The Drug Controller General of India (DCGI) has, earlier this week, issued notice to Glenmark Pharmaceuticals asking it to respond to allegations of overpricing and claim that its antiviral drug Fabiflu is effective in COVID-19 patients with co-morbidities.
The DCGI has sought a response from the company.
“It has been mentioned in representation that Glenmark has 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,” said V.G. Somani, DCGI, in the notice to the company.
The notice adds that Fabiflu was not tested as monotherapy in any of the mild or moderate cases and that claims by the company were misleading.
On pricing of the drug, the drug controller said Glenmark’s drug had been priced too high and was not in the interest of the poor and the common man.
Glenmark said in a regulatory filing recently that it has slashed the price of its Favipiravir tablet by 27% to ₹75 MRP. “The price reduction has been made possible through benefits gained from higher yields and better scale, as both the active pharmaceutical ingredient (API) and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country,” it had stated in the filing.