On September 12th, the minutes of a meeting on national drug collection and collection were released. For a while, one stone stirred up thousands of waves, and the traditional Chinese medicine plate of the domestic stock market fell in an all-round way. For a long time, the whole industry has been busy with the work of "generic drug quality and efficacy consistency evaluation", working day and night to overcome difficulties (see: depth | all kinds of consistency evaluation). But when the long-awaited policy dividend arrives, the reaction seems to be more of a disappointment.
However, the national pilot project provided 11 key cities (Beijing, Shanghai, Tianjin, Chongqing and Shenyang, Dalian, Guangzhou, Shenzhen, Xiamen, Chengdu, Xi'an) with 60% of the drug purchase volume and 30% advance payment for the whole year. It is not insincere to ensure the order quantity and basic rebate of the winning enterprises. From the point of view of drug companies, however, the price must be reduced. Spending millions or even tens of millions of dollars, as well as countless manpower and painstaking efforts through the consistency evaluation, the original expectation of an appropriate price increase has been dashed, and it still seems to be an era of "low price theory". In addition to price cuts, drug companies must also ensure supply in the bid-winning year. When it comes to this point, in addition to distribution guarantee, the most important link is whether the production capacity of pharmaceutical companies can match 60% of the purchase volume of these 11 cities, taking into account the vast market outside these 11 cities.
National Drug quantity Purchasing Variety and generic Drug Enterprises through consistency Evaluation
It can be seen from the table that 5 of the 33 varieties, including Atto vastatin, rosuvastatin, clopidogrel, irbesartan and amlodipine, purchased more than 100 million tablets, with a maximum of 300 million tablets. From the point of view of pharmaceutical companies, if all of them win the bid, the pharmaceutical companies that are likely to take on the largest orders of more than 100 million are:
Although the scale of hundreds of millions of tablets in terms of a single order is indeed staggering, in terms of production capacity, people may generally think that it is bearable for many pharmaceutical companies. after all, the voice we often hear is that the annual production of 1 billion tablets or more, for this small demand of hundreds of millions of pieces, it should be said that the production capacity is more than enough.
However, how many pharmaceutical companies actually produce 1 billion tablets a year? Of the above 33 varieties, most of the original products account for more than half of the market, and even most of the market, the rest is divided up by domestic enterprises and imported generic drugs. Only a few imitation pharmaceutical manufacturers approach or exceed the market share of the original research, that is, there is a very stable supply market of large production capacity at ordinary times. As for some other domestic enterprises, the so-called large capacity is theoretical, but has not really been put into practice, so all aspects of the daily operation of the factory are configured according to the low capacity.
Although purchasing with volume means reducing prices, domestic pharmaceutical companies are mainly generic drugs, which are unlikely to sell at high prices, but in the face of such a large order, they are still willing to fight for it. At present, the enterprises that pass the consistency evaluation are mainly domestic large pharmaceutical companies, but with the progress of the consistency evaluation, some small and medium-sized enterprises will also have the opportunity to step into this threshold. Once you enter this threshold, you are naturally unwilling to go for a scuffle in the remaining 30%, 70%, and that 60%, 70%, is the goal. However, in the face of this big goal, pharmaceutical companies should first consider whether they can live in hold. Once the supply cannot be guaranteed because of production capacity, the penalty is inevitable. Although specific penalties have not yet been introduced, it is possible to restrict or deprive the right to supply as well as fines, and the losses outweigh the gain.
Even for big pharmaceutical companies, it may not be easy. Even if a large order can be digested by itself, it is bound to crowd out the resources of other varieties, and the production potential must still be tapped in order to ensure the supply of other varieties. If only one variety won the bid, it would be better, after all, multiple batches of continuous production, reduce the clearance work brought about by the replacement of products, and save time and cost. If more than one variety wins the bid, it is definitely a good thing, but we have to consider the supply cycle of different products, switch production schedules between different products, and we need to make a careful production plan.
Therefore, when dealing with the bidding, bargaining and negotiation of procurement with volume, we should also look back and figure out how to increase production capacity, so that we can better take orders and complete the supply task.
The following is a simple discussion from many angles.
人
If the production capacity is increased and the factory is busy, of course the workers will have to work more. The simplest and rudest way is to increase the number of shifts, from the previous one to two or even three. However, as a result, the front-line workers in the production workshop will certainly be very tired and complain, so they must be hired. However, unlike other factories, pharmaceutical workers must be physically healthy, free from infectious diseases, and more importantly, receive GMP and EHS training and pass the examination before taking up the post.
With the substantial increase in the number of product batches, the resulting inspection and release of raw materials, intermediate products and finished products are bound to increase, so it is inevitable to increase the number of QC posts. However, the supervision and management of production and inspection can not be left behind, and QA must be equipped to ensure that the quality of the product production inspection process can be controlled.
With the wave of mergers and acquisitions in recent years, many pharmaceutical companies are now collectivized. This gives rise to the possibility of mutual secondment of staff for emergency treatment. Nowadays, it is not easy to recruit workers, especially to recruit suitable employees for pharmaceutical companies in a short period of time. But the order is not waiting for people, so you can try to seconde personnel from the brother factory, which usually occurs in the workshop and inspection positions. Compared with recruiting new employees, the training content for seconded employees is much easier, and the operation department can pay more attention to how to settle down the lives of these temporary employees. If there is already a spare staff dormitory, it will naturally be much more convenient. If there are corresponding incentives to follow up, it will be more efficient.
