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Fixed dose combinations – declared unapproved by Drug Controller General of India

Sl No Name of fixed dose combinations 1. 5 - bromosalicyl - 4 - chloranilide + 2. * + + Chlorzoxazone 3. * Aceclofenac + Paracetamol + Serratiopeptidase 4. * Aceclofenac + Paracetamol + Tizanidine 5. * Aceclofenac + Paracetamol + 6. Aceclofenac + Serratiopeptidase 7. Aceclofenac + Tramadol 8. Acetaminophen + Codine phosphate 9. Acetyl Salicylic acid + 10. Choline Bitartrate + Pyndoxine + Folic Acid + Vitamin E + Cyanocobalamin + Vitamin E + Cyanocobalamin + Vitamin E + Cyanocobalamin + Chromium Nicotmate + Manganese Sulfate + Zinc Sulfate" 11. Acriflavine + Gentian violet + Brilliant green 12. * Activated charcoal + Fungal distase + Lactic acid 13. Adepalene + Methyl Paraben 14. Adenocyl Cobalamine + Carbonyl lon + Folic Acid + Zinc Ascorbate 15. Adenocyl Cobalamine + Carbonyl Iron + Folic acid 16. Alendronate sodium + Calcium Carbonate + Vit - D3 17. Alendronate sodium + Chlicalceferol f+ Calcium Citrate + Magnesium Hydroxide 18. Allantoin + Dimethicone + Metylparaben + Propylparaben 19. Allantoin + Triclosan + Vit - E + Zinc Oxide 20. Allantoin + Vit - E + Cammelina Sinensis 21. Allobarbitone + Phospho - dimethyl - isopropyl - pyrazolone 22. Aloe extract + allantocin + Alfa tocoferal acetate + D-panthemol + Vita-A 23. Aloe extract + Vit - E + Dimethicone + Glycerine 24. Aloe vera + Jojoba oil + Vit - E 25. Aloe vera + Orange oil 26. Aloe vera + Vit-e acetate 27. Aloe + tocopherol 28. Aloevera + Glycerine + PEG 100 stearate + Vit E 29. Aloevera + Jojoba oil + Wheat germ oil + Tea tree oil 30. Aloevera + Vit - E + Herbal 31. * Alprazolam + Melatonin 32. Alprazolam + Propranolol 33. Amlodipine + Lovastatin 34. Amoxicillin + Cloxacillin + Lactic acid bacillus 35. * Amoxicillin + Serratiopertidase + Lactobacillus Sporogenes 36. Amoxycillin + Clavulanic acid + Lactic acid bacillus 37. Amoxycillin + Clavulanic acid + Lactobacillus 38. Amoxycillin + Cloxacillin + Lactic acid bacillus 39. * Amoxycillin + Cloxacillin + Lactic acid bacillus+serrapeptase 40. Amoxycillin + Cloxacillin + Lactic acid bacillus 41. Amoxycilin + Lactic Acid bacillus 42. Amoxycillin + Lactobacillus 43. Amoxycillin + Lactobacillus Acidophilus 44. Amoxycillin + Lactobacillus acidophilus + Clavulanic Acid 45. Amoxycillin + Lactobacillus acidophilus + Flucloxaxcillin Sodium 46. Amoxycillin + Serratiopeptidase 47. Ampicillin + Cloxacillin + Lactic acid bacillus 48. Ampicillin + Flucloxacillin Sodium Salt 49. Ampicillin + Flucloxacillin Sodium Salt + Lactobacillus Acidophilus 50. Ampicillin + Lactic acid bacillus 51. Analgin + Dextropopoxyphene 52. Analgin + Diazepam 53. Analgin + Diazepam + Diphenhydramine 54. Analgin + Diazepam + Paracetamol 55. Analgin + Diazepam + Propylene Glycol 56. Analgin + Dicyclomine + Diazepam 57. Analgin + Dihydroethaverine chlonde 58. Analgin + 59. Analgin + KET.P.PIPER.ETH.O.CARB M 60. * Artesunate + Arteether + Artemether 61. Atenolol + Hydrochlorothiazide + Amilonde 62. Atenolol + Losartan + Hydrochlorothiazide 