CSIR, Laxai get DCGI nod for Phase 2 trials of Colchicine for Covid

Hyderabad: The Drugs Controller General of India (DCGI) has granted approval to Council of Scientific & Industrial Research (CSIR) and Hyderabad-based Laxai Life Sciences Pvt Ltd to conduct a Phase-II clinical trial to assess the safety and efficacy of gout treatment drug Colchicine in hospitalised Covid-19 patients, CSIR said on Saturday.
Dr Ram Vishwakarma, advisor to DG-CSIR, pointed out that Colchicine in combination with standard of care can be an important therapeutic, life-saving intervention for Covid-19 patients with cardiac co-morbidities and for reducing proinflammatory cytokines, leading to faster recovery.
Laxai CEO Dr 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 large population of India based on the results of this trial and regulatory approval.
India is one of the largest producers of this key drug and if successful, it will be made available to the patients at an affordable cost, said CSIR-Indian Institute of Chemical Technology Hyderabad director Dr S Chandrasekhar and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu director Dr DS Reddy. Both these CSIR partner institutes will be participating in the study.
A number of global studies have now 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, CSIR said in a statement.