A recent study has revealed significant differences in the quality and safety of generic drugs based on their manufacturing location. Generic drugs produced in India were found to be associated with more severe adverse events, including hospitalization, disability, and in rare cases, death, compared to their U.S.-manufactured counterparts.
This finding challenges the long-held belief that all generic drugs are equivalent. The study focused on mature generic drugs that had been on the market for a considerable time. Researchers emphasize that drug manufacturing regulations and quality assurance practices differ between emerging economies like India and advanced economies like the United States.
Despite these findings, it's important to note that generic drugs still play a crucial role in healthcare. They account for 90% of prescriptions dispensed in the U.S. while only representing 17.5% of total drug costs. The FDA continues to require generic medications to be bioequivalent to their branded counterparts in terms of active ingredients, benefits, dosage form, safety profile, strength, and administration method.
As of February 2025, new generic drug approvals continue, with recent additions including treatments for pulmonary arterial hypertension, hemorrhagic cystitis prophylaxis, and hypertension. These developments underscore the ongoing importance of generic medications in providing affordable healthcare options.
Source: Kelley School of Business
Advertisement
Advertisement
