Regulatory status record
Is Ofloxacin + Ornidazole (O2) banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Ofloxacin + ornidazole is not banned in India as of 19 Sep 2026; the CDSCO's 11 Apr 2025 direction halted the three-drug ofloxacin + ornidazole + racecadotril product, not the two-drug combination sold as O2.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for ofloxacin + ornidazole; CDSCO direction of 11 Apr 2025 covers the racecadotril version
- Latest action
- 11 April 2025
- Last checked
- 19 September 2026details being verified
Ofloxacin sterile eye and ear drops. Photo: Ofloxacin Eye and Ear Drops Sterile.jpg by Abdsomod (CC0). 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 Always check the linked government document for the current position, and tell us if something is out of date.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 for ofloxacin + ornidazole
- Halted (11 Apr 2025)
- Ofloxacin + ornidazole + racecadotril; cefixime + ofloxacin + lactobacillus
- Common brands
- O2 (Medley), Zanocin-OZ (Sun), Oflox-OZ (Cipla), Ornof
- Note
- Antibiotic stewardship guidance discourages routine use for diarrhoea, a clinical point, not a ban
Where the claim comes from
The 11 April 2025 CDSCO letter halting 35 unapproved FDCs included ofloxacin + ornidazole + racecadotril and cefixime + ofloxacin + lactobacillus. Coverage listed 'ofloxacin-ornidazole combination' among the halted products, and O2, the best-known two-drug brand, inherited the question.
Ofloxacin + ornidazole, sold as O2, Zanocin-OZ, Oflox-OZ and many generics, is one of India's most prescribed combinations for infectious diarrhoea and dysentery. It is not banned.
The combination has central approval and does not appear in any of the Section 26A notifications of 2016, 2018, 2023, 2024 or 2026. What happened on 11 April 2025 was different in kind: the CDSCO directed state licensing authorities to halt 35 fixed-dose combinations that had been licensed at state level without the central new-drug approval the law requires. Two of the 35 contained ofloxacin, ofloxacin + ornidazole + racecadotril, and cefixime + ofloxacin + lactobacillus. Both are three-ingredient products. The two-drug ofloxacin + ornidazole was not affected, and the legal nature of the April 2025 action, a direction rather than a Gazette ban, is itself flagged for verification in our plan.
There is a separate clinical conversation about this combination: antibiotic stewardship guidance in India discourages its routine use for acute diarrhoea, most of which is viral, because of resistance concerns. That is advice to prescribers, not a regulatory restriction, and it is sometimes mistaken for one.
If you have been prescribed O2 or an equivalent, the product is legal. If a pack lists a third active, particularly racecadotril, check with your pharmacist.
What this means for you
O2 and similar brands remain available
The two-drug combination is licensed and can be dispensed on prescription.
Count the ingredients
If a pack lists racecadotril as a third active, it is the halted product; ask your pharmacist.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Levofloxacin + Ornidazole + Alpha Tocopherol Acetate | Banned | S.O. 4430(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Ornidazole + Zinc Bis Glycinate | Banned | S.O. 4444(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Ofloxacin + Ornidazole + Terbinafine | Banned | S.O. 4672(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Ornidazole Suspension | Banned | S.O. 4684(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Ornidazole Injection | Banned | S.O. 4703(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Ofloxacin + Ornidazole Injection | Banned | S.O. 1852(E) | 8 June 2017 | 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. |
| Levofloxacin + Ornidazole + Alpha Tocopherol Acetate | Quashed | S.O. 761(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ofloxacin + Ornidazole + Zinc Bisglycinate | Quashed | S.O. 775(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Ofloxacin + Ornidazole + Terbinafine | Quashed | S.O. 1018(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Official sources and primary records
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025
- Business Standard: CDSCO halts manufacture, sale, distribution of 35 FDCs over safety concernsNewsBusiness Standard · 16 April 2025
- Regulator