India, China, pharmaceutical companies face increasing scrutiny in Washington
India, China, pharmaceutical companies face increasing scrutiny in Washington

India, China, pharmaceutical companies face increasing scrutiny in Washington

The pandemic revealed gaping holes in US supply chains. Everyone knows it. Everything medical-related was at the center when it came to critical items that were lacking in action. The country’s excessive reliance on China and India, especially for medical supplies, namely important generic drugs, is gaining Washington’s attention. So far, little has been done to address this. That is likely to change.

ONE vote by Morning Consult performed on behalf of the newly formed advocate group Americans for safe drugs showed that 85% of respondents said they were concerned about the pharmaceutical industry’s dependence on India and China. A further 70% said the United States should not be dependent on foreign sources for key generic drugs.

That trust is strong. The United States imports about two-thirds of its generic drug needs, and nearly 90% of generic APIs came from laboratories abroad.

Main Street understands the anecdotal evidence of the supply chain root.

Remember, since we all had to wear masks and no one could buy them, so they made semi-useless of fabrics instead, because China was the preferred manufacturer of N95s and the kind of masks you might see your dentist wear. Generic drugs are a more serious problem.

India stopped exporting important drugs during the pandemic. The most important was the anti-malarial drug hydroxychloroquine and all the active ingredients involved in its manufacture (or APIs as they are called). Hydroxychloroquine was distributed in India as a way to combat Covid. Overall, about 26 APIs was banned from being sent abroad.

China threatened to stop selling key starting materials for APIs and also APIs – which are included in the final drug in either tablet or liquid form. It was revenge for the travel ban and for the Trump administration that blamed them for the 2020 Wuhan outbreak.

China never lived on this threat. But that was enough to allow local drug manufacturers to show how India and China, more often competitors than partners, could harm the US supply chain for essential medicines.

The government is attentive but moving slowly.

Two years ago, in the fall of 2020, the Food and Drug Administration, at the request of the Trump White House, came up with a list of hundreds of drugs that it considered essential, which were either produced exclusively abroad – namely in Indian and European laboratories – or was a shortage of national stocks.

Numerous members of Congress have put forward fourth bills to help manufacture these drugs in the United States, but none of them have yet been voted on.

In March, Senator Tina Smiths (D-MN) Onhoring Essential Antibiotics Act and Senator Jacky Rosens (D-NV) Strategic Planning for the Emergency Medical Manufacturing Act were unanimously approved by a Senate committee to be part of the PREVENT Pandemics Act. No date has been set for the vote on this bill.

The Smith change would provide $ 500 million in subsidies to domestic drug manufacturers.

“We should be able to produce essential antibiotics that Americans need here on American soil. This is a matter of public health and national security,” Smith said in a statement. “By strengthening our country’s capacity to store critical medicines, we will have more security and resources to promote public health during the pandemic and beyond. “

Bad drugs

Drug manufacturers abroad are rarely inspected by the FDA. When an inspector finds a problem with the laboratory or the treatment of medicines, the company receives a so-called warning letter. Indian API manufacturers – such as Aurobindo Pharmaceuticals – are mostly on the receiving end of these letters. China’s facilities for key source materials are not inspected at all.

Companies that receive warning letters are still allowed to sell drugs to the United States. This has also prompted local generic drug companies to step down against this, leading to the creation of the American for Safe Drugs group. Their Morning Consult survey showed that over 80% of respondents either wanted these drugs banned or wanted them inspected on arrival at a US port before being given to patients.

About 86% of these surveys said they felt it was important to get the U.S. government to support domestic generic drug manufacturers.

Yet companies often receive these letters and remain operational in the United States

March 30, 2022, a site called Premium Light Supplier, with a San Francisco phone number, was sent a warning letter from the FDA for the sale of illegal, uninspected drugs.

Although the FDA website did not specify where this company was based, it is most likely that this is a US consumer-direct-to-China e-commerce operation that sells $ 6 per. pill Adderall and $ 4 per. anti-depressant pill Celexa.

The FDA warning letter said:

“The easy availability of these stimulants over the Internet poses additional significant risks to U.S. consumers. In addition, the sale of branded drugs, including branded stimulants, poses an inherent risk to consumers who purchase these products. Drugs that have circumvented regulatory safety measures may be contaminated. , counterfeit, contain varying amounts of active ingredients or contain completely different ingredients. “

Nevertheless, it looked pretty easy to buy some Percocets for $ 400.

The United States is no longer a producer of generic antibiotics that is instead dependent on imports. It includes medicines for children’s ear infections, sore throats, pneumonia, urinary tract infections, sexually transmitted diseases, Lyme medicines like doxycycline and other infections.

“People should know who makes their generic drugs; they are overseas manufacturers in China and India, and for many of these companies, the FDA violates safety regulations,” said Rosemary Gibson, author of the book China Rx. “The answer to this problem is to revive the generic pharmaceutical manufacturing industry. “

China’s drug exports are now in decline, although this is due to a shift in the nature of the SARS2 pandemic.

China has also tried spans down on private companies that give it a bad name, either in the pharmaceutical industry – an industry where China sees itself in becoming world-class – or in medical devices.

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