Global attention is focused on Indian pharmaceutical companies for subpar performance. Specifically, Intas Pharmaceuticals, which manufactures cancer treatments for the U.S. market, has experienced a quality downturn.
This situation prompts the U.S. to reconsider its dependency on Indian medicine suppliers due to prevalent regulatory challenges.
Nikkei Asia reports that outdated practices and issues with data integrity have led to severe consequences, including fatalities, especially in children.
The scarcity of crucial cancer medications has alarmed American medical professionals, fearing more deaths. Consequently, the U.S. is exploring alternatives, with China becoming a potential source.
The U.S. Food and Drug Administration (FDA) inspection at an Indian drug production facility highlighted serious issues. The discovery of tampered data at Intas Pharmaceuticals led the FDA to categorize their product as contaminated, exacerbating the drug shortage crisis in the U.S.
Over recent years, the FDA has banned numerous Indian drug makers, such as Dr. Reddy’s Laboratories, for failing to meet quality standards.
Further, FDA scrutiny in western India has revealed systemic issues within the pharmaceutical sector, indicating a broader problem with quality control measures.
