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 I Surrendered Product Permission
|
Sr. No. |
Name of FDC |
|
1 . |
Combipack of Each film coated extended release tablet contains: Mirabegron 25mg and Each film coated tablet contains: Solifenacin Succinate 5mg |
|
2. |
Nefo am H drochloride 30m + Paracetamol 325m tablets |
|
3. |
Metformin Hydrochloride IP 500mg (as extended release form) + Glimepiride IP 3mg + Dapagliflozin Propanediol Monohydrate IP eq. to Da a liflozin 10m film coated bila ered tablets |
|
4. |
FDC of: (i) Dextromethorphan Hydrobromide IP 10mg + Phenylephrine Hydrochloride IP 5mg per 5ml Syrup & (ii) Diphenhydramine Hydrochloride IP 12.5mg + Phenylephrine Hydrochloride IP 5mg per 5ml S ru |
|
5. |
Cilnidipine IP 20mg + Metoprolol Succinate IP 47.5mg eq. to Metoprolol Tartrate 50m film coated Bila ered tablet |
|
6. |
Ketoconazole IP 2.0%w/w + NeomycinSulphatelP 0.5%w/w + Iodochlorhydroxyquinoline IP 1%w/w + Tolnaftate IP 1%w/w + Clobetasol Pro ionate IP 0.05%w/w cream |
|
7. |
Dehydroepiandrosterone SR 75mg + Melatonin BP 3mg + Ubidecarenone Coenz me Q 10 BP 100m ca sules |
|
8. |
Cefixime IP 200mg + Ofloxacin IP 200mg + Lactic acid bacillus 60 million s ores tablets |
|
9. |
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 Li uorice 400m er 5ml oral sus ension |
|
1 0. |
Alpha amylase IP(I (fungal Diastase derived from Apergillus oryzae) Digest not less than 22.5g of cooked starch, Papain IP 15mg + Anise Oil I.P Img + Caraway oil IP Img + Cinnamon Oil BP 1m + Dill oil BP 1m s ru |
|
1 1 . |
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 Img + Copper sulphate pentahydrate BP Eq. to elemental copper Img + Selenium Dioxide USP E . to elemental selenium 75mc soft elatin ca sules |
|
1 2. |
Pregabalin (SR) IP 75mg + Nortriptyline HCI IP 10mg + Vitamin D3 IP 200011J + Mecobalamin IP 1500mc tablet |
|
1 3. |
Acebrophylline (SR) 200mg + Montelukast Sodium IP 10mg + Fexofenadine H drochloride IP 120m tablet |
|
14. |
Dehydroepiandrosterone 75mg (as sustained release) + Folic Acid IP 4.5m tablet |
|
1 5. |
Dyhdroepiandrostrone 75mg + Melatonin BP 5mg + Ubidecarenone BP 100m tablet |
|
16. |
Sertraline Hydrochloride IP eq. to Sertraline 50mg + Clonazepam IP 0.5m tablets |
|
1 7. |
Sertraline Hydrochloride IP eq. to Sertraline 50mg + Clonazepam IP 0.25m 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 Gastro-Resistant Pellets Ca sule |
|
1 9. |
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 Gastro-Resistant Pellets Ca sule |
|
20. |
Tamsulosin H drochloride IP 0.4m & Finasteride IP 5m Tablet |
|
21. |
Metoprolol Succinate USP 23.75 mg eq. to Metoprolol Tartrate 25mg and Rami ril IP 2.5m Tablet |
|
22. |
Biso rolol Fumarate IP 5m & Cilnidi ine IP 10m tablets |
|
23. |
Chlorpheniramine Maleate IP 4mg + Codeine Phosphate IP 10mg + Sodium Citrate IP 75m S ru |
|
24. |
Rifaximin BP 200mg & Metronidazole Benzoate IP Eq. to Metronidazole 400m Tablets |
|
25. |
Cefixime (as Trihydrate) IP eq. to Anhydrous Cefixime 200mg + Azithromycin Dihydrate IP eq. to Anhydrous Azithromycin 250mg + Lactic Acid Bacillus 60 million s ores film coated tablets |
|
26. |
Norfloxacin IP 125mg + Metronidazole Benzoate IP eq. to Metronidazole 120m + Simethicone IP 10m sus ension |
|
27. |
Cyproheptadine HCI IP 4mg + Zinc Sulphate Monohydrate IP eq. to Elemental Zinc 5m uncoated tablet |
|
28. |
Mero enem 1 m + EDTA for in•ection ln•ection |
|
29. |
Glime iride IP 1m & Metformin HCL IP 500m Tablet |
|
30. |
Glimepiride IP 2mg, Metformin Hydrochloride IP (As Sustained Release form 500m and Vo libose IP 0.3m Tablet |
|
31 |
Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Vo libose IP 0.2m Tablet |
|
32. |
Ofloxacin IP 50mg, Ornidazole IP 125mg and Racecadrotril IP 15mg s ru |
|
33. |
Ambroxol Hydrochloride IP 20mg + Dextromethorphan Hydrobromide IP 10m + Chlor heniramine Maleate IP 2m er 5ml s ru |
|
34. |
Ketoconazole IP 2.0%w/w + Iodochlorhydroxyquinoline IP 1%w/w + Tolnaftate IP 1%w/w + Clobetasol Propionate IP 0.05%w/w + Neomycin Sul hate IP 0.10%w/w cream base |
|
35. |
Meropenem 1000mg + Avibactam (Sterile) IP eq. to Avibactam 500mg ln•ection |
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).