Approved foreign vax don't need trials in India

June 02, 2021 10:31

The Drug Controller General of India (DCGI), India's drug regulator, has done away with the requirement of India-specific trials for foreign vaccines. Foreign vaccines approved by other countries and WHO for emergency use will no longer need bridging trials in India. This move will in effect, fast-track the import of doses needed to bolster vaccinations.

Pfizer and Moderna were among the companies that had requested the government for waivers like indemnity and for post-approval local trials. The government has yet to take a decision on indemnity or liability from compensation for any severe side effects.

A DCGI letter says it has waived the requirement for foreign companies to carry out "post-launch bridging trials" and to test the quality and stability of their vaccines in India if they have approvals from specific countries or health bodies.

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