Abstract

A COMPARATIVE STUDY OF REGULATORY REQUIREMENTS FOR FILING GENERIC DRUG PRODUCT BETWEEN USA, INDIA, AND CHINA

Sita Priya Darsini Yallabandi*, Sujatha K., Jaya Prakash V., Raga Padmasri Deepika M., Basava Raju D. and Ravi Kumar Reddy J.

ABSTRACT

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, India, and China and also provide enough information for the drug safety and efficacy in humans. Generic drugs are identical, indistinguishable with-in 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" in USA, "Central drugs standards control organization" in India, and "National Medical Product Administration" in China 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, but in China, there is complete information about a Drug substance, whereas in module III in USA and India there is complete information about Drug Substance and Drug Product, but in China, module III contains complete information about drug product only. 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: Bio-equivalence, CTD, Generic Drug Submissions, USFDA, DCGI, NMPA.