Brand check
Is Combiflam banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Combiflam is not banned in India as of 19 Sep 2026; the ibuprofen + paracetamol combination has never been notified under Section 26A, and the 2016 to 2017 findings concerned specific batches.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for ibuprofen + paracetamol
- Latest action
- 2 August 2024
- Last checked
- 19 September 2026details being verified
Ibuprofen 200 mg tablets; ibuprofen is Combiflam's active ingredient alongside paracetamol. Photo: 200mg ibuprofen tablets.jpg by Ragesoss (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: Drugs banned in India (consumer section)
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Ban notification
- None
- Composition
- Ibuprofen 400 mg + paracetamol 325 mg
- Manufacturer
- Sanofi India
- NSQ history
- Batches failed disintegration tests in CDSCO alerts, 2016 to 2017 (batch-specific)
Where the claim comes from
In 2016 and 2017 CDSCO monthly alerts listed several Combiflam batches as not of standard quality because they failed a disintegration test. Sanofi recalled the batches. Headlines of the time said 'Combiflam fails quality test', and the story hardened into 'Combiflam banned', reinforced whenever a new FDC ban list circulates.
Combiflam is Sanofi's brand of ibuprofen with paracetamol, one of the most familiar painkillers in Indian homes. It is not banned, and the combination has never been named in a Section 26A notification.
The rumour has a concrete origin. In 2016 and 2017 the CDSCO's monthly drug alerts listed a handful of Combiflam batches as "not of standard quality" after they failed a disintegration test, the tablets took longer than the pharmacopoeial limit to break up. Sanofi withdrew the affected lots. A quality failure of that kind is a batch-level finding under the Drugs and Cosmetics Act; it does not affect the product licence, and the brand continued to be made and sold.
Ibuprofen + paracetamol was not in the 344-FDC ban of 2016, the 328-FDC re-ban of 2018, the 156 combinations prohibited in 2024 or the 16 prohibited in June 2026. It also does not appear in the April 2025 list of 35 unapproved combinations. Flexon and Brufen, which searchers ask about together with Combiflam, are in the same position: Flexon is the same combination, and Brufen is plain ibuprofen.
If you use the product often, the sensible check is the batch number against current CDSCO alerts, which our database covers, rather than the brand name against a ban list.
What this means for you
Available as before
Combiflam, Flexon and generic ibuprofen + paracetamol tablets remain licensed.
Old batch reports are not a ban
The 2016 to 2017 findings were about how quickly certain batches dissolved; those lots were recalled at the time.
Use within limits
Ibuprofen is an NSAID; people with kidney problems, ulcers or on blood thinners should check with a doctor.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Is Brufen banned in India?
No. Brufen is plain ibuprofen and is not subject to any ban.
Batches flagged in CDSCO alerts
Products whose name matches this brand or molecule in CDSCO monthly NSQ alerts. A flagged batch is a single batch; the company's response, where reported, is noted on the page above.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Flexon Suspension | DPK241894Mfg 2024-10 · Exp 2027-09 | Aristo Pharmaceuticals Pvt. Ltd. Survey No. 371Daman & Diu | Suspension does not dispose uniformaly on shakingOther | DTL Jabalpur (M.P.)State lab | Jul 2026 |
Official sources and primary records
- Regulator
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Regulator