Ingredient record · Painkiller (NSAID)
Nimesulide: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
40 entries containing Nimesulide are on India's banned-drugs list, and 24 are banned today. 18 batches of medicines containing Nimesulide failed a government lab test between December 2019 and July 2026, from 16 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
24
Banned combinations in force
16
Other listed orders (stayed, restricted, quashed)
18
Batches failed a lab test
Jul 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 | 11 | 11 | Jul 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 & Paracetamol Tablets | Not MentionedMfg ? · Exp ? | Euphoria India PharmaceuticalsHimachal Pradesh | MISBRANDED DRUGS.Misbranded | SFDTL UttarakhandState lab | Jul 2026 |
| Nimesulide & Paracetamol Tablets. | IPL24832Mfg 2024-10 · Exp 2027-09 | IBN HerbalsHimachal Pradesh | Disintegration test : does not comply with IP.Disintegration | SDTL, UttarakhandState lab | May 2026 |
| Nimesulide & Paracetamol Tablet | T-25066Mfg 2025-11 · Exp 2027-10 | 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) | GST30990Mfg 2023-06 · Exp 2026-05 | HSN InternationalUttarakhand | Test for Disintegration onlyDisintegration | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Nimesulide & Paracetamol Tablets | T3604Mfg 2024-11 · Exp 2027-10 | Leben Laboratories Pvt. Ltd | Test for DisintegrationDisintegration | RDTL, Bellary, KarnatakaState lab | Mar 2026 |
| Nimesulide and Paracetamol Tablets (Noomi-P) | MT-240521Mfg 2024-02 · Exp 2026-01 | Matins Healthcare Pvt. LtdUttarakhand | DescriptionDescription | KarnatakaState lab | Jul 2025 |
| NIMESULIDE AND PARACETAMOL Nimucet | STI25103Mfg 2025-03 · Exp 2028-02 | Shivalik Remedies Pvt. LtdUttarakhand | AssayAssay | Drug Control Department ChhattisgarhState lab | Jul 2025 |
| Nimesulide & Paracetamol Tablets (Somu Gold) | TTX0093Mfg 2024-01 · Exp 2026-12 | Pro-pharma Care Pvt. LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiCDSCO lab | Apr 2025 |
| Nimesulide & Paracetamol Bolus (Vet.) (Nip-UP Bolus) | NPB-23221Mfg 2024-02 · Exp 2026-01 | Akme BiotecUttarakhand | Disintegration TestDisintegration | State Lab KarnatakaState lab | Apr 2025 |
| Nimesulide & Paracetamol Tablets (SOMOO) | T-24004Mfg 2024-04 · Exp 2026-03 | Kshipra Drugs Pvt. Ltd | DisintegrationDisintegration | RDTL GuwahatiCDSCO lab | Jan 2025 |
| Nimesulide & Paracetamol Tablets (Nimuvent-P Tablets) | GD332005Mfg 2022-04 · Exp 2025-03 | Innova Captab LtdHimachal Pradesh | DescriptionDescription | CDL KolkataCDSCO lab | Sep 2024 |
| Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim- Cold) | T-23115Mfg 2023-01 · Exp 2024-12 | Unispeed Pharmaceuticals Pvt. LtdHimachal Pradesh | DescriptionDescription | CDL KolkataCDSCO lab | Aug 2024 |
| Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) | GS22236Mfg 2022-09 · Exp 2025-08 | HSN InternationalUttarakhand | DisintegrationDisintegration | CDL KolkataCDSCO lab | Aug 2024 |
| NIMESULIDE & PARACETAMOL TABLETS (CABLIDE-P) | ST-908AMfg 2023-01 · Exp 2024-12 | Senate LaboratoriesUttarakhand | DisintegrationDisintegration | CDTL HyderabadCDSCO lab | Nov 2023 |
| Nimesulide and Paracetamol Tablets (CDNIM-P TABLETS) | SMP- 2205Mfg 2023-01 · Exp 2024-12 | Cyper PharmaHimachal Pradesh | Uniformity of weight and Assay of Nimesulide and ParacetamolAssay | RDTL ChandigarhState lab | Jul 2023 |
Showing 15 of 18 records
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