DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)(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
Drug Registration Guidance Document (<strong>DRGD</strong>)4.4.3 CLAIMS SUBSTANTIATIONClaims must be in line with the respective HS principles and supported by adequate evidence. To reflect the totalavailable usage evidence (including relevant scientific evidence), the evidence shall be summarized as part of thesubstantiation document for the claim as in the Table 4 below.Indication/claimProduct/IngredientstudiedDosage andadministrationrouteDurationoftreatmentType ofevidence(scientificevidence)StudydesignStudypopulationSummary offindingsLimitations ofthe studySource of evidencei) Authorii) Titleiii) Publicationdetailsiv) Yearv) Type (text,…)Note: Evidence not summarised as in the above format will not be further evaluated.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 185
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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