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# Indian-Made Generics Have Higher Risk: Study
- URL: https://www.fdaweb.com/indian-made-generics-have-higher-risk-study/
- Published: 2025-03-05T12:00:00.000Z
- Updated: 2026-09-14T14:54:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158771

Ohio State University researchers say generic drugs made in India are linked to a significantly higher number of adverse events, including hospitalizations and deaths, than their counterparts that are made in the U.S. *SciTechDaily* [reports](https://scitechdaily.com/not-all-generics-are-created-equal-study-exposes-a-54-higher-risk-in-indian-made-drugs/?ref=fdaweb.com) online that the study was published in the journal *Production and Operations Management*.

The researchers say they found a way to use the FDA Structured Product Labeling dataset to link drugs to their specific manufacturing plant, information that the agency does not disclose. They found a 54% higher risk associated with Indian-made generics, especially those that have been marketed for a longer time, the post says.

Study co-author **John Gray**, a professor of operations at the Ohio State University Fisher College of Business, says all generic drugs are not equal, even though patients often are told that they are. “Drug manufacturing regulation and therefore quality assurance practices differ between emerging economies like India and advanced economies like the U.S.,” he said. “Where generic drugs are manufactured can make a significant difference.”

Co-author **George Ball**, associate professor of operations and decision technologies at Indiana University’s Kelly School of Business, said, “FDA assures the public that all generics patterned after the same original drug should be equivalently safe and effective. However, this is not necessarily the case when it comes to generic drugs made in India.”

The researchers say they matched 2,443 drugs made in the U.S. and emerging economies. Although they included other countries in their analyses, 93% of generic drugs from emerging economies are made in India, meaning that the data from India fully explains the results, they say.

Gray said the findings were driven by drugs that had been on the market for a longer time. “In the pharmaceutical industry, the older drugs get cheaper and cheaper and the competition gets more intense to hold down costs,” he said. “That may result in operations and supply chain issues that can compromise drug quality.”

He emphasized that the results are not meant to be a reason to stop overseas production of generic drugs. “There are good manufacturers in India and there are bad manufacturers in the U.S.,” he said. “We’re not advocating for ending offshore production of drugs or bashing India in any way. We believe this is a regulatory oversight issue that can be improved.”

He says it could improve compliance in India if FDA were to conduct unannounced inspections rather than arranging for them in advance, which may allow manufacturers to hide problems and make it harder for the agency to find those that exist. He also recommended that FDA make drug manufacturing locations, such as the country of manufacture, and drug quality transparent for consumers. “This can help create a market in which drug quality is incentivized more than it is today,” he concluded.