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Coming Soon: Generic Drugs from China

Safety concerns temper enthusiasm over increased competition





June 23, 2008

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---
Medicare News

If you liked the heparin, dog food, lead-painted toys toothpaste and truck tires from China, you'll be happy to hear that Chinese-made generic drugs are making their way to the U.S.

While the development raises some safety concerns, it also holds out the prospect of even fiercer competition in the generic field. Manufacturers in the U.S., Europe, India, Israel and elsewhere are already competing for market share and more retail drug stores and supermarkets are offering discounts on popular generics.

The U.S. drug industry is watching the development with interest.

Roger Williams, chief executive of U.S. Pharmacopeia, the official standards-setting authority for all prescription and over-the-counter medicines, said China is capable of manufacturing safe and effective drugs but the U.S. Food and Drug Administration will have to be cautious before it approves the sale of any Chinese-made generics.

"We should be concerned, because the U.S. safety nets are frayed, and China has become a poster child for problems," Williams told the Newark Star-Ledger.

The use of generics continues to grow in the U.S., as brand-name prescription drugs lose their patent protection. More than 67 percent of all prescriptions in 2007 were for generics.

Teva, an Israeli company, has the biggest U.S. market share for generics, with 19 percent. It is followed by Sandoz, a company owned by European-based drugmaker Novartis; Mylan; Watson Pharmaceuticals; and Barr Pharmaceuticals, according to IMS Health.

China is already a big supplier of active ingredients used in both generic and brand-name drugs, and many over-the-counter medicines sold here are made in China..



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