New Delhi: Pharmaceutical firm Glenmark Tuesday said allegations that it was selling the Covid drug favipiravir at a “high price” and with “misleading claims” was damaging its reputation when, in fact, the drug is sold in India at one of the cheapest prices.
The company had sent a response to the Drug Controller General of India (DCGI), the apex body that approves and regulates drugs in India, a day after it came under the scanner of the Narendra Modi government for the pricing of favipiravir and using “misleading claims” to market it.
The DCGI had shot off a letter to the company saying his 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.” Fabiflu is the brand name of favipiravir.
The letter accused the company of selling the drug at high price, quoting the MP’s representation.
“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.”
Glenmark’s response
In a statement issued Tuesday, Glenmark said it had denied the allegations in a five-page response sent to the DCGI on 20 July, in which it said favipiravir is cheapest in India.
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“Favipiravir in India, when launched, was at the lowest market cost (Rs 103 per tablet) as compared to the cost of Favipiravir in other countries where it was approved,” said the letter signed by Anurag Khera, senior vice president, Corporate Affairs at Glenmark.
The drug was formally launched a month ago, on 20 June, for “restricted emergency use” in Covid-19 treatment. Subsequently, on 13 July, Glenmark reduced the price of FabiFlu to Rs 75 per tablet.
Clarifying the concerns, point by the point, the company told DCGI that “it is clear that Glenmark’s communication at the launch of the said product has been completely misread and/or quoted out of context which is harming our reputation.”
According to the data quoted by the company for the comparison, the drug is sold in Russia at Rs 600 per tablet whereas in Japan it is available for Rs 378 per tablet. In Bangladesh, its price is Rs 350 per tablet whereas in China, it is priced at Rs 215 per tablet.
Glenmark became the first pharmaceutical company in India to get approval for the manufacture and marketing of the antiviral drug, which is one of the medicines that is being explored as potential treatment for Covid-19.
Claims about use in co-morbid conditions and monotherapy
The DCGI’s letter had also referred to the MP’s representation, which accused Glenmark of claiming that “this drug is effective in co-morbid conditions like hypertension, diabetics, whereas in reality, as per protocol summary, this trial was not designed to access the Fabiflu in co-morbid condition.”
The statement pertaining to co-morbidity in the press release dated 20 June 2020 “was not derived from or alluded to Glenmark’s ongoing Phase 3 clinical trial,” the company replied.
“On the contrary, the reference to co-morbidity was clearly based on data from Japanese registry — the largest collection of real-world evidence on clinical use of Favipiravir in COVID-19,” it said while adding that “none of the product promotional literature, summary of product characteristics or product information leaflet makes any such claim that Favipiravir can be used in mild to moderate COVID-19 patients with comorbid conditions such as diabetes and heart disease.”
The last concern raised in DCGI’s letter was that Fabiflu was not tested as monotherapy (only Fabiflu) in any of the mild or moderate patients.
Glenmark has denied making any such claim at any point in time that “Favipiravir alone” is effective in treating Covid patients with mild to moderate symptoms.
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