The General Drug Controller of India (DCGI) sought clarification from Glenmark Pharmaceuticals regarding its alleged "false claims" regarding the use of antiviral FabiFlu (favipiravir) in patients with COVID-19 with comorbidities.
The main drug regulator has also asked for an explanation about the "price" of the drug. This move came after the drug regulator received a complaint from a Member of Parliament (MP).
On June 19, ANI had reported that the drug regulator gave the green signal for the antiviral favipiravir for "restricted emergency use" in mild to moderate cases of COVID-19 in view of the emergency and unmet medical need during the pandemic. Thereafter, Glenmark Pharmaceuticals launched FabiFlu last month at a price of Rs 103 per tablet.
In a letter, Dr. VG Somani, DCGI, has written to the Glenmark pharmaceutical giant for clarification after his office received representation from a Member of Parliament.
The legislator, in his complaint, to the drug regulator stated: "The total cost of treatment with FabiFlu (favipiravir) will be around Rs 12,500 and that the cost proposed by Glenmark is definitely not in the interest of the poor, middle class low and middle class people from India. "
"According to Glenmark's claim, the patient must take the tablet for 14 days, which means that a patient will have to take approximately 122 tablets (18 tablets on day 1 and 8 tablets per day from day 2 to day 14.) the total cost of the treatment will be around Rs 12,500, "said the complaint in a representation to the DGCI.
According to Glenmark's statement and media reports, DCGI had accelerated the process of clinical trials and reviews taking into account the pandemic situation, unmet medical conditions, and the unavailability of a specific therapeutic treatment against COVID-19. for this medicine, the plaintiff said.
From NDTV News
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