In a positive move, the Drugs Controller General of India (DCGI) has approved the manufacturing and marketing of the first oral antiviral drug in the Indian market. Following the approval, Mumbai-based drug company Glenmark Pharmaceuticals launched the latest anti-viral drug called Favipiravir under a new brand named FabiFlu. The drug is expected to treat coronavirus patients with mild to moderate symptoms.
The company has capped the price at Rs 3,500 for a pack of 34 FabiFlu tablets, each containing 200mg tablets, priced at Rs 103 individually. Medical experts have suggested that the dosage of the new drug is 200mg x 9 tablets on the first day and 200mg x 4 tablets for 14 days in a row to combat the infection. The drug is sold on a prescription basis only.
According to Glenmark, the antiviral drug will be supplied both through medical centres as well as retail networks.
According to reports, 11 areas in India were involved during the clinical trials performed by Glenmark, where around 90 patients with mild Covid-19 symptoms and 60 moderate patients were tested. The drug has proved to be effective with as high as 80% in treating infected patients.
Associate Director of Internal Medicine, Max Healthcare, Dr Rommel Tickoo claimed that the drug is expected to be a "potential game-changer."
PTI quoted Dr Rommel Tickoo saying, "We don't have much data, but whatever data we have shows that it is promising. We will have clearer information about the efficacy of the drug in the next two months. The preliminary report is promising which means that they (Glenmark) know that it works." He further added, "It has to be given at an early stage and is a potential game-changer as it can be given in tablet form and thus is easy to administer, and is relatively inexpensive."
Glenmark was responsible for developing the API (Active Pharmaceutical Ingredient) and the preparation of FabiFlu through extensive research and development. According to reports, rapid phase III human trials were permitted by the DCGI but on a limited scale.
However, the Emergency Use Authorization (EUA) is yet to give its approval. With positive cases and fatality rates increasing in the country, it is a pressure on the scientists and medical experts to develop an effective drug to battle the infection.
Glen Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals said, "The approval comes at a time when cases in India are spiralling like never before, and putting tremendous pressure on our healthcare system. FabiFlu will reduce this pressure. Glenmark will work with the government and medical community to make it quickly accessible to patients across the country."
The pharmaceutical firm is working at its Ankleshwar plant to develop active pharmaceutical ingredients (API), while the formulation is being manufactured at their Baddi plant.
Glenmark claimed that patients with diabetes and heart problems, along with mild symptoms of COVID-19 can take the drug. According to claims, the drug enters the cell, starts the activity of viral replication and reduces the load of the virus within four days, the company said.
Dr Vikas Maurya, Director, Fortis Hospital, Department of Pulmonology and Sleep Disorders was quoted as saying, "It is not a magic bullet as it is not the only thing we have to give. This is not a specific drug made for Covidi-19 and is useful, but how much it will be useful we will have to see. Real efficacy will be known when administered on a large scale."
Glenmark is expected to supply at least two strips of FabiFlu for approx 82,500 patients in the first month. According to sources, other Indian firms like Brinton Pharmaceuticals in Delhi, Bengaluru based Strides Pharma, Mumbai-based Lasa Supergenerics and others have also applied for the approval, and are preparing for the drug to roll out in India.