Written By: Longjam Dineshwori | Updated : June 22, 2020 11:18 AM IST
Earlier this month, the DCGI had approved remdesivir for “restricted emergency use” on severely ill hospitalised coronavirus patients.
Two domestic pharmaceutical companies--Cipla and Hetero have received green light from the Drug Controller General of India (DCGI) to manufacture and sell anti-viral drug remdesivir for the treatment of COVID-19 patients in the country.
Remdesivir is an antiviral drug originally developed to treat Ebola. The U.S. Food and Drug Administration (USFDA) had already given emergency use authorisation (EUA) of this investigational drug for treatment of hospitalised patients with severe COVID-19. Earlier this month, the DCGI had also approved it for "restricted emergency use" on severely ill hospitalised coronavirus patients. Cipla and Hetero will be required to follow the same conditions set out by the DCGI.
Last month, US based Gilead Sciences the patent holder of the drug remdesivir had signed non-exclusive voluntary licensing agreements with five Indian generic pharma firms -- Cipla, Jubilant Life Sciences, Hetero, BRD and Mylan -- for production and sale of remdesivir. Following which, these five domestic pharma giants and another drug company Dr. Reddy's Labs sought permission from the India's drug regulator to make and sell remdesivir in the country. Among these 6 companies, only Hetero and Cipla have got approval from the DCGI so far.
Hyderabad-based Hetero will sell its generic version of Gilead's Remdesivir under the brand name 'Covifor' in India. According to the company, Covifor will be available in 100 mg vial (injectable) and it will be only given intravenously in a hospital setting under the supervision of a healthcare practitioner and after getting the consent of the patients. Company officials informed a leading national daily that each 100 mg vial may costs between 5,000 and 6,000. Currently, remdesivir is also being imported from Bangladesh and it costs as much as Rs 10,000 per dose. Once local production starts, the cost of treatment (11-dose course per patient) will come down drastically.
Covifor will not be retailed through chemists, it will only be made available to hospitals treating COVID-19 patients, the company officials told the daily. The company is likely to start supply of the drug in a week.
In its latest clinical management guidelines for COVID-19, the union health ministry has described the use of Remdesivir drug as investigational therapy on coronavirus patients. It said that the drug cannot be administered to a pregnant or lactating mother, children below age of 12years and people with liver problems and renal complications.
Domestic firm Glenmark Pharmaceuticals has also received nod from the DGCI to manufacture and market oral anti-viral drug Favipiravir, under the brand name FabiFlu, for the treatment of mild to moderate COVID-19 patients in the country.
Glenmark was also the first domestic company to be given approval by the drug regulator to conduct Phase 3 clinical trial of Favipiravir antiviral tablets for COVID-19 patients. The study included patients from over 10 leading government and private hospitals. Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan. Glenmark has successfully developed the API (Active Pharmaceutical Ingredient) and the formulations for the product through its inhouse R&D team. It has been approved in Japan for the treatment of novel influenza virus infections
