Bharat Biotech gets DCGI nod for PHASE II trials of COVAXIN
The subject expert committee (SEC) has recommended that the trial will be conducted on 380 participants
According to a report by The Indian Express, the Drugs Controller General of India (DCGI) has given clearance to Bharat Biotech for conducting Phase II human clinical trials of its indigenously developed Covaxin.
The report informed that the subject expert committee (SEC) has recommended that the trial will be conducted on 380 participants. A letter from Joint Drugs Controller Dr S Eswara Reddy, dated September 3, has notified the company about this.
Reportedly, the first phase of the Covaxin trial was done with 375 participants from across 12 sites.
Zydus Cadila and Serum Institute of India have also started conducting phase II trials for ZyCoV-D and Covishield (by Oxford-AstraZeneca) in India.