No bridge trials required in India for imported COVID vaccines

The Drugs Controller General of India in a notification has said that vaccines which have been approved for restricted use by US FDA, EMA, UK MHRA and PMDA Japan and under the WHO Emergency Use Listing (EUL) and where millions of individuals have been vaccinated, the requirement of conducting post approval clinical trials and the requirement of testing every batch of the vaccine by Central Drugs Laboratory (CDL), Kasauli can be exempted if the vaccine batch has been certified and released by National Control Laboratory of country of origin.