Regulatory status record
Is Nimesulide + Paracetamol banned in India?
Last checked 21 September 2026
Nimesulide + paracetamol dispersible tablets have been prohibited in India since the 14-FDC notification of 2 Jun 2023; the earlier 2016 ban was quashed by the Delhi High Court and never took effect.
- Classification
- Prohibited under Section 26A, Drugs and Cosmetics Act, 1940
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- Section 26A notification, 2 Jun 2023, 14-FDC list; earlier S.O. 712(E) of 10 Mar 2016 quashed
- Latest action
- 2 June 2023
- Last checked
- 21 September 2026
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.
Deccan Herald: Govt bans 14 fixed-dose combination drugs used to treat cough, fever
Our team has checked this record against the published reports, last on 21 September 2026. The government order itself is not published online, or we have not found it yet, so we link the best public report. If you have the order, send it to us and we will link it instead.
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 Always check the linked government document for the current position, and tell us if something is out of date.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 explain what has been reported. The report above is the best source we hold.
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. Press reports of that order list "nimesulide + paracetamol dispersible tablets" among them. We have not yet matched the entry to its S.O. number in the Gazette, and the wording appears to be limited to dispersible tablets, so both points are flagged for verification before this page is treated as final.
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.
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 / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Nimesulide + Paracetamol Dispersible Tablets | Banned | S.O. 2394(E) | 2 June 2023 | Prohibited 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 Injection | Banned | S.O. 4393(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol Suspension | Banned | S.O. 4413(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Cetirizine + Phenylephrine | Banned | S.O. 4530(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine | Banned | S.O. 4579(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol Dispersible Tablets | Under examination | S.O. 712(E) | 10 March 2016 | Quashed 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 Injection | Quashed | S.O. 721(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol Suspension | Quashed | S.O. 743(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol + Cetirizine + Phenylephrine | Quashed | S.O. 867(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine | Quashed | S.O. 918(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Official sources and primary records
- Deccan Herald: Govt bans 14 fixed-dose combination drugs used to treat cough, feverNewsDeccan Herald · 3 June 2023
- News
- Scroll: Delhi High Court stays ban on D'Cold, Vicks Action 500 and 300+ medicinesNewsScroll.in · 1 December 2016
- News