NEW DELHI/MUMBAI:The Drug Controller General of India (DCGI) has granted permission to manufacture and sell Glenmark pharmaceuticals’ Favipiravir for Covid-19. The approval for Favipiravir 200 mg tablet has been given following the recommendation of special subject expert committee (SEC) on Covid-19.
“Under an accelerated approval process at the Central Drugs Standard Control Organisation (CDSCO), the SEC has recommended the grant of permission to manufacture and market Glenmark’s Favipiravir, 200 mg tablet,” sources added.
“Glenmark Pharmaceuticals has received the manufacturing and marketing approval from India’s drug regulator to launch the oral antiviral drug Favipiravir (FabiFlu®) for the treatment of mild to moderate Covid-19 patients in India,” said the company in a statement.
Reportedly, each strip containing 34 tablets will come at an approximate MRP of Rs 3,500. For the treatment 122 tablets will be required for 14 days.
The approval comes with a caveat that the company will have to submit a copy of the informed consent and report of the ongoing clinical trials within three months. The SEC has also recommended that the drug should be used with caution in patients with a history of abnormalities in metabolism of uric acid.
It also asked the company that postmarketing surveillance should be conducted on the first 1,000 patients to assess safety and efficacy of the drug.
In a seperate development, Maharashtra’s health minister Rajesh Tope said that Cipla and Hetero have received emergency marketing approval for Remdesivir for the treatment of severe Covid-19 patients from the drug controller of India, a move that would help companies launch it officially in hospitals across the country.
The emergency approval is given to an unapproved therapy for compassionate use provided drug companies share the clinical data of the drug on patients where it is used. Officials from DCGI and Hetero and Cipla did not confirm this development to ET.
The other licensees of Gilead who are awaiting a nod from the drug regulator are Jubilant Pharma, Zydus Cadila, Dr Reddys.