Firm seeks DCGI nod to extend Covaxin shelf life even as high prices raise eyebrows

Bharat Biotech has written to the India's drug regulator seeking extension of the shelf life of its indigenously developed COVID-19 vaccine Covaxin from six to 24 months, sources said on Sunday.

The Hyderabad-based Bharat Biotech was given permission for sale and distribution of Covaxin with shelf life of six months when stored at two to eight degrees Celsius.

"Now, we are herewith applying for the extension of shelf life from six months to 24 months when stored at 2-8 degrees Celsius," the firm said in its application to the Drugs Controller General of India.

In support of their proposal, Bharat Biotech has submitted updated accelerated and real-time stability data of Coaxin along with the justification for the extension of shelf life.

The DCGI had earlier extended the shelf life of Covishield from six to nine months from its manufacturing date in February.

On Saturday, Bharat Biotech had announced fixing fixed the price of Covaxin at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals.

In a statement, Bharat Biotech Chairman and Managing Director Krishna M Ella said the company is supplying the vaccine to the Central Government at Rs 150 per dosage.

"We would like to state that more than 50 per cent of our capacities have been reserved for Central Government supplies," Ella said.

The company has tagged the vaccine between USD 15-20 for export markets.

Of the 127,605,870 COVID-19 vaccination jabs administered till now, 11,60,65,107 are of Covishield, while 1,15,40,763 are Covaxin, according to the government's CO-WIN portal.

Senior Congress leader P Chidambaram had on Saturday criticised the high costs of the vaccines. While welcoming the decision to vaccinate all citizens above the age of 18 years from May 1, he said, "We have to caution the government that this decision brings with it huge responsibilities."

"The government is standing (not helplessly) and silently endorsing the blatant profiteering and exploitation by the two manufacturers. Why is the government not invoking the provision of 'compulsory licensing'?” the former Union minister wrote on Twitter.

"Will those who justified the COVISHIELD prices of Rs 400 and 600 also justify the COVAXIN prices of Rs 600 and 1200 announced today?" he asked in a series of tweets.

Another former Union minister and Congress leader Jairam Ramesh too had raised questions over the differential pricing of vaccines for the Centre and the states.

"Deferential to Centre. Differential to States. SII recently said Rs 400 is new price for ALL new govt procurements -- States and Centre. What's the truth? States have to buy from SII at Rs 400 ($5.30) -- Highest in the World -- for Made in India vaccine. Why?" he asked.

"COVISHIELD at Rs 400 for new govt procurement is higher than what govts of US, UK, EU, Saudi, Bangladesh & SA pay. Made in India & highest price for India? By SII's own admission profits are made even at Rs 150. Prices must be renegotiated," the former Union minister wrote on Twitter.

Ramesh had also pointed out said that a report by the Parliamentary Standing Committee on Health and Family Welfare had said in November 2020 that "there is a strong need to ensure oxygen inventory and that prices are controlled". It had also pointed towards the affordability and availability of oxygen cylinders at all hospitals.

"Shortage of Oxygen in hospitals across the country is an UNMITIGATED MAN-MADE DISASTER! Standing Committee on Health in report presented to RS Chairman on 21.11.2020, recommended Modi Govt to 'encourage adequate production of Oxygen' to meet needs of hospitals. Why wasn't it done?" he asked on the microblogging website.

On Sunday, Ramesh again took to Twitter about the issue:

Several users also took to social media to question the high prices of Covaxin announced by its manufacturer: