The past few days have seen a lot of activity from companies who are part of the vaccine race in India. First, Pfizer applied for emergency use authorisation (EUA) of its vaccine candidate. Then it was the turn of Pune-based Serum Institute of India, whose CEO Adar Poonawalla tweeted on Monday that his company, too, had applied for EUA for Covishield, the Oxford-AstraZeneca vaccine candidate. Hyderabad-based Bharat Biotech International, which is developing Covaxin, the country’s first indigenous Covid-19 vaccine in partnership with the Indian Council of Medical Research (ICMR), has also applied for an EUA.

All eyes are now on the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, which has to take a call on the matter.

But what exactly is an EUA? Emergency use authorisation is a term which comes under the U.S. Food and Drug Administration's (USFDA's) medical countermeasures or MCMs. These are USFDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency.

This was the American emergency preparedness to counter terrorism and emerging threats under the Project Bioshield Act of 2004. Since then, the law has been further strengthened. The USFDA, in 2013, set up the Global Coalition for Regulatory Science Research to meet with the changing nature of regulation. The panel uses advanced data analytics and scientific risk prediction with the use of artificial intelligence. Till date, the USFDA has approved more than 121 MCMs since 2012, and has issued more than 200 EUAs since 2005.

The Indian regulator, though, has a tough task ahead. Amit Dinda, professor at the department of pathology, All India Institute for Medical Sciences, and an executive council member at the Global Coalition for Regulatory Science Research, says that except for Covaxin by Bharat Biotech, which uses an attenuated virus vaccine, it would take time for new technology platforms to get an approval for EUA. The Indian regulator, according to Dinda, would wait till the company applies for approval in a regulated market and receives it.

Once the vaccine is approved in a regulated country and data is submitted to the USFDA or the Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K., the Indian regulator will use the certificate received by the company from that country, examine the data, and endorse it.

In a chat with Fortune India, Dinda explains the process flow for a vaccine to get approval, and whether the Indian regulator is prepared for such approvals. Edited excerpts:

Global Coalition for Regulatory Science Research

Vaccines: The road to an emergency nod