DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 176
Drug Registration Guidance Document (<strong>DRGD</strong>)4.4.4 ILLUSTRATIVE SUSBSTANTIATION EVIDENCEi) Reference textsa. Martindale, latest edition. The Complete Drug. Pharmaceutical Press, 2009.b. The ABC Clinical Guide to Herbs. American Botanical Councilc. WHO Monographs on Selected Medicinal Plantsd. British Pharmacopoeiae. United States Pharmacopoeiaf. Indian Pharmacopoeiag. Chinese Pharmacopoeiah. Natural Standards (www.naturalstandard.com)i. Office of Dietary Supplements, National Institutes of Health - Dietary SupplementFact Sheets(http://ods.od.nih.gov/Health_Information/Information_About_Individual_Dietary_Supplements.aspx)ii) Organisationsa. American Botanical Council (www.herbalgram.org).b. American Nutraceutical Association (www.ana-jana.org)c. CODEX Alimentariusd. Global Information Hub for Integrated Medicine (http://www.globinmed.com)e. National Centre for Complementary and Alternative Medicine (http://nccam.nih.gov/)f. Office of Dietary Supplements, National Institutes of Health (USA)(http://ods.od.nih.gov)iii) Reference regulatory authoritiesa. Australia TGAb. Chinese Health Authority on Chinese medicinal herbsc. European Commissiond. Health Canadae. United States FDANotes: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 in thereport to ensure that the health claim is substantiated.3. The Authority will be willing to consider review other than the listed above, if the standards ofevidence are consistent with those of the Authority.4. All references must be current.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 177
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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