In a massive announcement, Bharat Biotech confirmed that the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of the shelf-life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf-life extension was based on the availability of additional stability data, which was submitted to CDSCO.
Earlier in April of this year, Bharat Biotech had written to India’s drug regulator seeking an extension of the shelf-life of its indigenously developed Covid-19 vaccine Covaxin from six to 24 months.
The Hyderabad-based Bharat Biotech was given permission for the sale and distribution of Covaxin with a shelf-life of six months when stored at two to eight degrees 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 firm had said in its application to the Drugs Controller General of India.
Also Read: Bharat Biotech Seeks DCGI’s Nod to Extend Shelf Life of Covaxin from Six to 24 Months
In support of their proposal, Bharat Biotech had also submitted the updated accelerated and real-time stability data of Coaxin along with the justification for the extension of shelf-life. The DCGI had extended the shelf-life of Covishield from six to nine months from its manufacturing date in February which has now further been extended to 12 months.
Covaxin, along with Covishield manufactured by Serum Institute of India, are the two vaccines so far being used in India’s current Covid-19 vaccination drive. Russian vaccine Sputnik-V has also been approved for emergency use in India.
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