Vial policy: Mixed response to Centre’s letter

Some private hospitals to follow manufacturer’s instructions which Union Goverment does not permit

The Centre’s letter to Karnataka, clarifying that open vial policy for Covaxin cannot be allowed, has evoked mixed response from private hospitals in the State. The Centre has also said that all vaccines, including for COVID-19, should not be utilised beyond the expiry date mentioned.

This is opposed to the manufacturer Bharat Biotech’s announcement on Monday that opened vials of its vaccine against COVID-19 can be stored at 2-8 degrees Celsius for up to 28 days and are not required to be discarded immediately in a day or at the end of the immunisation session. The company had stated that the extension of Covaxin’s shelf life up to 12 months from the date of manufacturing was recently approved by the Central Drugs Standard Control Organisation (CDSCO).

While the Private Hospitals and Nursing Homes’ Association (PHANA) has said that hospitals should ideally go by the manufacturer’s instructions as they have purchased the vaccine stock from the company, the Association of Healthcare Providers – India (AHPI) said that all private hospitals are bound to follow the Centre’s norms on vaccination.

Private hospitals in Karnataka, who have a stock of nearly six lakh Covaxin vials, are worried that they will incur huge losses if the Centre’s directions are followed.

Expressing concern, PHANA president H.M. Prasanna said the Centre’s norms can be applicable for government stocks as they have been supplied free of cost to the States. “We have invested huge amounts on the vaccines and cannot afford to allow them to go waste. We will issue an advisory to our member hospitals to follow the instructions given by the company. They are free to follow the Centre’s norms if they are able to bear the losses,” he said.

He said he will write to the Union Health Secretary Rajesh Bhushan seeking a proper clarification on the issue. Although Bharat Biotech, the manufacturer of Covaxin, has assured the private hospitals that the company will revalidate their stock by re-labelling the vials with the extended expiry date of a year, hospitals are worried as it is a huge challenge to transport the stock to the company and get it back.

“Thursday’s letter to the State is a knee jerk reaction to the company’s recent announcement. If the CDSCO has permitted extension of Covaxin’s shelf, why has this not been taken into consideration by the Health Ministry?” Dr. Prasanna said.

However, AHPI national president Alexander Thomas said all hospitals involved in the vaccination programme are bound to follow the Centre’s norms.

“As of now, hospitals are not storing an opened vial beyond four hours. We have been following up with Union Health Minister Mansukh L. Mandaviya, who had assured us that the Government will explore the possibility of exporting the ample stocks in private hospitals to countries that are in dire need of vaccines,” he said.

“Based on deliberations of our scientific committee, we had recommended that the Government should consider allowing booster doses on a voluntary basis. We are following up on this aspect too as it will enable effective utilisation of the ample stock of COVID-19 vaccines available with the private sector,” Dr. Thomas said.

Arundathi Chandrashekar, State Mission Director, National Health Mission, said guidelines on vaccination issued by the Centre are applicable to all hospitals, including private facilities.

“We understand the practical problems being faced by the private hospitals and will discuss this in our steering committee on vaccination. We will also flag it again with the Centre,” she said.

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