63. Atorvastatin + Acetyl Salicylic acid 64. Atorvastatin + Acetyl Salicylic acid + Caffeine 65. Atorvastatin + 66. Atorvastatin + Aspirin + Ramipril 67. * Atorvastatin + Mecobalamine + Folic acid 68. * Atorvastatin + Mecobalamine + Folic acid + Vit-B6 69. Atorvastatin + Omega 3 Fatty Acid 70. Atorvastatin + Ramipril 71. Atorvastatin + Ubidecarenone 72. Atorvastatin + Vitamin 73. Benfotimine + Pyridoxine + Mecobalamine + Inositol + Alphalipoic acid 74. Calcium dobesilate + Decusate sodium 75. Calcium dobesilate + Lignocaine 76. Calcium dobesilate + Lignocaine + Hydrocortisone 77. Calcium Dobesilate + Troxerutin 78. Cefadroxyl + Ambroxol 79. Cefadroxyl + Lactic Acid bacillus 80. cefadroxyl + Probenecid 81. Cefdinir + Lactic Acid bacillus 82. Cefixime + Lactic acid bacillus + Ambroxol 83. Cefixime + Lactobacillus acidophilus 84. Cefixime + Lactobacillus acidophilus + Ambroxol 85. Cefixime + Lactobacillus + Clavulanic Acid 86. Cefixime + Lactobacillus + Dicloxacillin 87. * Cefixime + Ornidazole 88. Cefpodoxime + prozetil + Lactic acid bacillus 89. Cefpodoxime + Cloxacillin + Lactobacillus 90. Cefpodoxime + Lactic acid bacillus 91. Cefprozil + Lactobacillus 92. Ceftriaxone + Vanacomycin 93. * Cefuroxime + Onidazole 94. * Cefuroxime + Serratiopeptidase 95. Cepodoxime + Cloxacillin + Lactic acid bacillus 96. * Chlormezanone + Paracetamol + sodium 97. * Chlormezanone + Paracetamol + 98. Chlorzoxazone + Ibuprofen + Paracetamol + Diclofenac + Oxyphenbutazon +Magnesium Hydroxide 99. Paracetamol + Diclofenac + Oxyphenbutazon 100. Chlorzoxazone + 101. Chlorzoxazone + Paracetamol 102. Chlorzxazone + Paracetamol + Diclofenac 103. Chlorzoxazone + Paracetamol + Diclofenac Potassium 104. Chlorzoxazone + Paracetamol + Diclofenac Sodium 105. Chlorzoxazone + Paracetamol + Ibuprofen 106. * Chlorzoxazone + Paracetamol + Ibuprofen + Diclofenac sodium 107. * Chlorzoxazone + Paracetamol + Nimesulide 108. * Ciprofloxacin + Tinidazole + Dicyclomine 109. Clinadamycin + Clotrimazole + Metronidazole 110. Clomdine + Chlorthalidone 111. Clonidine + Hydrochlorathiazide 112. Clopidoprel + Aspirin + Atorvastatin 113. * Condrortin + Vitamin + Selemum zink Sulphate + Monohydrate 114. * Diclofenac Potassium + Prtolenone hydrochlonde + Fenprvireneum bromide + Paracetamol 115. Diclofenac Potassium + Serratiopephdase 116. Diclofenac Sodium + Rabeprazole 117. Diclofenac Sodium + Serratiopeptidase 118. Diclofenac + + Paracetamol 119. Diclofenac + Famotidine 120. Diclofenac + + Lmoleic acid + 121. * Diclofenac + Paracetamol + Chlormezanone 122. Diclofenac + Paracetamol + Dextropropoxyphene 123. Diclofenac + Paracetamol + Serratiopeptidase 2 124. Diclofenac + Paracetamol + Tizanidine 125. * Diclofenac + Paracetamol + Chlorzoxazone 126. Diclophenac + Paracetamol + Chlormeznone 127. Diclofenac + Rabeprazole 128. Diclofenac + Serratiopeptidase. 