Zydus Cadila submits additional data to DCGI: Sources
Jul 27, 2021
New Delhi [India], July 27 : Ahmedabad-based Zydus Cadila has submitted additional data related to immunogenicity and safety to India's drug regulator Drugs Controller General of India (DCGI), as per sources.
Earlier the drug regulator had asked the Ahmedabad-based pharma company to come back with more data, the sources informed ANI earlier.
DCGI will consider giving emergency use authorisation (EUA) after review of data recommended in the meeting of regulator's Subject Expert Committee (SEC). If data is found to be satisfied then final approval from DCGI may be granted in August.
Previously, the sources had told ANI that a continuous and rolling review of data was being undertaken and final approval would take a few more days.
Zydus Cadila had on July 1, requested emergency use approval for ZyCoV-D, its three-dose COVID shot - the world's first Plasmid DNA vaccine. If approved it will be the country's second indigenous vaccine after Bharat Biotech's Covaxin.
