India Bans High-Dose Nimesulide to Safeguard Public Health

India's government has banned high-dose oral formulations of nimesulide, a painkiller, citing health risks. The decision follows a review by the ICMR and excludes lower doses and non-oral forms. Medical experts welcome the move, emphasizing the need for safer alternatives.

By Shalini Bhardwaj: India's government has announced a ban on the manufacture, sale, and distribution of oral formulations of nimesulide containing more than 100 mg in immediate-release dosage forms.

The Ministry of Health and Family Welfare clarified that the ban excludes formulations under 100 mg, higher strengths in sustained or extended-release forms, and non-oral options such as topical gels, creams, and suppositories. This decision follows an evaluation by the Indian Council of Medical Research (ICMR), highlighting potential health risks associated with higher-dose oral formulations of nimesulide and the availability of safer alternatives.

A government notification stated confidence that the use of oral formulations over 100 mg of nimesulide poses a risk to human health and safer alternatives exist. Leveraging its powers under section 26A of the Drugs and Cosmetics Act, 1940, and after consulting the Drugs Technical Advisory Board, the government prohibits these formulations with immediate effect.

Dr. S Chatterjee, a Senior Consultant in Internal Medicine at Apollo Hospitals, praised the government's decision, noting that nimesulide had already been restricted in several countries due to its adverse effects. He emphasized the risks of liver and kidney injury and gastritis associated with its injudicious use.

(With inputs from agencies.)