In a strong-worded reaction to the Drugs Controller General of India (DCGI)’s move to pull up drug major Glenmark on charges of alleged overpricing, false and misleading claims related to its COVID-19 drug Favipiravir, the company has responded to the apex drug controller saying it was “dismayed” over the careless, unsubstantiated allegations that are devoid of merits.
In a letter to DCGI V.G. Somani, Glenmark said compared to other therapies approved for emergency use in COVID-19 in India, FabiFlu is much more economical and an effective treatment option. The estimated total cost of therapy for full course is only Rs 9,150, when compared to the prices of Remdesivir (Rs 24,000-30,000), Tocilizumab (Rs 44,000) and Itolizumab (Rs 32,000).
Further, given that Favipiravir is an oral therapy, patients can be treated on an out-patient basis without incurring additional hospitalisation expenses, unlike other approved drugs which are injectable and hence require administration at hospitals.
Despite significant investment in developing it, Favipiravir in India when launched was priced at the lowest market cost of Rs 103/tablet/200mg compared to its cost in other countries where it was approved. The drug’s price was further voluntarily reduced to Rs 75 per tablet. Comparatively, 200 mg per tablet prices in Russia is Rs 600, Japan Rs 378, Bangladesh Rs 350 and in China Rs 215.
The DCGI, in a letter to Glenmark on July 17 based on a representation from a Parliament member, had asked to clarify on the allegation that the drug was unaffordable due to its high pricing.
Reacting to the allegation of misleading/false claim that Favipiravir is effective in COVID-19 patients with co-morbidity like diabetes, hypertension as Phase 3 clinical trial was designed to evaluate the efficacy in these co-morbidities, Glenmark said the reference to co-morbidity was clearly based on data from Japanese registry – the largest collection of real-world evidence on clinical use of Favipiravir in COVID-19 and was not linked to its trial. Glenmark clarified that none of the product promotional literature, Summary of Product Characteristics (SmPC) or product information leaflet makes any such claim that Favipiravir can be used in mild to moderate COVID-19 patients with co-morbid conditions such as diabetes and heart disease.
Reacting to the DCGI concern on Favipiravir being not tested as monotherapy in Phase 3 clinical trial in India, Glenmark said it has not made any claim at any point in time that “Favipiravir alone” is effective in treatment of COVID-19 patients with mild to moderate disease. In the Glenmark study, as per the guidelines issued by ICMR/ MoH&FW, patients with mild to moderate COVID 19 symptoms were treated with Favipiravir plus recommended standard supportive care versus standard supportive care alone, said Glenmark.
In the letter, Glenmark noted that it was the first to bring an oral anti-viral agent in less than three months of the pandemic in India with end-to-end synthesis and active pharmaceutical ingredients (API) and formulation catering to Indian populace and even export markets. It is also the first and only company to conduct a robust 150-patient randomised controlled trial.