DCGI pulls up Glenmark for false claims, overpricing of coronavirus drug FabiFlu

The letter has been sent to the company following a complaint by a Member of Parliament (MP) regarding the drug.

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Medicine
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India’s drug regulator has pulled up Mumbai-based pharmaceutical giant Glenmark, accusing the company of selling its Covid-19 drug, Fabiflu (favipiravir), at a price “not in the interest” of a certain class of people in India.

The Central Drug Standard Control Organisation (CDSCO), the drug regulatory authority in India had approved the drug in June for the treatment of Covid-19. The letter has been sent to the company following a complaint by a Member of Parliament (MP) regarding the drug.

Drug Controller General (India) VG Somani in a letter dated July 17 has asked for a clarification on the matter for taking necessary action. The MP wanted the company to review the price of Fabiflu 200 mg to ensure accessibility and affordability of common people to this new approved treatment. However, the MP has further alleged that the company is misleading people.

Referring to the representation Somani said in its letter, “it has been mentioned in the representation that Glenmark has also claimed that this drug is effective in comorbid conditions like hypertension, diabetics, whereas in reality as per protocol summary, this trial was not designed to access the Fabiflu in comorbid condition.”

Also read: Glenmark launches hypertension awareness symbol

“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,” the letter said Glenmark declined to comment on the matter.

The representation highlighted that the company was misleading the practitioners, “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 patients. Also, patients with 94% Spo2 who are excluded from the trail,” it said.

“This data clearly shows that the claims mentioned by Glenmark in their press conference, published in media/social media that Fabiflu alone is effective in mild and moderate patients are completely misguided to all clinical practitioners and people in India,” it further added. It needs to be noted that Glenmark had last week reduced the price of the drug.

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