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Glenmark slams allegations on Fabiflu as careless, unsubstantiated – Home Health Choices

New Delhi: In a powerful rebuttal to the drug regulator, Glenmark Pharma mentioned it has been on the receiving finish of careless, unsubstantiated allegations which might be devoid of deserves associated to Covid drug, Fabiflu.

In a reply to V.G. Somani, Directorate General of Health Services, Central Drugs Standard Control Organisation, Glenmark has responded to allegations made within the illustration by an unnamed Member of Parliament.

Glenmark mentioned it’s “dismayed” by the allegations because it introduced an oral anti-viral agent in lower than three months, being the primary and solely firm to conduct a strong 150-patient randomized managed trial and launching the drug at a inexpensive worth.

“Glenmark has been at the receiving end of such careless, unsubstantiated allegations that are devoid of merits whatsoever as amply demonstrated above”, it mentioned.

On the priority raised by the MP on unaffordability resulting from excessive worth, Glenmark mentioned Compared to different therapies accepted for emergency use in COVID-19, FabiFlu is rather more economical and an efficient therapy choice.

Further, provided that Favipiravir is an oral remedy, sufferers may be handled on an out-patient foundation with out incurring further hospitalization bills, in contrast to different accepted medicine that are injectable and therefore require administration at hospitals.

Favipiravir in India when launched was on the lowest market value (Rs 103/tab) as in comparison with the price of Favipiravir in different international locations the place it was accepted.

Despite investing considerably all through the method of producing, Glenmark has managed to maintain the pricing of Favipiravir decrease as in comparison with worth of Favipiravir in different international locations.

Subsequently on July 13, Glenmark decreased worth of FabiFlu to Rs 75 per pill. The worth discount was made potential by way of our efforts to acquire higher yield and higher scale, and with each API and formulations manufactured at Glenmark’s personal services in India.

Today, Favipiravir is part of a number of state authorities protocols and hundreds of COVID-19 sufferers have benefited from the prescription of the product, the corporate mentioned.

There is an alllegation of deceptive/false declare that Favipiravir is efficient in COVID-19 sufferers with comorbidities like diabetes, hypertension as Phase three scientific trial was designed to guage the efficacy in these co-morbidities.

In its response, Glenmark mentioned the alleged assertion pertaining to co-morbidity within the press launch dated June 20 was not derived from or alluded to Glenmark’s ongoing Phase three scientific trial. On the opposite, the reference to comorbidity was clearly primarily based on knowledge from Japanese registry — the most important assortment of real-world proof on scientific use of Favipiravir in COVID-19.

“In fact what is surprising is that the allegation of false claim is being made that when Glenmark, being a responsible corporate citizen, explicitly referenced upfront the Japanese registry, and at no point linked it to our India Phase 3 clinical trial,” it mentioned.

“In view of the above, it is clear that Glenmark’s communication at the launch of the said Product has been completely misread and/or quoted out of context which is harming our reputation,” Glenmark mentioned.

There can also be an allegation that Favipiravir just isn’t examined as monotherapy in Phase three scientific trial in India. “At the outset, Glenmark denies having made any such claim at any point in time that “Favipiravir alone” is effective in treatment of Covid-19 patients with mild to moderate disease,” it mentioned.

In the sunshine of the pandemic, in all COVID-19 trials being proposed/carried out throughout India, all sufferers obtain customary supportive care as per the steerage of Health Ministry as giving the sufferers placebo alone in such a state of affairs could be unethical as it could deprive the sufferers of any care in any respect.

Globally, related strategy, together with customary supportive care is adopted in scientific trials which might be being carried out to contemplate therapy choices for COVID-19 sufferers.

Similarly, within the Glenmark Study, as per the rules issued by ICMR and Health Ministry, sufferers with gentle to reasonable COVID 19 signs have been handled with Favipiravir plus advisable customary supportive care versus customary supportive care alone.

“It is pertinent to note that the standard supportive care in Glenmark Study did not include HCQ or any other anti-viral drug. Consequently, since both arms of the Glenmark Study received standard supportive care under this design, any advantage observed in the treatment arm can solely be attributed to the administration of Favipiravir,” Glenmark rebutted.

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