DCGI queries Glenmark Pharma on claims of FabiFlu use for COVID-19 patients with comorbidities

New Delhi: India's drug regulator DCGI has sought a clarification from Glenmark Pharmaceuticals over its alleged "false claims" about the use of anti-viral FabiFlu on COVID-19 patients with comorbidities. Also, the "pricing" of the drug is in question after a Member of Parliament complained about the same.

The letter was issued by the office of Drugs Controller General of India (DCGI) Dr V G Somani on July 17 drawing attention to the 'false claims' and 'over pricing' of tablet FabiFlu (favipiravir). A clarification was sought for taking further necessary action in the matter.

The letter also said that a representation from an MP was filed agianst the total cost of the treatment with FabiFlu (favipiravir) which is around Rs 12,500 and that such a cost is not in the interest of the poor, lower middle class and middle-class people of India.

Glenmark had claimed that the drug is effective in co-morbid conditions like hypertension, diabetics, while the protocol summary states that this trial was not designed to assess the FabiFlu in comorbid condition, the letter read.

No clinically sufficient data specific to these conditions are available, the DCGI said in its letter.

There was no immediate comment from the company.

The Mumbai-based pharma had on July 13 said it has cut the price of its antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 symptoms by 27 per cent costing upto Rs 75 per tablet.

The company had launched FabiFlu last month at a price of Rs 103 per tablet.

The letter sent to the firm by the DCGI encloses the representation made by the MP which refers to an online press conference by Glenmark Pharmaceuticals and media reports that the cost of FabiFlu per tablet is Rs 103.

"As per the claim by Glenmark, 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 2 to day 14). Total cost of the treatment will be around Rs 12,500," the representation read.

However, the cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class and middle-class people of India, the representation noted.

On June 19, the drug regulator had approved anti-viral drug favipiravir for "restricted emergency use" in mild to moderate cases of COVID-19.