Full List Of 156 Drugs Fixed-Dose Combinations Banned By Government

New Delhi: 'Aceclofenac 50mg plus Paracetamol 125mg tablets are among 156 widely sold fixed-dose combination (FDC) drugs including antibacterial medicines used for fever, cold, allergies and pain which have been banned by the government saying that they are "likely to involve risk to human beings".

FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as "cocktail" drugs.

According to a gazette notification issued by the Union health ministry on August 12, the government has banned 'Aceclofenac 50mg + Paracetamol 125mg tablet', one of the popular combinations used as pain-relieving medicines manufactured by top pharma companies.

The list also includes Mefenamic Acid + Paracetamol Injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine and Camylofin Dihydrochloride 25 mg + Paracetamol 300mg.

The Centre also banned the combination of Paracetamol, Tramadol, Taurine and Caffeine. Tramadol is an opioid-based pain killer.

"The Central government is satisfied that the use of the Fixed Dose Combination drug is likely to involve risk to human beings whereas safer alternatives to the said drug are available," the notification said.

It said that the matter was examined by an Expert Committee appointed by the Centre which considered these FDCs as "irrational".

It further stated that the apex panel Drugs Technical Advisory Board (DTAB) also examined these FDCs and recommended that "there is no therapeutic justification for the ingredients contained in these FDCs".

"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," the notification read.

"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," it added.

Following the DTAB's recommendations, the notification said that "the Central government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale and distribution for human use of the said drug in the country".

The list includes certain products which were already discontinued by many drug makers. Below is the complete list of drugs and their combinations banned by the Centre.

