Bharat Biotech seeks DCGI’s nod to extend shelf life of Covaxin

Bharat Biotech seeks DCGI’s nod to extend shelf life of Covaxin [ad_1]

Bharat Biotech has written to the India’s drug regulator in search of extension of the shelf-life of its indigenously developed COVID-19 vaccine Covaxin from six to 24 months, sources stated on Sunday. Covaxin, together with Covishield manufactured by Serum Institute of India, are the 2 vaccines to date being utilized in India’s present COVID-19 vaccination drive. Russian vaccine Sputnik-V has additionally been accepted for emergency use in India.

The Hyderabad-based Bharat Biotech was given permission on the market and distribution of Covaxin with shelf life of six months when saved at two to eight levels Celsius.

“Now, we are herewith applying for the extension of shelf life from six months to 24 months when stored at 2-8 degreesCelsius,” the agency stated in its software to the Drugs Controller General of India.

In help of their proposal, Bharat Biotech has submitted up to date accelerated and real-time stability knowledge of Coaxin together with the justification for the extension of shelf-life.

The DCGI had prolonged the shelf-life of Covishield from six to 9 months from its manufacturing date in February.

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