India’s First Oral Vaccine for Moderate COVID-19 Cases gets Approval

For the treatment of mild to moderate COVID-19 positive patients across the country, on 19th June 2020, for manufacturing and marketing of oral antiviral drug ‘Favipiravir (Fabiflu)’ was approved by the National Regulatory Authority for Indian pharmaceuticals -Central Drugs Standard Control Organisation (CDSCO) to Mumbai based Glenmark Pharmaceuticals.

The approval for the drug was given in India based on the global evidence of the ongoing clinical trial on 150 subjects. The drug must be strictly sold by the pharmacists to customers having a valid prescription.

Background

The drug has shown notable efficacy as per results from Russia and Japan. Japan and Russia have already approved the drug for COVID-19 treatment on 15th March and 1st June 2020 respectively.

Favipiravir

It is an antiviral drug that was approved first in the year 2014 in Japan. Tokyo based Toyama Chemicals was the first to develop and manufacture the drug. The drug has been used to treat a number of viral infections over the years, especially for influenza. In 2019 it became a generic drug.

The drug targets the Ribonucleic Acid (RNA) polymerase (RdRp) enzymes that are dependent on RNA. For transcription and replication, the RNA polymerase enzymes are necessary for the DNA or RNA genes of the virus.

Medication

Glenmark Pharmaceuticals has assured the availability of the drugs in the next 7 to 10 days across the country. The price of each tablet will be Rs 103/-. The tablets will be available in a combined strip of 34. The cost of the strip will be Rs 3,500. Each tablet will be of 200 mg.

On the first day of treatment, the patient is advised to take 18 tablets (9 each in the morning and evening). From the second day onwards, 4 tablets each in the morning and evening. The company has stated that the treatment through Favipiravir could last up to 14 days.

The medication is for COVID-19 positive patients in the age group from 18 to 75 years having mild to moderate symptoms of COVID-19.

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