Panel to meet today to take up applications seeking nod for Molnupiravir

The subject expert committee (SEC) of India's drug regulator will be meeting on Thursday to examine applications of over a dozen drugmakers seeking accelerated approval of MSD's Covid-19 antiviral medication molnupiravir. People in the know said the SEC is expected to make a decision on recommending approval to molnupiravir by the end of the day.

The firms whose applications that will be taken up are Dr Reddy's Laboratories which has filed for approval in a consortium with five other companies and MSD, Hetero Labs, , , Optimus Pharma, Strides Pharma, MSN Pharma and BDR Pharmaceuticals.

The Drug Controller General of India has asked the firms to send a detailed summary of the proposals and PowerPoint presentations to the SEC.

The meeting is scheduled between 12 noon and 6 pm and will be conducted via video conference, the people said.

MSD and Ridgeback Biotherapeutics have jointly developed molnupiravir. The antiviral received approval from UK drug regulator MHRA earlier this month.

The advisory committee of the US FDA will be meeting on November 30 to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease in adults.