Expanded Access and Emergency Use Authorization: COVID-19 Indian scenario

Author Balaji More
Co-Author Anju More
DOI https://ww

Country : India
Subject : Pharmacology

Keywords : Emergency use, repurposing of drugs, biotherapeutics, drug approval, drug review process.

Abstract

Globally, the development, review, and approval process of novel medicinal products is a time consuming and costly affair. The new drug has to face several reviews and scrutiny before it receives the marketing authorization from the regulator. However, few situations such as pandemics, serious life-threatening conditions necessitate expanded access and shortening the review process with emergency use authorisation. The present article identifies the salient features, reforms and gaps in regulatory approval process for new therapies during emergency situation in India. Some reforms and mechanisms introduced to overcome the associated hurdles and intricacies have been highlighted so as to enable access to the newer therapeutics. A narrative analysis of published regulatory data available in the public domain was carried out to comprehend the regulatory provision for expanded access and restricted use of drug in emergency situation in India. The various challenges and mechanisms to address them were identified. The documents reviewed were related peer-reviewed publications, conference proceedings, book chapters, press release, official communications and notifications by regulatory bodies, official reports and guidelines from the regulatory authority. This review was carried out based on the literature search, data and information in public domain on the internet. Very few articles describe regularity approval process with clarity, in addition to bringing to light the problems and challenges faced by different stake holders. In light of the current COVID-19 pandemic various regulatory reforms have been made to provide solutions for the problems and challenges identified. The findings suggest the several reforms are happening in the regulatory environment to expedite the review and approval process of investigational drugs in emergency situation. Newer guidelines and rules have been formulated to simply and expedite the process for various stakes holders. However, there is still scope to identify opportunities for significant improvements to the regulatory review and approval process.

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