**Executive Summary**
This document addresses Unstarred Question No. 1191 in Lok Sabha, concerning the ban on Nimesulide dosage. It confirms the ban on oral formulations exceeding 100 mg due to safety concerns, effective from December 29, 2025, via Gazette Notification S.O. 6091(E). The document also notes the prior ban on Nimesulide for children under 12 years of age and outlines awareness initiatives to ensure safe usage.
**Key Points / Main Content**
* **Ban on Nimesulide Dosage:**
* The Central Government has banned the manufacture, sale, and distribution of oral Nimesulide formulations above 100 mg for human use, effective December 29, 2025.
* The ban is based on the report of the Indian Council of Medical Research (ICMR) and recommendations from the Drugs Technical Advisory Board (DTAB) meeting held on April 24, 2025.
* The ban is implemented via Gazette Notification S.O. 6091(E).
* Formulations covered are immediate-release dosage forms.
* The ban is applicable throughout the country.
* **Enforcement and Penalties:**
* Manufacturing, selling, or distributing prohibited or banned drugs is a punishable offense under Section 18 of the Drugs and Cosmetics Act, 1940.
* Licensing authorities are empowered to take regulatory action.
* **Prior Restrictions:**
* The Central Government previously prohibited the manufacture, sale, and distribution of Nimesulide formulations for children below 12 years of age (G.S.R. 82(E) dated 10.02.2011).
* **Pharmacovigilance and Awareness:**
* The Indian Pharmacopoeia Commission (IPC) collates and analyzes Individual Case Safety Reports (ICSRs) related to adverse drug reactions (ADRs).
* One case of ADR associated with high-dose Nimesulide (>100 mg) requiring hospitalisation was reported from Mumbai district of Maharashtra during the last five years.
* The IPC has undertaken awareness initiatives, including the circulation of safety advisories and posters, to strengthen the safe use of Nimesulide.
* Information is disseminated through PvPI social media platforms and the official website (www.ipc.gov.in).
**Impact Analysis**
**Pharmaceutical Manufacturers and Distributors:**
* **Impact:** They are prohibited from manufacturing, selling, and distributing oral formulations of Nimesulide above 100 mg.
* **Action Required:** Cease production and distribution of non-compliant formulations and adhere to regulatory actions taken by licensing authorities.
**Healthcare Professionals (Doctors, Chemists):**
* **Impact:** They need to be aware of the ban on high-dose Nimesulide and the risks associated with its use, especially in children.
* **Action Required:** Provide safer therapeutic alternatives and rational use of analgesics and ensure awareness of the ban.
**Patients/Public:**
* **Impact:** Patients will not have access to Nimesulide formulations exceeding 100 mg. The risk of adverse drug reactions, particularly liver toxicity, should be reduced.
* **Action Required:** Consult healthcare professionals for safer analgesic alternatives and follow advisories on the safe use of medications.
**Indian Pharmacopoeia Commission (IPC):**
* **Impact:** Responsible for collating, analysing and reporting adverse drug reactions, and responsible for undertaking and disseminating risk communication to strengthen the safe use of Nimesulide.
* **Action Required:** Continue to perform pharmacovigilance duties, as well as circulation of safety advisories.
Key Entities Referenced
Nimesulide: Painkiller drug which is the subject of a dosage ban due to safety concerns.
Drugs and Cosmetics Act, 1940: Law under which the manufacture, sale, and distribution of banned drugs is a punishable offense.
Ministry of Health and Family Welfare: The ministry responsible for answering questions regarding the Nimesulide ban.
Indian Pharmacopoeia Commission (IPC): National Coordination Centre for Pharmacovigilance Programme of India (PvPI) that collates and analyses Individual Case Safety Reports (ICSRs) related to adverse drug reactions and has undertaken multiple awareness and risk-communication initiatives to strengthen the safe use of Nimesulide.
Drugs Technical Advisory Board (DTAB): A board that examined the report of the Indian Council of Medical Research (ICMR) and made recommendations leading to the prohibition of the manufacture, sale and distribution of oral formulations containing Nimesulide above 100 mg.
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).
*******