35 unapproved combination drugs, including antidiabetics, banned in India; Find full list

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a strict directive to drug controllers across all states and Union Territories, ordering an immediate halt to the production and sale of 35 unapproved Fixed Dose Combinations (FDCs).

These formulations—ranging from antidiabetics, antihypertensives and antibiotics to pain relievers, fertility medications and multivitamins—were being sold without mandatory clearance from central drug authorities.

The April 2025 circular, issued under File No. 4-01/2023-DC (Misc. 3) from the FDC Division of CDSCO, highlighted grave concerns over the health risks posed by the unauthorised manufacture and sale of these combinations. According to the Drugs Controller General of India (DCGI), several FDCs had been approved for marketing without undergoing safety and efficacy assessments as stipulated by the New Drugs and Clinical Trials (NDCT) Rules, 2019, under the Drugs & Cosmetics Act, 1940.

The DCGI noted in the circular that the approval of such formulations, without scientific validation, was putting public health at risk and could lead to adverse reactions and harmful drug interactions.

The CDSCO also reminded state authorities that FDCs classified as ‘New Drugs’ must not be approved for manufacture without prior regulatory clearance. The issue had been raised earlier in 2013 and again as recently as February 2025. Despite multiple warnings and show-cause notices, several manufacturers had maintained that their licences were granted by State Licensing Authorities (SLAs), thereby complicating enforcement.

In light of these developments, CDSCO directed drug controllers to review and revoke manufacturing licences issued for unapproved FDCs, investigate these approvals thoroughly, submit findings to CDSCO without delay, and ensure full compliance with the NDCT Rules and Drugs & Cosmetics Act, 1940.

The matter was described as "urgent and serious”, and the agency emphasised the need for close coordination between port, zonal and sub-zonal CDSCO offices for effective implementation.

The notice also includes an annexed list of the 35 FDCs now banned due to regulatory violations. 

List of unapproved Fixed Dose Combinations (FDCs) 

1. Mirabegron 25mg (ER tablet) + Solifenacin Succinate 5mg (film-coated tablet)
2. Nefopam Hydrochloride 30mg + Paracetamol 325mg tablets
3. Metformin Hydrochloride (ER) 500mg + Glimepiride 3mg + Dapagliflozin 10mg (film-coated bilayered tablets)
4. (i) Dextromethorphan HBr 10mg + Phenylephrine HCl 5mg per 5ml syrup; (ii) Diphenhydramine HCl 12.5mg + Phenylephrine HCl 5mg per 5ml syrup
5. Cilnidipine 20mg + Metoprolol Succinate 47.5mg (equivalent to Metoprolol Tartrate 50mg, film-coated bilayered tablet)
6. Ketoconazole 2% w/w + Neomycin Sulphate 0.5% w/w + Iodochlorhydroxyquinoline 1% w/w + Tolnaftate 1% w/w + Clobetasol Propionate 0.05% w/w (cream)
7. Dehydroepiandrosterone (SR) 75mg + Melatonin 3mg + Coenzyme Q10 100mg (capsules)
8. Cefixime 200mg + Ofloxacin 200mg + Lactic Acid Bacillus 60 million spores (tablets)
9. Aluminium Hydroxide 365mg + Magnesium Hydroxide 80mg + Simethicone 100mg + Liquorice extract 400mg per 5ml (oral suspension)
10. Alpha amylase (Fungal Diastase) + Papain 15mg + Anise Oil 1mg + Caraway Oil 1mg + Cinnamon Oil 1mg + Dill Oil 1mg (syrup)
11. 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 gel capsules)
12. Pregabalin (SR) 75mg + Nortriptyline 10mg + Vitamin D3 2000 IU + Mecobalamin 1500mcg (tablet)
13. Acebrophylline (SR) 200mg + Montelukast Sodium 10mg + Fexofenadine Hydrochloride 120mg (tablet)
14. Dehydroepiandrosterone 75mg (SR) + Folic Acid 4.5mg (tablet)
15. Dehydroepiandrosterone 75mg + Melatonin 5mg + Coenzyme Q10 100mg (tablet)
16. Sertraline 50mg + Clonazepam 0.5mg (tablet)
17. Sertraline 50mg + Clonazepam 0.25mg (tablet)
18. Rosuvastatin 20mg + Clopidogrel 75mg + Aspirin 150mg (capsule, all as pellet forms)
19. Rosuvastatin 10mg + Clopidogrel 75mg + Aspirin 150mg (capsule, all as pellet forms)
20. Tamsulosin Hydrochloride 0.4mg + Finasteride 5mg (tablet)
21. Metoprolol Succinate 23.75mg + Ramipril 2.5mg (tablet)
22. Bisoprolol Fumarate 5mg + Cilnidipine 10mg (tablet)
23. Chlorpheniramine Maleate 4mg + Codeine Phosphate 10mg + Sodium Citrate 75mg (syrup)
24. Rifaximin 200mg + Metronidazole 400mg (tablet)
25. Cefixime 200mg + Azithromycin 250mg + Lactic Acid Bacillus 60 million spores (film-coated tablet)
26. Norfloxacin 125mg + Metronidazole 120mg + Simethicone 10mg (suspension)
27. Cyproheptadine Hydrochloride 4mg + Zinc Sulphate (Elemental Zinc 5mg, uncoated tablet)
28. Meropenem 1g + EDTA (injection)
29. Glimepiride 1mg + Metformin Hydrochloride 500mg (tablet)
30. Glimepiride 2mg + Metformin (SR) 500mg + Voglibose 0.3mg (tablet)
31. Metformin (PR) 500mg + Voglibose 0.2mg (tablet)
32. Ofloxacin 50mg + Ornidazole 125mg + Racecadotril 15mg (syrup)
33. Ambroxol 20mg + Dextromethorphan 10mg + Chlorpheniramine Maleate 2mg per 5ml (syrup)
34. Ketoconazole 2% + Iodochlorhydroxyquinoline 1% + Tolnaftate 1% + Clobetasol Propionate 0.05% + Neomycin Sulphate 0.10% (cream)
35. Meropenem 1000mg + Avibactam 500mg (injection)

CDSCO has also mandated prompt reporting of action taken and urged uniform enforcement to avoid any compromise on patient safety.