Mumbai: The Subject Expert Committee (SEC) under the Indian drug regulator is expected to review the EUA application from drug companies that seek approval for Merck Antivirus Pills, Molnupiravir, on Thursday.
Some companies including Natco, Dr.
Reddy’s, Cipla, Sun Pharma, Hetero and BDR Pharma are waiting for a ruling nod to introduce generic antivirus in India, which is expected to be available at affordable prices.
The drug, considered a potential game modifier in treating Covid-19 infection is light, it can be the first oral antiviral pill to be launched in India.
At present, antiviral drugs are used in covid therapy such as remdesivir, given intravenously, and in hospital settings.
Although price details are not available, experts believe the cost of a five-day course can be around Rs 1,200-1,500 in India, considering strict competition.
This is a small portion of the price charged in the United States and England.
SEC is expected to study the trial data submitted by the company, and provide recommendations to controller Medicines General India who will receive the last call on the application.
Molnupiravir, Merck Sharpe Dohme (MSD) antivirus therapy (MSD) and Ridgeback of its partners, has shown a promise in the treatment of Covid-19 which is light to medium to adults, after almost splitting in the risk of hospitalization and death.
Although antivirus has not been approved by the provision of US food and medicine, the prospect of approval here has been supported by a “conditional” nod recently by British drugs and the health product supervisory agency, source to TOI.
Previously in June, MSD signed a license agreement with five generic companies – Sun Pharma, Cipla, Torrent, Emcure and Dr.
Reddy’s – to produce and supply Molnupiravir in India, and to more than 100 low and medium income countries.
Hetero, Natco and BDR Pharma have also sent clinical trial data to the regulator.
Dr.
Reddy’s leads the Phase-3 clinical trial with Molnupiravir in India for five companies licensed by MSD.
“The trial is at Covid-19 light in the outpatient arrangement, and in the term India, comparable to the light to moderate categories, studied by Merck and Ridgeback.
We strongly followed developments related to the approval in countries around the world and in India,” said a company spokesman before.
Furthermore, the US government hoarded 1.7 million molnupiravir care programs around $ 700 per patient.
However, it is expected to be charged a fee at a fraction of global costs in India, with certain domestic companies including Optimus Pharma manufacturing raw materials in this country.
Significantly, the first generic version of Molnupiravir, maybe globally, launched recently, media reports show, in Bangladesh around $ 33 per course.