Drugmaker Hetero has received the Drug Controller-General of India (DCGI) approval to manufacture and sell its generic version of Gilead’s Remdesivir for the treatment of COVID-19 patients in the country.
The generic version will be marketed under the brand name ‘Covifor’ in India, Hetero said about the product, that is being manufactured at its facility in Hyderabad.
Chairman of Hetero Group of Companies B. Partha Saradhi Reddy said the approval of Covifor (Remdesivir), amid the increasing COVID-19 cases in the country, can prove to be a game-changer given the positive clinical outcomes.
“Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country. We are prepared for ensuring enough stocks required to cater to the present needs,” he said in a statement on Sunday.
DCGI had granted approval for use of Remdesivir in the treatment of suspected or laboratory-confirmed cases of COVID in adults and children, hospitalised with severe symptoms of the disease. Covifor (Remdesivir) will be available in 100 mg vial (injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner, Hetero said.
Sources in the company said since the product has been approved for emergency use and in hospital/institutional set up only, it will not be retailed through chemists. Instead Covifor will be made available to hospitals treating COVID-19 patients. The supplies are expected to begin in a week.
Each 100 mg vial is likely to be priced between ₹5,000 and ₹6,000. The drug is to be administered only after getting the consent of patients.
Deals with Gilead
The product is being launched under a licensing agreement with Gilead Sciences Inc to expand access to COVID-19 treatment in low and middle-income countries. Besides Hetero, a clutch of other drugmakers, including Jubilant Lifesciences, Mylan, Dr. Reddy’s Laboratories, Biocon company Syngene and Zydus Cadila Healthcare, have entered into non-exclusive, voluntary licensing agreements with Gilead under which they get to manufacture the product for distribution in 127 countries.
An investigational drug, Gilead’s Remdesivir, had received emergency use authorisation (EUA) from the U.S. Food and Drug Administration (USFDA) for treatment of hospitalised patients with severe COVID-19.
The DGCI approval for Hetero’s product comes close on the heels of Glenmark Pharmaceuticals receiving the drug regulator’s nod to manufacture and sell oral antiviral drug Favipiravir, under the brand name FabiFlu, for treatment of mild to moderate COVID-19 patients in India.