Regulatory status record
Is Nimesulide banned in India?
Last checked 3 November 2026
Oral nimesulide above 100 mg has been banned for adults in India since 29 Dec 2025; 100 mg tablets and topical gels remain legal, and use in children under 12 has been banned since 2011.
- Classification
- Prohibited under Section 26A, Drugs and Cosmetics Act, 1940
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- S.O. 6091(E), 29 Dec 2025 (Section 26A)
- Evidence
- Government document
- Latest action
- 29 December 2025
- Last checked
- 3 November 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.
CDSCO: Updated banned drugs list with present status (as on 22.11.2021)
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Notification
- S.O. 6091(E), 29 Dec 2025, under Section 26A
- Effective
- 29 Dec 2025 (reported 29 to 31 Dec 2025)
- Still legal
- 100 mg tablets, topical gels; SR forms reported exempt
- Children under 12
- Banned since 10 Feb 2011, GSR 82(E)
- Banned nimesulide FDCs
- Nimesulide + levocetirizine, S.O. 1851(E), 8 Jun 2017; 16 combinations on 7 Sep 2018; 4 more on 11 Jan 2019; nimesulide + paracetamol dispersible tablets, S.O. 2394(E), 2 Jun 2023
- Veterinary use
- Banned by Gazette notification, Jan 2025 (vulture protection; number)
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that India kept on sale long after it was withdrawn in several other markets. Its status in India now depends on the strength and on the patient's age.
On 29 December 2025 the Ministry of Health and Family Welfare prohibited the manufacture, sale and distribution of oral nimesulide in strengths above 100 mg for adults, using its powers under Section 26A of the Drugs and Cosmetics Act. All India Radio reported the decision the same day. The 100 mg tablet, which is the most common strength in brands such as Nise, Nimulid and Nicip, was not covered, and neither were topical gels. Deccan Herald reported that sustained-release forms were also left out; that wording is not in the Gazette text we have seen.
Two older restrictions remain in force. GSR 82(E) of 10 February 2011 banned nimesulide formulations for children under 12, which is why paediatric syrups disappeared from the market. In January 2025 a separate Gazette notification banned veterinary nimesulide because residues in cattle carcasses poison vultures.
We have not found any court stay on the December 2025 order, and no new nimesulide notification between 8 October and 3 November 2026. Many nimesulide combinations are banned separately: nimesulide + levocetirizine under S.O. 1851(E) of 8 June 2017, 16 in the September 2018 wave, four more on 11 January 2019, and nimesulide + paracetamol dispersible tablets under S.O. 2394(E) of 2 June 2023.
What this means for you
Check the strength on the strip
100 mg tablets and gels are not affected. If you hold 200 mg tablets, ask your pharmacist whether they can still be dispensed.
Talk to your doctor about alternatives
If nimesulide was prescribed for long-term pain, your doctor can suggest a replacement at a routine visit.
Do not give to children under 12
This restriction has applied since 2011 and is unchanged.
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
- 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.
- Do not stop a medicine your doctor prescribed without talking to your doctor or pharmacist first.
- Keep the pack and the bill. Ask the shop that sold it to take it back.
- Report it to your state drug controller, or through CDSCO's consumer page. You can also check a batch number.
Common questions
What is the nimesulide ban notification number?
S.O. 6091(E) of 29 Dec 2025, issued under Section 26A, for oral nimesulide above 100 mg.
Is Nimesulide 100 mg banned in India?
No. Only oral strengths above 100 mg are prohibited for adults under the December 2025 notification.
Is nimesulide gel banned?
No. Topical gels were not covered by the December 2025 order.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Nimesulide (oral, above 100 mg, immediate release) | Banned | S.O. 6091(E) | 29 December 2025 | Prohibited with immediate effect under s.26A (Gazette CG-DL-E-30122025-268922). Nimesulide up to 100 mg, sustained-release forms and topical gels are not covered. Separate 2011 ban for children under 12 (GSR 82(E)). |
| 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). |
| Ranitidine + Dicyclomine + Nimesulide | Banned | S.O. 249(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Phenylephrine + Chlorpheniramine Maleate + Caffeine | Banned | S.O. 254(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Pitofenone + Fenpiverinium Bromide | Banned | S.O. 255(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Pseudoephedrine + Cetirizine | Banned | S.O. 256(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Diclofenac | Banned | S.O. 4380(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Cetirizine + Caffeine | Banned | S.O. 4381(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Tizanidine | Banned | S.O. 4382(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Serratiopeptidase | Banned | S.O. 4389(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol | Banned | S.O. 4391(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol Injection | Banned | S.O. 4393(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
Ingredient records
Every banned combination and failed batch containing each ingredient.
