Business Club January 28th

“I think this regulation has little impact on the Chinese medicine manufacturing companies that have their own pre-processing processes.” Xie Rongbao, sales director of the Kunming Chinese Medicine Factory Business Division, said in an interview with the author recently.

According to Xie, the “Pharmacopoeia” for the first time in 2010 clearly requested that prescriptions of proprietary Chinese medicine preparations should be filled with raw materials, and preparation methods for Chinese patent medicines should be adjusted. The names of the Chinese herbal medicines should be changed in terms of their medicinal tastes to make them more consistent with Chinese medicine “decoction pieces”. The actual clinical practice.

When this provision was released, it was once considered "a possible shock to Chinese patent medicine companies." The author recently learned that the strict implementation of policies will bring greater pressure on those companies that have previously been operating irregularly. Most of the Chinese medicine companies on the scale have their own pre-processing workshops. Difficult to achieve.

Drop pressure

In the 2010 edition of the Pharmacopoeia, Article 31 of the General Regulations states that the medicinal tastes in the formulation prescriptions refer to the decoction pieces. The pieces of the "Pharmacopoeia" that are loaded into this edition must be processed accordingly. In addition, Article 32 of the General Principles also stipulates that: Unless otherwise specified, all decoction pieces are made according to the corresponding methods stipulated in the “Pharmacopoeia” of this edition; the specifications of the decoction pieces used in the preparation shall meet the requirements of the actual process of the corresponding varieties.

"Pharmacopoeia" provisions of the Chinese medicine decoction pieces refers to the industrial decoction pieces, not the clinical use of decoction pieces, before everyone's understanding may be misunderstood." National Pharmacopoeia Commission experts said.

"This means that the decoction pieces used in the preparation of industrial decoction pieces or drug production enterprises are based on the actual production process of the varieties, and other aspects are in compliance with the requirements of the "Pharmacopoeia" for the decoction pieces, that is, the specifications of decoction pieces in clinical and pharmaceutical production. There is a distinction between them.” The expert said that currently mainstream Chinese patent medicine companies can do it and there is no pressure. The reason why such a definition is made is to emphasize and highlight the attributes of Chinese herbal medicines as clinical prescription drugs. .

"The Pharmacopoeia" must be a piece of decoction in the formulation prescription, but also pointed out that the specifications of the decoction pieces used in the preparation should meet the requirements of the actual process of the corresponding species, that is, the concept of "net medicinal material" prescribed by the GMP in the industry. For a GMP-certified Chinese medicine company, the concept of net medicine is only converted into pieces. At present, as the prices of Chinese herbal medicines generally increase, some Chinese herbal medicines have even surged by several times, and their quality is gradually increasing. Under the declining situation, it is bound to have a definite influence on the decoction pieces. Enterprises can only ensure the quality of the decoction pieces after processing the traditional Chinese medicine decoction pieces.” said Xu Yuling, manager of Kangyuan Pharmaceutical Quality Department.

As for the previously rumors of increasing costs, the situation of companies is not the same. Xie Rongbao said: “In terms of cost, I think there is no real impact on us, and the impact of medicine prices is even greater.” And Xu Yuling believes that the rising prices of Chinese herbal medicines and the processing and processing of Chinese herbal medicines will inevitably increase the production costs of companies.

The key is to perform

Mainstream companies generally believe that although this regulation will have little impact on their own companies, the strict implementation of policies will be conducive to the regulation of some small businesses, thus raising the level of the entire industry.

According to statistics, by the year 2008, there are nearly 1,500 Chinese medicine companies in China, and the scale of industrial economy has exceeded 100 billion yuan. However, due to the low level of industrial concentration, the number of small factories is not small. "The small plant has a large loophole because of the small production volume and the relatively high cost of pre-processing. There is a huge loophole," Xie Rongbao pointed out.

In fact, in order to reduce costs, some small-scale enterprises are cutting corners, lowering the limit, or investing in the ultra-low limit materials on materials. This is affecting the confidence of the outside world in the entire Chinese medicine industry. The industry believes that the strict implementation of the Chinese medicine decoction pieces will help improve this situation. According to relevant sources of the State Food and Drug Administration, a document on “strengthening the supervision and administration of raw materials for Chinese patent medicines” is in the pipeline.

Behind the implementation of this rule, the industry is full of worries about the development of the decoction industry itself. "Now there is no lack of standard pieces of wine, the key is to implement." Jiang Yun, chairman of the new Lotus Flower Co., Ltd., such as emphasis.