Seventy percent of enterprises or eliminated injection consistency evaluation is faced with three options

On 15 November, the Technical Requirements for the Evaluation of the Quality and Efficacy of Chemical Injection Imitations (Draft for Comments) and the Requirements for the Declaration of Information on the Quality and Efficacy Consistency Evaluation of Injectables of Listed Chemical Injections (Draft for Comments) will conclude the consultation. Recently, CDE's official website also published the "Chemical injection generic drugs (special injections) quality and efficacy of consistent evaluation of technical requirements (draft for comments), the consultation time as of December 5.The industry's attention to the long-time evaluation of injection consistency really opened the curtain. The reason why the draft for comments caused everyone to attach great importance to, first, the difficulty of injection consistency evaluation, second, behind its huge market and profits, and third, followed by injection consistency evaluation is of course the national drug concentration belt procurement.The industry is, whether in the production or sale of drugs, injections are in the leading position in the pharmaceutical market. Data show that domestic chemical injections accounted for 72% of the share of injections, generic drugs in the two major categories - solid preparations and injections accounted for more than 80% of the public hospital market, and injections accounted for about two-thirds; The requirements of injection production level are very high, and there is a big gap with foreign advanced production technology, so the consistent evaluation of generic injections has been considered to be a major policy affecting China's pharmaceutical industry structure.It is estimated that after the consistent evaluation, only 20% to 30% of the thousands of enterprises remain. To this end, the relevant departments of the state to the injection consistency evaluation is cautious, but for the social and economic benefits of the dual considerations, but also must be resolved as soon as possible. After the successful implementation and experience of the consistent evaluation of solid preparations, the evaluation of injection consistency has become the national will to improve the quality of medicines and solve the problems left over from history, and it is also a hot topic at the moment. And this draft for comments should be the hope of the people, water into the canal.The reason why enterprises are eager to evaluate the consistency of injections, the deep-seated driving force is of course, such as the "4 plus 7" urban belt volume and other national procurement policies. Of course, at present, generic drug companies on the consistency evaluation is not all heartless, go all out to participate. There are probably three kinds of enterprises: one is the desire to win, mainly strong enterprises and medium-sized enterprises with technological advantages;However, in either case, the end result of the choice will still fall on the market competition. Therefore, the formulation of market strategy must change the past "market for the market" traditional model, market strategy must be ahead of the way. At the same time, the enterprise strategy is also extended to the market operation accordingly, that is, the enterprise strategy and the market strategy should be highly integrated, in order to get out of a development path in line with the characteristics of the enterprise itself.Do not blindly follow the trendspecifically, the first enterprise strategy is to go all out to take the injection consistency evaluation. First screen the varieties, there is a sequence. The main varieties focus on the advantage of the force to pass at the fastest speed, do not give opponents any chance, to avoid delay or price reduction determination is small and "lost Jingzhou"; The market strategy should consider the size of the market stock and the future price reduction after the profit comparison.Although the second enterprise chose to give up, but by no means a military-style escape, can not lose confidence, to grasp the time, space two buffer factors. Although injection consistency evaluation and national centralized procurement is the general trend, but after all, full implementation is still a period of time, some even a considerable period of time, in this rare gap can make a difference, this is a time opportunity.In addition to national health insurance, there are private clinics, private hospitals and other self-funded markets. Do a good job of transformation operation, open up out-of-hospital pharmacies is a small and medium-sized generic pharmaceutical companies to avoid the market way out, but also can get involved in OTC and large health market, step a little bigger, the transition to the policy-influenced small high-end medical market and private hospital market. This is room for space. There is also room for products, such as the choice of not centralized procurement without consistent evaluation, similar efficacy of varieties to operate.For a third business, wait-and-see is itself a stopgap measure to balance market opportunities and strategic direction, and static braking is not a way, but don't procrastinate too long. Now injection consistency evaluation costs are 8 million to 10 million yuan, small and medium-sized enterprises is a small investment, and the future market and participate in the centralized procurement of blood after the profit support is not known, if not pay attention to control production costs, pour all its completion of consistency evaluation, it is not necessarily able to purchase the winning bid.Faced with the choice of life and death, either backwater war may be put to death, or the strategic shift jumped out of the "Red Sea." Really can not, can also move forward to the market, tilt to the API, because the chemical injection is only the finished product, the core is ultimately the API, "the RAW drug to get the market" truth is still valid. Those enterprises with the integration of raw material preparations, although there are not many varieties of consistent evaluation drugs, will still have significant advantages in the future competition. Because even after centralized procurement, the price of preparation drugs dropped, but the production of raw materials enterprises are after all a minority. Therefore, being able to control the production of raw materials is likely to be idle.In short, in the national collection, drug price reduction trend, pharmaceutical production enterprises must not blindly follow the trend, to do not panic in the chaos, in a variety of options to do a good job in the strategy and the market's high integration, in order not to fear the clouds to cover their eyes, and strive to be at the highest level.
(Medical Economics)