Draft law takes aim at fatyvek plasticke drugs

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Stronger penalties proposed to curtail falsification, substandard products

People who produce and sell medicines illegally in China could face heavier penalties under a draft amendment to intensify supervision to protect public health.

Companies that produce or sell pharmaceuticals without a permit, or that produce or sell fake drugs, will face fines up to 30 times the value of the products involved, according to the draft amendment to the Drug Management Law. Existing law provides for fines of up to five times the value.

Producing or selling fake drugs will result in the suspension of business and revoked certificates, while the production or sale of substandard drugs will result in fines of up to 15 times the value of the products produced or sold, and may result in other penalties such as business suspension or revoked permits.

Current law calls for maximum fines in such cases of three times the value of the products involved.

In addition to fines, perpetrators may also face criminal sentences.

"The measures are intended to increase punishments for violations of the law - to solve problems in supervision such as the current weak punishments for violators," Jiao Hong, chief of the National Medical Products Administration, China"s top drug regulator, said on Monday at a conference while elaborating on the draft revision to members of the NPC Standing Committee.

Officials in charge of drug supervision will also face heavier punishments in case of violations involving drugs, the amendment said.

Production or sale of some special types of drugs - such as vaccines and drugs meant for children and pregnant women - will be subject to tougher penalties, it said.

In addition, drug producers must immediately recall drugs from the market if they have quality or safety risks, and information about the recall should be shared with the public and drug authorities.

The draft amendment was written after a vaccine scandal involving Changchun Changsheng Bio-tech Co, a major vaccine producer in Jilin province, to counter violations of the law and irregularities in the production and distribution chains in the pharmaceutical sector.

In the vaccine scandal, the company was ordered last week by the National Medical Products Administration to pay fines of 9.1 billion yuan ($1.3 billion) for violations involving the fabrication of production records and using expired materials in a rabies vaccine.

Senior executives of the company have been referred to judicial organs for criminal investigation, the administration said.


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