DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)‣ Product containing multiple ingredients (contains ingredients which are notknown to be used traditionally):- Information on the use and safety of every new ingredient;- Safety data on the new formulation;- Regulatory status in other countries.2.1.2 PREMIXEffective from 1 December 2007, premixed ingredient(s) shall not be used ina traditional product formulation, as directed in circular Bil (71) dlmBPFK/02/5/1.3, 1 Jun 20072.1.3 PROHIBITED/ BANNED INGREDIENTSThe following lists are prohibited/ banned ingredients which are not allowed inthe formulation of natural products registered by the Authority:a) Botanicals (and botanical ingredients) containing scheduled poisons aslisted under the Poisons Act 1952;b) Botanicals (& botanical ingredients) which are banned due to reportedadverse event;c) Ingredients (botanicals and substance derived from animals) which arebanned due to safety reasons.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 236
Drug Registration Guidance Document (DRGD)a) Table 1: Botanicals (and botanical ingredients) containing scheduledpoisons as listed under the Poisons Act 1952Part of plantprohibitedGenusSpeciesCommon/Local Name(whole plantunlessotherwisespecified)Constituent(s) ofconcernAconitum All species AconiteAsidospermaquebrachoWhitequebrachoAsidospermine,yohimbineAtropabelladonnaDeadlynightshadeAtropine,hyoscine(scopolamine),hyoscyamineBerberineBerberisAll species* Also present inHydrastiscanadensis(Goldenseal) andCoptic chinensis(Golden thread)Cabola albarrane Squill GlycosidePeriwinkleMadagascar,Old Maid,Vinca rosea,MyrtleCatharanthusroseusSyn: Vincabalcanica,Vincadifformis,Vinca heracea,Vinca major,Vinca minor,Vincae minorisherbaVinca, Vincristine,VinblastineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 237
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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