SCRUTINY SCANT IN INDIA, CHINA AS DRUGS POUR INTO UNITED STATES

June 18, 2007

India and China, countries where the Food and Drug Administration (FDA) 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.

Over the past seven years, amid explosive growth in imports from India and China, the FDA conducted only about 200 inspections of plants in those countries.  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.
  • 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 drug makers 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.

"As the manufacturing goes to China and India, the risk to human health is growing exponentially," said Brant Zell, past chairman of the Bulk Pharmaceuticals Task Force.  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.

Source: Marc Kaufman, "FDA Scrutiny Scant In India, China as Drugs Pour Into U.S.; Broad Overseas Checks Called Too Costly," Washington Post, June 17, 2007.

For text:

http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295.html

 

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