New Delhi: The Drug Controller General of India (DCGI), the apex body to approve and regulate drugs in India, has sent a letter to the Mumbai-based pharmaceutical giant Glenmark, accusing the company of selling its newly-approved Covid-19 drug, favipiravir, at an “unreasonable price” through “false claims”.
The DCGI, who heads the Central Drug Standard Control Organisation (CDSCO), a wing under the Health Ministry, had approved favipiravir in June.
The letter by DCGI V.G. Somani states that the apex body received a complaint from a Member of Parliament (MP) regarding favipiravir. The letter, titled “regarding the false claims and pricing of Fabiflu 200 mg by Glenmark Pharmaceutical limited”, does not name the MP.
“This office has received a representation from an honourable member of parliament that the total cost of the treatment with Fabiflu will be around Rs 12,500,” the letter, dated 17 July, states. “After all the 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 letter — which encloses an extract of the representation made by the MP — does not mention that Glenmark has recently slashed the price of the drug to Rs 75 per tablet.
Glenmark became the first pharmaceutical company in India to get approval for the manufacture and marketing of antiviral drug, which is one of the medicines that is being explored as a potential treatment for Covid-19.
It formally launched the drug on June 20 in a virtual press conference for “restricted emergency use” as Covid-19 treatment.
While the complaint focuses on the high price of Fabiflu, the price of another sought after Covid drug remdesivir is in the range of Rs 4,000-Rs 5,000 per vial and the total cost of treatment is estimated between Rs 40,000 and Rs 55,000.
DCGI asks for ‘clarification’
Somani, in the letter, referred to the representation and said, “it has been mentioned in the representation that Glenmark has also claimed that this drug is effective in comorbid conditions like hypertension, diabetics, whereas in reality as per protocol summary, this trial was not designed to access the Fabiflu in comorbid condition.”
“In view of this, you are requested to provide your clarification on the above points for taking further necessary action in the matter,” the letter reads.
A mail has been sent to the company for its comment. The story will be updated if it responds.
What the representation said
The representation by the MP drew on the company’s statements from its online press conference and media reports. It calculated that the approximate cost of treatment with the drug is around Rs 12,500.
“Cost of fabiflu 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 to day 14.),” the representation said.
It also mentions that while DCGI and health authorities “accelerated the process for clinical trials and reviews considering the pandemic situation, unmet medical conditions and unavailability of specific therapeutic management against Covid for this drug” but, “the cost proposed by Glenmark is definitely not in interest of the poor, lower middle class and middle-class people of India.”
“In fact, 6 out of 12 centres wherein the clinical trials are conducted are government medical colleges from Maharashtra, Gujrat and Delhi,” it said. “This indicates that the poor and middle-class patients have contributed to the clinical trials and subjects. The price quoted for this drug is definitely unaffordable to the common people.”
It further highlighted that Glenmark’s drug was tested in the clinical trial in India during April, May 2020 on 150 patients (90 mild and 60 moderate). “Going by the protocol summary available at CTRI website, Fabiflu was not tested as monotherapy (only Fabiflu) in any of the mild or moderate patients,” the representation alleged.
“It was given along with ICMR approved standard protocol treatment in selective clinically stable covid patients. Also, patients with 94% Spo2 who are excluded from the trail,” it said. According to Healthline, SPO2 is a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen.
“This data clearly shows that the claims mentioned by Glenmark in their press conference, published in media/social media that Fabiflu alone is effective in mild and moderate patients are completely misguided to all clinical practioners and people in India.”
The representation also accuses that “Glenmark has also claimed that this drug is effective in comorbid conditions like hypertension, diabetes, whereas in reality as per protocol summary, this trial was not designed to assess the Fabiflu in comorbid conditions.”
It added that “no clinically sufficient data specific to this condition is available making false claims without substantial clinical evidence in media is misleading to patients and clinicians.
“Pharma companies should be refrained from making such claims in future,” it said.
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