After Hetero and Cipla, Mylan has received permission from CDSCO to manufacture and market anti-viral drug remdesivir for ‘restricted emergency use’, 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.
The Union Health ministry recommended the use of the drug in COVID-19 patients with moderate stages of the illness (those on oxygen support).
It is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, the document stated.
The drug, administered in the form of an injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for five days.
“The approval was given by the CDSCO on Thursday,” an official source in the know of the developments told PTI.
Jubilant, BDR and Dr Reddy’s Labs have also applied to CDSCO for permission to manufacture and market the drug in India and are still awaiting due permission.