Is nimesulide and paracetamol banned in India? Status in 2026
India has no blanket ban on nimesulide and paracetamol tablets. Some dosage forms and cold mixtures are banned, with further limits on nimesulide.
Is nimesulide and paracetamol banned in India?
No blanket ban applies to nimesulide and paracetamol in India. The ordinary nimesulide 100 mg + paracetamol tablet is still permitted, but some dosage forms and three cold-and-flu combinations are banned, and further limits apply to nimesulide itself.
The February 2026 PIB release lists nimesulide 100 mg + paracetamol 325 mg tablets in the Jan Aushadhi basket as of 31 December 2025.
Which nimesulide + paracetamol products are banned
| Product | Notification | Date |
|---|---|---|
| Nimesulide + paracetamol dispersible tablets | S.O. 2394(E) | 2 June 2023 |
| Nimesulide + paracetamol injection | S.O. 4393(E) | 7 September 2018 |
| Nimesulide + paracetamol suspension | S.O. 4413(E) | 7 September 2018 |
| Nimesulide + paracetamol + cetirizine + phenylephrine | S.O. 4530(E) | 7 September 2018 |
| Nimesulide + paracetamol + levocetirizine + phenylephrine + caffeine | S.O. 4579(E) | 7 September 2018 |
| Cetirizine + phenylephrine + paracetamol + caffeine + nimesulide | S.O. 4639(E) | 7 September 2018 |
These are Section 26A prohibitions on manufacture, sale and distribution. The five 2018 notifications are in the CDSCO copy of the S.O. 4379(E) batch. For dispersible tablets, S.O. 2394(E) of 2 June 2023 prohibits them with immediate effect, in supersession of S.O. 712(E) of 10 March 2016.
The August 2024 ban on 156 fixed-dose combinations (FDCs) has no nimesulide combination. The June 2026 ban on 16 FDCs doesn't either.
Nimesulide ban and use restrictions
- Children under 12: nimesulide formulations for children below 12 were prohibited by gazette notification on 10 February 2011 (PIB; G.S.R. 82(E)). Combinations with paracetamol are included.
- Animal use: S.O. 5633(E) of 30 December 2024 prohibits "Nimesulide and its formulation for animal use", with immediate effect.
- Above 100 mg: S.O. 6091(E) of 29 December 2025 prohibits, with immediate effect, "All oral formulations containing Nimesulide above 100 mg in immediate release dosage form" for human use.
The wording covers nimesulide above 100 mg in an immediate-release oral dose, not the combined weight with paracetamol. Exactly 100 mg sits outside that line. Extended-release, sustained-release and non-oral forms are not named in this notification. The under-12 ban and the veterinary ban still apply.
Is paracetamol banned in India?
No. On 5 August 2025 the government stated that "the drug Paracetamol is not banned in the country". Only certain paracetamol FDCs are. The 2024 list includes mefenamic acid + paracetamol injection and cetirizine + paracetamol + phenylephrine. The 2026 batch added paracetamol + lignocaine (S.O. 3079(E)).
Dolo 650, Crocin, Combiflam and Disprin
The notifications name compositions, not brands. Read the pack's ingredients, strength and dosage form.
For Dolo 650 or Crocin, the government's no-ban statement applies if the pack is only paracetamol. For Combiflam, check for ibuprofen + paracetamol alone. That two-drug combination is not banned: ibuprofen 400 mg + paracetamol 325 mg tablets are on the Jan Aushadhi list.
Some ibuprofen combinations are banned. The consolidated list includes glucosamine + ibuprofen (S.O. 1854(E) of 8 June 2017) and some ibuprofen + paracetamol FDCs with three or more ingredients (S.O. 196(E) and 197(E) of 2019).
A CDSCO alert flagged Combiflam batch A150825 as Not of Standard Quality for failing disintegration. A batch quality failure is not a composition ban.
For Disprin, check whether the pack is plain aspirin. There is no ban on plain aspirin: it is on the National List of Essential Medicines, and aspirin tablets are in the Jan Aushadhi list.
For cold-and-flu products, match every ingredient against the table. S.O. 4595(E) of 18 August 2026 restricts, rather than bans, combinations containing chlorpheniramine and phenylephrine. The label must warn against use in children under 4.
Where to check a product
CDSCO's consolidated banned drugs list is dated 22 November 2021, so it misses the later notifications. Check those on the CDSCO FDC page and gazette notifications page. Some FDC bans are under court challenge with interim protection, which PIB noted on 6 February 2026, so confirm the status of any specific ban before you rely on it.
You can also ask RegAffairs AI, which answers this question with links to each notification.