India may approve anti-COVID-19 drug molnupiravir soon: Report
India is reportedly likely to approve Merck's anti-COVID-19 drug molnupiravir soon. Emergency Use Authorization (EUA) for the drug may come within days, Dr. Ram Vishwakarma told NDTV. Dr. Vishwakarma is the chairperson of the COVID-19 Strategy Group, Council Of Scientific And Industrial Research (CSIR). Pfizer's anti-COVID-19 pill Paxlovid may take longer, he said.
Why does it matter?
- Last week, the United Kingdom had granted conditional approval to molnupiravir.
- The move made molnupiravir the first oral antiviral treatment for COVID-19 to be approved by any country.
- The drug is intended to prevent COVID-19 from progressing into a severe version of the disease and could hence save lives.
- Merck says it cuts hospitalizations and deaths by half in patients with early COVID-19 symptoms.
'Drug regulators already reviewing EUA'
Trial data for molnupiravir has been "sitting" with India's regulator since before the UK regulator's approval, Dr. Vishwakarma told NDTV. "So already Subject Expert Committees are looking at it. And I think they will get faster approval now," he said. Dr. Vishwakarma assigned a "safe" timeline of a month to molnupiravir being approved in India.
'Drugs more important than vaccines'
Molnupiravir and Pfizer's Paxlovid are going to be more important than vaccination as "we move from pandemic to endemic," Dr. Vishwakarma said. He called the drugs the "final nail in the coffin of the virus by science."
How does molnupiravir work?
Molnupiravir targets an enzyme essential in the reproductive processes of the coronavirus, thus impacting its ability to replicate and spread. The re-purposed drug is to be taken twice a day for five days in mild to moderate cases of COVID-19 involving adults. It reduces the risk of hospitalization or death by approximately 50% in early COVID-19, Merck said, citing interim trial data.
Paxlovid cuts severity risk by 89%: Pfizer
Meanwhile, according to Pfizer, its protease inhibitor Paxlovid (PF-07321332) reduces the risk of hospitalization or death by 89% in non-hospitalized high-risk adults with COVID-19. The experimental drug awaits clearance by the United States Food and Drug Administration. The pharmaceutical major said it has entered into advance purchase agreements with "multiple countries and is in negotiations with several others."
Merck in talks with 5 Indian firms
Earlier, Merck's MSD Pharmaceuticals had signed pacts with five Indian firms to manufacture molnupiravir—Sun Pharmaceutical Industries, Cipla, Dr Reddy's Laboratories, Emcure Pharmaceuticals, and Hetero Labs. Pfizer will also have to enter similar agreements as it relies on India to manufacture drugs, Dr. Vishwakarma said.
How much will molnupiravir cost?
Reportedly, molnupiravir costs about $18 to make and the US paid $700 for each drug treatment. However, Dr. Vishwakarma said molnupiravir would be much cheaper in India. There would be a "dual pricing system and a staggered pricing system" in India, he said. The drug may initially cost Rs. 2,000-4,000 per treatment, which will eventually come down to Rs. 500-1,000, he added.