"Pharmaceutical packaging materials are the biggest headache for our pharmaceutical manufacturers now." Recently, in the Ministry of Industry and Information Technology of the pharmaceutical industry "Twelfth Five-Year Plan" proposal to solicit views at the forum, Beijing Shuanghe Pharmaceutical Group Co.

　　In the past two years, China's large infusion market thanks to the new medical reform policy, the market volume showed a rapid upward trend, with growth rates of more than 10% for two consecutive years. However, the market expansion has not brought a hint of relief to I.V. companies. On the contrary, with the implementation of the 2010 version of the Pharmacopoeia and the new version of GMP, I.V. companies have felt unprecedented pressure. Among them, the biggest pressure comes from the pharmaceutical packaging materials, not only the quality is worrying, but also the lack of high-end products to match the new drug standards. The industry believes that the pharmaceutical packaging materials have become the biggest obstacle to improve the quality standard of drugs, and if the status quo is not reversed as soon as possible, improving the quality of drugs will become a paper talk.

　　Pharmaceutical packaging materials are "sick"

　　Information released by the China Pharmaceutical Packaging Association shows that by the end of 2010, China's pharmaceutical packaging materials industry has a total of 3200 registration certificates, 1500 production enterprises, the industry's total annual output value of 35 billion yuan. Cai Hong, secretary-general of the China Pharmaceutical Packaging Association, said that before the "Eleventh Five-Year Plan", the annual total output value of the pharmaceutical packaging industry accounted for about 10% of the annual total output value of the whole pharmaceutical industry, but according to the 2008 and 2009 annual reports of pharmaceutical statistics, the total output value of the pharmaceutical packaging industry in the total output value of the whole pharmaceutical industry has dropped to 5%, which is much lower than the level of 30% in developed countries. It is much lower than the 30% level of developed countries.

　　The "Outline of the 12th Five-Year Development Plan for the Pharmaceutical Packaging Industry" draft written by the China Pharmaceutical Packaging Association points out that at present, China's pharmaceutical packaging materials industry is highlighted by a large number of enterprises, small scale, products in the low-end market for a long time, the overall research and development of enterprises, manufacturing capacity is weak, the lack of high-end products. All new technologies, new equipment and high-end raw materials for pharmaceutical packaging materials rely on imports. For example, all butyl glue is imported, and most of the raw materials for multilayer co-extruded film and capsules are imported. The amount of these raw materials is large, but the price is all controlled by foreign investors ......

　　Yu Shunting said, drug manufacturers are very confused in the choice of packaging materials, especially in the development of new products, quality upgrade, because the overall quality of domestic pharmaceutical packaging materials is low. The problem of the compatibility of the packaging material with the liquid has not been completely solved for a long time, and the quality of the drug is very risky, and enterprises are like dancing on the edge of a knife every day.

　　Another industry insider said, according to the regulations, the shelf life of drugs is generally 2 to 3 years, but if you look carefully you will find that the market circulation of certain injectable drugs as long as the market for six months has not moved, the production enterprises will automatically recall. This is because after half a year, these drugs will fail in the market quality sampling indicators such as solubility and clarity. These failures have a great deal to do with the quality of the pharmaceutical packaging materials.

　　For the dissatisfaction of drug manufacturers, pharmaceutical packaging material enterprises also have a stomach full of bitterness.

　　In recent years, the National Development and Reform Commission has led 27 price reductions for drugs. The procurement policy for the basic drug system bidding promoted by the new healthcare reform also aims to reduce drug prices and improve the accessibility of healthcare services for all. Under such circumstances, reducing the cost of drug manufacturing has become a top priority for pharmaceutical companies. Pharmaceutical packaging materials are at the lowest end of the drug production chain, and therefore are the most costly area for upstream pharmaceutical companies to squeeze.

　　The industry estimates that in the I.V. product category, the cost of pharmaceutical packaging materials has reached 60%. But the long-standing domestic phenomenon of I.V. fluids being sold at a lower price than mineral water has left pharmaceutical companies struggling. Recently, Shandong's basic drug bidding procurement is the emergence of 100 ml volume of I.V. only 0.77 yuan of the winning bid. "How can I calculate the cost account is impossible to produce the same infusion products with such a low price." An industry insider said.

　　Recently, Hualan, the largest butyl rubber stopper company in China, called on rubber stopper manufacturers to stop adding trimmings to butyl rubber raw materials, and pharmaceutical companies to stop using such plugs to ensure drug safety. And this may be just the tip of the iceberg.