129. Diclotenac + Tizamdine 130. * Dicyclomme + Dextromethorphan + Paracetamol 131. * Dicyclomme + Diclofenac Sodium + Paracetamol 132. Dicyclomme + + Paracetamol 133. Dicyclomme + Paracetamol + Analgin 134. * Dicyclomme + Paracetamol + Chlordiazepoxide 135. Dicyclomme + Paracetamol + Clidinium Bromide 136. Dicyclomme + Paracetamol + Clidinium Bromide + Chlordiazepoxide 137. * Dicyclomine + Paracetamol + Dextropropoxyphene 138. Dicyclomine + Paracetamol + Dextropropoxyphene + Clordiazepoxide 139. * Dicyclomine + Paracetamol + Dimethylpolysiloxane 140. Dicyclomine + Paracetamol + Phenylisoprophyl Pyrazolon 141. * Dicyclomine + Paracetamol + Simethicone 142. * Dicyclomine + Ranitidine 143. * Dicyclomine + Serrartiopeptidase 144. * Dicylomine + Parcetamol + Dimethylpolysiloxane 145. Domperidone + Paracetamol 146. * Domperidone + Paracetamol + Tramadol 147. Domperidone + Ranitidine 148. Doxycycline + Lactobacillus 149. Doxycycline + Tinidazole 150. Drotaverine hydrochloride + Mefenamic Acid 151. Drotaverine + Nimesulide 152. Drotaverine + Omeprazole 153. Drotaverine + Paracetamol 154. * Duloxetine + Mecobalamin 155. Fenpiverinium bromide + Analgin + Pitofenone hydrochloride 156. * Fenpiverinium bromide + Diclofenac sodium + Pitofenone hydrochlonde 157. Fenpiverinium hydroxide bromide + Diclofenac sodium + Pitofenone hydrochloride 158. Gebapentin + Mecobalamin + Thiocitic acid 159. Gebapentin + Mecobalamin + Thioctic acid + Folic Acid + Pyndoxine 160. Gabapentin + Mecobalamin + Pyridoxine + Folic Acid 161. Gliclazide + Chromium picolinate 162. * + Ascorbic Acid 163. * Glucosamine + Boswellia Serrata 164. * Glucosamine + Calcium Carbonate 165. * Glucosamine + Cetylmyristate Oleate 166. * Glucosamine + Chondroitin Sulphate + Methyl sulphonyl methane 167. * Glucosamine + Chondroitin Sulphate + Vit + C + manganise sulphate" 168. * Glucosamine + Chondroitin + Vit C + Vit E + Manganese" 169. * Glucosamine + Chondroitin + Vit C 170. Glucosamine + Condroitin + Vit C + Manganese + Sodium Borate + Selinium Dioxide 171. * Glucosamine + Chondroitin + Vit - C + Vit - E + Manganese" 172. * Glucosamine + Colecalciferol + Manganese + Ascorbic acid" 173. * Glucosamme + Manganese 174. * Glucosamine + Mecobalamin + Dimethyl Sultone 175. * Glucosamine + Mecobalamine 176. * Glucosamine + Mecobalamine + Milk calcium 177. * Glucosamine + Methyl sulphonyl methane 178. * Glucosamine + Methyl sulphonyl methanamine + Cetylmystate 179. * Glucosamine + Vit C + Calcium + Methyl Sulfonyl Methane + Chondroitin + Manganese 180. * Glucosamine + Vit C + Vit E + Chondroitin sulphate + Methyl sulfonyl methane + Manganese sulphae 181. * Gluosamine sulphate + Chondroitin + Sulphate + Vit E + Manganese 182. * Gluosamine + Calcium + Vit D3 183. Hydrochlorothiazide + Ramipril + Losartan Potassium Salt 184. Ibuprofen + Carisoprodol 185. Ibuprofen + phosphate 186. Ibuprofen + Codeine Sulphate 3 187. Ibuprofen + Colchicine 188. Ibuprofen + Dextropropoxyphene 189. * Ibuprofen + Dextropropoxyphene + Paracetamol 190. Ibuprofen + Paracetamol + Caffeine 191. * Ibuprofen + Paracetamol + Colchicine 192. * Ibuprofen + Paracetamol + Dextropropoxyphene 193. Ibuprofen + Paracetamol + magnesium triscillicate 194. * Ibuprofen + Paracetamol + magnesium trisilicate 195. * Ibuprofen + Paracetamol + + Phenylisopropyl pyrazolon 