A comparative study of regulatory trends of pharmaceuticals in Brazil, Russia, India and China (BRIC) countries

摘要

BRIC basically include the emerging markets of Brazil, Russia, India and China. The growth of pharmaceutical market in these countries has been very eye-popping during the last two decades. The growth of pharmaceutical market depends upon the drug regulatory system and drug regulatory laws. The drug regulatory system in these countries is on the way of continuous improvement e.g. introduction of product patent in India, provisions for drug approval in China, bioequivalence testing requirement in Brazil, Russian new law on circulation of medicines 2010. In this article the drug regulatory system of BRIC countries has been analyzed. These drug regulatory trends include following: drug regulatory framework, drug regulatory laws, clinical trials, drug registration procedures, drug pricing mechanism, GMP practices, pharmacovigilance, patents system on pharmaceuticals, patent linkage and data protection, etc. Drug regulatory framework has been analyzed by studying the composition of various central and state drug regulatory authorities and drug testing institutions regulating the pharmaceutical industry. The basic drug regulatory laws regulating approval, manufacturing, packing, labeling, selling, advertising, use of drugs, cosmetics and medical devices has been reported. The drug pricing mechanism over the essential and nonessential drugs and drug price calculation formula has been reported. The drug manufacturing law, manufacturing approval and inspection system has also been analyzed. The pharmacovigilance system for the reporting of Adverse Drug Reactions in these countries has been studied. Finally an analysis of the intellectual property rights related to pharmaceuticals has been made in BRIC countries.