Sale of Nimulid in the Country
Marketing authorization of Nimesulide containing medicinal products were suspended in Finland and Spain in 2002 and in Ireland in 2007 because of serious side effects affecting the liver. Further, the drug was prohibited in Malaysia (2008), Singapore (2008), Vietnam (2008) and Argentina (2009). However, the Committee for Medicinal Products for Human Use of European Union recommended for restricted use of Nimesulide containing medicinal products and the treatment with Nimesulide limited to maximum 15 days.
Safety issues of Nimesulide drug formulations were assessed in consultation with an Expert Committee. As per the recommendations made by the Expert Committee, the Government prohibited the manufacture, sale and distribution of Nimesulide formulations for human use in children below 12 years of age through a Gazette Notification 82(E) dated 10.02.2011 as the use of drug is likely to involve certain risks to human beings and whereas safer alternatives to the drug are available. Further, it has been directed to all manufacturers of nimesulide containing formulations, on recommendations of the Drug Technical Advisory Board (DTAB), to incorporate a box warning on label as well as package insert and other promotional literature of nimesulide formulations that use of nimesulide should ordinarily be restricted to 10 days. If longer clinical use is warranted, liver function test should be assessed periodically.
The above information was given by the Union Minister for Health & Family Welfare, Shri Ghulam Nabi Azad in a written reply to a question in the Rajya Sabha today.
source : PIB