China, India expand low-cost drug sales

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

India-based companies were bit players in the U.S. drug market 10 years ago, selling eight generic drugs.

Today, almost 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs purchased by Americans are made by Indian manufacturers.

Five years ago, Chinese drugmakers exported about $300 million worth of products to the United States.

Eager to meet U.S. demand for lower-cost medicines, they, too, have expanded rapidly. The Chinese companies sold more than $675 million in pharmaceutical ingredients and products in the U.S. market last year.

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

Growing health risk

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 U.S. drug-ingredient makers that filed a 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 said that they are not aware of any health problems caused by drugs imported from India or China, and that the U.S. companies that import them usually do quality and safety testing.

The agency acknowledged 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.

What is clear is that the odds are growing rapidly that the contents of a U.S. medicine cabinet will hold products from one or both of those two countries.

Analysts estimate that up to 20 percent of finished generic and over-the-counter drugs and more than 40 percent of active ingredients for pills made in the United States come from India and China. Within 15 years, they predict, up to 80 percent of 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 the FDA inspection system is so weak that many foreign manufacturers think 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 U.S. trade groups sometimes "urge quality controls as a trade barrier to protect the interests of their members."

Troubled history

Hubbard and other experts agree many Indian and Chinese drugmakers are high-quality firms. But, they add, Indian and Chinese companies also come from nations that have recent histories of widespread drug counterfeiting, lax quality control and limited government regulation.

The former head of the Chinese drug- and food-safety agency, for instance, recently was 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 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.

FDA officials 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.

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