DGCI gives approval for human clinical trials of COVAXIN
HEALTH DESK
INDIA’S National regulatory body for Indian Pharmaceuticals and medical devices, the Central Drug Standard Control Organisation, has granted approval to Bharat Biotech India to conduct human clinical trials for Corona Vaccine called ‘Covaxin’.
The company in a statement said it is the first indigenous COVID-19 vaccine to receive the approval. The Covaxin has been developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune. Bharat Biotech Chairman and Managing Director of Bharat Biotech Dr Krishna Ella informed that these trials are scheduled to start across the country during the month of July.
According to the company, the Drug Controller General of India approved Bharat Biotech’s application to conduct phase I and II clinical trials for Covaxin.
Dr Krishna further said the permission was granted after the company submitted results from pre-clinical studies of the vaccine that demonstrated its safety and immune response. The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured at the Bio-safety level 3 lab of the Bharat Biotech located in Genome Valley in Hyderabad.