CDSCO approves shelf life of COVID-19 vaccines

Health worker administers a COVID-19 vaccine to beneficiaries at BBMP Health centre, in Bengaluru on November 23, 2021.   | Photo Credit: K. MURALI KUMAR

The Central Drugs Standard Organisation (CDSO) has approved the shelf life of COVID-19 vaccines Covaxin to 12 months, Covishield to nine months, and ZyCoV-D to six months from the date of manufacture, the Lok Sabha was informed on Friday.

Regarding administration of booster doses, Union Health Minister Mansukh Mandaviya said the National Technical Advisory Group on Immunisation (NTAGI) and the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) are deliberating and considering scientific evidences related to this aspect.

Responding to a question on the shelf life of Covid vaccines approved in the country and their active period among the vaccinated people, Mr. Mandaviya, in a written reply, said the vaccines were developed very recently, therefore, scientific evidence regarding the duration of protection is still evolving globally.

"The National Regulator, i.e. the CDSO, has approved the shelf life of nine months for Covishield vaccine, for Covaxin vaccine it is 12 months and for ZyCoV-D vaccine it is six months from the date of manufacture," Mr. Mandaviya said.

On whether the government has taken stock of vaccines lying unused in government and private hospitals and proposes to procure and redistribute the unused vaccines before their dates of expiry, Mr. Mandaviya said the central government closely monitors COVID-19 vaccine stocks in states and Union Territories to ensure their optimal utilisation.

COVID-19 vaccine stock which has not been utilised in private hospitals and nearing expiry has been taken up for redistribution by respective state governments, as advised by the Union government, for their timely utilisation, he said.

Listing steps taken by the government to ensure adequate production and supply of Covid vaccines and booster doses along with the total expenses incurred and funds allocated and disbursed in this regard, Mandaviya said under ‘Mission Covid Suraksha’ being implemented by the Biotechnology Industry Research Assistance Council (BIRAC), a PSU of Department of Biotechnology, efforts have been made to strengthen COVID-19 vaccine manufacturing capabilities of Indian industry, to ensure optimal vaccine production.

In this regard, augmentation of manufacturing facilities was supported at Bharat Biotech International Limited (BBIL) and Indian Immunologicals Limited (IIL), Hyderabad.

The IIL, supported under the mission, has achieved a production capacity of around 20 lakh doses/month equivalent Drug Substance (DS) of Covaxin.

The validation of the BBIL facility at Malur, Bengaluru is complete and production of DS started in August 2021. Further, support for facility augmentation at Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL), Bulandshahr; and Haffkine Biopharmaceutical Corporation Ltd (HBPCL), Mumbai; for Covaxin production is under consideration.

An amount of ₹ 260 crore has been allocated to support facility upgradation for augmented Covaxin production, out of which, an amount of ₹ 27.25 crore has been disbursed so far, Mandaviya said.

Additionally, DBT along with the PSU BIRAC, is facilitating expert advisory support for facility up-gradation at Gujarat COVID Vaccine Consortium (GCVC), for augmented production of Covaxin, he said in the written reply.

In the current financial year i.e. 2021-22, ₹ 35,000 crore has been budgeted for implementation of COVID-19 vaccination programme.

As on November 27, an expenditure of ₹ 19,675.46 crore has been incurred against this allocation which has been utilised for procurement of COVID-19 vaccines for free of cost supply to states and Union Territories, he said.

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Printable version | Jan 18, 2022 11:21:43 AM |

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