Mumbai-based pharmaceutical firm Glenmark on Tuesday delivered a point-by-point reply to the central government regarding the earlier notice seeking clarification over the firm allegedly 'overcharging' and making 'false claims' about the usage of branded generic 'FabiFlu'. In its reply, Glenmark Pharmaceuticals has defended the pricing of the tablets, while addressing the problem of "unaffordability due to high price" and has said that it is still a more economical and effective treatment compared to other therapies approved for COVID-19.
Glenmark had launched FabilFlu last month at a price of Rs. 103 per tablet. Since the entire two-week course of treatment requires 122 tablets, it leads to a total cost of Rs. 12,500. The price of Glenmark's FabiFlu tablets were last week slashed by 27% to Rs 75 per pill, but even then the entire treatment course still costs Rs 9,150.
In its reply, Glenmark has compared the cost of other therapies approved for emergency use in COVID-19 and argued that a full course treatment with alternatives like Remdesivir, Tocilizumab, and Itolizumab cost three to five times higher than that of Favipiravir.
Not just this, Glenmark Pharma has also compared the prices in rupees of Favipiravir in other countries like Russia, Japan, Bangladesh, and China and showed that FabiFlu in India still costs a lot lesser. For example, in Russia, Favipiravir costs Rs. 600/tab while FabiFlu in India costs Rs. 75/tab (amended price).
Earlier, sending a clear message to the pharmaceutical industry that it is under the strict vigilance of the central government, the Drug Controller General of India (DCGI) VG Somani had pulled up Glenmark over the usage of 'FabiFlu', the branded generic of the anti-viral Favipiravir, on patients with co-morbidities suffering from coronavirus disease (COVID-19), after a complaint about the same was received from a Member of Parliament.
"The cost proposed by Glenmark is definitely not in the interest of the poor, middle class, and lower-middle-class people of India," the DCGI had mentioned in the letter.
The letter had also mentioned that there were alleged "false claims" about the usage of branded generic 'FabiFlu' on patients with co-morbidities suffering from coronavirus disease (COVID-19).
Glenmark had claimed that the drug is effective in co-morbid conditions like hypertension, diabetics, whereas in reality, as per protocol summary, this trial was not designed to assess FabiFlu in co-morbid conditions, the letter had read, adding that no clinically sufficient data specific to these conditions were available.
To this, Glenmark Pharma has now replied by saying that at no point did the firm mention the co-morbidity point as being derived from the ongoing Phase-III clinical trial. "On the contrary, it was based on data from the Japanese registry - the largest collection of real-world evidence on the clinical use of Favipiravir in COVID-19," the reply clarified.
DCGI Somani, who heads India's drug regulatory body Central Drugs Standards Control Organisation (CDSO), had earlier enclosed the representation from the legislator that raised issues with FabiFlu, in the letter, and sought a clarification from Glenmark regarding the matter.
On June 19, the drug regulator had approved anti-viral drug favipiravir for "restricted emergency use" in mild to moderate cases of COVID-19.
