CDSCO approves extension of Covaxin shelf life up to 12 months

Written by Ruchika Sharma Published On 2021-12-21T13:00:00+05:30 | Updated On 21 Dec 2021 5:22 PM IST

CDSCO approves extension of Covaxin shelf life up to 12 months

Covaxin Open Vial is stable at 2 to 8 degrees Celsius for 28 days and not required to be discarded immediately in a day or at the end of immunisation session.

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has approved the extension of Bharat Biotech's COVID-19 vaccine Covaxin's shelf life up to 12 months from the date of manufacture, the vaccine-maker said.

This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO. With the shelf life extension, hospitals can now utilise the stock to avoid vaccine wastage, a press release said.

Covaxin is approved for use under the 28-day multi-dose vial policy from Drug Controller General of India and the WHO Emergency Use Listing (WHO EUL).

"Covaxin Open Vial is stable at 2 to 8 degrees Celsius for 28 days and not required to be discarded immediately in a day or at the end of immunisation session," reports PTI.

Bharat Biotech said it believes in doing a bit for the environment. The multi-dose vial policy saves money for procurement agencies by reducing the cold chain logistics and management thereby reducing the carbon footprint, costs related to open vial wastage, cold chain distribution, cold chain storage and biomedical waste disposal among others.

Most importantly, we believe in being environmentally friendly by reducing the quantum of packing materials and single-use plastics that are utilised in vaccines manufacturing, storage, distribution and disposal, the company said.

COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.

Bharat Biotech International Limited is an Indian multinational biotechnology company headquartered in Genome Valley, Turakapally, Hyderabad. The company was founded by Krishna Ella in 1996.

It is engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products.

Read also: Bharat Biotech resumes Covaxin exports

covaxincoronavirus vaccinecdscocentral drugs standard control organisationbharat biotechbharat biotech news

Source : with agency inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751