DBT facilitates rapid response regulatory enabling mechanism for COVID-19

Aims to streamline and ease development of vaccines, diagnostics, prophylactics and therapeutics
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The Department of Biotechnology (DBT) has given out information on the various measures taken to streamline the biosafety regulation and to facilitate researchers and industries which are undertaking research and development in recombinant DNA technology and hazardous microorganisms. It includes:

  1. Operationalisation of Indian Biosafety Knowledge Portal: The Indian Knowledge Biosafety Portal launched in May 2019 was made fully operationalised and now the Department is receiving all new applications through online portal only. This has made the whole process transparent and time-bound.
  2. Notification of Revised Simplified Guidelines on Import, Export and Exchange of GE Organisms and Product thereof for R&D purpose: The Department issued the Revised Guidelines in January 2020 in which Institutional Biosafety Committee has been delegated authority to take decisions on applications of import-export and exchange of GE organisms and product thereof for R&D purpose for RG1 and RG2 items.
  3. Facilitation of R&D on COVID-19: Considering the emerging situations of the spread of coronavirus and with the understanding on the requirement of rapid research and development for COVID-19, the Department has taken several steps to facilitate researchers and industries involved in research on COVID19.

DBT has issued following guidelines, orders and checklist on COVID 19:

  1. Rapid Response Regulatory Framework for COVID-19 to deal with the application for the development of vaccines, diagnostics, prophylactics and therapeutics has been notified on March 20, 2020
  2. DBT notified ‘Interim Guidance Document on Laboratory Biosafety to Handle COVID-19 Specimens’ on April 8, 2020.
  3. IBSCs are allowed to conduct their meeting through video conferencing up to June 30, 2020.
  4. Rapid response regulatory framework for the development of recombinant DNA COVID 19 vaccine was issued on May 26, 2020.
COVID-19DBTDepartment of Biotechnologyhazardous microorganismsIndian Biosafety Knowledge PortalR&DRapid Response Regulatory Framework
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