Establish a formal system for the circulation of traditional Chinese medicine to ensure the safety of traditional Chinese medicine

　　Traditional Chinese medicine is the quintessence of China. It plays an important role in promoting and protecting people's health and the reproduction and prosperity of the Chinese nation. Traditional Chinese medicinal materials are the material basis for the inheritance and development of traditional Chinese medicine. Since wild and cultivated Chinese medicinal materials belong to the category of agricultural and sideline products, there has always been a situation of being scattered, chaotic and miscellaneous; as the country With the development of the national economy and the further improvement of people's health needs, the demand for traditional Chinese medicinal materials is increasing. Some precious medicinal materials or medicinal materials with long growth cycles often experience periodic price surges and plummets, which leads to counterfeiting, mixed dyeing, and even the processing of extracted medicinal residues and selling them as raw medicinal materials (pieces).

　　The Chinese herbal medicine circulation traceability system launched by the Ministry of Commerce is based on the development of modern circulation methods and uses information technology to realize the electronicization of important circulation certificates and invoices and purchase and sale ledgers through the unique electronic label ( ) on the packaging bags of Chinese herbal medicine products, thus forming a quality and safety traceability system with traceable sources and traceable destinations. Using this system, consumers can use their mobile phones to lightly scan the electronic code or QR code on the packaging of Chinese herbal medicines or Chinese herbal pieces, and the entire process of the purchased Chinese herbal medicines and Chinese herbal pieces from cultivation to processing and distribution can be seen at a glance.

　　Traceability system promotes quality improvement

　　Shen Danyang, spokesperson of the Ministry of Commerce, disclosed at a regular press conference held recently that as of the end of June this year, the first four Chinese herbal medicine pilot cities, including Baoding, Bozhou, Yulin, and Chengdu, as the first batch of pilot cities for the government, have established traceability systems in more than 600 companies. It is understood that in addition to the first batch of Chinese herbal medicine pilot cities, it will also implement the second batch of construction provinces, including Jilin, Jiangxi, Henan, Hunan, Guangdong, Yunnan, and Gansu. Shanxi, Inner Mongolia, Liaoning, Shandong, Hubei, Qinghai, and Ningxia will be included in the third batch of provinces implementing construction.

　　In the final analysis, the quality of the decoction pieces is closely related to the quality of the raw medicinal materials. China is a vast country with different climates and soil differences between the north and the south. The same medicinal material comes from different regions, and its quality will definitely be different. Without a detailed traceability system, it is difficult to ensure the quality of the decoction pieces.

　　Therefore, the establishment of this traceability system is like a person's. From the information of the planting area to the processing, storage, and transportation conditions of the medicinal materials, use your mobile phone to lightly scan the QR code on the package, and the entire process information and quantity will be clear at a glance. After the piece manufacturing company completes the processing and production of the piece, it will affix the corresponding association code on the package. When it is in the hands of the hospital or user, the entire process information and quantity will be clear at a glance.

　　In fact, the advantages of the traditional Chinese medicine traceability system in ensuring the quality of traditional Chinese medicine materials, traditional Chinese medicine pieces, and finished traditional Chinese medicine products and supporting the good and eliminating the bad are obvious, and are comparable to other supervision methods. At the same time, the impact on the industry is also very large, specifically reflected in:

　　First of all, counterfeiting and counterfeiting can be fundamentally eliminated, because each package of medicinal materials (pieces) has its own "number", which is bound to key data such as the information of the Chinese medicinal product planting base, the person responsible for each link of the product, quality parameters, circulation information, etc. It can also use the network platform to complete information transmission and verification, linking the quality control links of the traditional Chinese medicine industry, so that counterfeiters have nowhere to hide.

　　Secondly, the cost of Chinese herbal medicines, Chinese herbal medicine pieces, and Chinese patent medicines has increased significantly:

　　First, the cost of origin of Chinese medicinal materials will increase a lot: The traditional Chinese medicine traceability information platform attaches two-dimensional barcode electronic labels to the cultivated medicinal materials, and uses sensors to collect and record the key parameters of the medicinal materials, including temperature, humidity, light during the growth process of the medicinal materials, pesticide ingredients added during the production process, etc., forming a standardized planting information management platform, consisting of subsystems such as front-end information perception, back-end data services and communication networks. The cost of growing medicinal materials will definitely increase a lot.

　　Second, increase the cost of packaging labeling: because of the formation of standard packaging and labeling methods, the current method of unpackaging or random packaging of Chinese medicinal materials and using various waste woven bags has been changed. At the same time, a unified format of electronic supervision traceability labels has been added to the packaging, which has increased packaging costs.

