Serum Institute applies for full approval of Covishieldtext_fields
New Delhi: Serum Institute has requested the Indian health ministry and Central Drugs Standard Control Organisation (CDSCO) for full market authorisation for its Covishield vaccine, Chief Executive Officer (CEO) Adar Poonawalla informed in a tweet on Friday.
Serum Institute, which produces AstraZeneca's COVID-19 vaccine under the brand name Covishield, has supplied more than 1.25 billion doses of the shot in India.
The Indian government now has enough data to consider a full market authorisation, Poonawalla said on Twitter.
"Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses, " Adar said. "The government of India now has enough data for full market authorisation," he said.
Serum Institute, which is also the world's biggest vaccine maker, was granted approval for emergency use of Covishield in India at the beginning of the year.
The country's inoculation drive so far has been dominated by Covishield and Bharat Biotech's inactivated vaccine Covaxin.
Serum Institute has nearly quadrupled its monthly capacity of AstraZeneca's shots to as many as 240 million doses and is prepared to export "large volumes" from January, Mr Poonawalla told news agency Reuters in October.
However, with not enough orders for Covishield from the central government, the Serum Institute was looking at slashing the monthly production of vaccines by at least 50 per cent, Mr Poonawalla was quoted as saying earlier this month.
"I am actually in a dilemma that I never imagined... we are producing 250 million doses a month but the good news is that India has covered up a large part of its population and we would have completed all our orders to the Ministry of Health in a week's time," Mr Poonawalla said in an interview to CNBC-TV18.
On his future production strategy, the SII CEO said that as there was "no other orders in hand so I am going to reduce the production by at least 50 per cent to begin with...on a monthly basis until the orders again pick up either in India or the world".