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Volume: 9, Issue: 2, February, 2019
DOI: 10.7324/JAPS.2019.90206

Research Article

A descriptive cross-sectional study to evaluate the Generic Drug User Fee Act: A boon or loss to the Indian generic pharmaceutical industry

Sarika Prasanna Pardhe

  Author Affiliations


This study embraces the Generic Drug User Fee Act (GDUFA) implication on the Indian generic pharmaceutical industry based on the primary analysis. A sample size of randomly selected 250 employees from the generic industry of India, were the study participants and were provided with a close-ended questionnaire. The survey response is subjected to both descriptive and inferential analyses using the SPSS version 21.0 package. The benefits of GDUFA were greater than the challenges to the Indian pharmaceutical industry are the key findings noted in this study. It was further found that the different challenges faced due to the GDUFA did not alter the attention of the Indian generic industry to the other market significantly. Correspondingly, the statistical outcomes of the respondent’s viewpoints implied that the overall impact of the GDUFA on the return on investments for the Indian pharmaceutical industry was increased. It is inferred that the GDUFA has compelled the pharmaceutical industry of India to be in compliance with the United States Food and Drug Administration all the time. Nevertheless, India remains one of the key exporters of generic drugs for the United States. Fundamentally, the GDUFA has displayed an encouraging influence on the Indian pharma sector.


GDUFA, Indian pharma industry, benefits, challenges, economic impact, generic drug.

Citation: Sarika PP. A descriptive cross-sectional study to evaluate the generic drug user fees act: A boon or loss to the Indian generic pharmaceutical industry. J Appl Pharm Sci, 2019; 9(02):044–051.

Copyright: The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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