Cipla seeks approval to launch experimental COVID-19 drug
Cipla has applied for permission from DCGI to market Favipiravir in India as an experimental medicine for COVID-19. Under the guidances of ICMR, Cipla will also conduct a suitable limited trial prior to marketing the product as Ciplenza.
CSIR has been leading the fight against Covid19 epidemic on multiple fronts, with major emphasis on repurposed drugs as they can be quickly deployed for treatment as opposed to new drugs which need almost a decade of development. Globally many drugs are under clinical trials on Coronavirus patients to establish their efficacy against Covid19.
Towards providing drugs for Coronavirus patients in India, CSIR has identified the top 25 drugs/ drug candidates for repurposing. Among these top 25 drugs, Favipiravir a broad spectrum inhibitor of viral RNA polymerase has emerged as of one of the most promising drugs. Favipiravir was developed by Fujifilm Toyama Chemical Ltd.,and is an approved treatment for common influenza and is marketed in Russia, China and Japan.
CSIR-IICT, based in Hyderabad has developed a convenient and cost effective synthetic process for Favipiravir. As a collaborative effort with industry, CSIR-IICT transferred the entire process and significant quantities of pharma grade API of Favipiravir to Cipla a leading pharmaceutical company.
Cipla will be conducting the investigations prior to launching on this drug against Covid-19 in India. Cipla approached regulatory authority DCGI for approval for Favipiravir to be launched in India. Favipiravir is a generic drug and already being used for treatment of influenza and also is in clinical trials for Covid-19 in many countries such as in China, Japan and Italy. Under the auspices of ICMR, Cipla will conduct a suitable limited trial prior to marketing the product as Ciplenza.
CSIR and Cipla have a long history of working together for affordable drugs in India and globally. Many of the technologies for HIV generic drugs were established at CSIR labs and Cipla was successful in providing affordable treatment to HIV patients worldwide which led to saving of millions of lives. They have assured the government that they will do same for Favirpiravir.