DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)When describing liquids, state clearly whether it is in the form of a solution(clear), suspension, emulsion, etc.5. Pharmacodynamics (for full evaluation only)Please provide a concise and comprehensive summary of thepharmacological profile:Main and supplementary pharmacological effects (mechanism of action,actions other than the therapeutic effects);Relevant pharmacokinetics (absorption, plasma-protein binding,distribution, biotransformation, metabolism, excretion, etc);Bioavailability and bioequivalence studies in man.6. Pharmacokinetics (for full evaluation only)Details are as for A5.1 Pharmacodynamics stated above.7. IndicationState briefly on the recommended clinical use(s) of product, indicatingclearly whether curative, palliative, adjunctive, diagnostic, etc.Indications should be specific; phrases such as „associated conditions‟ or„allied diseases‟ would not normally be considered appropriate.Indications other than those specified and accepted at the time ofregistration must not be included in any product literature, data sheets,package inserts, labels, etc. without prior permission of the Authority.Should it be desired to include new indications, an application shall be filedto the Authority together with supporting clinical documentation onevidence of efficacy and safety for the additional uses (indications).In the case of products which are to be used as health supplements, noclaims shall be made for the prevention and treatment of disease states.For natural products, please state briefly on recommended use(s) of theproduct, starting with the phrase “Traditionally used for...../Homeopathyically used for......”.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 444