Serum Institute gets DCGI nod for clinical trials of Oxford vaccine
New Delhi: The Drugs Controller General of India (DCGI) has given approval to Pune’s Serum Institute of India (SII) to conduct clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine in India.
The SII received approval by the India’s top drug regulator on Sunday after a thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19.
In a statement, the Health Ministry said, “Drugs Controller General of India has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine (COVISHIELD) in India.”
The institute had submitted a application seeking permission for conducting the trial in July last week.
The vaccine candidate is in the midst of Phase II and III clinical trials in the UK, Phase III trials in Brazil, and Phase I and II clinical trials in South Africa.