DCGI slams Glenmark over misleading claims, price of COVID drug FabiFlu
Making false claims without substantial clinical evidence in media is misleading to the patients and clinicians in such a global pandemic situation. Pharma companies should also be refrained from making false claims about the medicine in the future, DCGI noted.
New Delhi: Drug major, Glenmark Pharmaceuticals Ltd. has recently fallen under the scanner of the Drug Controller General of India ( DCGI ), as the regulator has issued a letter to the firm seeking clarification over its alleged "false claims" about the use of anti-viral FabiFlu on Covid-19 patients with comorbidities and also over the "pricing" of the drug.
This comes following a complaint from a member of Parliament. As per the complainant, the total cost of treatment with Fabifle (Favipiravir) will be around Rs 12500/-(Twelve thousand five hundred Rs). After all positive approach, accelerated processes, and efforts by DCGI, Health ministry, and relevant State FDA departments, the cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class, and middle-class people of India. Extract of the representation enclosed.
"Further, it has been mentioned in representation that Glenmark has also 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," the letter quoted.
Dr V G Somani further highlighted in the letter that "no clinically sufficient data specific to these conditions are available. Citing the same, he sought clarification while mentioning as;
"In view of this, you are requested to provide your clarification on the above points for taking further necessary action in the matter," he added.
On July 13, Glenmark had stated that it has cut the price of its antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate Covid-19 by 27 percent to Rs 75 per tablet. The company had launched FabiFlu last month at a price of Rs 103 per tablet.
Also Read: Glenmark Announces Price Reduction Of 27pc For COVID Drug FabiFlu
The letter sent to the firm by the DCGI encloses the representation made by the MP which refers to an online press conference by Glenmark Pharmaceuticals and media reports that the cost of FabiFlu per tablet is Rs 103.
"As per the claim by Glenmark, a patient has to take the tablet for 14 days, which means one 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," the representation read.
As per a statement by the Glenmark and media reports, the DCGI had accelerated the process for clinical trials and reviews considering the pandemic situation, unmet medical conditions, and unavailability of specific therapeutic management against Covid-19 for this drug, it said.
However, after all, positive approach, accelerated processes, and efforts by DCGI, health ministry, and relevant state FDA departments, the cost proposed by Glenmark is definitely not in the interest of the poor, lower middle class, and middle-class people of India, the representation noted.
"In such a global pandemic where the world is struggling against Covid-19, the government of India should ensure the affordability of the drug to the common people. In fact, 6/12 centers wherein these clinical trials were conducted are government medical colleges from Maharashtra, Gujarat, and Delhi. This indicates that poor and middle-class patients have contributed to the clinical trial as subjects. Price quoted for this drug is definitely unaffordable to the common people," it stated.
The drug regulator had on June 19 approved anti-viral drug 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.
Review the pricing to ensure accessibility of the common and affordability of common people to this newly approved treatment.
Along with the price of Fabiflu, Somani also brought to the notice of the company that Fabiflu medicine by Glenmark was tested in a clinical trial in India during April/May 2020 on 150 patients (90 mild and 60 moderate COVID patients).
"Going by the protocol summary(CTRL/2020/05/025114) available at CTRI website (ctri.nic.in) Fabiflu wad not tested as monotherapy (ONLY FABIFLU) in any of the mild or moderate patients. FABIFLU was given along with ICMR approved standard protocol treatment in selective clinically stable COVID patients-Mild(Not more than 2 symptoms of COVID) and moderate(not more than 4 symptoms of COVID)conditions. Also, patients with less than 94% SPO2 were excluded from the trial," DCGI stated.
The drug regulator further added that this data clearly shows that the claims mentioned by Glenmark Pharma in their press conference, published in media./social media that FABIFLU alone is effective in all mild and moderate COVID patients are completely misguiding to all clinical practitioners and people of India.In line with this, there are also published news in the media stating "NO EVIDENCE of Fabiflu ALONE in mild and moderate-Covid patients" by many COVID experts and Clinicians.
Along with this, it was also pointed out that Glenmark has also 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
Making false claims without substantial clinical evidence in media is misleading to the patients and clinicians in such a global pandemic situation. Pharma companies should also be refrained from making false claims about the medicine in the future, DCGI noted.
