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DCGI approaches Glenmark over Favipiravir claims

An explanation has been requested by DCGI ( the Drugs Controller General of India) from Glenmark Pharmaceuticals scrutinizing it’s alleged “ false claims” on the implementation of the viral fabiflu ( favipiravir ) on COVID–19 patients with comorbidities( a denoting medical condition that co-occurs with another medical condition).

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After the drug regulator received a grievance from a member of Parliament(MP), the drug regulator also asked for a clarification on the price of the medication.

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On 19th July 2020, ANI announced that the drug regulator bestowed the permission for antiviral drug favipiravir for “ restricted emergency use” in Clement to average cases of COVID-19 in the belief of the emergency and dissatisfied medical need during the epidemic. Then last month on 20th June Glenmark pharmaceuticals launched fabiflu at a price of Rs. 103 per tablet. It was launched in a virtual press conference.

Dr. VG Somani, DCGI wrote in a letter to Glenmark Pharma gaint ordering them to furnish a clarification after his office encountered a representation from an MP. The subject of the letter was in regard to “ false claims and pricing of the tablet fabiflu 200 MG by Glenmark pharmaceutical limited India.

The legislator told in his complaint to the drug regulator that The total cost of the treatment with favipiravir will be around Rs. 12,500 and that the cost recommended by Glenmark is definitely not in concern of the poor, lower middle class, and middle-class people of India.

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As per the claim by the Glenmark, the patient needs to take the tablet for 14 days continuously which means one patient will consume about 122 tablets ( on day one 18 tablets and then 8 tablets per day from day 2 to day 14.

The presentation made by the legislature expressed that in this time of the epidemic the central government should make sure of the affordability of the drug to the common people.

In fact, about 6-12 centers where those clinical trials we’re conducted are government medical colleges from Maharashtra, Gujarat, and Delhi. This stipulates that poor and middle-class patients have put up to clinical trials as subjects.

DCGI: It has been spotted in the representation that Glenmark has also asserted that this drug is productive in comorbid conditions like hypertension and diabetes but in reality, as per the protocol summary, this trail wasn’t compelled to evaluate the fabiflu in comorbid conditions.

On 13th July Glenmark declared the price drip for the antiviral drug favipiravir as the name of Fabiflu by 27 per cent to Rs. 75 per tablet.

Also Read: Finally Covid-19 Drugs medicine launched by Glenmark at Rs 103 per tablet