Central Drugs Standard Control Organisation (CDSCO) has pulled up COVID-19 treatment drug FABIFLU maker Glenmark pharmaceuticals for its misleading claims and high pricing of the drug.
The drug controller of India on the complaint of a Member of parliament today wrote to Glenmark and asked for its clarification for making those claims and fixing the high price of the drug.
Fabiflu 200 mg (Favipiravir) is a drug made by Glenmark, which is being used by doctors in treating COVID-19 patients with mild and moderate symptoms. In the absence of any single effective medicine, FABIFLU is given in conjunction with other ICMR approved drugs for the treatment of COVID 19.
However, as per the CDSCO letter, Glenmark has not only given misleading claims about Fabiflu alone being an effective treatment against COVID 19 but also being effective in patients with comorbidities.
Contradicting Glenmark's claim, CDSCO in its letter pointed out that the trial of FABIFLU was conducted on clinically stable COVID 19 patients with mild (not more than 2 COVID 19 symptoms) and moderate (not more than 4 symptoms) conditions. Moreover, patients with less than 94 % SP02 were excluded from the trial.
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It also pointed out Glenmark's fallacious claim that the FABIFLU is effective in comorbid conditions like hypertension, diabetes, etc. CDSCO says FABIFLU was not tested for efficacy in comorbid conditions and that there is not enough clinical data to support Glenmark's claim about the drug.
CDSCO also raised objection to the pricing of FABIFLU. Glenmark pharmaceutical has fixed the rate of FABIFLU at Rs 103 per tablet. As per the medication requirement, a patient would need a total of 122 tablets for a 14 days course which would make the total cost of the treatment to be around 12500/-. Which, CDSCO says, is unaffordable for the common man and is not in the interest of the poor, lower middle class and middle-class people of the country.
In its letter, CDSCO has asked Glenmark to refrain from making false about the medicines and to review the pricing of FABIFLU to make it more affordable to common people.
CDSCO has also asked Glenmark for its clarification on both matters.