India’s drug regulator to take a decision to grant Emergency Use Authorization (EUA) of Covid-19 vaccines within three working days of receiving the applications from the candidates, the union health ministry informed on Thursday.
The decision is a part of the fast track approval policy of the government for the foreign Covid-19 vaccine candidates in the country.The vaccines that would be eligible for the fast-track approval will include those that have been granted a EUA by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or those that have been pre-qualified by the WHO for emergency use.
However, the ministry said that the DCGI will grant EUA, inter alia, certain conditions:
a) Vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme.
b) First 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further Vaccination program.
c) Applicant shall initiate conduct of post-approval bridging clinical trials within 30 days of such approval.