April 18, 2020

Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has permitted the conduct of clinical trial of Convalescent Plasma In COVID-19 Patients. The trial protocol was developed and submitted by Indian Council of Medical Research (ICMR), New Delhi.

CDSCO in their Public Notice date 17.04.2020 has stated that “In light of public interest the proposal of ICMR for conducting the said trial has been reviewed through the Subject Expert Committee (SEC) in its meeting held on 13.04.2020 under accelerated approval process in light of the current prevailing situation of COVID-19 and based on the recommendation of the committee CDSCO has conveyed it’s No Objection for conduct of the clinical trial subject to certain amendments in the protocol and various conditions under the New Drugs and Clinical Trials Rules 2019.”

As per the notice, ICMR has also given a list of institutes to CDSCO which have shown interest in the conduct of said trial.

The SEC opined that the protocol developed by ICMR for a controlled clinical trial and has been reviewed by the committee may also be considered by the applicants as appropriate.

Accordingly, any person/ institute/ organization interested in carrying out clinical trial as per ICMR protocol, may do so in consultation with ICMR and may approach ICMR for the conduct of trial.

A copy of protocol has also been placed on CDSCO website for reference.

Earlier, US Food and Drug Administration had approved the use of plasma from recovered patients to treat people who are critically ill with COVID-19.