Oral antiviral drug favipiravir will be available in the Indian market under the brand name FabiFlu at Rs 103 for a tablet from Glenmark Pharma that secured the drug regulator's nod on Friday to manufacture and market the drug in India. It will be used to treat patients with mild to moderate Covid-19 infection.
The drug has shown promise in multiple global studies - reduction in viral load, faster fever resolution, and faster clinical recovery. In India the drug would be sold both at retail chemist outlets as well as hospitals. This is an emergency use authorisation due to the pandemic situation prevalent in the country and the need for timely treatment.
Whenever a doctor prescribes favipiravir, he would have to do so with an 'informed consent' from the patient. A patient with a valid prescription can procure the drug from a retail chemist. This is because the drug is to be used on mild to moderate patients, many of whom may not need hospitalisation.
Sujesh Vasudevan, President India Formulations, Middle East and Africa, Glenmark Pharmaceuticals said that the drug would be made at the company's Baddi facility in Himachal. Glenmark would also make the active pharmaceutical ingredients for the drug. "It will be available in areas close to our manufacturing site immediately, and we expect to make it available across the country within this week," Vasudevan said.
Commenting on whether he thought the price of the tablet was high at Rs 103, Vasudevan reasoned that the drug would also ensure that a patient recovered faster and did not slip into a severe stage of the disease that may require hospitalisation.
India is adding over 12,000 cases of Covid-19 positive patients everyday. About 70-80 per cent these are mild to moderately sick people. That means the potential market for the drug is roughly over 9000 users every day.
Industry sources, however, indicate that several players are ready to launch their version of favipiravir in the market and that the prices would come down soon. Already companies like Optimus Pharma and Brinton Pharma have started commercially exporting the drug from here.
Glenmark's stock prices had ended Friday's trade on BSE up only 0.93 per cent. The announcement on marketing approval, however, came in after the market hours. The company's net debt level was over Rs 3600 crore at the end of the third quarter. Fabiflu may give a decent push to its domestic business
While the company said that it would first cater to the domestic market requirements, it added that exports would depend on the regulatory requirements of other countries. The potential is significant - the drug is to be used in Turkey, it is available already in Bangladesh, approval granted in UAE, while the protocol is approved in Jordan. More than 15 companies are under registration approval process to launch the drug in Egypt. Indonesia and Thailand have approved clinical protocol, several CIS countries like Ukraine have already adopted it in Covid-19 protocol, Iraq and Saudi Arabia are evaluating the drug.
Glenmark did a randomised, multi-centric study in Indian patients evaluating efficacy and safety of favipiravir with standard of care versus standard of care alone in mild to moderate Covid-19. The sample size is roughly 150 patients for a treatment duration of 14-days across 11 sites across India.