Ingredient record · Antifungal, often in creams and shampoos
Ketoconazole: 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
11 entries containing Ketoconazole are on India's banned-drugs list, and 6 are banned today. 17 batches of medicines containing Ketoconazole failed a government lab test between April 2019 and July 2026, from 15 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
6
Banned combinations in force
5
Other listed orders (stayed, restricted, quashed)
17
Batches failed a lab test
Jul 2026
Latest lab alert
On the banned-drugs list
Ketoconazole 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 |
|---|---|---|---|---|---|
| Ketoconazole 2.0% w/w + Neomycin Sulphate 0.5% w/w + Iodochlorhydroxyquinoline 1% w/w + Tolnaftate 1% w/w + Clobetasol Propionate 0.05% w/w CreamFixed-dose combination · skin | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 6 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Ketoconazole 2.0% w/w + Iodochlorhydroxyquinoline 1% w/w + Tolnaftate 1% w/w + Clobetasol Propionate 0.05% w/w + Neomycin Sulphate 0.10% w/w CreamFixed-dose combination · skin | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 34 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Ketoconazole + Zinc Pyrithione + D-Panthenol + Tea Tree Oil + AloesFixed-dose combination · skin | Banned | S.O. 3318(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ketoconazole + Aloe Vera + Vitamin a AcetateFixed-dose combination · skin | Banned | S.O. 3319(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Ketoconazole + Aloes + ZPTOFixed-dose combination · skin | Banned | S.O. 3320(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Clobetasol + Ofloxacin + Ketoconazole + Zinc SulphateFixed-dose combination · skin | Banned | S.O. 4664(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Gentamicin + Tolnaftate + Iodochlorhydroxyquinoline + KetoconazoleFixed-dose combination · skin | Banned | S.O. 4666(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ketoconazole + Tea Tree Oil + Allantoin + Inc Oxide + Aloe Vera + Jojoba Oil + Lavender Oil + Soap NoodlesFixed-dose combination · skin | Banned | S.O. 4671(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Clobetasol + Ofloxacin + Ketoconazole + Zinc SulphateFixed-dose combination · skin | Quashed | S.O. 1010(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Clobetasol + Gentamicin + Tolnaftate + Iodochlorhydroxyquinoline + KetoconazoleFixed-dose combination · skin | Quashed | S.O. 1012(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ketoconazole + Tea Tree Oil + Allantion + Zincoxide + Aloevera + Jojobaoil + Lavanderoil + Soa P NoodlesFixed-dose combination · skin | Quashed | S.O. 1017(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 |
|---|---|---|---|
| Ketoconazole | 4 | 4 | Apr 2026 |
| Ketoconazole Medicated Soap | 2 | 2 | Mar 2026 |
| Ketoconazole Chloridexidine Glueconate Cetrinide Shampoo | 1 | 1 | Jul 2026 |
| Ketoconazole Chlorhexidine Gluconate | 1 | 1 | Jun 2026 |
| Ketoconazole Cetrimide Soap | 1 | 1 | May 2026 |
| Ketoconazole Soap W/w | 1 | 1 | Mar 2026 |
| Ketoconazole Iodochlorhydroxyquinoline Tolnaftate Neomycin Sulphate Clobetasol Propionate | 1 | 1 | Feb 2026 |
