A new study has found that generic drugs manufactured in India are associated with 54 percent more severe adverse events, including hospitalization, disability, and death, compared to their US-made counterparts. The findings, published in Production and Operations Management, highlight concerns over drug manufacturing quality differences between emerging economies and advanced markets.
Manufacturing Location Matters
According to John Gray, professor at The Ohio State University’s Fisher College of Business, the study reinforces that where a drug is manufactured can significantly impact its quality. While generic drugs are designed to be equivalent to brand-name medicines in terms of chemical composition, dosage, and effectiveness, the study suggests that not all generics perform equally due to variations in regulatory standards.
The researchers analyzed 2,443 generic drugs produced in both the United States and emerging economies, with 93 percent of the emerging economy drugs manufactured in India. They compared adverse event reports from the FDA Adverse Event Reporting System (FAERS) and found a 54.3 percent higher risk for severe outcomes with India-made generic drugs, particularly those classified as mature generics—drugs that have been on the market for an extended period.
Cost Pressures and Supply Chain Concerns
The study suggests that as generic drugs age, competition increases, leading to cost-cutting pressures in operations and supply chains, which may compromise drug quality. These concerns are not unique to India, but they emphasize the need for strong regulatory oversight and quality assurance measures to maintain safety standards.
Also read: Pharma Firms Told to Cut MRP After Tax Exemptions
Despite these findings, Gray cautioned against discontinuing overseas drug manufacturing entirely, noting that global production remains essential to ensuring affordable access to medicines. The study’s unique methodology—linking large samples of generic drugs to their specific manufacturing plants—adds weight to its conclusions, offering insights for regulators, healthcare providers, and policymakers.
With India being a major global supplier of generic drugs, the findings highlight the importance of strengthening drug quality controls to ensure patient safety while maintaining cost-effective pharmaceutical production.
