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Regulatory status record

Is Nimesulide + Paracetamol banned in India?

Last checked 1 October 2026

Nimesulide + Paracetamol. Status: Banned (14-FDC order, Jun 2023).
Banned or prohibited

Nimesulide + paracetamol dispersible tablets have been prohibited in India since the 14-FDC notification of 2 Jun 2023; the earlier 2016 ban was set aside in court (Delhi High Court, 1 Dec 2016; Supreme Court, 15 Dec 2017).

Classification
Prohibited under Section 26A, Drugs and Cosmetics Act, 1940
Decided by
CDSCO / Ministry of Health and Family Welfare
Reference
S.O. 2394(E), 2 Jun 2023 (nimesulide + paracetamol dispersible tablets); earlier S.O. 712(E) of 10 Mar 2016, set aside in court
Evidence
Government document
Latest action
2 June 2023
Last checked
1 October 2026
See the source Report a mistake

Nimesulide 100 mg tablets in a blister pack. Photo: Nimesulide tablets.jpeg by Pnapora (CC BY-SA 3.0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.

Primary government sourceTier 1: government primary source

List of Prohibited FDC drugs (14 FDCs) dated 02.06.2023

CDSCO / Ministry of Health and Family Welfare · S.O. 2394(E), 2 Jun 2023 (nimesulide + paracetamol dispersible tablets); earlier S.O. 712(E) of 10 Mar 2016, set aside in court · 2 June 2023

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Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.

Key facts

Governing authority
CDSCO, Ministry of Health and Family Welfare
Current notification
Section 26A, 2 Jun 2023, one of 14 FDCs
Earlier notification
S.O. 712(E), 10 Mar 2016, quashed by Delhi High Court 1 Dec 2016
Supreme Court
15 Dec 2017: pre-1988 FDCs excluded from 2018 re-ban and sent to expert committee
Brands historically sold
Sumo, Nicip Plus, Nimek Para, Nimulid-P

The nimesulide + paracetamol combination has one of the longer legal histories among Indian fixed-dose combinations (FDCs), and search results still mix up its three stages.

The first ban came on 10 March 2016, when the Health Ministry prohibited 344 FDCs in one go; this combination was S.O. 712(E). Manufacturers went to the Delhi High Court, which quashed the entire wave on 1 December 2016 on the ground that the Drugs Technical Advisory Board had not been consulted. The government appealed, and on 15 December 2017 the Supreme Court sent the list back to the Board but carved out FDCs that had been licensed before 1988. Nimesulide + paracetamol was in that carved-out group, so it was not part of the 328-FDC re-ban of September 2018 and stayed on sale as a combination "under examination".

The expert committee's review of those older combinations ended with a notification on 2 June 2023 prohibiting 14 FDCs. Item 1 of CDSCO's list of those 14 is "nimesulide + paracetamol dispersible tablets", notified as S.O. 2394(E). The prohibition covers the dispersible form only.

The single-ingredient rules are separate: nimesulide above 100 mg was banned for adults in December 2025 and for children under 12 in 2011.

What this means for you

Ask your pharmacist about any old strips

Stock of the dispersible tablet should no longer be dispensed. Your pharmacist can confirm what a particular pack is.

Single-ingredient options remain

Nimesulide 100 mg and paracetamol are both still legal for adults; your doctor can advise which, if either, suits you.

This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.

If you have this at home

  1. Check that the product name, strength, batch number and maker on your pack match this record. Only the batches or the formula named here are affected.
  2. Do not stop a medicine your doctor prescribed without talking to your doctor or pharmacist first.
  3. Keep the pack and the bill. Ask the shop that sold it to take it back.
  4. Report it to your state drug controller, or through CDSCO's consumer page. You can also check a batch number.

Common questions

Is Sumo tablet banned?

Sumo is a nimesulide + paracetamol brand. The dispersible-tablet combination was prohibited in June 2023; check the pack with your pharmacist.

Entries on the banned drugs list

Drug / combinationActionNotificationDateStatus note
Nimesulide + Paracetamol Dispersible TabletsBannedS.O. 2394(E)2 June 2023Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included).
Nimesulide + Paracetamol InjectionBannedS.O. 4393(E)7 September 2018In force per CDSCO list as on 22.11.2021
Nimesulide + Paracetamol SuspensionBannedS.O. 4413(E)7 September 2018In force per CDSCO list as on 22.11.2021
Nimesulide + Paracetamol + Cetirizine + PhenylephrineBannedS.O. 4530(E)7 September 2018In force per CDSCO list as on 22.11.2021
Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineBannedS.O. 4579(E)7 September 2018In force per CDSCO list as on 22.11.2021
Nimesulide + Paracetamol Dispersible TabletsUnder examinationS.O. 712(E)10 March 2016Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14).
Nimesulide + Paracetamol InjectionQuashedS.O. 721(E)10 March 2016Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Nimesulide + Paracetamol SuspensionQuashedS.O. 743(E)10 March 2016Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Nimesulide + Paracetamol + Cetirizine + PhenylephrineQuashedS.O. 867(E)10 March 2016Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban
Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineQuashedS.O. 918(E)10 March 2016Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban

Ingredient records

Every banned combination and failed batch containing each ingredient.

NimesulideParacetamol

Sources

Government documents

News reports

Researched and written by The Blacklisted team
We are not doctors or pharmacists. Everything on this page comes from the documents listed above, which you can open and check. Last checked 1 October 2026. How we check · Who we are · Spotted a mistake? Tell us.