The Ministry of Health and Family Welfare (MoHFW) has banned the manufacture, sale, and distribution of oral formulations containing Nimesulide above 100 milligrams (mg) in immediate-release dosage form, citing potential health risks to humans.<\/p>\n
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed for pain relief, inflammation and fever in adults, and is sold widely across India under popular brand names such as Nimulid, Nicip, Nimegesic and several fixed-dose combinations used for pain and fever.<\/p>\n
Nimesulide has been linked to\u00a0liver damage, ranging from mild enzyme increases to\u00a0serious liver failure. This kind of liver harm is called\u00a0hepatic risk\u00a0\u2014 basically, the drug can damage the liver.
Unlike many other NSAIDs,\u00a0Nimesulide was never approved in the United States\u00a0because of safety concerns. It is also\u00a0not approved in Canada, Japan, Australia, and several other countries. Some European nations had allowed it on prescription, but many later restricted or banned it due to liver safety issues.<\/p>\n
The decision, announced in a government notification released on December 29, is aimed at protecting public health and safety. According to a notification issued by the Ministry of Health and Family Welfare, the government is satisfied that the use of high-dose Nimesulide formulations poses a risk to human beings and that safer alternatives are available.<\/p>\n
\u201cWhereas the Central Government 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 to the said drug is available; And, whereas, the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use,\u201d the release stated.<\/p>\n
The ban is effective immediately and applies to all oral formulations containing Nimesulide above 100 mg in immediate-release dosage form.<\/p>\n
The move is based on recommendations from the Drugs Technical Advisory Board (DTAB) and is in exercise of powers conferred under Section 26A of the Drugs and Cosmetics Act, 1940.<\/p>\n
\u201cNow, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, the Central Government hereby prohibits the manufacture, sale and distribution of the following drug, with immediate effect, namely: \u2018All oral formulations containing Nimesulide above 100 mg in immediate release dosage form\u2019,\u201d it added.<\/p>\n
The Ministry had already banned Nimesulide formulations for use in children below 12 years of age on the recommendations of an Expert Committee constituted by the DTAB, citing safety concerns.<\/p>\n
\u201cThe drug has been considered to be hepatotoxic, and children are considered more susceptible to hepatotoxicity,\u201d the notification said.<\/p>\n
In February this year, the Ministry had also prohibited the manufacture, sale, distribution and use of Nimesulide and its formulations for animal use.
\n<\/p>\n
While most large pharmaceutical companies had phased out higher-dose nimesulide formulations years ago, smaller generic manufacturers and trade-led brands continued to market such products, prompting regulators to issue a comprehensive ban to eliminate residual and grey-market availability.<\/p>\n
The ban applies only to oral, immediate-release Nimesulide formulations above 100 mg and does not amount to a blanket prohibition. Patients are advised not to stop medication abruptly and to consult doctors for alternatives if required.<\/p>\n
(Edited by : Amrita)<\/p>\n
First Published:\u00a0Dec 31, 2025 9:59 AM IST<\/p>\n","protected":false},"excerpt":{"rendered":"The Ministry of Health and Family Welfare (MoHFW) has banned the manufacture, sale, and distribution of oral formulations…\n","protected":false},"author":3,"featured_media":482134,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[218281,210,1567,218278,1060,82928,218280,218279,67,132,68],"class_list":{"0":"post-482133","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-government-notification","9":"tag-health","10":"tag-india","11":"tag-india-prohibits-the-use-of-nimesulide","12":"tag-medication","13":"tag-ministry-of-health-and-family-welfare","14":"tag-mohfw","15":"tag-nimesulide-above-100-mg-banned","16":"tag-united-states","17":"tag-unitedstates","18":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115813625732732566","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/482133","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=482133"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/482133\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/482134"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=482133"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=482133"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=482133"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}