Home >Current Issue
Volume: 9, Issue: 2, February, 2019
A descriptive cross-sectional study to evaluate the Generic Drug User Fee Act: A boon or loss to the Indian generic pharmaceutical industryAuthor 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.
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.
Coates M. Industry and FDA overview on GDUFA: Where have we been, where are we now and what is next? 2015 [Online]. Available via https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees ucm318042.htm (Accessed 5 November 2015).
Cohen L, Manion L, Morrison K. Strategies for data collection and researching: Questionnaire. In: Research methods in education. 6th edition. Routledge, Abingdon, United Kingdom, pp 317–46, 2007. https://doi.org/10.4324/9780203029053
Dong K, Boehm G, Zheng Q. Economic impacts of the generic drug user fee act fee structure. Value in health. J Int Soc Pharm Outcomes Res, 2017; 20:792–8.
FDA. Generic drug user fee amendments: GDUFA legislation. 2015 [Online]. Available via https://www.fda.gov/forindustry/userfees/genericdruguserfees/ucm337385.htm (Accessed 20 October 2017).
Gaugh D. GDUFA Past and present. 2015 [Online]. Availablevia http://www.gphaonline.org/media/cms/GDUFA_Public_Meeting_PPT_6.15.15.pdf (Accessed 07 January 2016).
Glessner M. GDUFA's impact on the API industry –an update. 2014 [Online]. Available via http://www.chemanager-online.com (Accessed 10 December 2017).
Gummerus A, Airaksinen M, Bengtström M, Juppo A.Outsourcing of regulatory affairs tasks in pharmaceutical companies—Why and what? J Pharm Innov, 2016; 11:46–52. https://doi.org/10.1007/s12247-015-9235-4
IBEF. Pharmaceuticals. 2017 [Online]. Available via https://www.ibef.org/download/Pharmaceutical January-2017-D.PDF (Accessed
Khan AN, Khar RK. Current scenario of spurious and substandard medicines in India: a systematic review. Indian J Pharm Sci, 2015; 77:2–7. https://doi.org/10.4103/0250-474X.151550
Kotabe M, Kothari T. Emerging market multinational companies evolutionary paths to building a competitive advantage from emerging markets to developed countries. J World Business, 2016; 51:729–43. https://doi.org/10.1016/j.jwb.2016.07.010
Kulkarni N. Warning letters and Indian pharma. 2017 [Online]. Available via https://www.biospectrumindia.com/features/69/9283/warning-letters-and-indian-pharma.html (Accessed 11 February 2018).
Mahajan R, Bidkar N. Managing growth through better compliance management: a survey report. 2015 [Online]. Available via https://www2.deloitte.com/content/dam/Deloitte/in/Documents/finance/infa-pharma-survey report-noexp.pdf (Accessed 8 March 2016).
Patel D. The resurgence of pharma sector in India. Express Pharma News, 2017; 13:35–9.
Saini M, Tripathy S, Dureja H. USA FDA's implementation of QbD and GDUFA: a wakeup call for other regulatory agencies across the globe. J Med Market, 2014; 14:108–14. https://doi.org/10.1177/1745790414564259
Woodcock J. Implementation of the generic drug user fee amendments of 2012 (GDUFA). 2016 [Online]. Available via https://www. fda.gov/newsevents/testimony/ucm484304.htm (Accessed 15 January 2016).