Health and Medicines

Deerfield, Illinois-based Baxter Healthcare spent $730,000 lobbying the US government on health care issues in the first quarter of 2008. Baxter markets the blood thinning drug heparin which is used by kidney patients to prevent clotting during dialysis.


Baxter was forced to recall its heparin vials due to contamination that has been linked to 81 deaths and hundreds of allergic reactions. The Food and Drug Administration (FDA) has said it suspects the problems stem from a contaminant found in raw heparin imported from China. But Chinese officials say it is too early to tell who is at fault and have accused the U.S. of blocking its attempts to investigate the problems.

U.S. Health and Human Services secretary Mike Leavitt said he was optimistic that American and Chinese officials could soon resolve a dispute over the FDA's investigation into the cause of deaths and reactions linked to heparin. He added that Heparin is now safe because of tighter testing and controls, but warned that future shipments would face closer scrutiny.

"We have put in place processes that we believe can ensure the safety of the heparin supply within the United States," Leavitt told The Associated Press in an interview in Shanghai. The US now plans to set up FDA offices in China to help improve product safety following allegations that many of Beijing's exports — from toys to fish — are shoddy or dangerous.

FDA finds it difficult to inspect foreign manufacturing facilities as their number has risen rapidly in recent times. There are at least 4,000 foreign manufacturers that export active drug ingredients to the US. In the past five years, only 12.5 per cent of FDA inspections were in foreign countries. Normally the FDA regards regulating and approving new drugs as more important than inspecting foreign manufacturing facilities.


Implications for India:

Indian firms may shrug this off as China’s problem, but during hearings, India does get mentioned in the same breath as China. The problem of contamination is higher in biologics such as heparin, and Chinese companies make far more biologics than India. However, this situation may not last for long. Says Mukund Chorghade, a pharma consultant near Boston who specialises in collaborations with Indian companies, "A large number of pharma and biotech companies are now interested in manufacturing biologicals out of India." India now has the largest number of FDA certified facilities outside the US. But that may not save Indian companies from close US scrutiny.