A COMPREHENSIVE COMPARATIVE ANALYSIS OF EMERGENCY USE AUTHORIZATION FRAMEWORKS: INDIA'S CDSCO AND THE U.S. USFDA

Dr. Ashok Kumar P.*, Sushmitha R., Abhishek G. R., Pavan B. Mylapur, Harshitha H. P., Emran Bhasha S.

ABSTRACT

The global response to public health emergencies necessitates agile regulatory pathways for medical products. This article presents a comparative study of the Emergency Use Authorization (EUA) frameworks of India's Central Drugs Standard Control Organization (CDSCO) and the U.S. Food and Drug Administration (USFDA), two of the world's most influential regulatory bodies. The research dissects their legal frameworks, procedural flows, data requirements, and post-authorization surveillance, focusing on their application during the COVID-19 pandemic. The analysis reveals that while both agencies utilize a risk-benefit assessment, key differences emerge in their statutory origins, transparency, and data standards. The USFDA's pathway is rooted in a well-defined legal statute with a public, data-driven review, while the CDSCO's process is more adaptable and context-specific. The findings underscore that no single model is universally superior; each has strengths embedded in its legal and administrative landscape. This analysis serves as a foundation for a discussion on global best practices and concludes with a series of recommendations for strengthening these pathways and enhancing global preparedness for future health crises.

Keywords: EUA, CDSCO, USFDA, COVID-19.