The Indian government has banned 156 fixed-dose combination (FDC) medicines, including antibiotics, painkillers, and multivitamins, due to potential risks to human health. This decision was announced on Thursday and follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB).

What Are Fixed-Dose Combination Medicines?

Fixed-dose combination (FDC) drugs are medications that contain two or more active ingredients in a fixed ratio. They are often referred to as "cocktail" drugs and are used to target multiple symptoms or conditions at once.

Details of the Ban

The Union Health Ministry issued a gazette notification prohibiting the manufacture, sale, and distribution of these medicines under Section 26A of the Drugs and Cosmetics Act, 1940. The expert committee found no therapeutic justification for the ingredients in these FDCs, stating that they pose a risk to human health and that safer alternatives are available.

The central government stated that these FDCs are considered "irrational" and that their use could pose significant health risks. The decision is aimed at protecting public health and ensuring that only safe and effective medicines are available in the market.

Previous Actions and Ongoing Efforts

This recent ban is part of an ongoing effort by the government to regulate the use of FDCs in India. In 2016, the government banned 344 drug combinations following recommendations from an expert panel set up by the Supreme Court. Earlier this year, in June 2023, 14 more FDCs were banned. Some of the banned products had already been discontinued by manufacturers before the official announcement.

Combination Medicines Banned 

• FDC of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain
• FDC of Antimony Potassium Tartrate + Dried Ferrous Sulphate
• FDC of Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride
• FDC of Bismuth Ammonium Citrate + Papain
• FDC of Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide
• FDC of Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride
• FDC of Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide
• FDC of Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol
• FDC of Omeprazole Omeprazole Magnesium + Dicyclomine HCl
• FDC of S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L-Methylfolate + Choline bitartratee + Silymarin + L-ornithine L-aspartate + Inositol + Taurine
• FDC of Silymarin + Thiamine Mononitrate + Riboflavin+ Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12
• FDC of Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid
• FDC of Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate
• FDC of Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol
• FDC of Sucralfate + Acelofenac
• FDC of Sucralfate + Domperidone + Dimethicone
• FDC of Sucralfate + Domperidone
• FDC of Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol
• FDC of Ursodeoxycholic Acid + Metformin HCl
• FDC of Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit +Chloroform +Sodium Bicarbonate +Compound Cardamom + Alcohol
• FDC of Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate
• FDC of Aloe + Vitamin E Soap
• FDC of Povidone Iodine + Metronidazole + Aloe
• FDC of Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles
• FDC of Azithromycin + Adapalene
• FDC of Calamine + Aloes + Allantoin
• FDC of Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor
• FDC of Chlorphenesin + Zinc oxide + Starch
• FDC of Clindamycin Phosphate + Zinc acetate
• FDC of Gamma Benzene Hexachloride + Benzocaine
• FDC of Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin
• FDC of Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w
• FDC of Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes
• FDC of Ketoconazole +Aloe vera+ Vitamin A Acetate
• FDC of Ketoconazole +Aloes + ZPTO
• FDC of Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry
• FDC of Lornoxicam + capsaicin + menthol + camphor
• FDC of Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate
• FDC of Menthol + Aloe vera Topical Spray
• FDC of Menthol + Lignocaine HCl+Aloe vera gel + Clotrimazole + Diphenhydramine
