A recent study in the journal Production and Operations Management has revealed that Indian-made generic drugs are linked to 54% more serious adverse events, such as hospitalization, disability, and death, than their US-manufactured counterparts. The research is raising alarm about variations in drug manufacturing regulations between emerging economies such as India and developed economies such as the United States.

Key Highlights:
Study Findings on Generic Drug Safety:

• The research compared 2,443 US- and emerging economy-made generic drugs and found that 93% of emerging economy-based drugs were produced in India.

• India-produced seasoned generic drugs (longer-in-market) exhibited substantially higher adverse event rates at a severe level.

• Fewer safety issues were reported in the US-made generic drugs, with the same active ingredients, strength, and method of administration as the India-made version.

Manufacturing Practices and Quality Differences:

• The research indicates that over time, making cost competition stronger could result in supply chain problems and compromised quality of drugs in established generic drugs.

• Regulatory variations between the US and India might impact manufacturing practices and drug safety.

Industry Experts' Point of View:
Professor John Gray, Co-Authored By, The Ohio State University's Fisher College of Business:

• "Where generics are produced may matter. Although all generics are expected to be similar, the manufacturing regulations of emerging and advanced economies differ, which affects quality control."

• The US FDA tracks adverse event reports in its FAERS (FDA Adverse Event Reporting System) database, which was utilized as one of the major sources in the research.

Caution on Interpretation of Findings:
Scholars point out that the findings do not mean a halt to international production of generics since India continues to be one of the main global providers of cheap medicines.The research emphasizes stricter quality control and monitoring of generic drugs that have matured, especially those that are produced in emerging economies. Since India remains a leading player in the global market for generic drugs, the findings can be expected to initiate further regulatory scrutiny and better standards of drug manufacturing.