GDUFA is a law enacted by the US Food and Drug Administration (FDA), intended to accelerate access to safe and effective generic drugs. Fees required under  GDUFA are used to help FDA perform its regulatory functions and enhance the timeliness of generic drug application reviews. Congress first enacted GDUFA in 2012, in 2017 it was reauthorized up until September 2022.

Importantly, GDUFA applies to all firms that manufacture generic drugs distributed in the US, even if the manufacturer is not itself located in the US.

A study recently published in the Journal of Applied Pharmaceutical Science assessed the influence of GDUFA on generics manufacturers in India, the world’s third largest pharmaceutical industry (in terms of volume) and one of the top five drug suppliers to the US.

The paper suggests GDUFA has had a critical influence on the structure and growth of the Indian pharmaceutical industry. Indian drug manufacturers have had significant numbers of abbreviated new drug applications (ANDAs) approved, making India the major FDA-accepted overseas generic drug producer.

To investigate the influence of GDUFA in greater depth, questionnaires were given to 250 randomly selected employees of generics manufacturers in India. The questionnaire focused on the benefits of GDUFA, challenges of implementation, and its overall impact on return on investment (ROI).

The article discusses various beneficial impacts of GDUFA in India, including increasing ANDA filings; ensuring high quality standards; increasing the number of facility inspections and increasing the credibility of Indian pharmaceutical firms.

The paper concludes that the benefits of GDUFA for Indian generics manufacturers are greater than the challenges. It suggests that GDUFA has helped to increase generic drug manufacturing and export, and consequently provided a financial boost to the Indian pharmaceutical industry. The article also suggests that GDUFA has helped to bring Indian pharmaceutical firms in line with US regulation on drug manufacturing, which has improved their performance.

The author of the study closes with a number of recommendations for the Indian pharmaceutical industry, including to continue increasing the rate of generic drug export, maintain compliance with FDA regulations and to raise awareness of the importance of GDUFA and its strategic objectives.

Conflict of interest
The author of the research paper [1] declares no competing interests.

Related articles
India tightens regulation on generics manufacturers

FDA significantly increases generic user fees in 2019

FDA to speed up review of priority generics

Reference
1. Pardhe S. A descriptive cross-sectional study to evaluate the Generic Drug User Fee Act: a boon or loss to the Indian generic pharmaceutical industry. J Appl Pharm Sci. 2019;9(2):44-51.

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