Govt fast-tracks regulatory approvals to fight COVID -19

In order to accelerate research and development pertaining to COVID-19, the Review Committee on Genetic Manipulation (RCGM) functioning in DBT has processed/considered more than 100 applications till date, on a fast-track mode

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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.
In order to accelerate research and development pertaining to COVID-19, the Review Committee on Genetic Manipulation (RCGM) functioning in DBT has processed/considered more than 100 applications till date, on a fast-track mode. These include applications received from various Institutes, Universities and Industries on import, export, transfer, receipt of COVID-19 clinical specimens/SARS-CoV2 isolates/process intermediates, undertake research for the development of COVID-19 prophylactics, therapeutics or diagnostic platforms.