The National Drugs Authority (NDA) has approved the importation of Remdesivir injection into the country to be used in the management of Covid-19.
In a letter to all pharmaceutical importers, Dr David Nahamya, the NDA secretary, yesterday said the injection will strictly be imported for use within healthcare facilities designated for management of Covid-19 where patients can be closely monitored.
“There is growing clinical and scientific evidence indicating that Remdesivir injection shows potential for positive clinical outcomes in the management of Covid-19. As a result, the drug has received emergency use authorisation for the management of Covid-19 from a number of drug regulatory authorities worldwide,” the statement reads in part.
In June, India’s Cadila Healthcare entered into a non-exclusive agreement with U.S. bio-pharmaceutical company - Gilead Sciences Inc to manufacture and sell Remdesivir, XinhuaNet states.
The investigational drug has been issued an Emergency Use Authorisation by the US Food and Drug Administration (FDA) to treat patients suffering from severe symptoms of Covid-19.
Dr Nahamya said the pharmacist in charge will submit periodic accountability on the use and distribution of the drug when required by NDA.
“The pharmacist shall be professionally responsible for ensuring safety of patients during the usage of product, the importer shall liaise with manufacturer to avail quality data confirming that manufacturing processes and controls will consistently produce product of suitable quality for the intended use,” reads the statement.