Noida-based Jubilant Life Sciences has sought permission from Drugs Controller General of India (DCGI) to roll out Remdesivir in tablet form.
At present, this antiviral drug is administered intravenously to treat Covid-19 patients.
The company had presented its proposal to the drug authority on August 25.
The company has given bioavailability protocol to the subject expert committee (SEC), which has been set up to evaluate proposals related to Covid-19.
According to the proposal, the company is in the process of launching 20 mg sublingual tablets.
Sublingual tablets are placed under the tongue so that it gets dissolved and absorbed into the blood through the tissues.
Subject expert committee (SEC) of theDCGI has asked Jubiliant to provide more details on the proposal. Before giving permission, SEC wants to make sure that there is a clear justification for use of the drug through sublingual route.
The company has been asked to provide details like evidence/literature including animal pharmacokinetic (PK) data generated with the drug through sublingual route.
The broad-spectrum antiviral agent remdesivir is a nucleotide analog prodrug. On May 1, 2020, The US FDA issued EUA of remdesivir to allow emergency use of the agent for severe COVID-19 (confirmed or suspected) in hospitalized adults and children. The remdesivir EUA was expanded to include use for moderate disease August 28, 2020.