Abstract

REGULATORY REQUIREMENTS FOR REGISTRATION OF GENERIC DRUGS IN BRICS COUNTRIES

T. Mohini*, M. V. Ngabhushanam, S. Mounika, Y. Ratna Sindhu, Brahmaiah Bonthagarala and G. Ramakrishna

ABSTRACT

The purpose of the study was to compare generic drug registration process and to find out differences lacunae among the rules. Brazil, Russia, India, China and South Africa are ordinarily delivered as "the BRICS" or "the BRICS economies". The registration process for Brazil and Russia are totally different. Despite the fact that India, China and South Africa follow the CTD design the prerequisites for Module 1 are different. It can be concluded that the world pharmaceutical economy, the quickest developing and biggest emerging markets economies of Brazil, Russia, India, China and South Africa (BRICS) nations are appearing positive development and expanding foreign investment. The disadvantage in Brazil, Russia and China are the regulations are in their local languages and the documents required for registration of drugs should translate into their local languages. To rectify the differences, 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.

Keywords: Brazil, Russia, India, China and South Africa (BRICS) Countries, Generic Drugs, Regulatory Requirements.