The Central government has banned oral formulations of nimesulide containing doses above 100mg, marking a significant step in strengthening drug safety regulations in India. Nimesulide is a widely used non-steroidal anti-inflammatory drug (NSAID) prescribed for pain relief, inflammation control, and fever reduction. While the drug continues to be permitted at approved dosage levels, higher-dose oral formulations have now been prohibited due to safety concerns.

Nimesulide works by inhibiting the production of prostaglandins—chemicals in the body responsible for pain, swelling, and fever. Because of its fast-acting nature, it has been commonly prescribed for conditions such as musculoskeletal pain, dental pain, post-operative discomfort, and acute fever. However, over the years, medical experts and regulatory bodies have raised concerns about its potential adverse effects, particularly on the liver.

The decision to ban oral formulations above 100mg is based on evidence suggesting that higher doses of nimesulide increase the risk of hepatotoxicity, or liver damage. Several studies and post-marketing surveillance reports have linked excessive or prolonged use of high-dose nimesulide to serious liver-related complications, including acute liver failure in rare cases. These risks are especially pronounced when the drug is used without proper medical supervision or for longer durations than recommended.

Health authorities have emphasized that the move is not a complete ban on nimesulide, but a dosage restriction aimed at ensuring patient safety. Oral formulations containing up to 100mg of nimesulide remain approved for use under medical guidance. The restriction is intended to discourage misuse, overprescription, and self-medication—issues that have long plagued the use of painkillers in India.

For pharmaceutical manufacturers, the ban means that higher-strength oral formulations must be withdrawn from the market or reformulated to comply with the new dosage limits. Retailers and healthcare providers have also been advised to review their inventories and prescribing practices to ensure compliance with the updated regulation.

From a public health perspective, the decision reflects a growing focus on rational drug use. NSAIDs are among the most commonly consumed medicines in the country, often taken without prescriptions. By limiting the maximum permissible oral dose of nimesulide, the Centre aims to reduce preventable drug-induced liver injuries and promote safer pain management practices.

Patients are advised not to panic or abruptly stop their medication without consulting a healthcare professional. Instead, they should follow prescribed dosages strictly and report any symptoms such as nausea, abdominal pain, dark urine, or jaundice, which may indicate liver-related issues.

In conclusion, the Centre’s ban on oral formulations of nimesulide above 100mg underscores the importance of balancing therapeutic benefits with patient safety. The move aligns with global trends in drug regulation, reinforcing the message that effective pain relief should never come at the cost of long-term health risks.