U.S. Lawmakers Revive Drug Origin Debate, Cite Reliance on Indian Exports

WASHINGTON, D.C. — U.S. lawmakers on Thursday renewed a push to require country-of-origin labeling on prescription drugs, pointing to India’s temporary restrictions on pharmaceutical exports during the Covid-19 pandemic as evidence that the nation’s drug supply remains vulnerable to foreign disruptions.

The issue was raised during a hearing of the Senate Special Committee on Aging titled “Truth in Labeling: Americans Deserve to Know Where Their Drugs Come From.”

Committee Chairman Rick Scott announced his proposed CLEAR LABELS Act, legislation that would require prescription drugs sold in the United States to disclose where they and their key ingredients are manufactured.

“What we uncovered during this investigation will shock you,” Scott said.

Scott said 91 percent of prescriptions filled in the United States are for generic drugs and that “almost 94 percent use APIs produced and processed overseas and factories predominantly in Communist China and India.”

He argued that the lack of transparency leaves patients, doctors, and pharmacists without basic information about the medicines they rely on and complicates federal oversight of manufacturing standards.

Scott said U.S. regulators often provide advance notice before inspecting foreign drug plants, giving facilities time to prepare. “That’s crazy,” he said, citing reports of unsanitary conditions found even after warnings.

He framed the issue as both a public health and national security concern.

“We face not just a serious public health risk, but a massive national security risk as well,” Scott said, warning that the United States has “absolutely no plan” to ensure access to life-saving medicines if foreign suppliers cut off exports.

Referring to the pandemic, Scott said, “During the Covid pandemic, India blocked the export of critical pharmaceutical ingredients. So it can happen again.”

Sen. Ashley Moody, who presided over part of the hearing, said consumers have little ability to determine where their medicines are produced. She noted that FDA import alerts have cited problems at foreign facilities, including “carcinogenic impurities, falsified batch records and non-sterile conditions.”

She said seniors are particularly vulnerable because they rely heavily on generic medicines and often have limited alternatives.

Witnesses broadly supported greater transparency but cautioned that labeling alone would not resolve deeper structural problems in the generic drug market.

John Gray, a professor at Ohio State University, said he “strongly supports giving consumers, doctors, pharmacists, and other stakeholders access to basic drug information, including country of origin and some valid assessment of drug quality risk.”

Gray said the long-standing assumption that all generic drugs are interchangeable “is no longer a defensible assumption,” particularly as manufacturing has shifted overseas and inspections are frequently announced in advance.

He recommended placing QR codes on drug packaging to link consumers to searchable information showing where finished drugs and active ingredients are produced, along with public quality data that would allow manufacturers to compete on more than price.

Michael Ganio of the American Society of Health-System Pharmacists said, “Every American has a right to know where their prescription drugs are manufactured,” noting that country-of-origin disclosures are currently voluntary.

Ganio said greater transparency could help counter what he described as a “race to the bottom” in generic drug pricing and urged Congress to strengthen incentives for domestic manufacturing and oversight. He said research shows patients and pharmacy purchasers tend to prefer drugs made in the United States or Canada when origin information is disclosed, but cautioned that “country of origin alone is not a reliable proxy for drug product quality.”

Stephen W. Schondelmeyer, a professor at the University of Minnesota, described India as a critical but complex part of the global supply chain.

“India is our major supplier of generic pharmaceuticals,” he said. “There are good quality products that come out of India, not all of them, but some of them.”

He said uneven regulation and limited public visibility into manufacturing locations make it difficult to assess quality and supply risks, calling it “unconscionable” that the United States requires origin labels for food and clothing but not for “the critical drugs that save people’s lives.”

Schondelmeyer pointed to New Zealand’s public drug database as a model for transparency.

Steven Colville of the Duke-Margolis Institute for Health Policy said the pharmaceutical supply chain faces overlapping challenges, including chronic shortages, quality concerns, geopolitical risks, and efforts to expand domestic manufacturing.

Colville supported better access to information for consumers but said “labeling reforms alone are likely to have a limited impact,” noting that patients often have little control over which generic drugs hospitals and pharmacies stock.

The committee said the hearing record will remain open until next week as lawmakers continue reviewing draft legislation.

U.S. officials have warned for years that reliance on overseas drug manufacturing exposes the health system to shortages and quality lapses, concerns that intensified during the Covid-19 pandemic when several countries restricted exports of medical goods and pharmaceutical ingredients. (Source: IANS)