　　Third, it has completely changed the current method of storing some insect-prone Chinese medicinal materials using aluminum phosphide fumigation, refrigeration or controlled atmosphere technology. Storage costs will definitely increase a lot, thus increasing storage costs. In addition, transportation costs will also increase accordingly: some medicinal materials that need to be stored in a cool place must be transported in a sealed vehicle with a space system, otherwise the transportation system information will be unqualified, so the transportation costs will also increase compared to now.

　　For the above reasons, the author predicts that the price of traditional Chinese medicine pieces, especially those that require the use of excipients, will be at least 50% higher than the current price, that is, it will be at least 1.5 times the current price (mainly due to the increase in storage conditions, medicinal material inspection costs, piece inspection costs and corresponding process costs); the corresponding cost of raw materials for Chinese patent medicines will increase by at least double the current price, and more than 80% of pharmaceutical companies that mainly produce ordinary traditional Chinese medicine preparations will face the pressure of soaring costs. Because of the increase in inspection costs for the procurement, transportation, corporate inventory maintenance, raw material inspection, preparation production material balance information monitoring, inspection, finished product inspection, etc., the collection and uploading of quality and quantity specification information in all links of the entire industry chain will make the actual cost of ordinary traditional Chinese medicine preparation products one to several times higher than it is now.

　　Due to high demand, the price of drinks may increase

　　In recent years, government departments have made continuous moves in industrial guidance, policy formulation, and standardization construction. In January 2015, the General Office of the Ministry of Commerce issued the "Notice on Accelerating the Construction of a Modern Logistics System for Traditional Chinese Medicines"; in May, the General Office of the State Council forwarded it to 12 ministries including the Ministry of Industry and Information Technology and the National Administration of Traditional Chinese Medicine. "Protection and Development Plan for Traditional Chinese Medicine (2015-2020)"; on July 15, the Office of the State Administration of Traditional Chinese Medicine "Notice on Application for National Traditional Chinese Medicine Standardization Project"; on July 21, ISO18664:2015 "Traditional Chinese Medicine - Heavy Metal Limits in Chinese Herbal Medicine" was officially released by ISO.

　　In June, the new version was officially promulgated and will be implemented on December 1 this year. Pharmacies in the new version have higher standards and requirements for the quality of traditional Chinese medicine pieces. Its implementation will not only improve the quality, but will also further push up the price of the pieces. In terms of supervision, unannounced inspections have been frequent. Since January, the national bureau and provincial and municipal bureaus have continued to conduct unannounced inspections of the traditional Chinese medicine slice industry. According to incomplete statistics, as of the end of July, nearly 50 herbal slice manufacturers across the country had had their GMP certificates confiscated due to unannounced inspections, accounting for about 8% of the total number of Chinese herbal slice manufacturers.

　　It is not difficult to see from this that the country has made great efforts in the management and quality management of the traditional Chinese medicine industry chain. Industrial policy guidance is at the forefront, and standard construction is closely followed. Coupled with the inspection and rectification of the professional regulatory department (Food and Drug Administration), all efforts are combined to move step by step towards effective supervision of the entire traditional Chinese medicine industry chain and stable and controllable quality of the slices. With the controllable quality of medicinal materials and the improvement of the traceability system, the era of traditional Chinese medicine becoming an aristocratic medicine has truly arrived.

　　At the same time, it will no longer be far away that the decoction pieces will enter the tender process. Commonly used pieces of traditional Chinese medicine are included in the 2012 edition of the National Essential Medicines Catalog. According to the national essential medicine catalog procurement policy, all localities must conduct unified bidding. However, there has been no bidding initiative for traditional Chinese medicine pieces in various places for many years.

　　On July 29, the General Office of the People's Government of Guangdong Province issued the "Notice on the Key Points of Recent Work in Deepening the Reform of the Medical and Health System in Guangdong Province". Only this notice clearly stated that it would promote the trading of traditional Chinese medicine pieces through the platform. As for how to trade and what standards (quality) should be used as the basis for the transaction, the author will wait and see.

　　However, it can be expected that with the establishment of standards and the improvement of the quality of the slices in the future, nationwide bidding for the slices will not be imaginary. Enterprises of traditional Chinese medicine pieces and traditional Chinese medicine preparations should proactively take advantage of the advantages of national industrial policies and combine with the actual conditions of their own enterprises to carry out extensive alliances or cooperation among enterprises. For some commonly used key bulk medicinal products, they should adopt methods such as leasing land, cooperation, and equity participation in the main production areas. Starting directly from the planting and processing of raw materials, and establishing cooperation or close relationships with modern logistics companies, this will not only meet the needs of national industrial development policies, but also effectively predict and control the cost of raw materials, ensuring product quality while giving the company considerable development potential.