The Drug Controller General of India (DCGI) issued notices to Glenmark seeking clarification from the company regarding false claim that its antiviral drug Fabiflu, is effective on COVID-19 patients with co-morbodities.
"It has been mentioned in representation that Glenmark has 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. No clinically sufficient data specific to these conditions are available," said VG Somani, DCGI in the notice to the company.
Fabiflu is the generic version of Favipiravir, which was approved by DCGI for treating mild COVID-19 patients in June.
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DCGI issued notices based on a representation by a Member of Parliament (MP), who complained about the cost of the drug and the false claims.
Glenmark initially fixed the price of the Fabiflu at Rs 103 per tablet, taking the overall cost of the 14-day regimen that includes 122 tablets to Rs 12,500. The company last week dropped the prices to Rs 75 per tablet that brought the cost down to Rs 9,150.
The MP said that the cost proposed by Glenmark is definitely not in interest of the poor, lower middle class and middle class people.
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