COMPARATIVE STUDIES FOR FILING AND MARKETING AUTHORISATION OF GENERIC DRUGS IN EUROPE, UNITED STATES AND INDIA

The goal of this study is to understand differences in regulatory requirements, bio-equivalence data, drug registration, approval process and, guidelines associated with the generic drug filing in the USA, Europe, and India and also provide enough information for the drug safety and efficacy in humans. Generic drugs are identical, indistinguishable within an acceptable bio-equivalent level for the innovator product name counterpart esteems to the "Pharmacokinetics and Pharmacodynamics" properties. A generic drug product must meet the standards, established by "United States Food and Drug Administration 9USFDA)" in USA, "Central drugs standards control organization (CDSCO)" in India, and "European Medical Agency (EMA)" in Europe to be approved to successfully enter the pharmaceutical market. It must their bioequivalent to the branded medicine. In USA and India, in Module II there is complete information on the quality overall summary. Hence by comparing all the above differences and similarities, generic drug approval procedures and submissions become easy for registration of drugs in those countries. This compilation provides a view of harmonizing the Generic Drug submissions in these three countries which may reduce the tedious work that has to be done in altering the submission format.

Keywords: CTD, generic drugs, bioequivalence, Bio-equivalence, CTD, Generic Drug Submissions, USFDA, DCGI, EMA