Baxter's Chinese Heparin Debacle to Encourage Better Production Management

Recent deaths in the United States linked to China-sourced heparin may make Chinese pharmaceutical companies implement more sustained efforts to review production management practices, business insiders said at the Pharmaceutical Outsourcing Conference held in Nanjing last week.

"In the short term, I think the heparin scandal in the United States will affect the exports of Chinese heparin products, which will cause Chinese pharmaceutical companies to pay more attention to production management issues in the longer term," said Yan Zhiyang, chief engineer at Fujian Fukang Pharmaceutical Co. Ltd., one of China's major antibiotics manufacturers.

Over the past two months, the U.S. Food and Drug Administration and Baxter International Inc. (BAX) have come under the spotlight as Baxter's blood thinning agent heparin was linked to four deaths in the United States. Changzhou SPL, a Chinese company, was the supplier of the active pharmaceutical ingredient, sparking U.S. media accusations as to the quality of Chinese APIs.

Inspection of Changzhou SPL's facilities by China's State Food and Drug Administration in the wake of the discovery revealed chondroitin sulfate mixed in with the heparin.

Chinese exports of heparin sodium APIs last year were worth $26.37 million, of which exports to the United States accounted for 51 percent. The largest exporter was Zhejiang Huilong Foreign Trade Co. Ltd., producing 24.2 percent of the total volume shipped out of the country, while Changzhou SPL accounted for 7.6 percent, said Wu Huifang, president of Heathoo.com, a pharmaceutical information provider.

Chinese companies have received bad press over other drugs as well. Last week, the SFDA announced that it had stripped Shanghai Hualian Pharmaceutical Co. Ltd. of all its drug production approvals after two of its leukemia drugs for intrathecal injection had caused dozens of adverse drug reactions, leaving people partially paralyzed and in pain. The drugs were later shown to have been contaminated with another substance.

Though China's companies are all Good Manufacturing Practice-certified [GMP], they still have problems with management, said Kang Lee, director of the Asia Facility Quality Operations in U.S.-based Perrigo Co. (PRGO).

"The problem lies not in that China's pharmaceutical companies have inadequate production equipment, but that they have weak management over production, such as supervising employees and keeping records," Kang said.

For example, Chinese employees have been known to shut off electricity at night to save costs, which could lead to microorganism growth in supposedly clean environments. Another problem is that they sometimes make adjustments to improve production efficiency, but do not record the adjustments.

"These are violations of GMP," Kang said. "If FDA officials think you cannot reach or maintain GMP standards, companies will not be qualified." Kang added that Chinese companies should do more to assure U.S. FDA officials that China adheres to every aspect of GMP standards, including production management as well as the quality of devices.

As for whether the heparin scandal will affect buyers from foreign countries in the long term, Avi Laor, director of Swiss-based AZAD Fine Chemicals, said it will not deter buyers from looking to China for their APIs. According to him, one cannot write off the whole country's industry just because of an individual case.

Comments

[life is pre...:]

All pharmaceutical and food products should be clearly labeled, in large readable letters, to reveal the origin of ingredients. Consumers have a right to free informed choice and the option to refuse products made in China. "Made in the USA" means preservation of health, more jobs, fewer mortgage defaults.

2008 Apr 30 12:02 AM