Glenmark’s response to DCGI letter seeking clarification on FabiFlu
Buhubaneswar: In response to a letter regarding representation by a Member of Parliament, Mr Anurag Khera (Sr. Vice-president-Corporate Affairs) of Glenmark pharmaceuticals Limited sent a letter to Dr VG Somani, Director General of Health Services, Central Drugs Standard Control Organisation, clarifying its stand on the product Favipiravir tablets (200mg) manufactured and marketed by Glenmark that was granted permission by the latter’s office.
Glenmark said, compared to other therapies approved for emergency use in COVID-19, Favipiravir (FabiFlu) is much more economical and an effective treatment option. The estimated total cost of therapy for full course with Favipiravir is Rs 9150, while Remdesivir, Tocilizumab and Itolizumab cost Rs 24,000, Rs 44,000 and Rs 32,000 respectively. When launched in India, Favipiravir was at the lowest market cost (Rs 103/tab) as compared to the cost of Favipiravir in other countries. Now, Favipravir is available at a reduced cost of Rs 75/tab. Expressing Glenmark’s surprise over allegation of misleading/false claim that Favipiravir is effective in COVID-19 patients with comorbidities like diabetes and hypertension, Glenmark mentioned that it never claimed that Favipiravir can be used in mild to moderate COVID-19 patients with co-morbid conditions. Glenmark also denied having made any claim at any point in time that ‘Favipiravir alone’ is effective in treatment of COVID-19 patients with mild to moderate disease. The Glenmark letter stated, “We submit that the concerns raised by Hon’ble Member of Parliament that FabiFlu was not tested as a monotherapy i.e. only FabiFlu in any of the mild to moderate patient in Glenmark study is wholly misplaced and devoid of understandings of the clinical trial principles in a pandemic situation.”