Pfizer has sought permission from India’s drug regulator to allow the import, sale and distribution of its Covid-19 vaccine in the country.
The company has applied to the Drugs Controller General of India for emergency use authorisation for the Covid-19 mRNA vaccine BNT162b2 in the country, the Press Trust of India agency reported.
Pfizer is the first drug maker to seek approval in the country and submitted its application to the regulator on December 4, Indian media reported on Sunday.
The company has not responded to emails for confirmation.
The UK and Bahrain are the only two countries that have granted emergency use authorisation for the Pfizer-BioNTech Covid-19 vaccine.
Trials showed Pfizer's vaccine was 95 per cent effective in protecting people from coronavirus spurring hope of an end to a pandemic that has taken more than a million lives and hammered world economies.
The vaccine will be distributed in the UK from next week with the healthcare workers and elderly in care homes given the first priority for vaccination.
Concerns remain in India about the transport of the vaccine that must be stored at -70°C (-94F) posing logistical challenges in ensuring the double doses reach primary health centres in remote and rural areas.
Indian officials have also backed local vaccines being tested by drug makers that are in the third phase of safety and efficacy trials.
Prime Minister Narendra Modi has told citizens that a Covid-19 vaccine would be available in India within a few weeks.
Mr Modi said last week that the federal government was working closely with the states to identify priority groups for vaccination.
“About eight potential vaccines, currently in different stages of trials, will be manufactured in India and that includes three indigenous vaccines,” Mr Modi said after visits to three vaccine manufacturing facilities.
The country is struggling to cope with surging coronavirus cases with 36,011 new Covid-19 cases and 482 fatalities reported in a single day.
India has recorded more than 9.6 million Covid-19 cases with the death toll crossing 140,180 deaths placing it behind the US for the highest number of casualties.
The number of active Covid-19 cases has reached 403,248, with more than 9.1 million recoveries.
India is the largest buyer of Covid-19 vaccines globally with 1.6 billion doses, according to a recent US study.
India is followed by the European Union that has confirmed the purchase of 1.58 billion doses and the US with over a billion doses, an analysis by Duke University’s Global Health Innovation Centre found.