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DCGI pulls up Glenmark for false claims, overpricing of covid-19 drug FabiFlu
3 min read.Updated: 19 Jul 2020, 04:30 PM ISTLeroy Leo
Glenmark had priced FabiFlu, a branded generic of the antiviral Favipiravir, at ₹103 per tablet of 200 mg during its launch, and an entire two-week course of treatment required 122 tablets, leading to a total cost of ₹12,500
NEW DELHI: Drug Controller General of India V.G. Somani has pulled up Glenmark Pharmaceuticals Ltd for alleged false claims about the use of Fabiflu to treat covid-19 as well as overpricing of the branded generic, having received a complaint by an unnamed legislator.
“After all positive approach, accelerated processes and efforts by DCGI, health ministry and relevant state FDA departments, the cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class and middle class people of India," Somani said in a letter dated Saturday, a copy of which was reviewed by Mint.
“Further it has been mentioned in representation that Glenmark has also claimed that this drug is effective in co-morbid conditions like hypertension, diabetes, whereas in reality, as per protocol summary, this trial was not designed to assess the FabiFlu in co-morbid conditions."
Glenmark had priced FabiFlu, a branded generic of the antiviral Favipiravir, at ₹103 per tablet of 200 mg during its launch, and an entire two-week course of treatment required 122 tablets, leading to a total cost of ₹12,500.
It had, however, last week, slashed the price by 27% to ₹75 per pill, or ₹9,150 for the course.
Somani, who heads the country’s apex regulatory body Central Drugs Standards Control Organisation (CDSCO), has asked the company to provide a clarification on the matter. A spokesperson for Glenmark refused to comment on the letter.
CDSCO, in June, had given emergency use authorisation for the use of FabiFlu to treat mild and moderate covid-19 following a phase 3 randomised, open-label study of 156 patients.
While the data of the study has not yet been released, the government’s clinical trial registry showed that the drug was studied for only mild-to-moderate patients of covid-19, that is, patients with only up to four of the symptoms associated with the respiratory disease, and avoided including those with certain complications.
The drug has increasingly come under the scanner, with health experts divided around the use and for lack of evidence. Some have criticised the need for such an expensive drug for patients with mild symptoms as many can be treated by managing symptoms like fever and bodyache using paracetamol and other drugs.
Lok Nayak Hospital in Delhi had earlier this month barred the use of Favipiravir in its hospital due to certain side-effects like loss of appetite, nausea and potential risk to liver, and cardiac functioning.
Others say that they are choosing their patients based on age and other factors, prescribing symptomatic treatment for the young with mild symptoms and Favipiravir for older patients to avoid getting severe symptoms.
“The trick for Favipiravir is using it early. This is an antiviral which stops replication of the virus. So it works if it is used early. I have used it around 50 patients, and most of them have been treated well," Ram Shankar Mishra, director of internal medicine at Max Super Speciality Hospital in Delhi said.
Rahul Pandit, a specialist in critical care medicine at Fortis Hospital in Mulund, Mumbai, has prescribed the medicine to about two dozen patients, many of them over 50 years of age, and it has been a mixed bag.
While most patients have improved when on Favipiravir, a few didn’t and had to be treated later for moderate to severe symptoms, he said. Despite the limited evidence, he said the drug was needed.
"I agree that the data for favipiravir is not robust. We would definitely want to have a larger study to have more confidence in the drug, but this is a pandemic. These are unusual times and at least this drug is not causing more harm, which is the first thing we would look at," Pandit said.