Implications of Drug Price Competition and Patent Term Restoration Act (DPCPTRA) on Indian Pharma Industry.

The article focuses on the impact of the Drug Price Competition and Patent Term Restoration Act (DPCPTRA) in the pharmaceutical industry of India. The provision of the Act entails the simplification of U.S. Food and Drug Administration (FDA) approval process for generic drugs via Abbreviated New Drug Applications (ANDAs). The Act modifies the Patent Act of 1952 as it provides incentives to innovators and generic companies through patent extension based on 180-day exclusivity to generic firms.