Centre to lay down vaccine trial norms

Centre to lay down vaccine trial norms

Guidance document on anvil: DBT

The government is readying a document that will lay down guidelines for companies and institutions working on potential COVID­19 vaccines. The COVID­19 pandemic has prompted regulators across the world to issue emergency use authorisation for certain drugs and trials on potential vaccines to accelerate the approval process without compromising on objectively assessing whether the potential vaccine or investigational drug provides some additional benefit or reprieve over being defenceless. “There is likely to be a guidance document for COVID vaccines in a couple of days issued by the Central Drug Standards and Control Organisation,” said Renu Swarup, Secretary in the Department of Biotechnology.  There are five promising

candidate vaccines from India, including Covaxin from Bharat Biotech and one from Zydus Cadilla, which were cleared by the Drug Controller General of India for early human trials. Trials under way in India were “adaptive” trials, Ms. Swarup said.  “The guidance document outlines how to maintain rigour while also fast­tracking the process,” Ms. Swarup told The Hindu.