DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No. Field Disease Risk Reduction ClaimProceduresP5.4 Batch AnalysesP5.5 Characterization of impuritiesP5.6 Justification of SpecificationP6. Reference Standards or MaterialsP7. Container Closure SystemP8. StabilityP9. Product Interchangeability/EquivalentevidencePARTSS. HEALTH SUPPLEMENTSUBSTANCES1. General InformationS1.1 NomenclatureS1.2 StructureS1.3 General PropertiesS2. ManufactureS3. CharacterisationS4. Control of Health SupplementSubstanceS4.1 SpecificationS4.2 Analytical ProceduresS4.3 Validation of AnalyticalProcedureS4.4 Batch AnalysisS4.5 Justification of SpecificationS5. Reference Standards or MaterialsS6. Container Closure SystemS7. Stability√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 220
PART III: NON-CLINICAL DATADrug Registration Guidance Document (<strong>DRGD</strong>)- Applicable to disease risk reduction claims(For new active ingredient, new combination of active ingredients and new dose)Table 18:No. Field Disease Risk Reduction Claims1.2.3.4.Overview of non-clinical testing strategy- nomenclature- structure- general propertiesPharmacology- related information (including academicliterature) of pharmacology studies on thedeclared efficacyPharmacokinetics- related information (including academicliterature) of pharmacokinetics studies on thedeclared efficacyToxicology- related information (including academicliterature) of toxicology studies5. Integrated overview and conclusions √6. Other toxicity studies if available √7.References- List of references used√√√√√- All information must be provided in the following format/ table:StudyTitleTypeofStudyProduct(formulation)Study Summary- Study Design (e.g. casecontrol, randomisedplacebo controlled, invitro data, cohort study)- Dosage- Subject- Study Duration- Outcome parametersSummary findings(Includes scientific details such asstrength of evidence [e.g. p-values], conclusions, anyshortcomings, etc.For traditional evidence includeenough information todemonstrate relevance)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 221
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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