DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)- Any product to be regulated under NPCB shall not be in the conventional foodform such as cake, muffins, biscuits, gummy, jelly, chocolate, premixbeverages etc.iii) Unusual application- Products with unusual application for example spray may not be accepted byFSQD.- Products of coffee/ tea (coffea species/ camellia sinensis) containing herbsand a mixture of creamer and sugar are not allowed to be registered undercategory of natural product by NPCB.iv) Oils in pharmaceutical dosage formOils that are not traditionally used as food or are in combination with edible oil forexample evening primrose oil, garlic oil, fish oil, flaxseed oil and grapeseed oil incapsule or soft gel shall be regulated by NPCB.Notes:Applicant shall verify on FDI product classification with NPCB in order to determinewhether the product shall be registered by the Authority or otherwise.Reference: Circular (97)dlm.BPFK/PPP/01/03 Jld. 2National Pharmaceutical Control BureauFirst Edition, January 201340
Drug Registration Guidance Document (DRGD)1.3.3 PICTORIAL GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACE PRODUCTSFigure 3:ProductIngredient 1Legend:Regulated by FSQDRegulated by NPCBContent close to100% activeingredients (singly orin combination)Substances oringredients that areused for therapeuticpurposes shall notbe added to foodContent close to100% herbs (singlyor in combination)that are nottraditionally used asfood and havemedicinal propertyHerbs & spices thatare traditionally usedin food preparationsMixtures of foodingredients withactive ingredientsand/or herbsFor example:Amino Acids &PeptidesCollagenCoral calciumDietary Fibre 2EnzymesFatty AcidsLive microorganism 3, 4MineralsPlant Stanol/Sterol & Esters(≥3.5g/day)VitaminsFor example:GypsumfibrosumPearl PowderGamatFor example:AlfalfaAloe veraBarleygrassDukung AnakKacip FatimahManjakaniMas CotekMisai KucingNoni ExtractRoyal JellySpirulinaTongkat AliTunjuk LangitWheatgrassPsylliumHusk(≥3.5g/day)For example:Black cumin(Habbatussauda)GarlicGingerPegagaTraditionalChinese RawHerbsTurmeric> 20% activeingredients withpharmacological/therapeuticproperties, singly orin combination.≤ 20% of activeingredients or naturalingredients withpharmacological and/ortherapeutic properties.However, if a productcontains specific activeingredients whichpossess highpharmacological ortherapeutic potencies,the product may beregulated by NPCBeven if these activeingredients are presentin less than 20%National Pharmaceutical Control BureauFirst Edition, January 201341
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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