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FDA Scrutiny Scant In India, China as Drugs Pour Into U.S.

"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.

An 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 price charged by American and European manufacturers. But, they add, Indian and Chinese companies are not only new to the FDA standards, but they also are in 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 U.S. companies to check out foreign plants report finding very good ones but also some without walls and 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.

One frequently cited case involves the intravenous antibiotic gentamicin, which was supplied by a company in China and linked to deaths in the United States in the late 1990s. Tests by German researchers found a wide range in quality and effectiveness in what were supposed to be uniform dosages of the drug, leading the scientists to write that "it was assumed" the deaths "were related to faulty manufacture."

FDA officials say they have recently begun a risk-based approach to manufacturing oversight -- one that seeks to ensure that drugmakers have proper quality-control systems and that requires fewer inspections. But they acknowledge that financial constraints keep them from making more of the expensive and often hard-to-organize visits to plants in India and China.

"The FDA does the best as it can to regulate overseas good manufacturing practices and do inspections, given the limited resources we have," said Joseph Famulare, deputy director for international inspections. "If we had more resources, we would get more inspections done."

Despite repeated requests for information about the FDA's budget for overseas drug inspections, the agency did not make it available.


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