Pfizer is in discussions with the Indian government seeking an "expedited approval pathway" for its COVID-19 vaccine, its CEO Albert Bourla said on LinkedIn on Monday, announcing a donation of medicines worth more than $70 million.
"Unfortunately, our vaccine is not registered in India although our application was submitted months ago," he said.
"We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country."
This comes as India reported more than 300,000 new coronavirus infections for a 12th straight day on Monday to take its overall number of cases to just shy of 20 million, as scientists predicted a peak in the pandemic in the coming days.
With 368,147 new cases over the past 24 hours, India's total infections stand at 19.93 million, while total fatalities rose by 3,417 to 218,959, according to health ministry data.
Medical experts say actual numbers across the country of 1.35 billion may be five to 10 times higher than the official tally.
The health ministry offered a glimmer of hope, reporting that positive cases relative to the number of tests conducted fell on Monday for the first time since at least April 15.
India's coronavirus cases may peak between May 3-5, according to a mathematical model from a team of scientists advising the government, a few days earlier than a previous estimate as the virus has spread faster than expected.
Hospitals have filled to capacity, medical oxygen supplies have run short and morgues and crematoriums have been swamped as the country deals with the surge in cases.
At least 11 states and union territories have imposed some form of restrictions on movement to try and stem infections, but Prime Minister Narendra Modi's government is reluctant to announce a national lockdown, concerned about the economic impact.
"In my opinion, only a national stay at home order and declaring medical emergency will help to address the current healthcare needs," Bhramar Mukherjee, an epidemiologist with the University of Michigan said on Twitter.