The soaring cost of traditional Chinese medicinal materials is about to make them a noble medicine
On July 14, 2015, the official website of the Ministry of Commerce published the "Public Bidding Announcement of the Market Order Department of the Ministry of Commerce for the 2015 Annual Project for Business Management and Maintenance of the Online Information System for the Circulation of Medicines and Traditional Chinese Medicinal Materials."
Traditional Chinese medicine is the quintessence of China and plays an important role in promoting and safeguarding people's health and in the prosperity of the Chinese nation, while traditional Chinese medicinal materials are the material foundation for the inheritance and development of the traditional Chinese medicine cause. Because the wild collection and cultivation of traditional Chinese medicinal materials fall within the category of agricultural and sideline products, there has long been a scattered, disorderly and mixed situation; with the development of the national economy and the further rise in people's health needs, the demand for traditional Chinese medicinal materials is growing ever larger, and some precious medicinal materials or those with a long growth cycle often see periodic sharp rises and falls in price, thereby giving rise to the phenomena of counterfeiting and selling fakes, adulteration and dyeing, and even selling extracted dregs processed as raw medicinal materials (decoction pieces).
The circulation traceability system for traditional Chinese medicinal materials launched by the Ministry of Commerce is based on developing modern circulation methods and uses information technology means, through the unique electronic label (identity card) on the packaging bag of traditional Chinese medicinal material products, to realize the electronicization of certification and invoice requests and purchase-and-sale ledgers for important circulation, thereby forming a quality and safety traceability system in which the source can be traced and the destination can be held accountable.
Using this system, consumers can simply scan with a mobile phone the electronic code or QR code on the packaging of traditional Chinese medicinal materials or traditional Chinese medicine decoction pieces, and the entire process from cultivation to processing and circulation of the purchased traditional Chinese medicinal materials and decoction pieces is clear at a glance.
The quality of traditional Chinese medicine decoction pieces can be expected
On July 21, Ministry of Commerce spokesperson Shen Danyang disclosed at a recent regular press conference that as of the end of June this year, the first batch of 4 pilot cities for traditional Chinese medicinal materials, including Baoding, Bozhou, Yulin and Chengdu, as the government's first batch of pilot cities, had built traceability systems in more than 600 enterprises.
The author has learned that the provinces implementing construction in the second step are: Jilin, Jiangxi, Henan, Hunan, Guangdong, Yunnan and Gansu. The provinces implementing construction in the third batch are: Shanxi, Inner Mongolia, Liaoning, Shandong, Hubei, Qinghai and Ningxia.
In the final analysis, the quality of decoction pieces is still greatly related to the quality of the raw medicinal materials. China has a vast territory, with differing climates from north to south and large differences in soil, so the same kind of medicinal material from different regions will certainly differ in quality, and without a detailed traceability system it is very difficult to guarantee the quality of decoction pieces.
Therefore, the establishment of this traceability system is just like a person's identity card. From information on the cultivation region of the medicinal material to origin processing, storage and transportation conditions, a light scan of the QR code on the packaging with a mobile phone makes the entire process information and quantity clear at a glance; after decoction piece production enterprises complete the processing and production of decoction pieces, they affix the corresponding correlation code to the packaging, and by the time it reaches the hospital or the user's hands, the entire process information and quantity are clear at a glance.
The price of traditional Chinese medicine decoction pieces will rise by at least 50%
The advantages of the traditional Chinese medicine traceability system in guaranteeing the quality of traditional Chinese medicinal materials, traditional Chinese medicine decoction pieces and traditional Chinese medicine finished products and in supporting the superior and eliminating the inferior are obvious, and no other regulatory method is comparable. At the same time, its impact on the industry is also very great, specifically shown in:
First: it can fundamentally eliminate counterfeit and shoddy products and the behavior of counterfeiting and selling fakes, because each package of medicinal materials (decoction pieces) has its own “identity card number”, and this identity card number is bound to key data such as the information of the cultivation base of the traditional Chinese medicinal material product, the responsible person for each link of the product, quality parameters and circulation information; it can also complete information transmission and verification through a network platform, linking each quality control link of the traditional Chinese medicine industry, leaving counterfeit and shoddy products nowhere to hide.
Second: the costs of traditional Chinese medicinal materials, traditional Chinese medicine decoction pieces and Chinese patent medicines will increase substantially
1. The cost at the origin of traditional Chinese medicinal materials will increase considerably: the traditional Chinese medicine traceability information platform affixes two-dimensional barcode electronic labels to cultivated medicinal materials and uses sensors to collect and record key parameters of the medicinal materials, including the temperature, humidity and light during the growth process of the medicinal materials, the pesticide components added during production, and so on, forming a standardized cultivation information management platform composed of subsystems such as front-end information perception, back-end data services and communication networks. The cost of medicinal material cultivation will certainly increase considerably.
2. Increased packaging and labeling costs: because a standard packaging method and labeling method are formed, changing the current method of no packaging or random packaging of traditional Chinese medicinal materials and the use of various waste woven bags for packaging, while at the same time adding uniformly formatted electronic supervision and traceability labels to the packaging, the packaging cost increases.
3. Correspondingly, the current method in which some traditional Chinese medicinal materials prone to insect damage generally use aluminum phosphide fumigation is completely changed to refrigeration or controlled atmosphere storage technology. Storage costs will certainly increase considerably, thereby increasing storage costs.
4. Transportation costs will also increase correspondingly: some medicinal materials that need to be kept in a cool place must be transported in sealed vehicles with an air-conditioning system, otherwise their transportation system information will be unqualified, and therefore transportation costs will also increase compared with now.
5. Because of the above reasons, the author predicts that the price of traditional Chinese medicine decoction pieces, especially decoction pieces that require excipients for processing, will be at least 50% higher than the current price, that is, at least 1.5 times the current price (mainly due to increased storage condition costs, medicinal material inspection costs, decoction piece inspection costs and corresponding process costs); correspondingly, the raw material cost of Chinese patent medicines will increase by at least one fold net compared with now, and more than 80% of pharmaceutical enterprises mainly producing ordinary traditional Chinese medicine preparations will face the pressure of soaring costs!
Because of the increase in inspection costs for the procurement of traditional Chinese medicinal materials (traditional Chinese medicine decoction pieces), transportation, enterprise inventory maintenance, raw material inspection, monitoring of material balance information in preparation production, intermediate inspection and finished product inspection, and the collection and uploading of standardized tracking information on quality and quantity in each link of the entire industrial chain, the actual cost of ordinary traditional Chinese medicine preparation products will be one to several times higher than now.
The era of high-priced decoction pieces has already arrived
In recent years, government departments have repeatedly taken action 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 Advancement of the Guiding Opinions on Building a Modern Logistics System for Traditional Chinese Medicinal Materials"; in May, the General Office of the State Council transmitted the "Protection and Development Plan for Traditional Chinese Medicinal Materials (2015-2020)" of 12 departments including the Ministry of Industry and Information Technology and the National Administration of Traditional Chinese Medicine; on July 15, the Office of the National Administration of Traditional Chinese Medicine issued the "Notice on Applying for National Traditional Chinese Medicine Standardization Projects"; on July 21, ISO 18664:2015 "Traditional Chinese Medicine — Determination of Heavy Metals in Herbal Medicines Used in Traditional Chinese Medicine" was officially published by ISO.
In June, the new edition was officially promulgated and will be implemented starting December 1 this year. The new edition of the pharmacopoeia sets higher standards and requirements for the quality of traditional Chinese medicine decoction pieces, and its implementation, while improving quality, will also certainly further push up the price of decoction pieces.
In terms of supervision, flying inspections have been frequent and continuously launched. Since January, the national bureau and the provincial and municipal bureaus have continuously carried out flying inspections on the traditional Chinese medicine decoction piece industry. According to incomplete statistics, as of the end of July, nearly 50 decoction piece production enterprises across the country had had their GMP certificates confiscated due to flying inspections, accounting for about 8% of the total number of decoction piece enterprises nationwide.
From this it is not difficult to see that the state has put great effort into the management of the traditional Chinese medicine industrial chain and quality management, with industrial policy guidance first, standard construction following close behind, and, together with the inspection and rectification by the specialized regulatory department (the drug regulatory authority), all these forces working together are advancing step by step toward effective supervision of the entire traditional Chinese medicine industrial chain and stable and controllable quality of decoction pieces.
When the quality of medicinal materials is controllable and the traceability system is complete, the era in which traditional Chinese medicine becomes a noble medicine will truly arrive.
The next step for decoction pieces
Commonly used traditional Chinese medicine decoction pieces are included in the national 2012 edition Essential Medicines List. According to the national essential medicines list variety procurement policy, all localities must conduct unified bidding, but for many years no bidding measures for traditional Chinese medicine decoction pieces have been seen in any locality.
On July 29, the General Office of the People's Government of Guangdong Province issued the "Notice on the Recent Key Work Points for Deepening the Reform of the Pharmaceutical and Health System in Guangdong Province", and this notice alone explicitly proposed advancing the trading of traditional Chinese medicine decoction pieces through a platform. As for how to trade and what standard (quality) will be used as the basis for trading, the author waits and sees.
However, what can be expected is that in the future, with the establishment of standards and the improvement of the quality of decoction pieces, nationwide bidding for decoction pieces will not be an imaginary scenario.
Traditional Chinese medicine decoction piece and traditional Chinese medicine preparation enterprises should proactively take action, draw on the advantages of national industrial policy, combine them with their own enterprises' actual conditions, and carry out extensive alliances or cooperation among enterprises. For some commonly used key bulk medicinal material products, in the main production areas of the varieties, they should use methods such as leasing land, cooperation and equity participation to start directly from raw material cultivation and origin processing, and establish cooperative or close relations with modern logistics companies. In this way they can not only meet the needs of national industrial development policy, but also more effectively predict and control raw material costs, and while ensuring product quality, give the enterprise sustained momentum for substantial development.