Glenmark Pharmaceuticals launched FabiFlu last month at a price of Rs 103 per tablet.
New Delhi:
The Comptroller General of India (DCGI) has asked Glenmark Pharmaceuticals for clarification regarding its “false claims” claims regarding the use of antiviral FabiFlu (favipiravir) in patients with COVID-19 with co-morbidities.
The main pharmaceutical regulatory body has also asked for an explanation of the “price” of the drug. The move comes after the drug regulator received a complaint from an MP.
On June 19, ANI reported that the drug regulator gave the green signal for favipiravir, an antiviral medication intended for “restricted emergency use” in mild to moderate cases of COVID-19, given the emergency and unmet medical needs during the pandemic. Subsequently, Glenmark Pharmaceuticals launched FabiFlu last month at a price of Rs 103 per tablet.
In a letter, Dr. VG Somani, DCGI, wrote to the pharmaceutical giant in Glenmark asking for clarification after his office received representation from an MP.
The lawmaker, in his complaint to the drug regulator, said: “The total cost of treatment with FabiFlu (favipiravir) will be around 12,500 rupees and the cost proposed by Glenmark is certainly not in the interest of the poor, of the lower middle class. and the middle class people of India. “
“According to Glenmark’s request, 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.) On total cost of treatment will be around 12,500 rupees, “said the complaint in a representation at the DGCI.
In accordance with Glenmark’s statement and media reports, DCGI had accelerated the process of clinical trials and examinations given the pandemic situation, unfulfilled medical conditions and the unavailability of specific therapeutic management for COVID-19 for this medication, said the complainant.
“However, after a positive approach, accelerated processes and efforts by the DCGI, the Department of Health and the relevant FDA services, the cost proposed by Glenmark is certainly not in the interest of the poor, classes and middle classes of India “, briefing by the legislator.
“In such a global pandemic, where the world is fighting COVID-19, the central government should guarantee the affordability of the drug to ordinary people.” In fact, 6 to 12 centers in which these clinical trials have been conducted are faculties of medicine in Maharashtra, Gujarat and Delhi. This indicates that poor and middle class patients contributed to the clinical trial as subjects. “The price quoted for this drug is definitely unaffordable for ordinary people,” said the presentation.
The DCGI, in its letter, to the pharmaceutical giant joined the presentation made by the deputy on the basis of an online press conference of Glenmark Pharmaceuticals and media reports according to which the cost of FabiFlu per tablet is Rs 103.
“It was mentioned in the representation that Glenmark also claimed that this drug is effective in comorbid conditions such as hypertension and diabetics, when in reality, according to the protocol summary, this trial was not designed to assess FabiFlu in a comorbid condition “, read the letter sent by DCGI to the pharmaceutical company based in Mumbai dated July 17, a copy of which is with ANI.
“No clinically sufficient data specific to these conditions is available,” said DCGI in a letter.
“In light of this, you (Glenmark) are invited to provide clarification on the above points to take further necessary action in this matter,” reads the DGCI letter to Glenmark.
However, when ANI contacted Glenmark Pharmaceuticals, they refused to respond.
However, he said that on July 13, Glenmark had reduced its price for the antiviral drug Favipiravir, under the brand name FabiFlu, by 27%, for the treatment of patients with mild to moderate COVID-19, to Rs 75 per tablet.
(With the exception of the title, this story was not edited by GalacticGaming staff and is published from a syndicated feed.)
