The development of pharmaceutical glass bottle packaging industry still needs "dual wheel drive"

In recent years, local drug regulatory authorities have successively detected "visible foreign objects" in drug injections. Experts say that once these "visible foreignobjects" enter the human body, they can easily cause capillary blockage and granuloma, which can affect the quality of the drug solution in mild cases, affect the health of the drug user in severe cases, and even endanger life. After in-depth investigation by the media, it was found that the appearance of "visible foreign objects" is related to the use of low-quality glass bottles in some injections. At this point, the packaging defects of pharmaceutical glass bottles, known as "public secrets of the pharmaceutical industry" by industry insiders, have once again been put on the table.

Medicinal glass bottles are widely used in the industry and have a broad market

Compared to packaging materials such as plastic products, aluminum products, and paper products, glass bottles have been widely used in the food and drug packaging industry due to their stable chemical properties, transparency, aesthetics, and high temperature resistance. Especially in the pharmaceutical packaging industry, the unique characteristics of drugs require a certain level of packaging materials. For certain special formulations, pharmaceutical glass bottle packaging plays an irreplaceable role.　　

According to relevant statistical data, the global glass bottle market size was 33.1 billion US dollars in 2011, increased to 34.8 billion US dollars in 2012, and is expected to increase to 36.8 billion US dollars in 2013. China is the world's largest producer and consumer of glass bottles. The production of glass bottles in China exceeds 10 million tons. During the 12th Five Year Plan period, China's production of glass bottles also experienced rapid growth. Experts point out that drugs have always been a major user of glass bottle packaging, and a large part of the "achievements" in the glass bottle market come from the pharmaceutical industry.

With the inclusion of "Healthy China" in the 13th Five Year Plan, pharmaceutical reform has become a national strategy. Industry insiders predict that the continuous deepening of medical reform and the continuous introduction of various pharmaceutical policies will usher in a period of rapid development for China's pharmaceutical industry. Due to correlation, the development of the pharmaceutical industry will inevitably drive the development of additional industries, and the pharmaceutical glass bottle packaging market will continue to expand in scale with the development of the pharmaceutical industry. 2016 is the beginning year of the 13th Five Year Plan for healthcare reform, and the pharmaceutical glass bottle packaging market is expected to experience a growth peak this year.

Frequent problems, domestic products should strive for self-improvement　　

　　In July 2015, the Jiangxi Provincial Food and Drug Administration also issued a notice that 51 batches of injection were found to have "visible foreign objects" that were not qualified; Among the unqualified drugs sampled by the Anhui Provincial Food and Drug Administration, 16 batches of injection found "visible foreign objects"; In March 2016, according to the drug sampling information released by the Anhui Provincial Food and Drug Administration, Xiangdan Injection produced by Henan Tongyuan Pharmaceutical Co., Ltd. was batch number 140612; The injection of gentamicin sulfate and lincomycin hydrochloride produced by Jiangsu Lianshui Pharmaceutical Co., Ltd., batch numbers 15032541, 140820, etc., were detected as "visible foreign objects"……　　

What is "visible foreign object"? What are the hazards? The Chinese Pharmacopoeia specifies that visible foreign objects refer to insoluble substances such as glass shavings, cilia, white spots, and white lumps that are visible and larger than 50 microns. Experts say that once "visible foreign objects" enter the human body with the injection, they can easily cause capillary blockage and granuloma. Mild cases can affect the quality of the medication, while severe cases can affect the health of the user and even endanger their life. So where do these "visible foreign objects" come from? Liu Yan, Director of the Drug Packaging Material Testing Center of Tianjin Institute of Drug Control, said that "visible foreign objects" are not only related to raw materials, equipment, and environment in drug production, but also to the quality of packaging glass.

It is reported that pharmaceutical packaging glass is ranked in descending order according to its various properties: neutral borosilicate glass, high borosilicate glass, low borosilicate glass, and sodium calcium glass. Neutral borosilicate glass, due to its good chemical stability, low alkaline leaching, and water resistance, is particularly suitable for drugs that are slightly acidic, alkaline, and pH sensitive. Therefore, neutral borosilicate glass is widely used in injection packaging in developed countries, and countries such as Russia and India are also vigorously promoting it. However, in China, most injection glass packaging still uses low borosilicate glass.

A large part of the low usage rate of neutral borosilicate glass in Chinese pharmaceutical companies is due to cost issues. It is understood that currently, neutral borosilicate glass has been mainly monopolized by foreign enterprises in terms of technology, and the price entering the domestic market is more than ten times that of ordinary medicinal glass, with a price of about 27000 yuan per ton; The price of domestically produced qualified neutral borosilicate glass is also much more expensive than low borosilicate glass and sodium calcium glass, with a price of about 12000 yuan per ton. Experts say that even if domestic neutral glass is used, the packaging cost will increase by about twice. In the current provincial drug centralized bidding and procurement dominated by low prices, it is difficult to gain a competitive advantage by using neutral glass packaging injections.

Faced with the increasingly large market and the monopoly of foreign enterprises, domestic pharmaceutical packaging glass bottle production enterprises should continuously conduct research and innovation, improve production technology, break the monopoly of foreign enterprises, reduce production costs, and thus lower the price of pharmaceutical packaging glass bottles, while realizing enterprise value and reaping corporate social value.

Industrial growth cannot be achieved without policy support

It is understood that the utilization rate of neutral borosilicate glass in Chinese pharmaceutical companies is low, and another reason why many pharmaceutical companies have not yet updated or replaced is due to policy approval issues. On November 8, 2012, the State Food and Drug Administration issued a notice on strengthening the supervision and management of pharmaceutical glass packaging injection drugs ([2012] No. 132). According to the notice, for the upgrading of injection packaging materials, pharmaceutical companies need to report to the food and drug regulatory departments of their respective provinces, regions, and cities for approval. However, it is understood that some provincial and municipal food and drug regulatory departments do not accept such supplementary applications and require enterprises to apply to the National Food and Drug Administration. In some places, the approval time is too long. Taking Harbin Sanjing Pharmaceutical as an example, their production of vitamin B6 uses neutral borosilicate glass. The change report has been unsuccessful since 2012, so this variety has been forced to stop production until now.

On the other hand, the high testing costs have also deterred many pharmaceutical companies. After upgrading the pharmaceutical glass packaging and completing compatibility testing verification, the pharmaceutical company shall report to the local food and drug regulatory department for record. Some provincial, regional, and municipal food and drug regulatory departments require enterprises to provide testing reports issued by testing institutions recognized by the National Food and Drug Administration. Third party institutions can test one variety for as little as 70000 to 80000 yuan, and most enterprises have dozens of varieties, which is expensive and difficult to bear.

summary

Pharmaceutical packaging glass is related to the quality of pharmaceutical preparations and indirectly affects the life safety of drug users. In the current situation where food and drug safety issues frequently occur and the country continues to strengthen control, pharmaceutical production related enterprises should strictly control quality, prioritize product quality, and continuously update and improve processes. At the same time, in the face of the current difficulties in the pharmaceutical glass bottle packaging industry, the government should provide support and encouragement at the policy level, simplify the filing and approval procedures, improve work efficiency, and from the perspectives of both enterprises and the public, while finding ways to reduce enterprise costs, meet the needs of the people.