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 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 | 260
Drug Registration Guidance Document (<strong>DRGD</strong>)GenusSpeciesPart ofPlant/AnimalProhibited(whole plant/animalunlessotherwisespecified)Constituent ofConcern Reasonsfor ProhibitionReasons for Prohibition- Renal dysfunction andrelated to acute tubularnecrosis and glomerulardestructionMelaleuca alternifolia Tea tree oilSkin irritation, respiratorydistress, vomiting, diarrheaand cytotoxic for oraladministration.* Banned in oral preparation- Potential abusePapaverAll speciesMorphine andderivatives,codeine- Dependence, palpitation,hallucination, euphoricactivities, CNS depression- Nervous system toxicity- Possible death fromcirculatory and respiratoryfailurePilocarpuspinnatifoliusjaborandiBarkPilocarpineBronchospasm, ocularproblem, miosis, blurredvisionPodophyllumemodiipeltatumRoot, leafPodophyllin resin- Serious systemic toxicity withexcessive amounts(persistent nausea andvomiting, tachypnea, fever,stupor, coma, tachycardia,neuropathy and death)- Renal failure andhepatotoxicitySolanumdulcamaraLeaf,floweringtopsSolanaceousalkaloidsTypical antimuscarinic effecte.g. dry mouth, mydriasisNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 261
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Page 210 and 211: Drug Registration Guidance Document
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
Page 274 and 275: Route of AdministrationTAMC(CFU/g o
Page 282 and 283: e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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