Glenmark Pharma has come under the scanner of DCGI which sought clarifications from the company on pricing and claims of therapeutic efficacy.
Addressing the concerns put forth by Drug Controller General of India (DCGI) about the issue of high price on Favipiravir drug used for treatment of mild-to-moderate Covid-19 cases, Glenmark Pharma, which markets Favipiravir under brand FabiFlu, said that compared to other drugs approved for emergency use in Covid-19, FabiFlu is more economical and an effective treatment option.
Glenmark Pharma has come under the scanner of DCGI which sought clarifications from the company on pricing and claims of therapeutic efficacy. Sources said that the move was triggered by a letter written by Nationalist Congress Party legislator Amol Kolhe to the health minister.
In its response, Glenmark states, “Compared to other therapies approved for emergency use in Covid-19, FabiFlu is much more economical and an effective treatment option.” Drawing comparisons between FabiFlu and the other drugs being used for Covid-19 treatment, the company says that the estimated total cost of therapy for the full course of Favipiravir is Rs 9,150 but the estimated cost of therapy of Remdesivir, Tocilizumab and Itolizumab comes to Rs 24,000-30,000; Rs 44,000 and Rs 32,000, respectively.
“Favipiravir, when launched, was at the lowest market cost at Rs 103 per tablet compared to the cost of Favipiravir in other countries where it was approved,” the company said in a letter to DCGI. The letter also comprised a table listing price of Favipiravir (200mg) in other countries — Russia (Rs 600), Japan (Rs 378), Bangladesh (Rs 350), China (Rs 215). “With a view to make the product even more accessible to a larger section of the population, Glenmark further reduced FabiFlu price to Rs 75 per tablet from Rs 103,” the company stated.
The DCGI had also alleged that Glenmark made false claims about the use of FabiFlu on Covid-19 patients with co-morbid conditions like hypertension, diabetes. Responding to allegations of misleading claim, Glenmark said that the reference to co-morbidity was based on data from Japanese registry, which is the largest collection of real-world evidence on the clinical use of Favipiravir in Covid-19.
“In February 2020, Favipiravir was used on adult patients of all age groups, including with co-morbidities. The report published by Japanese Infectious Disease Society had 2,158 patients, which included 49% of the patients with co-morbidities including diabetes, hypertension and 52% aged above 60 years,” it said. “The results showed clinical improvement in 84.5% and 87.8% patients with Favipiravir in moderate and mild Covid-19 patients, respectively. Thus, the 88% clinical improvement mentioned is derived from the published Japanese clinical use,” Glenmark stated.
The company also denied making claims that “Favipiravir alone” is effective in the treatment of Covid-19 patients with mild to moderate disease. It states, “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. It is pertinent to note that the standard supportive care in Glenmark Study did not include HCQ or any other anti-viral drug. Consequently, since both arms of the Glenmark study received standard supportive care under this design, any advantage observed in the treatment arm can solely be attributed to the administration of Favipiravir.”