CDSCO approves institutes to conduct clinical trial with convalescent plasma in COVID-19 patients
New Delhi [India], April 18 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has given a green signal to interested institutes to conduct the clinical trial with convalescent plasma in COVID-19 patients, as per the protocol developed by Indian Council of Medical Research (ICMR).
ANI
Apr 18, 2020 04:29 IST
New Delhi [India], April 18 (ANI): The Central Drugs Standard Control Organisation (CDSCO) has given a green signal to interested institutes to conduct the clinical trial with convalescent plasma in COVID-19 patients, as per the protocol developed by Indian Council of Medical Research (ICMR).
In a notice regarding the clinical trial of convalescent plasma in COVID-19 patients, the CDSCO 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."
It said that the ICMR has given a list of institutes to CDSCO which have shown interest in the conduct of the said trial.
While deliberating the clinical trial protocols of other applicants for the conduct of clinical trial with convalescent plasma in COVID-19 patients, the SEC in the said meeting opined that ICMR has developed a protocol for a controlled clinical trial with convalescent plasma in moderate COVID-19 patients which has been reviewed by the committee and the same may also be considered by the applicants as appropriate.
Any person or institute organisation interested in the conduct of the trial of convalescent plasma as per the protocol developed by ICMR and approved by CDSCO, may do so in consultation with ICMR and accordingly, the applicant may approach ICMR for the conduct of the clinical trial, the notice undersigned by Drugs Controller General VG Somani read.
India's total number of coronavirus positive cases has risen to 13,835, including 1767 cured and discharged and 452 deaths, as per the Union Health Ministry. (ANI)
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