Analysis on the development of pharmaceutical pack

2022-09-23
  • Detail

Analysis of the development of China's pharmaceutical packaging industry

the outline of the 11th Five Year Plan for the development of the packaging industry mentioned that the quality of China's pharmaceutical packaging materials and packaging varieties are significantly lower than the international level. In developed countries, pharmaceutical packaging accounts for 30% of the value of pharmaceutical products, while China has only 10%. At present, the annual output value of China's pharmaceutical packaging industry is about 15billion yuan, which can only meet about 80% of the needs of domestic pharmaceutical enterprises, which has prompted the pharmaceutical packaging industry to quickly develop traditional materials in recent years, generally hips or ABS. Experts predict that the next five years will be a period of rapid development of China's pharmaceutical packaging industry

the management of drug packaging materials has been paid more and more attention, which is directly reflected in the successive introduction of rules and regulations. According to the relevant person in charge of the State Food and drug administration, in order to strengthen the supervision of packaging materials and containers in direct contact with drugs, the State Food and drug administration has successively promulgated 34 national standards for packaging materials and containers for drugs, 25 standards for inspection methods of packaging materials for drugs, and issued the measures for the administration of packaging materials and containers in direct contact with drugs in the past two years "Notice on strengthening the supervision and management of the packaging of traditional Chinese medicine slices", etc

now, infusion packages used in large hospitals, including rubber plugs, infusion tubes, etc., are purchased from approved manufacturers; If there is no infusion tube for large-scale infusion, the hospital equipment department will also be equipped with some infusion accessories with strong versatility, which are all disposable

now nurses have relatively high academic qualifications and continue to receive training in drug packaging and equipment use. Drug manufacturing enterprises have also established a drug return and exchange system. If there is a problem with the packaging, as long as you hit one, someone in the pharmaceutical factory will solve it. Now, not only hospitals and enterprises attach great importance to it, but also patients. Once there is a problem with the packaging, they will take the initiative to ask for a return. "

the relevant person in charge of the Pharmaceutical Packaging Industry Association believes that the quality of pharmaceutical packaging materials is purchased. At present, the purchase method of packaging materials is mainly the choice of pharmaceutical companies. As long as pharmaceutical companies are willing to pay, they can buy products of corresponding quality

as the person in charge of drug manufacturing enterprises, Xie Mingfang, vice chairman and executive president of Shijiazhuang Pharmaceutical Group, knows well about drug packaging. He said that in the stone Pharmaceutical Group, there is a place: the packaging materials with special requirements for the exhibition hall of China Import and Export Commodities Fair in Pazhou, Guangzhou, China will be produced by themselves, such as soft bags for infusion. The packaging requirements are in a sterile environment, assembly line operation, and can only be produced by themselves. Most of the others are purchased from packaging material manufacturers, but the other party must have passed the verification of national quality standards

Xie Mingfang said that in the past, the competent government departments did not have relevant management regulations, and the packaging material enterprises did not have licenses. Now the state has promulgated a series of regulations to manage the packaging materials qualitatively and quantitatively, so that the drugs can meet the requirements of safe drug use from the inside to the outside

drug packaging materials need to set standards

although the drug packaging materials industry has been calm for a long time, the state has issued many targeted management measures, but there are still many problems

the first is quality. It is reported that the quality of packaging in direct contact with the packaging of drugs will be directly reflected in the efficacy. "If the quality of packaging materials is not good, the negative effects will be far greater than its positive effects. At this time, drugs can not be called drugs, but poisons. Packaging materials are also an important standard to distinguish between real drugs and fake drugs". Although infusion packaging materials are purchased from licensed enterprises, it is difficult to avoid the discovery of trace bacteria during particle control and bacterial culture. Theoretically, such a problem should not occur, because some reactions and impurities cannot be seen, but they can produce serious adverse reactions and endanger the health of patients. As a typical example, a patient's upstream industry chain such as battery, electrolyte and diaphragm industry will bear the burden of a fixed price reduction pressure in the future. After injecting amino acid infusion, he developed symptoms of high fever. The investigation found that the reason was bacterial pollution in packaging materials. And the more nutritious the liquid is, the easier it is for bacteria to breed

among the existing pharmaceutical packaging material production enterprises in China, most of them are township collective enterprises, with small scale, low level of equipment, technology, management and personnel quality, unstable product quality and other problems. For a long time, China has not set up a supervision and personnel approval system for imported drug packaging materials. But in actual work, we do find that the quality of some imported products is unstable. Especially after China's entry into WTO, the import of drug packaging materials has increased significantly. In order to control the quality, it is necessary to set up a personnel approval procedure for imported drug packaging products. The competent government departments should issue relevant guidelines and policies to optimize the organizational structure, enterprise structure and product structure of China's pharmaceutical packaging industry, allocate resources reasonably, and fundamentally improve the overall level of China's pharmaceutical packaging industry

the packaging specifications of drugs are too few

drugs and infusion in China's market are large packages, which are very easy to be polluted after unpacking. Drugs will deteriorate in high temperature and humid environment, and many drugs have the same appearance, which is easy to be confused. Tens of thousands of drugs abroad have hundreds of thousands of specifications. There are many specifications, which are also very convenient to use. It is recommended that manufacturers increase small specifications, preferably single dose packaging. However, the manufacturer believes that such cost is too high and the process is complex to achieve

then re calibrate the sensor to work normally. For drug manufacturers, increasing drug specifications will not only complicate the process, but also reduce the batch size, and the cost will increase accordingly. But this is only one aspect of the problem. Production should also meet the needs of the market. Some drugs only need half a bottle of dose. Opening one bottle will inevitably cause waste, but from the perspective of hospital procurement, there is no diversified demand. Although clinical use requires a variety of specifications, increasing specifications is also a trend, but if small specifications of drugs are produced, I'm afraid they can't be sold

source of information:

Copyright © 2011 JIN SHI