Foreign produced COVID-19 vaccines: Decision on emergency use applications to be taken in 3 days

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April 15, 2021 3:54 PM

The Central Drug Authority, CDSCO, will process applications for registration certificates (registration of overseas manufacturing site and product; in this case COVID vaccine) and import license within three working days from the date of approval of restricted use in emergency situation.

The Union Health Ministry on Thursday issued regulatory pathways for foreign produced COVID-19 vaccinesThe Union Health Ministry on Thursday issued regulatory pathways for foreign produced COVID-19 vaccines

India’s drug regulator will take a decision on applications seeking approval for restricted emergency use of foreign produced vaccines within three working days from the date of submission, the government said on Thursday.

The Central Drug Authority, CDSCO, will process applications for registration certificates (registration of overseas manufacturing site and product; in this case COVID vaccine) and import license within three working days from the date of approval of restricted use in emergency situation.

The CDSCO issued detailed guidelines specifying regulatory pathway for approval of foreign approved COVID-19 vaccines after the central government on Tuesday decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the WHO or regulators in the United States, Europe, Britain or Japan.
The Union Health Ministry on Thursday issued regulatory pathways for foreign produced COVID-19 vaccines according to which the CDSCO has prepared detailed guidelines specifying regulatory pathway for approval of foreign approved COVID-19 vaccines.

The government had on April 13 approved streamlining and fast tracking of regulatory system for COVID-19 vaccines approved for restricted use 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 ministry said.

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