Guwahati: V.G. Somani, the Drug Controller General of India, having received complaint from an unnamed legislator, has pulled up Glenmark Pharmaceuticals Ltd for alleged false claims about the use of its Fabiflu to treat covid-19 as well as overpricing of the branded product.
Glenmark, in a statement on Saturday, said that after all positive approach accelerated processes and efforts by DCGI, health ministry and relevant state FDA departments, the cost proposed by Glenmark is "not in the interest of the poor, lower middle class and middle-class people of India."
The letter further stated that 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."
An entire two-week course of treatment with the FabiFlu required 122 tablets, leading to a total cost of ₹12,500. Last week, the rate had been slashed by 27% to ₹75 per pill, or ₹9,150 for the course. Somani has asked the company to provide clarification on the matter. FabiFlu had been okayed to treat mild and moderate covid-19 following a phase 3 randomised, open-label study of 156 patients.
The government's clinical trial registry showed that the drug was studied for only mild-to-moderate patients of covid-19 (patients with only up to four of the symptoms associated with the respiratory disease) and avoided including those with certain complications.
The use of the expensive drug for patients with mild symptoms has been widely condemned as many can be treated by managing symptoms like fever and bodyache using paracetamol and other drugs.
The rise in the number of COVID-19 cases in the country has led the medical fraternity to seek a fast cure for the dreaded disease. On Sunday, the number of COVID-19 cases rose dramatically by over 40,000 cases -- the largest single-day spike.
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