India’s top drug regulator Friday granted emergency use approval to Glenmark Pharmaceuticals for its antiviral FabiFlu (favipiravir), a drug whose effectiveness in COVID-19 treatment is being tested by the firm here, The Indian Express has learnt. The oral medicine is to be administered only in mild to moderate COVID-19 patients and may cost around Rs 100 per 200 mg tablet.
Central Drugs Standard Control Organisation (CDSCO) chief Dr VG Somani allowed restricted emergency use of the antiviral for a maximum course of 14 days, a senior Health Ministry official told The Indian Express on condition of anonymity. This includes a dosage of 3,600 mg on the first day followed by a dosage of 1,600 mg daily.
However, this approval has been granted on the condition that the drug be administered only with informed consent, and that Glenmark submit active post marketing surveillance data for the first 1,000 patients as soon as it receives the same. “The drug is already approved in Russia. The trials here have shown promising results,” said the official, who added that data submitted to CDSCO shows that patients have been showing improvement within four days of treatment with the drug.
Glenmark confirmed the approval, but did not comment on pricing and details related to its trials, which were conducted in 10 hospitals. At least 150 patients across states like Gujarat, Maharashtra and Delhi were a part of the trials.
“This approval has been granted based on evaluation of data and in consultation with the Subject Expert Committee, as part of an accelerated approval process, considering the emergency situation and unmet medical need of the COVID-19 outbreak,” the firm told BSE late on Friday. “It is for restricted emergency use in India. Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.”
Unlike in remdesivir’s case, favipiravir is not restricted to hospitals and institutional settings, The Indian Express has learnt. “However, it has to be given with informed consent of the patient,” said the official cited above. Glenmark has approached the National Pharmaceutical Pricing Authority to fix the retail price of its FabiFlu and proposed a price of around Rs 100 a tablet, said a source on condition of anonymity.
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