October 16, 2021

DCGI grants regulatory approval to conduct clinical trials of Colchicine, drug for cardiac complications in Covid-19 patients

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The Drugs Controller General of India (DCGI) has granted regulatory approval for the Council of Scientific and Industrial Research (CSIR) and Laxai Life Sciences Private Limited for initiating clinical trials of the drug Colchicine, according to reports of the news agency PTI on Saturday.

In a statement, CSIR said, “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.”

Ram Vishwakarma, advisor to the director general, CSIR, said to PTI that several studies have shown Covid-19 patients get cardiac complications during the infection, which leads to loss of several lives, so a new or repurposed drug is important. Colchicine is such a drug which when given to the patient with care, can be the potential drug for Covid-19 patients with cardiac comorbidities, and for cutting down the pro-inflammatory cytokines, which once up the recovery process.

Laxai Life Sciences’ CEO Ram Upadhayay told PTI that the patients have already started enrolling in multiple sites at different parts of the country, and the trial will go on for 8-10 weeks.

The trial will be conducted in partnership with the CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu.

Partner institute IICT’s director S Chandrasekhar revealed to PTI that on approval Colcicine will be easily available throughout the country at an economical rate as India is one of the largest producers.

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