Researchers say it all depends on where the drugs were produced
of ConsumerAffairsGeneric prescription drugs usually save consumers money because they are the same as the name brand, but the patent has expired. But a new study published in the journal Production and Operations Management suggests notall generic drugs are the same.
Researchers say they have uncovered significant disparities in the safety of generic drugs manufactured in India compared to those produced in the United States. The research, led by In Joon Noh from Korea University, found that generic drugs made in India are linked to a 54% increase in severe adverse events, including hospitalization, disability, and death, compared to their U.S. counterparts.
The study, which involved matching 2,443 generic drugs from the U.S. and emerging economies, highlights the critical role of manufacturing location in drug safety. John Gray, co-author and professor at Ohio State University, said that regulatory and quality assurance practices differ significantly between emerging economies like India and advanced economies such as the United States. This difference, he noted, can have a substantial impact on drug safety.
A focus on India
Despite the FDA's assurances that all generics should be equivalently safe and effective, the study's findings challenge this notion, particularly concerning Indian-manufactured generics. George Ball, a co-author from Indiana University, stressed the importance of transparency in drug manufacturing locations to enhance consumer safety.
The research team, which includes experts who have collaborated with the FDA, were able to link drugs to their manufacturing plants using the Structured Product Labeling dataset, overcoming the FDA's lack of transparency on this front. This breakthrough allowed for a direct comparison of pharmaceutically equivalent drugs from both countries.
The study also revealed that mature generic drugs, those on the market for a longer time, were primarily responsible for the increased adverse events. The researchers attributed this trend to intensified competition and cost-cutting measures in the pharmaceutical industry, which they suggested may compromise drug quality.
While the findings raise concerns, Gray cautioned against halting overseas production, acknowledging that there are both good and bad manufacturers in India and the U.S. Instead, he advocated for improved regulatory oversight, including unannounced inspections of overseas manufacturing plants, to ensure consistent drug quality.
The study's authors recommend that the FDA increase transparency regarding drug manufacturing locations and quality, enabling consumers to make informed choices and incentivizing higher standards in the industry.
Posted: 2025-02-20 12:33:08
