It’s been a rough end of 2022 for Indian pharmaceutical manufacturer Aurobindo. It may not be a household name, but there is no doubt that millions of Americans have taken generic drugs manufactured in an Aurobindo lab somewhere in India. In fact, Aurobindo is the largest supplier of dispensed generic drugs in the U.S.
Aurobindo manufactures hundreds of drugs. It is one of the largest producers of active pharmaceutical ingredients (API) in the world. And this year, their manufacturing facilities in India have come under intense scrutiny by the Food and Drug Administration (FDA)—and not for good reasons.
In October, Aurobindo voluntarily recalled two lots of a blood pressure medication called Quinapril and Hydrochlorothiazide from the U.S. market due to the presence of a Nitrosamine Drug Substance Related Impurity above the allowable limit. Aurobindo’s U.S. distributor began shipping those two batches nationwide in May, but only discovered the impurity in October.
This is not the first time Aurobindo voluntarily recalled a blood pressure drug. They did it again in 2019, pulling 80 lots of Amlodipine Valsartan tablets, Valsartan HCTZ tablets, and Valsartan tablets off the shelves for the same reason.
It’s not that Aurobindo is all alone here. Pfizer had some blood pressure medication recalled in March of this year, all because of a higher than allowable level of nitrosamines. It’s just that Aurobindo has been called out by the FDA numerous times this year, but remains a big supplier in the U.S. pharmaceuticals market. And despite repeated Warning Letters and violations of FDA regulations, as well as multiple drug recalls, Aurobindo continues to supply Americans with potentially unsafe drugs.
Aurobindo earned roughly 47% of its revenue from U.S. drug sales in 2022. APIs account for 15% of the company’s revenue. These are the substances in drugs that are responsible for the health benefits for patients. For example, the acetaminophen contained in a pain relief tablet is an API.
Its labs have been flagged dozens of times by FDA inspectors.
The same month its parent company in India was recalling blood pressure pills, AuroMedics Pharma LLC, a unit of Aurobindo based in the U.K., took 88,080 vials of Tranexamic acid injection off the market. The medication is used to control or prevent excessive bleeding in dental surgery. The voluntary recall was due to a “piece of metal found in a vial” of the medication. That’s one month, two recalls.
In September, following an inspection in August, Aurobindo was given a Form 483 with three observations. A Form 483 is issued when FDA investigators have observed any condition that in their judgment may constitute a violation of the Food and Drug Act. When given repeatedly, this means the lab is not following FDA good manufacturing practices. Usually, Form 483 filings require a Freedom of Information Act (FOIA) filing to get to the bottom of what inspectors found at the site. In September, FDA inspectors found three separate and noteworthy problems at the lab in Srikakulam in Andhra Pradesh state.
That was in September. Two months later, in November, Aurobindo’s lab in Telengana state was written up in a Form 483, this time with 10 observations. What made this visit so problematic for Aurobindo is that the lab was classified as requiring an Official Action Indicated on May 17, 2019, which means inspectors found a problem that needed immediate fixing. Aurobindo responded to the FDA and carried out the required corrective actions. But then after it was re-inspected in November, the company got hit with 10 observations. While none of them resulted in official regulatory action requirements, Aurobindo cannot seem to meet FDA requirements this year.
In fact, in January of this year, the Telengana lab, located in the city of Hyderabad, was given a Warning Letter by the FDA. The letter said inspectors found during an August 2021 visit “significant deviations from current good manufacturing practices” and that its API was not up to snuff – calling it “adulterated”.
FDA Playing Whack-a-Mole
Aurobindo has recalled over 21 products in the last 3 years and so 2022 was no anomaly for the Indian lab. Products have been recalled for all sorts of reasons, not just nitrosamine levels above limits. They have been recalled due to mold, hair, and foreign particulates like metal found in the drugs.
Despite this record, Aurobindo received approval by the FDA to manufacture Amphoterecin B, an antifungal medication that fights infections caused by fungus. This is a Gilead Sciences product and the only two generics on the market today are made by Indian labs—Sun Pharmaceutical Industries Ltd. and Aurobindo.
The fact that Aurobindo, with its long history of repeatedly violating FDA’s good manufacturing practices, is a serious problem that is only made worse by the United States’s dependence on foreign manufacturers in China and India. It also speaks to the FDA’s concern over keeping American shelves filled with drugs to avoid shortages, even if it means doing so with products made by companies consistently running afoul of FDA best practices.
Ironically, if addressing shortages is a reason the FDA is worried about cracking down on imports from bad drug manufacturers, it hasn’t worked. Currently, our nation is reeling from the effects of the ongoing Amoxicillin shortage. Amoxicillin is our go to drug for common pediatric maladies like ear infections and pneumonia.
Perhaps the best news for Aurobindo in 2022 in regard to FDA treatment is that they’re not alone in their run-ins with the FDA.
An Indian pharmaceutical company called Lupin was flagged for violations on Thanksgiving Day in a Form 483 that revealed 8 violations against best practices for producing API at its lab in Mandideep following an inspector visit that month.
In November, Lupin shut down U.S.-bound exports of drugs at its lab in Tarapur, Maharashtra state. The FDA told them to suspend production for the U.S. market at that lab until they passed inspections.
“Americans believe that if the FDA allows a generic drug to be sold in the U.S, then it is safe. This is no longer true,” says Rosemary Gibson, author of China Rx and chairwoman of the CPA Healthcare Committee. “The time has come for U.S. companies to stop buying substandard generics from untrustworthy foreign manufacturers, and start buying quality generics made in the U.S. The solution to this public health and national security threat is to reshore essential generic drug manufacturing,” she said. “Congress must pass production-based tax credits for domestic pharmaceutical manufacturers to help the U.S. rebuild its industrial base. These kinds of policies were passed into law in the Inflation Reduction Act for other industries, and they have already led to a wave of investment in the U.S. renewable energy industry.”