DCGI issued notice on 'Fabiflu' for high price & false claims

Mumbai: The Central Drugs Standard Control Organisation (CDSCO) issued a show-cause 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 show-cause 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 projected 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.

The notice further said, "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."

CDSCO said to media officials that, 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.

Glenmark Pharmaceuticals Ltd recently said that it would lower FabiFlu, to Rs 75 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.