Merck is developing COVID antiviral pill molnupiravir, while Pfizer is studying Paxlovid, another COVID pill, which could help control the ongoing pandemic.
Now, several Indian drug companies with licenses to develop generic versions of molnupiravir and Paxlovid are ramping up their capacities to make them, but they are awaiting approvals from the Indian government, according to Forbes.
Molnupiravir, which is developed by Merck in association with Ridgeback Biotherapeutics, has been authorized for use in the U.K. and Denmark. However, the U.S. Food and Drug Administration (FDA) has not yet approved Merck’s COVID pill.
In October, Merck announced a deal with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, which would allow drug companies to manufacture generic versions of molnupiravir.
The company has entered agreements with five Indian generic pharmaceutical companies. However, as of now, at least eight Indian drugmakers have agreements to manufacture generic molnupiravir, according to a spokesperson of Merck.
Unlike molnupiravir, Pfizer’s Paxlovid has not yet been approved by any drug regulatory bodies. However, earlier this week, the U.S. pharma giant confirmed that its drug has been found 89% effective in preventing hospitalizations and deaths for high-risk patients. Like Merck, Pfizer has allowed some Indian drug companies to manufacture Paxlovid.
Aurobindo Pharmaceutical has a license to produce generic molnupiravir. It said it is waiting on the expert committee to approve the treatment. Aurobindo CEO Sanjeev Dani said, “We have already stockpiled some of the materials and can ramp up the production on very short notice.”
BDR pharmaceutical is set to manufacture around three to five million pills of molnupiravir per month. It conducted clinical trials with generic molnupiravir and has submitted the data to the Drugs Controller General’s Subject Expert Committee, India.
BDR Chairman Dharmesh Shah said, “We definitely saw good results on molnupiravir, especially for the mild patients, where we saw the recovery on the fourth day.”
Dr. Reddy’s Laboratories, Cipla, Emcure, Sun Pharma, and Torrent Pharmaceuticals have teamed up to conduct clinical trials with a generic version of molnupiravir.
Dani said, “It’s like running a marathon, and you are still in the first 500 meters. Who is going to win, no one knows. The point is not what is superior or inferior. The fact that the pill works itself is great news.”
He explained that antivirals are not a replacement for vaccines, but they will eventually gain more relevance with the emerging threat of various variants, including the new Omicron strain. He said, “You can’t say I will fight only with missiles. You require guns and drones also.”
