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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.

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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 was analyzed using SPSS 21.0 version where descriptive and inferential analysis was performed. Key findings noted are, the benefits of GDUFA were greater than the challenges to the Indian pharmaceutical industry. 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 Return on investments (ROI) for the Indian pharmaceutical industry had increased. It is inferred that the GDUFA has compelled the pharmaceutical industry of India to be in compliance with the United States Food Drug Administration (USFDA) all the time. Nevertheless, India remains one of the key exporters of generic drugs for the USA. Fundamentally, the GDUFA has displayed an encouraging influence on the Indian Pharma sector.

Key words: GDUFA, Indian Pharma Industry, Benefits, Challenges, Economic Impact, Generic Drug

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