Nimesulide

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, with immediate effect. This decision was taken by the Union Health Ministry based on recommendations from expert bodies, including the Drugs Technical Advisory Board (DTAB) and the Indian Council of Medical Research (ICMR). The move aims to protect public health, as high-dose Nimesulide formulations pose potential risks, particularly liver toxicity.

Official Notification

The ban was formalized through a Gazette notification dated 29 December 2025, which stated that oral formulations of Nimesulide above 100 mg in immediate-release dosage form are likely to involve risks to human health. This notification makes the ban applicable nationwide, and authorities are ensuring strict compliance.

State-Level Actions

Several state governments, including Haryana and Telangana, have issued directives aligning with the central government’s decision. The states have also advised the public to immediately stop using banned Nimesulide products and consult a doctor if they were previously using high-dose tablets.

What Is Covered Under the Ban

• Banned: Oral immediate-release Nimesulide formulations containing more than 100 mg, such as 125 mg or 150 mg tablets.

• Allowed: Oral formulations with doses of 100 mg or less and non-oral forms of Nimesulide, such as topical gels or creams, are not affected by this ban.

About Nimesulide

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) first introduced in Italy in 1985. It is used for its pain-relieving, anti-inflammatory, and fever-reducing effects, commonly prescribed for conditions like acute pain, musculoskeletal disorders, dental pain, osteoarthritis, and dysmenorrhea. Nimesulide works by inhibiting the enzyme cyclooxygenase (COX), which reduces the production of prostaglandins, chemicals responsible for pain, inflammation, and fever.

Side Effects

While effective, Nimesulide can cause liver damage, gastrointestinal bleeding, and kidney problems with long-term or high-dose use. Other side effects may include sour stomach, dizziness, skin reactions, diarrhea, and elevated liver enzymes.

Global Regulatory Status

Nimesulide has faced safety scrutiny worldwide. It has never been approved in countries like the United States, the UK, Canada, Australia, New Zealand, and Japan. In 2008, the International Society of Drug Bulletins, supported by the World Health Organization, called for a global ban. In India, its use in children below 12 years was banned in 2011, but adults continued to use it under supervision until now.

Reason for the Ban

Authorities concluded that high-dose Nimesulide formulations offer no significant therapeutic advantage over safer alternatives while posing serious health risks. The ban aims to prevent liver toxicity and other complications and promote public safety.