DCGI gives approval to conduct clinical trial of Colchicine on COVID-19 patients

The Drugs Controller General of India (DCGI) has given the green light to CSIR and Laxai Life Sciences Private Limited to conduct clinical trial of Colchicine on COVID-19 patients. Colchicine is an oral anti-inflammatory medication beneficial in gout, pericarditis, and coronary diseases.

An official statement said the 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 coronavirus patients.

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.

Ram Vishwakarma, advisor of the CSIR Director General, said Colchicine is a combination with standard care with 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 post-COVID syndrome are leading to loss of many lives, and it is essential to look for new or repurposed drugs,” he said.

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S Chandrasekhar, IICT Director, said India is one of the largest producers of this key drug and if successful, it will be made available to patients at an affordable cost. Ram Upadhayay, Laxai Life Sciences CEO, 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 said this drug can be made available to a large population of India based on the results of this trial and regulatory approval.

The CSIR had announced last week that it has initiated phase II clinical trials of anti-helminitic drug Niclosamide for treatment of COVID-19 with Laxai Life Sciences Pvt Ltd. Niclosamide has been extensively used in the past for treatment of tapeworm infection in adults as well as children. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels.