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NEW DELHI/MUMBAI: The drug regulator has issued a notice to Mumbai-based Glenmark Pharma seeking a clarification against a complaint that the company is selling its recently approved Covid-19 drug Fabiflu at an “unaffordable” price and with “false claims” that it can be effective for patients with co-morbidities.
The notice from the Drugs Controller General of India is based on a complaint from a Member of Parliament.
“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,” the letter from DCGI VG Somani sent to Glenmark on Friday said.
The notice from the Drugs Controller General of India is based on a complaint from a Member of Parliament.
“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,” the letter from DCGI VG Somani sent to Glenmark on Friday said.
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