India bans exports of remdesivir

April 12, 2021

The Indian government has prohibited exports of the drug remdesivir as the country's coronavirus cases surge.

India reported 152,000 new cases of COVID-19 yesterday, taking the country's COVID toll to 13.3 million infections. The health ministry said the surge in cases has led to a "sudden spike in demand" for the antiviral drug.

Seven generic drug companies in India – Cipla, Hetero, Dr Reddy’s, Jubilant, Zydus Cadila, Mylan and Biocon’s Syngene – are producing remdesivir under voluntary licensing agreements with Gilead Sciences, who owns the patent under the brand name Veklury.

According to the Times of India, in order to increase the availability of the drug, the pharma industry in India has asked the government for emergency approval to manufacture remdesivir. An application for emergency approval could override the patent and open up production to other companies who do not have existing tie-ups with Gilead.

In October of last year, Gilead's Veklury (remdesivir) became the first COVID-19 treatment approved by the U.S. FDA. The FDA approval came despite  results from the WHO Solidarity Therapeutics Trial that found remdesivir to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients. But the remdesivir Solidarity findings conflicted with findings from the NIAID sponsored ACTT-1 trial — the results of which were cited in the FDA approval notice. NIAID's randomized, double-blind, placebo-controlled clinical trial evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. It found that the median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference.