Government Bans Nimesulide Oral Formulations Above 100 mg

The government has prohibited the manufacture, sale, and distribution of all oral formulations containing Nimesulide above 100 mg, with immediate effect. The Ministry of Health and Family Welfare, in a gazette notification, stated that the decision was taken in consultation with the Drugs Technical Advisory Board (DTAB) and has been enforced under Section 26A of the Drugs and Cosmetics Act, 1940.

The notification said that the use of oral formulations containing Nimesulide above 100 mg is likely to pose a risk to human health. It further added that safer alternative drugs are available in the market, making the continued availability of high-dose Nimesulide unjustified in the public interest.

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed for the treatment of acute pain, fever, and inflammation. However, due to concerns over its safety profile at higher doses, the government has taken this crucial step to restrict its use.

According to the government, medicines containing more than 100 mg of Nimesulide have been banned due to their potential adverse effects on human health. The Centre emphasized that since safer alternatives exist, allowing the continued sale of high-dose Nimesulide is not warranted.

The ban, issued under Section 26A of the Drugs and Cosmetics Act, 1940, empowers the government to prohibit drugs that pose a risk to patients and public health.