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 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 | 262
Drug Registration Guidance Document (<strong>DRGD</strong>)GenusSpeciesPart ofPlant/AnimalProhibited(whole plant/animalunlessotherwisespecified)Constituent ofConcern Reasonsfor ProhibitionReasons for ProhibitionHyoscyamusmuticusHyoscyamine,atropine, hyoscineDifficulty in swallowing andtalking, transient bradycardiafollowed by tachycardia withpalpitation and arrhythmias,CNS depression, comaJatropha multifida Fruit, seedPhytotoxin(toxalbumin -CurcinNausea, vomiting, seriouspurgative actionLantanacamaraLantadene,LancamaronCause toxicity in buffalo,cattle, sheep and goat.Symptoms includephotosensitive dermatitis,jaundice and yellowing ofmucous membrane and lossof appetite with a decrease inruminal motilityLobeliachinensisLobeline- Stimulant and has peripheraland central effects- Excessive use can causenausea, vomiting anddizzinesstupa- Stimulant and has peripheraland central effects- Caused arrhythmiasLyttavesicatoriaWhole body,tinctureCantharidin- Excessive salivation,abdominal pain, swelling ofkidney and urogenitalsystem, headache, vomitingand diarrhea accompaniedby bleeding- Burning of the mouth,dysphagia, nausea,hematemesis, grosshematuria and dysuriaNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 263
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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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