Snapshot

The COVID-19 vaccine approval in India for restricted use in emergency situation pathway has been developed by the of India.

This pathway can be used where COVID-19 vaccines.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA Japan United Kingdom United States WHO

CDSCO will process applications for Restricted Use in Emergency Situation on highest priority through expedited review/accelerated approval process as per provisions of New Drugs and Clinical Trial Rules, 2019 and DCG(I) will consider and take a decision within 3 working days from date of submission of complete application by the applicant. After approval of Restricted Use in Emergency situation, CDSCO will process applications for Registration Certificate (registration of overseas manufacturing site) and product (in this case COVID-19 vaccine) and Import License, within 3 working days from the date of approval of Restricted Use in Emergency Situation.