Study links India-made generic drugs with 54 pc more severe adverse outcomes than US-made ones

Generic drugs made in India are related to 54 per cent more severe adverse events, including hospitalisation, disability and death, compared to the equivalent generic drugs made in the US, a new study has found. The findings were largely driven by ‘mature generic drugs’ — or those that had been in the market for a long time. “Where generic drugs are manufactured can make a significant difference,” said co-author John Gray, a professor of operations at The Ohio State University’s Fisher College of Business.

A generic drug is a medicine created with the same chemical as an already marketed brand-name drug with same dosage, safety and effectiveness. The drug is allowed to be sold once patents for the original brand expire.

The results, published in the journal Production and Operations Management, show that all generic drugs are not equal, even though patients are often told that they are, Gray said.

“Drug manufacturing regulation and, therefore, quality assurance practices, differ between emerging economies like India and advanced economies like the United States,” Gray added.

The researchers looked at 2,443 generic drugs made in the US and emerging economies. About 93 per cent of generic drugs from emerging economy countries are made in India, they said. The team compared the frequency of adverse events reported for generic drugs made in India with that of adverse events reported for the equivalent generic drugs made in the US. “The predicted number of severe adverse events for generic drugs made in emerging economies is 54.3 per cent higher than the number of severe adverse events for the equivalent generic drugs made in advanced economies,” the authors wrote.

“This significant effect is completely explained by mature India-made generic drugs compared to equivalent mature US-made generic drugs,” they wrote.

“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,” Gray explained.

The study is significant because it is the first to link a large sample of generic drugs to the actual plant where they were manufactured, the authors said.

Another strength of the study is that “pharmaceutically equivalent” drugs with the same active ingredients, dosage and method of administration were compared, they added.

Gray cautioned that the results are not to be taken as a reason to stop overseas production of generic drugs.

The US Food and Drug Authority (FDA) makes adverse event reports available on the ‘FDA Adverse Event Reporting System’ (FAERS) database.