Ban order
35 unapproved FDCs halted on 11 April 2025
Last checked 20 September 2026. Parsed from the CDSCO notification PDF; status per CDSCO footnotes
A CDSCO direction to state licensing authorities, not a ban notified under Section 26A. One entry was removed by a corrigendum on 10 Sep 2025.35 entries are listed below with their notification number, date and current status.
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Mirabegron 25mg (Extended Release Tablet) + Solifenacin Succinate 5mg (Combipack)Fixed-dose combination · other | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 1 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Nefopam Hydrochloride 30mg + Paracetamol 325mg TabletsFixed-dose combination · painkillers | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 2 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Metformin Hydrochloride 500mg (Extended Release) + Glimepiride 3mg + Dapagliflozin 10mg Film Coated Bilayered TabletsFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 3 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride 5mg per 5ml Syrup & Diphenhydramine Hydrochloride 12.5mg + Phenylephrine Hydrochloride 5mg per 5ml SyrupFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 4 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Cilnidipine 20mg + Metoprolol Succinate 47.5mg (eq. to Metoprolol Tartrate 50mg) Film Coated Bilayered TabletFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 5 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| 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 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Dehydroepiandrosterone SR 75mg + Melatonin 3mg + Ubidecarenone (Coenzyme Q10) 100mg CapsulesFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 7 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Cefixime 200mg + Ofloxacin 200mg + Lactic Acid Bacillus 60 Million Spores TabletsFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 8 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Aluminium Hydroxide 365mg + Magnesium Hydroxide 80mg + Simethicone 100mg + Deglycyrrhizinated Liquorice 400mg per 5ml Oral SuspensionFixed-dose combination · gi | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 9 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Alpha Amylase (Fungal Diastase) 28.125mg + Papain 15mg + Anise Oil 1mg + Caraway Oil 1mg + Cinnamon Oil 1mg + Dill Oil 1mg SyrupFixed-dose combination · gi | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 10 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Omega-3 Fatty Acids 300mg (EPA 90mg, DHA 60mg) + Wheat Germ Oil 100mg + Green Tea Extract (Polyphenols 25mg) + Zinc 12.5mg + Biotin 5mg + Lutein 5mg + Zeaxanthin 1mg + Copper 1mg + Selenium 75mcg Soft Gelatin CapsulesFixed-dose combination · vitamins | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 11 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Pregabalin (SR) 75mg + Nortriptyline 10mg + Vitamin D3 2000IU + Mecobalamin 1500mcg TabletFixed-dose combination · vitamins | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 12 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Acebrophylline (SR) 200mg + Montelukast 10mg + Fexofenadine Hydrochloride 120mg TabletFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 13 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Dehydroepiandrosterone 75mg (Sustained Release) + Folic Acid 4.5mg TabletFixed-dose combination · vitamins | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 14 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Dehydroepiandrosterone 75mg + Melatonin 5mg + Ubidecarenone 100mg TabletFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 15 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Sertraline 50mg + Clonazepam 0.5mg TabletsFixed-dose combination · other | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 16 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Sertraline 50mg + Clonazepam 0.25mg TabletsFixed-dose combination · other | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 17 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Rosuvastatin 20mg + Clopidogrel 75mg + Aspirin 150mg (Gastro-Resistant) CapsuleFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 18 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Rosuvastatin 10mg + Clopidogrel 75mg + Aspirin 150mg (Gastro-Resistant) CapsuleFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 19 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Tamsulosin Hydrochloride 0.4mg + Finasteride 5mg TabletFixed-dose combination · other | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 20 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Metoprolol Succinate 23.75mg (eq. to Metoprolol Tartrate 25mg) + Ramipril 2.5mg TabletFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 21 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Bisoprolol Fumarate 5mg + Cilnidipine 10mg TabletsFixed-dose combination · cardiac | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 22 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Chlorpheniramine Maleate 4mg + Codeine Phosphate 10mg + Sodium Citrate 75mg SyrupFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 23 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Rifaximin 200mg + Metronidazole 400mg TabletsFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 24 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Cefixime 200mg + Azithromycin 250mg + Lactic Acid Bacillus 60 Million Spores Film Coated TabletsFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 25 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Norfloxacin 125mg + Metronidazole 120mg + Simethicone 10mg SuspensionFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 26 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Cyproheptadine HCl 4mg + Zinc 5mg Uncoated TabletFixed-dose combination · vitamins | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 27 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Meropenem 1gm + EDTA for InjectionFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 28 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Glimepiride 1mg + Metformin HCl 500mg TabletFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 29 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Glimepiride 2mg + Metformin Hydrochloride (Sustained Release) 500mg + Voglibose 0.3mg TabletFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 30 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Metformin Hydrochloride (Prolonged Release) 500mg + Voglibose 0.2mg TabletFixed-dose combination · diabetes | Ban revoked | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 31 | 11 April 2025 | Excluded from the 11.04.2025 list by CDSCO corrigendum dated 10.09.2025: found to be approved by CDSCO (recorded by Delhi HC on 14.07.2025). Originally: CDSCO direction to SLAs 11 Apr 2025, not a Section 26A ban. |
| Ofloxacin 50mg + Ornidazole 125mg + Racecadotril 15mg SyrupFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 32 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Ambroxol Hydrochloride 20mg + Dextromethorphan Hydrobromide 10mg + Chlorpheniramine Maleate 2mg per 5ml SyrupFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 33 | 11 April 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 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Meropenem 1000mg + Avibactam 500mg InjectionFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 35 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
Official sources and primary records
- Gazette
- Regulator
- Primary notification for this waveGazettecdsco.gov.in