Small Drug Plant GMP Reform Dilemma

Core Tip: Two years ago, China's small and medium-sized pharmaceutical companies have always been a part of the flow of drug companies. The new version of GMP began to implement, in the face of increasingly severe living conditions, change or not change? How to change? The harsh reality must push small and medium-sized pharmaceutical companies to the fork in the future and must make choices.

“There are more than 20 production approvals. There are only 5 actually produced drugs. There are only one or two drugs that can be said to be sales.” Two years ago, Xiao He graduated from the pharmaceutical graduate school and came to work for a small pharmaceutical company. It was his description of the pharmaceutical production and sales at the time.

Xiao He, who has just entered the pharmaceutical factory, will face changes in the production process of the pharmaceutical factory every day. The replacement of pharmaceutical excipients is even more prevalent. This makes him attach great importance to the quality and production of pharmaceutical products.

Xiao He said that as long as he wears clean clothes during work, he can rush into the operation room, and the materials can be pulled directly into the workshop without leaving the packaging. For all this, he was very helpless at the time. The situation encountered by Xiao He was still present in a small number of small pharmaceutical factories two years ago.

New GMP Ebb Tide <br> <br> two years ago, China's small and medium sized pharmaceutical companies has been a part of the drift pharmaceutical companies army. In March 2011, the "Standards for the Quality Control of Pharmaceutical Production (Revised in 2010)" (hereinafter referred to as the "new version of GMP") began to be implemented. In the face of increasingly severe living conditions, will it be changed or not? How to change? The harsh reality must push small and medium-sized pharmaceutical companies to the fork in the future and must make choices.

Xiao He's pharmaceutical factory belongs to one of the goals of this new version of the GMP regulation. "The reform of small and medium-sized pharmaceutical companies can not be realized by the owners of pharmaceutical companies. Compared with powerful large enterprises, the reform of small and medium-sized pharmaceutical companies requires financial support. To meet the requirements of the new GMP, the company invested the most There are a few million yuan, and a high one is a hundred million yuan. Therefore, whether or not they can successfully get loans from banks is a realistic issue facing them." For these issues, Xiao He paid special attention to discussions with friends in the circle.

According to a survey, 90% of China's more than 5,000 drug manufacturers currently belong to small and medium-sized pharmaceutical companies. The irregular development of small and medium-sized enterprises has caused the phenomenon of “small, scattered, chaotic, and bad” in China's pharmaceutical market. As the new version of GMP raises the threshold for quality requirements, there will be at least 500 small and medium-sized pharmaceutical companies in the future, which will gradually withdraw from the market under the dual blow of their own defects and policy pressures, and complete the market to eliminate the survival of the fittest.

The State Food and Drug Administration has stated that the new version of GMP certification is not only implementing new industry standards and is trying to bring China's pharmaceutical industry into line with international standards; it is also a means for industry consolidation to reshuffle pharmaceuticals, a once-disordered industry. Eliminating those companies with low production capacity, repeated projects, and delays in the industry.

Small pharmaceutical companies thinking: <br> <br> cost of reform under the new GMP norms constraints, domestic pharmaceutical companies in order to achieve regulatory requirements, funds must be to the force. For small and medium-sized pharmaceutical companies, they want to upgrade and upgrade their market competitiveness as quickly as possible, but at the same time, the high cost of reforms makes them prohibitive.

The chief engineer in charge of the GMP project at a pharmaceutical company told the reporter that the new GMP has the greatest impact on the company as a sterile drug. At present, there is a difference between the standards of cleanliness implemented in China and the WHO standards and EU classification settings. Most large-volume injection companies and some freeze-dried powder injection companies need to be transformed. The Food and Drug Administration has said that in accordance with the new regulations, only hardware inputs will require 200 billion to 300 billion yuan. Assuming that one-third of the company's factories need to be demolished and rebuilt, only this part of the investment will be 30 billion to 50 billion yuan.

After a number of accounts, many small and medium-sized pharmaceutical companies have begun to play drums. For them, after the successful transformation, they are faced with poor management and will once again face the issue of survival.

Xiao He's drug factory invested more than 20 million yuan last year to conduct a GMP transformation of a workshop. “Our employees feel it, and the burden on the factory is getting worse. Fortunately, there is support from the government. Otherwise, it will be difficult.” Perhaps the support of the government in the GMP transformation of SMEs can give them breath.

Another way for the transformation of resource sharing <br> <br> small problem GMP pharmaceutical companies, there are people in the industry may wish to put forward another angle to look at. In fact, in the process of the new GMP reform, there was no "single wood bridge" for small and medium-sized pharmaceutical companies. The State Food and Drug Administration has stated clearly for the GMP certification that the GMP reform is not encouraged in all the workshops of all pharmaceutical factories, and the conversion, reorganization, and merger are also feasible ways for pharmaceutical companies.

Moreover, small and medium-sized pharmaceutical companies cannot achieve once and for all after reaching the new GMP certification, and strengthening and improving the environmental quality in the pharmaceutical industry in the long run is the ultimate goal of the new version of GMP.

Xiao He told reporters that the owner of his own pharmaceutical factory has been worrying recently. Original GMP reform has increased the operating costs of the company, but after the certification, there is a lack of sufficient funds to invest in marketing, and the scale has been expanded, but the benefits have declined.

In this regard, the relevant experts said in the interview that for small pharmaceutical companies, it is necessary to think twice, whether to treasure all the new GMP reform.

After the introduction of the new version of GMP, some of the transformed pharmaceutical plants have significantly increased their production capacity. According to statistics, the pharmaceutical production capacity is twice that of 2011. However, as the production capacity has increased exponentially, the issue of overcapacity has surfaced again, resulting in 50% of the 70% of the companies are idle.

Xiao He said that he recently heard experts inside the circle suggest why they did not unite enterprises together to build a GMP plant and achieve the sharing of production resources.

“Actually, if we build a GMP factory together, we can save money and we can focus more on product research and development and product sales. This not only solves the shortage of funds before the transformation, but also lays the foundation for the next development of small pharmaceutical plants. Basic.” Xiao He said that if his own pharmaceutical factory and many small pharmaceutical companies can take this path, future development will certainly be better.