From January 1, 2026, the Government of India has prohibited the manufacture, sale, and distribution of all oral formulations of Nimesulide containing more than 100 mg in immediate-release form. The decision aims to reduce health risks and improve patient safety across the country.
What exactly has been banned
The ban applies to all oral Nimesulide products such as tablets, capsules, and liquid formulations that exceed 100 mg per dose in immediate-release form. These products can no longer be produced or sold in India. Existing stocks are expected to be withdrawn from the market under regulatory supervision.
Legal and regulatory basis
The government issued the ban under the Drugs and Cosmetics Act, 1940. Authorities acted after reviewing scientific data and expert recommendations. Regulators concluded that higher doses of Nimesulide present avoidable health risks when safer alternatives exist.
Why the government took this step
Nimesulide belongs to the group of non-steroidal anti-inflammatory drugs used for pain, inflammation, and fever. However, medical evidence has linked higher doses of the drug to liver-related side effects in some patients. To reduce the chance of serious adverse reactions, regulators decided to restrict exposure to high-dose formulations.
Global safety perspective
Several countries across the world have either restricted or never approved Nimesulide because of safety concerns. India’s latest move reflects a cautious regulatory approach that prioritises patient well-being over continued use of high-risk formulations.
Who will be affected
Patients currently using high-dose Nimesulide may need a change in medication. Doctors and hospitals must revise prescriptions. Pharmacists must stop dispensing banned strengths. Pharmaceutical companies manufacturing these products must discontinue production and ensure regulatory compliance.
What patients should do
Patients should not self-medicate or continue high-dose Nimesulide without medical advice. Anyone using the drug should consult a doctor to switch to a safer alternative. Symptoms such as yellowing of eyes, dark urine, nausea, or persistent fatigue should never be ignored.
Common alternatives for pain and fever
Doctors usually recommend paracetamol or other NSAIDs such as ibuprofen, depending on the patient’s age, condition, and medical history. Non-drug measures and short-term therapy at safe doses are also preferred whenever possible. Treatment choices should always be individualised.
Impact on the pharmaceutical industry
Drug manufacturers will need to stop production, manage recalls where required, and adjust product portfolios. Supply chains may shift towards safer dose strengths and alternative medicines. Regulatory monitoring is expected to increase in the coming months.
What to expect next
Health authorities may issue detailed guidelines for enforcement and compliance. State drug controllers are expected to monitor implementation closely. Further safety reviews of similar drugs may also follow.
Bottom line
The ban on oral Nimesulide formulations above 100 mg marks a strong step toward safer pain management in India. Patients should seek medical guidance, and healthcare providers must adapt quickly. The focus now remains on safety, awareness, and responsible use of medicines.
