Glenmark Pharmaceuticals Ltd in a letter to the Drug Controller General of India V.G. Somani on Monday quashed allegations that it made ‘false claims’ for the use of favipiravir and of overpricing the drug.
“What has dismayed us the most is that despite bringing an oral anti-viral agent in less than 3 months of the pandemic setting in to India, …launching the drug at an affordable price and …ensuring continuous availability of the drug to various state governments, Glenmark has been at the receiving end of such careless, unsubstantiated allegations that are devoid of merits,” the company said in a letter to Somani.
The letter was in reply to a showcause notice sent by Somani to the company on Saturday over allegations made by a Nationalist Congress Party’s legislator Amol Kolhe.
More To COVID-19
The member of Parliament had alleged that the company had made misleading and false claim that Favipiravir, sold by Glenmark under the brand FabiFlu, is effective in COVID-19 patients with comorbidities like diabetes, hypertension as Phase 3 clinical trial was designed to evaluate the efficacy in these co-morbidities, and that at ₹103 rupee per pill, the drug was overpriced.
Glenmark in its letter on Monday clarified that the price of the drug was last week slashed by 27% to ₹75 per tablet, which along with it, brought the cost of an entire course of 122 tablets for two weeks down to ₹9,150.
The company said that the cost of favirpiravir in India was cheaper than Japan, Russia, Bangladesh and China. Where the drug costs ₹215-600 per pill. And the cost of an entire course is cheaper than for remdesivir, tocilizumab and itolizumab. However, each of which costs anywhere between ₹24,000-44,000.
Favipiravir was last month given an emergency use authorization from the Central Drugs Standards Control Organisation. Which is headed by Somani, for the treatment of mild and moderateCOVID-19 following a phase 3 randomized. Also a open-label study of 156 patients.
Glenmark Denies Claim
On the other hand, Gilead Sciences Inc’s novel drug remdesivir was also given an EUA last month, but for treatment of severe covid-19 hospitalised patients. Roche’s tocilizumab and Biocon’s itolizumab have been given EUAs for cytokine storm, which is a severe immune system overreaction caused by covid-19.
Glenmark said that the lack of requirement for hospitalisation was an added cost benefit for favipiravir.
“Given that Favipiravir is an oral therapy, patients can be treated on an out-patient basis without incurring additional hospitalization expenses, unlike other approved drugs which are injectable and hence require administration at hospitals,” Glenmark said.
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. But using paracetamol and other drugs. 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.
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. However, patients with only up to four of the symptoms associated with the respiratory disease. And avoided including those with certain complications.
Source: Live Mint
Mylan launches Remdesivir drug in India.
