Before scientists identified the omicron species in South Africa, Covid’s cases began to increase worldwide. The two Covid antiviral therapies developed by Merck and Pfizer are seen by some health officials as key to controlling the outbreak, especially in areas where vaccines are not available or where many people refuse to be vaccinated.
Several Indian drug manufacturers licensed to make generic versions of the Qovid 19 Merck and Pfizer antiviral pills are increasing their capacity to make these pills, but are still waiting for an emergency use permit from the Indian government.
An antiviral that is closer to use is called molnopiravir, which is a treatment for mild to moderate cases of Covid. The drug was first developed as a treatment for influenza and then modified by Merck and Rijbek Biotherapy to fight Covid. It is now approved for use in the United Kingdom and Denmark. A delegation from the Food and Drug Administration on November 30 recommended limited approval of the drug, but the organization has not yet made a final decision.
In April 2021, Merck signed agreements with five public medicine manufacturers in India in collaboration with the International Medicines Patent Pool, which helps developing countries access affordable drugs through voluntary non-exclusive licenses. According to Merck’s spokesman, since December 2020, at least eight Indian pharmacists have signed agreements to produce melenopiravir.
Pfizer’s antiviral treatment, Paxloid, has not yet been approved by regulatory agencies in any country. However, the company recently confirmed that strong clinical data show that their drug is 89% effective and prevents hospitalization and death of high-risk patients. Pfizer has also allowed Indian companies to make its own antiviral drug, but did not disclose how many drug manufacturers have licensed it.
Prior to the sale of tablets in India, pharmaceutical companies are required to conduct trials in accordance with the protocols established by the General Drug Control Organization in India. Several manufacturers have spoken to Forbes about their situation.
Mumbai-based pharmaceutical company Bediar Pharma says it is ready to produce between 3 and 5 million units of mulnopiravir per month if demand increases as a result of the omicron species. The company conducted clinical trials with the public prescription of the drug and provided the data to the specialized committee of the responsible organization. “We saw good results with molnopiravir, especially for patients with mild illness, and on the fourth day we saw their recovery,” said Darmash Shah, the company’s president.
Arubindo Pharma is also licensed to produce a prescription for mulnopiravir and is awaiting the opinion of an expert committee on treatment. “We have saved some materials and we can increase production in a short time,” said Sanjio Danny, the company’s CEO. “The company has provided its clinical trial data to the government and can produce tens of millions of pills a month.”
The laboratory of Dr. Reddy, an Indian pharmaceutical giant, is collaborating with several other companies to conduct clinical trials of molnopiravir. These companies did not respond to a request for comment on the results of the trial or the status of their production operations.
The expert committee evaluates the manufacturers’ safety and efficacy before issuing the authorized clinical trial data. The committee also did not respond to a request for comment.
Based on clinical trials conducted in the United States, Merck had previously stated that molnopiravir could reduce the hospitalization or death rate by 50 percent in patients with mild to moderate coronary artery disease. However, the company later said in a clinical trial that the pill reduced the risk of hospitalization and death in high-risk patients by 30%.
Indian pharmaceutical companies that have signed licensing agreements with Merck were not discouraged by the declining data. “It’s like running a marathon and you’re still in the first 500 meters,” says Danny of Arubindo Pharma. It is not clear who will win. It does not matter who gets first. “The fact that the pill works is great news.”
Dr. Serinivasa Reddy, CEO of Optimus Pharma, hopes Merck antivirus will be effective against omicron. However, he noted that most of the patients enrolled in the trial were delta-infected when the molnopiravir trials were performed. “Different species have different levels of severity, but I feel that with viruses, all species can be suppressed,” Reddy added. “If it works on Delta, it should work on Omicron, but we do not have strong data yet.” He also says that Optimus Pharma can increase the scale of production and produce more than 40 million mulnopiravir capsules per month.
Indian companies have not joined hands while waiting for the approval of the expert committee. They are making anti-virus pills and have started exporting them to other countries. Optimus, for example, currently orders from more than 20 countries, including Iran, the Dominican Republic, Laos, Cambodia and Sri Lanka. “While antivirals are not a substitute for vaccines, they will become more important in the coming months as new species become threatened,” says Danny. “You can not say that we are only fighting with missiles, you also need guns and drones.”