The Drug Controller General of India has sent a show cause notice to Glenmark Pharmaceuticals over 'overpricing' and 'false claims' of its drug Fabiflu. The drug controller said that Glenmark's drug has been priced too high and is not in the common interest of poor, lower middle class and middle class people of the country. It also said that the company has made false claims and stated that the drug is effective in co-morbid conditions. The DCGI has sought a response from the company.
The notice stated that the DCGI has received reports that Fabiflu -- a version of favipiravir -- has been priced at Rs 12,500 for the entire course. "The cost proposed by Glenmark is definitely not in interest of the poor lower middle class and middle class people of India," it said. The regulator said that as per Glenmark, per tablet of Fabiflu is priced at Rs 103. A patient would be required to take 18 tablets on Day 1 and eight tablets every day from Day 2 to Day 14, amounting to Rs 12,500 for the complete course.
However, it must be mentioned that Glenmark said in a regulatory filing recently that it has slashed the price of its favipiravir tablet by 27 per cent to Rs 75 MRP. "The price reduction has been made possible through benefits gained from higher yields and better scale, as both the active pharmaceutical ingredient (API) and formulations are made at Glenmark's facilities in India, the benefits of which are being passed on to patients in the country," it had stated in the filing.
"In such a global pandemic where the world is struggling against Covid, Government of India should ensure affordability of the drug to common people. In fact, 6 of the 12 centres wherein these trials were conducted are government medical colleges from Maharashtra, Gujarat and Delhi. This indicates that poor and middle class patients have contributed to the clinical trials as subjects. The price quoted for this drug is definitely unaffordable for common people," said DCGI.
The DCGI said that Glenmark made claims that Fabiflu alone would suffice as treatment in mild and moderate coronavirus cases and that it is effective for patients with comorbidities. The notice mentioned that Fabiflu was not tested as monotherapy in any of the mild or moderate cases. "Fabiflu was given along with ICMR approved standard protocol treatment in selective clinically stable COVID patients - mild (not more than 2 symptoms) and moderate (not more than 4 symptoms) conditions. 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.
The regulator further added that while Glenmark has claimed that this drug is effective in patients with comorbidities, the trial "was not designed to assess Fabiflu in comorbid conditions". It said that no clinically sufficient data specific to these conditions are available.
The DCGI has asked Glenmark to respond to these issues and said that further action will be taken according to the clarification.