DCGI nod for clinical trials of Colchicine

● 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.

New Delhi, June 12: The Drugs Controller General of India (DCGI) has given approval to the Council for Scientific and Industrial Research (CSIR) and Laxai Life Sciences Private Limited of Hyderabad to conduct clinical trials of Colchicine on Covid-19 patients, according to a statement on Saturday.

Ram Vishwakarma, adviser to the CSIR Director-General, said Colchicine in combination with standard care will be an important therapeutic intervention for Covid-19 patients with cardiac comorbidities and for reducing pro-inflammatory cytokines, leading to faster recovery.

The approval is for a twoarm 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 are Indian Institute of Chemical Technology (IICT), Hyderabad, and 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 begun at multiple sites across India and the trial is likely to be completed in eight to ten weeks.

Last week, the CSIR announced that it along with Laxai Life Sciences had initiated phase II clinical trials of antihelminitic drug niclosamide for treatment of Covid-19. Niclosamide has been used in the past for treatment of tapeworm infection. 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.