Biden has deprived China of its leading position in the manufacture of generic drug ingredients sold in the United States. But a new report shows that most of the ingredients may still still come from China anyway.
America's dependence on Chinese pharmaceutical ingredients has sounded alarm bells in Congress. House committees are set to hold two hearings on Tuesday on drug shortages and the U.S. Food and Drug Administration's foreign inspection program, which has led to a significant drop in visits to Chinese factories over the past few years, in large part due to the virus pandemic.
The report, compiled by the Prosperity America Coalition (an organization that promotes tax breaks for domestic manufacturing), before the hearing, shows India-based Aurobindo Pharma LtdAbout 55% of the raw materials come from China. Aurindo is the leader in the industry: the company has the largest number of generics to the US**, with $3.1 billion in revenue in 2023, the second-highest among Indian drugmakers, according to data. The company's 2022-2023 annual report said it was "highly dependent on the Chinese market" for the materials and ingredients it uses to make its medicines.
We do suspect they have ties to China, we just don't know how many," said Nick Iacovella, a spokesman for the coalition. "It's really a red flag. ”
Biden's focus is on deepening cooperation with India, where the United States has good relations compared to China. As tensions with the Asian superpower rise, so do concerns about how the United States and the rest of the world rely on China for many medicines, especially the key ingredients used to make them.
The U.S. side has even called vulnerabilities in the drug chain a threat, and the Department of Defense has begun testing the safety and efficacy of generic drugs. At the same time, the ** chain has become more fragile than ever: the number of drug shortages in the United States peaked last year at 309 pieces, the highest number in nearly a decade.
With low labor costs and relaxed environmental standards, China and India dominate the production of generic drugs. However, companies in these countries are largely exempt from FDA regulation. While the agency can easily conduct surprise inspections of U.S. factories, inspections are usually announced in both countries in advance.
The report also shows that Aurobindo is doing business with companies with ties to Zhongshi Industry with questionable safety records, headquartered in Xinjiang, and the United States warns that there is "evidence of widespread use of forced labor."
Mr. Orobindo did not respond to a request for comment, including questions about whether they use materials from Chinese companies in drugs they make for the U.S. market.
The consortium works with experts and research analysts to examine import and export data.
According to reports, one of the top companies in China last year was a pharmaceutical company in Zhejiang, which said that Aurobindo ordered a blood pressure drug valsartan from Huahai.
Five years ago, the drug was in short supply due to the discovery of a potentially carcinogenic N-nitrosodimethylamine (NDMA) in the raw materials supplied to make it. FDA inspectors found that the Chinese company had ignored evidence that the ingredient was contaminated.
Biden's focus is on deepening cooperation with India, where the United States has good relations compared to China. As tensions with the Asian superpower rise, so do concerns about how the United States and the rest of the world rely on China for many medicines, especially the key ingredients used to make them.
The U.S. side has even called vulnerabilities in the drug chain a threat, and the Department of Defense has begun testing the safety and efficacy of generic drugs. At the same time, the ** chain has become more fragile than ever: the number of drug shortages in the United States peaked last year at 309 pieces, the highest number in nearly a decade.
With low labor costs and relaxed environmental standards, China and India dominate the production of generic drugs. However, companies in these countries are largely exempt from FDA regulation. While the agency can easily conduct surprise inspections of U.S. factories, inspections are usually announced in both countries in advance.
The report also shows that Aurobindo is doing business with companies with ties to Zhongshi Industry with questionable safety records, headquartered in Xinjiang, and the United States warns that there is "evidence of widespread use of forced labor."
Mr. Orobindo did not respond to a request for comment, including questions about whether they use materials from Chinese companies in drugs they make for the U.S. market.
The consortium works with experts and research analysts to examine import and export data.
International Baccalaureate