“India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines.”
We have been warning about drugs imported from abroad for more than a decade. That’s because readers of our syndicated newspaper column and visitors to our website
have been telling us for years that there were problems with the generic medicines they were taking. At first we were skeptical of these protests, thinking there might be a psychosomatic component to some people’s bad experience. (We had long been big supporters of generic drug quality and the savings that can be gained by substituting generic for brand-name medications. It was hard to accept that we might have been overly enthusiastic.)
Eventually the sheer number of complaints and the compelling nature of the stories convinced us that there was something very wrong with the way the FDA approved and monitored generic drugs. The article by Mr. Harris confirms that there is indeed a scandal of immense proportions that has pretty much been ignored by physicians, pharmacists, patients, regulators and Congress. Here’s the straight and skinny.
India now supplies roughly 40% of the active pharmaceutical ingredients found in our prescription and over-the-counter medications. Until recently, the FDA was incapable of inspecting most of India’s manufacturing plants. It didn’t have the resources or the manpower. New legislation has allowed the FDA to accept money from the generic drug industry to speed drug approvals. Some of those funds also go to inspections. Last year the FDA visited 160 Indian manufacturing facilities, triple the number from four years ago.
In the process the FDA has uncovered fudged data, shoddy plants and questionable quality control in a number of facilities, including India’s largest drug maker, Ranbaxy. Just recently, the FDA banned all active pharmaceutical ingredients made at Ranbaxy’s Indian facilities from the U.S. market. This was one of the first large foreign generic drug makers to make a splash in the U.S., starting its exports to this market in 1998. Perhaps coincidentally, that was the year we began to receive enough complaints to make us start to question our trust in the FDA’s ability to guarantee generic quality. Here is just one example of the kind of story we were receiving from readers at that time:
“I have been treated for hypothyroidism for over thirty years, and have been on Synthroid 0.125 mg for the past ten. This year my doctor wrote the prescription for a generic at the same dose.
“By the fourth day on the generic, I felt as though I was on the end of a tightly coiled spring. I couldn’t sleep; I had a slight case of diarrhea; I was sweating more than usual and my heart felt as though it would pound out of my chest. When I finally realized all this might be due to the change in medication, I had the pharmacist give me Synthroid instead. Almost immediately I calmed down, my heart stopped pounding so hard and I was back to my normal self.” [published May 18, 1998]
We now know more about the flaws in the Indian drug regulatory system. The head of the Indian drug monitoring program is G. N. Singh. In response to a question about quality control he replied that, “If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country. Our priority is to make medicines available and affordable to all.”
If the goals of Indian regulation are availability and affordability over quality, then it is little wonder that the FDA officials are finding problems. It was alarming to read in Mr. Harris’s article that many generic drugs are under the supervision of state health departments in India rather than the national authority. He points out that:
“The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry.”
The other large supplier of generic ingredients and products to the U.S. and the world is China. The former head of China’s national drug regulatory authority was executed for corruption in 2007. He had taken office in 1998, the year we started hearing from our readers about increasing problems with generic medications. The FDA has historically had difficulty making unannounced inspections of drug manufacturing facilities in China. Here is whatGardiner Harris of The New York Times
has to say about oversight there:
“Using its new revenues, the F.D.A. tried to bolster its staff in China in February 2012. But the Chinese government has so far failed to provide the necessary visas despite an announced agreement in December 2013 during a visit by Vice President Joseph R. Biden Jr., said Erica Jefferson, an F.D.A. spokeswoman.
“The United States has become so dependent on Chinese imports, however, that the F.D.A. may not be able to do much about the Chinese refusal. The crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China.”
Despite all these concerns, the FDA still maintains that generic drugs are “identical” to brand names and that“FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.”
If you are having some doubts about the FDA’s ability to guarantee quality in drugs from foreign manufacturing plants, you may want to get the rest of the story. Twelve years ago we interviewed key players at the Food and Drug Administration about these very issues. You can read what we discovered in our book, Best Choices from The People’s Pharmacy
. More recently, we uncovered another scandal at the FDA involving the process for approving generic drugs. We document those problems in our book Top Screwups
and also provide guidelines on how to use generic drugs more safely in our Guide to Saving Monehy on Medicine