China To Set Up National Surveillance Network For Controlled Substances
The State Food and Drug Administration announced last week that China will set up a national surveillance network to monitor the production, distribution and use of narcotic and psychotropic drugs.
According to the announcement, published in official state media June 25, the network has already been piloted in 11 provinces and municipalities and will cover all provinces of China by the end of this year. The goal of the network is to enable regulators to detect irregularities in the production and distribution of narcotic and psychotropic drugs.
One example of an enterprise that is already inspected monthly is the Beijing-based Yinmin Pharmaceutical Plant. The plant mainly produces raw materials, tablets, capsules and injection products, which are classified as narcotic, psychotropic and cardiovascular drugs.
“We do our best to cooperate with SFDA,” the plant’s quality control department spokesman told PharmAsia News, though he declined to give details about the inspection.
Foreign pharmaceutical firms would be under increased scrutiny too.
The French firm Ethypharm is one foreign company that could be impacted by the new system.
“We are trying to import buprenorphine that we manufacture in France, but so far have got no registration from the SFDA,” Ethypharm China General Manager Philippe Malecki said in an interview with PharmAsia News. “For a foreign pharmaceutical enterprise, it is a very sensitive and political issue as far as these kinds of products go.”
Malecki also said that the Chinese government usually prefers to have local companies, under local regulatory oversight, manufacturing narcotic and psychotropic drugs.
The SFDA announcement coincides with a series of government announcements about crackdowns on drug trafficking. The need for narcotics control has never been higher in China, which has seen an increase in drug abuse cases during the past few years, officials say.
“As of April this year, our national database logged 803,900 drug addicts,” Deputy Minister of Public Security Zhang Xinfeng said at a June 25 press conference.
Violators of the new SFDA regulations would face civil rather than criminal penalities, according to Mi Liangyu, a partner with the Beijing-based New Era law firm. New Era specialises in legal affairs involving the pharmaceutical, food and cosmetic industries.
“According to section 225 of the Criminal Law, selling narcotic drugs and psychotropic drugs without the distribution approval will be considered as unlicensed selling, but not drug trafficking,” Mi told PharmAsia News.
- Ying Huang
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