Delayed testing and factory issues have led to dangerous pills and patient deaths.
The Food and Drug Administration has taken action against a drug company in India after years of repeated problems. Glenmark Pharmaceuticals, a company that makes generic drugs sold in the U.S., has received a formal warning from the FDA. This came after inspectors visited one of Glenmark’s plants and found serious issues that had not been addressed for years. The company had already recalled dozens of drugs from the same site, but the inspection revealed that even more medicines could pose risks to people taking them.
The inspection happened after a report last year described how Glenmark’s factory in central India had made pills that didn’t dissolve the way they were supposed to. That’s a big problem because pills that don’t dissolve right can release too much or too little medicine into the body. One of the recalled drugs, a potassium chloride pill, was especially dangerous. If a person gets too much potassium, their heart can stop. The FDA had known for years that this plant had problems but hadn’t visited it in over four years. After the inspection, Glenmark pulled more drugs off the market.
The FDA’s warning letter pointed out that Glenmark had made similar mistakes at other factories. Three of the company’s plants had been flagged in the past, with one being banned from shipping drugs to the U.S. The FDA said the company’s leaders have not kept proper control over how their drugs are made. They were told to take a hard look at their operations worldwide and fix anything that does not meet federal rules.
One of the biggest problems found at the factory involved the way Glenmark checks whether its drugs continue to work overtime. Drug makers are supposed to hold on to samples from each batch they sell and test those samples until the expiration date. These tests make sure the pills still work as intended. Glenmark, however, was behind on many of these tests, and in some cases, it took more than three months for the company to find out the pills were faulty. This delay in testing meant that recalls didn’t happen as quickly as they should have.
In at least one case, this delay may have had deadly consequences. A 91-year-old woman in Maine was taking Glenmark’s potassium chloride pills when she died. Her family later received a letter saying the pills had been recalled, but the letter came three weeks after her death. Glenmark has denied that its pills were to blame, but the lawsuit is still ongoing. The company has since stopped making the drug for American patients.
The FDA’s letter criticized Glenmark for not digging deep enough into what was causing the problem with the pills. It also said the company failed to explain why some drugs were not tested properly. In many places, the letter had information blacked out because the FDA said it was protecting business secrets.
Another problem was that Glenmark hadn’t made sure its testing methods were working as they should. If tests aren’t done right, then there’s no way to know if a drug is safe or not. The FDA said that Glenmark couldn’t prove its lab results were accurate because of this problem.
The FDA has warned that if Glenmark doesn’t fix the issues soon, it may stop the company from sending any more drugs into the U.S. Glenmark says it is working with the agency and making changes, but didn’t say much else, citing legal matters. For now, the FDA’s warning is the latest move in a long history of problems between the agency and the company.
Sources:
FDA Cracks Down on Indian Factory That Made a Drug Linked to U.S. Deaths
Glenmark Pharmaceuticals Faces FDA Action after Report Links Its Generic Drug to US Deaths
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