Quality-control slim on imported medications

Companies based in India were bit players in the American drug market 10 years ago, selling just eight generic drugs here. Today, almost 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs purchased by American consumers are made by Indian manufacturers.

Five years ago, Chinese drugmakers exported about US$300 million worth of products to the United States. Eager to meet Americans’ demand for lower-cost medicines, they, too, have expanded rapidly. Last year, they sold more than US$675 million in pharmaceutical ingredients and products in the U.S. market.

Over the past seven years, however, the FDA conducted roughly 200 inspections of plants in India and China, and only a few were the kind that U.S. firms face regularly to ensure that the drugs they make are of high quality.

The agency, which is responsible for ensuring the safety of drugs for Americans wherever they are manufactured, made 1,222 of these quality-assurance inspections in the United States last year. In India, which has more plants making drugs and drug ingredients for American consumers than any other foreign nation, it conducted a handful.

After the pet food scandal that triggered widespread fears over the safety of human and animal foods imported from China, experts say medicines from that country and from India pose a similar risk of being contaminated, counterfeit or simply understrength and ineffective.

“As the manufacturing goes to China and India, the risk to human health is growing exponentially,” said Brant Zell, past president of the Bulk Pharmaceuticals Task Force, which represents American drug-ingredient makers that filed a citizen’s petition with the FDA last year asking the agency to oversee foreign firms more aggressively.

“The low level there” of follow-up inspections, “combined with the huge amount of importing, greatly increases the potential that consumers will get products that have impurities or ineffective ingredients,” he said.

FDA officials say that they are not aware of any health problems caused by drugs imported from India or China, and that the American companies that import them usually do their own quality and safety testing. But the agency acknowledges that it is virtually impossible to know whether poor-quality or contaminated drugs from lightly regulated Asian plants have caused patients to get sicker or remain ill, especially because patients or doctors are unlikely to suspect poorly manufactured drugs as a problem. What is clear is that the odds are growing rapidly that the contents of an American medicine cabinet will hold products from those two countries.

Analysts estimate that as much as 20 percent of finished generic and over-the-counter drugs, and more than 40 percent of the active ingredients for pills made here, come from India and China. Within 15 years, they predict, as much as 80 percent of the key ingredients will come from those countries — which are quickly becoming attractive to brand name drug makers, too.

William Hubbard, a former FDA associate commissioner, called the situation dire and deteriorating.

“You have this confluence of events, with so much more product coming from abroad and fewer and fewer inspections,” Hubbard said. “This is very serious stuff, because a contaminated drug hitting the market could cause lots of injuries or worse before it got tracked down.”

He also said that the FDA inspection system is so weak that many foreign manufacturers believe they “can play games without consequences.”

Dilip Shah, secretary general of the Indian Pharmaceutical Alliance, which represents many Indian drugmakers, said he would like to see a more permanent FDA presence in his country because “it would help improve standards” and encourage more companies to seek FDA approval of their products.

He said, however, that when U.S. groups raise questions about the quality of India’s products, “one must not forget that they may have some agenda,” such as protecting their market share. All drugs imported from India, Shah said, come with “assurance of quality, safety and efficacy” from the FDA.

One executive for Shanghai Pharmaceutical, one of China’s largest drugmakers, made a similar argument in a recent interview with the U.S. magazine Chemical & Engineering News. He said that all drug ingredients his company exports to the United States meet stringent FDA standards and that American trade groups sometimes “urge quality controls as a trade barrier to protect the interests of their members.”

Hubbard and other experts agree that many Indian and Chinese drugmakers are high-quality firms that provide products at a fraction of the cost charged by American and European manufacturers. But, they add, Indian and Chinese companies are not only new to the FDA standards, but they also come from nations that have recent histories of widespread drug counterfeiting, lax quality control and very limited government regulation.

The former head of the Chinese drug and food safety agency, for instance, was recently sentenced to death for taking bribes from companies he regulated, and two major Indian companies received warning letters from the FDA in the past two years over serious infractions involving drug quality control.

Private inspectors hired by American companies to check out foreign plants report finding very good ones but also some without walls that are open to dust and pests, chemical equipment crowded in ways that could lead to cross-contamination, and one plant that had a hornet’s nest atop a drugmaking vat.

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