Balram Bhargava, the Chief of the Indian Council of Medical Research (ICMR) asked the Bharat Biotech International Private Limited to take consent from volunteers.
On the 5th of January, the ICMR said, the Hyderabad based Bharat Biotech’s COVAXIN, the Novel Coronavirus or COVID-19 cleared all clinical trial modes. Following the clinical trials approval, the company needs to take consent of the participants.
Mr. Bhargava said, “Permission for restricted use in clinical trial mode has been allowed which means consent of participants has to be taken and there has to be a regular follow up of participants.”
Balram Bhargav explained the process followed in granting a nod to AstraZeneca-Oxford University’s COVID-19 vaccine and Bharat Biotech’s COVAXIN during a press conference.
Mr. Bhargava said, “The existing pandemic situation, high mortality, available science and lack of definitive treatments were considered by the subject expert committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (DSCO) for granting accelerated approval to these vaccines, and that is in our legal provision.”
With the Emergency Authorizations Usage (EAU,) given to the Serum Institute of India (SII) and Bharat Biotech, the companies are hopeful to manufacture in bulk for the people of India.
Meanwhile, the Indian Government also assured the India made vaccine, for the Novel Coronavirus or COVID-19 to be launched soon.
Until then, the Union Health Minister Dr. Harsh Vardhan asked citizens of India to be cautious and follow all the guidelines of COVID-19.
Stay tuned for further updates.
