This approval of shelf-life extension was based on the availability of additional stability data, which was submitted to CDSCO
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 was stated by Bharat Biotech in an announcement.
This approval of shelf-life extension was based on the availability of additional stability data, which was submitted to CDSCO.
The Hyderabad-based Bharat Biotech was permitted 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.
To put this in context, India’s drug regulator has allowed the AstraZeneca Covid-19 vaccine to be used for up to nine months from its date of manufacture in April last year.
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