| Ketoconazole Soap | 1 | 1 | Feb 2026 |
| Ketoconazole Zinc Pyrithione Shampoo | 1 | 1 | Jun 2025 |
| Kelan Soap | 1 | 1 | Apr 2025 |
| Dermotil K Spray Ketoconazole Chlorhexidinegluc Onate | 1 | 1 | Nov 2024 |
| Ketoconazole Shampoo | 1 | 1 | Apr 2020 |
| Ocona Ct Scalp | 1 | 1 | Apr 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| ketoconazole, Chloridexidine Glueconate & Cetrinide Shampoo | L047D25Mfg 2025-04 · Exp 2027-03 | Disinfecto Chemical Industrial Pvt. Ltd. D-7Uttar Pradesh | Assay for chlorhexidine Gluconate onlyAssay | RDTL. Bellary KarnatakaState lab | Jul 2026 |
| Ketoconazole & Chlorhexidine Gluconate Lotion | 129Mfg 2025-09 · Exp 2027-02 | Argion Cosmed India Pvt. LtdTamil Nadu | ContentOther | DTL, Chennai-06State lab | Jun 2026 |
| Ketoconazole & Cetrimide Soap | CX-041Mfg 2025-11 · Exp 2027-10 | SMB Healthcare | ContentOther | DTL, Chennai-06State lab | May 2026 |
| Ketoconazole Tablets IP 200 mg | AD00112001Mfg 2025-01 · Exp 2026-12 | Admed Pharma Pvt. LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Ketoconazole Soap 2% w/w) | ADE25561Mfg 2025-05 · Exp 2027-04 | Astonea Labs Pvt. LtdHaryana | Assay ketoconazoleAssay | RDTL, Bellary, KarnatakaState lab | Mar 2026 |
| Ketoconazole Medicated Soap 75 g | 9221Mfg 2025-10 · Exp 2027-09 | Vimson DermaGujarat | ContentOther | DTL,ChennaiState lab | Mar 2026 |
| Ketoconazole, Iodochlorhydroxyquinoline, tolnaftate, Neomycin Sulphate & Clobetasol Propionate | GE25077Mfg 2025-06 · Exp 2027-05 | Lifecom Pharmaceuticals (India) Pvt.LtdUttarakhand | Assay of clobetasol Propionate IP & Ketoconazole IPAssay | FDTL,UttarakhandState lab | Feb 2026 |
| Ketoconazole Soap | KEZ-017Mfg 2025-08 · Exp 2027-07 | SMB Healthcare | ContentOther | DTL, Chennai-06State lab | Feb 2026 |
| Ketoconazole Tablets IP 200mg | PGT241013Mfg 2024-12 · Exp 2026-11 | Affy ParenteralsHimachal Pradesh | The sample does not conforms to IP 2022 in respect of the Assay of KetoconazoleAssay | DTL, Baddi, Himanchal PradeshState lab | Jul 2025 |
| Ketoconazole & Zinc Pyrithione Shampoo (Ketocross Shampoo) | L25Y2002Mfg 2025-03 · Exp 2027-02 | Om Sai Pharma PackUttarakhand | Assay of Zinc PyrithioneAssay | CDL KolkataCDSCO lab | Jun 2025 |
| Ketoconazole Tablets I.P. 200mg | GT301737Mfg 2024-03 · Exp 2026-02 | Gnosis Pharmaceuticals Pvt. LtdHimachal Pradesh | Description onlyDescription | State Lab KarnatakaState lab | Apr 2025 |
| Kelan Soap(Ketoconazole Meidcated Soap) | 8091Mfg 2026-10 · Exp 2026-09 | Vimson DermaGujarat | sample does not conform to label claim with respect to the content of KetoconazoleLabelling | DTL MaduraiState lab | Apr 2025 |
| Dermotil-K Spray. Ketoconazole with chlorhexidineGluc onate Solution | E1207Mfg 2024-09 · Exp 2026-08 | Vinsmile | Sample does not conform to label claim with respect to the content of Ketoconazole.Labelling | DTL ChennaiState lab | Nov 2024 |
| Ketoconazole Cream BP (Nozal Cream) | 4129Mfg 2024-07 · Exp 2026-06 | Olcare Laboratories 505/AGujarat | AssayAssay | CDL KolkataCDSCO lab | Sep 2024 |
| Ketoconazole Medicated Soap (Seboket Soap) | SP-29Mfg 2022-11 · Exp 2024-10 | MARS MedisoapGujarat | AssayAssay | CDL KolkataCDSCO lab | Mar 2024 |
Showing 15 of 17 records
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.