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DCGI approves Favipiravir's manufacture & sale in India

The Drug Controller General of India (DCGI) has approved the manufacture and sale of antiviral drug Favipiravir in India. Accordingly, Glenmark Pharmaceutical's Favipiravir has been allowed to be used for treating Covid-19 patients with mild and moderate patients.

Favipiravir
Favipiravir
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Published : Jun 21, 2020, 4:15 AM IST

New Delhi: In a major development, Drug Controller General of India (DCGI) has approved the manufacture and sale of antiviral drug Favipiravir in India. Accordingly, Glenmark Pharmaceutical's Favipiravir has been allowed to be used for treating Covid-19 patients with mild and moderate patients in India.

It is believed that Favipiravir, which is considered an influential drug against Covid-19, could further increase India's Covid-19 recovery rate. The permission for the manufacture and sale of Favipiravir-200 mg tablet 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 antiviral drug for the treatment to mild and moderate Covid-19 patients," the company has said in a statement. Each strip of Favipiravir (FabiFlu) containing 34 tablets will cost Rs 3500. A Covid-19 affected person needs to complete a two-week course of 122 tablets.

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. The Association of Healthcare Providers-India (AHPI) hailed the development.

Also read: A consumer smartwatch can work as a powerful health-monitoring system

"It's a good decision of giving approval for Favipiravir drugs which has been proven effective against Covid19 disease," said Dr Giridhar Gyani, director general to AHPI. He believes that in the coming days more drugs will come which would be effective against Covid-19. It may be mentioned here that Favipiravir, is an antiviral drug used to treat influenza in Japan. It was also being studied to treat other infectious diseases.

Meanwhile, Health Ministry statistics said that in the last 24 hours, a total of 9130 Covid 19 patients have been cured taking the total figure to 213830 with a percentage of 54.13. There are 168269 active Covid cases in India till date. As many as 6616496 samples have been tested for the country's 974 testing centres, the ministry said. India till Saturday has recorded 12948 deaths with 375 reported in last 24 hours. Total number of Covid cases stands at 395048. However, states like Maharashtra with 124331 Covid cases, Delhi with 53116 cases and Tamil Nadu with 54449 cases remain a cause of concern for the Health Ministry.

New Delhi: In a major development, Drug Controller General of India (DCGI) has approved the manufacture and sale of antiviral drug Favipiravir in India. Accordingly, Glenmark Pharmaceutical's Favipiravir has been allowed to be used for treating Covid-19 patients with mild and moderate patients in India.

It is believed that Favipiravir, which is considered an influential drug against Covid-19, could further increase India's Covid-19 recovery rate. The permission for the manufacture and sale of Favipiravir-200 mg tablet 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 antiviral drug for the treatment to mild and moderate Covid-19 patients," the company has said in a statement. Each strip of Favipiravir (FabiFlu) containing 34 tablets will cost Rs 3500. A Covid-19 affected person needs to complete a two-week course of 122 tablets.

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. The Association of Healthcare Providers-India (AHPI) hailed the development.

Also read: A consumer smartwatch can work as a powerful health-monitoring system

"It's a good decision of giving approval for Favipiravir drugs which has been proven effective against Covid19 disease," said Dr Giridhar Gyani, director general to AHPI. He believes that in the coming days more drugs will come which would be effective against Covid-19. It may be mentioned here that Favipiravir, is an antiviral drug used to treat influenza in Japan. It was also being studied to treat other infectious diseases.

Meanwhile, Health Ministry statistics said that in the last 24 hours, a total of 9130 Covid 19 patients have been cured taking the total figure to 213830 with a percentage of 54.13. There are 168269 active Covid cases in India till date. As many as 6616496 samples have been tested for the country's 974 testing centres, the ministry said. India till Saturday has recorded 12948 deaths with 375 reported in last 24 hours. Total number of Covid cases stands at 395048. However, states like Maharashtra with 124331 Covid cases, Delhi with 53116 cases and Tamil Nadu with 54449 cases remain a cause of concern for the Health Ministry.

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