China watchdog steps up standards on food and drug recalls

CHINA - The China Food and Drug Administration, or CFDA, the country's top food and drug watchdog, has vowed to further strengthen quality supervision over products to ensure timely recalls, particularly from overseas.

The high-profile pledge came in an online notice issued by the administration on Thursday, informing the public of a meeting earlier that day between it and Johnson & Johnson, a US medical device, pharmaceutical and consumer packaged goods manufacturer.

Since 2009, the company has issued 33 product recalls on the Chinese mainland, statistics from the administration show.

However, the Health Times reported on Sunday that Johnson & Johnson has issued 51 product recalls since 2005 worldwide, of which 48 were not issued on the Chinese mainland.

Products recalled ranged from blood-sugar meters to hip-implant parts, while most were over-the-counter medications, including the allergy medicine Zyrtec and pain reliever Motrin, reports said.

Complaints about these products included musty smell, the presence of metal shavings and excessive dose concentrations.

Many of the products have remained on the mainland market.

The company has withdrawn about 1.6 million bottles of products, including the popular cold syrup Children's Tylenol, in South Korea in late April, citing a risk of liver damage.

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 centre 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.

TIMELINE

• Jan 14:

Several models of two types of separately packaged contact lenses were recalled because they might not have been completely sealed.

• Jan 30:

The US FDA found that meticillin-resistant coagulase-negative staphylococcus in baby calming comfort lotion made by Aveeno, a subsidiary of Johnson & Johnson, exceeded the permitted level and asked Johnson & Johnson to remove it from the markets.

• Feb 15:

A subsidiary of Johnson & Johnson recalled hip-implant products branded Adept.

• Feb 22:

The US FDA asked Johnson & Johnson to recall implantable orthopedic equipment in backbone sleeves made by DePuy.

• March 25:

Johnson & Johnson recalled more than 2 million glucose meters branded OneTouch, made by subsidiary LifeScan.

• April 23:

Johnson & Johnson withdrew about 1.6 million bottles of its products including Children's Tylenol in South Korea.

Source: Health Times/ China.org.cn

Purchase this article for republication.

SERVICES