Biotechnology company Serum Institute of India has applied to the Drugs Controller General of India and the Union health ministry for full market authorisation of its Covid-19 vaccine Covishield, the company’s chief executive officer Adar Poonawalla said on Friday.
Poonawalla said that the Union government now has enough data for full market authorisation. He added that supplies of Covishield in India have crossed 1.25 billion doses.
Authorities in India grant emergency use approval during public health emergencies when they find that the known and potential benefits of a medical product outweigh its known and potential risks. For full market authorisation, the products need to undergo the standard regulatory process that involves an assessment of its quality, safety and effectiveness, PTI noted.
The Serum Institute of India had submitted phase 2 and 3 clinical study reports on Covishield in October, the agency reported.
Covishield and Bharat Biotech’s Covaxin were the first coronavirus vaccines to have received emergency use authorisation from the Drugs Controller General of India in January. According to the CoWin dashboard, 1,28,94,02,360 doses of Covishield have been administered in the country till now.
On Tuesday, the Central Drugs Standard Control Organisation approved two more coronavirus vaccines and one anti-viral drug for emergency use in India. The two vaccines that received emergency use approval were Serum Institute of India’s Covovax and Biological E’s Corbevax. The authority has also approved United States-based pharmaceutical company Merck’s anti-viral pill molnupiravir.
Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V and the United States-made Moderna and Johnson and Johnson have also received emergency use authorisation from the Indian drug regulator.
Till Friday, a total of 1,44,54,16,714 coronavirus vaccine doses have been administered in India, data from the Union health ministry showed. In the past 24 hours, 66,65,290 doses were administered.