Foreign vaccines don't need to conduct bridging trials for approval: DCGI
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New Delhi: In a bid to speed up the vaccination process in the country, the Drug Controller General of India informed that foreign vaccines would no longer need to conduct India-specific trials.
As recommended by the National Expert Group on Vaccine Administration for COVID-19 or NEGVAC, foreign vaccines approved by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL) shall no longer need bridging trials in India given that millions worldwide have already received it.
The testing of every batch of the vaccine by the Central Drugs Laboratory can also be avoided if the vaccines are certified and released by the National Control Laboratory of Country of origin, DCGI chief VG Somani informed.
The move was taken considering the huge vaccination requirements and the need for increased imported vaccines in the ongoing fight against the second wave of COVID-19. Currently, the Serum Institute of India's Covishield, Bharat Biotech's Covaxin and Russia's Sputnik V are approved for use in India.
Foreign vaccine companies Pfizer and Moderna had earlier requested waivers for indemnity and post-approval trials. The government, however, hasn't yet waived indemnity or compensation for severe side effects.