Generic Drugs Regulations in BRICS Countries: A Regulatory Assessment

Author(s)

Venkatesh, M.P., Bandla, D.T.

Author's Affiliation

Abstract

BRICS is an alliance of five major emerging markets: Brazil, Russia, India, China and South Africa. The pharma regulated industries should follow all rules and regulations that are enforced by the regulatory authorities to protect the health and well being of the public. The regulatory requirements of various countries vary from one another. Therefore it is demanding for the companies to develop single drug and get simultaneous market approval in different countries. One of the primary challenges of the regulatory authority is to ensure that the products are developed according to the regulatory requirement of that country. ANVISA requires BE studies should be done only against Brazilian innovator and at ANVISA approved centre in fast conditions. Whereas in Russia it is quite contrast that the BE studies can be done against any innovator in both fast and fed conditions. Further the changes may happen in dossier submission mode. e.g.: From 2020 Russia is going to follow EU procedures and from 2017 South Africa follows eCTD in submission of the dossiers. The requirements vary among different countries and also in dossier submission. The aim of this study is to review and compare the regulatory requirements that vary among these five countries and also to emphasize the changes in dossier submission paving the way for simultaneous submissions.

Keywords

Generic, Regulatory requirements, Dossier, Compare

Cite This Article

Venkatesh, M.P., & Bandla, D.T. (2017). Generic Drugs Regulations in BRICS Countries: A Regulatory Assessment, International Journal for Pharmaceutical Research Scholars (IJPRS), 6(1), 76-89.