Govt Bans 35 Combination Drugs, See Full List
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a stern directive to all State and Union Territory Drug Controllers, instructing them to immediately stop the manufacture and sale of 35 unapproved Fixed Dose Combinations (FDCs).
The list includes widely used formulations combining antidiabetics, antibiotics, antihypertensives, painkillers, fertility drugs and multivitamins, many of which were marketed without central regulatory clearance.
The notice, dated April 2025, warns that such practices pose a serious threat to public health and violate the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019. The directive was issued under File No. 4-01/2023-DC (Misc. 3) by the Directorate General of Health Services, CDSCO (FDC Division), from FDA Bhawan, New Delhi.
“It has come to the notice of this Directorate that certain Fixed Dose Combination (FDC) drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy as per the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940. This poses a serious risk to public health and safety, " the Drugs Controller General of India (DCGI) said in the circular.
The CDSCO reiterated that FDCs falling under the definition of a "New Drug" must not be granted manufacturing licenses without due approval. A similar concern had been raised back in 2013 (vide F.No. 4-01/2013-DC), and again most recently on February 28, 2025.
Following issuance of show cause notices, several manufacturers claimed that their licenses were granted by State Licensing Authorities (SLAs) and that they had not violated any rules. However, the lack of uniform enforcement across the country has resulted in regulatory inconsistency, said CDSCO.
“The approval of such unapproved FDC's compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation, " the latest circular warns.
CDSCO has now directed all State and UT Drug Controllers to- Reassess their approval processes for FDCs; Cancel any licenses issued for unapproved FDCs; Investigate such cases thoroughly and submit details to CDSCO; Ensure strict compliance with NDCT Rules and the Drugs & Cosmetics Act, 1940.
The circular added that the matter is to be treated as “urgent and serious.”
A detailed list of unapproved FDCs—either cancelled by SLAs or voluntarily surrendered by manufacturers— annexed with the notice reads;
List of Unapproved FDCs with Cancelled / Surrendered Product Permission
| Sr. No. | Name of FDC |
| | Cornbipack of Each film coated extended release tablet contains: Mirabegron 25mg and Each film coated tablet contains: Solifenacin Succinate 5mg |
| | Nefopam Hydrochloride 30mg + Paracetamol 325mg tablets |
| | Metformin Hydrochloride IP 500mg (as extended release form) + Glimepiride IP 3mg + Dapagliflozin Propanediol Monohydrate IP eq. to Dapagliflozin 10mg film coated bilayered tablets |
| | FDC of: (i) Dextromethorphan Hydrobromide IP 10mg + Phenylephrine Hydrochloride IP 5mg per 5m1 Syrup & (ii) Diphenhydramine Hydrochloride IP 12.5mg + Phenylephrine Hydrochloride IP 5mg per 5mISyrup |
| | Cilnidipine IP 20mg + Metoprolol Succinate IP 47.5mg eq. to Metoprolol Tartrate 50mg film coated Bilayered tablet |
| | Ketoconazole IP 2.0%w/w + NeomycinSulphatelP 0.5%w/w + lodochlorhydroxyquinoline IP 1%w/w + Tolnaftate IP 1%w/w + Clobetasol Propionate IP 0.05%w/w cream |
| | Dehydroepiandrosterone SR 75mg + Melatonin BP 3mg + Ubidecarenone (Coenzyme Q 10) BP 100mg capsules |
| | Cefixime IP 200mg + Ofloxacin IP 200mg + Lactic acid bacillus 60 million spores tablets |
| | Aluminium Hydroxide Gel IP eq. to Aluminium Hydroxide 365mg + Magnesium Hydroxide Paste 1 USP eq. to Magnesium Hydroxide 80mg + Simethicone USP 100mg + Deglycyrrhizinated Liquorice eq. to Liquorice 400mg per 5ml oral suspension |
