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Letter to the editor

Drug imports from India and China rise, but FDA checks lag

By WASHINGTON POST
Published June 17, 2007

WASHINGTON - India and China, countries where the Food and Drug Administration rarely conducts quality-control inspections, have become major suppliers of low-cost drugs and drug ingredients to American consumers. Analysts say their products are becoming pervasive in the generic and over-the-counter marketplace.

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 $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 $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.

Pet food scandal

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.

FDA officials say that they are not aware of 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.

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.

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."

Hubbard and other experts agree that many Indian and Chinese drugmakers are high-quality firms. 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 in 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, and chemical equipment crowded in ways that could lead to cross-contamination.

Yet inspections of Indian and Chinese plants remain few and relatively brief and are scheduled in advance, unlike the surprise visits that FDA inspectors pay to domestic manufacturers. FDA records show that 32 inspections were carried out last year in India, and most were for companies seeking approval to sell a drug or ingredients, not to check on the quality of manufacturing. Fifteen visits were made to Chinese plants last year.

[Last modified June 17, 2007, 01:14:59]