The soaring cost of traditional Chinese medicine is about to become an aristocratic medicine.
On July 14, 2015, the official website of the Ministry of Commerce of the People's Republic of China issued the Announcement on Public Bidding for the 2015 Online Information System Business Management and Maintenance Project of the Department of Market Order of the Ministry of Commerce.
Traditional Chinese medicine is the quintessence of China, which plays an important role in promoting and safeguarding people's health and the reproduction and prosperity of the Chinese nation. Traditional Chinese medicine is the material basis for the inheritance and development of traditional Chinese medicine. Since the wild and planted traditional Chinese medicine belong to the category of agricultural and sideline products, there has always been a scattered, chaotic and miscellaneous situation. With the development of the national economy and the further improvement of people's health needs, the demand for Chinese medicinal materials is increasing, and some precious medicinal materials or medicinal materials with long growth cycles often have periodic price surges, which leads to the phenomenon of making and selling fake products, dyeing and even treating extracted residues as raw medicinal materials (decoction pieces).
The circulation traceability system of traditional Chinese medicinal materials launched by the Ministry of Commerce is based on the development of modern circulation mode. By using information technology means, through the unique electronic label (ID card) on the packaging bag of traditional Chinese medicinal materials products, the electronic demand for certificates and tickets and purchase and sales accounts of important circulation can be realized, thus forming a quality safety traceability system with traceable source and traceable destination.
With this system, consumers can scan the electronic code or two-dimensional code on the packaging of traditional Chinese medicinal materials or Chinese herbal pieces gently through their mobile phones, and the whole process of the purchased traditional Chinese medicinal materials and Chinese herbal pieces from planting to processing and circulation can be clearly seen at a glance.
The quality of Chinese herbal pieces can be expected
On July 21, Shen Danyang, spokesman of the Ministry of Commerce, disclosed at a regular press conference held recently that by the end of June this year, the first four pilot cities of traditional Chinese medicinal materials, including Baoding, Bozhou, Yulin and Chengdu, had established a traceability system in more than 600 enterprises as the first batch of pilot cities of the government.
The author learned that the second step-by-step implementation of the construction of the provinces: Jilin, Jiangxi, Henan, Hunan, Guangdong, Yunnan, Gansu. The third batch of provinces to implement construction: Shanxi| Inner Mongolia, Liaoning, Shandong, Hubei, Qinghai, Ningxia.
In the end, the quality of decoction pieces has a great relationship with the quality of the original medicinal materials. China has a vast territory, different climates from north to south, and great differences in soil. The same medicinal materials come from different regions, and their quality must also be different. Without a detailed traceability system, it is difficult to ensure the quality of decoction pieces.
Therefore, the establishment of this traceability system is just like a person's ID card. From the information of planting area to the processing, storage and transportation conditions of medicinal materials, the two-dimensional code on the package can be scanned gently with mobile phone, and the information and quantity of the whole process can be clearly seen. After the production of decoction pieces is completed, the corresponding association code shall be affixed to the package by the production enterprise of decoction pieces, and the whole process information and quantity shall be clearly seen in the hands of hospitals or users.
The price of Chinese herbal pieces has increased by at least 50%
The advantages of traditional Chinese medicine traceability system in quality assurance of traditional Chinese medicine, Chinese herbal pieces and finished products of traditional Chinese medicine and elimination of the superior are obvious, and it is also comparable to other supervision methods. At the same time, the impact on the industry is also very large, specifically manifested in:
First: can fundamentally eliminate counterfeit, fake and fake behavior, because each package of medicinal materials (decoction pieces), has its own "ID card number", the ID card number bound to the Chinese herbal medicine product planting base information, product links responsible person, quality parameters, circulation information and other key data, but also to the network platform to complete information transmission and verification, link the quality control links of the Chinese medicine industry, so that counterfeit and shoddy nowhere to hide.
Second, the cost of Chinese herbal medicines, Chinese herbal pieces and proprietary Chinese medicines has increased significantly.
1. The origin cost of traditional Chinese medicine will increase a lot: the traceability information platform of traditional Chinese medicine is to form a standardized planting information management platform by attaching two-dimensional barcode electronic labels to the planted medicinal materials and collecting and recording the key parameters of the medicinal materials with sensors, including the temperature, humidity and illumination of the medicinal materials during the growth process, pesticide ingredients added during the production process, etc., which consists of front-end information perception, back-end data service and communication network subsystems. The cost of planting medicinal herbs would definitely increase by quite a bit.
