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DCGI approves use of favipiravir for restricted emergency use in moderate Covid-19 cases

India’s drug regulator has approved anti-viral drug favipiravir for “restricted emergency use” in mild to moderate cases of COVID-19, official sources said, as instances of coronavirus infection and fatalities in the country continued its steady upward trend.

DCGI approves use of favipiravir for restricted emergency use in moderate Covid-19 cases
DCGI approves use of favipiravir for restricted emergency use in moderate Covid-19 cases
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Published : Jun 21, 2020, 8:45 AM IST

New Delhi: In a major development, India's Drug Controller General of India (DCGI) has approved manufacture and sale of anti viral drug Favipiravir, which is considered as an influential drug against the coronavirus and is believed to increase India's Covid-19 recovery rate.

The permission to Glenmark Pharmaceutical's Favipiravir to treat Covid-19 patients with mild and moderate patients in India, was given following the recommendations of special subject expert committee on COVID-19.

"Glenmark Pharmaceutical has received the manufacturing and marketing approval from DCGI to launch the oral anti viral drug for the treatment of patients with mild to moderate cases of Covid-19," the company said in a statement.

Each strip of Favipiravir (FabiFlu) containing 34 tablets will costs Rs 3,500. A COVID-19 patient need to complete a course of 122 tablets in two weeks.

Sources said that following the approval, Glenmark Pharmaceutical will now have to submit a copy of the informed consent and report of the ongoing clinical trial within three months.

It is suggested that the drug should be used with caution for patients with history of differences in metabolism of uric acid.

The company has also been asked for a surveillance on the first 1000 patients to assess safety and efficacy of the drugs.

Hailing the development, Giridhar Gyani, director general to Association of Healthcare Providers-India (AHPI) said, "It's a good decision of giving approval for Favipiravir drugs which has been proven effective against Covid-19 disease."

He believes that in the coming days more drugs will come which would be effective against Covid-19.

Mentioning that the drug was being studied to treat other infectious diseases, Gyani said that Favipiravir, is an antiviral drugs used to treat influenza in Japan.

Meanwhile, statistics show that in the last 24 hours, a total of 9,130 Covid-19 patients have been cured taking the total figure to 213830 with a percentage of 54.13. There are 1,682,69 active Covid-19 cases in India till date.

As many as 66,164,96 samples have been tested in the country's 974 testing centres, the health ministry said.

India till Saturday has recorded 12948 deaths with 375 reported in last 24 hours. Total number of virus cases stand at 3,950,48.

However, states like Maharashtra with 124331 coronavirus cases, Delhi with 53116 cases and Tamil Nadu with 54449 cases remain a cause of concern for the Health Ministry.

Also read: Military chopper, fighter jet activity seen in Leh

New Delhi: In a major development, India's Drug Controller General of India (DCGI) has approved manufacture and sale of anti viral drug Favipiravir, which is considered as an influential drug against the coronavirus and is believed to increase India's Covid-19 recovery rate.

The permission to Glenmark Pharmaceutical's Favipiravir to treat Covid-19 patients with mild and moderate patients in India, was given following the recommendations of special subject expert committee on COVID-19.

"Glenmark Pharmaceutical has received the manufacturing and marketing approval from DCGI to launch the oral anti viral drug for the treatment of patients with mild to moderate cases of Covid-19," the company said in a statement.

Each strip of Favipiravir (FabiFlu) containing 34 tablets will costs Rs 3,500. A COVID-19 patient need to complete a course of 122 tablets in two weeks.

Sources said that following the approval, Glenmark Pharmaceutical will now have to submit a copy of the informed consent and report of the ongoing clinical trial within three months.

It is suggested that the drug should be used with caution for patients with history of differences in metabolism of uric acid.

The company has also been asked for a surveillance on the first 1000 patients to assess safety and efficacy of the drugs.

Hailing the development, Giridhar Gyani, director general to Association of Healthcare Providers-India (AHPI) said, "It's a good decision of giving approval for Favipiravir drugs which has been proven effective against Covid-19 disease."

He believes that in the coming days more drugs will come which would be effective against Covid-19.

Mentioning that the drug was being studied to treat other infectious diseases, Gyani said that Favipiravir, is an antiviral drugs used to treat influenza in Japan.

Meanwhile, statistics show that in the last 24 hours, a total of 9,130 Covid-19 patients have been cured taking the total figure to 213830 with a percentage of 54.13. There are 1,682,69 active Covid-19 cases in India till date.

As many as 66,164,96 samples have been tested in the country's 974 testing centres, the health ministry said.

India till Saturday has recorded 12948 deaths with 375 reported in last 24 hours. Total number of virus cases stand at 3,950,48.

However, states like Maharashtra with 124331 coronavirus cases, Delhi with 53116 cases and Tamil Nadu with 54449 cases remain a cause of concern for the Health Ministry.

Also read: Military chopper, fighter jet activity seen in Leh

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