The Drugs Controller General of India (DCGI) has approved Glenmark Pharmaceuticals, an Indian pharmaceutical company, to sell generic versions of Favipiravir for the treatment of COVID-19. This drug, originally invented by a Japanese company, was meant to treat influenza. After the outbreak of COVID-19, doctors in China and Russia started using it to treat COVID-19 patients although there is no scientific consensus on the efficacy of the drug.
As per Glenmark’s filing with the Bombay Stock Exchange, the company has received “accelerated approval” from the DCGI for “restricted emergency use in India”. On what basis did the DCGI grant approval? Will the underlying data be made publicly available to the medical community? While the New Drugs and Clinical Trial Rules, 2019 allow the DCGI to grant approvals for the use of certain drugs based on approvals granted overseas, they do not absolve it from making their rationale for such decisions public.
In this The Hindu piece, Dinesh Thakur and I question the very role of Favipiravir in the management of Covid19. We also argue that all our interventions to fight Covid should be governed by solid science.
