Drug manufacturing is a highly regulated business. It’s not enough to merely keep floors swept and the factory clean. There are catalogues of federal regulations, quality programs and regulatory procedures in addition to tracking and documenting the use of current good manufacturing practices (GMPs). There must be a valid way to track complaints, which feeds information into the quality program. Tests for purity must be validated, and much more. There is a lot more to FDA compliance than what I’ve written. I have tried to explain in less than a paragraph what quality engineers spend their entire careers trying to learn. Virtually all drug and medical device manufacturers hire consultants to help them meet U.S. Food and Drug Administration (FDA) guidelines. My wife, an engineer, is a quality & regulatory consultant formerly with the FDA.
The quality of drugs made abroad is a major concern. The FDA regularly inspects factories, including those that produce medications in other countries. Some are better than others, while some attempt to hide their deficiencies:
Amid ongoing concern over the quality of medicines made in India, a major supplier of generic medicines was seen removing three truckloads of “scrap materials” from a facility that was being inspected last month by the Food and Drug Administration.Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana, India. And when confronted by the FDA inspectors, the plant management acknowledged the papers should not have been destroyed.
FDA inspectors found numerous items that compromised the quality of drugs made at the factory. Inspectors observed filthy conditions:
According to reports, USFDA inspectors found microbial contaminationin the air purification units of the facility as well as various fungal and bacterial colonies. The form 483, reports suggested, pointed to bird droppings and feathers on the air purification units even as the water tank was found to be in poor condition as it had not been cleaned since installation.
The FDA found six major violations of current good manufacturing practices in Granules facility. It’s not alone, 11 days ago the FDA sent a warning letter to another Indian drug maker after finding glass in vitamin B injections. Large Indian drug maker Ranbaxy was busted a few years ago for falsifying records on a grand scale.
Ranbaxy had falsified data for over 200 drug products in more than 40 countries. The company’s scientists had secretly altered ingredients to try and get better results. The company tested brand-name drugs and used those results in applications as if the data had come from tests of its own drugs. In short, it used every imaginable subterfuge to speed drug approvals and increase profits, a scheme that jeopardized the health of patients around the world.
Policing the quality of generic drugs allowed into the United States is a constant battle. Here is what investigative journalist, Katherine Eban had to say:
The FDA’s warning letters and import alerts from overseas plants typically appear as blips on the public radar. But as I delved into them, I saw they revealed patterns of conduct aimed at the deliberate manufacturing of substandard drugs as a way to increase profits.
If those findings are not bad enough, the FDA has reduced inspections over the past few years. Inspectors often never leave the facility conference room. They never go out and walk the production floor where they might learn something not in the official papers brought to them by the company executives. Indeed, since Covid the FDA is conducting some inspections over Zoom.
A good resource on the problems with drugs manufactured abroad is the book, Bottle of Lies: The Inside Story of the Generic Drug Boom.