Nimesulide and Paracetamol Ban in India
Is nimesulide and paracetamol banned in India?
No, not as a blanket ban. India prohibits specific nimesulide + paracetamol products, not the combination as such. The CDSCO list of drugs banned under Section 26A of the Drugs and Cosmetics Act, 1940 covers the dispersible tablet, suspension and injection forms, plus several multi-drug cold/flu combinations containing both. The plain tablet, "Nimesulide 100mg + Paracetamol 500mg Tablets", is in the DCG(I) list of approved fixed dose combinations (FDCs), recorded as "Approved for more than 4 years" [1]. The banned list includes no entry for paracetamol on its own.
Banned nimesulide + paracetamol products (CDSCO banned drugs list)
| Serial | Product as listed | Notification |
|---|---|---|
| 103 | Nimesulide + Paracetamol dispersible tablets | S.O. 712(E), 10.03.2016 [2] |
| 112 | Nimesulide + Paracetamol injection | S.O. 721(E), 10.03.2016 [3] |
| 134 | Nimesulide + Paracetamol suspension | S.O. 743(E), 10.03.2016 [4] |
| 258 | Nimesulide + Paracetamol + Cetrizine + Phenylephrine | S.O. 867(E), 10.03.2016 [5] |
| 309 | Nimesulide + paracetamol + levocetirizine + phenylephrine + caffeine | S.O. 918(E), 10.03.2016 [6] |
| 376 | Cetirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide | S.O. 985(E), 10.03.2016 [7] |
Other limits on nimesulide that also apply to the tablet combination
- Children under 12: nimesulide formulations for human use in children below 12 years are prohibited under GSR 82(E) of 10.02.2011 [8].
- Boxed warning: in April 2012 the DCG(I) told State Drug Controllers to require a box warning on labels, package inserts and promotional literature for nimesulide products used in patients aged 12 and over. It says use should ordinarily be limited to 10 days, with periodic liver function tests if longer use is needed [9].
- Other banned nimesulide FDCs: the list also bans nimesulide with diclofenac, dicyclomine, serratiopeptidase, tizanidine and levocetirizine, among others (e.g. serial 97 [10]; serial 440, S.O. 1851(E), 08.06.2017 [11]).
Later development: the above-100 mg limit
- At its 92nd meeting (24.04.2025), the Drugs Technical Advisory Board (DTAB) recommended prohibiting all oral nimesulide formulations above 100 mg in immediate-release dosage form. It also recommended that nimesulide be used only as a second-line drug, and not in pregnancy, lactation, or renal or hepatic impairment (92nd DTAB minutes, Agenda No. 7).
- I could not open the Gazette notification that put this into effect, so I can't confirm its number or date from an official page.
- The approved tablet contains nimesulide 100 mg, which is at the threshold, not above it. A higher-strength immediate-release product would fall within this recommendation.
Approach: I searched the CDSCO Section 26A banned drugs list, the DCG(I) approved FDC register, and CDSCO circulars and public notices. I also read the 92nd DTAB minutes on the CDSCO website. The banned list is a consolidated document and may not include notifications issued after it was compiled.
What about nimesulide on its own?
Nimesulide on its own is not banned outright in India, but two Section 26A prohibitions limit it. Nimesulide formulations for human use in children under 12 are banned. Since late December 2025, oral immediate-release formulations above 100 mg for human use are also banned. Adult products at 100 mg or less remain permitted, but they must carry the box warning described below.
What applies to single-ingredient nimesulide
| Measure | Scope | Instrument |
|---|---|---|
| Paediatric ban | "Nimesulide formulations for human use in children below 12 years of age" (CDSCO banned drugs list, serial 82) | GSR 82(E), 10.02.2011 [8] |
| Box warning (ages 12 and over) | The DCG(I) told State Drug Controllers to require this warning on the label, carton, package insert and promotional literature: "Use of Nimesulide should ordinarily be restricted to 10 days. If longer clinical use is warranted, liver function test should be assessed periodically." This followed the DTAB's 60th meeting (10.10.2011). | DCG(I) order, 14 April 2012 [9] |
| High-dose oral ban | All oral formulations above 100 mg, "with immediate effect". The ministry said these are "likely to involve risk to human beings" and that safer alternatives exist. | Section 26A notification after consulting the DTAB, reported by All India Radio on 31 December 2025 (newsonair.gov.in) |
About the December 2025 ban
- It puts into effect the DTAB recommendation from its 92nd meeting (24.04.2025) that I cited last time. That recommendation was limited to doses above 100 mg in immediate-release form (92nd DTAB minutes, Agenda No. 7).
