Biocon gets DCGI nod for device to treat critical COVID-19 patients
Biotechnology major Biocon on Wednesday said its subsidiary has received approval from the Drugs Controller General of India (DCGI) for a medical device to treat critical COVID-19 patients.
Biocon Biologics, a unit of the company, has got DCGI nod for an extracorporeal 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, Biocon said in a statement.
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 said.
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.
The goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented.
Biocon Biologics has received approval from DCGI in Form MD-15 (medical device) for reducing pro-inflammatory cytokine levels in order to control the cytokine storm and benefit COVID-19 patients who are in a critical condition, the company said.
In April, the US Food and Drug Administration (USFDA) had granted emergency use authorisation of CytoSorb for use in patients with COVID-19.