Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Voice of America - September 23, 2008
Carol Pearson
Washington
Ranbaxy Laboratories says all of its drugs are safe, including those supplied to African countries to fight AIDS. The U.S. Food and Drug Administration has blocked more than 30 medications made by the giant pharmaceutical company. Other countries have started their own investigations. VOA's Carol Pearson has more.
The medicines banned from entering the U.S. are made at two of Ranbaxy's factories in India.
Ranbaxy (Laboratories) makes generic medications, cheaper copies of brand name drugs. They treat high cholesterol, diabetes and other conditions.
The U.S. Food and Drug Administration cites inadequate sterile processing as one of many violations at the two plants.
"We in the FDA need to assure those quality issues are addressed before we let another drug from those factories come into the United States," Dr. Douglas Throckmorton said. Dr. Throckmorton is with the Food and Drug Administration.
Dr. Throckmorton says there is no proof that any of these drugs are harmful.
U.S. Congressman Bart Stupak disagrees. "If I am an American consumer and my drug's made by Ranbaxy, I'm throwing it out," he said.
The drug agency says people should continue taking their medications.
The Ranbaxy case illustrates the way medicines are increasingly made...in developing countries with underregulated environments, according to Dr. Peter Lurie of Public Citizen, a non-profit agency. "This is a major international problem," Dr. Lurie said. "...and we are only beginning to wrestle with it."
Earlier this year Baxter International had to temporarily stop making heparin, a drug used in kidney dialysis.
Eighty-one people died after taking it. Baxter says it traced a contaminant in the drug to a manufacturing plant in China.
Quality control is just one of the charges against Ranbaxy.
The U.S. drug agency says the company sold fake or adulterated versions of an HIV drug to patients in Africa. The medications were paid for by the United States as part of the President's Emergency Plan for AIDS relief.
Other countries are now reviewing Ranbaxy's procedures.
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