The State Food and Drug Administration reiterated the limitation of 6 Chinese medicine formula granule enterprises

Recently, the State Food and Drug Administration issued a document to strictly control the pilot research and management of traditional Chinese medicine formula granules, calling for the approval of traditional Chinese medicine formula granules production enterprises The document of the State Food and Drug Administration pointed out that traditional Chinese medicine formula granules are still in the pilot study of scientific research, and will work with relevant departments to promote the pilot study of traditional Chinese medicine formula granules, find problems, summarize experience, and timely issue relevant regulations Before that, the provincial food and drug administration shall not approve the production of traditional Chinese medicine formula granules in any name According to the analysis of the insiders, for several enterprises such as China Resources 39, Shanghai Jiahua, HongRi pharmaceutical, the move of the regulatory authorities will continue to maintain their monopoly advantages Reporters learned that the State Food and Drug Administration issued this ban is based on Anhui, Jilin and other provinces to release the approval of the pilot production qualification of traditional Chinese medicine granules In July 2001, the State Food and Drug Administration issued the Interim Provisions on the management of granules of traditional Chinese medicine formula, which clearly included the granules of traditional Chinese medicine formula in the management of pieces of traditional Chinese medicine Since then, the control of the qualification of the pilot production enterprises of traditional Chinese medicine formula granules has been in a strict state, and only six enterprises in the country have obtained this qualification The six Chinese medicine enterprises include China Resources Sanjiu, Jiangyin Tianjiang Pharmaceutical Co., Ltd., a subsidiary of Shanghai Jiahua, Beijing kangrentang Pharmaceutical Co., Ltd., Peili (Nanning) Pharmaceutical Co., Ltd., Sichuan new green Pharmaceutical Technology Development Co., Ltd and Guangdong Yifang Pharmaceutical Co., Ltd (acquired by Tianjiang pharmaceutical) According to the relevant financial report data, HongRi pharmaceutical achieved an operating revenue of 1.229 billion yuan in 2012, of which 498 million yuan was generated from traditional Chinese medicine formula granules, an increase of 85.69% year on year According to the 2012 annual report of Shanghai Jiahua, 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 last year According to the data of the Ministry of health in 2009, the annual trial production of Chinese herbal formula granules is over 10000 tons, with an annual sales volume of more than 1 billion yuan, accounting for 6% of the annual sales volume of Chinese herbal pieces, and is increasing by more than 30% every year Industry insiders pointed out that the sales volume of traditional Chinese medicine is about 50 billion yuan If 60% of the market is converted into the share of traditional Chinese medicine granules, the sales volume and profit will be very large But now six enterprises have only achieved more than 3 billion yuan of sales, so many enterprises hope that the State Food and Drug Administration will open the access conditions and enter the market of traditional Chinese medicine formula granules "The lack of a unified and high-level quality standard for traditional Chinese medicine formula granules leads to the uneven quality of traditional Chinese medicine formula granules, which restricts the enthusiasm of traditional Chinese medicine formula granules production enterprises in strict quality management and scientific research." Industry insiders said that this was the main reason why the State Food and Drug Administration strictly controlled the number of enterprises and was reluctant to let go, but this also brought about the situation of six enterprises forming a monopoly market.