Drug costs are spiraling out of control and out of reach for many Americans. As a result many patients are turning to generic drugs and drugs manufactured in India and China. In 2002, the U.S. imported $331million of pharmaceutical products from China. In 2010, the U.S. imported more than $1.7 billion and there doesn’t appear to be an end to this outsourcing of medications to China and India.
All that glitters is not gold
In 2007 a tainted heparin was brought to the U.S. from China and it was directly responsible for 149 deaths of American patients. Baxter Healthcare, the company that imported the heparin said that the drug was tested for efficacy but the tests did not detect the contaminant that caused the fatal allergic reaction.
Another drug, Neoral, which is used to prevent rejection of transplanted kidneys, and is manufactured in China resulted in a unacceptable 10% rejection rate.
The French have identified that the chemotherapy drug, Taxotere, did not meet approved specifications and as a result the efficacy of the drug may be affected.
In China poor oversight, weak governmental regulation and occasional gross negligence are likely to persist in compromising drug quality. The Chinese drug regulation system has a daunting task in overseeing a huge industry. Our government through the FDA has established an office in China and is increasing investigations of the plants that export to the U.S., but the agency is understaffed. At the moment and with the existing staff, the agency can assess each site only once every 13 years. The best we can hope for is that the FDA pressure the Chinese authorities to test what is on the market and remove any substandard products that are identified.
Bottom Line: Those generic drugs from China and India may be available at a steep discount but the price you pay may be affecting your health.
Dr. Neil Baum's Urology Blog 