The problem of missing regulatory standards for the production of Chinese medicinal materials urgently needs to be solved
A reporter recently received a proposal titled "Suggestions on Strengthening the Quality Management of Chinese Medicinal Materials" from Wang Liping, a member of the Chinese People's Political Consultative Conference of Jiaxing City, Zhejiang Province. The proposal states that in recent years, frequently reported traditional Chinese medicine safety incidents have been worrying, and the substandard quality of Chinese medicinal materials is one of the most important factors triggering the safety problems of traditional Chinese medicine.
⟦NL> Data cited in the proposal show that the unqualified rate of traditional Chinese medicine decoction pieces has consistently been higher than that of Western medicines. According to surveys on adverse drug reactions, traditional Chinese medicine accounted for 10% in 2003, and by 2013 this proportion had risen to 17.3%. Wang Liping pointed out that the current market for Chinese medicinal materials mainly has four major problems: first, counterfeit and substitute products are increasingly common, with practices such as passing off inferior goods as superior ones, adulteration and falsification, and mixing different varieties; second, pesticide residues and heavy metal contamination in Chinese medicinal materials are serious; at the same time, improper processing severely affects clinical efficacy; finally, improper transportation and storage lead to mildew and contamination.
The reporter then interviewed Wang Jianwei, director of the Quality Supervision Division of the Zhejiang Provincial Department of Agriculture, on this issue. He believes that the most prominent problem in the current quality and safety supervision of Chinese medicinal materials is that both producers and regulators have fallen into the awkward predicament of "having no standards to follow."
Wang Jianwei said that for pest and disease control in the production of Chinese medicinal materials, chemical control is currently the main approach, but at the national level, whether in terms of technical requirements including site selection and planting, fertilizer and water management, pest and disease control, and harvesting and processing, or in terms of input requirements, there is a lack of production standards specifically for Chinese medicinal materials, and there are almost no registered pesticides for Chinese medicinal materials. This has led to frequent occurrences of illegal pesticide use, excessive pesticide use, and mistaken pesticide use.
Not only producers, but even professional testing institutions and relevant regulatory departments have fallen into the awkward predicament of "having no standards to follow" in actual operations because of the lack of testing methods and standards specifically for Chinese medicinal materials. Wang Jianwei said that at present, in all links of the production, processing, and storage of Chinese medicinal materials, there is a lack of clear laws, regulations, and standards. Whether they belong to agricultural products or traditional Chinese medicine, the standards are inconsistent and ambiguous, resulting in vacuum zones among various regulatory departments.
Such a situation has become a common phenomenon nationwide, which is undoubtedly detrimental to the sustained and healthy development of Chinese medicinal materials. Zhejiang is one of the important production areas for Chinese medicinal materials nationwide. In recent years, the province has carried out a series of explorations regarding pest and disease prevention and control, pesticide use management, and quality control for Chinese medicinal materials. For example: raising the level of organization and scale in the production of Chinese medicinal materials, establishing associations for Chinese medicinal materials, formulating, updating, and improving technical operating procedures for the production of Chinese medicinal materials, and accelerating the registration of pesticides for Chinese medicinal materials as well as the formulation of pesticide residue standards, and so on.
Moreover, at the county level, Zhejiang has also made many explorations. For example, as early as 2002, Pan'an County established a traditional Chinese medicine association composed of major medicinal material dealers, major growers, relevant management personnel from processing enterprises, and scientific and technical personnel. In the past two years, in response to the current lack of national or industry standards for quality and safety indicators of Chinese medicinal materials, the association took the lead in formulating the "Panwuwei" alliance standard, and at the same time established standardized demonstration bases to achieve industry self-discipline. This exploration has achieved good results and has been of great help in promoting local industrial development.
However, it must be admitted that Pan'an's exploration is limited to a certain region, and there are still many obstacles and difficulties in actual implementation. Wang Jianwei believes that to solve the problems in the production and supervision of Chinese medicinal materials, ultimately it is still necessary to rely on the national level and relevant departments to issue specific, clear, and complete standards systems and regulatory policies. Only by doing a good job in top-level design can various localities, in light of actual conditions, better promote the sustained and healthy development of the Chinese medicinal materials industry.