Although Merck went down what many critics, including this platform, called a twisted, curvy path to get Molnupiravir commercialized—including signed deals with multiple pharmaceutical producers in India—it’s looking bleak for the antiviral therapy’s prospects in India. Why? As TrialSite reported, India’s apex medical research organization called Indian Council of Medical Research (ICMR) declared that despite the approval of the drug by this nation’s drug regulatory body—the Drugs Controller General of India (DCGI)—the top doctor for ICMR, Balram Bhargava recently stated publicly that his influential group had “major safety concerns” associated with molnupiravir. Now, the Times of India and several other media in the world’s second-most populous nation report that an ICRM national task force focused on COVID-19 will opt to not recommend the antiviral drug molnupiravir in their clinical management protocol for COVID-19. U.S. taxpayers subsidized this product, with $356 million to support research and $1.2 billion in guaranteed procurement contracts.

Safety Concerns

Even though molnupiravir has been authorized for use on an emergency basis in the United States, Europe, and other countries, mounting safety concerns compelled this task force to reject the Merck drug.

As TrialSite recently reported, Dr. Balram Bhargava expressed serious concerns which apparently led to several meetings and a collective decision to reject use of the drug despite an extensive Merck deal made in that country.

Dr. Bhargava, noting serious safety risks, declared, “We have to remember that this drug has major safety concerns.” He went on record that the drug shows the potential to cause defects in fetal development, not to mention adversely impacting muscle tissue. He stated, “Contraception will have to be done in three months …If this drug is given.”

The ICMR task force apparently made this decision on Monday of this week with an official statement:

“Members of the national task for COVID were not in favor of including the drug in the national treatment guidelines, citing that it does not have much benefit in the treatment of coronavirus infection and that there were safety concerns.”

Status Elsewhere?

By mid-November the European Medicines Agency first issued an advisory allowing select use of the antiviral drug in certain cases.

In America, an Emergency Use Authorization (EUA) was issued by the Food and Drug Administration (FDA) on December 23, 2021. The decision was based on the results of the MOVe-OUT study indicating the drug could reduce hospitalization and death by 30%. TrialSite’s Dr. Ron Brown praised the company’s move to publish the study’s Absolute Risk Reduction (ARR) at 2.9%–ten-times lower than their reported Relative Risk Reduction (RRR).

TrialSite reported on Merck’s journey to commercialize this drug, securing $356 million in American taxpayer money as well as $1.2 billion in guaranteed procurement contracts from President Joe Biden’s executive branch. Along the way the company aligned with federal bureaucrats and the mainstream press to aggressively vilify ivermectin, a possible low-cost competitor—not approved for the COVID-19 indication, however.