How to solve the puzzle of high unqualified rate of Chinese herbal pieces?

[market analysis of chinapharma.com] according to Ma Shuangcheng, director of the Institute of traditional Chinese medicine and national medicine inspection and determination of China food and drug inspection and Research Institute (hereinafter referred to as "CFDA"), the national drug quality sampling and monitoring from 2013 to 2016 showed that the overall qualification rates of Chinese herbal medicine and decoction pieces were 64%, 68%, 75% and 77% respectively, showing a trend of increasing year by year and steadily improving However, compared with other drugs, the unqualified rate of traditional Chinese medicine and decoction pieces is still high The quality problem of Chinese herbal pieces has existed for a long time, but in its back end, the qualified rate of Chinese patent medicine is much better than that of Chinese herbal pieces According to the data of the Chinese Academy of inspection, in 2015, in the national evaluation sampling inspection, 43 varieties were inspected 5669 batches according to the current drug standards and the existing supplementary inspection methods and inspection items, 146 batches were unqualified, with a qualified rate of 97.42% The 2016 annual drug inspection report issued by the State Food and Drug Administration confirmed the existing problems of Chinese herbal pieces Ding Jianhua, director of the Department of pharmaceutical and chemical supervision of the State Food and drug administration, revealed in the report release conference that 172 GMP (drug production quality management specification) certificates were withdrawn in 2016 Among them, 81 pieces of traditional Chinese medicine were involved, accounting for 47.6% It seems that the traditional logic of "death of the lips and cold of the teeth" has hit a wall here In fact, unqualified traditional Chinese medicine cannot produce qualified Chinese patent medicine "If a large number of Chinese herbal pieces are unqualified, the risk of unqualified Chinese patent medicines will be increased." An expert from the National Pharmacopoeia Commission said The development of traditional Chinese medicine plays an important role in the national policy of "healthy China", and the policies of the state to encourage the development of traditional Chinese medicine industry have been issued continuously, which has brought opportunities for rapid development of the industry The policy of medical reform puts forward many favorable policies for the use of Chinese Herbal Pieces in hospitals For example, the traditional Chinese medicine pieces do not cancel the hospital bonus, do not participate in the provincial unified bidding, do not calculate the proportion of hospital drugs, temporarily do not implement the two vote system, and all the traditional Chinese medicine pieces that enter the Pharmacopoeia are included in the basic drugs and medical insurance catalog The new version of medical insurance catalog continues to implement the reimbursement management of the traditional Chinese medicine pieces using exclusion catalog (some expensive and fine herbs) In addition, foreign capital is also prohibited from entering the Chinese herbal medicine industry (the application of processing technology such as steaming, frying and roasting) In the future, endangered technical varieties, toxic processed varieties, technological innovation, characteristic pieces of decoction are expected to be included in the regulations on the protection of traditional Chinese medicine varieties "Under the national policy, the year-on-year growth rate of 12.45% of Chinese herbal pieces is higher than that of chemical drugs and Chinese patent medicines, but at the same time, we should also see that the profit rate of Chinese Herbal Pieces in the industry is low, and its profit rate is only a single digit, 6.96% The main reason is that the production scale of the decoction pieces enterprises is generally small, the fixed asset investment is relatively small compared with the finished medicine, in addition, the whole decoction pieces industry is full of fish and eyes, and the vicious competition is fierce " A pharmaceutical industry expert said At the same time of development, due to the long industrial chain of Chinese herbal pieces, across many industries, involving many regulatory departments, the industry has problems such as difficult supervision and uneven quality For the problems of Chinese herbal pieces, the supervision of the State Food and drug administration has not stopped From 2016 to now, the General Administration of the people's Republic of China has issued a total of 5 issues of unqualified announcement on the market sampling of traditional Chinese medicine pieces, involving 184 suppliers or manufacturers, 16 varieties of traditional Chinese medicine / pieces and 286 batches of unqualified batches According to Ma Shuangcheng, the existing problems are mainly fake and shoddy; using organic dyes to dye inferior medicinal materials; being driven by interests to increase weight maliciously; excessive sulfur fumigation; irregular storage leading to moth and mildew; and improper cultivation leading to poor quality "Because most of the organic dyes are toxic, even carcinogenic and teratogenic, the dyeing behavior of medicinal materials is not only a fake behavior, but also increases the safety risk, which must be severely cracked down In the industry, sulfur fumigation is mostly used to moisturize and increase weight, improve appearance and increase sales Studies have shown that the extensive use of sulfur fumigation will not only affect the quality of medicinal materials and pieces, but also cause harm to human health " Ma Shuangcheng said "There are always problems in the quality of Chinese herbal pieces After all, they are agricultural and sideline products From the beginning of planting, in order to increase production, a large number of chemical fertilizers and pesticides are used Ginseng looks like radish In the storage link, in order to prevent insects and mildew, sulfur fumigation is used The cost of new storage means is high Many people use sulfur fumigation to save costs " Li Congxuan, general manager of OTC Business Department of Kangmei Pharmaceutical Co., Ltd., told finance and economics In fact, in order to rectify the market of Chinese herbal pieces, the State Food and drug administration has carried out special actions in 2013 