The Drug Controller General of India (DCGI), on Sunday, approved Hetero, an Indian pharmaceutical company, to manufacture and retail the investigational antiviral drug Remdesivir for treating COVID-19 patients. The generic version of Remdesivir produced by Hetero will be sold in India, under the name COVIFOR and will be launched under a licensing agreement with Gilead Sciences Inc.
Dr. B. Partha Saradhi Reddy, Chairman of the Hetero Group of Companies, after getting the approval from DCGI 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."
The Ministry of Health and Family Welfare (MoHFW) in June, approved the use of antiviral drug Remdesivir as an "investigational therapy" for emergency cases related to COVID-19. The drug got approval from DCGI for treating patients, who are suffering severely due to the virus after MoHFW updated the Clinical Management Protocol for COVID-19 patients. The ministry also approved the off-label application of immunomodulator, tocilizumab and convalescent plasma therapy for treating patients in the medium stage of criticality.
This drug has to be injected intravenously under the supervision of a doctor or medical staff only and will be available in the market in 100 mg vials.
"We are prepared to ensure supply of enough stocks required to cater to the present need. We will continue to work closely with the government and medical community to make a difference in the fight against Covid-19. This product is made indigenously in line with Prime Minister Narendra Modi's Make in India campaign," added Dr. Reddy.
Another India-based pharmaceutical company named Glenmark Pharmaceuticals, on Saturday launched an antiviral drug called Favipiravir, which will be sold under the brand FabiFlu to treat patients with mild to moderate symptoms of the virus.