Glenmark Pharma shares fall as India's drug regulator sends notice on overpricing

Modesto Morganelli
Luglio 20, 2020

The DCGI has also pulled up Glenmark over the alleged overpricing of FabiFlu, the branded generic of the anti-viral Favipiravir, after a complaint about the same was received from a Member of Parliament.

Glenmark Pharmaceuticals had launched FabiFlu last month at a price of Rs 103 per tablet.

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". The DCGI has sought a response from the company.

On pricing of the drug, the drug controller said Glenmark's drug had been priced too high and was not in the interest of the poor and the common man. He had urged "the government to should ensure affordability of the drug to the common people".

Kolhe said six of the 12 centers for clinical trials were government medical colleges from Maharashtra, Gujarat, and Delhi. This indicates that poor and middle class patients have contributed to the clinical trials as subjects.

"I'm surprised that the DCGI is asking for safety and efficacy data through post-marketing surveillance after approving the drug", said Shri Prakash Kalantri, professor of medicine at the Mahatma Gandhi Institute of Medical Sciences, Wardha.

"It has been mentioned in the representation that Glenmark has also claimed that this drug is effective in comorbid conditions like hypertension and diabetics, whereas in reality, as per protocol summary, this trial was not created to assess the FabiFlu in comorbid condition", read the letter sent by DCGI to the Mumbai-based pharmaceutical company dated July 17, a copy of which is with ANI.

The Central Drugs Standard Control Organisation, which had last month approved restricted emergency use of favipiravir for mild and moderate Covid-19 patients, has conveyed the MP's concerns about treatment cost and about alleged claims that the drug is effective in patients with underlying health disorders.

The DCGI has asked Glenmark to respond to these issues and said that further action will be taken according to the clarification. "Also patients with less than 94% SP02 were excluded from the trial", it stated, adding that Glenmark's claims that Fabiflu alone is effective in mild and moderate cases are misleading.

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