- The All India Radio report gives neither the notification number nor the release-type qualifier. I could not open the Gazette notice on an official site, so I can't confirm its S.O. number from an official page.
- The consolidated CDSCO banned list does not yet include it. The only nimesulide entry in that list that is not a combination is the paediatric ban.
Approved single-ingredient nimesulide products affected by the ban (CDSCO new drug approvals)
- Nimesulide ER 200 mg: approved 16.05.2009 for an additional indication, acute pain in orthopaedic, ENT, dental and post-operative conditions [12]. Because it is extended-release, it falls outside the immediate-release wording of the DTAB recommendation.
- Nimesulide Injection 75 mg/ml: approved 28-06-2004 for short-term treatment of post-operative pain [13]. It is not oral, so the high-dose ban does not reach it. The age restriction and box warning do apply.
- Nimesulide Injection 100 mg/ml (veterinary): approved 10-08-2004 [14]. Both prohibitions above apply only to human use. I found no record of a veterinary prohibition in the datasets I can search.
- Topical nimesulide 1% w/w solution: approved 17.11.2009 [15]. It is not oral, so the high-dose ban does not reach it.
Approach: I searched the CDSCO Section 26A banned drugs list, CDSCO circulars and public notices, and CDSCO's yearly new drug approval lists. For the December 2025 notification, which the consolidated list does not yet include, I relied on All India Radio's report.
Is Dolo 650 or Combiflam banned?
No. Neither Dolo 650 nor Combiflam is on India's Section 26A banned drugs list, and I found no prohibition on either brand in the CDSCO records I searched. The ibuprofen + paracetamol combination in Combiflam is a DCG(I)-approved fixed dose combination (FDC). The only Combiflam record is a 2016 quality failure for one batch, which is not a ban.
Combiflam (ibuprofen + paracetamol)
- Banned list: it has no ibuprofen + paracetamol entry. The only ibuprofen entry is serial 443, the FDC of glucosamine + ibuprofen, banned by S.O. 1854(E) of 08.06.2017 [16].
- Approved FDC: "Ibuprofen 400mg + Paracetamol 325mg tablet" is in the DCG(I) approved FDC register, with an approval date of Oct-84 [17]. The CDSCO records I found don't give Combiflam's strengths, so I can't confirm from them that it matches this exact entry.
- Quality alert (one batch only): CDSCO's list of drugs declared Not of Standard Quality for February 2016 includes Combiflam (Ibuprofen & Paracetamol Tablets), batch A150825, made by Sanofi India Limited at Ankleshwar. It failed the disintegration test; the sample was drawn by CDSCO East Zone, Kolkata and tested by CDL, Kolkata [18]. This kind of listing covers that batch only.
Dolo 650
- I found no record of Dolo 650 in the CDSCO brand-name register, the quality alerts or the public notices I searched, and none of them gives its composition.
- If it is a single-ingredient paracetamol tablet, nothing on the banned list applies to it. As noted earlier, the list has no entry for paracetamol on its own. The paracetamol entries are all specific combinations, and one of them explicitly exempts metoclopramide FDCs with aspirin/paracetamol (serial 38, substituted by GSR 603(E) of 24.08.2001) [19].
- I found no CDSCO quality alert for any Dolo batch.
Approach: I searched the CDSCO Section 26A banned drugs list, the DCG(I) approved FDC register, CDSCO's Not of Standard Quality/spurious drug alerts, the CDSCO brand-name register, and CDSCO circulars and public notices. The banned list is a consolidated document, and the quality alerts only cover the months CDSCO has published.