The Food and Drug Administration is cracking down on drug makers selling products in the U.S. (mostly generic drugs) that were made at certain plants in India. On April 1, 2014, the FDA banned U.S. imports of some generic drugs associated with the Canadian drug behemoth Apotex, which like so many drug makers, has a manufacturing presence in India, presumably to keep costs low. But Apotex is just one of the latest in a long list of companies with plants situated in India that have been subject to sanctions in the last year, including Ranbaxy, Sun Pharmaceutical, and Wockhardt, among others.
These sanctions raise concerns about the quality of the drugs the U.S. imports from India and from other parts of the world. We talked to the FDA and industry experts to find out whether generic drugs made in India are safe and address other important issues.
Why has the number of FDA sanctions against companies with drug plants in India increased?
One of the main reasons is that inspectors from the U.S. and India have ramped up efforts to make sure that plants in India making the drugs exported to the U.S. adhere to the strict manufacturing standards and regulations required by the FDA. With more and more companies such as Apotex making drugs in other countries, FDA inspectors were spread far too thin. In 2012, Congress passed the FDA Safety and Innovation Act, which among other things, requires the agency to inspect foreign facilities that make drugs sold in the U.S. as frequently as it does domestic plants. Last year, the Indian government approved adding seven new FDA drug investigators, to bring the total up to 19 U.S. staff members working in India.
A spokesman for the FDA confirmed in an e-mail that the agency is stepping up its efforts abroad, including in India. “What we’ve found is that most Indian firms understand good manufacturing practices and use them, but we’ve seen problems with a few companies," the representative said. "That’s why we‘ve chosen to make quality one of our highest priorities this year.” The agency also says that import bans affect only a fraction of the drugs made in India for the U.S. market.
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Are problems confined to India?
Not at all. “The problems FDA investigators encounter in India are similar to those seen around the world in manufacturing,” according to an FDA representative. For example, in the last year, the FDA has sent warning letters about manufacturing or packaging violations not only to companies with plants in India, but also to companies operating plants in Australia, Austria, Canada, China, Germany, Japan, Ireland, and Spain. Common issues include inadequate testing and quality checks, inconsistencies in data collection, and contaminated products.
In particular, imports of drugs and medical devices from China increased by nearly fivefold from 2007 to 2013, and the FDA is scrambling to keep up. Our review of FDA import alerts reveals that the agency sanctioned about as many Chinese factories in the last five years as it did those in India. (Under these alerts, products can be stopped from coming into the U.S. until the importer proves that they comply with relevant laws and regulations.) As in India, the FDA is working with the Chinese government and plans to increase staff—from the current eight U.S. officers to 27—to conduct timely inspections of more Chinese plants and other tasks.
Are name-brand drugs safer?
No. Manufacturing standards are the same for brand-name and generic drugs. In fact, many brand-name drugs are produced overseas as well, often in the same plants as the generic equivalents.
And manufacturing problems also occur in connection to brand-name drugs made by U.S. companies in this country. For example, in what is probably the largest related series of drug recalls in U.S. history, according to an analysis by QuarterWatch, a drug safety publication from the nonprofit Institute for Safe Medication Practices, millions of bottles of over-the-counter medications, including Tylenol and Motrin, were yanked from pharmacy shelves beginning in September 2009 by Johnson & Johnson's McNeil Consumer Healthcare subsidiary, headquartered in Fort Washington, Pa. At least one of the manufacturing plants at the center of the recalls was in Pennsylvania; another, in Puerto Rico.
The FDA had received more than 2,000 reports of adverse events associated with the recalled products, according to the agency.
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Should you take drugs made only in the U.S.?
It’s unrealistic in this age of globalization. About 40 percent of the medications Americans use everyday are made outside the U.S. And two of the world's leading drug exporters are India and China, each with about 500 drug manufacturing plants registered with the FDA.
Plus, when you consider that about 80 percent of all raw drug ingredients used to make medications we take in the U.S. come from other countries, it is very difficult to know where all the components of a medication come from, regardless of where it was manufactured.
“These days it can be very hard to track where your drugs come from,” Young said. “There’s not even always a straight line from the manufacturer. Sometimes drugs are repackaged and rebranded along the way.”
Costco told us that it would try to help patients who want to source their medications from a certain company or country, though prices may vary according to manufacturer cost. But many times it might be difficult, if not impossible, to accommodate such a request, according to Victor Curtis, R.Ph, senior vice president of pharmacy at Costco Wholesale. "Pharmaceutical manufacturers don't disclose the country of origin on the product's label," Curtis said. "And, if contacted, some will disclose what country the medication came from and some will not."
What’s being done to ensure the safety of drugs from overseas?
In addition to putting more resources into its own quality assurance efforts, the FDA says it is working more closely with regulatory counterparts in other countries. In addition, the agency has started a major research initiative to work with academic institutions to ultimately improve the safety and availability of generic drugs in the U.S.
Meanwhile, Consumer Reports is following the situation closely. Stay tuned for a more detailed report from us later in the year.
—Teresa Carr
Related Information:
Worried about generics?
Is it okay to order my medications online from outside the U.S.?
Cymbalta, Celebrex among blockbuster drugs going generic
This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).
Consumer Reports has no relationship with any advertisers or sponsors on this website. Copyright © 2007-2013 Consumers Union of U.S.
