Remdesivir and favipiravir price regulation required to safeguard patients’ interest in India: GlobalData

Regulatory bodies such as the National Pharmaceutical Pricing Authority (NPPA) and the Drug Controller General of India (DCGI) are keeping a close eye on remdesivir and favipiravir amid the COVID-19 pandemic to safeguard patients’ interest around pricing, says GlobalData, a data analytics and research company.

The Indian Council of Medical Research (ICMR) has recently proposed price cap for remdesivir, whereas Glenmark’s Fabiflu (favipiravir) was under scrutiny by DGCI for both pricing and claims made.

Remdesivir and favipiravir have been extensively used in the treatment of severe and mild to moderate patients, respectively. Both drugs have seen a sharp decline in price since the availability of the first generic in India. Hetero was the first company to launch remdesivir generic Covifor in India at Rs 5,400 ($72) per vial. Cipla’s remdesivir generic Cipremi at Rs 4,000 ($53.4) is the cheapest version.

Similarly, Glenmark’s Fabiflu (favipiravir) was priced at Rs 103 ($1.38) per 200 mg tablet, which was again reduced to Rs75 ($1) owing to benefits gained from higher yields and better scale. Following the launch of other favipiravir generics in India, Favivent by Jenburkt Pharmaceuticals is the cheapest version available at Rs 39 ($0.52) per 200 mg tablet. Cipla’s Ciplenza is priced at Rs 68 ($0.91) whereas Brinton Pharmaceuticals’ Faviton and Hetero Labs Favivir have priced same at Rs 59 ($0.79) per tablet.

Prashant Khadayate, Pharma Analyst at GlobalData, comments, “Considering the wide variation and fluctuations in the pricing of remdesivir and favipiravir, the NPPA should invoke paragraph 19 of the Drug Price Control Order of 2013 which allows fixing the prices of drugs which are of public interest. The NPPA is already considering a proposal for a remdesivir price cap; however, a price cap for favipiravir should also be considered. During these unprecedented times, regulatory bodies should ensure that companies are not thinking too much about profit.”

Even though Glenmark has clarified the pricing and claims related issues to DCGI, there should be more transparency in pricing, especially during this emergency situation. Primarily, cost analysis of the bulk drug used in the generic formulation should be evaluated by the regulatory bodies from the pricing perspective.

Khadayate concludes, “There is no doubt that India’s situation with respect to COVID-19 infection is getting worse. Therefore, it is very important that the remdesivir and favipiravir prices be made as affordable as possible, which is in the best interest of patients and healthcare providers. The NPPA should quickly make a decision on the pricing regulation irrespective of remdesivir and favipiravir falling outside the purview of the NPPA as both are considered experimental therapies for COVID-19 and not approved as a drug.”