The Indian regulatory environment: a historical perspective


The regulatory system for the biopharma industry in India has been many decades in the making. This chapter discusses the inception of the regulatory system post-World War I, much of it implemented in an ad hoc manner and the beginnings of a comprehensive drug policy which culminated in the Drugs and Cosmetics Act, 1940. This act is still in force today, although it has been amended from time to time. As the biopharma industry has expanded, the regulatory framework has also widened its scope, with the addition of several new legislations and regulatory bodies. The industry has received a massive boost during the post-liberalisation period of the Indian economy in the 1990s, ...

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