DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)IngredientsClaimsGeneralFunctionalReduced RiskReduction ClaimCalciumHelps inmaintenanceof good healthHelps in theformation andmaintenance ofbones and teethClaim for specificsubgroup:- Additionalcalcium isrequired forpregnant andlactatingwomen, whendiet does notprovide asufficient dailyintake to helpin proper boneformation indevelopingbabyPhosphorusHelps inmaintenanceof good healthHelps in theformation andmaintenance ofbones and teethMagnesiumHelps inmaintenanceof good healthHelps the body tometabolizecarbohydrateIronHelps inmaintenanceof good healthHelps in theformation of redblood cellHelps to preventiron anemiaHelps to preventanemia due toiron deficiencyIodineHelps inmaintenanceof good healthHelps in thefunction of thethyroid glandsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 236
Drug Registration Guidance Document (<strong>DRGD</strong>)IngredientsGeneralClaimsFunctionalReduced RiskReduction ClaimZincA factor inmaintenanceof good healthHelps tometabolizecarbohydrates,fats and proteinCopperA factor inmaintenanceof good healthHelps in theformation of redblood cellManganeseA factor inmaintenanceof good healthHelps tometabolizecarbohydratesand proteinsProbioticsHelps to improvea beneficialintestinalmicrofloraNotes:1. This list is not meant to be exhaustive and will be reviewed from time to time.2. The Authority will nonetheless conduct a detailed evaluation of the evidence included inthe report to ensure that the health claim is substantiated.3. The Authority will be willing to consider review other than the listed above, if thestandards of evidence are consistent with those of the Authority.4. All references must be current.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 237
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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