NEW DELHI: Several questions are being raised over the government’s recent clearance of anti-viral drug Favipiravir for restricted emergency use to treat mild-to-moderate Covid-19 patients. Many experts said the drug was not only expensive but it was still under trial in most countries and its efficacy was yet to be proven.
They said the drug was in the clinical trial stage for the treatment of Covid-19 not only in Japan, where the drug is approved for treating influenza but also in the US and Europe. While Japan has commenced phase 3 clinical trials, in the United States a phase 2 trial will start.
“It’s still under trial and has not been approved in the US or Europe so it is a little difficult to understand why India has already approved it,” a member of the Indian Council of Medical Research’s national Covid-19 task force said.
“A hype has been created around this drug in India,” he added, pointing out that the drug’s trial even in Japan for Covid-19 patients did not show any efficacy.
Others said the evidence cited for emergency use authorization by the Central Drugs Standard Control Organisation was rather weak. They said only an observational trial, not a clinical trial, had been conducted with 160 patients in 10 hospitals without any comparison with a placebo arm.
A day after the CDSCO gave EUA to the drug, pharmaceutical major Glenmark on Saturday announced it has launched the medicine under the brand name FabiFlu at a price of about Rs 103 per tablet of 200 mg.
The drug manufacturer said it is a prescription-based medication for Covid-19 patients with the recommended dose being 1,800 mg twice daily on the first day followed by 800 mg twice daily up to day 14.
It means patients will need to consume 18 pills on the first day after which they will need eight tablets every day for the next 13 days. This means they will need to spend Rs 12, 566 for a course of two weeks.
Drug Controller General of India V G Somani did not respond to calls or messages but Dr. R R Gangakhedkar, the chief epidemiologist of the ICMR, said the national task force would review the medicine once the data of the trial conducted by Glenmark is available.
“Until then the EUA granted by the CDSCO with its preconditions can be used by the physicians for its use,” he told this newspaper.
But physicians, researchers, and bioethicists questioned the clearance to Favipiravir. “Now that anti-malaria drug hydroxychloroquine has been proved to be a dead horse in the context of Covid-19, a dangerous hype is being created around this medicine, which has no scientific backing,” said Dr. S P Kalantri, a researcher and medical superintendent of the MGIMS in Wardha.
Dr. Amar Jesani, researcher and editor of the Indian Journal of Medical Ethics, called the development “baffling.” He not only disapproved of the clearance for emergency use but said the CDSCO should have ensured safeguards before its use.
Reached for comment, Glenmark said the CDSCO had granted accelerated approval of the drug taking into account Covid-19’s severity, rarity, and lack of alternative treatment.
“Another key requirement is for the drug to be backed by clinical evidence of safety and efficacy and all of these conditions hold true in the case of FabiFlu,” a company spokesperson said, adding that the interim clinical trial findings in India were in line with several clinical studies elsewhere.
On the cost of the drug, the firm said the price incurred would work out to about Rs 1,000 a day. “However, most patients may not require a full 14-day course as many recover within seven days or so,” it said.