Hetero Labs and Cipla have received approvals from the Drug Controller General Of India (DCGI) to to manufacture and market much awaited remdesivir for the treatment of severe Covid-19 patients.
The emergency approval is given to an unapproved therapy for compassionate use provided drug companies share the clinical data of the drug on patients where it is used.
Remdesivir is an experimental drug from US based drug maker Gilead that has shown to bring down the viral load in patients and hence help in faster discharge.
The efficacy of the drug on severe patients is still under study. Gilead sciences had earlier given voluntary licenses to five Indian companies to manufacture and sell this drug.
An updated Clinical Management Protocol for COVID-19 released by the government last week has approved Remdesivir as an “investigational therapy” for patients with moderate disease (those on oxygen). It excludes pregnant women, children under the age of 12, patients with severe renal ailment from using this drug.
“Patient can be administered with 200 mg IV on day 1 followed by 100 mg IV daily for 5 days. The drug cannot be administered to a pregnant or lactating mother and children below age of 12years. The drug is not recommended to patient with liver problems and renal complications,” stated the clinical management protocol on Covid-19.
The other licensees of Gilead who are awaiting a nod from the drug regulator are Jubilant Pharma, Zydus Cadila, Dr Reddys.
Gilead had signed non-exclusive voluntary licensing agreements with five generic pharma firms — Cipla, Jubilant Life Sciences, Hetero, BRD and Mylan to manufacture and distribute remdesivir, a potential antiviral therapy for Covid-19.
Following which, the six domestic pharma giants–Cipla, Hetero Labs, BRD, Mylan, Jubilant Life Sciences, Dr. Reddy’s Labs approached to the India’s drug regulator to make and sell remdesivir in the country.
