DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No. Issue Example Note4.Clinical Trial results orany information onclinical trial done onproductExample :“Clinically Tested”“Randomized Double BlindPlacebo Control ClinicalStudy”Such statementsare prohibited onlabels (as perMedicines(Advertisementand Sale) Act1956Requirement5.Reference to Hadith/ Al-Quran/ Bible/ ReligiousbooksProhibited onproduct label6.Opinion of prominentfigure(s) onproduct or its activeingredient/contentExample:Opinion ofproduct/formulation inventorProhibited onproduct label7.Label design (graphicand color) similar tolabels from anothercompanyProhibited onproduct label8.Statement on activeingredient originExample:Source from the Mountainsof AlpsAllowed if proventrue9.Introduction of founder/ManufacturerProhibited onproduct label10. Logo with certificationExample:SIRIM/ ISO / GMP/ HACCPProhibited onproduct labelbecausecertificationrenewal is on ayearly basisNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 206
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Issue Example Note11.Name/ Statement/Logo/ registeredtrademark which doesnot satisfy thespecificationsExample:“Dr.ABC‟s Formula”“Nothing like it”Prohibited onproduct label12.Patency claim/ Patencynumber/ Specialtechnique used/superiority iningredients (Example:capsule coat)Example:Patented techniqueAllowed if proventrue13.Nutritional claims withanalysis certificateattachedExample:Calorie, Fat, Protein andothersProhibited onproduct label14.Graphics or picture ofinternal organsExample:Kidney, Heart, Nerves.Prohibited onproduct label15.Sex symbol(male or female)(♀ and/or ♂)Prohibited onproduct label16.Indecent photographs/pornographyProhibited onproduct label17.Graphics which areincoherent withthe indicationExample:- Noted indication is forconstipation, but graphicson label shows a slimlookinglady whichdenotes indication forweight loss- Indication for urination butlabel graphics containspicture of a water hose.Prohibited onproduct labelNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 207
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Page 156 and 157: Drug Registration Guidance Document
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Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 230 and 231: APPENDIX 5:Drug Registration Guidan
Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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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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