NEW DELHI: Keeping in mind the alarming situation arising due to the increasing number of people affected by coronavirus, the Centre has allowed fast-tracking of regulatory approvals for the development of vaccines, diagnostics, prophylactics and therapeutics for the virus.
Under the Rapid Response Regulatory Framework for COVID -19 to deal with applications regarding the same, the Review Committee on Genetic Manipulation (RCGM) will now approve the application fulfilling all criteria within seven days from the receipt of applications for import and exchange.
The Drug Controller General of Indian (DCGI) and RCGM, take around 35-40 day for similar approvals.
“Taking into account the rapid response of COVID 19 in various countries and the need for immediate research and product development, it has been decided to fat track the regulatory approval process in consultation with the DCGI to deal with the application for the development of vaccines, diagnostics, prophylactics and therapeutics for COVID-19,” according to an office memorandum signed by Nitin K Jain, Member Secretary, RCGM.
The Centre has also constituted an empowered committee of RCGM and the CDSCO (Central Drug Standard Control Organisation) has been constituted to examine the application and to recommend the application for approval as per agreed time frame.
Under the framework, permission for initiating research will be also be given within seven day while for the examination of physicochemical and molecular characterisation data, approval of animal toxicity protocol and clinical trials within 10 days after the submission of data.
The test licence to manufacturers/ noc will be provided within 10 days from receipt of application.
Meanwhile, the Technology Development Board has invited applications from Indian companies and enterprises to address protection and home-based respiratory intervention for COVID-19 patients.