DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No. Subject Matter Example(s) Notes4. Clinical Trial results or anyinformation on clinical trial done onproductExample:“Clinically Tested”“Randomized Double BlindPlacebo Control Clinical Study”Such statements are prohibited onlabels, as per Medicines (Advertisementand Sale) Act 1956 requirement5. Photograph of product pioneer Not allowed6. Reference to Hadith/ Al-Quran/Bible/Prohibited on product labelReligious books7. Opinion of prominent figure(s) onproduct or its active ingredient/content8. Label design (graphic and color)similar to labels from anothercompanyExample:Opinion of product/formulation inventorProhibited on product labelProhibited on product label9. Statement on herbal origin Example:Source from theMountains of AlpsAllowed if proven trueNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 298
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 | 299
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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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