| 10. | Alpha amylase IP(1:800):28.125mg (fungal Diastase derived from Apergillus oryzae) Digest not less than 22.5g of cooked starch, Papain IP 15mg + Anise Oil I.P 1mg + Caraway oil IP 1mg + Cinnamon Oil BP 1mg + Dill oil BP 1mg syrup |
| 11. | Omega-3 fatty acids BP 300mg Eq. to EPA 90mg Eq. to DHA 60mg + Wheat germ oil BP 100mg +Green tea extracts Eq. to Polyphenols 25mg + Zinc sulphate monohydrate IP eq. to elemental zinc 12.5mg + Biotin BP 5mg + Lutein USP 5mg + Zeaxanthin 1mg + Copper sulphate pentahydrate BP Eq. to elemental copper 1mg + Selenium Dioxide USP Eq. to elemental selenium 75mcg soft gelatin capsules |
| 12. | Pregabalin (SR) IP 75mg + Nortriptyline HCI IP 10mg + Vitamin D3 IP 2000IU + Mecobalamin IP 1500mcg tablet |
| 13. | Acebrophylline (SR) 200mg + Montelukast Sodium IP 10mg + Fexofenadine Hydrochloride IP 120mg tablet |
| 14. | Dehydroepiandrosterone 75mg (as sustained release) + Folic Acid IP 4.5mg tablet |
| 15. | Dyhdroepiandrostrone 75mg + Melatonin BP 5mg + Ubidecarenone BP 100mg tablet |
| 16. | Sertraline Hydrochloride IP eq. to Sertraline 50mg + Clonazepam IP 0.5mg tablets |
| 17. | Sertraline Hydrochloride IP eq. to Sertraline 50mg + Clonazepam IP 0.25mg tablets |
| 18. | Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As Immediate Release Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Immediate Release Pellets) & Aspirin IP 150mg (As Castro-Resistant Pellets) Capsule |
| 19. | Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As Immediate Release Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Immediate Release Pellets) & Aspirin IP 150mg (As Castro-Resistant Pellets) Capsule |
| 20. | Tamsulosin Hydrochloride IP 0.4mg & Finasteride IP 5mg Tablet |
| 21. | Metoprolol Succinate USP 23.75 mg eq. to Metoprolol Tartrate 25mg and Ramipril IP 2.5mg Tablet |
| 22. | Bisoprolol Fumarate IP 5mg & Cilnidipine IP 10mg tablets |
| 23. | Chlorpheniramine Maleate IP 4mg + Codeine Phosphate IP 10mg + Sodium Citrate IP 75mg Syrup |
| 24. | Rifaximin BP 200mg & Metronidazole Benzoate IP Eq. to Metronidazole 400mg Tablets |
| 25. | Cefixime (as Trihydrate) IP eq. to Anhydrous Cefixime 200mg + Azithromycin Dihydrate IP eq. to Anhydrous Azithromycin 250mg + Lactic Acid Bacillus 60 million spores film coated tablets |
| 26. | Norfloxacin IP 125mg + Metronidazole Benzoate IP eq. to Metronidazole 120mg + Simethicone IP 10mg suspension |
| 27. | Cyproheptadine HCI IP 4mg + Zinc Sulphate Monohydrate IP eq. to Elemental Zinc 5mg uncoated tablet Meropenem 1gm + EDTA for injection Injection |
| 28. | |
| 29. | Glimepiride IP 1mg & Metformin HCL IP 500mg Tablet |
| 30. | Glimepiride IP 2mg, Metformin Hydrochloride IP (As Sustained Release form) 500mg and Voglibose IP 0.3mg Tablet |
| 31. | Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Voglibose IP 0.2mg Tablet |
| 32. | Ofloxacin IP 50mg, Ornidazole IP 125mg and Racecadrotril IP 15mg syrup |
| 33. | Ambroxol Hydrochloride IP 20mg + Dextromethorphan Hydrobromide IP 10mg + Chlorpheniramine Maleate IP 2mg per 5mI syrup |
| 34. | Ketoconazole IP 2.0%w/w + lodochlorhydroxyquinoline IP 1%w/w + Tolnaftate IP 1%w/w + Clobetasol Propionate IP 0.05%w/w + Neomycin Sulphate IP 0.10%w/w cream base |
| 35. | Meropenem 1000mg + Avibactam (Sterile) IP eq. to Avibactam 500mg Injection |
To see the full list click on the LINK Below:
The CDSCO has asked for close coordination among port, zonal, and sub-zonal offices to ensure strict enforcement. Investigations and updates on action taken must be reported to the Office of the Drugs Controller General (India).