• FDC of Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate
• FDC of Miconazole +Tinidazole
• FDC of Minoxidil +Aminexil + Alcohol
• FDC of Minoxidil +Azelaic acid + saw palmetto
• FDC of Minoxidil +Aminexil
• FDC of Pine Bark extract + Kojic acid + Sodium Ascorbyl Phosphate
• FDC of Povidone Iodine + Tinidazole + Zinc sulphate
• FDC of Povidone Iodine + Ornidazole + Dexpanthenol
• FDC of Salicyclic acid + Aloe vera + Allantoin + D-Panthenol
• FDC of Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate
• FDC of Sodium salicylate + Zinc gluconate + Pyridoxine HCl
• FDC of Tetracycline + Colistin Sulphate
• FDC of Clomiphene + Ubidecarenone
• FDC of Combikit Clomiphene Citrate + Estradiol Valerate
• FDC of Flavoxate HCl + Ofloxacin
• FDC of Clomiphene Citrate + N-Acetylcysteine
• FDC of Evening Primerose Oil +Cod liver oil
• FDC of Sildenafil Citrate +Papaverine +L-Arginine
• FDC of Tranexamic acid + Mefenamic acid + Vitamin K1
• FDC of Divalproex Sodium +Oxcarbazepine
• FDC of Divalproex Sodium +Levetiracitam
• FDC of Ergotamine tartrate + Caffeine + Paracetamol + Prochlorperazine maleate
• FDC of Piracetam + Ginkgo biloba extracts + Vinpocetin
• FDC of Ginkgo biloba + methylcobalamin + Alpha lipoic acid + Pyridoxine HCl
• FDC of Ginseng Extract + Dried extract of Ginkgo Biloba
• FDC of Meclizine HCl+ Paracetamol + Caffeine
• FDC of Nicergoline + Vinpocetine
• FDC of Gamma Linolenic Acid + Methylcobalamin
• FDC of Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl
• FDC of Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor
• FDC of Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose
• FDC of Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose
• FDC of Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose
• FDC of Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl
• FDC of Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine
• FDC of Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose
• FDC of Ketorolac Tromethamine + Flurometholone
• FDC of Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate
• FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor
• FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid + Sodium Chloride + Zinc Sulphate
• FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid
• FDC of Naphazoline HCl + Chlorpheniramine Maleate + Methyl Cellulose
• FDC of Naphazoline HCl + Hydroxy Methyl Cellulose + Boric Acid + Menthol + Camphor
• FDC of Naphazoline HCl + Boric Acid+Menthol+Camphor +Methyl Cellulose + Chlorpheniramine Maleate + Zinc Sulphate + Sodium Chloride
• FDC of Naphazoline HCl + Phenylephrine HCl+ HPMC + Chlorpheniramine Maleate + Menthol+ Camphor
• FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid + Sodium Chloride + Zinc Sulphate + Menthol + Camphor
• FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid +Zinc Sulphate
• FDC of Naphazoline HCl + Azelastine HCl+ Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex
• FDC of Naphazoline HCl + Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex
• FDC of Naphazoline Nitrate + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Methyl Cellulose + Boric Acid+ Menthol+ Camphor
• FDC of Naphazoline Nitrate + Chlorpheniramine Maleate + Zinc Sulphate + Boric Acid + Sodium Chloride
• FDC of Norfloxacin + Tinidazole (with Betacyclodextrin) Eye ointment
• FDC of Ofloxacin + Beclomethasone Dipropionate + Lignocaine HCl
• FDC of Naphazoline HCl + Chlorpheniramine Maleate + Phenylephrine HCl+ Menthol+ Camphor
• FDC of Phenylephrine HCl + Naphazoline HCl +Menthol+ Camphor + Hydroxy Propyl Methyl Cellulose
• FDC of Phenylephrine HCl + Naphazoline HCl + Menthol + Camphor
• FDC of Sulphacetamide Sodium + Zinc Sulphate + Chlorpheniramine Maleate + Boric acid + Sodium Chloride
• FDC of Zinc Sulphate + Boric acid + Naphazoline HCl + Sodium Chloride + Phenyl Ethyl Alcohol
• FDC of Cetirizine HCl + Paracetamol + Phenylephrine HCl
• FDC of Cetirizine HCl + Phenylephrine HCl
• FDC of Levocetirizine + Phenylephrine HCl
• FDC of Levocetirizine + Phenylephrine HCl + Paracetamol
• FDC of Phenylephrine HCl + Paracetamol + Levocetirizine HCl + Menthol
