DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No. Issue Example3. Prohibited use of superlativeNames which indicates superiority inefficacy4. Prohibited use of spelling of words whichmay cause confusioni)Words which involve names of/partthereof:20 disease names prohibited in the Medicines(Advertisement and Sale) Act 1956 (Revised1983)ii) Other diseases without scientific proofiii) Prohibited indication5. Prohibited use of names which may causeambiguityAmbiguous product name6. Prohibited use of names which may beoffensive or indecentPower, Superior, Pure, Mustajab,Safe, Healthy, Penawar, VIP,Good, World Number 1Go Out = GOUT (label)UtixB For Energy?SENXBIG=SEnXBIG(label)Sexy, Enjoy, Paradise, Heavenly,Blue boy, Casanova, Desire7. Product name which is not congruent withthe active ingredient.The active ingredient is EveningPrimrose oil (EPO) and theproduct name: “Marine tablet” isnot allowed.8. Prohibited use of product names which haselements of ludicrous beliefStatements referring to ancientbelieve/negative spirits/supernatural powerWords such as miracle, magic,magical, miraculous, saintly,heavenlyNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 188
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Issue Example9. Prohibited use of product names similar tothe existing approved product namesProduct name similar to the spelling andpronunciation of words of an existing productnames10. Prohibited use of product names whichmay cause ambiguity in the nature ofproduct (drug/ food/ beverage)Product name similar to a food/ beveragename11. Prohibited use of product names whichrepresents professional advice or opinionElegen vs L-gen vs L-jen Fortevs FortJuice, Health drink, Beverage,KookyDr Sunny, Professor12. Product name that symbolize a claim Vigour, Youthful, High, Hi13. Product name that uses strength butformulation contains more than one activeingredient.If the product containsmultivitamins and minerals.Product name:“XXX multivitamins and minerals500mg” is not allowed.14. Other prohibited product names Minda, IQ, Smart, Unique, UltraMega, Detox15. Names of organs and brain Heart, kidney, skin, liverNote:1. This list is not meant to be exhaustive and will be reviewed from time to time.2. The Authority reserves the right to disallow any other words, phrases or graphics for productlabel which in its opinion is misleading, improper or not factual.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 189
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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