DGCI gives regulatory approval for clinical trials of Colchicine, the drug expected to reduce cardiac complications in C
- Colchicine when administered in combination with standard care has the potential to act as an important therapeutic intervention for Covid patients with cardiac comorbidities
The Council of Scientific and Industrial Research (CSIR) and Laxai Life Sciences Private Limited have received the Drugs Controller General of India’s (DCGI's) regulatory approval to conduct clinical trials of the drug Colchicine, news agency PTI reported on Saturday.
"The Council of Scientific and 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 the improvement of clinical outcomes during the treatment of COVID-19 patients,” CSIR said in a statement.
Ram Vishwakarma, the advisor to CSIR's director general, told PTI that a number of studies have shown Covid-19 patients develop cardiac complications during the course of the infection and which leads to the loss of many lives, thus the search for a new or repurposed drug is important. Colchicine is one such drug which when administered in combination with standard care, has the potential to act as an important therapeutic intervention for Covid patients with cardiac comorbidities, and also for reducing pro-inflammatory cytokines, leading to faster recovery.
Laxai Life Sciences' CEO Ram Upadhayay told PTI that enrollment of patients in the trial across multiple sites in India has already begun and the trial is expected to be completed in the upcoming 8-10 weeks.
The CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu will be partnering in this trial.
Partner institute IICT’s director S Chandrasekhar told the news agency that if approved the drug can be made easily available all over the country at an affordable price since India is one of its largest producers.
India recorded 367,081 Covid-19 fatalities since the pandemic started. The country has the second-highest number of coronavirus cases in the world after the United States, and the third-highest death toll in the world, right behind the US and Brazil.