Forbes Watch: Pharmaceutical companies in India and China face increasing scrutiny in the United States

Forbes published Kenneth Rapoza's article on April 17, 2022, analyzing that Indian and Chinese pharmaceutical companies are facing increasing scrutiny in Washington.

The pandemic has exposed vulnerabilities in U.S. supply chains. Everyone knows this. Anything medically related is the front desk and center of critical items missing in the operation. The U.S. over-reliance on China and India, particularly on medical supplies, key generic drugs, is drawing Washington's attention. So far, little has been done to address this problem. But now, that could change.

A poll conducted by Morning Consulting on behalf of the newly formed U.S. Safe Drug Advocacy Group showed that 85 percent of respondents said they were concerned about the pharmaceutical industry's dependence on India and China. Another 70 percent said the U.S. should not rely on key generic drugs of foreign origin.

This dependency is very obvious. About two-thirds of generic drugs in the United States need to be imported, and nearly 90% of non-patent APIs come from laboratories overseas.

Remember that we all had to wear masks, but no one could buy them, so they made half-scrap masks out of fabric instead, because China is the manufacturer of N95 masks and the kind of masks you might see your dental hygienist wearing. Generic drugs are also a more serious problem.

India stopped exporting key medicines during the pandemic. The main one is the antimalarial drug hydroxychloroquine and all the active ingredients or APIs called APIs that make it. Hydroxychloroquine is being distributed in India as a way to fight the coronavirus. In total, about 26 APIs are banned from being shipped overseas.

China has threatened to stop selling key starting materials for APIs, as well as APIs, which enter final drugs in tablet or liquid form. It's retaliation for the travel ban and for the Trump administration's attribution of the 2020 Wuhan outbreak to them.

However, China has never cashed in on this threat. But that's enough to give local drugmakers a window of opportunity to show how India and China, more often than partners, can hurt the U.S. essential medicine supply chain.

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 what it considered essential drugs to be either produced entirely abroad — that is, in laboratories in India and Europe, or in short supply in national stockpiles.

Many members of Congress have proposed a fourth bill to help produce the drugs in the United States, but none of these bills have yet to go to the voting process.

In March, Senator Tina Smith's Essential Antibiotic Outsourcing Act and Senator Jack Rosen's Emergency Medical Production Strategic Planning Act were unanimously approved by Senate committees as part of the Pandemic Prevention Act. No date has been set for an on-site vote on the bill.

Smith's amendment calls for a $500 million grant for domestic drug manufacturers.

"We should be able to produce the basic antibiotics that Americans need on American soil." This is an issue involving public health and national security," Smith said in a statement. "By strengthening our nation's capacity to produce and store critical medicines, we will have more certainty and resources to promote public health during and beyond the pandemic."

Poll figures show that more than 80 percent of Americans oppose the U.S. Food and Drug Administration's (FDA) job in India.

Some bad drugs

Overseas drug manufacturers are rarely inspected by the FDA. When inspectors find problems in laboratories or drug processing, the company receives so-called warning letters. Indian APIs manufacturers, such as Aurora Pharmaceuticals, are mostly at the end of receiving these letters. China's key starting material facilities have not been inspected at all.

Companies that receive warning letters are still allowed to sell drugs to the United States. This also prompted local generic pharmaceutical companies to fight back, leading to the establishment of the American Safe Drug Organization. Their morning counseling poll showed that more than 80 percent of respondents either wanted to ban the drugs or want them to be checked upon arrival at u.S. ports before being given to patients.

About 86 percent of those surveys said they thought it was important to get the U.S. government to support domestic generic drug manufacturers.

Still, the company receives these letters frequently and continues to operate in the United States.

On March 30, 2022, a website called Premium Light Supplier, whose San Francisco phone number, was issued a warning letter by the FDA for selling illegal, unchecked drugs.

While the FDA website doesn't say where the company's headquarters are, it's highly likely an E-commerce business where U.S. consumers go directly to China, selling $6 per tablet of Adderall and the $4-per-tablet antidepressant Celexa.

The FDA's warning letter states that "easy access to these stimulants via the Internet poses an additional significant risk to U.S. consumers." In addition, selling the wrong brands of drugs, including the wrong brands of stimulants, poses an inherent risk to consumers who buy these products. Drugs that circumvent regulatory safeguards may be contaminated, counterfeit, contain different amounts of active ingredients, or contain different ingredients altogether".

Still, spending $400 on some Percocets looks easy.

The United States is no longer a manufacturer of generic antibiotics, but relies on imports. This includes drugs for the treatment of childhood ear infections, streptococcus, pneumonia, urinary tract infections, sexually transmitted diseases, Lyme disease drugs such as doxycycline, and other infections.

Rosemary Gibson, author of The Chinese Prescription, said: "People should know who is making their generic drugs; there are too many overseas manufacturers in China and India who are violating the safety regulations of the U.S. Food and Drug Administration." The answer to this problem is to re-shift the generic manufacturing industry to the domestic market. "

China's pharmaceutical exports are currently declining, although this is due to changes in the nature of the COVID-19 pandemic.

China has also tried to clamp down on the private companies that have given it a bad reputation, both in the pharmaceutical industry and in medical devices.

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