Generic drugs, dirty plants, and FDA exemptions
12 days ago
- #FDA-regulation
- #pharmaceutical-safety
- #drug-contamination
- Sun Pharma faced FDA scrutiny in 2014 for dangerous violations at its Halol factory, including contamination risks and unknown impurities in drugs.
- Despite repeated promises to reform, Sun Pharma's fixes were inadequate over eight years, yet the FDA delayed banning the factory until 2022.
- The FDA allowed exemptions for over a dozen drugs from the import ban, continuing shipments without regular testing or public disclosure.
- Inspections in 2022 and 2023 revealed ongoing issues like dirty equipment, impurities in injectables, and improper handling of sterile medications.
- Sun Pharma's history includes recalls, unreliable testing records, and hundreds of adverse event reports, yet key drugs remain exempt from the ban.
- The FDA's lack of transparency left doctors and patients unaware of risks associated with drugs from the Halol plant.