A REVIEW OF INFLUENCE OF THE GENERIC DRUG USER FEES ACT UPON THE EXPORT FROM THE INDIAN PHARMACEUTICAL INDUSTRY Sarika Prasanna Pardhe *

Abstract

The review article evaluates the influence of the Generic Drug User Fee Act (GDUFA) on the Indian pharmaceutical industry. The GDUFA come into existence in Oct 2012. The GDUFA enables the US citizen to access safe, effective, and cost-effective generic drugs. Due to the GDUFA fees structure and other significant modifications, it is vital to understand its imprint on the various facets of Indian generic business. On the inception of the GDUFA, the Indian generic market has increased significantly in terms of both value and volume. It was observed that during the Post-GDUFA epoch, the pharmaceutical export was not influenced. The overall US Pharmaceuticals export contribution in the total revenue has illustrated an upward trend. Also, the % market share (value) of the domestic generic performers in the US generic marketplace indicates the positive growth. Bulk drug export shows a sliding trend, whereas the formulation export demonstrates in a growing manner. Hence, in summary, it can be concluded that the GDUFA has not squeezed the overall revenue growth of Indian Pharma business. The Indian pharmaceutical industry has played an enormous role to boost the Country’s economy, moreover, it has also created the employment opportunities.