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June 19, 2020

CDRI gets approval for Phase III trial of Umifenovir to treat Covid-19

Central Drug Research Institute (CDRI), a constituent lab of India-based Council of Scientific and Industrial Research (CSIR), has secured approval for carrying out Phase III trial for the use of Umifenovir in the treatment of Covid-19.

Central Drug Research Institute (CDRI), a constituent lab of India-based Council of Scientific and Industrial Research (CSIR), has secured approval for carrying out Phase III trial for the use of Umifenovir in the treatment of Covid-19.

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In this randomised, double-blind, placebo-controlled trial, CDRI will test the efficacy, safety and tolerability of  Umifenovir.

According to a statement by the government: “This drug has a good safety profile and acts by preventing entry of virus into human cells and also by priming the immune system.”

Umifenovir is a drug primarily used to treat influenza. Available in China and Russia, the drug rose to the prominence given its potential in treating Covid-19 patients.

CSIR-CDRI is conducting this trial to analyse its efficacy in Indian patients.

The Phase III trial will be conducted at Dr Ram Manohar Lohia Institute of Medical Sciences (RMLIMS), Era’s Lucknow Medical College & Hospital, and King George’s Medical University (KGMU).

CSIR-CDRI has not only developed the economical process technology for the drug in record time but also licensed the technology for manufacturing and marketing the drug to Medizest Pharmaceuticals of Goa.

Medizest has already secured a test license from the Drug Controller General of India (DCGI).

CSIR-CDRI director Tapas Kundu said that all the raw materials required for Umifenovir are available in the country and if the trial comes out a success, Umifenovir will prove to be a safe, efficacious, affordable drug in treating Covid-19.

Kundu also added that this drug comes with the potential for prophylactic use.

CSIR director-general Shekhar Mande said that the clinical trial forms a key part of the CSIR strategy of repurposing drugs to treat Covid-19.

According to the Union Health Ministry, the clinical trial application was processed on high priority according to DCGI’s initiative in treating Covid-19.

The following steps of the trial are being accelerated in order to make the drug available to Indian patients.

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