Parliament Question: Nimesulide Dosage Ban

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 1191 TO BE ANSWERED ON06THFEBRUARY, 2026 NIMESULIDE DOSAGE BAN

1191.DR. AMOLRAMSING KOLHE:

PROF. VARSHAEKNATH GAIKWAD:

SHRIMOHITE PATILDHAIRYASHEELRAJSINH:

SHRISANJAYDINAPATIL:

SMT. SUPRIYASULE:

SHRIBHASKAR MURLIDHAR BHAGARE:

Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:

(a) whether the Government has banned the manufacture, sale and distribution of oral formulations of Nimesulide above 100 mg for human use in the country due to serious safety concerns, includinglivertoxicity andif so, the detailsthereof;

(b) whether thisbanisbeingeffectively enforcedinMaharashtra andif so,the detailsthereof;

(c)the scientific studies, pharmacovigilancedata andexpert recommendations relieduponfor this decision, including inputs from the Indian Council of Medical Research and the Drugs Technical Advisory Board;

(d) whether cases of adverse drug reactions, hospitalisation or liver damage linked to high dosage nimesulide have been reported in Maharashtra during the last five years, district-wise andthe regulatoryaction takenthereon;and

(e) whether any advisories, monitoring drives or awareness programmes have been undertaken in Maharashtra for doctors, chemists and the public on safer alternatives and rationaluse of analgesicsand if so, the detailsthereof? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SHRIPRATAPRAO JADHAV)

(a)to(e): Based on the examination of the report of the Indian Council of Medical Research (ICMR) by the Drugs Technical Advisory Board (DTAB) and its recommendations made in the meeting held on 24.04.2025, the Central Government, has prohibited the manufacture, sale and distribution of all oral formulations containing Nimesulide above 100 mg in immediate-release dosage form vide Gazette Notification S.O. 6091(E) dated29.12.2025, as such formulations are likely to involve risk to human beings and safer therapeutic alternatives are available. Further, vide G.S.R. 82(E) dated 10.02.2011, the Central government had already prohibited the manufacture, sale and distribution of Nimesulide formulations for human use in children below 12 years of age. These notificationsare applicable throughout the country.

The manufacture, sale and distribution of prohibited or banned drugs is a punishable offence under Section 18 of the Drugs and Cosmetics Act, 1940, and the concerned licensing authoritiesare empowered totake appropriate regulatoryactioninthisregard.

The IndianPharmacopoeiaCommission(IPC)asNational CoordinationCentre (NCC) for Pharmacovigilance Programme of India (PvPI) collates and analyses, Individual Case Safety Reports (ICSRs) related to adverse drug reactions. As per the reporting mechanism of IPCfor suspected adverse drug reactions(ADRs), during the last five years, one case of ADR associated with high-dose Nimesulide (>100 mg) requiring hospitalisation was reported from Mumbai district of Maharashtra.

Further, the Indian Pharmacopoeia Commission has undertaken multiple awareness and risk-communication initiatives to strengthen the safe use of Nimesulide. These include circulation of safety advisories and awareness posters emphasising the prohibition of Nimesulide use in children below 12 years of age to Adverse Drug Reaction Monitoring Centres (AMCs) and Marketing Authorisation Holders (MAHs). Dissemination hasalso been carried out through PvPI social media platforms and information hosted on the official website of the IndianPharmacopoeia Commission (www.ipc.gov.in).

*******