US’S Gilead to ship 50k more remdesivir vials
NEW DELHI US pharma major Gilead Sciences’ another shipment of 50,000 vials of its antiviral drug, remdesivir, is likely to reach India in the next couple of days, people aware of the matter said.
Injection remdesivir has emergency use authorization in India, and is also a part of India’s national clinical treatment protocol for Coronavirus disease (Covid-19).
“Around 1,50,000 doses were already shipped a few days back to Mumbai, and another consignment of about 50,000 vials (2 consignments of 25k each) is about to land in another couple of days,” said the person, on condition of anonymity.
With the sudden surge in Covid-19 cases, India faced acute shortage of the antiviral drug, and to meet the sudden increased demand, Gilead sciences that holds patent for the drug, announced that it was donating 4,50,000 vials of the injection to Indian government till the domestic production was scaled up.
The company has partnered with Klinera Global Services that holds market approval and import license of the antiviral in
India, making them the authorized distributor partner of Gilead’s in India.
The donations come at a zero cost to the Indian government.
“The scaling up takes time— at least three to four weeks— which is why the company decided to bridge the gap by making supplies in the interim period,” the person said.
Apart from donating vials, the company also announced that it will be providing its voluntary licensing partners with technical assistance, to rapidly scale up production in the wake of the exponential surge in cases.
“The recent surge of Covid-19 cases in India is having a devastating impact on communities and has created unprecedented pressure on health systems,” Johanna Mercier, chief commercial officer, Gilead Sciences, had said earlier.
“We are committed to doing our part to help tackle this crisis. Our immediate focus is to help address the needs of patients in India who may benefit from remdesivir as quickly as we can by working together with the government, health authorities and our voluntary licensees.”
Gilead sciences holds patent for remdesivir that is one of the investigational drugs prescribed under restricted emergency use in treating Covid-19 patients in India and globally. Remdesivir has broad-spectrum antiviral activity both in vitro (test-tube), and in vivo (living beings) in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-COV-2, the virus that causes Covid-19.
Gliead sciences has seven licensing partners based in India, and all seven of the licensees have significantly accelerated production of remdesivir by scaling up their batch sizes, adding new manufacturing facilities and/or onboarding local contract manufacturers across the country.
Experts in India, however, have been reiterating that the drug was no magic bullet, and one of the many investigational therapies recommended for use in Covid-19 patients.
“The drug hasn’t shown any mortality benefit in Covid-19 patients but in a US study it showed reduction in hospitalisation time by a few days,” said Dr Randeep Guleria, director, All India Institute of Medical Sciences, Delhi, who is also a senior pulmonologist in the country.