Abstract

DRUG APPROVAL PROCESS – AN INDIAN SECNARIO COMPARED TO ITS COUNTERPARTS

Dornala Chaitanya Dixit* and J. Teja

ABSTRACT

Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on history, regulatory policy and administration, and related issues with respect to different countries like U.S.A , Brazil, Japan, Australiaand India.

Keywords: USFDA, TGA, ANVISA, PMDA, CDSCO Clinical trials, Approval stages.