Generic drugs manufactured in India are associated with more “severe adverse events” for patients who use them than comparable drugs produced in the US, new research finds .
These adverse events included hospitalization, disability, and in some cases death. Researchers have found that mature generic drugs, those that have been on the market for a relatively long time, are responsible for their discovery.
The results show that all generic drugs are not equal. John Grayresearch co-author and professor of administration at Ohio State University. Fisher College of Business.
“Drug manufacturing regulations, and therefore quality assurance practices, differ between emerging economies like India and developed economies like the United States,” Gray said.
“The location where generic drugs are manufactured can make a huge difference.”
“The FDA assures the public that all generics patterned after the same original drug are equally safe and effective, but not necessarily when it comes to generic drugs made in India. ” and another co-author, George BallAssociate Professor of Operations and Decision Technology at the Kelly School of Business at Indiana University.
Recently published in the journal Production and operational managementthe study is led by Jun Noh, who received his PhD from Ohio and is now an assistant professor at Korea University. Other authors include Zachary Wright, a PhD from Ohio, and is currently an assistant professor at Brigham Young University. Hyun Woo Park, a former assistant professor at Ohio State University, is currently at Seoul National University.
Although some of the authors of this paper have worked closely with the Food and Drug Administration on federal grants and contracts, the study was conducted entirely independent of the FDA. These authors said they provided a deep appreciation for the importance of working closely with the FDA to study drug quality in general.
This study is important as it allows large samples of generic drugs to be linked to actual plants produced. The FDA will not disclose that information through the Freedom of Information Act process. But Gray said No found a way to link drugs to the factory where they were manufactured using what they called structured product labeling data sets.
“Overcoming this lack of transparency in drug manufacturing sites is one of the key results of our research,” Gray said.
Another key to this study was that drugs made in India matched the same drugs made in the US. Drugs had the same active ingredients, the same dosage form, and the same route of administration.
“That means the drug is pharmaceutically equivalent and you are comparing apples to apples,” he said.
Researchers matched 2,443 drugs made in the US and emerging economies. Although researchers included other countries in their analysis, Indian data fully explained the results, as 93% of generic drugs in emerging economies are produced in India.
The researchers compared adverse event reports for generic drugs made in India and associated frequencies with adverse event reports for matched drugs made in the US. These adverse event reports are available in the FDA’s Adverse Event Reporting System (FAERS).
Although FAERS includes all reported adverse events, in this study, the researchers only used people with the most severe outcomes, including hospitalization, disability, and death.
The results showed that the number of severe adverse events for generic drugs made in India was 54% higher than for comparable, matched generic drugs made in the US. That was after considering a variety of other factors that could affect the outcome, such as the amount of drugs sold.
The findings were driven by drugs that had been on the market for longer.
“In the pharmaceutical industry, older drugs are cheaper and cheaper, and competition is stronger to keep costs down,” Gray said. “It could result in operational and supply chain issues that could undermine the quality of the drug.”
Gray emphasized that the results should not be taken as a reason to halt overseas production of common drugs.
“India has good manufacturers. In the US there are bad manufacturers. We don’t advocate for ending offshore drug production or bashing India,” Gray said. .
“We believe this is a regulatory oversight issue that can be improved.”
Gray says one important issue is that when the FDA inspects plants that manufacture generic drugs in the United States, no tests have been announced. However, in overseas locations, inspections are pre-located, allowing manufacturers to hide the problem and make it difficult to find what the FDA exists. Having all tests unknown can make a huge difference, he said.
“The key recommendations made in this study are for the FDA to create a drug production site that is transparent to consumers, such as the country of manufacture and drug quality,” Ball added. “This will help create a market where drug quality is more incentivized than it is today.”
