Indian generic drug manufacturer Zydus has history of significantly violating FDA regulations
Zydus Lifesciences may have an office in New Jersey, but this is not an American manufacturer. In fact, Zydus does not make anything in the United States. It is a multinational pharmaceutical company headquartered in India that has repeatedly violated FDA regulations, but is still allowed to sell its generic drugs in the U.S. market.
On August 5, the FDA issued another Form 483 to Zydus containing four observations after inspecting its Moraiya manufacturing facility located at Ahmedabad from July 26 to August 5. A Form 483 is issued when an FDA inspector finds problems that may violate U.S. law and FDA regulations.
As a patient and consumer, why should you worry about generic drug manufacturers that receive a Form 483?
In practice, it’s a potential red flag before the FDA issues a Warning Letter, which is when the FDA notifies manufacturers of significant violations of FDA regulations and works with the company to ensure they are corrected. However, even when the FDA issues a Warning Letter, it does not remove those potentially unsafe drugs from the U.S. market or even conduct tests on them to ensure they are safe and working as they should.
According to a poll conducted by Morning Consult, 84% of Americans want the FDA to ban imports of generic medicines from foreign manufacturers that have received a Warning Letter. Additionally, 86% of Americans support the FDA testing generic medicines imported into the U.S. from foreign manufacturers that have received a Warning Letter.
The FDA has issued Warning Letters to the Zydus lab in Moraiya in the past, and has issued Form 483s as well for 14 observations found by inspectors in 2019. At the time, Zydus was operating under the name of Cadila Healthcare. The company changed its name to Zydus Lifesciences in February 2022.
The Moraiya lab is Zydus’s largest lab making drugs for the U.S. market. The FDA issued the facility a Warning Letter in 2015 for a variety of shortcomings, including “serious breaches” of good manufacturing practices and serious quality problems. As STAT News documented, Zydus employees left notebooks detailing how bacteria was present in the water system.
Problems have been found at other Zydus facilities as well, including at a sterile injectables plant in India. In 2019, the FDA served Zydus’ sterile injectables facility with its second Warning Letter in four years. The FDA found manufacturing issues, but failed to notify the public of what those issues were.
Prior to receiving the Warning Letter in 2019, the FDA hit Zydus with 14 observations in a Form 483 after an inspector found grimy aseptic equipment and improper employee procedures that could lead to microbial contamination. It even called out workers in one area that the inspector believed were responsible for microbial contamination at the plant.
In 2020, Gilead Sciences awarded Zydus with a contract to make ingredients for the anti-Covid injectable, Remdesevir. Zydus sells that drug in over 127 countries.
In December of 2021, Gilead issued a recall of two lots of that drug when a customer found glass particulates in the injectable. The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material. If the glass particulate reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death in a worse-case scenario, Gilead said.
To date, Gilead Sciences Inc. has not received any reports of adverse events related to this recall and never said which of its contractors was responsible for the faulty lot. Unfortunately, Gilead did not disclose to patients and consumers whether Zydus was responsible for manufacturing an injectable that contained glass.
But what we do know is this: it is time for the FDA to hold Zydus, and other Indian generic drug manufacturers, accountable for repeatedly violating safety regulations and putting American patients at risk.
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.