India’s CDSCO approves generics of Favipiravir and Remdesivir for Covid-19 treatment

Following the approval from the drug regulator, Glenmark Pharmaceuticals has launched the generic version of oral antiviral drug Favipiravir under the brand name of FabiFlu.

Favipiravir was developed by Toyama Chemical, a subsidiary of Japanese conglomerate Fujifilm. The drug has been used for the treatment of novel or re-emerging influenza virus infections in Japan since 2014.

FabiFlu has been approved for the treatment of Covid-19 patients with mild to moderate infection.

According to Glenmark Pharmaceuticals, FabiFlu will be available as a prescription-based medicine, priced at INR103 ($1.35)/tablet. The recommended dose of the antiviral tablets is 1,800mg twice daily on day 1, after which 800mg of the tablets has to be taken twice daily up to day 14.

Glenmark Pharmaceuticals chairman and managing director Glenn Saldanha said: “We hope the availability of an effective treatment such as FabiFlu will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option.

“FabiFlu has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications.”

On the other hand, the two generic injectable formulations of Remdesivir have been approved for the treatment of patients with severe Covid-19 infection. The approval for the drug is under CDSCO’s Restricted Emergency Use.

Hetero Drugs has secured approval from CDSCO’s Drug Controller General of India
(DCGI) for COVIFOR, which is the company’s generic version of Remdesivir, an investigational antiviral developed by US-based Gilead Sciences.

COVIFOR will be available in 100mg vial, which has to be intravenously administered in a hospital setting under the supervision of a healthcare practitioner, said Hetero Drugs.

Cipla, another Indian pharma company, has launched CIPREMI as its generic version of Remdesivir.

DCGI VG Somani said: “Both Remdisivir and Favipiravir formulations are required to be sold under the prescription of medical specialists only. Further, Remdisivir formulations are required to be supplied for use only to the hospital / institutions to ensure proper use of the drug as recommended.

“In both the cases, informed consent of the patient or his /her representative in the prescribed form is mandatory before initiating the treatment.”