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by Ying Huang
PharmAsia News



The Beijing Drug Administration banned ten drugs for illegal advertising June 28, marking the first time Chinese authorities have implemented their enhanced enforcement authority under drug advertising regulations enacted earlier this year.

The banned drugs include Xiaofeng antipruritic series for psoriasis, Qingzhuoyisheng and Chongcaoqishen capsules for kidney damage, Miniaoning for urinary infection, OsteoKing for bone diseases and fractures, Thirty Six Species Xiaoke and Tangwei capsules for diabetes, Hawkthorn capsule for hypertension, and Liexietai capsule and Yiqixiaoke grain for chemotherapy.

Some of these drugs were directly advertised to customers on television or in pharmacies, the agency said. The advertisements exaggerated the effectiveness of the drugs and promoted uses that were not in line with labeling specifications and not listed on the approval applications

The drugs were manufactured by nine Chinese pharmaceutical firms. Manufacturers included some well-known local companies such as Nanjing Tongrentang Pharmaceutical Co., which produced the Hawkthorn capsules.

Beijing stores have been told to stop selling these drugs and all nine pharmaceutical firms must run a correction and apology notice in the same media outlets that carried the original advertisements, the agency announced.

The Beijing Drug Administration said it will decide by mid-July whether to retract the sales ban.

This is the first time that a drug has been banned because of improper advertising, the agency said, and is the result of new rules implemented this spring. In May, the State Food and Drug Administration and the State Administration for Industry and Commerce issued new standards for drug advertisements providing for bans. Previously, pharmaceutical companies could only be fined for violating drug advertisement regulations.

“The ban of these ten drugs is an indication that China is going to discipline market behaviors in the food and drug industry,” attorney Paul Li from Squire Sanders & Dempsey’s San Francisco office told PharmAsia News.

Under the Chinese laws, Li noted, indicated uses must be established in clinical trials and reviewed and approved by SFDA. Claiming unapproved efficacy is a violation of China's food and drug law.

Under the new drug advertisement rules, pharmaceutical companies must submit in advance advertisements to the provincial level drug administration for approval. According to the rules, regulators will process applications within ten working days. In addition, prescription drugs may be advertised only in professional medical and pharmaceutical publications, not in the mass media.

The affected companies have begun to take action to resolve the enforcement action.

Crystal Natural Pharmaceutical Co., one of the nine pharmaceutical enterprises, has released an announcement to the public correcting and retracting the exaggerated advertising, said a company official who decline to give his name because he was not authorized to speak to the press.

“In a few days the products will be back to the market,” he predicted.

“Prescription drugs should not be advertised to the public and by using exaggerated words, that’s why our product is being banned,” said the Crystal Natural official.

Crystal Natural sells its product OsteoKing in all major Chinese cities as well as in foreign countries, including the United States where it is marketed as a dietary supplement by Fairfield, Iowa-based Nature’s Healing Solutions.

In light of a series of contamination scandals, the safety and effectiveness of Chinese medicines has come under increased scrutiny in recent months, both in China and overseas.

At the same time, China’s pharmaceutical exports continue to rise. From January to April of this year, Chinese medicinal exports reached $362 million, an increase of 9.6 percent over last year. Products exported to the United States increased by 7.9 percent, according to China Customs statistics.

“The recent events abroad put the export-related food and drug industry at risk and can cause major political embarrassment to the government and to China as a nation,” Li said.



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PharmAsia News is a regular contributor to BioHealth Investor
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