Some Cold Thoughts on Current Situation of Pharmaceutical Industry

Looking at the modernization process of Kampo medicine in Japan, there are mainly the following experiences and practices worth learning and learning from:

One is the core of product quality. Japan's Kampo medicine production companies attach great importance to product quality, will improve quality as the key to Kampo medicine development strategy. Japanese Kampo medicine companies apply strict quality management from raw materials to the entire process of preparation. In this regard, the Japan Association of Industry Associations has played a huge role. Among them, as the largest industrial organization of Japan's Kampo Pharmaceutical Manufacturers, the Japanese Kampo Pharmaceutical Preparation Association has adopted the form of self-discipline in the industry and strictly requires member companies to use the raw drugs of the Japanese authorities. The microbial limit test method enriches and strengthens the test system to prevent microbial contamination. In addition, the association fully promotes the development of new quality standards, placing emphasis on quality control in the ingredients, content, specifications, and biological evaluation of the effectiveness of crude drugs. At present, all Japanese medicine manufacturers in Japan have met the GMP requirements, and generally implemented a number of management systems such as GLP, GSP, and PMS, forming a relatively complete quality management system.

The second is to ensure the stable supply of raw materials. Japan's country is narrow and the vast majority of Kampo medicinal herbs need to be imported from abroad. It is therefore important to ensure the stable supply of herbal medicine raw materials in Kampo. To this end, Japanese Kampo medicine companies are making greater efforts to ensure overseas supply of raw materials for Chinese crude drugs and to improve domestic crude drug production and cultivation capabilities. In the supply of crude drug raw materials, China is the largest source of Japan's crude drugs, many Japanese companies directly import medicinal herbs from China, and some companies such as Tsumura have built factories in China directly and processed them locally. At present, crude drug raw materials imported from China account for as much as 70% of raw materials needed for crude drugs.

Japan also continues to strengthen coordination and cooperation with China and promote measures such as resource protection, greening, and GAP implementation in the source of raw materials. More importantly, Japan adopts strict examination and approval standards for crude drug raw materials imported from China, including the identification of the purity of appearance traits according to the general rules for crude drug specifications. The laboratory inspection items involve ash, acid insoluble ash, water, bacteria, etc., for water extracts. , alcohol extracts, ether extracts to determine the amount of extract. Japan's Kampo Pharmaceutical Preparation Association also repeatedly called on China and Japan to implement common actions in the establishment of international standards for crude drugs.

In order to avoid over-reliance on foreign countries, Japanese Kampo medicine companies also try to increase the domestic production capacity of crude drugs and cultivate medicinal plants in Japan. About 100 kinds of raw medicinal materials are produced, including Rehmannia glutinosa, Achyranthes bidentata, Pinellia, Campanulaceae, Phellodendron, Huangmao, Gentian, Zanthoxylum bungeanum, Chinese peony, Perilla frutescens, Ginger, Polygala, etc. The total planting area is 4,000 hectares. The annual output is about 50,000 tons. In addition, Japanese scholars also used biological and genetic methods for selection of excellent varieties. They have accumulated a lot of experience in breeding, cultivation, and transplantation. They have built a professional plantation of Chinese medicinal herbs and transplanted and cultivated Coptis chinensis, peony, and Zhebei. About 500 varieties such as mother, white-blue, Chinese wolfberry, Chuanxiong, and angelica.

The third is to continuously increase investment in scientific research. At present, there are more than 30,000 researchers in the Chinese research institutes established by some medical universities and medicine companies in Japan. As early as the 1980s, the Japanese Ministry of Science and Technology launched the "Scientific Explaining the Investigation of the Oriental Medicine" plan, and gradually increased the investment in Kampo medicine research, forming a cooperative research and development trend of production, education, and officials. At the corporate level, many large companies have their own research institutes. For example, Tsumura's research institutes are relatively comprehensive. They are divided into the Central Research Institute and 15 institutes and ministries. They include intelligence, crude drugs, chemistry, phytochemicals, biochemistry and metabolism, and pharmacology. There are nearly 300 researchers in the electronic computer room. More than half of them have advanced degrees in pharmacy, 20% are doctoral, and each person in charge of a room requires a doctorate. At this stage, the R&D work of Kampo medicine companies in Japan is limited to the study of the mechanism of ancient prescriptions, including biopharmaceutical cells and gene research, but almost no new drug development is involved. The main purpose of the existing research work is to ensure the pharmacological stability and consistency of the bulk drug production.

The fourth is to focus on improving the level of production technology. Japan's Kampo medicine manufacturing companies have long attached importance to the improvement of the technological level, and the mechanization, linkage, and automation of Kampo preparations have mostly reached a high level, and all of them have adopted advanced technology. Taking the production of extracts as an example, the dry extracts are prepared from feed stock to freeze-drying. The entire process is automatically controlled by the operating terminal of the central management office. Solid-liquid separation technology, freeze-drying process, vacuum packaging technology, cleaning and sterilization technology have been widely used. In terms of dosage forms, Japanese companies are unique, and the introduction of "standard decoction" is the best example. In recent years, all manufacturers have made efforts to improve their formulations. For example, Tsumura recently launched a pack of small and light-weight Chinese medicines on the basis of condensate pills, bagging agents and granules. Drink immediately. The major breakthroughs in preparation formulations met the high demands of modern people for medical services and the market responded enthusiastically.

The fifth is to adopt flexible marketing strategies. Kampo companies generally set up one or several factories, specializing in the production of drugs. The products are arranged and sold by the company, and the division of labor is clear. In general, there are more people engaged in business activities than those engaged in production. In Japan, drug advertisements are severely restricted. Therefore, the marketing methods of Kampo medicine in Japan are mostly scientific research, academic journals and academic conferences as media, and directly to hospitals and even doctors. In addition, Japanese Kampo medicine companies often promote their products by introducing marketing methods such as member drugstores. In recent years, with the increasing number of herbal medicine enthusiasts, especially women herbal medicine lovers, Japan's Kampo medicine companies have also lost no time in adjusting their business ideas. They have expanded herbal medicines for use in food seasonings, beauty skin and cosmetics, and related baths. Aromatherapy herbal products for disease prevention and treatment are introduced to the market. In general, Japan's Kampo medicine companies have their own unique business strategies. Their commonality is to establish extensive sales outlets, seize the hot spots of consumption, conduct scientific popularization, strengthen public awareness, and expand derivative functions of products.

Sixth, it entered the international market in a roundabout way. In order to open the market for Kampo medicine in the United States, Tsumura submitted a new drug application including the new drug Guizhi, which was used to relieve menopausal symptoms, to the US FDA several years ago. Guizhi Qi once entered the clinical trial stage. However, Tsumura had to withdraw its new drug application due to the high initial costs. In view of the high barriers to entry and the low international recognition, Tsumura began a circuitous strategy to break through through the export of home and personal care and health derivatives, including herbal ingredients, baby lotions, and hair growth agents. Fragrances, medicinal cosmetics and OTC functional foods. In order to open up sales channels, Tsumura has also established a US branch in the United States, relying on local network advantages to launch a new round of marketing offensives.

In recent years, with the rapid growth of China's economy and Japan's Kampo medicine market becoming saturated, Japan's Kampo medicine companies have also begun to adjust their strategies for the Chinese market, gradually shifting China as a raw material supply base to the supply of raw materials and sales, and preparing Large-scale participation in the Chinese medicine market competition.