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) ofconcernStrychnosnux-vomicaPoison nut,Quaker button,strychninetree, ma qianzi/maqianziStrychnineValerianAll speciesAll partsexcept forroot partValepotriatesVeratrumAll speciesVincaAll speciesIncludingCatharanthusroseusVinca, Vincristine,Vinblastine,VinpocetinNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 250
Drug Registration Guidance Document (<strong>DRGD</strong>)b) Table 2: Botanicals (& botanical ingredients) which are banned due toreported adverse eventGenusSpeciesCommon/ LocalNamePart ofplantprohibitedReason forprohibitionAristolochiaAll speciesContain AristolochicAcid reported tocause kidney toxicity(**Please refer tofootnote below)DrybalanopsaromaticaBorneo/Malay/SumatraCamphor, PokokKapurWhole herbContain camphor- notallowed for oralpreparationBorneolum syntheticum Bingpian,borneolContain borneol- notallowed for oralpreparationLarreatridenatamexicanaChapparalReported to causeliver toxicityHydrastiscanadensisGoldenseal,EyeBalm, IndianDyeReported to causedisturbance of thenervous systemMagnoliaStephaniaofficinalistetrandraHoupu,MagnoliaReported to causekidney toxicityPipermethysticumKava-kavaofficinaleSymphytumasperumx. uplandicumComfreyReported to causeliver toxicityNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 251
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Page 200 and 201: 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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