Glenmark Pharmaceuticals had on Friday received manufacturing and marketing approval from India’s drug regulator, making FabiFlu the first oral Favipiravir-approved medication in India for the treatment of COVID-19 .
FabiFlu will be used for treating COVID-19 patients with mild to moderate symptoms and will be made available from today evening and by next week across the country. The company has got approval under emergency category.
Each tablet of 200 mg costs ₹103 and a strip containing 34 tablets has been priced at ₹3500. It will be made available at hospitals and chemist shops and will be sold under medical presciption.
On the first day, a patient will be administered 1800 mg twice each. From the second day, the patient will be given 800 mg twice a day for upto 14 days as per the doctor’s advice. The medicine can be administered to patients between the age group of 18 and 75.
Since the approval is under emergency category due to the pandemic, the patient has to give an undertaking before consuming the medicine.
70 to 80% of Covid-19 patients are from the mild and medium category for which the drug has been approved. A patient of this type need not be admitted to the hospital and can stay at home.
Glenmark is taking care of end to end processes of this medication starting from manufacturing API and development of formulation to manufacturing as well as marketing and supply. Company executives said this will help in reducing the pressure on hospitals.
Clinical trial is on for 150 patients in India. For the next stage, the company is planning for a combination trial for Covid-19 treatment.
Once administered the drug will help in bringing down the viral load on the patient, company executives said.
Glenmark is the first company to come out with an oral antiviral drug for mild and moderate Covid-19 treatment.
Favipiravir has been used in Russia, Japan and China to treat such patients and has been proved successful.
At the moment the drug will be under restricted use, which means it can be consumed only under doctor’s guidance and supervision. People without prescription cannot buy it.