Colchicine approved for clinical drug trial by DCGI

On Saturday, it was reported that the Council of Scientific and Industrial Research (CSIR) and Laxai Life Sciences Private Limited have received the Drugs Controller General of India’s (DCGI) regulatory approval to conduct the clinical drug trial of Colchicine.

CSIR in a statement said that CSIR and Laxai Life Sciences Pvt Ltd Hyderabad have been given the regulatory approval by DCGI to ‘undertake the two-arm phase-II clinical trial to assess the safety and effectiveness of Colchicine’ in the improvement of COVID-19 patients.

The advisor to CSIR’s director general, Ram Vishwakarma, told PTI that a number of studies have shown COVID-19 patients to develop cardiac complications during the course of the infection, which led to the loss of many lives.

Colchicine is a new drug which when administered in combination with the standard care, has the potential to act as an important therapeutic intervention for COVID-19 patients. This drug leads to faster recovery of the patients suffering from pro-inflammatory cytokines or with cardiac comorbidities.

Ram Upadhyay, the Laxai Life Sciences CEO, mentioned that the enrolment of patients in the trial across multiple sites in India has already begun and the trial is expected to be completely in the upcoming 8-10 weeks. The CSIR-IICT Hyderabad, and CSIR-IIIM Jammu, will be partnering in this trial.

“If the drug gets approved then it can be made easily available all over the country at an affordable price since India is one of its largest producers,” said Partner Institute IICT’s director S Chandrasekhar.

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