CDSCO Approves the Extension of COVAXIN Shelf-Life to 12 Months Based on Stability Data

The Hyderabad-based company further said that the approval is based on the availability of additional stability data, which was submitted to Central Drugs Standard Control(CDSCO).

Written by: India.com News Desk Edited by: Sumaila Zaman

Updated: November 3, 2021, 4:18 PM IST

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Bharat Biotech's COVID-19 vaccine Covaxin

New Delhi: The Biotechnology company Bharat Biotech, on Tuesday said 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, as reported by news agency ANI. The Hyderabad-based company further said that the approval is based on the availability of additional stability data, which was submitted to Central Drugs Standard Control Organisation(CDSCO).

Earlier during the month of April 2021, the Hyderabad-based Bharat Biotech has written to India’s drug regulatory body CDSCO seeking an extension on the shelf life of the vaccine ‘Covaxin’ from a period of six months to 24 months.

CDSCO( Central Drugs Standard Control Organisation) has approved extension of self life of Covaxin up to 12 months, from date of manufacture. This approval is based on the availability of additional stability data, which was submitted to CDSCO: Bharat Biotech pic.twitter.com/BlhIPmvTBV

— ANI (@ANI) November 3, 2021

The company was permitted the sale and distribution of its indigenously developed Covid-19 vaccine ”Covaxin” with a shelf life of six months when kept at 2°C-8°C.

The firm in its application to the Drugs Controller General of India said, “Now, we are herewith applying for the extension of shelf life from six months to 24 months when stored at 2-8 degreesCelsius.” Bharat Biotech’s Covaxin is one of the most used vaccines in India.