DCGI sends notice to Glenmark for “false claims and pricing” of Covid-19 drug favipiravir, Fabiflu

The Central Drugs Standard Control Organisation (CDSCO) has issued a showcause notice to Mumbai-based pharmaceutical giant Glenmark regarding the “false claims and pricing” of their recently-approved generic version of Covid-19 drug favipiravir, Fabiflu.
CDSCO, in its showcause notice to the company, said that it received a complaint from a Member of Parliament (MP) that the total cost of treatment with Fabiflu will be around Rs 12,500, and the cost proposed by Glenmark is “not in the interest of the poor, lower middle class and middle-class people of India”.
The CDSCO, under Drug Controller General of India (DCGI), Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) for Indian pharmaceuticals and medical devices.
“Further, it has been mentioned in the representation that Glenmark has also claimed that this drug is effective in co-morbid conditions like hypertension, diabetes, whereas, in reality, as per protocol summary, this trial was not designed to assess the Fabiflu in co-morbid conditions. No clinically sufficient data specific to these conditions are available,” the notice further said.
CDSCO said that as per an online press conference by Glenmark pharmaceuticals, the cost of Fabiflu is Rs 103 per tablet. As per the claim by the company, a patient has to take the tablet for 14 days, which means one patient will have to take approximately 122 tablets (18 tablets on Day 1 and 8 Tablets per day from day to day 14.). Total cost of treatment will be around Rs 12,500, the notice said.
It further mentions that while DCGI and health authorities “accelerated the process for clinical trials and reviews considering the pandemic situation, unmet medical conditions and unavailability of specific therapeutic management against Covid for this drug” but, “the cost proposed by Glenmark is definitely not in interest of the poor, lower middle class and middle-class people of India.”
Glenmark Pharmaceuticals Ltd had on Monday said it would lower FabiFlu, to 75 rupees ($0.9983) per tablet for restricted emergency use in patients with mild-to-moderate Covid-19 symptoms in India.
Glenmark last month received Indian regulatory approval to make and sell anti-flu drug favipiravir, which is manufactured under the brand name Avigan by a unit of Japan’s Fujifilm Holdings Corp.
Glenmark had priced FabiFlu at 103 rupees per tablet earlier, making it one of the cheapest Covid-19 treatment available in the country.