Home >News >India >Cipla seeks approval to launch experimental coronavirus drug in India

Domestic pharma major Cipla has sought approval from Indian regulators to launch experimental coronavirus drug favipiravir in India for treatment of Covid-19 patients. Under the auspices of Indian Council of Medical Research or ICMR, Cipla will conduct a limited trial prior to marketing the product as Ciplenza. Mumbai-based Glenmark Pharmaceuticals on Thursday said it has received approval from the Drug Controller General of India to conduct clinical trials of antiviral drug favipiravir on coronavirus patients. Glenmark said it has received approval for conducting the trial on mild to moderate patients.

Globally many drugs are under clinical trials on coronavirus patients to establish their efficacy against Covid-19. In India, Council of Scientific and Industrial Research or CSIR has identified the top 25 drugs/drug candidates for repurposing. Among these top 25 drugs, favipiravir has emerged as of one of the most promising drugs, the Ministry of Science & Technology said. Favipiravir was developed by Fujifilm Toyama Chemical Ltd.,and is an approved treatment for common influenza.

"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. Cipla will be conducting the investigations prior to launching on this drug against Covid-19 in India," said Ministry of Science & Technology.

"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," it said.

Another Indian pharmaceutical company, Strides Pharma Science Ltd, said on Wednesday it had developed and commercialized favipiravir antiviral tablets, and had applied to the authorities to start trials.

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