A new study has revealed that generic medicines which are copies of biologics are not made equally and may have serious impact on your health. The research uncovers initial evidence that some generic drugs imported to the US are not as safe as those made locally.
A team from Korea and the US studied 2,443 generic drugs made in ‘advanced’ and ’emerging’ economies, finding that compared to those produced in the US, those manufactured in India were associated with a 54 percent higher number of serious adverse events (SAEs), like hospitalization, disability, and death, Science Alert reported.
However, it is still not known if these events are specifically caused by the generic drugs, but typically, the FDA doesn’t take SAEs associated with approved medicines lightly.
“This study serves as a clarion call for the FDA to carefully study the underlying reasons for the important quality risk difference we identify,” write the authors, led by In Joon Noh, now a supply chain scientist at Korea University.
“The FDA possesses much more granular data than do academic researchers, and this is precisely what is needed to determine exactly which aspects of the operations and supply chain explain our results.”
The researchers also maintain that all drugs made in India are of poor quality, or that the US should stop buying generic drugs from foreign producers.
The data included other countries too, but the core finding was “generic drugs made in India, where a majority of emerging economy generic drugs are made, experience significantly more SAEs than equivalent generic drugs made in the US, where a majority of advanced economy generic drugs are made.”
Researchers maintain that generic drugs may have the same active ingredients, the same dosage form, and the same routes of administration, but that doesn’t mean they are made with the same best practices.
The FDA maintains these generic drugs are all interchangeable, but some research has warned that generic drugs are “not as safe as the FDA wants you to believe.”
The study was published in Production and Operations Management recently.