Drug regulator DCGI waives off Phase-III trials for Biocon’s
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
Get authentic, real-time news that helps you fight COVID-19 better.
Install PlexusMD App for doctors. It's free.
Indian drug regulators have exempted Biocon from carrying out the Phase-III clinical trial of its drug Itolizumab that has been repurposed to treat Covid-19 patients in hospitals.

A subject expert committee at the Central Drug Standards and Control Organisation recommended waiving off the phase-3 clinical trial for the Biocon drug on the basis of a Phase-II trial on 30 patients.

The regulatory panel asked the company to carry out phase-IV clinical trials (post-marketing surveillance) besides submitting the risk management plan to the DCGI to address safety issues and informed consent.

The decision, however, raised concerns with some of the medical researchers questioning the regulator on the waive-off.

“We should have details on what basis such decisions are made. It should not be sufficient to say ‘After detailed deliberation, the committee recommended for grant of permission to market the drug for Restricted Emergency Use.’ Skipping Phase-III trial given small numbers in Phase-II does raise concerns,” Anant Bhan, researcher, global health, bioethics and health policy and past president of the International Association of Bioethics told DH.

Source: https://www.deccanherald.com/amp/business/drug-regulator-dcgi-waives-off-phase-iii-trials-for-biocon-s-drug-860854.html
Dr. T●●●●z H●●●●●●i and 4 others like this3 shares
Like
Comment
Share