Hetero Gets DCGI Nod To Launch COVID-19 Drug ‘Covifor’
New Delhi: Drug firm Hetero on Sunday said it has received approval from regulator DCGI to launch investigational antiviral drug Remdesivir for the treatment of COVID-19.
Domestic pharma firm Glenmark Pharmaceuticals had on Saturday launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a price of about Rs 103 per tablet
Hetero has received the manufacturing and marketing approval for Remdesivir from the Drug Controller General of India (DCGI) for the treatment of COVID-19, it said in a statement.
Hetero’s generic version of Remdesivir will be marketed under the brand name ‘Covifor’ in India.
The drug 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, it said.
Asked about the price of the drug, Hetero Group of Companies MD Vamsi Krishna Bandi told PTI it will be in the range of Rs 5,000-6,000 per dose.
Currently, the drug is being manufactured at the company’s formulation facility in Hyderabad. The active pharmaceutical ingredient (API) is being made in the firm’s Visakhapatnam facility, he added.
The drug will be available only through hospitals and government, and not the retail channel, Vamsi said
The company is focused on providing one lakh doses in the next few weeks, and the production can be ramped up based on demand, he added.
The drug has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalised with severe symptoms of the disease, the company said.
“In the light of increasing COVID-19 cases in India, the approval of ‘Covifor’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes.
“Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country,” Hetero Group of Companies Chairman B ParthaSaradhi Reddy said.
The company is prepared for ensuring enough stocks to cater to the present needs, he added.
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, Hetero said.
In May, domestic pharma firms Hetero, Cipla and Jubilant Life Sciences had entered into non-exclusive licensing agreements with drug major Gilead Sciences Inc for manufacturing and distribution of Remdesivir.
The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (USFDA) to treat COVID-19 patients.