BEIJING Chinese officials said on Tuesday a Chinese-made blood thinner was not to blame for fatalities linked to the product, and accused U.S. drugmaker Baxter International Inc of obstructing the investigation into the cause of the problem.
Baxter has recalled batches of the drug heparin that were found to be tainted with a similar but cheaper chemical that U.S. Food and Drug Administration officials say may have killed some 81 patients and caused allergic reactions in others.
But China says the chemical, hypersulfated chondroitin sulfate, is not to blame.
"Apart from the U.S. and Germany, more than 10 other countries using heparin products containing the 'heparin-like substance' have not reported adverse reactions," China's State Food and Drug Administration said in a statement.
Reactions had also occurred in some batches of heparin products that did not contain the substance, it said.
But Jin Shaohong, of China's National Institute for the Control of Pharmaceutical and Biological Products, did not address the issue of how the chemical came to be present in the batches of heparin when he gave a news conference on Tuesday.
Heparin is used in kidney dialysis and various procedures to prevent blood clots and is made from pig intestines often collected from small, often unregulated farms in China.
Baxter's heparin recall was the latest in a string of problems with Chinese-made products that have highlighted oversight gaps and corruption in China's food and drug regulators. It has also caused worries in the United States over how its drugmakers oversee foreign manufacturing sites.
BAXTER DENIES ALLEGATIONS
China's regulator said Baxter was not cooperating with Chinese authorities in investigating the root of the problem.
"Baxter failed to provide necessary cooperation in the process of the investigation, which is not conducive to further identifying the reasons for the adverse reactions to heparin," it said.
Baxter denied the charge.
Baxter had also destroyed some samples of the drug and production records that China considered key to investigating the cause of the problems, Jin said.
"I was very surprised," said Jin. "This is extremely regrettable."
A company spokeswoman said that was not the case.
"So far, Baxter has agreed to provide samples to the State Food and Drug Administration in respect to their requests," said Xing Rongwang, associate director of communications for Baxter in China.
"We have been cooperating with all parties involved in the heparin situation," she said by telephone.
But the case has raised questions over both the oversight of foreign plants manufacturing products for U.S. drugmakers and the nature of China's ability to monitor pharmaceuticals.
China says the supplier, Changzhou SPL Co Ltd., is a holding of the U.S.'s Scientific Protein Laboratories LLC, which should bear responsibility for the plant.
It also says Changzhou was not registered with China's State Food and Drug Administration because of a loophole in which the company is considered a chemical-maker, rather than a maker of pharmaceutical products.
But U.S. Undersecretary of Commerce Christopher Padilla has said Chinese regulators must strengthen oversight to ensure they have authority over both makers of active pharmaceutical ingredients as well as makers of bulk chemicals which may be used in pharmaceuticals.
(Editing by Nick Macfie)