Biocon Biologics gets DCGI nod for use of CytoSorb in critical COVID-19 cases
Biopharmaceutical company Biocon on Wednesday announced that its subsidiary Biocon Biologics has received the Drugs Controller General of India's (DCGI) approval for CytoSorb, an extracorporeal blood purification (EBP) device.
CytoSorb is aimed at reducing pro-inflammatory cytokines levels in critical COVID-19 patients who are being treated in the intensive care unit (ICU) with confirmed or imminent respiratory failure.
The license will be effective until COVID-19 is controlled in the country and will be used for emergency use of CytoSorb to treat COVID-19 patients who are 18 or above.
"As a science-led organization, Biocon's endeavour is to provide innovative solutions to patients to address their unmet needs. CytoSorb is an in-licensed unique device that reduces cytokine storm in critically ill patients and was introduced by Biocon in India in 2013," said Kiran Mazumdar-Shaw, Executive Chairperson, Biocon.
"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. CytoSorb will be an important addition to the Indian medical community's arsenal against the deadly coronavirus," she added.