2018 is a crucial year for generic drug companies, because the end of this year will complete the quality consistency evaluation of chemical solid drug oral solid preparations in the National Essential Drugs List approved before October 1, 2007. In order to improve and improve the supply and protection policies for generic drugs, at the second meeting of the Central Comprehensive Deepening Reform Leading Group held on January 23, the “Opinions on Reforming and Perfecting the Supply and Protection Policies for Generic Drugs†were reviewed and approved. (hereinafter referred to as "Opinions").
The "Opinions" clearly stipulate that it is necessary to focus on the needs of the masses, focus on clinical necessity, exact curative effect, supply shortage, prevention and treatment of major infectious diseases and rare diseases, handling public health emergencies, and children's medications, and promote the innovation and promotion of generic drugs. Quality and efficacy, improve the ability to supply medicines, and better protect the needs of the people.
From this point of view, in the future, ensuring the demand for generic drug use and quality efficacy will become the focus of corporate work. According to relevant statistics, at present, China's generic pharmaceutical companies account for more than 90%. The introduction and landing of this "Opinions" will completely affect their destiny for more than 4,500 generic drug companies, and it is not for pharmaceutical equipment companies. What?
Although the relevant documents have not yet been published, the policies promulgated from the previous issues, such as the “Standards for the Evaluation of the Quality of Drugs for Conformity Evaluationâ€, the “Opinions on Reforming the Examination and Approval System for Medical Devices for Drugsâ€, and the encouragement of drugs for the reform of the review and approval system The opinions of medical device innovation can find the key points to ensure supply, increase quality and increase efficiency.
However, because generic drugs spend less time, manpower, and financial resources than the original research drugs, and the benefits come quickly, the phenomenon of domestic enterprises gathering together to produce generic drugs has also led to fierce competition in the industry. Therefore, in order to assist the generic drug companies to complete the consistency evaluation work before the deadline, and to ensure the supply and quality of the drugs, the pharmaceutical equipment enterprises will also be a busy year in 2018.
In terms of guaranteeing the supply of medicines, the shortage of cheap life-saving drugs, the shortage of rare medicines and the shortage of children's medicines have sounded the alarm for the pharmaceutical industry. With the introduction of the "Opinions", pharmaceutical companies will increase production. Strength, improve production efficiency. At this time, the automation and intelligence of pharmaceutical equipment needs to play a role. The author understands that the degree of equipment automation in the industry has been greatly improved, and the intelligence is gradually emerging. However, from the perspective of the demand of the pharmaceutical market, in order to better protect the supply, the pharmaceutical equipment enterprises will also need automatic equipment in 2018. Intelligentization is the goal of research and development.
In fact, the domestic industry has made some achievements in the research and development of automatic intelligent equipment. For example, in the pre-pulverization treatment system of traditional Chinese medicine, not only the equipment is operated automatically, but also the staff is not required to be on duty, and the production efficiency can be improved by 20% compared with the previous equipment. Parameters such as crushing temperature, material addition, motor current, and system mixing can be automatically maintained in an optimal working state to achieve intelligent production.
In addition, some pharmaceutical companies are also improving the level of integration, continuity, automation, digitization, networking and intelligence on the basis of improving the basic performance of pharmaceutical equipment. By improving the compliance and openness of pharmaceutical equipment, enhancing the functions of information uploading and control and Netcom interconnection, a truly intelligent pharmaceutical equipment is formed, which realizes batch control and batch management of pharmaceutical production automation and flexibility, and establishes a real MES system. And to create the foundation for smart manufacturing and smart factories.
In terms of drug quality enhancement and efficiency enhancement, the "Opinions" have been specified, and the relevant experts have clearly stated that the generic drug evaluation work cannot pursue the quantity at the expense of quality, and must always adhere to the quality priority, and the drug that has passed the consistency evaluation will be followed. Increase supervision. Therefore, for generic pharmaceutical companies, quality is always a level in front of development, and quality production should be done.
Quality, quality first. Although the "low price" is no longer "crazy", it does not mean that it has completely disappeared. There are still some pharmaceutical equipment companies struggling in this regard. However, from the overall perspective of the pharmaceutical industry as a whole, high-quality and high-end equipment will be the star of the future. Just relying on “lower price and more†will not bring substantial effect to the generic drug companies through consistency evaluation. Therefore, the time limit for the long distance is long, and the rectification and upgrading of pharmaceutical equipment companies is not too late. So how do you do it?
It is not practical to abandon these devices at once. After all, we must survive in the market. Enterprises can start with the most basic production. From the materials and components required for the equipment to the production technology and quality supervision, if you do it, these can bring practical results to improve the quality of the equipment. And gradually enter the right track, forming a set of high-quality production system of the enterprise itself, and those equipment that does not meet the market demand will be automatically eliminated.
Of course, for a leading company with strength, the above may be "pediatrics." However, quality is always the foundation of production. Enterprises with stronger strength also have a day when the details and quality fall to the altar. Isn't Japan's Kobelco fraud a good example? Therefore, starting from the basics, doing a good job in daily production, pharmaceutical equipment companies can contribute to the quality and efficiency of drugs.
Faced with the advent of generic consistency evaluation, pharmaceutical equipment companies should be nervous. This is not only about their own destiny, but also whether pharmaceutical companies can increase their concentration in the industry. Most companies will survive the current situation of elimination. The people's medication needs and medication safety. Therefore, now that it is too late, pharmaceutical equipment companies need to produce quality and quantity, and they must always practice innovative ideas to develop equipment.
(Author: Fan Ying)
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