SEC to review companies' applications for Molnupiravir on Monday

The drug regulator's subject expert committee (SEC) will meet on Monday to examine applications of drugmakers seeking market authorisation for Merck's antiviral molnupiravir for Covid-19 treatment. All eight companies that had applied for licence have been invited for the meeting, people aware of the development said.

The drug is touted as a game-changer in the fight against the pandemic, and a panel of experts of the US Food and Drug Administration (FDA) early this week recommended its emergency use for treatment of Covid-19.

If FDA gives its nod, it "may help speed up approval of antiviral molnupiravir in India", a senior official in the health ministry said. SEC of the Central Drugs Standard Control Organisation (CDSCO) had reviewed the applications of Dr Reddy's, Hetero Labs, Natco Pharma, Aurobindo Pharma, Optimus Pharma, Strides Pharma, MSN Pharma, and BDR Pharmaceuticals on November 18 and sought additional data from the companies.


"We have submitted our responses to the regulatory authority," said a top executive of a drugmaker that has done phase-3 clinical trials of the antiviral medication. He confirmed that SEC is expected to meet next week to review their application along with others.