Enterprises all say that employees are the most valuable wealth, so how to use this wealth is a test of the wisdom and ability of human resources departments.
机
To increase production capacity, in addition to increasing batches, it is easy to think of a way to replace large equipment and add new instruments. In this way, the batch can be significantly expanded and the inspection efficiency can be improved. However, this must take full account of the delivery cycle, as well as equipment 3Q certification and instrument verification. In addition, there is also the necessary process verification. Of course, the price cannot be blindly considered when purchasing equipment, and after-sales service is also very important. after all, the machine can never be fault-free, and some failures cannot be solved by colleagues in the engineering department.
Similarly, if there is a sibling unit and the equipment happens to be idle, you can also consider secondment or asset transfer after valuation.
This work requires close cooperation between the purchasing department and the engineering department.
料
A skillful housewife cannot make bricks without rice, and a large order means an increase in the purchase of raw materials.
First of all, the most important thing is the API, if it is self-produced, it is better to control; if it is your own factory, you should make the production plan of the API at the same time, and if it is the brother's, you also need to communicate well to ensure the quality and quantity of the API is supplied on time. If you are outsourced, you must do a good job in supplier management. in addition to ensuring timely supply, you also need to specify quality requirements in the quality agreement, especially if there are changes in the process and testing methods, which must be notified in time; the second is auxiliary materials, which basically need to be purchased, and it is also necessary to ensure supply and quality, especially to pay attention to imported accessories, and the supply cycle should be paid special attention. Generally speaking, the inner packing material will attract enough attention, but the outer packing material and instructions are easy to be ignored. once a mistake is made, it will delay the packaging process and lead to the failure of random inspection and release. In addition, in the QC department, the probability of problems with reagents is generally low, but attention must be paid to the key materials such as standards and chromatographic columns.
This work requires the business department to estimate the order demand as accurately as possible so that the production planning position can determine the material demand. At the same time, the purchasing department is also required to maintain close contact with suppliers. QA do a good job of supplier qualification identification, as well as QC timely inspection and release.
法
Every action of pharmaceutical activities is inseparable from the compliance requirements of laws and regulations, which is not only the responsibility of the registration department or QA department, but also the responsibility of all employees of pharmaceutical companies.
In order to cope with orders that may have never existed before, production capacity must be increased, and in the process, large and small changes must be made, such as expanding batches, adding or replacing equipment, and so on. Or add production lines in other workshops in the factory, transfer technology within the group, or even find external contract sites directly, and there must be validated data behind these changes. Some changes can be submitted to the competent authorities for filing, while some changes must be submitted for supplementary application and approved before they can be implemented. However, no matter what kind of change, it needs to be cyclical, supported by research data, and carried out under the premise of compliance, all of which need to be prepared in advance.
环
The whole life cycle of the product is a dynamic process, and the production inspection of drugs is not fixed in a certain place.
Some production capacity can be tapped through the internal potential of the factory, and sometimes we can find suitable facilities within the group to increase the production site, or consider looking for external resources to take commissioned processing after combining various factors. The former work mainly involves internal personnel, while the latter two will be much more complicated, especially external resources not only need to involve commercial negotiations, but also must be approved by the regulatory authorities, with a longer cycle, if their own plant is unable to expand capacity within a short period of time, commissioned processing is the only way. The ideal situation is for the two sides to reach a strategic alliance, and it is OK for each other as a reserve force, but if both sides get large orders, they must find another partner.
As mentioned above, there are many ways to increase production capacity, of course, there may be other ways, and there can be a variety of combinations to make reasonable choices according to the actual situation. The above ways of capacity expansion, upfront cost input, and cost calculation and cost allocation in the production process are not the same, but also to a certain extent affect where their own floor price is during the bidding negotiation. In addition, the mode of production and supply of pharmaceutical factories may also affect the grading of the competent authorities when choosing enterprises to a certain extent.
In short, at present, the country is only taking 11 cities as a pilot project. Although these 11 cities play an important role in the national pharmaceutical market, there is still a large gap between them and the whole country. If the pilot work is popularized in the future, the order volume will rise sharply. In the past, it was the original R & D drug factory that occupied a large share of the market, but now take out this part of the order. If the original R & D pharmaceutical company is willing to reduce the price and participate in it, it will naturally benefit medical insurance funds and the general public; if the original R & D drug factory gives up, it will be left to local generic drug companies. Of course, there may be twists and turns, and everyone will have the opportunity every year. At this time, a new requirement is put forward, that is, the production capacity of each manufacturer should be more flexible, like a sponge. If you don't win the bid, you have to fight for a smaller market, which is easier to deal with from the factory's point of view, but once you win the bid, it will be a huge capacity demand. The question that may need to be considered at this time is, where is such a large scalable capacity usually hidden, without bringing huge cost-sharing to drug companies? Will the CMO business be an opportunity?