Study co-authored by IU researcher finds generic drugs made in India have more severe adverse events

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A study co-authored by an Indiana University researcher found that generic drugs made in India—the source for most imported generic medications—were linked to more severe adverse events including hospitalization, disability, or even death, than generic drugs made in the United States.

The researchers said that the difference was “entirely explained” by adverse events with mature drugs made in India that had been on the market for years because those were most susceptible to operations and cost-reduction efforts.

The results showed that the number of severe adverse events for patients was 54.3% higher than that of drugs made in emerging economies.

“Since drug volume is so huge, these problems can remain hidden in small events that people don’t pay attention to, or don’t attribute to the drug itself, because so many people are taking pharmaceuticals,” said study co-author George Ball, associate professor of operations and decision technologies at IU’s Kelley School of Business in Bloomington.

“It’s not happening every, every day to every person, but that’s kind of why this is important to study, because it still matters for that one person that it does happen to—it matters a lot,” he said.

According to the FDA, generic drugs account for about 90% of U.S. prescriptions. Once a patent expires on a brand name drug, others may manufacture the medication with the same active ingredient for the same therapeutic effect but sell the drugs at typically a much lower price.

The study looked at 2,443 generic drugs made in “emerging economies,” 93% of those from India, and compared outcomes of the same generic drug made in “advanced economies,” 81% of those made in the United States. The study said that China is another emerging economy maker of generic drugs, and Canada and Europe are other advanced economy makers of the medications.

Study co-author John Gray, professor of operations at the Ohio State University’s Fisher College of Business, pointed to the need for improvements in regulatory oversight.

“There are good manufacturers in India, there are bad manufacturers in the U.S.,” he said in a written statement, “and we’re not advocating for ending offshore production of drugs or bashing India in any way.”

Of higher severe adverse events with older generic drugs, Gray said: “In the pharmaceutical industry, the older drugs get cheaper and cheaper and the competition gets more intense to hold down costs. That may result in operations and supply chain issues that can compromise drug quality.”

The study was published this month in the Production and Operations Management journal, with Joon Noh of Korea University leading the research.

The study highlighted differences in the oversight of generic drug manufacturing in the United States in India.

In the United States, the FDA conducts unannounced inspections of plant quality and compliance.

In India, “the FDA typically notifies foreign plants many weeks or even months in advance before conducting an inspection at the plant,” the study said.

IU’s Ball said it is difficult for patients to trace the origins of their generic drugs.

“One of the recommendations that we make is to make manufacturing location transparent for the consumer,” Ball said. “It’d be harder for insurance agencies and pharmacists and doctors to prescribe drugs that are at least perceived to be of lower quality.”

Stephen R. Byrn, professor of Medicinal Chemistry at Purdue University’s College of Pharmacy, said he was not surprised by the recent study’s findings. He said generic medicines are recalled more often than those made by the original drugmaker.

In India, Byrn said a maker of generic drugs might have 10 sites where they may make a medication, adding to the complexity. “The companies retain the right to make a product once it’s approved by the FDA at any of their sites, and they can move from one to another,” he said. “They don’t really have to tell what site it was made.”