City-based firm gets DGCI nod for phase 2 drug trials

Council of Scientific & Industrial Research (CSIR), and city-based Laxai Life Sciences have been given the regulatory approval by Drugs Controller General of India (DGCI) to undertake a two-arm 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.

CSIR institutes in this important clinical trial are the Indian Institute of Chemical Technology (IICT) in Hyderabad and Indian Institute of Integrative Medicine (IIIM) at Jammu.

“CSIR’s two partner institutes are looking forward to the outcome of this phase II clinical efficacy trial on Colchicine, which may lead to life-saving intervention in the management of hospitalised patients. 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 IICT director S. Chandrasekhar and IIIM director DS Reddy in a joint statement.

Enrolment of patients for clinical trials has already begun at multiple sites across the country and is likely to be completed in the next 8-10 weeks. This drug can be made available to the large population based on the results of trials and regulatory approval, said Laxai CEO Ram Upadhayay.

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Printable version | Aug 2, 2021 3:55:54 PM | https://www.thehindu.com/news/cities/Hyderabad/city-based-firm-gets-dgci-nod-for-phase-2-drug-trials/article34805293.ece

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