DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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ATTACHMENT 2Drug Registration Guidance Document (<strong>DRGD</strong>)Table 20: Allowable claims for specific active ingredients in HS productsIngredientsVitamin AVitamin CVitamin DVitamin EGeneralMaintenanceof good healthMaintenanceof good healthMaintenanceof good healthClaimsFunctionalHelps to maintaingrowth, vision andtissuedevelopmentAids inmaintaining thehealth of the skinand mucousmembraneFor healthybones,(cartilage), teeth,gums as well asgeneral make-upof the bodyHelps in normaldevelopment andmaintenance ofbones and teethHelps the bodyutilize calciumand phosphorusClaim for specificpopulationsubgroups:Elderly peoplewho are confinedindoorsReduced RiskReduction ClaimNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 230
Drug Registration Guidance Document (<strong>DRGD</strong>)IngredientsBeta CaroteneVitamin B1 (Thiamine)Riboflavin (Vitamin B2)Niacin (Vitamin B3)GeneralMaintenanceof good healthHelps tomaintain goodhealthA factor inmaintenanceof good healthA factor inmaintenanceof good healthClaimsFunctionalHelps inmaintenance ofgrowth, vision andtissuedifferentiationHelps inmaintenance ofgrowth, vision andtissuedifferentiationHelps the body toutilize energyfrom food/metabolizeprotein, fats andcarbohydratesClaim for specificpopulationsubgroups:-Additionalamounts ofRiboflavin arerequired duringpregnancy andbreast feedingwhen diet doesnot provide asufficient dailyintakeHelps normalgrowth anddevelopmentHelps the body inutilization ofenergy from foodReduced RiskReduction ClaimNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 231
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Page 180 and 181: Drug Registration Guidance Document
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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