Centre Bans Nimesulide Above 100 mg in Oral Medicines to Safeguard Public Health

The Union Health Ministry of India has taken a decisive step to protect public health by banning the manufacture, sale, and distribution of all oral formulations of the painkiller nimesulide containing more than 100 mg in immediate‑release form, effective immediately across the country. 

The government’s notification, issued under Section 26A of the Drugs and Cosmetics Act, 1940, follows recommendations from the Indian Council of Medical Research (ICMR) and consultation with the Drugs Technical Advisory Board (DTAB). Authorities said that higher‑dose nimesulide products are likely to pose health risks to users, and that safer alternative medicines are available in the market.

Nimesulide, a non‑steroidal anti‑inflammatory drug (NSAID) commonly used to treat pain, fever, and inflammation, has long been under scrutiny due to concerns over liver toxicity and other adverse effects at higher dosages. Critics and health experts have pointed out that several countries have already restricted or phased out high‑dose nimesulide formulations for safety reasons.

According to the official notification, the ban applies specifically to oral immediate‑release tablets, capsules, and similar products containing more than 100 mg of nimesulide for human use. Lower‑dose oral formulations and alternative treatments remain available, and patients currently using high‑dose products have been advised to consult qualified medical practitioners for safer options. 

Pharmaceutical companies marketing affected formulations are required to halt production immediately and recall existing stocks, with regulators expected to monitor compliance across supply‑chains and retail outlets. Health officials also stressed that this regulatory action aims to align India’s drug safety norms with global best practices and minimize preventable drug‑related harm. 

Patients and caregivers have been urged not to purchase or consume banned products and to seek advice from registered medical professionals regarding appropriate pain management alternatives.