2, increase packaging labeling costs: because the formation of standard packaging methods and labeling methods, change the current Chinese herbal medicine without packaging or random packaging, packaging with a variety of waste woven bags, while adding a uniform format of electronic regulatory traceability labels on the packaging, so that packaging costs increase.
3. Correspondingly, it completely changes the current method of aluminum phosphide fumigation commonly used in some Chinese medicinal materials that are prone to insects into the storage method of refrigeration or controlled atmosphere control technology. Storage costs will certainly increase considerably, which in turn will increase storage costs.
Transportation costs will also increase accordingly: some medicinal materials that need to be stored in shade must be transported in a closed vehicle with an empty system, otherwise the transportation system information will not be qualified, so the transportation cost will also increase compared with the present.
5. Because of the above reasons, the author predicts that the price of Chinese herbal pieces, especially those that need to be processed with excipients, will be at least 50% higher than the current price, that is, at least 1.5 times the current price.(Mainly due to the increase in storage conditions, the cost of medicinal materials inspection, the cost of decoction pieces inspection and the corresponding process costs); the corresponding raw material cost of proprietary Chinese medicines will be at least doubled compared with the present, and more than 80% of pharmaceutical enterprises mainly producing ordinary Chinese medicine preparations will face the pressure of soaring costs!
Because of the increase of inspection expenses such as procurement, transportation, enterprise inventory maintenance, raw material inspection, monitoring of material balance information of preparation production, intermediate inspection, finished product inspection, etc. of traditional Chinese medicine (Chinese herbal pieces), and the collection and uploading of quality and quantity tracking standard information in each link of the whole industry chain, the actual cost of common traditional Chinese medicine preparation products will be one to several times higher.
The era of high-priced decoction pieces has arrived
In January 2015, the General Office of the Ministry of Commerce issued the Circular on Guiding Opinions on Accelerating the Construction of Modern Logistics System of Traditional Chinese Medicine; in May, the General Office of the State Council forwarded the Plan for the Protection and Development of Traditional Chinese Medicine issued by 12 departments including the Ministry of Industry and Information Technology and the State Administration of Traditional Chinese Medicine.(2015-2020)"; July 15, the Office of the State Administration of Traditional Chinese Medicine" Notice on the Application of National Traditional Chinese Medicine Standardization Project "; July 21, ISO 18664:2015" Traditional Chinese Medicine-Chinese herbal medicine heavy metal limit "officially released by ISO.
In June, the new edition was officially promulgated and began to be implemented on December 1 this year. The new edition of pharmacies put forward higher standards and requirements for the quality of Chinese herbal pieces, and its implementation will further push up the price of Chinese herbal pieces while improving the quality.
Since January, the State Administration and provincial and municipal bureaus have continuously inspected the Chinese herbal pieces industry. According to incomplete statistics, by the end of July, nearly 50 Chinese herbal pieces production enterprises have confiscated GMP certificates due to inspection, accounting for about 8% of the total number of Chinese herbal pieces enterprises.
It is not difficult to see from this that the state has made great efforts in the management and quality management of the traditional Chinese medicine industry chain, with industrial policy guidance in the first place, standard construction closely followed, inspection and rectification by professional supervision departments (Food and Drug Administration), and joint efforts to move step by step towards the effective supervision of the whole traditional Chinese medicine industry chain and the stable and controllable quality of decoction pieces.
With controllable quality of medicinal materials and perfect traceability system, the era of traditional Chinese medicine becoming noble medicine will really come.
Pieces Next
Commonly used Chinese herbal pieces are included in the National Essential Drugs Catalogue 2012 Edition. According to the procurement policy of the National Essential Drugs Catalogue, all localities must conduct unified bidding, but there have been no bidding measures for Chinese herbal pieces in various localities 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 of Deepening the Reform of Medical and Health System in Guangdong Province. Only the notice clearly proposed to promote the trading of Chinese herbal pieces through the platform. As for how to trade and what standard (quality) should be used as the basis for trading, the author will wait and see.
However, it can be expected that with the establishment of standards and the improvement of the quality of decoction pieces in the future, it will not be hypothetical to carry out bidding for decoction pieces nationwide in the future.
Enterprises of Chinese herbal pieces and Chinese herbal preparations should take the initiative to take advantage of the advantages of national industrial policies and combine with the actual situation of their own enterprises to carry out extensive alliance or cooperation among enterprises. For some commonly used key bulk medicinal materials, in the main production areas of varieties, they should directly start from the cultivation and processing of raw materials, and establish cooperation or close relations with modern logistics companies. This can not only meet the needs of national industrial development policies, More effective prediction and control of raw material costs, while ensuring product quality, so that enterprises get considerable development stamina.
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