DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 248
Drug Registration Guidance Document (<strong>DRGD</strong>)GenusSpeciesCommon/ LocalNamePart ofplantprohibitedReason forprohibitionaureusLife rootjacobaeaTansy ragwort,TansyButterweedbicolornemorensisSilver ragwortAlpane ragwort,Wood ragwortReported to causeliver toxicitySeneciovulgarisCommongroundsel,Groundsel, Oldman-inthespringlongilobus-syn .withdouglasii,filifoliusThreadleafgroundsel,ThreadleafragwortScandensBuch.-HamGerman/African/Cape Ivy,ClimbingGroundsel** To identify the Botanicals which may contain Aristolochic Acid besidesthe Aristolochia genus, please refer the following lists on the nextpage:a. List A - Botanicals Known or Suspected to contain Aristolochic Acidb. List B - Botanicals which may be Adulterated with Aristolochic AcidNotes:Products containing any of the listed herbs (EXCEPT for Aristolochia spp. whichis totally banned) will have to be sent to any governmental doping centre fortesting and the result shall be attached with the registration form.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 249
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Page 198 and 199: 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
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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