Batches declared Not of Standard Quality
Batches of products containing Nimesulide flagged in CDSCO monthly alerts. An NSQ result concerns one batch, not the molecule or the brand.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Nimesulide and paracetamol Tablets | Batch SPT-39912Mfg Apr 2025 · Exp Mar 2027 | Shervotech PharmaceuticalsHimachal Pradesh | Mottled appeareanceOther | DTL Jabalpur (M.P.)State lab | Aug 2026 |
| Nimesulide & Paracetamol Tablets | Batch Not MentionedMfg ? · Exp ? | Euphoria India PharmaceuticalsHimachal Pradesh | MISBRANDED DRUGS.Misbranded | SFDTL UttarakhandState lab | Jul 2026 |
| Nimesulide & Paracetamol Tablets. | Batch IPL24832Mfg Oct 2024 · Exp Sep 2027 | IBN HerbalsHimachal Pradesh | Disintegration test: does not comply with IP.Disintegration | SDTL, UttarakhandState lab | May 2026 |
| Nimesulide & Paracetamol Tablet | Batch T-25066Mfg Nov 2025 · Exp Oct 2027 | Soft Medicaps LtdMadhya Pradesh | The sample does not conforms to the claim with respect to Assay of Nimesulide and Paracetamol.Assay | DTL JaipurState lab | May 2026 |
| Nimesulide, Paracetamol and Chloroxazone Tablets) | Batch GST30990Mfg Jun 2023 · Exp May 2026 | HSN InternationalUttarakhand | Test for Disintegration onlyDisintegration | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Nimesulide & Paracetamol Tablets | Batch T3604Mfg Nov 2024 · Exp Oct 2027 | Leben Laboratories Pvt. Ltd | Test for DisintegrationDisintegration | RDTL, Bellary, KarnatakaState lab | Mar 2026 |
| Silky Gold Foley Balloon Catheter (Siliconised) | Batch 25F22Mfg Jun 2025 · Exp May 2030 | Ribbel International Ltd. 20th Mile Jatheri RoadHaryana | The sample does not comply as per I.P. 2022 with respect to the Bacterial Endotoxins Test.Bacterial endotoxins | RDTL, GuwahatiCDSCO lab | Feb 2026 |
| Nimesulide and Paracetamol Tablets (Noomi-P) | Batch MT-240521Mfg Feb 2024 · Exp Jan 2026 | Matins Healthcare Pvt. LtdUttarakhand | DescriptionDescription | KarnatakaState lab | Jul 2025 |
| NIMESULIDE AND PARACETAMOL Nimucet | Batch STI25103Mfg Mar 2025 · Exp Feb 2028 | Shivalik Remedies Pvt. LtdUttarakhand | AssayAssay | Drug Control Department ChhattisgarhState lab | Jul 2025 |
| Nimesulide & Paracetamol Tablets (Somu Gold) | Batch TTX0093Mfg Jan 2024 · Exp Dec 2026 | Pro-pharma Care Pvt. LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiCDSCO lab | Apr 2025 |
| Nimesulide & Paracetamol Bolus (Vet.) (Nip-UP Bolus) | Batch NPB-23221Mfg Feb 2024 · Exp Jan 2026 | Akme BiotecUttarakhand | Disintegration TestDisintegration | State Lab KarnatakaState lab | Apr 2025 |
| Nimesulide & Paracetamol Tablets (SOMOO) | Batch T-24004Mfg Apr 2024 · Exp Mar 2026 | Kshipra Drugs Pvt. Ltd | DisintegrationDisintegration | RDTL GuwahatiCDSCO lab | Jan 2025 |
| Nimesulide & Paracetamol Tablets (Nimuvent-P Tablets) | Batch GD332005Mfg Apr 2022 · Exp Mar 2025 | Innova Captab LtdHimachal Pradesh | DescriptionDescription | CDL KolkataCDSCO lab | Sep 2024 |
| Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim- Cold) | Batch T-23115Mfg Jan 2023 · Exp Dec 2024 | Unispeed Pharmaceuticals Pvt. LtdHimachal Pradesh | DescriptionDescription | CDL KolkataCDSCO lab | Aug 2024 |
| Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) | Batch GS22236Mfg Sep 2022 · Exp Aug 2025 | HSN InternationalUttarakhand | DisintegrationDisintegration | CDL KolkataCDSCO lab | Aug 2024 |
Sources
Government documents
- Regulator
- CDSCO: Updated banned drugs list with present status (as on 22.11.2021)RegulatorCDSCO · 22 November 2021
- List of Prohibited FDC drugs (14 FDCs) dated 02.06.2023RegulatorCDSCO · 2 June 2023
News reports
- AIR: Govt bans manufacturing, sale and distribution of oral nimesulide above 100 mgNewsAll India Radio · 29 December 2025
- Deccan Herald: Health ministry moves to remove syrups as OTC medicine, bans nimesulideNewsDeccan Herald
- News
- SAVE: India issues gazette notification of veterinary nimesulide banNewsSaving Asia's Vultures from Extinction