Overview on Current Regulatory Requirements for Non-Proprietary (Generic Drugs) in United States and BRICS Nations

A generic medication is defined as "a medication product that is equivalent to a brand/reference listed medication product in terms of dosage form, strength, quality, and intended use."It is a less expensive, safer, and more effective substitute for the original branded medication available, hence these should be made easily accessible across the whole world.Each country has its own registration process for getting approval to market the generic medication.The study aims to evaluate the registration processes for generic drugs and identify any discrepancies or gaps in the guidelines in various countries including the BRICS countries.Commonly Brazil, Russia, India, China, and South Africa are collectively termed as "the BRICS" or "the BRICS economies".Ensuring that drug development, manufacture, and testing have been completed in compliance with rules and guidelines and that everything has been properly documented is one of the regulatory authorities' primary responsibilities.The International Conference on Harmonisation (ICH) developed a uniform application format for the registration of pharmaceutical products to minimize some of the challenges being faced during registration.This paper addresses the need for generic drug registration and the processes.