DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)(iii) Table 3: Disease risk reduction (high)Types ofHS claimDiseaseriskreductionDefinition• Significantlyaltering orreducing arisk factor ofa disease orhealth relatedcondition.Examples/Wording ofclaims• Helps toreduce risk ofosteoporosisbystrengtheningbone• Helps toreduce the riskofdyslipidaemiaCriteria• The relationshipbetween the HSingredient or productand disease riskreduction issupported byconsistent scientificevidence• Documented inauthoritativereference texts• Recognised by theAuthority referenceor internationalorganisations orregulatoryauthorities• Adheres to the keyprinciples of HSclaimsEvidence tosubstantiate HS ClaimsCompulsory evidence:i) Scientific evidencefrom humanintervention study oningredient and/orproductii) Toxicological study(chronic)iii) PharmacologicalstudyAt least 1 additionalevidence:i) Standard referencee.g. referencetextbooks,pharmacopoeia,monographs etc.ii) Recommendationson usage fromreference regulatoryauthorities orreferenceorganisationsiii) Evidence frompublished scientificreviews or metaanalysisiv) Report prepared byexpert committees/expert opinion(subject to theAuthority approval)Please refer to Illustrative Substantiation Evidence List for the list of acceptable references,organisations and authorities.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 184