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Bharat Biotech seeks DCGI nod to extend Covaxin shelf life to 24 months

April 26, 2021 11:37 AM

Bharat Biotech seeks DCGI nod to extend Covaxin shelf life to 24 months
DCGI approval from the Drug Regulatory Authority of India to extend the shelf life of Corona vaccine Kovaggin, manufactured by India Bharat Biotech.

The company has sought DCGI approval from the Drug Regulatory Authority of India to extend the shelf life of Corona vaccine Kovaggin, manufactured by India Bharat Biotech. Credible sources informed that it has been sought to increase the period from the current 6 months to 24 months.

DCGI has given permission to Hyderabad-based Bharat Biotech to sell and distribute covagin stored at 2-8 degrees Celsius for six months from the date of manufacture. The company said in a letter to DCGI that it wants to increase the shelf life of Covaxin from 6 months to 24 months.

Deeply concerned by severe COVID outbreak in India, working to deploy more supplies: USCoronavirus crisis: Maharashtra to vaccinate its citizens for free. In support of this proposal, it appears that the latest accelerated, real-time stability data related to Kovacgin has been submitted.

Also Read: We will provide the necessary assistance to India: US President Joe Biden

Bharat Biotech has reportedly written to the Drugs Controller General of India (DCGI) to extend the shelf life of its COVID-19 vaccine Covaxin. Originally the shelf life of the vaccine was determined to be six months when stored at 2-8 degrees Celsius.

“Now, we are herewith applying for the extension of shelf life from six months to 24 months when stored at 2-8 degrees Celsius,” news agency PTI cited the firm’s application to the drugs regulator. The Hyderabad-based vaccine manufacturer has submitted updated accelerated and real-time stability data of Coaxin along with the justification for the extension of shelf life.

Covaxin has been developed jointly by Bharat Biotech, Indian Council of Medical Research and the National Institute of Virology (NIV). The inoculation is based on the coronavirus sample isolated by the NIV. It also is the first indigenous vaccine against coronavirus.

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