Regulatory nod given to conduct clinical trials of Colchicine: CSIR

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 post-Covid syndrome are leading to loss of many lives, and it is essential to look for new or repurposed 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.

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, IICT Director S Chandrasekhar said.

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 of India based on the results of this trial and regulatory approval.

Last week, the CSIR announced that it along with Laxai Life Sciences Pvt Ltd has initiated phase II clinical trials of anti-helminitic drug Niclosamide for treatment of COVID-19.

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, the CSIR said.