DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 216
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Issue Example Note18.Highlightingunnecessary body partsExample:Indication is for generalhealth but graphics on labelhighlights male and femalesexual organ partsProhibited onproduct label19.Graphics of plants oranimal whichmay cause confusionExample:Radix Ginseng which isimprovised as a malesexual partProhibited onproduct label20. Other statementsExample:- This product is blendedwith premium quality- Certified chemical residuefreeProhibited onproduct labelNotes:1. This list is not meant to be exhaustive and will be reviewed from time to time2. The Authority reserves the right to disallow any other words, phrases or graphics forproduct label which in its opinion is misleading, improper or not factualNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 217
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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