Glenmark pharma on Tuesday termed the "over pricing" and "false claim" allegations levelled by the Drug Controller General of India (DCGI) on its COVID-19 drug Favipiravir as "unsubstantiated and careless".
The pharmaceutical company, which slashed the prices of the drug from $1.37 (INR130) to $1 (INR 75) per tablet recently, claimed its oral COVID-19 drug, branded as FabiFlu, is much more affordable and effective than other treatment options available.
The Mumbai-based pharma's response to the regulator also mentioned the price of the drug (200mg) in other countries - Russia ($8), Japan ($5), and Bangladesh ($4).
In response to the DCGI's letter seeking clarification over its "false claim" saying that the drug can be used among patients having co-morbidities, the pharma firm has said the reference to co-morbidity was based on data from the Japanese registry.
The Indian drug regulator asked the firm how it could claim the drug's effectiveness on patients with co-morbid conditions like hypertension abd diabetes when the trials were not designed to assess FabiFlu in such conditions.
The notice issued to the pharma major said that health authorities had “accelerated the process for clinical trials and reviews considering the pandemic situation, unmet medical conditions and unavailability of specific therapeutic management against Covid for this drug”, but “the cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class and middle class people of India”.
On 22 June, Glenmark launched the re-purposed antiviral drug FabiFlu for treating coronavirus patients with mild to moderate symptoms after approval from the DCGI.
The medical prescription-based drug, which the firm claimed to be the first oral Favipiravir-approved medication for COVID-19 treatment, showed a quick reduction in the viral load among patients within four days during the trials.
Meanwhile, India's vaccine candidate developed by Bharat Biotech, in coordination with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), started human trials on Monday in Delhi's premier AIIMS hospital, one of 12 sites where trials will be conducted.