Study raises safety concerns over some imported generic drugs

Generic drugs have made essential medications more affordable, saving billions of dollars. However, a new study suggests that not all generic drugs offer the same level of safety. Researchers have found that some imported generic drugs may pose a higher risk of severe side effects compared to those made in the US.

Higher risk of adverse events in some imports  

A team of researchers from Korea and the US analysed 2,443 generic drugs manufactured in both advanced and emerging economies. They found that generic drugs produced in India were linked to a 54 per cent higher rate of serious adverse events (SAEs), such as hospitalisation, disability or death, compared to those made in the US. While the study does not confirm that these drugs directly cause these adverse effects, it highlights the need for stricter oversight. The study was published in Production and Operations Management

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Call for better regulation and quality control

The study’s lead author, In Joon Noh of Korea University, emphasised the need for the FDA to investigate these findings. He pointed out that the agency has access to more detailed data than academic researchers, which could help determine the root causes of the quality differences.

Experts stress that the study does not imply that all Indian-made drugs are of poor quality or that the US should stop importing generic medicines. However, it raises concerns about whether all generic drugs meet the same safety and manufacturing standards. 

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Manufacturing practices and oversight gaps 

While generic drugs contain the same active ingredients as their brand-name counterparts, differences in manufacturing processes and supply chains may impact their safety. Some experts argue that the FDA does not inspect foreign drug manufacturers as rigorously as domestic ones due to logistical and resource constraints.

India’s growing role in the US drug market  

India has rapidly expanded its pharmaceutical industry and now supplies nearly half of all generic prescription drugs sold in the US. These include medications for hypertension, mental health, and nervous system disorders. With generic drugs making up over 90 per cent of prescriptions in the US, the reliability of foreign manufacturers is a crucial issue. 

Business analytics researcher John Gray from Ohio State University believes the issue lies in regulatory oversight rather than the country of origin. He notes that there are both high- and low-quality manufacturers in every country.