Indian drugmakers Cipla and Hetero Drugs have received an emergency marketing approval for the antiviral remdesivir for the treatment of severe Covid-19 patients from the drug controller of India. These companies had earlier received regulatory approval from the Drug Controller General of India to manufacture the drug.
The emergency approval is typically given to an unapproved therapy for lifesaving use with a precondition that the approved manufacturer or seller share the clinical data of the drug on patients to whom it was administered. As per this condition, the drug is permitted to be used only in hospitals or approved medical institutions.
Remdesivir is an experimental drug from the US drug researcher Gilead Sciences. This molecule has been found helpful in bringing down the viral load on patients, though the complete efficacy of it on severe patients is yet to be confirmed. Gilead has already given voluntary licenses to five Indian companies to manufacture this drug. The other licensees include Jubilant Pharma, Zydus Cadila and Dr Reddys Laboratories. These companies are awaiting the drug regulator’s a nod from the drug regulator are
The Government’s current Clinical Management Protocol for COVID-19 permits remdesivir as an “investigational therapy” for patients with oxygen support, though it excludes pregnant women, children under the age of 12 and patients with severe renal ailment