New Delhi: Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), commonly known as the 2019 novel coronavirus was first reported from Wuhan, China in December 2019. The impact of the resulting disease, COVID-19, was enormous and by January 2020, the World Health Organization had declared it as a public health emergency of international concern (PHEIC). Deeply concerned both by the alarming levels of spread and severity, WHO declared it as a pandemic in March 2020.
The Department of Biotechnology (DBT), Ministry of Science & Technology has been proactively working on the development of Diagnostics, Therapeutics, Drugs and Vaccines to combat the healthcare challenges posed by COVID-19. DBT has also taken several measures to facilitate research-driven and technology-based interventions, on a fast-track mode. As a paramount effort to stimulate and facilitate research and development activity towards combating COVID-19, DBT has evolved a set of Rapid Response Regulatory Frameworks in the form of following notifications:
Rapid response regulatory framework for COVID-19 to deal with applications for the development of vaccines, diagnostics, prophylactic, and therapeutics dated 20th March 2020 for fast track review and approval of applications.
Interim guidance document on laboratory biosafety to handle COVID-19 specimens for R&D purposes dated 8th April 2020.
Rapid Response Regulatory Framework for COVID-19 Vaccine development; Checklist for application to conduct pre-clinical toxicity (PCT) studies for a recombinant vaccine for COVID-19 dated 26th May 2020.