India's drug regulator 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 and also over the "pricing" of the drug, after receiving a complaint from a member of Parliament.
In a letter to the Mumbai-based company, Drugs Controller General of India (DCGI) Dr V G Somani stated that his "office received a representation from an MP that the total cost of the treatment with FabiFlu" (favipiravir) will be around Rs 12,500 and that the "cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class and middle-class people of India."
"Further it has been mentioned in the representation that Glenmark has also claimed that this drug is effective in co-morbid conditions like hypertension, diabetics, whereas in reality, as per protocol summary, this trial was not designed to assess the FabiFlu in comorbid condition," the letter dated July 17 read.
No clinically sufficient data specific to these conditions are available, the DCGI said in its letter.
The 'subject' of the letter was stated as: "Regarding the false claims and pricing of tab FabiFlu 200 mg (favipiravir) by Glenmark Pharmaceuticals Limited, India".
"In view of this, you are requested to provide your clarification on the above points for taking further necessary action in the matter," he said.
There was no immediate comment from the company.
Glenmark Pharmaceuticals 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 by 27 per cent to 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.
As per statement by the Glenmark and media reports, the DCGI had accelerated the process for clinical trials and reviews considering the pandemic situation, unmet medical conditions and unavailability of specific therapeutic management against COVID-19 for this drug, it said.
However, after all positive approach, accelerated processes and efforts by DCGI, health ministry and relevant state FDA departments, 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.
"In such a global pandemic where world is struggling against COVID-19, government of India should ensure affordability of the drug to the common people. In fact, 6/12 centres wherein these clinical trials were conducted are government medical colleges from Maharashtra, Gujrat and Delhi.
"This indicates that poor and middle class patients have contributed to the clinical trial as subjects.
"Price quoted for this drug is definitely unaffordable to the common people," it stated.
The drug regulator had on June 19 approved anti-viral drug favipiravir for "restricted emergency use" in mild to moderate cases of COVID-19 in view of the emergency and unmet medical need during the pandemic.