DRUGS AND COSMETICS (2 ND AMENDMENT) …

1 DRUGS AND COSMETICS (2ND AMENDMENT) RULES, 2006. MINISTRY OF HEALTH AND FAMILYWELFARE. (Department of Health). NOTIFICATION. New Delhi, the 16th March, 2006. 160(E). Whereas a draft of certain rules further to amend the DRUGS and COSMETICS Rules, 1945 was published, as required by Sections 12 and 33 of the DRUGS and COSMETICS Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 24th February, 2005, under the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health), number 105(E), dated the 24th February, 2005, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of forty five days from the date on which copies of the Official Gazette containing the said notification were made available to the public;. And whereas copies of the said Gazette were made available to the public on 25th February, 2005.

2 And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government. Now, therefore, in exercise of the powers conferred by Sections 12 and 33 of the said Act, the Central Government, after consultation with the DRUGS Technical Advisory Board, hereby makes the following rules further to amend the DRUGS and COSMETICS Rules, 1945, namely: . 1. (1) These rules may be called the DRUGS and COSMETICS (2nd Amendment) Rules, 2006. [Published in the Gazette of India (extraordinary) Part-II, section 3, sub-section (i). vide 160(E), dated 16th March, 2006.]. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the DRUGS and COSMETICS Rules, 1945, for Schedule H, the following Schedule shall be substituted, namely:- SCHEDULE-H. (See Rules 65 and 97). PRESCRIPTION DRUGS .. 1 12. ALENDRONATE SODIUM.

3 1. ABACAVIR 13. ALLOPURINOL. 2. ABCIXIMAB 14. ALPHACHYMOTRYPSIN. 3. ACAMPROSATE CALCIUM 15. ALPRAZOLAM. 4. ACEBUTOL hydrochloride 16. ALPROSTADIL. 5. ACLARUBICIN 17. AMANTADINE hydrochloride . 6. ALBENDAZOLE 18. AMIFOSTINE. 7. ALCLOMETASONE DIPROPIONATE 19. AMIKACIN SULPHATE. 8. ACTILYSE 20. AMILORIDE hydrochloride . 9. ACYCLOVIR 21. AMINEPTINE. 10. ADENOSINE 22. AMINOGLUTETHIMIDE. 11. ADRENOCORTICOTROPHIC 23. AMINOSALICYLIC ACID. HORMONE (ACTH) 24. AMIODARONE hydrochloride . 25. AMITRIPTYLINE 71. BUPIVA CAINE hydrochloride . 26. AMLODIPINE BESYLATE 72. BUPROPION. 27. AMOSCANATE 73. BUSPIRONE. 28. AMOXOPINE 74. BUTENAFINE hydrochloride . 29. AMRINONE LACTATE 75. BUTORPHANOL TARTRATE. 30. ANALGIN 76. CABERGOLINE. 31. ANDROGENIC ANABOLIC, 77. CALCIUM DOBESILATE. OESTROGENIC & 78. CANDESARTAN. PROGESTATIONAL SUBSTANCES 79. CAPECITABINE. 32. ANTIBIOTICS 80. CAPTOPRIL. 33. APRACLONIDINE 81. CARBIDOPA.

4 34. APROTININ 82. CARBOCISTEINE. 35. ORGANIC COMPOUND OF 83. CARBOPLATIN. ARSENIC 84. CARBOQUONE. 36. ARTEETHER 85. CARISOPRODOL. 37. ARTEMETHER 86. L-CARNITINE. 38. ARTESUNATE 87. CARTEOLOL hydrochloride . 39. ARTICAINE hydrochloride 88. CARVEDILOL. 40. ATENOLOL 89. CEFADROXYL. 2 90. CEFATOXIME SODIUM. 41. ATRACURIUM BESYLATE 91. CEFAZOLIN SODIUM. INJECTION 92. CEFDINIR. 42. ATORVASTATIN 93. CEFEPIME hydrochloride . 43. AURANOFIN 94. CEFETAMET PIVOXIL. 44. AZATHIOPRINE 95. CEFPIROME. 45. AZTREONAM 96. CEFPODOXIME POXETIL. 46. BACAMPICILLIN 97. CEFTAZIDIME PENTAHYDRATE. 47. BACLOFEN 98. CEFTIZOXIME SODIUM. 48. BALSALAZIDE 99. CEFUROXIME. 49. BAMBUTEROL 100. CELECOXIB. 50. BARBITURIC ACID 101. CENTCHROMAN. 51. BASILIXIMAB 102. CENTBUTINDOLE. 52. BENAZEPRIL hydrochloride 103. CENTPROPAZINE. 53. BENIDIPINE hydrochloride 104. CETIRIZINE hydrochloride . 54. BENSERAZIDE hydrochloride 105. CHLORDIAZEPOXIDE.

5 55. BETAHISTINE DIHYDROCHLORIDE 106. CHLORMEZANONE. 56. BETHANIDINE SULPHATE 107. Omitted vide GSR 790 (E) dated 57. BEZAFIBRATE 58. BICALUTAMIDE 108. CHLORPROMAZINE. 59. BICLOTYMOL 109. CHLORZOXAZONE. 60. BIFONAZOLE 110. CICLOPIROX OLAMINE. 61. BIMATOPROST 111. CIMETIDINE. 62. BIPERIDEN hydrochloride 112. CINNARIZINE. 63. BIPHENYL ACETIC ACID 113. CIPROFLOXACIN. 64. BITOSCANATE hydrochloride . 65. BLEOMYCIN MONOHYDRATE / LACTATE. 66. PRIMONIDINE TARTRATE 114. CISPLATIN. 67. BROMHEXINE HYDROCLORIDE 115. CITALOPRAM HYDROBROMIDE. 68. BROMOCRIPTINE MESYLATE 116. CLARITHROMYCIN. 69. BUDESONIDE 117. CLAVULANIC ACID. 70. BULAQUINE 118. CLIDINIUM BROMIDE. 119. CLINDAMYCIN 167. DOXEPIN hydrochloride . 120. CLOBAZAM 168. DOXORUBICIN hydrochloride . 121. CLOBETASOL PROPENATE 169. DROTRECOGIN-ALPHA. 122. CLOBETASONE 17-BUTYRATE 170. EBASTINE. 123. CLOFAZIMINE 171. ECONOZOLE. 124. CLOFIBRATE 172. EFAVIRENZ.

6 125. CLONAZEPAM 173. ENALAPRIL MELEATE. 126. CLONIDINE hydrochloride 174. ENFENAMIC ACID. 127. CLOPAMIDE 175. EPINEPHRINE. 128. CLOPIDOGREL BISULPHATE 176. EPIRUBICINE. 129. CLOSTEBOL ACETATE 177. EPTIFIBATIDE. 130. CLOTRIMAZOLE 178. ERGOT, ALKALOIDS OF. 131. CLOZAPINE WHETHER HYDROGENATED OR. 132. CODEINE NOT, THEIR HOMOLOGOUES, 133. COLCHICINE SALTS. 134. CORTICOSTEROIDS 179. ESOMEPRAZOLE. 135. COTRIMOXAZOLE 180. ESTRADIOL SUCCINATE. 136. CYCLANDELATE 181. ESTRAMUSTINE PHOSPHATE. 137. CYCLOSPORINS 182. ETANERCEPT. 138. DACLIZUMAB 183. ETHACRIDINE LACTATE. 139. DANAZOLE 184. ETHAMBUTOL hydrochloride . 140. DAPSONE 185. ETHAMSYLATE. 141. DESLORATADINE 186. ETHINYLOESTRADIOL. 142. DESOGESTROL 187. ETHIONAMIDE. 143. DEXRAZOXANE 188. ETIDRONATE DISODIUM. 144. DEXTRANOMER 189. ETODOLAC. 145. Omitted vide GSR 790 (E) dated 190. ETOMIDATE. 191. ETOPOSIDE. 146. DEXTROPROPOXYPHENE 192. EXEMESTANE.

7 147. DIAZAPAM 193. FAMCICLOVIR. 148. DIAZOXIDE 194. FAMOTIDINE. 149. DICLOFENAC 195. FENBENDAZOLE. SODIUM/POTASSIUM/ACID 196. FENOFIBRATE. 3 197. FEXOFENADINE. 150. DICYCLOMIN hydrochloride 198. FINASTERIDE. 151. DIDANOSINE 199. FLAVOXATE hydrochloride . 152. DIGOXINE 200. 5-FLUOROURACIL. 153. DILAZEP hydrochloride 201. FLUDARABINE. 154. DILTIAZEM 202. FLUFENAMIC ACIDS. 155. DINOPROSTONE 203. FLUNARIZINE HDROCHLORIDE. 156. DIPHENOXYLATE, ITS SALTS 204. FLUOXETINE hydrochloride . 157. DIPIVEFRIN hydrochloride 205. FLUPENTHIXOL. 158. DI-SODIUM PAMIDRONATE 206. FLUPHENAZINE ENANTHATE. 159. DISOPYRAMIDE AND DECANOATE. 160. DOCETAXEL 207. FLURAZEPAM. 161. DOMPERIDONE 208. FLURBIPROFEN. 162. DONEPEZIL hydrochloride 209. FLUTAMIDE. 163. DOPAMINE hydrochloride 210. FLUTICASONE PROPIONATE. 164. DOTHIEPIN hydrochloride 211. FLUVOXAMINE MALEATE. 165. DOXAPRAM hydrochloride 212. FORMESTANE. 166. DOXAZOSIN MESYLATE 213.

