The research, published Feb. 6 in Production and Operations Management, examined a large sample of mature generic drugs and found that those produced in India had a 54% higher rate of serious adverse events compared to the U.S. equivalents. This was after taking into account other factors that could affect results, including the volume of drugs sold.
The study’s authors, including researchers from The Ohio State University in Columbus and Bloomington-based Indiana University, linked adverse event reports to the manufacturing plants, with there being a level of transparency typically unavailable through FDA disclosures.
Another key issue one researcher pointed to was the fact that FDA plant inspections are unannounced, whereas inspections abroad, including in India, often are scheduled in advance, according to a Feb. 19 news release from Ohio State University.
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