DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)GenusSpeciesPart ofPlant/AnimalProhibited(whole plant/animalunlessotherwisespecified)Constituent ofConcern Reasonsfor ProhibitionReasons for ProhibitionCannabissativaindicaCannabinoids- Potential abuse- Psychoactive on CNS- Prolonged heavy use maylead to tolerance andpsychological dependenceCatharanthus roseus Vinca alkaloidsBone marrow depression,central and peripheral(including autonomic)neurotoxicitymanghasSeedDigitoxynglycoside,Cerberine,Cerberoside,thevetin- Drastic purgative and emetic- Burning in the stomachsensation, vertigo, nausea,violent purgation and colic- Heart failureCerbera- Gastro intestinal symptoms- cardiac toxicityodollamSeedCerberine,Cerberoside,odollin, odolotoxin,thevetin andcerapain- Nausea, severe retching,vomiting, abdominal pain,blurring of vision- Arterial block and nodalrhtym, hyperkalaemia- Irregular respiration, collapseand death from heart failure- Resistance of malarial vectorCinchonaAll speciesQuinine andderivatives- Use of bark iscontraindicated in pregnancyand ulcers, intestinal orgastric, and if takenconcommitantly withanticoagulants can increasedNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 252
Drug Registration Guidance Document (<strong>DRGD</strong>)GenusSpeciesPart ofPlant/AnimalProhibited(whole plant/animalunlessotherwisespecified)Constituent ofConcern Reasonsfor ProhibitionReasons for Prohibitiontheir effects- Can elicit thrombocytopeniawith purpura- Cinchona alkaloids are toxic.Can cause symptoms suchas blindness, deafness,convulsions and paralysisCitrullus Colocynthis Seed, fructus Curcubitacin- Carcinogenic effects, induceinfertility in both sexes- Enterohepatonephro-toxicityDryopteris filix-mas Rhizome Filicin, aspidinol Hepatotoxic and blindnessEuphorbiaantiquorumtrigonaLatexApha euphorbol,Beta amyrincycloartenol EupholInflammation of thegastrointestinal mucousmembrane, irritate skin,difficult respiration, eyespupil dilatedExcoecaria agallocha LatexExcoecariaphorbol- Highly irritant to skin- Cause blindness if it entersthe eye- BiocidalGarciniaacuminatehanburyimorellaGum resinCambogic acid, β-guttiferin, α-1guttiferinVomiting, hypercarthasis,sympathetic irritation ofsympathetic nervous system,caused death by gastroenteritisGelsemiumelegansRoot, leaf,rhizomeGelsemine &gelseminine(Gelsemium indolealkaloid)Paralysis, shortness ofbreath, musclestiffeningcoma, hypocyclosisNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 253
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Appearance/organoleptic(odor, color
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Page 202 and 203: Drug Registration Guidance Document
Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 224 and 225: ATTACHMENT 2Drug Registration Guida
Page 230 and 231: APPENDIX 5:Drug Registration Guidan
Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
Page 268 and 269: Route of AdministrationTAMC(CFU/g o
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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