DCGI gives nod to Hetero Labs and Cipla to manufacture and market remdesivir

The Drug Controller General of India (DCGI) on Saturday gave approval to both Hetero Labs and Cipla 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.

Sources told ET that the approval was given after the companies presented their “test analysis” report to the drug regulatory authority.

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.

The other licensees of Gilead who are awaiting a nod from the drug regulator are Jubilant Pharma, Zydus Cadila, Dr Reddys.

Amid spike in the number of Covid cases, patients have even resorted to importing the drug from Bangladesh for personal use. There are also reports that a few domestic companies are supplying it unapproved at Rs 7,000 per vial.

Gilead has on June 1 received emergency approval from India’s drug controller to sell Remdesivir under the brand name Veklury. It had earlier told ET that its own brand of the drug will be available in the country from next month.