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Biocon will get DCGI nod for system to deal with important COVID-19 sufferers – Home Health Choices

Biocon Biologics, a subsidiary of Biocon, has acquired approval from the Drugs Controller General of India (DCGI) for its blood purification system CytoSorb meant for Covid-19 sufferers.

The system goes for use for extracorporeal blood purification (EBP) to cut back pro-inflammatory cytokines ranges in confirmed COVID-19 sufferers who’ve been admitted to the intensive care unit with confirmed or imminent respiratory failure, mentioned the corporate in a press launch.

The United States Food and Drug Administration in April accepted CytoSorb for emergency use in Covid-19 sufferers.

Biocon Biologics has been granted licence for emergency use of CytoSorb in public curiosity by the Indian well being regulator to deal with coronavirus sufferers who’re 18 years of age or older. The licence will probably be efficient till management of the Covid-19 outbreak within the nation, mentioned the corporate.

Studies have proven that COVID-19 sufferers who develop critical problems expertise a ‘cytokine storm,’ also called Cytokine Release Syndrome (CRS), which ends up in extreme irritation, organ failure and demise. CytoSorb remedy is aimed to cut back cytokine storm and the lethal inflammatory response via blood purification in order that this injury could also be mitigated or prevented.

The Company has acquired approval from DCGI in Form MD-15 (Medical Device) for lowering pro-inflammatory cytokine ranges as a way to management the cytokine storm and profit Covid-19 sufferers who’re in a important situation.

“CytoSorb was introduced by Biocon in India in 2013. Since then many patients undergoing organ transplant and sepsis treatment have benefitted from it. 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,” mentioned Kiran Mazumdar-Shaw, government chairperson, Biocon.

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