DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)a) Table 1: Botanicals (and botanical ingredients) containing scheduledpoisons as listed under the Poisons Act 1952Part of plantprohibitedGenusSpeciesCommon/Local Name(whole plantunlessotherwisespecified)Constituent(s) ofconcernAconitum All species AconiteAsidospermaquebrachoWhitequebrachoAsidospermine,yohimbineAtropabelladonnaDeadlynightshadeAtropine,hyoscine(scopolamine),hyoscyamineBerberineBerberisAll species* Also present inHydrastiscanadensis(Goldenseal) andCoptic chinensis(Golden thread)Cabola albarrane Squill GlycosidePeriwinkleMadagascar,Old Maid,Vinca rosea,MyrtleCatharanthusroseusSyn: Vincabalcanica,Vincadifformis,Vinca heracea,Vinca major,Vinca minor,Vincae minorisherbaVinca, Vincristine,VinblastineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 246
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 | 247
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Page 196 and 197: Drug Registration Guidance Document
Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233: - All information must be provided
Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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