New Delhi: Biocon said Wednesday that its medical device to treat COVID-19 patient has received approval from the Drugs Controller General of India (DCGI). The medical device has been made by a subsidiary of Biocon which is a biotechnology.
‘Biocon Biologics’, a unit of the company, has got the DCGI nod for ‘CytoSorb’ It is an extracorporeal blood purification device to reduce pro-inflammatory cytokines levels in COVID-19 patients. The machine will be useful to those admitted to ICU 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. The patients must be 18 years of age or older, the company said in a statement. The licence will be effective until control of the COVID-19 outbreak in the country, Biocon said.
“DCGI approval for emergency use of CytoSorb is an important example of how industry and regulators are working in tandem. The device will provide physicians and patients with new treatment options in the fight against COVID-19. This certainly is an important development, Biocon executive chairperson Kiran Mazumdar-Shaw said.
CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus, added Mazumdar-Shaw.
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’. It is also known as ‘Cytokine Release Syndrome’. It leads to excessive inflammation, organ failure and death. The goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification.
Biocon Biologics has received approval from DCGI in ‘Form MD-15’ (medical device) for reducing pro-inflammatory cytokine levels. This in turn will control the cytokine storm and benefit critical COVID-19 patients, the company said.
In April, the US Food and Drug Administration had granted emergency use authorisation of CytoSorb for use in patients with COVID-19.
PTI
