CDSCO shows green flag to Mylan for remdesivir for 'restricted emergency use'
Written informed consent of each patient is required before the use of the drug while active post-marketing surveillance data and reporting of serious adverse events have to be submitted.;
New Delhi: After Hetero and Cipla, another pharmaceutical major Mylan was given permission by India's drug regulator on Thursday to manufacture and market the anti-viral drug remdesivir for "restricted emergency use" on hospitalized COVID-19 patients, official sources said.
Written informed consent of each patient is required before the use of the drug while active post-marketing surveillance data and reporting of serious adverse events have to be submitted.
On June 21, Hetero and Cipla were given permission to manufacture and market the drug on the same conditions.
The Union Health Ministry in its 'Clinical Management Protocols for COVID-19' recommended the use of the drug in COVID-19 patients with moderate stages of the illness (those on oxygen support).
The drug has been included as an "investigational therapy" only for restricted emergency use purposes.
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