Xinhua News Agency, Beijing, August 22 (Reporters Zhao Wenjun and Qu Ting) The current law defines the scope of counterfeit and substandard drugs relatively broadly, making it difficult to punish them accurately. The revised draft of the Drug Administration Law, submitted for consideration at the 12th meeting of the Standing Committee of the 13th National People's Congress on the 22nd, clearly defines the scope of counterfeit and substandard drugs.

Experts said that scientifically defining counterfeit and substandard drugs and implementing scientific supervision are important issues in the revision of the law, which have a great bearing on the interests of pharmaceutical production and operation enterprises and the reputation of the industry.

In the second review draft of the revised draft, separate regulations are made for drugs that are prohibited from use by the State Council's drug regulatory department in the original "disposal as counterfeit drugs" or "disposal as inferior drugs"; drugs that must be approved but are produced and imported without approval; drugs that must be inspected but are sold without inspection; drugs that are produced using raw materials that must be approved but are not approved; and drugs that are produced using unapproved packaging materials and containers that are in direct contact with the drugs. The production, import, sale, and use of these drugs are clearly prohibited, and the penalties are strictly stipulated.

Song Hualin, deputy dean of Nankai University School of Law, said that defining and clarifying the concepts of counterfeit and inferior drugs will make the concepts of counterfeit and inferior drugs more consistent with the nature of things, relatively easier to identify, more consistent with law enforcement practice, and help to better crack down on behaviors that endanger drug safety. In addition, the second review draft sets legal responsibilities for illegal acts in a more systematic and seamless manner, thus forming a thorough supervision network.

The second review draft of the revised draft proposes that if a small amount of overseas drugs that have been legally marketed are imported without approval and the circumstances are minor, the punishment can be reduced; if there is no personal injury or delay in treatment, the punishment can be exempted.

Tang Minhao, president of the Shanghai Food and Drug Safety Research Association, said that the second review draft of the revised draft separates violations of laws and regulations in drug production and operation activities from fake and inferior drug quality, and lists them separately for expression, which will help make supervision and law enforcement scientific.