COVID-19: Big relief for foreign vaccine makers as DCGI exempts post-approval bridging trials

Cipla, which has been looking to commit USD 1 billion into bringing Moderna's single-dose mRNA booster vaccine to India, also requested an exemption.

In a big relief, the Drugs Controller General of India (DCGI) on Tuesday said that foreign COVID-19 vaccines approved by specific countries and World Health Organisation (WHO) for emergency use will not require bridging trials in India. Similar demands have been raised by foreign companies like Pfizer and Cipla for some time.

The move by DCGI 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.

Cipla, which has been looking to commit USD 1 billion into bringing Moderna’s single-dose mRNA booster vaccine to India, had also requested an exemption from bridging trials in India.

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