The Drugs Controller General of India (DCGI) has given go-ahead to a medical device of Biocon Biologics to treat critical COVID-19 patients. Biocon Biologics is a subsidiary of Biotechnology major Biocon.
In a statement, Biocon said approval has been given for an extra corporeal blood purification device CytoSorb to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit with confirmed or imminent respiratory failure
The company has been granted licence for emergency use of CytoSorb in public interest to treat COVID-19 patients who are 18 years of age or older, it added.
The licence will be effective until control of the COVID-19 outbreak in the country, Biocon said.
“DCGI approval for emergency use of CytoSorb for critical COVID-19 patients is an important example of how industry and regulators are working in tandem to urgently provide physicians and patients with new treatment options in the fight against COVID-19,” Biocon Executive Chairperson Kiran Mazumdar-Shaw was quoted as saying by PTI.
CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus, she added.
The device reduces cytokine storm in critically ill patients and was introduced by Biocon in India in 2013. Since then, many patients undergoing organ transplant and sepsis treatment have benefitted from it.
Studies have shown that COVID-19 patients who develop serious complications experience a ‘cytokine storm’, also known as Cytokine Release Syndrome, which leads to excessive inflammation, organ failure and death.