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6 lakh Covaxin doses with private hospitals in Karnataka, shelf life extendedPrivate hospitals in Karnataka have been writing to Bharat Biotech to take back the vials worth lakhs of rupees
Suraksha P
DHNS
Last Updated IST
Representative image. Credit: AFP file photo
Representative image. Credit: AFP file photo

In a major relief to thousands of private hospitals across the state with unused Covaxin vaccine stocks, pharma major Bharat Biotech has informed them that the shelf life of their Covid vaccine has been increased from the current six months to one year.

This means six lakh unused doses with the private sector in the state that were set to expire at the end of this month can be used till May next year.

Bharat Biotech, in a letter (a copy is with DH) dated October 28 to a city private hospital said, “...the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), has approved extension of Covaxin’s shelf life up to 12 months from the date of manufacture.”

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The letter goes on to spell out that if the date of manufacture was between April and October this year, then the current expiry date would have been between September and June next year. But according to the revised expiry date, these vaccine doses can be used between March next year and September next year.

Private hospitals in Karnataka have been writing to Bharat Biotech to take back the vials worth lakhs of rupees.

A standalone hospital in the city with 1,000 unused Covaxin doses worth Rs 12 lakh has written to the state drugs controller for a green signal as they are in a legal quandary. “This is totally unheard of. This is the first time that we are seeing expiry date of a vaccine being extended retrospectively.”

The hospital source said that any vaccine post expiry is typically recalled and destroyed. “We have written to the company to give us proof that the DCGI has extended the shelf life and also to the state drugs controller asking if it is legal because according to current laws, we cannot use a product past the mentioned expiry date on the vial merely on the company’s word.

“There should be some mechanism for them to at least inspect our vials and cold chain,” he said.

India’s second-largest corporate hospital chain Manipal Hospital Group which has 27 hospitals in 15 cities across the country has consumed 45,000 Covaxin doses so far and is left with 10,000 doses across hospitals, 70% of which are in Karnataka.

Chief Operating Officer (COO) of Manipal Hospitals Karthik Rajagopal told DH, “The Director General has sent us a communication that the expiry date is 12 months from the date of manufacture. We have spoken to our teams and they say since it is the same drug (which was dispatched in June and its shelf-life now extended) and the cold chain has been maintained, the same vaccine vials can be used for another six months.”

Narayana Health (NH), however said, since they have time till the end of the month for the doses to expire, they will wait to hear from Bharat Biotech. The group had ordered 40,000 Covaxin doses and is left with 15,000 doses pan-India. NH has a majority presence in Karnataka.

Group COO Viren Shetty told DH, “In case of drugs and other medicines, it is out in the open, in the heat. For vaccines, it is all about cold chain. As long as that is maintained, it should be fine.

“If we get a clear communication from Bharat Biotech, that they are extending the date of the expiry for a particular batch number for another six months, then we will abide by that, but if we don’t get the clearance, we have no other option but to discard the stock, because different batches are produced at different times.”

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(Published 03 November 2021, 00:52 IST)