: Serum Institute of India applies for full market authorisation of Covishield vaccine #IndiaNEWS Biotechnology company Serum Institute of India has applied to the Drugs Controller General of India and

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Serum Institute of India applies for full market authorisation of Covishield vaccine #IndiaNEWS
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.Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission.— Adar Poonawalla (@adarpoonawalla) December 31, 2021 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...Read more

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