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US inspectors have discovered new dangerous breakdowns in drugmaking at an Indian factory owned by Sunpharma, which produces generic drugs for American consumers.
The latest issues arise two years after the Food and Drug Administration gives facilities special passes and then gives them special passes to keep certain drugs sent to the US, even after they are officially banned from the US market.
The factory was unable to investigate the source of bacteria found in the test vials, nor address damaged equipment that contaminated the drug with metal particles.
The report found that workers improperly disposed of vials and stoppers intended for sterilization, and in some cases failed to disinfect manufacturing areas and equipment. One FDA inspector saw workers wearing sterile gowns, polishing their waste bottles, and using their hands to push down overflowing garbage. Investigators also saw the fluid dripping cracks in the ceiling and growing what appeared to be fungi and mold in the storage area of the sample used for testing.
In late 2022, the FDA banned the Halol city factory from transport drugs to the US due to similar manufacturing failures.
Propublica reported last month that a modest group within its agency simultaneously exempts several drugs from the ban, ostensibly waives it from preventing drug shortages. The FDA has granted similar exemptions for drugs made in more than 20 other foreign factories that have been banned from the US market for violating key drugmaking standards.
The FDA maintained practices that are primarily hidden from the public. The agency did not regularly test drugs from prohibited factories or actively monitor reports of potential harm by consumers, Propublica found.
In the case of Sun, more than a dozen drugs were first excluded from the Halol import ban. Government records show that the company is still allowed to send five to the US, including vecuronium bromide, a muscle relaxant used during surgery and a cancer drug doxorubicin. DivalProex delayed release tablets that treat seizures and other conditions have also been ruled out. Leuprolide injections used by people with prostate cancer, endometriosis, or other conditions. Temozolomide capsules for brain tumors.
Last month’s inspection was two years since the FDA imposed an import ban and the Sun began sending drugs exempt to the US, and it was the first time they had returned to the factory in five years. Inspectors have discovered that procedures designed to prevent microbiological contamination of sterilizers have not been established or followed, and that “equipment is not maintained to prevent malfunctions that change the safety, identity, strength, quality or purity of the medicine.
Some of the concerns focused on the fact that exempt drugs are still being sent to the US, according to those familiar with situations they don’t want to name because they’re not allowed to speak publicly. The FDA blocked names of potentially infringed drugs in published testing reports, including drugs made on a production line that had to reject several batches because they were filled with black particles.
Part of the FDA’s June testing report compiled the names of potentially infringed drugs manufactured at Sun, which continue to be released to the US market. Credit: Get by Propublica
“It’s a shame to see the continued problems occur on this site given the role of sites that could potentially produce drugs that are important to U.S. consumers,” said someone familiar with the test results.
Sun did not answer questions about the latest FDA inspections or its regulatory history. In an email, the company said compliance with quality standards is “a top priority for the Sun and a relentless focus on quality and compliance to ensure an uninterrupted supply of medicines to customers and patients around the world.
FDA layoffs could undermine the safety of drugs made in foreign factories, inspectors say
The FDA said factories exempt from import bans would be required to carry out additional testing on drugs with third-party oversight before being sent to the US, ensuring patient safety. However, Sun’s Halol Plant was cited in 2022 and was cited last month for failing to thoroughly investigate quality issues of unknown cause, including impurities discovered during drug testing. The FDA did not respond to requests for comment regarding the latest solar inspection.
D-Michigan Rep. Debbie Dingell recently co-hosted a bill to reduce the costs of prescription drugs, but in a statement from ProPublica said the FDA is responsible for ensuring that drugs entering the country are safe.
“We need complete transparency as to the extent that exemptions distribute sub-par, insecure, or ineffective medications to patients in America,” she said.
Katherine Dailey, a student at Medill Investigative Lab, contributed the report.
