US Lawmakers Demand Clear Country-of-Origin Labels on Imported Drugs

Washington: US lawmakers have renewed their call for prescription drugs to clearly display the country where they are manufactured. This demand comes amid concerns over America’s heavy dependence on foreign countries, including India and China, for drug ingredients and supplies—a reliance that surfaced as a vulnerability during the COVID-19 pandemic when some nations restricted exports.

The issue was raised during a hearing by the Senate Special Committee on Aging titled, “Truth in Labeling: Americans Have a Right to Know Where Their Drugs Come From.” Committee Chair Rick Scott introduced the ‘Clear Labels Act,’ a legislative proposal that would require all prescription drugs sold in the US to indicate the origin of both the drug and its key ingredients.

Rick Scott highlighted that about 91 percent of medicines dispensed in the US are generic, and nearly 94 percent of their active pharmaceutical ingredients are produced overseas, mainly in China and India. He pointed out that patients, doctors, and pharmacists currently lack adequate information about the manufacturing origins of the drugs they use, complicating oversight of foreign facilities by US agencies.

Scott emphasized the risks, stating, “We face not only a serious public health threat but also a national security risk. If foreign suppliers halt exports, the US has no reliable plan to secure life-saving medicines.” He cited the COVID-19 pandemic period when India restricted exports of critical drug materials, warning such situations could recur.

Senator Ashley Moody, who co-chaired part of the hearing, noted how difficult it is for consumers to trace where their medications come from. She referenced FDA import alerts that have flagged issues such as carcinogenic impurities, inaccurate batch records, and non-sterile conditions in foreign manufacturing sites. Moody also stressed that elderly patients are most impacted due to their higher reliance on generic drugs and limited alternatives.

Experts present supported the idea of public disclosure of drug origins but cautioned that changing labels alone won’t resolve deeper systemic problems in generic drug manufacturing. Professor John Gray from Ohio State University stated that consumers, doctors, and pharmacists deserve clear information on where drugs and their ingredients are made and the associated quality risks. He challenged the assumption that all generics are identical, especially when production occurs overseas with inspections that are often pre-announced.

Gray suggested adding QR codes on drug packaging linking to searchable data about manufacturing locations and quality metrics. This transparency could encourage competition based on quality, not just cost.

Michael Ganio from the American Society of Health-System Pharmacists asserted, “Every American has the right to know where their prescription drugs are made.” He noted that transparency might help curb the “race to the bottom” in generic drug pricing. Research shows that when origin information is available, patients and pharmacies tend to prefer medicines made in the US or Canada over those from India or China, although country of origin alone doesn’t guarantee quality.

Professor Stephen W. Schondelmeyer of the University of Minnesota described India as a critical but complex part of the supply chain. He acknowledged that while India supplies many quality generics, not all products meet standards. Schondelmeyer criticized the lack of labeling rules for life-saving medicines, contrasting it with requirements for food and clothing. He cited New Zealand’s public drug information system as a good example.

Steven Colville from the Duke-Margolis Institute for Health Policy highlighted challenges facing the drug supply chain, including chronic shortages, quality concerns, geopolitical risks, and efforts to boost domestic manufacturing.

The committee announced that while lawmakers review the draft legislation, the hearing record will remain open for public comments until next week.

US officials have long warned that reliance on foreign sources weakens the drug supply system. The COVID-19 pandemic reinforced these concerns as many countries restricted exports of medicines and medical supplies, prompting bipartisan discussions on the issue.