DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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ATTACHMENT 1Drug Registration Guidance Document (<strong>DRGD</strong>)CHECKLIST OF DOSSIER REQUIREMENT FOR HEALTH SUPPLEMENTSDepending on the level of claims, submission may follows the route as outlined:i) General/ Nutritional and Medium Claims - Abridge evaluationii) Disease Risk Reduction Claims - Full evaluationTable 16: Checklist for General/ Nutritional and Medium ClaimNo.FieldGeneral orNutritionalClaimsFunctionalClaimsA1A2A3Product NameBrand name and product nameProduct Description- Describe visual and physical characteristics ofthe product including shape, size, superficialmarkings, colour, odour, taste, type ofcoating, type of capsule etc where applicable- Animal shape is only allowed for „For ExportOnly‟ (FEO) ProductsDosage Form- COA capsule shell is required- Source of capsule shell- BSE/ TSE free certificate if capsule fromanimal source from competent authority- Letter to rectify the source of gelatine from theproduct manufacturer- Colouring agent used in capsuleA4 Product indication/ Usage √ √A5Dose/ Use Instruction- Quantity and frequency- Dosing schedule must be stated(e.g. take before/ after/ with meal)A6 Contraindication, if applicable √ √A7 Warning/ Precautions, if applicable √ √√√√√√√√√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 220
Drug Registration Guidance Document (<strong>DRGD</strong>)No.FieldGeneral orNutritionalClaimsFunctionalClaimsA8 Drug Interaction, if applicable √ √A9 Side Effects/ Adverse Reactions, if applicable √ √A10Signs and Symptoms of overdose andtreatment, if applicable√√A11Storage Condition- According to stability data√√Shelf lifeA12- Must be supported by stability study- Please refer to B5√√A13Therapeutic Code- As a health supplement√√B1.1 Batch Manufacturing Formula √ √B1.2List of Active ingredient(s)- BSE/ TSE free certificate if active ingredientfrom animal sourceB1.3 List of excipient(s) √ √B1.4Attachment of Batch Manufacturing Formula- Shall be on the product owner‟s/manufacturer‟s original letterhead, productdetails, date and signature & designation ofauthorized personnelB2.1 Manufacturing Process √ √√√√√B2.2Attachment of Manufacturing ProcessDocument or Manufacturing Flow Diagram√√B3In-Process Quality Control (IPQC)√*LOC to submitdata during postregistration√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 221
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Page 170 and 171: Drug Registration Guidance Document
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Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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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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