Chinese and Indian manufacturers receive the most FDA warning letters for violations of good manufacturing practices which can result in unsafe generic drugs.
On Aug. 15, the Food and Drug Administration issued yet another toothless warning letter to Eugia Pharma Specialties, a wholly owned subsidiary of Indian pharma giant Aurobindo. Despite failure to comply with Current Good Manufacturing Practice, a necessity for drug makers who want to sell medications to the U.S., Aurobindo said that exports from the facility in question will not be impeded.
An Aurobindo spokesperson told The Business Standard, an Indian daily, that, "There is no impact on the existing supplies to the U.S. markets."
This is standard procedure. A warning letter is essentially a D grade issued by FDA inspectors after a lab visit. It rarely leads to import restrictions because the FDA is at least as concerned about America’s drug shortage problems as it is efficacy and safety. The warning letter did not specify if any particular drug was contaminated, only that the lab failed to provide safety data and proper equipment sterilization checks.
Eugia is a generic drugs lab, based in Hyderabad, a city in Telangana state. They make cancer drugs and generic injectable drugs, including cisplatin, a chemotherapy injectable considered to be a critical drug by the FDA. Cisplatin faced widespread shortages in 2023. The FDA turned to China to make up for that supply shortfall.
Eugia’s parent is no stranger to warning letters.
Aurobindo was issued a warning letter in 2022. In 2022, the FDA inspectors wrote: “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”
Chinese and Indian manufacturers receive the most FDA warning letters for violations of good manufacturing practices which can result in unsafe generic drugs. Companies that have received multiple warning letters are often allowed to continue to sell into the U.S., including from the labs on the receiving end of poor inspection results. Because of its concern of drug shortages, the FDA does not act to suspend imports from those labs until the problem is resolved. This is especially true for critical drugs, where the U.S. domestic market lacks production capacity. As a result, patients are at risk of lacking the medications they need, or injecting ineffective, or tainted medication that can harm them.
The United States is suffering from the worst drug shortage crisis in recent history, and is being made worse by foreign government subsidies. Whether it is basic generic drugs, antibiotics, or chemotherapy drugs, patients, doctors, and hospitals are facing shortages that are claiming American lives and straining our nation’s health care system.
Read more about the crisis and solutions to solve it here.
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.
Comments