America’s drug supply is increasingly reliant on companies who continually get failing grades from the Food & Drug Administration.
America’s drug supply is increasingly reliant on companies who continually get failing grades from the Food & Drug Administration. Indian pharmaceutical giant Aurobindo is a case in point. Fresh off of a series of recalls last year, Aurobindo was inspected by the FDA in India and found to have numerous lapses in quality control, including faulty equipment used to make medications used daily by Americans.
Auditors reportedly uncovered “deficient” manufacturing equipment, cleaning and poor drug storage controls during a visit in May at an Aurobindo facility in Anakapalli, located in eastern India, according to a FDA report obtained by Bloomberg News through a Freedom of Information Act request. This visit has not yet been posted on the FDA’s Inspections Dashboard.
Sampling tools weren’t cleaned and maintained to prevent contamination at the plant, which produces certain active pharmaceutical ingredients — the raw materials core to making drugs. Laboratory controls also didn’t include the establishment of scientifically sound and appropriate specification, designed to assure that drug products conform to appropriate standards of identity, quality and purity, the report said. During a warehouse walk-through the auditors also observed raw materials being stored in excessively hot and humid conditions and not compliant with label storage requirements, it said.
In January last year, Aurobindo’s Doultabad lab in India was given a “warning letter”, which often leads to export bans. This one did not lead to an export ban, meaning that despite the lapses in the lab’s following the FDA’s Current Good Management Practices, they were still allowed to sell medication to the U.S.
The FDA said the facility made adulterated active pharmaceutical ingredients, or API, and that repeated failures in their production “demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”
Since 2019, Aurobindo has had around 20 recalls of its drugs exported to the United States, averaging about 5 recalls per year. If a U.S. company was hit with similar problems, the FDA would probably shut them down. Or at the very least, a U.S. lab would have FDA inspectors and third party consultants on site constantly.
The FDA often states that it is dealing with a careful balancing act of supply and safety. As the generic drug market in the U.S. is heavily reliant on imports, with some medication in short supply, the FDA prefers not to restrict exports. This is the case even if the lab is found to be sub-par by FDA standards.
There are currently more than 150 drugs that are in short supply as of mid-June, according to the FDA. Some well known drugs include amoxicillin, used to fight pneumonia, and epinephrine injectables. Epinephrine is the primary drug administered during cardiopulmonary resuscitation (CPR) to reverse cardiac arrest. This drug is now hard to find in the U.S. because of our import reliance. Epinephrine is considered an essential medication.
It’s not just Aurobindo getting lackluster reviews from FDA inspections.
Indian drugmakers have received failing grades from FDA visits all year. FDA inspectors currently have a backlog of more than 1,000 foreign drug-plant inspections that were missed due to travel restrictions during Covid, Bloomberg reported on June 30. Despite this uptick in 2022 inspections, foreign laboratory visits were down 74% from 2019’s level.
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.