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

ABSTRACT

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