• FDC of Levocetirizine HCl + Ambroxol HCl + Paracetamol
• FDC of Levocetirizine HCl + Ambroxol HCl + Phenylephrine HCl
• FDC of Diethylcarbamazine Citrate + Chlorpheniramine maleate
• FDC of Diethylcarbamazine Citrate + Levocetirizine HCl
• FDC of Ambroxol HCl + Phenylephrine HCl + Guaiphenesin
• FDC of Bromhexine HCl + Phenylephrine HCl
• Etofylline + Theophylline anhydrous eq. to Theophylline hydrate + Ambroxol HCl
• FDC of Etofylline + Theophylline anhydrous eq. to Theophylline hydrate + Montelukast
• FDC of Ambroxol HCl + Terbutaline Sulphate + Ammonium Chloride + Guaiphenesin + Menthol
• FDC of Ambroxol HCl + Salbutamol Sulphate + Ammonium Chloride + Guaiphenesin + Menthol
• FDC of Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + Guaiphenesin
• FDC of Dextromethorphan Hydrobromide + Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate + Menthol
• FDC of Salbutamol Sulphate + Bromhexine HCl + Guaiphenesin + Ammonium Chloride + Menthol
• FDC of Terbutaline Sulphate + Bromhexine HCl + Chlorpheniramine Maleate
• FDC of Chlorpheniramine Maleate + P.G Sulphonate + Ammonium Chloride + Sodium Citrate + Menthol
• FDC of Aminophylline + Ammonium Chloride + Sodium Citrate
• FDC of Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine
• FDC of Trithioparamethoxyphenyl Propene + Chlorpheniramine Maleate
• FDC of Aceclofenac 50mg + Paracetamol 125mg oral liquid
• FDC of Aceclofenac 50mg + Paracetamol 125mg tablet
• FDC of Adenosine triphosphate diphosphate + Magnesium Orotate
• FDC of Amoxicillin Trihydrate + Dicloxacillin Sodium + Lactobacillus
• FDC of Camylofin Dihydrochloride 25 mg + Paracetamol 300mg
• FDC of Cefixime + Acetyl Cysteine
• FDC of Cephalexin Monohydrate + Serratiopeptidase
• FDC of Cetyl Myristoleate + glucosamine Sulphate Potassium+ Methyl Sulfonyl methane
• FDC of Diacerin IP + Glucosamine Sulphate Potassium Chloride USP + MSM (Methylsulphonyl Methane) + Cetyl Myristoleate
• FDC of Paracetamol + Diclofenac Potassium + Caffeine Anhydrous
• FDC of Diclofenac sodium + Thiocolchicoside Injection
• FDC of Doxycycline + Ornidazole + Bromelain + Lactobacillus Rhamnosus + Lactobacillus Reuteri RC
• FDC of Doxycycline HCl + Betacyclodextrin + Serratiopeptidase
• FDC of Erythromycin stearate eq.to Erythromycin +Lactic acid Bacillus
• FDC of Etodolac + Paracetamol +Serratiopeptidase
• FDC of Flupirtine Maleate 400 mg + Paracetamol 325 mg tablet
• FDC of Glucosamine sulphate potassium chloride 410 mg + Chondroitin Sulphate 100 mg
• FDC of Glucosamine sulphate potassium chloride+ Methyl Sulphonyl Methane(MSM) + Sodium Borate+ Copper Sulphate pentahydrate+ Manganese Sulphate + Vitamin D3
• FDC of Glucosamine Sulphate Sodium Chloride +Manganese +Boron + Zinc + Copper
• FDC of Glucosamine sulphate + Chondroitin sulphate + Methylsulfonylmethane +Vitamin D3 + Vitamin E + Vitamin C + Selenium +Elemental Zinc +Elemental Manganese + Elemental Chromium + Elemental Copper +Elemental Boron
• FDC of Glucosamine sulphate + Methyl sufonyl methane + manganese sulphate +Vit E acetate +calcium Carbonate
• FDC of Glucosamine Sulphate + +Vitamin E acetate + Calcium Pantothenate + Vitamin D3
• FDC of Glucosamine Sulphate Potassium chloride +Calcium Carbonate from an organic source (oyster shell) eq. to elemental Calcium+ Vitamin D3
• FDC of Cetyl Myristoleate + Glucosamine Sulphate Potassium chloride + Methyl sulfonyl methane
• FDC of Glucosamine Sulphate Potassium chloride + Methyl sulfonyl methane +Calcium carbonate +Vitamin E+ Manganese
• FDC of Glucosamine Sulphate Potassium chloride + Calcium carbonate + Methyl sulfonyl methane +Vit D3
• FDC of Glucosamine Sulphate Potassium + Methyl sulphate Sodium+ Sulphonyl Methane +Chondroitin Sulphate Sodium+ Calcium Carbonate +Vitamin D3+Sodium Borate+ Cupric Oxide+ Colloidal Silicon Dioxide+ Manganese Chloride
• FDC of Methocarbamol + Diclofenac Sodium Injection
• FDC of Paracetamol + Pentazocin
• FDC of Sucralfate +Domperidone+ Simethicone
• FDC of Sulfaquinoxaline +Diaveridine HCl+ Vitamin K
• FDC of Tramadol HCl +Dicyclomine HCl + Domperidone
• FDC of Tramadol HCl +Paracetamol +Caffeine +Taurine