DGCI will review applications for full market approval of Covaxin and Covishield
New Delhi, January 14, 2022:
The Subject Experts Committee, led by India’s Drug Controller General (DCGI), will consider applying for Bharat Biotech and SII on Friday for full market approval for Covaxin and Cobishield.
The move comes after Hyderabad-based Bharat Biotech announced Thursday that its proprietary Covid-19 vaccine, Coavaxin, is now a universal vaccine for adults and children.
In an application submitted to the Indian Drug Controller General (DCGI) this week, V Krishna Mohan, full-time director of a Hyderabad-based company, provided complete information on chemistry, manufacturing and management with preclinical and clinical data. I submitted it with. We are seeking regular market approval for Kovacin.
Previously, the manufacturer claimed that the Covid vaccine covaxin could neutralize both the delta and omicron variants of the coronavirus.
The Serum Institute of India has already filed a similar plea against Cobishield, and both applications will be reviewed by the Subject Expert Committee (SEC) of the Directorate General of Pharmaceutical Management (DCGI) of India. ET Health World