Foreign Jabs Approved By Specific Countries Exempted From Bridging Trials In India
NDTV
Foreign Covid vaccines approved by specific countries and WHO for emergency use will not need bridging trials in India, the Drug Controller General of India (DCGI) has said in an attempt to fast-track the import of doses needed to bolster vaccinations.
This will clear the way for the entry of vaccines like Pfizer and Moderna, who had requested the government for waivers like indemnity and for post-approval local trials.
The DCGI says it has waived the requirement for foreign companies to carry out post-launch bridging trials and test the quality and stability of their vaccines in India if they have approvals from specific countries or health bodies.
The DCGI chief, VG Somani, has said in a letter that the decision was taken "in the light 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".
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