An import alert means the lab’s products are off limits to the U.S. until corrections are made to its manufacturing processes.
Intas Pharmaceuticals has become one of India’s more infamous drug makers. Written up in The New York Times on May 17 for destroying evidence about drug manufacturing sought by the Food and Drug Administration, the cancer drug lab was recently on the receiving end of a dreaded Import Alert. This is the worst of the warnings the FDA can give a lab after inspection. It means the lab’s products are off limits to the U.S. until corrections are made to its manufacturing processes.
The FDA issued an Import Alert for Intas on June 1, but is allowing the company to export cancer drugs and even B-12 vitamins to the U.S. anyway. All told, roughly 26 drugs, both tablet and injectable form, were given the Import Alert, but due to cancer drug shortages, the drugs will be allowed to be shipped and sold domestically.
Three FDA inspectors visited the Intas facility located near Ahmedabad between November 22 and December 2, 2022. The inspectors made 11 negative observations at the lab, including some common areas the FDA will write companies up about such as data integrity, standard documentation practices, and test methods. The FDA also found procedures designed to prevent microbiological contamination of drug products were substandard and did not align with Current Good Manufacturing Practices required to sell drugs to the U.S.
Intas and its U.S. subsidiary, Accord Healthcare, have worked with the FDA’s Drug Shortage Staff and the Office of Compliance to identify certain critical drugs that it will continue to supply to the U.S. market after further testing and verification, the company said.
Additionally, Intas is working with FDA on a plan for it to return to manufacturing for the U.S. market as soon as possible. “Intas is fully dedicated to continuing its heritage of supplying quality medicines,” the company said in a statement.
It seems that the Import Alert stems from the visit were FDA inspectors found documents relating to the production of medicines “torn randomly into pieces and disposed inside black scrap bags” The documents found by inspectors contained handwritten information under a section designed to describe “events” and “problems” in the wash room and filling room or finished drugs but could not be verified due to missing information. Intas said that information was non-critical but the FDA said the lack of information made it harder to determine how drugs were being safely produced in the lab for human consumption.
For years, the FDA has said it has to balance drug safety with supply. The latest Intas situation with an inspection gone bad shows that the FDA is willing to give foreign labs a pass so long as the drugs they make are in short supply, even if that means the drugs could lack efficacy, or be harmful to patient health.
According to the FDA, Intas has had seven products face import refusals since 2016, including an anticonvulsant generic drug used to treat patients suffering from epileptic seizures. Its antidepressant3 generic escitalopram oxalate was on the Import Alert list in June and was banned from the U.S. as recently as April 2017.
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.