DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Part of plantprohibitedGenusSpeciesCommon/Local Name(whole plantunlessotherwisespecified)Constituent(s) ofconcernChondodendrontomentosumCurare, Velvetleaf, Ice Vine,TubocurarineClaviceps purpurea Ergot ErgometrineColchicumautumnaleAutumnCrocus/MeadowSaffron/ NakedLady)ColchicineDaturametelDevil‟sTrumpet,Metel, JCaliforniaJimson WeedAtropine,ScopolamineSyn.: DaturawrightiiDaturastramoniumJimson Weed/GypsumWeed,LocoWeedAtropine,Hyoscyamine,ScopolamineDelphiniumstaphysagriaLice bane,StavesacreDelphinineDigitalispurpureaCommonFoxglove,PurpleFoxglove,KecubungLeafGlycosideSquillDrimiamaritimaSyn.:Urgineamaritima, ScillamaritimaGlycosideNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 244
Drug Registration Guidance Document (<strong>DRGD</strong>)Part of plantprohibitedGenusSpeciesCommon/Local Name(whole plantunlessotherwisespecified)Constituent(s) ofconcernRelatedsubstance:Urginea indica,Urgineapancreatium,Urginea scillaEphedra All species Ma HuangEphedrine,PseudoephedrineGelsemiumsempervirensYellowJessamine,EveningTrumpet,Carolina JessamineGelsemineHyoscyamusmuticusEgyptianhenbaneHyoscyamineHyoscyamus niger Black henbaneHyoscyamineatropineLobeliainflataLobelia,pokeweed,Indian tobacco,gagroot,asthma weed,vomitwort,bladderpod,rapuntiuminflatum.LobelineLobelia nicotianifolia Wild Tobacco LobelineMitragyna speciosa Daun Ketum MitrogynineNicotianatabacumCommontobaccoNicotineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 245
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Page 194 and 195: Drug Registration Guidance Document
Page 202 and 203: Appearance/organoleptic(odor, color
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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