The company said, as directed by the Government of India, less than 10 per cent of the total production of Covaxin to date has been supplied to private hospitals.
No vaccine manufactured or developed from India has ever received emergency use authorisation or full licensure from USFDA.
Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission.
With the latest purchase orders, the government has secured 74 crore coronavirus vaccine doses for the country from August onwards, announced V K Paul.
Ocugen in a regulatory filing said it has agreed to pay another USD 10 million to Bharat Biotech within a month from the commercial launch of Covaxin in the North American country.
Decks cleared for import of Bharat Biotech's Covaxin, Russia's Sputnik V into Brazil, conditions apply
According to Anvisa's approval, Brazil is expected to receive four million doses of Covaxin initially.
‘Manufacturer didn’t meet commitment’: Kejriwal government to HC on Covaxin shortage in national capital
The court said that the Delhi government should have stopped providing people with the first dose of Covaxin when it realised that it will not be getting any more supplies from Bharat Biotech.
Responding to a question on recognition of Covaxin by the WHO, NITI Aayog Member (Health) V K Paul said the government is pursuing it.
Pharma firm will now produce Covaxin vials from existing Biovet facility at Malur
Amid shortage of vaccines, the State government has started the process to woo manufacturers to set up their units in Tamil Nadu.
The vaccine production process involves two stages – drug substance and final drug product, the official explained.
It said that the current production capacity of Covaxin, which is 1 crore per month, will be doubled by May-June and then increased 6-7 fold by July – August.
Experts said that the statement by Bharat Biotech may further heighten the confusion around vaccine availability rather than clearing the air.
Bharat Biotech's clarification comes at a time when the country is facing a shortage of COVID-19 vaccines, leading to disruptions in the nationwide inoculation programme.
The government has been stressing on the need to wear a mask and adherence to other coronavirus protocols.