8 FOSFESTRIL SODIUM. 214. FOSINOPRIL SODIUM 260. IRON PREPARATION FOR. 215. FOSSPHENYTOIN SODIUM PARENTERAL USE. 216. FOTEMUSTINE 261. ISEPAMICINE. 217. GABAPENTIN 262. ISOCARBOXSIDE. 218. GALANTHAMINE 263. ISOFLURANE. HYDROBROMIDE 264. ISONICOTNIC ACID HYDRAZINE. 219. GALLAMINE, ITS SALTS, ITS AND OTHER-HYDRAGINE. QUATERNARY COMPOUND DERIVATIVES OF ISONICOTINIC. 220. GANCYCLOVIR ACID. 221. GANIRELIX 265. ISOSORBIDE DINITRATE/. 222. GATIFLOXACIN MONONITRATE. 223. GEMCITABINE 266. ISOTRETINOIN. 224. GEMFIBROZIL 267. ISOXSUPRINE. 225. GEMTUZUMAB 268. ITOPRIDE. 226. GENODEOXYCHOLIC ACID 269. KETAMINE hydrochloride . 227. GLICLAZIDE 270. KETOCONAZOLE. 228. GLIMEPIRIDE 271. KETOPROFEN. 229. GLUCAGON 272. KETOROLAC TROMETHAMINE. 230. GLYCOPYRROLATE 273. LABETALOL hydrochloride . 231. GLYDIAZINAMIDE 274. LACIDIPINE. 232. GOSERELIN ACETATE 275. LAMIVUDINE. 233. GRANISETRON 276. LAMOTRIGINE. 234. GUANETHIDINE 277.

9 LATANOPROST. 235. GUGULIPID 278. LEFUNOMIDE. 236. HALOGENATED 279. LERCANIDIPINE. HYDROXYQUINOLINES hydrochloride . 237. HALOPERIDOL 280. LETROZOLE. 238. HEPARIN 281. LEUPROLIDE ACETATE. 239. HEPATITIS B. VACCINE 282. LEVAMESOLE. 240. HYALURONIDASE 283. LEVARTERENOL. 241. HYDROCORISONE 17-BUTYRATE 284. LEVOBUNOLOL. 242. HYDROTALCITE 285. LEVOCETIRIZINE. 243. HYDROXIZINE 286. LEVODOPA. 244. IBUPROFEN 287. LEVOFLOXACIN. 245. IDEBENONE 288. LEVOVIST. 246. IINDAPAMIDE 289. LIDOFLAZINE. 247. IMIPRAMINE 290. LINEZPLID. 248. INDINAVIR SULPHATE 291. LITHIUM CARBONATE. 249. INDOMETHACIN 292. LOFEPRAMINE DECANOATE. 250. INSULIN HUMAN 293. LOPERAMIDE. 251. INTERFERON 294. LORAZEPAM. 252. INTRAVENOUS FAT EMULSION 295. LOSARTAN POTASSIUM. 253. IOBITRIDOL 296. LOTEPREDNOL. 254. IOHEXOL 297. LOVASTATIN. 255. IOPAMIDOL 298. LOXAPINE. 4 299. MEBENDAZOLE. 256. IOMEPROL 300. MEBEVERINE hydrochloride . 257. IOPROMIDE 301.

10 MEDROXY PROGESTERONE. 258. IRBESARTAN ACETATE. 259. IRINOTECAN hydrochloride 302. MEFENAMIC ACID. 303. MEFLOQUINE hydrochloride . 304. MEGESTROL ACETATE 350. NEBIVOLOL. 305. MEGLUMINE IOCARMATE 351. NEBUMETONE. 306. MELAGENINA 352. NELFINAVIR MESILATE. 307. MELITRACEN hydrochloride 353. NETILMICIN SULPHATE. 308. MELOXICAM 354. NEVIRAPINE. 309. MEPHENESIN, ITS ESTERS 355. NICERGOLINE. 310. MEPHENTERMINE 356. NICORANDIL. 311. MEROPENAM 357. NIFEDIPINE. 312. MESTEROLONE 358. NIMESULIDE. 313. METAXALONE 359. NIMUSTINE hydrochloride . 314. METHICILLIN SODIUM 360. NITRAZEPAM. 315. METHOCARBAMOL 5. 316. METHOTRAXATE 361. NITROGLYCERIN. 317. METOCLOPRAMIDE 362. NORETH ISTERONE ENANTHATE. 318. METOPROLOL TARTRATE 363. NORFLOXACIN. 319. METRIZAMIDE 364. OCTYLONIUM BROMIDE. 320. METRONIDAZOLE 365. OFLOXACIN. 321. MEXILETINE hydrochloride 366. OLANZAPINE. 322. MIANSERIN hydrochloride 367. OMEPRAZOLE. 323.