China regulator promises action to fix 'grim' drug safety situation

China's drug regulator has confirmed what the FDA has known for some time. Oversight of pharmaceutical manufacturing in the country that is the major supplier of cheap active pharmaceutical ingredients (APIs) is "weak." But the China Food and Drug Administration, as it has other times, promised that it will get better in the new year.

To accomplish that, the agency said it will step up "active" regulation and that drugmakers and food companies can expect unannounced, on-site inspections, random tests and other actions. The regulator made the admissions in statement on its website following meetings in Beijing, Reuters reports.

"We must soberly recognize the current foundations of China's food and drug safety are still weak, with new and old risks together creating a grim situation," read the statement.

The agency acknowledged in the statement that its employees lacked expertise and the agency lacked the technology and legal muscle to adequately ensure the safety of drugs and food. But it promised to recruit better employees and to provide standardized training and see that there is more cooperation among regions.

While Chinese companies do not make many novel drugs or finished products for the U.S. market, the country has become the go-to place for drugmakers to get cheap APIs and imports of Chinese pharma products have skyrocketed in recent years. The U.S. does not rely on China for oversight but has had a difficult time itself keeping up with the huge growth in producers there.

FDA Commissioner Margaret Hamburg--FiercePharma file photo
FDA Commissioner Margaret Hamburg

The FDA is in the process of nearly tripling the number of drug and food inspectors it has stationed in China, to 34 from 13 now, but China has not been cooperative in that effort, sitting on visas needed to get them moved there. Following a meeting with top health officials in Beijing in November, FDA Commissioner Margaret Hamburg said that issue was being worked out.

The FDA has stepped up inspections there, sending in personnel from other countries to help. Late last month, the FDA issued a warning letter to a Chinese API maker, Novacyl Wuxi Pharmaceutical plant in Wuxi, Jiangsu, citing the company for having questionable data testing procedures after finding a failed test result in the trash and discovering the computer record of it had been overwritten.

Chinese regulators have proclaimed crackdown intentions before, usually in response to public embarrassments when local media have uncovered shortcomings in its systems. In 2013, regulators rounded up dozens in a crackdown on drug counterfeiting. Several times, they have investigated companies illegally manufacturing capsules from chromium-laced gelatin from industrial waste products. In September, authorities arrested 11 people tied to a company that they said had made and sold about 90 million potentially tainted capsules.

- read the Reuters story

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