China's SFDA Launches Inspection Campaign To Ferret Out Fake Drugs Sold In Retail Outlets

SHANGHAI - China's State FDA together with the Ministry Of Health launched nationwide inspections this month in retail pharmacies to sweep out non-pharmaceutical products that are marketed as medicines, the agency announced Nov. 11.

The labeling of some nutritional food, health products, cosmetics and other non-pharmaceutical products makes claims that the products can be used to treat or protect patients from certain diseases, and SFDA will suspend the sales of such products immediately, the agency said.

The aim of the inspections is to stop the commercial activities of these "fake drugs" in drug retail markets, SFDA said.

"To prevent these products from further damaging public health, we will suspend the sales of these products," SFDA spokeswoman Yan Jiangying told local reporters during a Nov. 11 press conference.

Following inspections of retail outlets, the agencies will also investigate the manufacturing processes for these non-pharmaceutical products, according to Yan.

"Compared with the high investment and high standards of highly regulated pharmaceutical products, these non-pharmaceutical products are low cost and cheaply produced," the spokeswoman said. "These companies can make high profits from marketing these products as drugs, which will also damage the healthcare-related market."

Deadly Mix Of Drugs

Some companies also illegally add active pharmaceutical ingredients to non-pharmaceutical products, which creates a higher potential risk to public health, the agency said.

For example, labeling on some nutritional foods claim products can "help reduce blood sugar," Yan said, when in fact the manufacturer has "added hypoglycemic drugs to the products, which can cause hypoglycemia."

The non-pharmaceutical products together with the added hypoglycemic drug ingredients have already led to two deaths in the Xinjiang Uyghur Autonomous Region this year, she said.

Products that contain active pharmaceutical ingredients without a prescription and advice from doctors are dangerous, Yan said.

Non-pharmaceutical products fall into six main categories: food, healthcare products, health food or supplements, disinfection products, cosmetics and products with no approval.

In China, different departments are responsible for approving these different products. For example, SFDA began reviewing health food in 2003, and prior to that the MOH was responsible for approving health food. Regulating food on the market falls within the purview of the Administration of Quality Supervision, Inspection and Quarantine, while the MOH is responsible for supervising disinfection products.

Products found in violation of regulations during inspections will have their approval numbers revoked, and SFDA will notify the appropriate governmental departments about their status, Yan said.

Products Not Approved Considered Counterfeit

Products with no approvals will be regarded as counterfeit drugs and SFDA will deal with these cases, the agency said.

Moreover, if any illegal advertising is found during the inspections, the advertising approval will be cancelled and SFDA will transfer the information to the Administration for Industry and Commerce.

Last year, SFDA conducted a study of 1,253 retail drugstores in six provinces, which concluded that 10 percent of sales in drugstores were from these non-pharmaceutical products marketed as drugs.

SFDA said that 96 percent of health product stores sell non-pharmaceutical products as drugs, according to a study of 176 stores.

"However, SFDA is not regulating health product stores; we will communicate with other departments [to inspect these stores]," Yan said.

In May, SFDA and the MOH together with 11 relevant government departments set up an inter-ministerial joint conference system to lead a concerted effort to crack-down on counterfeit drug production and sales (PharmAsia News, May 25, 2009).

The inspection follows a series of SFDA campaigns against illegal drug sales. In 2007, SFDA launched a sweep of online drugstores and issued a list of four legal websites to sell drugs and five websites to distribute drugs (Also see "SFDA Sticks To Familiar Theme During Second Press Conference: Food And Drug Safety Dominates Discussion" - Scrip, 20 Aug, 2007.). In 2008, SFDA blocked 74 websites operated by companies illegally selling traditional Chinese medicines online (Also see "China Will Block 74 Websites Operated By Companies Illegally Selling Traditional Chinese Medicines Online" - Scrip, 17 Dec, 2008.).

-Dai Jialing ([email protected])