DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No. Subject Matter Example(s) Notes10. Introduction of founder/manufacturer11. Logo with certification Example:SIRIM/ ISO / GMP /HACCPProhibited on product labelProhibited on product label becausecertification renewal is on a yearly basis12. Name/ Statement / Logo/ registeredtrademark which does not satisfythe specifications of the TraditionalUnit13. Patency claim/ Patency number/Special technique used/ superiorityin ingredients(Example: capsule coat)14. Nutritional claims with analysiscertificate attached15. Graphics or picture of internalorgansExample:“Dr.ABC‟s Formula”“Nothing like it”Example:Patented techniqueExample:Calorie, Fat, Protein andothersExample:Kidney, Heart, Nerves.Prohibited on product labelAllowed if proven trueProhibited on product labelThis is not a food supplement.Prohibited on product label16. Photograph of celebrities Example: Prohibited on product labelNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 296
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Subject Matter Example(s) NotesArtiste, Sports person(s),Politician17. Sex symbol (male or female) (♀ and / or ♂) Prohibited on product label18. Indecent photographs/ pornography Prohibited on product label19. Graphics which are incoherent withthe indicationExample:- Noted indication is forconstipation, but graphics onlabel shows a slim-lookinglady which denotes indicationfor weight loss- Indication for urination butlabel graphics containspicture of a water hose.Prohibited on product label20. Highlighting unnecessary bodypartsExample:Indication is for general healthbut graphics on label highlightsmale and female sexual organpartsProhibited on product label21. Graphics of plants or animal which Example: Prohibited on product labelNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 297
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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