Covid-19 Vaccine: Decision On Applications For Foreign Jabs' Emergency Use To Be Taken In 3 Days

The government expedited the process of EUA of foreign-made Coronavirus vaccines to increase the availability of shots as several states reported shortage amid the second and more severe wave of the pandemic.

New Delhi: The Union government on Thursday announced that India's drug regulator Central Drugs Standard Control Organisation (CDSCO) will decide upon applications seeking restricted emergency use authorisation of foreign-produced vaccines in a matter of three working days from the date of submission.

Central Drugs Standard Control Organisation (CDSCO) will process applications for registration certificates (registration of overseas manufacturing site and Covid vaccine) and have the license imported within three working days from the date of emergency use authorisation (EUA).

The detailed guidelines were issued by CDSCO elaborating the regulatory route for approval of Covid-19 vaccines being administered in other countries, as the Indian government on Tuesday decided to fast-track emergency authorisation for coronavirus shots that been approved by the WHO or regulators in Europe, Britain, United States, or Japan.

This means that the fast-tracking for Covid-19 vaccines will bring jabs approved by the US FDA, EMA, UK MHRA, PMDA Japan, or which are listed in WHO Emergency Use Listing (EUL).

This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity, which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country, the Union Health Ministry had stated. 

The government expedited the process of EUA of foreign-made vaccines to increase the availability of shots as several states reported shortage amid the second and more severe wave of the pandemic being witnessed in the country.

(With Agency Inputs)