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CDSCO Gives Nod To Convalescent Plasma Therapy Clinical Trial In COVID-19 Patients

CDSCO has given a go-ahead to interested institutes for conducting the clinical trial with convalescent plasma in COVID-19 patients, as per ICMR protocols.


The Central Drugs Standard Control Organisation (CDSCO) has given a go-ahead to interested institutes for conducting the clinical trial with convalescent plasma in COVID-19 patients, as per the protocol developed by the Indian Council of Medical Research (ICMR). It said that the ICMR has given a list of institutes to CDSCO which have shown interest in the conduct of the said trial.

READ | COVID-19 Doubling Rate Improves To 6.2 Days; Growth Rate Declines By 40%: Health Ministry

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."

"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," read the notice, undersigned by Drugs Controller General VG Somani.

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What is Convalescent Plasma treatment?

People who've recovered from COVID-19 have antibodies to the disease in their blood. Doctors call this convalescent plasma (sera). Researchers hope that convalescent plasma can be given to people with severe COVID-19 to boost their ability to fight the virus. Convalescent plasma treatment involves injecting the COVID-19 patient with the convalescent plasma of people who recovered from the infection recently. The patient cured of the disease will have antibodies that drive Coronavirus away, says the report of the WHO-China Joint Mission on COVID-19.

READ | ICMR Asks States To Use Rapid Antibody Tests For Surveillance In COVID-19 Hotspots

In a piece of good news, the Ministry of Health said on Friday said the average growth rate of COVID-19 cases has declined by 40% imposition of a nationwide lockdown in mid-March, while the doubling rate of the disease has gone up from initial 3 days to 6.2 days according to data of last seven days. The Ministry informed that the doubling rate is lower than the national average in 19 States and Union Territories. The recovery rate of COVID-19 patients has also improved to 13.06%.

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.

READ | India Received 5 Lakh Rapid COVID-19 Testing Kits From China: Health Ministry

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