1. FDC of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain
2. FDC of Antimony Potassium Tartrate + Dried Ferrous Sulphate
3. FDC of Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride
4. FDC of Bismuth Ammonium Citrate + Papain
5. FDC of Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide
6. FDC of Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride
7. FDC of Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide
8. FDC of Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol
9. FDC of Omeprazole Omeprazole Magnesium + Dicyclomine HClFDC of S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L-Methylfolate + Choline bitartratee + Silymarin + L-ornithine L-aspartate + Inositol + Taurine
10. FDC of Silymarin + Thiamine Mononitrate + Riboflavin+ Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12
11. FDC of Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid
12. FDC of Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate
13. FDC of Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol
14. FDC of Sucralfate + Acelofenac
15. FDC of Sucralfate + Domperidone + Dimethicone
16. FDC of Sucralfate + Domperidone
17. FDC of Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol
18. FDC of Ursodeoxycholic Acid + Metformin HCl
19. FDC of Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit +Chloroform +Sodium Bicarbonate +Compound Cardamom + Alcohol
20. FDC of Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate
21. FDC of Aloe + Vitamin E Soap
22. FDC of Povidone Iodine + Metronidazole + Aloe
23. FDC of Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles
24. FDC of Azithromycin + Adapalene
25. FDC of Calamine + Aloes + Allantoin
26. FDC of Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor
27. FDC of Chlorphenesin + Zinc oxide + Starch
28. FDC of Clindamycin Phosphate + Zinc acetateFDC of Gamma Benzene Hexachloride + Benzocaine
29. FDC of Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin
30. FDC of Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w
31. FDC of Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes
32. FDC of Ketoconazole +Aloe vera+ Vitamin A Acetate
33. FDC of Ketoconazole +Aloes + ZPTO
34. FDC of Kojic Acid +Arbutin +Octinoxate +Vitamin E + MulberryFDC of Lornoxicam + capsaicin + menthol + camphor
35. FDC of Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate
36. FDC of Menthol + Aloe vera Topical Spray
37. FDC of Menthol + Lignocaine HCl+Aloe vera gel + Clotrimazole + Diphenhydramine
38. FDC of Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate
39. FDC of Miconazole +Tinidazole
40. FDC of Minoxidil +Aminexil + Alcohol
41. FDC of Minoxidil +Azelaic acid + saw palmetto
42. FDC of Minoxidil +Aminexil
43. FDC of Pine Bark extract + Kojic acid + Sodium Ascorbyl Phosphate
44. FDC of Povidone Iodine + Tinidazole + Zinc sulphate
45. FDC of Povidone Iodine + Ornidazole + Dexpanthenol
46. FDC of Salicyclic acid + Aloe vera + Allantoin + D-Panthenol
47. FDC of Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate
48. FDC of Sodium salicylate + Zinc gluconate + Pyridoxine HCl
49. FDC of Tetracycline + Colistin Sulphate
50. FDC of Clomiphene + Ubidecarenone
51. FDC of Combikit Clomiphene Citrate + Estradiol Valerate
52. FDC of Flavoxate HCl + Ofloxacin
53. FDC of Clomiphene Citrate + N-Acetylcysteine
54. FDC of Evening Primerose Oil +Cod liver oil
55. FDC of Sildenafil Citrate +Papaverine +L-Arginine
56. FDC of Tranexamic acid + Mefenamic acid + Vitamin K1
57. FDC of Divalproex Sodium +Oxcarbazepine
58. FDC of Divalproex Sodium +Levetiracitam
59. FDC of Ergotamine tartrate + Caffeine + Paracetamol + Prochlorperazine maleate
60. FDC of Piracetam + Ginkgo biloba extracts + Vinpocetin
61. FDC of Ginkgo biloba + methylcobalamin + Alpha lipoic acid + Pyridoxine HCl
62. FDC of Ginseng Extract + Dried extract of Ginkgo Biloba
63. FDC of Meclizine HCl+ Paracetamol + Caffeine
64. FDC of Nicergoline + Vinpocetine
65. FDC of Gamma Linolenic Acid + Methylcobalamin
66. FDC of Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl
67. FDC of Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor
68. FDC of Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose
69. FDC of Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose
70. FDC of Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose
71. FDC of Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl
72. FDC of Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine
73. FDC of Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose
74. FDC of Ketorolac Tromethamine + Flurometholone
75. FDC of Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate
76. FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor
77. FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid + Sodium Chloride + Zinc Sulphate
78. FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid
79. FDC of Naphazoline HCl + Chlorpheniramine Maleate + Methyl Cellulose
80. FDC of Naphazoline HCl + Hydroxy Methyl Cellulose + Boric Acid + Menthol + Camphor
81. FDC of Naphazoline HCl + Boric Acid+Menthol+Camphor +Methyl Cellulose + Chlorpheniramine Maleate + Zinc Sulphate + Sodium Chloride
82. FDC of Naphazoline HCl + Phenylephrine HCl+ HPMC + Chlorpheniramine Maleate + Menthol+ Camphor
83. FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid + Sodium Chloride + Zinc Sulphate + Menthol + Camphor
84. FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid +Zinc Sulphate
85. FDC of Naphazoline HCl + Azelastine HCl+ Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex
86. FDC of Naphazoline HCl + Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex
