Ingredient record · Antifungal cream
Miconazole: 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
10 entries containing Miconazole are on India's banned-drugs list, and 6 are banned today. 10 batches of medicines containing Miconazole failed a government lab test between October 2019 and July 2026, from 5 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Miconazole on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Miconazole Nitrate + Gentamicin + Fluocinolone Acetonide + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 3326(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Miconazole + TinidazoleFixed-dose combination · skin | Banned | S.O. 3327(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Clobetasol + Ofloxacin + Miconazole + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 4657(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Gentamicin + Miconazole + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 4658(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Neomycin + Miconazole + ClotrimazoleFixed-dose combination · skin | Banned | S.O. 4670(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Neomycin + Miconazole + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 4673(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Ofloxacin + Miconazole + Zinc SulphateFixed-dose combination · skin | Quashed | S.O. 1003(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Gentamicin + Miconazole + Zinc SulphateFixed-dose combination · skin | Quashed | S.O. 1004(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Neomycin + Miconazole + ClotrimazoleFixed-dose combination · skin | Quashed | S.O. 1016(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Neomycin + Miconazole + Zinc SulphateFixed-dose combination · skin | Quashed | S.O. 1019(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
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 |
|---|---|---|---|
| Clobetasol Propionate Neomycin Miconazole Nitrate Chlorhexidine | 5 | 1 | Jul 2026 |
| Clobetasol Propionate Neomycin Sulphate Miconazole Nitrate | 1 | 1 | Sep 2025 |
| Miconazole Nitrate W/w | 1 | 1 | Sep 2025 |
| Miconazole | 1 | 1 | Jul 2025 |
| Miconazole Nitrate Fluocinolone Acetonide | 1 | 1 | Feb 2024 |
| Clobetasol Propionate Neomycin Sulphate Miconazole Nitrate Panderm ++ | 1 | 1 | Oct 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Clobetasol Propionate, Neomycin, Miconazole Nitrate & Chlorhexidine Cream | DLPS5111Mfg 2025-11 · Exp 2027-10 | Leeford Healthcare LtdHimachal Pradesh | Content of Chlorhexidine (51.5%)Other | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Clobetasol Propionate, Neomycin, Miconazole Nitrate & Chlorhexidine Cream | DLPS5108Mfg 2025-11 · Exp 2027-10 | Leeford Healthcare LtdHimachal Pradesh | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Clobetasol Propionate, Neomycin, Miconazole Nitrate & Chlorhexidine Cream | DLPS5027Mfg 2025-07 · Exp 2027-06 | Leeford Healthcare LtdHimachal Pradesh | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Jan 2026 |
| Clobetasol Propionate, Neomycin, Miconazole Nitrate & Chlorhexidine Cream | DLPS5033Mfg 2025-07 · Exp 2027-06 | Leeford Healthcare LtdHimachal Pradesh | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Jan 2026 |
| Clobetasol Propionate, Neomycin, Miconazole Nitrate & Chlorhexidine Cream | DLPS5019Mfg 2025-07 · Exp 2027-06 | Leeford Healthcare LtdHimachal Pradesh | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Jan 2026 |
| Miconazole Nitrate Cream IP 2% w/w | MZP-2502Mfg 2025-08 · Exp 2027-07 | Apple Formulations Pvt. LtdUttarakhand | AssayAssay | SDTL, PunjabState lab | Sep 2025 |
| Clobetasol Propionate Neomycin Sulphate and Miconazole Nitrate Cream | 18241408AMfg 2024-07 · Exp 2026-06 | Macleods Pharmaceuticals LtdSikkim | SpouriosOther | SDTL Raipur ChhattisgarhState lab | Sep 2025 |
| Miconazole Cream IP 2% | XE04Mfg 2025-05 · Exp 2027-04 | Snehai Pharma & Surgicals Pvt. LtdMaharashtra | The Content of Miconazole Nitrate found to be 1.285% W/w (64.25%) against labelled claim of 2% W/W.Labelling | State Drugs Laboratory, PunjabState lab | Jul 2025 |
| Miconazole Nitrate and Fluocinolone Acetonide Ointment (Zole - F) | SXE1800AMfg 2023-08 · Exp 2026-07 | Sun Pharmaceutical Ind. LtdHimachal Pradesh | AssayAssay | CDL KolkataCDSCO lab | Feb 2024 |
| Clobetasol Propionate, Neomycin Sulphate and Miconazole Nitrate Cream (PANDERM ++CREAM) | PCF901AMfg 2019-02 · Exp 2021-01 | Macleods Pharmaceuticals LtdSikkim | IdentificationIdentification | RDTL ChandigarhState lab | Oct 2019 |
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.