used for its analgesic, anti-inflammatory, and antipyretic results. This can be a prescription drug primarily meant for short-term, second-line remedy (when different medicine haven’t labored) resulting from considerations about potential liver toxicity.
In keeping with an official notification issued earlier this week, the ministry has banned the manufacture, sale and distribution of the oral formulation resulting from critical well being dangers.
“The Central Authorities is happy that using all oral preparations containing greater than 100 mg of nimesulide in rapid launch dosage kind is more likely to contain dangers to people and that safer options to the drug can be found,” the notification mentioned.
“Accordingly, in train of the powers now conferred by Part 26A of the Medication and Cosmetics Act, 1940, and after session with the Pharmaceutical Technical Advisory Committee, the Middle hereby prohibits the manufacture, sale and distribution of this drug with rapid impact,” the notification mentioned.
Nimesulide was first accepted in Italy in 1985 and is now out there in additional than 50 nations. The Narcotics Controller Basic of India accepted nimesulide in 1995.
Fastened drug combos are broadly accepted resulting from their superior therapeutic efficacy and security, enhanced affected person compliance, decreased affected person prices in comparison with monotherapy, and improved adherence.
In keeping with a abstract of product traits, nimesulide is accepted for the remedy of acute ache, symptomatic reduction of painful osteoarthritis, and first dysmenorrhea, in addition to the administration of fever, acute tendonitis, and postoperative tooth ache in folks 12 years of age and older, in line with the research titled “Nimesulide: A Vital Analysis of Security and Efficacy in Acute Ache.”
