REGULATORY REQUIREMENTS AND REGISTRATION PROCESS FOR DRUG APPROVAL OF FIXED DOSE COMBINATIONS (FDCS) IN INDIA: A REVIEW
Journal Title: Journal of Biological and Scientific Opinion - Year 2017, Vol 5, Issue 1
Abstract
The article reveals the data required for fixed-dose combinations (FDCs) in Indian market occupies a higher pedestal when the efficacy of a finished product is under question. Although these have advantages that make them appear a good therapy option, In the Indian market, FDCs occupies a huge share; therefore the rational approval of FDCs is important for the development of public health perspectives in India. Some of the data required for market authorization balancing of advantages, disadvantages and Pharmacovigilance. Bioavailability (BA)/Bioequivalence (BE) studies are the basis for regulatory considerations of FDC product discussed according to India. Therefore, before getting an FDC approval, a manufacturer has to make available information to the health authority on quality, safety, efficacy and post-marketing surveillance studies (PMS). we shall briefly see the data required to be made available to the Central Drug Standard Control Organization (as per relevant guidelines) to get an FDC approved and the registration process.
Authors and Affiliations
Ankit Saxena, J Saminathan
Keywords
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