The Drug Controller General of India (DCGI) has sent a show cause notice to Glenmark Pharmaceuticals over 'overpricing' and alleged 'false claims' of its drug Fabiflu. The drug controller said that Glenmark's drug has been priced too high and is not in the common interest of poor, lower middle class and middle class people of the country.
The DCGI, who heads the Central Drug Standard Control Organisation (CDSCO), a wing under the Health Ministry, had approved favipiravir in June.
The DCGI also said that Glenmark made claims that Fabiflu alone would suffice as treatment in mild and moderate coronavirus cases and that it is effective for patients with comorbidities. The notice mentioned that Fabiflu was not tested as monotherapy in any of the mild or moderate cases.
"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," Businesstoday reported quoting VG Somani as saying in the notice to the company.
The notice stated that the DCGI has received reports that Fabiflu -- a version of favipiravir -- has been priced at Rs 12,500 for the entire course.
The regulator said that as per Glenmark, per tablet of Fabiflu is priced at Rs 103. A patient would be required to take 18 tablets on Day 1 and eight tablets every day from Day 2 to Day 14, amounting to Rs 12,500 for the complete course.
Glenmark had priced FabiFlu, a branded generic of the antiviral Favipiravir, at Rs. 103 per tablet of 200 mg during its launch, and an entire two-week course of treatment required 122 tablets, leading to a total cost of Rs. 12,500.
It had, however, last week, slashed the price by 27 per cent to Rs. 75 per pill, or Rs. 9,150 for the course.
The DCGI has asked Glenmark to respond to these issues and said that further action will be taken according to the clarification.