Indian pharmaceutical manufacturers are ready to bring Covid antivirals to the World

KATHMANDU: Covid-19 cases were already beginning to surge around the world before scientists in South Africa identified the omicron variant. Two Covid antiviral treatments developed by Merck and Pfizer are seen by some public health officials as key to controlling renewed outbreaks, especially for areas that lack access to vaccines or face large numbers of people who refuse to take them.

Several Indian pharmaceutical manufacturers with licenses to develop generic versions of Merck and Pfizer’s Covid-19 antiviral pills are ramping up their capacities to make them, but they’re still awaiting emergency use authorizations from the Indian government.

The antiviral that’s the furthest along is molnupiravir as a Covid-19 treatment for mild to moderate cases. It was originally developed as a flu treatment that was repurposed by Merck and its partner Ridgeback Biotherapeutics. So far, the drug has been authorized for use in the U.K. and Denmark. An FDA panel narrowly recommended authorization on November 30, but the agency hasn’t made a final decision yet.

In April 2021, Merck along with the Medicines Patent Pool, an international organization that helps developing countries access affordable medicines through non-exclusive voluntary licensing, entered agreements with five generics manufacturers in India as the country went through a devastating second wave of Covid-19. As of December 2021, at least eight Indian pharmaceuticals have agreements to manufacture molnupiravir, according to a Merck spokesperson.

Pfizer’s antiviral treatment, called Paxlovid, has not yet been authorized by any country’s regulators. However, earlier this week the company confirmed strong clinical data suggesting it has 89% efficacy and preventing hospitalizations and deaths for high risk patients. Pfizer has also allowed Indian companies to manufacture its antivirals, but the company would not divulge how many manufacturers have licensed its drug.

Before selling the pills in India, pharma companies are required to conduct trials based on protocols laid out by the Central Drugs Controller General of India, a government body in charge of approving investigational drugs. Several of the manufacturers spoke to Forbes about their status.

BDR pharmaceutical, based in Mumbai, India, says it is prepared to manufacture anywhere between three to five million units of molnupiravir per month, should there be a surge in demand due to the Omicron variant. The company conducted clinical trials with its generic version of the treatment and has submitted the data to the Drugs Controller General’s Subject Expert Committee.

“We definitely saw good results on molnupiravir, especially for the mild patients, where we saw the recovery on the fourth day, ” says Dharmesh Shah, the company’s chairman.

Hyderabad-based Aurobindo Pharmaceutical also has a license to produce a version of molupiravir, and says its just waiting on the expert committee to authorize the treatment. “We have already stockpiled some of the materials and can ramp up the production on very short notice,” says CEO Sanjeev Dani. The company, which has submitted its clinical trial data to the government, will be able to manufacture tens of millions of pills per month, he added.

Indian pharmaceutical giant Dr Reddy’s Laboratories collaborated with Cipla Limited, Emcure Pharmaceuticals, Sun Pharmaceutical and Torrent Pharmaceuticals to conduct clinical trials with molnupiravir. The companies did not respond to a request for comment on trial results or the status of their manufacturing operations.

The expert committee thoroughly evaluates clinical trial data from manufacturers for safety and efficacy before giving a nod. The expert committee did not respond to requests for comment asking about the timeline.

Based on its own clinical trials in the U.S, Merck had earlier announced that molnupiravir could lead to 50% reduced risk of hospitalization or death in patients with mild-to-moderate Covid-19. However, the company later said, based on its final trials, that the pills reduced the risk of hospitalization and death among high-risk Covid patients by 30%.

Indian pharma companies who have license agreements with Merck are undeterred by the reduced efficacy data. “It’s like running a marathon, and you are still in the first 500 meters. Who is going to win, no one knows,” says Dani of Aurobindo Pharmaceutical. “The point is not what is superior or inferior. The fact that the pill works itself is great news,” he added.

D. Srinivasa Reddy, the managing director of Hyderabad-based Optimus Pharma is hopeful that Merck’s antivirals would work against omicron. However, he pointed out that when the clinical trials were conducted with molnupiravir, most patients enrolled were infected with the delta variant.

“All the variants have different intensity levels but I feel that with antivirals all the variants can be suppressed. If it worked on delta, it should work on Omicron, but we still don’t have solid data,” Reddy added. He also says that his company would be able to scale up the production to over 40 million molnupiravir capsules per month.

But these Indian companies aren’t sitting on their hands while they wait for the expert committee. They’re already manufacturing antiviral pills and have started exporting the medicines to other countries. For instance, Optimus already has orders from over 20 countries, including Iran, Dominican Republic, Laos, Cambodia and Sri Lanka.

Dani says that while antivirals are not a replacement for vaccines, they will gain more relevance in the coming months with the emerging threat of transmission from variants. “You can’t say I will fight only with missiles,” he says. “You require guns and drones also.” Forbes