Drugs

Urgent Steps to Counter Need for Chinese Drugs: Exiger

David McFarland

— 1 min read
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Exiger, a business consulting firm, says the U.S. drug supply chain “faces critical risks stemming from deep dependence on foreign drug manufacturers, complex geopolitical dynamics, and unethical international sourcing practices.” In a new white paper, “A Bitter Pill: America’s Dangerous Dependence on China-Made Pharmaceuticals,” Exiger cites these “critical risks” in U.S. drug supply chains:

  • the U.S. imports 75% of its essential medicines;
  • China and India dominate the global market, producing about 60% of active pharmaceutical ingredients (APIs);
  • while India supplies about half of all generic drugs used in the U.S., it depends on China for 80% of its APIs;
  • China supplies nearly 90% of the antibiotic APIs consumed in the U.S., creating an acute dependence that could be exploited in a geopolitical crisis;
  • over 500 generic drugs, including 10 essential medicines, have only one identified API manufacturing country;
  • systemic quality control failures have already affected U.S. consumers;
  • more than 30% of all new FDA Import Alerts have been for sites in China, and 16% for India sites, highlighting recurring manufacturing issues;
  • drug ingredients linked to forced labor pose serious ethical and legal issues;
  • Aurobindo Pharma, the largest producer of Medicaid-reimbursed prescriptions, is linked to forced labor; and
  • Lupin, the third-largest prescription provider for Medicaid, procures pharmaceuticals from companies tied to forced labor and Chinese state ownership.

Exiger says immediate action is needed in these areas:

  • strategic stockpiling and advanced research pathways;
  • boost domestic production;
  • diversify and secure supply chains;
  • strengthen regulatory oversight;
  • expand supply chain visibility and tracking; and
  • eliminate forced labor.

The report includes specific recommendations for each of the areas in which Exiger calls for urgent action.

Also addressing the supply chain issues, a United States Pharmacopeia Quality Matters blog post reports that over half the APIs for prescription medicines in the U.S. come from India and the European Union (EU). The post lists these takeaways:

  • major hubs of production are India and the EU;
  • generic drugs, which make up some 90% of U.S. prescription volume, come primarily from India;
  • some 43% of branded prescription APIs come from the EU;
  • some 12% of the total API volume is made in the U.S.; and
  • while China contributes 8% of the total volume of API, there is case-by-case evidence of significant dependence on China for key starting materials, the building blocks of APIs.

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