Covifor will only be available to hospitals treating COVID-19 patients.
Despite strict lockdown measures and contact tracing, COVID-19 cases continue to increase in alarming numbers in India. As of today, there are 4,25,282 confirmed cases and as many as 13,699 people have succumbed to the disease in the country, according to data on the Union Health Ministry website. There is good news amidst the gloomy headlines. The Drug Controller General of India (DCGI) has approved two highly touted antiviral drugs for the treatment of COVID-19 patients in the country - Remdesivir and Favipiravir. The drug regulator has also given approval to three domestic generic pharma companies to manufacture and market these drugs in the country. The generic versions of these drugs would be available under different brand names. Read on to know more when these drugs will hit the market and how effective it is against the novel coronavirus.
Hetero set to launch its generic version of Gilead's Remdesivir
Covifor is the generic version of Gilead's Remdesivir, which the Drug Controller General of India (DCGI) has approved for "restricted emergency use" on severely ill hospitalised coronavirus patients. The drug regulator has given approval to Hyderabad-based Hetero to manufacture and sell its generic version of Remdesivir under the brand name 'Covifor' in the country. Another domestic pharma company Cipla has also received the DCGI nod to manufacture the antiviral drug for the treatment of COVID-19 patients in the country.
According to officials at Hetero, Covifor will be available in 100 mg vial (injectable) form which may cost between 5,000 and 6,000. Imported remdesivir costs as much as Rs 10,000 per dose. This means once Covifor hits the market, COVID-19 treatment with this drug will cost not more than 30,000 per patient. A COVID-19 patient may be given around 5 to 6 doses of Covifor, according to the current Indian government guidelines. However, Covifor will be given intravenously in a hospital setting under the supervision of a healthcare practitioner and only after getting the consent of the patients, said the DCGI guidelines.
As it is only permitted under "restricted emergency use," Covifor will only be made available to hospitals treating COVID-19 patients. Also, the drug is not recommended for pregnant or lactating mother, children below age of 12 years and people with liver problems and renal complications.
Hetero is likely to start supply of the drug in a week, the company officials told a leading national daily.
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Glenmark Pharmaceuticals Gets DCGI Nod To Sell Fabiflu
Fabiflu is another antiviral drug that will hit the Indian market soon. It will be used for the treatment of mild to moderate COVID-19 patients in the country.
Domestic firm Glenmark Pharmaceuticals recently received nod from the DGCI to manufacture and market oral antiviral drug Favipiravir, under the brand name FabiFlu, in India. According to Glenmark, the prescription-based drug will be available as a 200 mg tablet at an MRP of 3,500 for a strip of 34 tablets, i.e. Rs 103 per tablet. The drug will be administered orally to mild to moderate COVID-19 patient 1,800 mg twice daily on day one, followed by 800 mg twice daily for up to day 14.
Unlike Covifor, FabiFlu will be available both through hospitals and the retail channel. Glenmark is developing the active pharmaceutical ingredients (API) for the drug at its Ankleshwar plant in Gujarat, and the formulation is being manufactured at its Baddi plant in Himachal Pradesh. Glenmark is aiming to provide FabiFlu for about 82,500 patients in the first month itself.
According to the drug manufacturer, Favipiravir administration has resulted in clinical improvement of up to 88 per cent in mild to moderate COVID-19 cases. The drug can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms, it said.
Glenmark was the first company in India to receive DGCI 's approval to conduct phase-3 clinical trial of Favipiravir antiviral tablets for COVID-19 patients. Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. and has been approved in the country for the treatment of novel influenza virus infections.
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