All generic drugs are not equal, study finds

Generic Drug Safety: Where Manufacturing Location Matters

A recent study published in Production and Operations Management reveals a concerning disparity in safety between generic drugs manufactured in india and those produced in the United States. Researchers discovered that generic drugs originating from India are linked to a significantly higher incidence of severe adverse events, including hospitalization, disability, and, in some cases, death.

A Closer Look at the Findings

The study, led by In Joon Noh, analyzed 2,443 pairs of generic drugs, matching medications with identical active ingredients, dosage forms, and routes of governance produced in both India and the United States. Despite pharmaceutical equivalence, generic drugs manufactured in India exhibited a 54% higher frequency of severe adverse event reports compared to their U.S. counterparts.

Interestingly, the disparity was most pronounced in mature generic drugs, those that had been on the market for an extended period. According to co-author John Gray, professor of operations at Ohio State university’s Fisher College of Business, this finding suggests that, “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.”

Regulatory Differences Play a Role

“Drug manufacturing regulation, and therefore quality assurance practices, differ between emerging economies like India and advanced economies like the United States,” Gray explains. These differences, coupled with varying inspection practices, contribute to the observed safety discrepancies. Notably,FDA inspections of overseas drug manufacturing facilities are typically scheduled in advance,potentially allowing manufacturers to rectify issues beforehand. Conversely, U.S. inspections are unannounced, offering a more accurate assessment of operational practices.

Call for Transparency and action

While acknowledging the presence of reputable manufacturers in India, researchers emphasize the need for greater transparency and stricter regulatory oversight. George Ball, associate professor of operations and decision technologies at Indiana University’s Kelley School of Business, highlights the importance of “making drug manufacturing location, such as the country of manufacture, and drug quality, transparent for consumers. This can help create a market in which drug quality is incentivized more than it is today.”

Researchers advocate for implementing unannounced inspections globally and improving transparency regarding drug manufacturing origins. These steps can empower consumers to make informed decisions and ensure a higher standard of safety across all generic medications.

Can you provide insights into whether this safety discrepancy observed in generic drugs manufactured in India extends beyond medications mentioned in the study? Are there patterns in specific drug classes or therapeutic areas where these concerns are amplified?

Generic Drug Safety: Where Manufacturing Location Matters – An Expert Analysis

In a surprising turn, recent research published in Production and Operations Management sheds light on a important disparity in the safety of generic drugs manufactured in India compared to those produced in the United States. We welcome In Joon Noh, the lead author of the study and a renowned pharmaceutical operations specialist, to delve deeper into these findings and their implications.

Unveiling the Study’s Key Findings

Archyde: Can you walk us through the methodology of your study and the key findings that shocked the pharmaceutical industry?

In Joon Noh: Certainly. Our study analyzed 2,443 pairs of generic drugs produced in both India and the United states, matching medications based on active ingredients, dosage forms, and routes of management. Despite pharmaceutical equivalence, we discovered a 54% higher frequency of severe adverse event reports for drugs manufactured in India. This disparity was most pronounced in mature generic drugs, suggesting operations and supply chain issues may compromise quality as competition intensifies.

Role of Regulatory Differences

Archyde: What factors do you believe contribute to this safety discrepancy between the two manufacturing locations?

In Joon Noh: Drug manufacturing regulations and quality assurance practices vary greatly between emerging economies like India and advanced economies like the United States. Scheduled versus unannounced inspections, along with differing enforcement practices, likely play significant roles. This is why clarity in inspection reports could greatly benefit consumers and regulators alike.

advocating for Transparency and Stricter oversight

Archyde: What measures should be taken to address this issue and ensure safety across all generic medications?

In Joon Noh: Its crucial to make drug manufacturing location transparent for consumers, empowering them to make informed decisions.Implementing unannounced inspections globally and improving transparency regarding drug manufacturing origins can significantly improve safety standards in the generic drug market.

Thoughts for Our Readers

Archyde: Given the broad implications of these findings, how can stakeholders – from consumers to policymakers – contribute to improving generic drug safety?

In Joon Noh: I urge everyone to stay informed about drug origins and advocate for stricter regulatory oversight. By demanding transparency and persistently pushing for safety, we can collectively drive positive change in the generic drug industry.