The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulator body, has approved the proposal of Indian Council for Medical Research (ICMR) for conducting clinical trial of convalescent plasma in Covid-19 patients, as per the protocol developed by the ICMR, reports Economic Times.
The Drug Controller General of India in a notice issued on Friday (17 April) said that its subject expert committee (SEC) reviewed the ICMR’s proposal and based on its regulation, the CDSCO has conveyed no objection for conduct of clinical trial.
"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 in its meeting held on April 13 under accelerated approval process in light of the current prevailing situation of COVID-19 and based on the recommendation of the committee,” the central drug regulator said in the notice.
"The CDSCO has conveyed its no objection for conduct of the clinical trial subject to certain amendments in the protocol and various conditions under the Drugs and Clinical Trial Rules 2019," it added.
In convalescent plasma therapy, the treatment of severely infected patients will be done using antibodies from the blood of patients who have recovered from Covid-19.
Further, the notice said that ICMR has submitted a list of institutes to CDSCO which have shown an interest in the conduct of the trial.
The notice underlined 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.
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