87. FDC of Naphazoline Nitrate + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Methyl Cellulose + Boric Acid+ Menthol+ Camphor
88. FDC of Naphazoline Nitrate + Chlorpheniramine Maleate + Zinc Sulphate + Boric Acid + Sodium Chloride
89. FDC of Norfloxacin + Tinidazole (with Betacyclodextrin) Eye ointment
90. FDC of Ofloxacin + Beclomethasone Dipropionate + Lignocaine HCl
91. FDC of Naphazoline HCl + Chlorpheniramine Maleate + Phenylephrine HCl+ Menthol+ Camphor
92. FDC of Phenylephrine HCl + Naphazoline HCl +Menthol+ Camphor + Hydroxy Propyl Methyl Cellulose
93. FDC of Phenylephrine HCl + Naphazoline HCl + Menthol + Camphor
94. FDC of Sulphacetamide Sodium + Zinc Sulphate + Chlorpheniramine Maleate + Boric acid + Sodium Chloride
95. FDC of Zinc Sulphate + Boric acid + Naphazoline HCl + Sodium Chloride + Phenyl Ethyl Alcohol
96. FDC of Cetirizine HCl + Paracetamol + Phenylephrine HCl
97. FDC of Cetirizine HCl + Phenylephrine HCl
98. FDC of Levocetirizine + Phenylephrine HCl
99. FDC of Levocetirizine + Phenylephrine HCl + Paracetamol
100. FDC of Phenylephrine HCl + Paracetamol + Levocetirizine HCl + Menthol
101. FDC of Levocetirizine HCl + Ambroxol HCl + Paracetamol
102. FDC of Levocetirizine HCl + Ambroxol HCl + Phenylephrine HCl
103. FDC of Diethylcarbamazine Citrate + Chlorpheniramine maleate
104. FDC of Diethylcarbamazine Citrate + Levocetirizine HCl
105. FDC of Ambroxol HCl + Phenylephrine HCl + Guaiphenesin
106. FDC of Bromhexine HCl + Phenylephrine HCl Etofylline + Theophylline anhydrous eq. to Theophylline hydrate + Ambroxol HCl
107. FDC of Etofylline + Theophylline anhydrous to Theophylline hydrate + Montelukast
108. FDC of Ambroxol HCl + Terbutaline Sulphate + Ammonium Chloride + Guaiphenesin + Menthol
109. FDC of Ambroxol HCl + Salbutamol Sulphate + Ammonium Chloride + Guaiphenesin + Menthol
110. FDC of Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + Guaiphenesin
111. FDC of Dextromethorphan Hydrobromide + Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate + Menthol
112. FDC of Salbutamol Sulphate + Bromhexine HCl + Guaiphenesin + Ammonium Chloride + Menthol
113. FDC of Terbutaline Sulphate + Bromhexine HCl + Chlorpheniramine Maleate
114. FDC of Chlorpheniramine Maleate + P.G Sulphonate + Ammonium Chloride + Sodium Citrate + Menthol
115. FDC of Aminophylline + Ammonium Chloride + Sodium Citrate
116. FDC of Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine
117. FDC of Trithioparamethoxyphenyl Propene + Chlorpheniramine Maleate
118. FDC of Aceclofenac 50mg + Paracetamol 125mg oral liquid
119. FDC of Aceclofenac 50mg + Paracetamol 125mg tablet
120. FDC of Adenosine triphosphate diphosphate + Magnesium Orotate
121. FDC of Amoxicillin Trihydrate + Dicloxacillin Sodium + Lactobacillus
122. FDC of Camylofin Dihydrochloride 25 mg + Paracetamol 300mg
123. FDC of Cefixime + Acetyl Cysteine
124. FDC of Cephalexin Monohydrate + Serratiopeptidase
125. FDC of Cetyl Myristoleate + glucosamine Sulphate Potassium+ Methyl Sulfonyl methane
126. FDC of Diacerin IP + Glucosamine Sulphate Potassium Chloride USP + MSM (Methylsulphonyl Methane) + Cetyl Myristoleate
127. FDC of Paracetamol + Diclofenac Potassium + Caffeine Anhydrous
128. FDC of Diclofenac sodium + Thiocolchicoside Injection
129. FDC of Doxycycline + Ornidazole + Bromelain + Lactobacillus Rhamnosus + Lactobacillus Reuteri RC
130. FDC of Doxycycline HCl + Betacyclodextrin + Serratiopeptidase
131. FDC of Erythromycin stearate eq.to Erythromycin +Lactic acid Bacillus
132. FDC of Etodolac + Paracetamol +Serratiopeptidase
133. FDC of Flupirtine Maleate 400 mg + Paracetamol 325 mg tablet
134. FDC of Glucosamine sulphate potassium chloride 410 mg + Chondroitin Sulphate 100 mg
135. FDC of Glucosamine sulphate potassium chloride+ Methyl Sulphonyl Methane(MSM) + Sodium Borate+ Copper Sulphate pentahydrate+ Manganese Sulphate + Vitamin D3
136. FDC of Glucosamine Sulphate Sodium Chloride +Manganese +Boron + Zinc + Copper
137. FDC of Glucosamine sulphate + Chondroitin sulphate + Methylsulfonylmethane +Vitamin D3 + Vitamin E + Vitamin C + Selenium +Elemental Zinc +Elemental Manganese + Elemental Chromium + Elemental Copper +Elemental Boron
138. FDC of Glucosamine sulphate + Methyl sufonyl methane + manganese sulphate +Vit E acetate +calcium Carbonate
139. FDC of Glucosamine Sulphate + +Vitamin E acetate + Calcium Pantothenate + Vitamin D3
140. FDC of Glucosamine Sulphate Potassium chloride +Calcium Carbonate from an organic source (oyster shell) eq. to elemental Calcium+ Vitamin D3
141. FDC of Cetyl Myristoleate + Glucosamine Sulphate Potassium chloride + Methyl sulfonyl methane
142. FDC of Glucosamine Sulphate Potassium chloride + Methyl sulfonyl methane +Calcium carbonate +Vitamin E+ Manganese
143. FDC of Glucosamine Sulphate Potassium chloride + Calcium carbonate + Methyl sulfonyl methane +Vit D3
144. 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
145. FDC of Methocarbamol + Diclofenac Sodium Injection
146. FDC of Paracetamol + Pentazocin
147. FDC of Sucralfate +Domperidone+ Simethicone
148. FDC of Sulfaquinoxaline +Diaveridine HCl+ Vitamin K
149. FDC of Tramadol HCl +Dicyclomine HCl + Domperidone
150. FDC of Tramadol HCl +Paracetamol +Caffeine +Taurine

The government in 2016 had announced the ban on the manufacture, sale and distribution of 344 drug combinations after an expert panel, set up at the behest of the Supreme Court, had stated they were being sold to patients without scientific data and the order was challenged by the manufacturers in court, sources said.

In June 2023, 14 FDCs which were part of those 344 drug combinations, were banned. Many of the FDCs banned recently were also from those 344 drug combinations, the sources said.

With inputs from PTI