REGULATORY REQUIREMENTS FOR REGISTRATION OF GENERIC DRUGS IN "BRICS" COUNTRIES

The purpose of the study was to compare generic drug registration process and to find out the differences, lacunae among the guidelines. Brazil, Russia, India, China and South Africa are typically rendered as "the BRICS" or "the BRICS economies". The registration process for Brazil and Russia are completely different. Even though India, China and South Africa follow the CTD format the requirements for Module 1 are different. It can be concluded that the world pharmaceutical economy, the fastest growing and largest emerging markets economies of Brazil, Russia, India, China and South Africa (BRICS) countries are showing positive growth and increasing direct foreign investment by creating significant opportunities for pharmaceutical companies to expand into these markets. They would be the largest entity on the global stage. To rectify the differences of the guidelines, we need to go for harmonization. So that we can expect a common guideline worldwide. It will take time to harmonize the guidelines. But once harmonized the guidelines, emerging countries like BRICS will get benefit. With ICH formation, the industry foresees harmonization of regulations, so that we can do filing easily. In the interest of industry, we are opinion that all regulations are harmonized and unified regulations are emerged. Keywords: Regulatory Requirements, Registration Process, Brazil, Russia, India, China and South Africa (BRICS), Generic Product