DCGI APPROVES CLINICAL TRIAL OF COLCHICINE DRUG

NEW DELHI: The Drugs Controller General of India (DCGI) has given approval to the CSIR and Laxai Life Sciences Private Limited to conduct clinical trial of Colchicine on Covid-19 patients, according to a statement on Saturday.

Ram Vishwakarma, the advisor to the CSIR director general, said Colchicine in combination with standard care will be an important therapeutic intervention for Covid-19 patients with cardiac co-morbidities and also for reducing pro-inflammatory cytokines, leading to faster recovery.

A number of global studies have confirmed that cardiac complications during course of Covid-19 infections and postcovid syndrome are leading to loss of many lives, and it is essential to look for new or re-purposed drugs, he said.

“Council of Scientific & Industrial Research (CSIR), and Laxai Life Sciences Pvt Ltd Hyderabad, have been given the regulatory approval by DCGI to undertake a two-arm phase-ii clinical trial to assess the safety and efficacy of the drug Colchicine in improvement of clinical outcomes during the treatment of COVID-19 patients,” the statement said.

The partner CSIR institutes in this important clinical trial are the Csir-indian Institute of Chemical Technology (IICT), Hyderabad and Csir-indian Institute of Integrative Medicine (IIIM), Jammu.

Laxai Life Sciences CEO Ram Upadhayay said the enrolment of patients has already begun at multiple sites across India and the trial is likely to be completed in the next 8-10 weeks. He further added that this drug can be made available to a large population based on the results of this trial and regulatory approval.