DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 256
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 | 257
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Appearance/organoleptic(odor, color
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Page 206 and 207: Drug Registration Guidance Document
Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
Page 274 and 275: Route of AdministrationTAMC(CFU/g o
Page 282 and 283: e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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