New Delhi [India], April 20 (ANI): The Indian Council of Medical Research (ICMR) has received 99 applications for participation in "Randomized controlled study to assess the safety and efficacy of convalescent plasma to limit COVID-19 associated complications".
A generic protocol has been approved by the Central Drugs Standard Control Organisation (CDSCO) in connection with the study. The CDSCO gave a green signal to interested institutes to conduct the clinical trial with convalescent plasma in COVID-19 patients, as per the protocol developed by ICMR.
In a notice regarding the clinical trial of convalescent plasma in COVID-19 patients, the CDSCO had said: "It is to inform 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 April 13 under accelerated approval process in light of the current situation of COVID-19 and based on the recommendation of the committee. The CDSCO has conveyed it has no objection for the conduct of the clinical trial subject to certain amendments in the protocol and various conditions under the New Drugs and Clinical Trial Rules 2019."
Moreover, the ICMR has given a list of institutes to CDSCO which have shown interest in the conduct of the said trial.
"Any person, institute or organisation interested in the conduct of the trial of convalescent plasma as per the protocol developed by ICMR and approved by the CDSCO, may do so in consultation with the ICMR and accordingly, the applicant may approach ICMR for the conduct of the clinical trial," read a notice by Drugs Controller General VG Somani. (ANI)