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Decision On Emergency Use Applications For Foreign Covid Vaccines In 3 Days

Decision On Emergency Use Applications For Foreign Covid Vaccines In 3 Days

NDTV
Thursday, April 15, 2021 12:14:32 PM UTC

The moves comes at a time when India is battling a surge in COVID-19 cases with over two lakh cases reported in a single day on Thursday, taking the total number of cases to 1,40,74,564.

India's drug regulator will take a decision on applications seeking approval for restricted  emergency use of foreign produced COVID-19 vaccines within three working days from the date of submission, the government said on Thursday. The moves comes at a time when India is battling a surge in COVID-19 cases with over two lakh cases reported in a single day on Thursday, taking the total number of cases to 1,40,74,564. The Central Drugs Standard Control Organisation (CDSCO), which is headed by the Drug Controller General of India (DCGI), will process applications for registration certificate (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 has 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.
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