DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

Drug Registration Guidance Document (<strong>DRGD</strong>)Botanical Name*Sinomenium acutum (Thunb.) Rehder & E.H. WilsonSyn. Cocculus diversifolius var. cinereus DielsSyn. Cocculus heterophyllus Hemsl. & E.H. WilsonSyn. Menispermum acutum Thunb.Syn. Sinomenium acutum (Thunb.) Rehder & E.H.Wilsonvar. cinereum (Diels) Rehder & E.H. WilsonSyn. Sinomenium diversifolium (Diels) DielsStephania spp.Stephania tetrandra S. MooreVladimiria souliei (Franch.) LingCommon or Other NamesOrientvineXunfengtengDafengtengDaqingmuxinagZhuigusanDa ye qingshenerMufangjiHanfangjiTutengZhuigufengMaofangjiStephaniaFen fang ji , fang jiFang ji (root)Han fang jiKanboi (Japanese)Hanbanggi (Korean)Fun-boui (Japanese)Sen-mokkouNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 250
Drug Registration Guidance Document (<strong>DRGD</strong>)c) Ingredients (Botanicals and Substance Derived from Animals) which arebanned due to safety reasons:Table 5:GenusSpeciesPart ofPlant/AnimalProhibited(whole plant/animalunlessotherwisespecified)Constituent ofConcern Reasonsfor ProhibitionReasons for ProhibitionAbrus precatorius SeedAbrin, Agrus,Agglutinin- Potent inhibitor of proteinand DNA synthesis- Severe diarrhea- Severe stomach cramp- Severe gastroenteritisAdonis vernalis AdonitoxinUncontrolled dose candamage heart and causedeathAnimal parts containing hormones (All species)Antiaris toxicaria Latex, sapCardiac glycoside(antiarin),Cardenolides &alkaloids withcardiac arrestingpotential- Latex is highly poisonous- Paralyze heart muscle andcause deathAristolochia All species Aristolochic acidReported to cause kidneytoxicity, interstitialnephropathyCalotropisgiganteanproceraLatexCardiac glycosides,calotropinSevere mucous membraneirritation characterized byvomiting, diarrhea,bradycardia, convulsion anddeathNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 251
Page 2 and 3:
Drug Registration Guidance Document
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Page 164 and 165:
Page 166 and 167:
Page 168 and 169:
Page 170 and 171:
Page 172 and 173:
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Appearance/organoleptic(odor, color
Page 198 and 199:
Page 200 and 201: Drug Registration Guidance Document
Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 224 and 225: ATTACHMENT 2Drug Registration Guida
Page 230 and 231: APPENDIX 5:Drug Registration Guidan
Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
Page 268 and 269: Route of AdministrationTAMC(CFU/g o
Page 276 and 277: d) Example of label approved by the
Page 300 and 301:
Page 302 and 303:
Page 304 and 305:
Page 306 and 307:
Page 308 and 309:
Page 310 and 311:
Page 312 and 313:
Page 314 and 315:
Page 316 and 317:
Page 318 and 319:
Page 320 and 321:
Page 322 and 323:
Page 324 and 325:
Page 326 and 327:
Page 328 and 329:
Page 330 and 331:
Page 332 and 333:
Page 334 and 335:
Page 336 and 337:
Page 338 and 339:
Page 340 and 341:
Page 342 and 343:
Page 344 and 345:
Page 346 and 347:
Page 348 and 349:
Page 350 and 351:
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366 and 367:
Page 368 and 369:
Page 370 and 371:
Page 372 and 373:
Page 374 and 375:
Page 376 and 377:
Page 378 and 379:
Page 380 and 381:
Page 382 and 383:
Page 384 and 385:
Page 386 and 387:
Page 388 and 389:
Page 390 and 391:
Page 392 and 393:
Page 394 and 395:
Page 396 and 397:
Page 398 and 399:
Page 400 and 401:
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438 and 439:
Page 440 and 441:
Page 442 and 443:
Page 444 and 445:
Page 446 and 447:
Page 448 and 449:
Page 450 and 451:
Page 452 and 453:
Page 454 and 455:
Page 456 and 457:
Page 458 and 459:
Page 460 and 461:
Page 462 and 463:
Page 464 and 465:
Page 466 and 467:
Page 468 and 469:
Page 470 and 471:
Page 472 and 473:
Page 474 and 475:
Page 476 and 477:
Page 478 and 479:
Page 480 and 481:
Page 482 and 483:
Page 484 and 485:
Page 486:
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Create successful ePaper yourself

Delete template?

Save as template?