Indian generic drugs linked to deaths in US? Trade group slams study blaming desi pharma

generic drugs to a higher risk of serious side effects in the US has drawn backlash from the industry’s most influential lobby group, as India moves to defend its dominant market share amid trade tensions under President Donald Trump.

The study, which analyzed more than 2,400 drugs sold in the US between 2009 and 2018, found that Indian generics were associated with a 54% greater risk of serious adverse events — including hospitalization, disability, and death — compared with equivalent domestically made medicines. The research links operations and supply chain issues in the manufacturing process as “most likely” explaining the findings.

Published last month in the journal Production and Operations Management, the findings prompted a three-page statement from the Indian Pharmaceutical Alliance, which represents two dozen of the country’s largest drugmakers.

“We strongly disagree with the study’s premise that differences in operations and supply chain factors — suppliers, manufacturing and/or distribution practices by different manufacturers — impact the quality and efficacy of Indian generic drugs,” the industry body said in its response.
Still, last month’s study — led by researchers with experience working with the US Food and Drug Administration — adds to mounting concerns over the quality of Indian-made medicines. India, the world’s largest supplier of generic medicines, produces about a fifth of the global supply and its 752 FDA-compliant factories meet roughly 40% of US demand for non-patented medications.