New Delhi: Drugmaker Mylan NV said on Monday it secured approval to launch its generic version of Gilead Sciences Inc's Covid-19 treatment drug remdesivir in India this month at ₹4,800 per 100 mg vial, as infections surge in the world's third worst-hit country by the virus.
The Drug Controller General of India (DCGI) approved Mylan's remdesivir version, to be launched under brand name Desrem, for restricted emergency use in Covid-19 patients, the company said in a statement
Mylan secured regulatory approval for remdesivir lyophilized powder for injection of 100 mg/vial for restricted emergency use.
Mylan's version comes after two Indian drugmakers, Cipla Ltd and privately-held Hetero Labs Ltd, launched their generic versions of the drug.
Cipla will price its version, Cipremi, at less than ₹5,000, while Hetero has priced its version, Covifor, at ₹5,400.
Gilead has priced remdesivir at $2,340 per patient for wealthier nations. It has agreed to send nearly all of its supply of the drug to the United States over the next three months, stirring concerns about availability elsewhere.
Remdesivir is in high demand after the intravenously-administered medicine helped to shorten hospital recovery times in a clinical trial. On Friday, it got conditional approval from the European Commission for use in severe COVID-19 patients.
Mylan NV said Mylan will manufacture remdesivir in India at its injectables' facilities. The drug has been approved in India for the treatment of suspected or laboratory confirmed severe incidences of COVID-19 in adults and children, the company said in a statement.
Gilead has signed licensing agreements with India's Dr.Reddy's Laboratories Ltd, Jubilant Life Sciences Ltd, Syngene International Ltd and Zydus Cadila, listed as Cadila Healthcare Ltd, to make and sell remdesivir.
The Union Health Ministry on Friday has revised the dosage of the antiviral drug--remdesivir, being administered to hospitalized Covid-19 patients from the earlier six-days to five-day treatment course.
According to the Health Ministry, remdesivir drug is only for restricted emergency use on patients with moderate disease (those on oxygen support). The drug cannot be administered to a pregnant or lactating mother and children below the age of 12 years. Also, the drug is not recommended to a patient with severe renal impairment and a high level of liver enzymes.
The Central Health Ministry has issued a fresh clinical management protocol for COVID-19 patients on Friday. In the latest protocol, the ministry has informed the dosage of remdesivir should be-- 200 mg IV on day 1 followed by 100 mg IV daily for 4 days (5 days in total). However, in the previous clinical protocol issued on June 13, the Health Ministry stated that the patient has to be administered with 200 mg IV on day 1 followed by 100 mg IV daily for 5 days, that was, 6 days in total.