India – India lowers bar for approval of COVID-19 vaccines already authorized overseas

India’s Central Drugs Standard Control Organization (CDSCO) has relaxed the requirements for the restricted-use emergency authorization of COVID-19 vaccines that are already on the market in some overseas territories.

The change exempts developers of certain COVID-19 vaccines from the need to run post-approval bridging clinical trials and for every batch to undergo testing at the Central Drugs Laboratory at a site in Kasauli. CDSCO is granting the exemption to vaccines that are already approved for emergency use in the US, EU, UK or Japan, or are part of the World Health Organization’s emergency use listing and have been given to millions of people in those territories.

CDSCO relaxed the requirements for products cleared for use by those authorities because of the “huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines to meet the national requirements.”…