Ingredient record · Painkiller (NSAID)
Nimesulide: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
40 entries containing Nimesulide are on India's banned-drugs list, and 24 are banned today. 19 batches of medicines containing Nimesulide failed a government lab test between December 2019 and August 2026, from 17 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Banned Is Nimesulide banned in India? Banned above 100 mg (oral). Read the full status record
24
Banned combinations in force
16
Other listed orders (stayed, restricted, quashed)
19
Batches failed a lab test
Aug 2026
Latest lab alert
Is it banned? Our answer pages
Banned (14-FDC order, Jun 2023)
Banned above 100 mg (oral)
On the banned-drugs list
Nimesulide itself appears on the list as a single drug, see the entries marked "Single molecule" below. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Nimesulide (oral, above 100 mg, immediate release)Single molecule · painkillers | Banned | S.O. 6091(E) | 29 December 2025 | Other orders | 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 TabletsFixed-dose combination · painkillers | Banned | S.O. 2394(E) | 2 June 2023 | 14 FDCs · Jun 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 + NimesulideFixed-dose combination · gi | Banned | S.O. 249(E) | 11 January 2019 | Other orders | 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 + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 254(E) | 11 January 2019 | Other orders | 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 BromideFixed-dose combination · gi | Banned | S.O. 255(E) | 11 January 2019 | Other orders | 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 + CetirizineFixed-dose combination · cough-cold | Banned | S.O. 256(E) | 11 January 2019 | Other orders | 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 + DiclofenacFixed-dose combination · painkillers | Banned | S.O. 4380(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Cetirizine + CaffeineFixed-dose combination · painkillers | Banned | S.O. 4381(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + TizanidineFixed-dose combination · painkillers | Banned | S.O. 4382(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + SerratiopeptidaseFixed-dose combination · painkillers | Banned | S.O. 4389(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Pitofenone + Fenpiverinium + Benzyl AlcoholFixed-dose combination · gi | Banned | S.O. 4391(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol InjectionFixed-dose combination · painkillers | Banned | S.O. 4393(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + DicyclomineFixed-dose combination · gi | Banned | S.O. 4402(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol SuspensionFixed-dose combination · painkillers | Banned | S.O. 4413(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Loratadine + Phenylephrine + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4523(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Phenylephrine + Caffeine + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4527(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4530(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Banned | S.O. 4579(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Nimesulide + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4601(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Banned | S.O. 4632(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Cetirizine + Phenylephrine + Paracetamol + Caffeine + NimesulideFixed-dose combination · painkillers | Banned | S.O. 4639(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 4702(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + LevocetirizineFixed-dose combination · cough-cold | Banned | S.O. 1851(E) | 8 June 2017 | Other orders | Five FDCs prohibited 08.06.2017 (S.O. 1851(E)-1855(E)); re-notified 07.09.2018 as S.O. 4702(E)-4706(E) after the SC-ordered DTAB review. Etodolac + Paracetamol (4706(E)) later quashed. |
| Nimesulide + DiclofenacFixed-dose combination · painkillers | Quashed | S.O. 706(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Cetirizine + CaffeineFixed-dose combination · painkillers | Quashed | S.O. 707(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + TizanidineFixed-dose combination · painkillers | Quashed | S.O. 708(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol Dispersible TabletsFixed-dose combination · painkillers | Under examination | S.O. 712(E) | 10 March 2016 | 344 FDCs · Mar 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 + SerratiopeptidaseFixed-dose combination · painkillers | Quashed | S.O. 717(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Pitofenone + Fenpiverinium + Benzyl AlcoholFixed-dose combination · gi | Quashed | S.O. 719(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol InjectionFixed-dose combination · painkillers | Quashed | S.O. 721(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + DicyclomineFixed-dose combination · gi | Quashed | S.O. 730(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol SuspensionFixed-dose combination · painkillers | Quashed | S.O. 743(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Loratadine + Phenylephrine + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 860(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Phenylephrine + Ceffeine + LevocetirizineFixed-dose combination · cough-cold | Quashed | S.O. 864(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Quashed | S.O. 867(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + CaffeineFixed-dose combination · cough-cold | Quashed | S.O. 918(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Nimesulide + PhenylephrineFixed-dose combination · cough-cold | Quashed | S.O. 943(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide + Cetirizine + PhenylephrineFixed-dose combination · cough-cold | Quashed | S.O. 975(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Cetirizine + Phenylephrine + Paracetamol + Caffeine + NimesulideFixed-dose combination · painkillers | Quashed | S.O. 985(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Nimesulide Formulations for Human Use in Children Below 12 Years of AgeSingle molecule · painkillers | Banned | GSR 82(E) | 10 February 2011 | Classic bans | In force per CDSCO consumer list (1983-2017) |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Nimesulide Paracetamol | 12 | 12 | Aug 2026 |
| Nimesulide | 2 | 1 | Jan 2020 |
| Nimesulide Paracetamol Chloroxazone | 1 | 1 | Mar 2026 |
| Nimesulide Paracetamol Nimucet | 1 | 1 | Jul 2025 |
| Nimesulide Paracetamol Bolus | 1 | 1 | Apr 2025 |
| Nimesulide Paracetamol Chlorzoxazone | 1 | 1 | Aug 2024 |
| Nimesulide Phenylephrine Hydrochloride Levocetirizine Dihydrochloride | 1 | 1 | Aug 2024 |
Most recent failed batches
| 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 |
| 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 |
| NIMESULIDE & PARACETAMOL TABLETS (CABLIDE-P) | Batch ST-908AMfg Jan 2023 · Exp Dec 2024 | Senate LaboratoriesUttarakhand | DisintegrationDisintegration | CDTL HyderabadCDSCO lab | Nov 2023 |
Showing 15 of 19 records
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