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 hospitalised 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. 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. — PTI