SEC makes recommendations to speed up process to consider Indian COVID-19 candidates

Source: Reuters

The Subject Expert Committee (SEC) has made recommendations to speed up the process to consider COVID-19 vaccine candidates being developed by Serum Institute of India, Bharat Biotech and Cadilla Healthcare on January 2.

"The Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) makes recommendations in respect of Accelerated Approval Process request of M/s Serum Institute of India and M/s Bharat Biotech International Ltd as well as about Phase-III Trials of M/s Cadila Healthcare Ltd,"  the statement issued by the central government said.

According to the statement, the recommendations included allowing restricted emergency use of the vaccine, subject to multiple regulatory conditionalities to Pune-based Serum Insitute of India.

Specially in the context of mutant strains, the SEC recommended that permission be granted to the candidate being developed by Bharat Biotech.

"Grant of permission for restricted use in an emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd," it said.

In addition to this, it also recommended that Cadila Healthcare be given permission to conduct Phase III clinical trials protocol.