The Health Ministry has banned 156 fixed dose combination (FDCs) medicines, which included commonly used antibiotics, painkillers and multivitamins. In a gazette notice published by the Health Ministry on August 21, the production, marketing, and distribution of medications is now outlawed after it was found that they pose health risks.
According to the notification, the list includes antibiotics, anti-allergic drugs, analgesics, multivitamins, and combination dosages for fever and hypertension are among the prohibited FDCs.
The decision comes following an expert group appointed by the central government as well as the Drug Technical Advisory Board (DTAB) made recommendations.
“…the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain is likely to involve risk to human beings whereas safer alternatives to the said drug are available,” it stated.
The notification also stated that the matter was examined by an Expert Committee appointed by the Central Government and “the said Expert Committee considered this FDC as irrational.”
The Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended.”
The list of major FDC medicines includes a combination dose of Omeprazole Magnesium and Dicyclomine HCl which is used for treating stomach pain, as well as a combination of Mefenamic Acid and Paracetamol Injection for reducing pain and swelling in various diseases.
Additional FDCs include a combination of povidone iodine, metronidazole, and aloe used to prevent and cure skin infections, as well as ursodeoxycholic acid and metformin HCl used to treat fatty liver in diabetics.
“The DTAB did not find the claims of these combination medicines correct and took the decision considering that the harm to the patient is more than the benefit,” the gazette notification stated. “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of Drugs and Cosmetics Act 1940,” the ministry stated in the notification.
The 156 banned drugs include popularly used combinations of anti-allergic medicines with nasal decongestant, syrups that break down mucus and paracetamol. The list also includes combinations of antibiotics with acne cream and iodine solution. Combination of migraine medicine with one to prevent nausea, combination of supplements such as menthol with aloe vera, and combination of burn medicine silver sulfadiazine with an antiseptic agent, aloe extract, and vitamin are among some of the combinations banned.
According to a report by Indian Express, this is the biggest crackdown on FDCs since the government banned 344 drugs in 2016, which was then challenged by drug makers. As per the court directions, the matter was referred back to the Drugs Technical Advisory Board, which decided 328 were “irrational” and should be prohibited. On this recommendation, the government banned the 328 combinations in 2018. Reportedly, 15 FDCs manufactured before 1988 were kept out of the purview of the ban.
Following the development, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance told Financial Express.com: “The discussion on FDC is going on over a period of time with recommendation from Kokate committee and Nilima Kshirsagar committee. This is a right step in interest of patients and all aspects have been taken into consideration.”
On August 12, the Health Ministry issued a gazette notification prohibiting “the manufacture, sale and distribution of human use of drug fixed dose combination of Etodolac + Paracetamol” manufactured by Emcure Pharmaceuticals Ltd.
“…the DTAB Sub-Committee considered the said fixed dose combination as irrational and recommended for its prohibition in public interest under section 26A of Drugs and Cosmetics Act, 1940,” the notification stated.
Following this recommendation, the central government has decided to prohibit the combination “with immediate effect as the said drug is found to have no therapeutic justification and may involve risk to the human beings.”
Here is the complete list of all the 156 banned combination medicines
- 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
