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

The Drugs Controller General of India (DCGI) has given approval to the CSIR and Laxai Life Sciences Private Limited to conduct clinical trial of Colchicine on COVID-19 patients, according to a statement on Saturday.

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

A number of global studies have confirmed that cardiac complications during course of COVID-19 infections and post-Covid syndrome are leading to loss of many lives, and it is essential to look for new or repurposed drugs, he said.

"Council of Scientific & 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 improvement of clinical outcomes during the treatment of COVID-19 patients,” the statement said.

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

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Frequently Asked Questions

How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

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There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

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Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Regulatory nod for conducting clinical trials of Colchicine on COVID-19 patients: CSIR

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

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

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