Made-in-India molnupiravir may get EUAs soon: Govt sourcesNovember 12, 2021
India will soon authorise the first oral antiviral drug to treat Covid-19 — molnupiravir of Merck — made in the country for emergency use, according to senior government officials responsible for India’s Covid fight. Five Indian drugmakers, including Cipla, Dr Reddy’s Laboratories, Sun Pharmaceutical Industries, Torrent Pharmaceuticals and Emcure Pharma, had early this year signed separate non-exclusive voluntary licensing agreements with the inventor Merck Sharp & Dohme (MSD) for manufacturing and marketing this drug locally. These companies had also partnered in the local trials of molnupiravir.
The drug was first approved by the British drug regulator in the first week of November, making UK the first country in the world to authorise it for emergency use. According to UK MCA, molnupiravir, was found 90 percent effective in preventing the disease’s progress and severity. As per the approval, the patient can start taking the medicine within the five days of the symptom onset. It is the first drug that patients could take at home to ease symptoms and speed up recovery.
The drug is also currently awaiting approval in the US. But the US FDA has asked its outside experts to meet late November to scrutinise the treatment claims of the drug, signalling that the US regulator will conduct a detailed review of the experimental treatment’s safety and effectiveness. The panelists are likely to vote on whether Merck’s drug should be approved, although the FDA is not required to follow their advice.
The US regulator has so far authorised a few antibody drugs since last year but they are expensive, hard to produce and require specialty equipment and health professionals to deliver. If authorised, Merck’s drug, molnupiravir, would be the first oral anti-viral that patients could take at home to ease symptoms and speed up recovery.