The U.S. Food & Drug Administration’s (FDA) recent decision to approve generic valsartan manufactured by two overseas pharmaceutical companies is coming under scrutiny, following reports of serious quality control issues at their manufacturing facilities in India.
Cadila Healthcare Ltd. and Alkem Laboratories Ltd. won approval for their generic valsartan products earlier this year. The medication, which is taken by millions of people to treat high blood pressure and heart failure, has been in short supply since last summer, thanks to a worldwide recall that has since grown to involve dozens of generic drug makers.
Neither Cadila or Alkem was ever caught up in the valsartan recall, and the FDA is counting on their products to help mitigate the ongoing shortage.
The FDA cleared Alkem’s generic valsartan on March 13th. Just three days later, the Cadila received approval to sell valsartan combined with hydrochlorothiazide.
The previous year, the agency’s own inspectors discovered workers at Alkem’s factory in Daman, India, had destroyed logbooks or deleted data on quality testing and ignored signs that drugs contained impurities. According to Bloomberg News, they also observed mosquitoes, gnats, and other flying insects that were “too numerous to count.”
The FDA conducted another inspection in January, and the facility passed without issue. However, the turnaround was surprising, given the plant’s extensive issues.
“That’s not realistic to fix that in nine months,” Moussoud Motamed, a former FDA inspector, told Bloomberg. “Working for industry, I can tell you it’s impossible.’’
This past April and May, FDA inspectors discovered that equipment at a Cadila plant in Ahmedabad, India, wasn’t cleaned appropriately to prevent contamination and that workers ignored signs of impurities.
These issues bear a striking similarity to problems that had plagued Zhejiang Huahai Pharmaceutical Co. Ltd., the Chinese supplier at the center of the continuing valsartan recall.
Moussoud Motamed visited Zhejiang Huahai’s manufacturing plant in 2017 before leaving the FDA. During the inspection, he discovered that quality-test failures had been omitted from official records, including those that flagged impurities in unnamed drugs the company didn’t attempt to identify.
Although Motamed wanted to impose strict penalties on Zhejiang Huahai, he was overruled by another FDA official who decided to let the company correct the problems on its own.
A year later, the first of three carcinogenic nitrosamines were detected in generic valsartan tablets, kicking off the current wave of recalls. The FDA ultimately traced the contaminant to active ingredients manufactured by Zhejiang Huahai and sold to dozens of generic drug companies around the world.