Covaxin shelf life: Private hospitals worried over getting expired stocks relabelled

Private hospitals may not be able to participate in child vaccination programme immediately

Private hospitals in Karnataka — who were eagerly waiting for the rollout of paediatric vaccinations to ensure that their huge stocks of Covaxin get utilised — are now apprehensive that they may not be able to participate in the vaccination programme immediately. This is mainly because they are finding it difficult to get the nearly six lakh doses that have crossed their expiry date relabelled from Bharat Biotech, the manufacturer.

Following the Centre’s directions, the State Government has told private hospitals that vaccines, including COVID-19 vaccine, should not be utilised beyond the expiry date mentioned on the label of each vial.

In the first week of November, Bharat Biotech had communicated to private hospitals that the Central Drugs Standard Control Organisation (CDSCO), had extended the shelf life of Covaxin doses to 12 months from the date of manufacturing. Following this, the vials that had an expiry date between September 2021 and June 2022 will now expire between March 2022 and September 2022, the communication had stated.

“The company had assured us that our stocks will be revalidated for efficacy and relabelled with the extended expiry date of a year. However, now the company has not been proactive in doing this and as of Wednesday not a single vial has been relabelled. Even if they start doing it now it may take at least three to four weeks for the relabelling process to be completed,” said H.M. Prasanna, president of Private Hospitals and Nursing Homes Association (PHANA).

Pointing out that the hospitals were not sure how the efficacy of the unused stock would be revalidated by the company, Dr. Prasanna said he was planning to write to the Union Government in this regard.

“The company has also said that under no circumstance should the hospitals ask for a buyback if the stocks still remain unsold after six more months. We were hopeful of utilising the stocks as the Centre has permitted only Covaxin for child vaccinations as of now. However, without the relabelling we cannot participate in the child vaccination programme. We had a meeting of hospital heads on Wednesday to sort this out. We will meet again to discuss the issue as we could not arrive at a consensus,” he said.

Sources said the company was dilly-dallying in taking back the stocks for relabelling as it wanted private hospitals to buy fresh stocks. “The manufacturer is adopting a wait and watch policy as private hospitals will be forced to buy fresh stocks if they want to participate in the paediatric vaccination programme. I have been trying in vain to get my stock relabelled for the last two months. Finally, when I told the company authorities that I will send the stock on my own to their manufacturing unit in Hyderabad for relabelling, they have now assured me to pick it up in the next few days,” said a hospital owner.

Several other hospital heads that The Hindu spoke to said private hospitals had pitched in to participate in the vaccination programme in the interest of society. “We are not making any profit out of vaccination. We get only ₹150 service charge per dose. Including this service charge, each Covaxin dose costs ₹1,410. We want to liquidate the existing stocks before we can think of buying new stocks,” said another hospital owner.

Former president of PHANA, R. Ravindra, who owns Suguna hospital in Rajajinagar, said private hospitals needed the support of the Government in resolving the relabelling problem. “We can participate in the vaccination programme if the government resolves this issue at the earliest. With the third wave approaching, there is an urgent need to strengthen the vaccination programme,” he said.

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