India’s drug regulator’s expert body recommends two Covid-19 vaccines for emergency use

The Indian government today announced that a committee of experts appointed by it has permitted emergency use of Bharat Biotech's Covid-19 vaccine candidate "Covaxin" and Oxford-AstraZeneca's vaccine which is being produced by the Serum Institute of India.

Read more

India begins nationwide Covid-19 vaccination dry run

The Subject Expert Committee of Central Drugs Standards Control Organization (CDSCO) met for two days -- today and yesterday -- and recommended that the Drugs Controller General of India (DCGI) "grant permission for restricted emergency use" of the Oxford-AstraZeneca vaccine, subject to multiple regulatory conditions to the Serum Institute of India based in Pune city, the health ministry said in a statement.

The committee also "granted permission" to Bharat Biotech "for restricted use of Covaxin in emergency situation in public interest as an abundant precaution in clinical trial mode", especially in the "context of infection by mutant strains," the statement also said.

The committee also granted permission for conducting Phase-III clinical trial protocol to Cadila Healthcare Ltd based in Ahmedabad which is also making vaccines against coronavirus.

It is now up to the DGCI make a call on the committee's recommendations.

The emergency use approval of a drug -- which is what has been recommended by the panel -- is usually granted if there is sufficient evidence to suggest that the drug is safe and effective.