The Indian government announced a ban on the drug in 2011 for paediatric usage, whereas the drug has been available as an over-the-counter medication for adult use, which has raised serious concerns about patient safety.
Published Dec 31, 2025 | 6:26 PM ⚊ Updated Dec 31, 2025 | 6:26 PM
Why did India ban high-dose Nimesulide. (Supplied)
Synopsis: Nimesulide is a commonly prescribed non-steroidal anti-inflammatory drug (NSAID) used to treat pain, fever and inflammation. It works primarily as a selective cyclooxygenase-2 (COX-2) inhibitor, reducing the production of prostaglandins responsible for pain and inflammation.
The Indian government has imposed an immediate ban on the manufacture, sale and distribution of all oral formulations of Nimesulide containing more than 100 milligrams in immediate-release dosage form, citing significant health risks to patients.
The prohibition, announced by the Ministry of Health and Family Welfare through a gazette notification dated 29 December 2025, has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board (DTAB), the country’s apex advisory body on technical matters related to drugs and cosmetics.
“The use of all oral formulations containing Nimesulide above 100mg in immediate release dosage form is likely to involve risk to human beings, and safer alternatives are available,” the Health Ministry notification stated.
Nimesulide is a commonly prescribed non-steroidal anti-inflammatory drug (NSAID) used to treat pain, fever and inflammation. It works primarily as a selective cyclooxygenase-2 (COX-2) inhibitor, reducing the production of prostaglandins responsible for pain and inflammation.
The drug is prescribed for the short-term treatment of acute pain (including headache, toothache, muscle aches and post-operative pain), painful osteoarthritis, primary dysmenorrhea (menstrual cramps), and fever associated with various conditions.
Nimesulide is widely available in over 50 countries. It is typically recommended to use the lowest effective dose for the shortest possible duration, usually taken with food or milk to minimise stomach upset, with a maximum recommended treatment duration of generally 15 days.
The ban specifically targets high-dose formulations due to long-standing concerns over the drug’s safety profile, particularly its association with liver toxicity (hepatotoxicity). Nimesulide-induced toxicity and its severity can lead to liver transplantation and sometimes death.
The cases reported throughout the world have prompted the drug to be banned completely in many countries.
Major regulatory bodies that have implemented specific bans on Nimesulide include:
The World Health Organization (WHO) has notably not included Nimesulide in its Model List of Essential Medicines, reflecting international caution around its use. WHO pharmacovigilance reports have documented concerns related to hepatic injury associated with the drug.
However, in India, the drug has been only partially banned. The Indian government announced a ban on the drug in 2011 for paediatric usage, whereas the drug has been available as an over-the-counter medication for adult use, which has raised serious concerns about patient safety.
No pharmacist warns patients about possible interactions and drug-induced toxicities of over-the-counter medications, as if they are bothered only about their sales and business. The inspectors are also not bothered to enquire about over-the-counter medication records.
Consumers have been purchasing the drug from pharmacies due to lack of knowledge about drug interactions and drug-induced hepatotoxicity, which are responsible for causing severe effects and sometimes death.
The Indian government’s latest decision to ban high-dose formulations aligns with global efforts to tighten safety standards and phase out high-risk medicines where safer alternatives exist.
Pharmaceutical companies currently marketing Nimesulide brands must immediately halt production and recall affected batches from the market.
Industry analysts forecast limited financial impact on large drugmakers, as Nimesulide represents a relatively small share of overall NSAID sales in India. However, smaller firms with significant exposure to high-dose Nimesulide formulations could face revenue pressure.
The ban applies only to high-dose products for human use, whilst lower-dose formulations and other therapeutic alternatives remain available for prescription.
Following the central government’s notification, the Telangana Drugs Control Administration also has issued a public advisory urging citizens to stop using all oral formulations containing Nimesulide above 100mg with immediate effect.
The Director General of Drug Control Administration, Telangana, advised patients currently using such medicines to discontinue use and consult a qualified registered medical practitioner for safer and appropriate alternative treatment. The public has been strongly advised not to purchase, use or store the prohibited formulations under any circumstances.
State drug control authorities are also taking necessary steps to ensure prohibited products are withdrawn from the market and supply chain. Citizens have been encouraged to report any instances of prohibited formulations being sold or distributed to the nearest Drugs Inspector or Drugs Control Administration office.
The government emphasised that this decision has been taken in the interest of public health and safety, with the cooperation of citizens solicited to ensure effective implementation of the ban.
(Edited by Sumavarsha)
