TCM formula granules: when to end pilot identity

In June this year, the State Food and Drug Administration issued a notice requiring strict processing standards of Chinese herbal pieces and pilot research and management of Chinese herbal formula granules The notice stressed that the provincial food and drug administration should not approve the production of traditional Chinese medicine formula granules in any name What is the current situation of the Chinese herbal formula granules that have been piloted for 20 years? When to become a regular? Under what circumstances should we "become regular"? In the face of an increasingly large market, how can other domestic enterprises enter this hot field except for six pilot enterprises? Enterprise standards are different in 1993, China approved the first enterprise of traditional Chinese medicine formula granules As a pilot, it is engaged in research and clinical practice, and it is hard to explore the development path of traditional Chinese medicine formula granules Later, China has approved five pilot enterprises Beijing kangrentang Pharmaceutical Co., Ltd was approved in 1998 It is the last pilot enterprise to enter the traditional Chinese medicine formula granules Among the six pilot enterprises, Beijing kangrentang Pharmaceutical Co., Ltd was the last one to be approved In the first 10 years, it mainly focused on scientific research, and in the last five years, it developed rapidly Kangrentang's take-off relies on three things: innovation, market and capital Kangrentang was the first one to complete the full capitalization In recent years, it developed from 3 million start-up capital to 600 million yuan of sales "We have been engaged in scientific research for the first 10 years, and the products have been on the market only in the last 5 years," Wu Fen, general manager of Beijing kangrentang Pharmaceutical Co., Ltd., told reporters that the research of traditional Chinese medicine formula granules needs time accumulation, and money cannot solve all relevant scientific problems It is through the accumulation of R & D in the previous 10 years that kangrentang can develop so fast People in the industry generally believe that it is in line with the drug law that the R & D will be launched 10 years later Generally speaking, the R & D investment of hundreds of millions of yuan will take about 10 years before the drug is launched During the pilot period, six enterprises tried various ways and methods according to their own ideas, researched and developed more than 400 kinds of commonly used traditional Chinese medicine, and achieved a series of research results However, the product process and quality standards of six enterprises are difficult to be unified, and there is no unified industry standard in China "Pilot" status when to withdraw "traditional Chinese medicine formula particles have been in the exploration of progress." Wu Bin said When the product was first put on the market, the Chinese medicine market initially took a skeptical attitude towards the new product, but after the clinical practice, it was finally recognized by many doctors and famous experts "Our product not only convinces opponents, but also is what the market needs, so it has vitality." When Wu Fen talked about his products, he was full of pride The identity of traditional Chinese medicine formula granules cannot always be "pilot" Wu Fen said, "the pilot is a reasonable solution for formula granules to enter the market of traditional Chinese medicine The end of the pilot is not a matter of time, but of method There's a way The sooner it ends, the better But if we open up blindly, according to the current market environment, once fake drugs and substandard drugs enter formula granules, the industry will soon be on the verge of death " In fact, there are no technical barriers to formulation granules If the pilot project is ended and the operation is liberalized, the key point is to design the product standard reasonably The State Food and drug administration has repeatedly mentioned "high standard, high starting point and high threshold" What is "high standard"? According to Wu Fen, if we only focus on the number of determination standards of index components, do not consider the inheritance relationship between traditional pieces of Decoction and formula granules, do not consider the process control standards of formula granules production, it is easy for fake and inferior drugs to drill holes, resulting in quality control risks, which may lead to the direction of high input and low output of formula granules The key point of ending the pilot and liberalizing the operation is to design the product standard reasonably According to Wu Fen, we must work out a reasonable standard that can avoid fake drugs and substandard drugs, avoid quality risks, and plug up fake loopholes in advance, so as to ensure the healthy development of the whole industry Zhou Jialin, general manager of Tianjiang Pharmaceutical Co., Ltd., a traditional Chinese medicine formula granule enterprise, said that the release of traditional Chinese medicine formula granules should ensure the safety of people's medication and promote the healthy development of the industry She believes that "the industry of traditional Chinese medicine formula granules cannot be liberalized at will, but must be standardized step by step," and "the industrial liberalization should be responsible for the history, the people and the pioneers." She called for the establishment of a unified base of traditional Chinese medicine, to improve the quality of formula granules, and not to engage in low-cost competition Industry insiders believe that the establishment of a unified standard is the key to the problem However, six pilot units have different technical processes and standards, each with its own advantages, so it is difficult to unify If the standards and rules of traditional Chinese medicine formula granules are well formulated and the "pilot" status of formula granules is removed, it will become a milestone on the development road of Chinese formula granules industry and also a milestone in the development of traditional Chinese medicine What is the industry prospect of the market far from saturation traditional Chinese medicine formula granules? The data shows that the traditional Chinese medicine formula granules, as the substitute of traditional Chinese medicine pieces, are in the golden growth period of rapid development at present The total income of formula granule industry increased from 230 million yuan in 2006 to about 3.2 billion yuan in 2012, with an average compound growth rate of more than 50% In recent years, the business expansion of TCM formula granules has gradually become a new profit growth point for TCM enterprises According to HongRi pharmaceutical's 2012 annual report, Beijing kangrentang pharmaceutical achieved an operating revenue of 498 million yuan, an increase of 85.69% year on year According to the 2012 annual report of Shanghai Jiahua, last year, Jiangyin Tianjiang had an operating revenue of 1.892 billion yuan, an operating profit of 484 million yuan, and a net profit of 411 million yuan The investment income contributed by the participating companies accounted for 16.54% of the net profit of the listed companies, and it became the only enterprise with an investment income of more than 10% of that of Shanghai Jiahua's participating companies In recent years, the sales of these six enterprises have been rapidly rising The figures show that at present, there are about 50 billion yuan of sales of Chinese herbal pieces If the traditional Chinese medicine formula granules can occupy half of the market, there will be 25 billion market sales every year, and now six enterprises have only achieved more than 3 billion yuan, and the sales of these six enterprises have been rapidly rising in recent years The market capacity of traditional Chinese medicine granules is huge and far from saturation With the deepening of medical reform, the future development prospect of traditional Chinese medicine market will be better, which is enough to make the large and medium-sized pharmaceutical enterprises with low profit and lack of growth point covet Compared with decoction pieces, the biggest advantage of traditional Chinese medicine formula particles is stable and controllable quality, which can effectively control heavy metal residues and pesticide residues Nowadays, the quality of Chinese herbal pieces has been questioned, the use of Chinese herbal formula granules is the future development trend, the development will inevitably bring changes, and the pilot project that has been carried out for 20 years will finally come to an end Wu said he hoped that in the future, formula granules will compete with Chinese Herbal Pieces in a benign way, so as to promote the common development of both sides In this way, the future doctors of traditional Chinese medicine will not worry about bullets.