The Drugs Controller General of India has approved the Phase-II trial of Colchicine, which can help Covid-19 patients with co-morbidities related to heart and also for their faster recovery.

The Council of Scientific and Industrial Research (CSIR) and Hyderabad’s Laxai Life Sciences Private Limited have received regulatory approval from the Drugs Controller General of India (DCGI) to conduct the clinical trial of Colchicine

The partner CSIR institutes in this two-arm phase-II clinical trial are the CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu.

A number of global studies have confirmed that cardiac complications during the 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, said Ram Vishwakarma, the advisor to the CSIR Director General.

Colchicine will be an important therapeutic intervention for Covid patients with co-morbidities related to heart and also for reducing proinflammatory cytokines, leading to faster recovery, said Dr Shekhar C Mande, Director General of CSIR.

The two partner institutes said they are looking forward to the outcome of this trial which may lead to life-saving intervention in the management of hospitalised patients.

Considering that 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 Dr Ram Upadhayay said, “The enrollment of patients has already begun at multiple sites across India and the trial is likely to be completed in the next 8-10 weeks.”

The drug can be made available to the people based on the results of this trial and regulatory approval, he added.

Recent clinical studies reported in leading medical journals suggest that colchicine can significantly reduce the rates of recurrent pericarditis, post-pericardiotomy syndrome, and peri-procedural atrial fibrillation following cardiac surgery and atrial fibrillation ablation.