to expose the problems of Chinese herbal medicine, and also interviewed the heads of the municipal governments where 17 Chinese herbal medicine professional markets are located, and signed the letter of responsibility for market management of Chinese herbal medicine However, the unqualified Chinese herbal pieces still exist today "Because the industrial chain of traditional Chinese medicine is not only long and has many links, but also the front-end links such as the cultivation of medicinal materials, the initial processing and storage of the origin of medicinal materials, and the transaction of traditional Chinese medicine are not within the scope of drug supervision, which makes it more difficult to guarantee the quality of raw materials for decoction pieces and finished drugs." Experts from the State Pharmacopoeia Commission said   According to a large number of on-the-spot investigations, the main problems in the cultivation and circulation stage of traditional Chinese medicine are as follows: unclear basic sources of traditional Chinese medicine, authentic degradation of traditional Chinese medicine, excessive agricultural residues and heavy metal residues; lack of seedling provision and scientific cultivation guidance for pharmaceutical farmers, lack of organized large-scale cultivation; large production fluctuation, easy market manipulation by speculators, high risk of cultivation for pharmaceutical farmers; several problems for pharmaceutical farmers Without the ability of primary processing and long-term preservation of the origin, fresh drugs can only be sold at a low price, while the drug operators not under the supervision generally take the means of adulteration, weight gain, dyeing and sulfur fumigation to make illegal profits In addition to quality problems, there are also problems in the circulation of Chinese herbal pieces "At present, the circulation of traditional Chinese medicine is more chaotic Among the 17 traditional Chinese medicine markets, there are many traditional Chinese medicine enterprises, the second is hospitals, and the third is pharmacies Substandard Chinese herbal medicines cannot be produced But because the quality testing project of Chinese patent medicine is only a certain component, some enterprises will add more medicinal materials containing this component, while other formula ingredients will be reduced, and even some enterprises will add chemical synthetic ingredients In this case, the qualified rate of Chinese patent medicine detected is very high " Li Congxuan said In addition to the problems of the source, the current situation of the circulation of traditional Chinese medicine is not optimistic According to the above experts, unlike the mode of multi dealer purchase of finished drugs, most medical institutions and retail pharmacies directly purchase and sell pieces with pieces factories, but in fact, due to the objective prevalence of geographical restrictions and "potential rules", pieces production enterprises are hardly able to actually control the marketing channels   Then came the following two models: first, only through the unqualified "drug bugs" can the pieces of prepared by the enterprises provide to the demander, and at the same time, the pieces of production enterprises are forcibly occupying most of the profits, resulting in the continuous decline of product quality, and even directly purchasing the finished products from the unqualified processing points; second, most pieces of production enterprises actually There is no ability to produce hundreds of pieces of medicinal materials Because of the inability to master the sales channels, a large number of Medicinal Materials operators not only make their own hands and feet on the purchased medicinal materials, but also illegally process the pieces themselves, and then purchase sales invoices from the regular pieces production enterprises, so as to enter the legal marketing channels All of these models seriously threaten the quality of Chinese herbal pieces, which makes the legal production and sales difficult "Chinese patent medicine enterprises need to feed according to GMP, otherwise it is illegal Large enterprises have little problem, mainly a few enterprises In order to save costs, they will buy some cheap and unqualified Chinese herbal medicines Because of the increase in the price of agricultural and sideline products, they will be fed with inferior raw materials " Tu Pengfei, chairman of the national pharmacopoeia commission's Professional Committee of Chinese herbal pieces, said In the flight inspection conducted by CFDA in 2016, it can be seen that 12 of the 19 Chinese patent medicine manufacturers did not produce according to GMP, and there was confusion in the management of Chinese herbal medicine and Chinese herbal pieces In order to cope with the supervision and inspection of drug supervision and administration departments at all levels, some Chinese patent medicine manufacturers have made up the warehouse material account and the in and out records According to the production volume of Chinese patent medicine, they have inverted the usage of Chinese herbal medicine and made up the material account according to the demand "For unqualified Chinese patent medicines, some can be found out, and some can't Because some Chinese patent medicines do not carry out the content determination, and some Chinese patent medicines do not have the object of identification of the ingredients, which can not be found out In addition, due to the high cost, at present, most Chinese patent medicine enterprises do not have fingerprint, only Cordyceps and other expensive herbs are in use " Tu Pengfei said Some experts in the industry said that in the Chinese herbal medicine has been in the high position of 25% unqualified, the high qualified rate of Chinese patent medicine is illogical Chinese patent medicine, Chinese herbal pieces and Chinese herbal medicines are an organic whole, with lips and teeth dependent and teeth cold The quality of traditional Chinese medicine is directly concerned with the therapeutic effect of traditional Chinese medicine However, the supervision of the Chinese herbal medicine industry has always been multi sector management, which is bound to extend to the field of Chinese herbal medicine breeding and trading Only multi sector cooperation can change the quality problems of Chinese herbal medicine, and even the threat to Chinese patent medicine.