US regulators have discovered yet another plant rife with problems run by Intas Pharmaceuticals Ltd., a generic drugmaker whose quality issues have caused one of the worst shortages of cancer medications in decades.
(Bloomberg) — US regulators have discovered yet another plant rife with problems run by Intas Pharmaceuticals Ltd., a generic drugmaker whose quality issues have caused one of the worst shortages of cancer medications in decades.
Intas, a privately held company, makes more than 100 generic drugs approved in the US and has three production facilities in Ahmedabad, India, according to Food and Drug Administration data. One of those facilities shut down after the FDA found shredded documents about drug quality, indicating serious lapses at the plant and raising doubts about the safety and efficacy of its drugs.
FDA inspectors visited another one of the company’s facilities in May, according to a 30-page inspection report reviewed by Bloomberg News. The inspectors on that visit described practices they said don’t ensure the “safety, efficacy, purity and overall quality of drug products manufactured” at the facility.
The FDA didn’t comment on the Intas inspection specifically but Jeremy Kahn, a spokesman, said the agency continues to monitor the quality of drugs coming into the US.
“The FDA does everything possible to work with firms to address any potential risks to keep medically necessary products available while also ensuring there will not be harm to patients associated with quality issues,” he said.
Intas did not respond to requests for comment.
The plant the FDA inspected in May makes injectable drugs. It manufactures treatments for breast cancer, nausea during chemotherapy, fluid retention caused by congestive heart failure, high blood pressure, Parkinson’s disease, depression and opioid abuse disorder, according to the report.
The latest Intas inspection report suggests that some of the country’s already problematic drug shortages could only get worse. The White House has formed a task force to tackle the quality problems in the drug supply chain that have led to recalls and plant shutdowns. The number of drugs in short supply in the US hit a five-year high and continues to grow.
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The US is dealing with a scarcity of chemotherapies cisplatin and carboplatin as a result of the first inspection at an Intas factory in November. The generic drug company stopped making drugs there while it attempts to fix issues US inspectors uncovered.
The cancer medications Intas has already made are undergoing enhanced testing to ensure their safety, slowing their ability to reach patients. The shortages didn’t emerge until a couple of months after the inspection.
Quality issues like shoddy manufacturing contribute to the majority of drug shortages in America. Factory shutdowns, recalls and extra testing can delay treatments getting to patients. The supply chain of generic drugs is largely consolidated in India and China where cutting corners has been a systemic problem despite efforts by the FDA to educate and train companies. FDA inspectors rely on a company’s own quality records to determine if a plant is operating safely.
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In the May visit, the FDA found that Intas employees were manipulating data so injections would pass visual checks for particles, including black specks, fiber and glass. The employees had put handwritten slash marks through originally recorded data sets that didn’t meet US standards for particles and recorded new ones that just met acceptable levels.
“This repeated pattern of altering and/or manipulating visual inspection records was observed since at least 2021 with multiple visual inspectors and supervisors involved,” according to the inspection report. The company’s quality department used “deficient records to release batches of drug products to the US market.”
Inspectors also said they found evidence indicating Intas employees ignored findings over three years of more than 1,000 “spore-forming organisms” that can include dangerous bacteria in sterile areas, including in a part of the plant where oncology drugs are made. And they said Intas hadn’t verified the accuracy of the quality test methods it uses for 112 FDA-approved generic drugs.
–With assistance from Chris Kay.
(Updates with FDA comment starting in fourth paragraph.)
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