DCGI seeks response from Glenmark Pharma over alleged 'false claims', overpricing of FabiFlu in treating COVID-19

Sending a clear message to the pharmaceutical industry that it is under the strict vigilance of the central government, the Drug Controller General of India (DCGI) VG Somani has now sought clarification from Glenmark Pharmaceuticals regarding alleged "false claims" about the usage of branded generic 'FabiFlu' on patients with co-morbidities suffering from coronavirus disease (COVID-19).

The DCGI has also pulled up Glenmark over the alleged overpricing of FabiFlu, the branded generic of the anti-viral Favipiravir, after a complaint about the same was received from a Member of Parliament.

The office of the DCGI issued a letter on Saturday that draws attention to the claims made by Glenmark Pharmaceuticals regarding FabiFlu and its pricing.

Glenmark had claimed that the drug is effective in co-morbid conditions like hypertension, diabetics, whereas in reality, as per protocol summary, this trial was not designed to assess FabiFlu in co-morbid conditions, the letter read.

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

Moreover, it is to be noted that Glenmark had launched FabilFlu last month at a price of Rs. 103 per tablet. Since the entire two-week course of treatment requires 122 tablets, it leads to a total cost of Rs. 12,500, as the legislator had pointed out in his representation to the DGCI's office.

Even though the pharmaceutical firm had last week slashed the price by 27% to Rs 75 per pill, the entire treatment course would still cost Rs 9,150.

"The cost proposed by Glenmark is definitely not in the interest of the poor, middle class, and lower-middle-class people of India," the DCGI mentioned in the letter.

DCGI Somani, who heads India's drug regulatory body Central Drugs Standards Control Organisation (CDSO), enclosed the representation from the legislator in the letter and sought a clarification from Glenmark regarding the matter.

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

As per sources, the legislator put forward that in such times of global pandemic where the world is struggling against COVID-19, the Government of India should ensure affordability of the drug to the common people.