　　The constraints of the lack of standards

　　For a long time, some of China's pharmaceutical packaging products lack of industry standards or standards deficiencies, compared with the perfect and constantly revised drug standards are obviously lagging behind. At present, China's drug quality standards are mainly based on the "Chinese Pharmacopoeia", but the pharmacopoeia does not cover the size, shape, material, thickness, etc., which has laid the groundwork for a cost-cutting-oriented drug packaging materials market chaos.

　　It is understood that after China's comprehensive replacement of butyl plugs, due to the continued rise in the price of butyl rubber raw materials, in order to reduce the cost of plugs, the mouth of infusion bottles repeatedly become smaller, resulting in the circulation of products such as large infusion jump plugs, leakage and other phenomena. Ltd. is one of the two domestic enterprises producing neutral borosilicate glass for pharmaceutical use. The company's general manager Wang Huan a said that foreign pharmaceutical glass generally uses neutral borosilicate glass. Most domestic enterprises use low borosilicate glass, and this glass for some of the drugs, in line with quality standards, the shelf life of the product is very short, the recycling of drugs resulting in a huge waste of resources. In addition, in accordance with the relevant provisions, drug changes in packaging materials need to supplement the application, a longer period of time, even if the manufacturer has the desire to improve the quality, but also discouraged.

　　"Neutral borosilicate glass was not produced domestically, the high price of foreign products, restricting the use of the market, but now our company can produce, the production indicators are comparable to foreign products, but the market response is still not good, simply because manufacturers consider the cost and pharmaceutical packaging materials change the barriers to approval. In the long run, pharmaceutical packaging material enterprises have even less incentive to innovate." Wang Huan Yi said.

　　Pharmaceutical packaging materials are also medicines

　　Beijing Aoxing Hengxun Packaging Technology Co., Ltd. technical director Zhang Wenfang introduced, now, most foreign countries in the quality management of drugs to take dual standards, that is, in addition to the pharmacopoeia, there is a detailed set of industry technical standards as a complement to the pharmacopoeia. For example, the EU has parallel ISO standards in addition to the EU Pharmacopoeia, with both standards taking effect at the same time in regulating the quality of medicines, while the industry technical standards give detailed regulations on the use of pharmaceutical packaging materials.

　　Cai Hong said that government management and society as a whole should establish an understanding that pharmaceutical packaging ensures the quality and safety of medicines throughout the entire process of production, storage, transport and use, and that if a bare medicine is not packaged, it cannot be circulated and listed as a medicine. Therefore, pharmaceutical packaging materials have never been an auxiliary industry of drug production, but an integral part of drug production, pharmaceutical packaging materials and drugs are on an equal footing. Pharmaceutical packaging material enterprises generally reflect that, over the years, although the state of pharmaceutical technology upgrading, equipment transformation, new product development have corresponding funds, tax breaks and other policy support, but pharmaceutical packaging material enterprises have never enjoyed. At the same time, like butyl rubber raw materials, domestic petrochemical giant enterprises are able to produce, but because the pharmaceutical packaging industry is too small, the demand is low, Sinopec simply do not give production.

　　"I hope that when the state co-ordinates the development of various industries, it will also pay attention to some small industries and rationalise the allocation of resources. Small industries, despite their small total output value and low contribution rate, should not be underestimated in terms of their impact on large industries." An industry insider said.

　　Recently, the Ministry of Industry and Information Technology is widely consulted on the draft of the 12th Five-Year Plan for the development of the pharmaceutical industry. Cai Hong called for the management of pharmaceutical packaging materials as drugs in the 12th Five-Year Plan of the pharmaceutical industry, encouraging technological innovation and gradually adjusting the product structure; setting up industry access thresholds and adjusting the industrial structure through unions and mergers and acquisitions; improving the standardization system of pharmaceutical packaging materials; attaching importance to the development strategy of human resources; and formulating regulations and provisions on the safe packaging of pharmaceuticals for children. regulations and provisions on safe packaging for children of pharmaceuticals, etc.

　　At present, China has become the third largest pharmaceutical market in the world. In the global pharmaceutical market, in the absence of new drug research and development, pharmaceutical companies have been through the route of administration, target changes, expanding the indications as the direction of secondary research and development of drugs, pharmaceutical packaging material innovation has also become the focus of drug innovation competition. In recent years, several of the world's largest pharmaceutical packaging material manufacturers, represented by the United States Calcon, have been vigorously expanding their business in China, and the rise of China's pharmaceutical packaging material industry has become imminent.

　　Link to China Pharmaceutical News: http://www.yybnet.com/site1/zgyyb/html/2011-04/19/content_47505.htm