DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 300
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Subject Matter Example(s) Notesmay cause confusion Radix Ginseng which isimprovised as a male sexualorgan22. Statement on sugars in traditionalproductsExample:- This product contains no sugar-This product contains no addedsugarAllowable on product label provided theproduct contains no fructose, glucose,sucrose or other kind of sugars with apotential to affect diabetics are notincluded in the formulation23. Other statements Example:- This product is blended withpremium quality- Certified chemical residue freeProhibited on product labelNotes:The Authority reserves the right to disallow any other words, phrases or graphics for product label which in its opinion ismisleading, improper or not factual.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 301
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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