DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)4.5 SPECIFIC DOSSIER REQUIREMENT FOR REGISTRATION OFHEALTH SUPPLEMENTSPRODUCT VALIDATION1. PRODUCT NAMEMay include product name, dosage form and strength (e.g. XYZ Capsule 500mg)Dosage form and strength of product would need to be entered as part of productname to allow for multiple dosage forms (e.g. tablet, capsule) and strengths (e.g.200mg and 400mg) for any particular named (proprietary or generic) product.In any event if found that registered product name is similar to another registeredproduct, NPCB reserve the rights to request for the change in the product name.Product with more than 1 active ingredient could not include strength of activeingredients in the product name.Product name may be included together with the brand name or trademark name, ifapplicable.Any product name which is the same or similar either in writing/ pronunciation, withthe product name of an adulterated product is prohibited.Table 5: List of Non-Permissible Product Name for Health Supplement ProductsNo. Issue Example1. Prohibited use of disease names as statedin the Medicines (Advertisement and Sale)Act 1956 (revised 1983)2. Prohibited use of a single active ingredientas a product name in products containingmore than one active ingredient unlessproduct name contains words such as„Plus, Compound, Complex, HerbanikaDiabetes, Asthma, CancerIf the product contain Vitamin C,Vitamin E and Fish OilProduct name: “Vitamin C” is notallowed but product name:“Vitamin C Plus” is allowed.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 184
Drug Registration Guidance Document (DRGD)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 | 185
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Page 134 and 135: Drug Registration Guidance Document
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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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