The Drug Controller General of India has sent a letter to the Glenmark seeking clarifications on pricing as well as claims of therapeutic efficacy.
While Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
Glenmark, which markets favipiravir under brand Fabiflu for treatment of mild-to-moderate Covid-19 patients, has come under the scanner of the country’s drug regulator over pricing of the drug and claims of its therapeutic efficacy.
The Drug Controller General of India (DCGI) has sent a letter to the Mumbai-based drugmaker seeking clarifications on pricing as well as claims of therapeutic efficacy.
The move was triggered by a letter Nationalist Congress Party legislator Amol Kolhe wrote addressed to the health minister.
The DCGI had given emergency use authorisation to favipiravir in the third week of June.
It was an expedited approval following review by the subject expert committee (SEC) given the pandemic situation in the country.
In his letter to Glenmark, V G Somani, India’s DCGI, who heads the Central Drug Standard Control Organisation (CDSCO) has said that it received a complaint from a member of the Parliament (MP) regarding the drug favipiravir. This letter, however, did not name the MP.
Kolhe, a medical professional, had written a letter to Health Minister Harsh Vardhan on June 26, right after Fabiflu was launched.
He had said that a patient has to take these tablets for 14-days (or around 122 tablets).
At a price of Rs 103 per tablet, this would bring the total cost of treatment to Rs 12,500.
He had urged “the government should ensure affordability of the drug to the common people”.
Later, however, Glenmark slashed the price of the drug to Rs 75 per tablet bringing down the cost of treatment to Rs 9,150.
Kolhe said six of the 12 centres for clinical trials were government medical colleges from Maharashtra, Gujarat, and Delhi.
He claimed that while common people contributed to the trial as subjects, the drug is definitely unaffordable to them.
Meanwhile, Somani referred to the MP’s representation and said that while Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
Kolhe claimed in his letter that “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... It was given along with ICMR-approved standard protocol treatment in selective clinically-stable Covid-19 patients.
"Also, patients with 94 per cent SPO2 who are excluded from the trail.”
SPO2 is a measure of the amount of oxygen-carrying hemoglobin in the blood in comparison to the amount of hemoglobin that is not carrying oxygen.
Kolhe further alleged that the data clearly showed that the claims made by Glenmark in their press conference that Fabiflu alone is effective in mild to moderate patients are “completely misguided” to all clinical practitioners and people of India.
Glenmark said it would respond to the DCGI as early as it could.
Meanwhile, sources in the CDSCO claimed that the letter was sent to the company as an MP sought some clarifications.
“The company will now clarify on the points raised by the MP,” a source said.
Earlier this month, Glenmark had said it had started a post-marketing surveillance study on its brand Fabiflu to monitor the efficacy and safety of the drug in 1,000 patients.
Glenmark has completed phase-III clinical studies, with favipiravir in mild-to-moderate Covid-19 patients in India.
The results from the study would be out within 10 days or so, sources said.
Glenmark is also conducting another phase-III clinical trial to evaluate the efficacy of two antivirals drugs favipiravir and umifenovir as a combination therapy in moderate hospitalised adult Covid patients in India.
The combination study, which is called the FAITH trial, is looking to enrol 158 hospitalised patients of moderate Covid in India.
Photograph: PTI Photo