DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 186
Drug Registration Guidance Document (<strong>DRGD</strong>)2. DOSAGE FORMDosage forms allowed:a) Tablets- Caplet, Lozenge, Chewable tablet, Dispersible tablet,Effervescence tablet, uncoated tablet, enteric coated tablet, Sugarcoated tablet, Film coated tablet, extended release tablet;b) Capsules- Soft capsule, Hard capsule, Enteric coated capsule, Chewable softcapsule, Extended released capsule;c) Powder/ Granules;d) Liquid- Emulsion, syrup, spray, suspension.Products in the shape of animal dosage forms are not allowed.Supporting data from established reference (e.g. Standard Pharmacopeia) shall berequired for new dosage form.The form that correctly describes it in terms of its product quality controlspecifications and performance shall be selected.A separate application for registration is required for each dosage form.The following documents will have to be provided during submission of productdossier for Sustained-release/ Extended-release/ Timed-release dosage formi) Protocol of analysis;ii) In-Process Quality Control (IPQC);iii) Finished Product Specification (FPQC);iv) Certificate of Analysis (COA).3. ACTIVE INGREDIENTName of Active Ingredient:Please select active ingredient from the search database. If substance is not listed,please select the „Not Listed Ingredient‟ button. Automatic e-mail will be send toNPCB for notification.Approved names, pharmacopoeia names of ingredients shall be used wheneverpossible.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 187
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Page 136 and 137: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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