At the beginning of this year, the double level 1 water-proof glass produced by the biggest injection bottle and ampoule bottle manufacturing enterprise in domestic-Chongqing Zhengchuan Glass Co., Ltd began to run at full capacity. On April 17, Zhengchuan Glass sales director Xiao Qing expressed that as the price of double level 1 water-proof glass is 30%~50% higher than the price of low borosilicate glass, the demand of last year is limited and the kiln operating rate is only 50%. With the promotion of new revised GMP certification, the requirement of pharmaceutical enterprises on packaging material quality is improved slightly. At present, double level 1 water-proof glass operating rate reaches 200%.
According to the process of new revised GMP certification, certification of sterile preparation had completed by the end of last year. In this year, only solid preparation needs full certification. The drug packaging material of our country starts late and the technical level lags behind relatively. With the promotion of new revised GMP certification, industrial upgrading admits no delay. The domestic butyl rubber manufacturing leading enterprise Jiangsu Hualan New Pharmaceutical Material Co., Ltd President Hua Guoping expressed that the new revised GMP drug packaging material industry upgrading is an opportunity and the standard improving function is gradually shown.
Drug packaging material improving standard
According to understanding, the largest change of the new revised GMP is that it improves the cleanliness requirement of sterile preparation production environment compared with the old version; especially the requirement on the package technology, sterilization and purification plant transformation, etc of injection medicine production enterprises is stricter. Therefore, infusion solution package, pharmaceutical glass and all kinds of packaging containers and its raw and auxiliary materials, accessories, etc face upgrading. If the drug packaging quality is sometimes substandard, it would not only lead to active pharmaceutical ingredient contamination, adsorption or even generating chemical reaction, making it into inferior medicines, more seriously, it would produce toxic and side effect.
Hua Guoping expressed that the quality of drug packaging material relies on the integrating degree with drug. The technological difficulty is compatibility, dissolved matter and transfer matters, etc. At the present stage, the understanding of our country’s drug packaging enterprise on drug compatibility test is superficial and research is limited. In addition, because the drug packaging material is a meager profit industry and the whole industry research input is insufficient, it is not practical to conduct compatibility research relying on a single enterprise.
As everyone knows that many rules and agents for one kind of drug is normal, which decides there are a wide range of drug packaging materials. It is a huge project if compatibility tests are conducted for all drugs. In view of the actual situation, our country’s competent department and industrial organization has launched several technical standards and guiding principles, trying to construct a complete drug packaging material quality prevention and control system.
Xiaoqing expressed that since the implementation of new revised GMP, the biggest change is the requirement on drug packaging materials in pharmaceutical enterprises is stricter, especially in production documents, raw material purchase and sale record and on-site inspection.
Related responsible person of Shanxi Guangsheng Capsule Co., Ltd said that the capsule disturbance was a major inspection in capsule industry and survival of the fittest purified the market. After the implementation of new revised GMP, some low-end capacity exits from the market; the industry concentration is improved and the situation of capsule products fighting each other is reversed. Viewing from the client base producing capsules, it involves wider and wider. Originally, the company customer base was mainly famous domestic enterprises and foreign enterprise; now, small and medium-sized drug companies begin to favor toward good capsules.
Cost driving is still not reversed
It is shown in relevant data that at present there are more than 1500 drug packaging materials enterprises which can produce over 90% drug packaging material products. However, most enterprises are small in size and low in technology and management level. The low level repeated production in medium and low-end products is serious. President of Jiangsu Runde Medical Materials Co., Ltd Zhu Shanben expressed that taking butyl rubber stoppers as an example, manufacturers develops to over 50 companies with production permits from a few factories, the production capacity is seriously surplus. At present, a half of enterprises are in shut down or semi-shutdown state. The running enterprises are running below capacity.
Film coated rubber stopper is a kind of rubber stopper developed to solve the compatibility of rubber stopper and the drug and lower potential safety hazard, widely used in ceftriaxone and other injection and biological products with higher safety. At the beginning of the product research, there were only less than 10 manufacturing enterprises in the whole country. As the competition becomes more and more intensively, it enters into low-profit era. Film coated rubber stopper begins to become "blue ocean” in the eyes of many enterprises and there are many registration applicants. By now, there are over 30 film coated rubber stopper manufacturing enterprises. Taking 20 specification film coated rubber stopper as an example, the price range is 0.8 yuan ~0.12 yuan. Hua Guoping expressed that 0.12 yuan is at a loss calculating according to the butyl rubber raw material cost and cost of production."
“In order to seize the market and shut out competitors, some enterprises even sacrifice profits to compete; this unfair competition and practice seriously disturbs the market.” Said Xiao Qing.
In fact, behind each fierce competition, the supply-demand relationship is working. Constant extrusion of pharmaceutical enterprises on upstream cost forced the packaging material enterprise to adapt and accommodate over and over. “After the implementation of medicine bidding “selecting the low price” policy, it is even harder for packaging material enterprises to operate” said Hua Guoping.
At present, the validity period of medicine is generally two years, but some medicines are about to reach the period of validity 8 months after some medicines coming into the market. It is shown in many sampling results conducted by the national authority that the clarity of large volume parenteral and chemical discoloration is the main unqualified items which are greatly connected with the packaging material’s quality. “Some enterprises constantly extrude the packaging material to reduce the cost. They know clearly that it is very likely to cause material migration when packaging with inferior packing materials and the period of validity can’t reach two years. Therefore, they increase effort in marketing, expecting to sell medicine in shortest time” said by an insider.
It is not enough to only rely on self-discipline
The main task of “the 12th five-year plan” development outline in pharmaceutical packaging industry is to improve industry concentration through uniting, merger and reorganization, etc, optimize existing pharmaceutical packaging material products varieties, promote the harmonious development of pharmaceutical packaging industry area, improve the creation and research ability of all kinds of pharmaceutical packaging products step by step, formulate standardization strategy, establish scientific and reasonable standardization system development goal, which are agreed in the industry. Taking Zhejiang Province as an example, it has formed an industrial distribution of Xinchang drug capsule area, Taizhou, Yuhuan medicine packaging area and Wenzhou medicine paddock.
Hua Guoping thinks that drug packaging material in our country here today faces major transformation. And it is not enough to just rely on industry self-regulation for product standard upgrading and quality improvement. It is a long way to go. “If the cost-oriented business model is not changed, the drug packaging material enterprises are far from self-regulation.” He called on that national authorities should increase drug inspection strength; especially the products that have launched for 20 months must be treated as required inspection items and should strengthen its inspection. In addition, association and industry organization should publish inspection results regularly and public recrimination to provide basis for pharmaceutical enterprises to search for good quality enterprises.
It is reported that since the implementation of new revised GMP, the capacity expansion of domestic packaging material enterprises is conducted synchronously and a new round of competition has started quietly. In future, developing new products, optimizing product structure, improve technical level and energy-saving and cost-reducing will be the mandatory quota to test the core competence of drug packaging enterprises, which also contains the path for enterprises to break through.
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