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April 17, 2024
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Covid19 | India’s DCGI Exempts Post-Approval Bridging Trial For Foreign Made Vaccines

In a new boost to India’s vaccination drive against Covid-19, foreign jabs approved by specific countries and WHO for emergency use will not need bridging trials in India, the Drug Controller General of India (DCGI) said on Wednesday.

The move will fast-track the import of doses needed to bolster vaccinations as well as clear the way for the entry of vaccines such as Pfizer and Moderna, who had requested the government for waivers like indemnity and post-approval local trials.

The exemption will, however, be limited to COVID-19 vaccines approved in India for restricted use in an emergency situation which is already approved for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or listed in WHO Emergency Use Listing (EUL) and has been already in use to inoculate masses in various countries.

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