Watchdog steps up standards on recalls(2)

In early May, South Korea's Ministry of Food and Drug Safety ordered Janssen Korea to halt production of five drugs, including the children's syrup, citing improper concentration of the main active ingredient.

Shanghai Johnson & Johnson Pharmaceuticals Ltd, the company's unit on the mainland, issued an announcement shortly after the recall alleging that the problem syrup was limited to South Korea.

In response to public concern over double standard practices, the company issued another online announcement on Friday, saying the same standards of quality control and product recall are enforced in all of its markets, including China.

All product recalls issued in China are carried out in line with the country's rules and regulations and are reported to the CFDA, it said.

The company added that overseas recalls not issued in China are for products that are not registered, sold or produced in the country.

According to China's regulations for drug recalls issued in 2007, the entity issuing the recall should be a specific producer of a problem drug.

Sun Zhongshi, a professor with the national monitoring center for the rational use of medication under the National Health and Family Planning Commission, said that recalls should be uniform in all countries if the problem detected involves the efficacy of, or an adverse reaction to, the drug products.

For problems mainly concerning quality control, the company only withdraws products in the affected areas, he added.

But Sun said that company should inform drug authorities in various markets of all recalls for reference purposes.

Despite the fact the latest recall in South Korea didn't affect products sold in other markets, including China and the US, the CFDA met with the company on Thursday to address product quality and recall issues.

Frequent recalls over quality concerns reflect possible flaws in the quality management system of Johnson & Johnson, and the company should carefully look into the sources of the issue to eliminate safety risks and ensure the quality of products for the market, the CFDA said in an online notice issued after the meeting.

"Problem drug products recalled outside of China have to be recalled within the country as well," it pointed out.