DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)IngredientsGeneralClaimsFunctionalReduced RiskReduction ClaimPyridoxine (Vitamin B6)A factor inmaintenanceof good healthHelps the body tometabolizeproteins, fats andcarbohydratesCyanocobalamine(Vitamin B12)Helps inmaintenanceof good healthHelps in theformation of redblood cellFolic AcidHelps in formationof red blood cellHelps preventneural tubedefects forwomen who areplanning apregnancy beforeconception andduring 12 weeksof pregnancy at adose of 400 mcgdailyBiotinHelps inmaintenanceof good healthHelps tometabolize fatsandcarbohydratesPanthothenic AcidHelps inmaintenanceof good healthHelps tometabolize fatsandcarbohydratesNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 232
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 | 233
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Page 182 and 183: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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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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