196. * Ibuprofen + Paracetamol + Phenylepherine + Chlorpheniramine maleate 197. * Ibuprofen + Paracetamol + Serratiopeptidase 198. Ibuprofen + Pseudoephedrine + Chlorpheniramine maleate 199. Ibuprofen + Tizanidine 200. Lansoprazole + Amoxycillin + Clanthromycin 201. Lansoprazole + Amoxycillin + Tinidazole 202. Lansoprazole + Dompendone 203. Lansoprazole + Tinidazole + Clanthromycin 204. Levocetrizine + Montelukast 205. Levofloxacin + Ambroxol 206. Levofloxacin + Omidazole 207. Lmcomycin + Lactobacillus 208. Losartan + Hydrochlorothazide + Atenotol 209. Losartan + Hydrochlorothazide + Rampril 210. Losartan + Penndopril 211. * Mebeverine + Alprazolam 212. Mebeverine + Plantago Ovata 213. Mecobalamin+alpoic acid + Folic acid + Vit B6+ Choline 214. Mecobalaminae + Alpha lipoic acid 215. Mecobalamine + Alphalipoic acid + Folic acid 216. Mecobalamine + Alphalipoic acid + Vit B1 + Folic acid 217. Mecobalamine + Biotin 218. Mecobalamine + Calcium Pantothenate 219. Mecobalamine + Carotmoid + Alpha lipoic acid + Charomm + Vit B1 + Vit B Complex 220. Mecobalamine + Folic acid 221. Mecobalamine + Methenamine mandelate 222. Mecobalamine + Vit A + Vit E + Vit C + Vit B1+ Vit B6 + Vit D3 + Selemum 223. Mecobalamine + Vitamins + Minerals 224. Mecobalamine + Vit B1 + Vit B2 + Vit B6 + Folic acid 225. Mecobalamine + Vit B1 + Vit B6 + Folic acid + Alpha lipoic acid 226. Mecobalamine + Vit B1 + Vit B6 + Nicotinamide + D-panthenol 227. Mecobalamine + Vit B6 + Folic acid 228. Mecobalamine + Vit B6 + Folic acid + Alpha lipoic acid 229. Metenamic acid + Dicyclomine 230. + Paracetamol 231. Mettormin hydrochloride + Mecobalamine 232. Methocarbamol + Ibuprofen 233. Methocarbamol + Nimesulide 234. Methocarbamol + Paracetamol 235. Metoclopramide hydrochloride + Paracetamol 236. Muprrocin + Metronidazole 237. + Domperidone 238. * Nimesulide + Paracetamol + Chlorsoxazone 239. * Nimesulide + Paracetamol + Serratropeptidase 240. Nimesulide + Phenylphenne + Chlorpheniramine maleate + Caffine 241. * Nimesulide + P. Piperidinoethoxy. O + Carbomethoxybenzophenone + Diphenyl Pipendenoeteyl 242. Nimesulide + pseudoephedine + Cetrazine 243. Norfloxacin + Ornidazole 244. * Norfloxacin + Tinidazole + Dicyclomine 245. * Norfloxacin + Tinidazole + Lactobacallus 246. * Norfloxacin + Tinidazole + Loperamide 247. * Ofloxacin + Diclofenac + Lignocane 248. Ofloxacin + Lactic acid bacillus 249. Ofloxacin + Metronidazole 4 250. * Ofloxacin + Ornidazole + Lactobacillus 251. Ofloxacin + Ornidazole + Lactobacillus Sporogenes 252. Ofloxacin + Prednisolone 253. Ofloxacin + Tinidazole 254. * Ondansetron + omeprazole 255. Ondansetron + Paracetamol 256. * Ondansetron + Ranitidine 257. * Ornidazole + Doxycycline 258. Omidazole + Flucanazole + Azithromycin 259. Paracetamol + Alprazolam 260. Paracetamol + Analgin 261. * Paracetamol + Diclofenac Sodium + Amoxicillin + Cloxacillin + Pantoprazole + Lactic Acid Bacillus + Serrapeptase 262. * Paracetamol + Diclofenac sodium + Magnesium Trisilicate + Chlorphenamine Maleate 263. Paracetamol + Dicofenac + Chlorzoxazone 264. Paracetamol + Dicycloverine + Mefenamic 265. * Paracetamol + Ketoprofen + Dextropropoxyphene 266. Paracetamol + Lignocaine 267. Pregabalin + Mecobalamine 268. * Pregabalin + Mecobalamine + Pyridoxine + Thioctic Acid + Folic Acid 269. * Pregabalin + Thioctic Acid + Folic Acid + Pyridoxine 270. Propranolol + Alprazolam 271. Propranolol + Diazepam 272. Propranolol + Hydrallazine 273. Propranololol + Hydrochlorothiazide + Dihydrallazine 274. Ranitidine + Cisapride 275. * Ranitidine + Dicyclomine 276. * Ranitidine + Dicyclomine + Clidinium bromide 277. * Ranitidine + Dicyclomine + Nimesulide 278. * Ranitidine + Dicyclomine + Simethicone 279. Ranitidine + Domperidone 280. * Ranitidine + Drotavenne 281. * Ranitidine + Omeprazole 282. * Ranitidine + Ondansetron 283. Roxithromycin + Ambroxol 284. Roxithromycin + Carbocisteine 285. Satranidazole + Ofloxacin 286. Telmisartan + Ramipril + Hydrochlorthazide 287. Tizanidine + Diclofenac potassium + Acetoammophan 288. * Tizanidine + Diclofenac potassium + Paracetamol 289. Tizanidine + Diclofenec sodium + Paracetamol 290. * Tizanidine + Nimesulide + Paracetamol 291. Torsemide + Spironolactone 292. Tramadol + Paracetamol + Domperidone

ANNEXURE V - BANNED FIXED DOSE COMBINATINS AVAILABLE IN THE COUNTRY Sl No Name of fixed dose combinations 1. * Analgin +Dextropopoxyphene 2. * Analgin + Diazepam 3. * Analgin + Diazepam + Diphenhydramine 4. * Analgin + Diazepam + Paracetamol 5. * Analgin + Diazepam + Propylene Glycol 6. * Analgin + Dicyclomine + Diazepam 7. * Analgin + Dihydroethaverine Chloride 8. * Analgin + Ketoprofen 9. * Analgin + KET-P-Piper.ETH.O.CARB M 10. * Fenpiverinium bromide + Analgin + Pitofenone Hydrochloride 11. * Paracetamol + Alprazolam 12. * Paracetamol + Analgin

5 ANNEXURE IV - REJECTED FIXED DOSE COMBINATIONS BY DCGI Sl No Name of fixed dose combinations 1. Aceclofenac+PCM+Rabeprazole 2. Aceclofenac+PCM+Serratiopeptidase 3. Aceclofenac + PCM + Tizanidine 4. Aceclofenac + Rabeprazole 5. Atorvastatin + Clopidogrel 6. Aspirin + Atorvastatin + Rampiril 7. Atorvastatin + Telmisartan + Aspirin 8. Atovaquone + Proguanil 9. Cefixime + Ornidazole 10. Cefixime + probincid 11. Cefuroxime + Ambroxol 12. Chromium Polynicotinate + Metformin 13. Diacerin + Aceclofenac + Paracetamol 14. Etophylline + Theophyulline + Ambroxol+Gauiphenesin 15. Fexofenadine + Ranitidine 16. Fluconazole + Cetrizine 17. HCTZ+Rosuvastatin + Ramipril+Nebivolol+Folic Acid + Aspirin 18. ISMN+Clopidogrel 19. Levocetrizine+Phenylephrine+PCM 20. Levocetrizine+Pseudoephedrine +PCM 21. Lignocaine+Feracrylum 22. * Melatonin+Alprazolam 23. Methylcobalamine + Duloxetine 24. Ofloxacin + Cefixime 25. Ofloxacin + Cefpodoxime 26. Ofloxacin + Orinidazole +Lactobacilli 27. Ofloxacin + Orinidazole +Simethicone 28. Pantoprazole + Alginic Acid 29. Paracetamol + tramadol+Dicyclomine 30. PCM+Codeine+Doxylamine+Caffeine 31. Rosuvastatin + Amlodipine 32. Rosuvastatin + Aspirin 33. Sulfadoxine+Pyrimethamine inj. 34. Ofloxacin+Ornidazole Susp

* notice from Director of Drugs Control Governement of West Bengal for withdrawal

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