Emergency Approval Mechanisms for Human Vaccines in India.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic highlighted the world's level of preparedness in managing public health emergencies (PHEs). It revealed the critical need for timely medical therapeutics, especially vaccines. To expedite response, many nations, including India, adopted emergency approval mechanisms and offered new ways of review, such as the rolling review along with the accelerated review procedure. This response resulted in reallocating internal resources and adopting new policies and measures, such as integrating digital technology with regulatory submissions and flexibility in statistical approaches. The present review focuses on the utilization of the New Drugs and Clinical Trials Rules 2019 for granting emergency approval to COVID-19 vaccines by the Drug Controller General of India (DCGI) and explores the legislative basis for such authorization during the PHE. The review aims to elucidate key intricacies and challenges inherent in the existing 'emergency use' framework within the Indian regulatory landscape. It assesses three critical facets of the 'emergency use' paradigm: the definition of the term, establishment of a transparent decision-making process, and formulation of rules governing termination or expiration of the emergency status. It makes policy recommendations regarding the 'emergency use' framework to respond to new, emerging, or re-emerging public health threats of the future.