Indian, Chinese drugs pouring into US

Monday, 18 June 2007, 07:00 Hrs
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Washington: India and China have become major suppliers of low-cost drugs and drug ingredients to American consumers, but the US Food and Drug Administration (FDA) rarely conducts quality-control inspections for such supplies, according to a US daily.

Products from the two countries are becoming pervasive in the generic and over-the-counter marketplace, the Washington Post said in a special front-page story Sunday citing unnamed analysts.

Lower down in the report, the daily cites FDA officials as saying 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, it said, acknowledges that it is virtually impossible for it 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 and doctors are unlikely to suspect poorly manufactured drugs as a problem.

The Post report said over the last seven years, amid explosive growth in imports from India and China, the FDA conducted only about 200 inspections of plants in those countries and a few were the kind that US 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, it said.

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.

"As the manufacturing goes to China and India, the risk to human health is growing exponentially," the Post quoted Brant Zell, former chairman of the Bulk Pharmaceuticals Task Force, as saying.

The group 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.

In turn, Dilip Shah, secretary general of the Indian Pharmaceutical Alliance, which represents many Indian drugmakers, told the Post he would like to see a more permanent FDA presence in India because "it would help improve standards" and encourage more companies to seek FDA approval of their products.

He said, however, that when US 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.

In addition to the United States' $675 million in pharmaceutical imports from China last year, India sold $800 million worth of finished drugs and ingredients here in 2006, according to US Commerce Department records.

Because of US drugmakers' concerns over quality control, US Pharmacopoeia - a non-profit organisation that works with drugmakers and regulators to set drug-quality standards - opened an office in Hyderabad, a centre of the Indian drug industry.

Executive Director Roger Williams told the Post that Dr. Reddy's Laboratories recently became the first Indian firm to agree to pay to check the quality of its products.

"The question is whether the perishingly low price of generics is making it impossible to get quality," Williams said. "It's the job of the FDA to make sure that doesn't happen, and I'm concerned that they just don't have the resources to get people over to places like India frequently enough."
Source: IANS
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