Base drug special risk warning path example

Based on the special risk warning path of the base medicine, select representative species to make demonstrations to demonstrate the existence of specific risks of the base medicine, the probability and probability of occurrence of the risk, and give a key technical route to identify risks.

Example

In the survey, the author selected three proprietary Chinese medicines of Compound Danshen Tablets, Radix Isatidis and Ginkgo Biloba in the 2009 edition of the list of basic medicines as representative representative products, which are all market-selling varieties.

From the comparison of the average price of the national average bid price of compound Danshen tablets and the market price of its core materials, we can see that the average bid price of this species has been declining for several years, and the market price of its core excipient Danshen has generally risen. From 2008 to 2009 At the end of the year, the overall trend of the two curves did not change much. In November 2009, the market transaction price of March rose significantly. Compared with 2010, the market price of borneol rises by more than 40%, the market price of Salvia changes by more than 60%, the market price of March 7 increases by more than 40%, and nationwide, the compound Salvia miltiorrhiza. The average bid price of the film was generally reduced. In 2013, the market price of Salvia miltiorrhizae continued to rise nearly twice, while the bid price of compound Danshen Tablets oscillated little.

Again kanban blue root. The average bid price of Banlangen in the country from the end of November 2009 to the end of 2011 fluctuates slightly but is not significant. Since 2009, the price of Radix Isatidis's core excipients in the nine Chinese herbal medicine markets has changed greatly. In 2010, raw material prices rose sharply. The average change rate in the two years increased by 140%, while Banlangen (the price of 20 packs) nationwide. The overall average price of the winning bids has changed slightly. Looking at the price of Ginkgo biloba leaves in 24 tablets, from December 2010 to December 2011, the prices of Ginkgo biloba leaf in the 9 Chinese herbal medicines market increased by an average of 150%. The average price of Ginkgo biloba leaves fell by nearly 200% during this period. , the bid price fluctuations. From the end of 2012 to the end of 2013, both the raw material market of Ginkgo biloba and the average bid price in the country experienced rapid short-term fluctuations.

Risk type

The enterprise bidding itself has the risk of winning the bid and not winning the bid. After the enterprise wins the bid, a successful contract is formed. If the objective environmental factors in the external market change, such as the sales volume is less than expected, the price of raw materials rises, the increase in labor costs and other factors are external factors beyond the control of the enterprise. However, the basic pharmaceutical species supply agreement has been Signed, the company's external environmental changes are facing default and non-default options.

The first option is a breach of contract, that is, no production is not available. At present, there are appropriate reasons for individual successful bidders to find out that they do not bear the liability for breach of contract, such as finding reasons from the perspective of raw material supply, adopting the decision of non-producing and non-supply without default, and avoiding the special risks caused by the bid-winning of base drugs and the risk of default and non-supply. The result of this choice is the shortage of essential medicines, which will cause ordinary people to become inaccessible to essential medicines, but it will not bring about risk of drug quality. In recent days, many ministries and commissions jointly issued a document to protect the supply of low-priced drugs, which will, to some extent, ease the supply of low-priced essential drugs.

The second option is no breach of contract, that is, continue production. This continuous production risk includes investment cost breakthroughs and expected difficulties in cash flow due to loan difficulties, coupled with the reduction in sales revenue due to rising labor costs, pressure from new GMP reforms, or sales volume that did not reach the expected target, and core materials. With long-term high prices and so on, the profits of enterprises are difficult to maintain. Whether it can guarantee the quality of the supply of drugs is a problem.

Warning signal

The use of compound Danshen tablets, Banlangen and Ginkgo biloba leaves as examples in the three market sales of large varieties can be seen that the raw material prices have great fluctuations, and the basic drug bid price is relatively stable. According to the general rules of product cost composition, raw materials account for 40% to 60% of the cost, equipment and labor costs account for about 20%, and product profits are generally around 20%. From the sample data, it can be seen that the transaction price of the basic drug raw materials market has changed a lot, and the change rate of the bid price is very small. From the perspective of the bid-based bidding of various regions this year, there is still the possibility of price cuts. According to the general law of product cost composition, the price of a certain class of base medicine raw materials rises by more than 40% within a certain period of time, which is the signal that such special medicine risks may occur. The longer the price of raw material transactions, the longer the price change. The greater the rate, the greater the risk of occurrence, because at this time the company is basically unprofitable, and it is highly probable that the quality risk of certain types of drug production is high. It is necessary to provide early warning and prevention of the specific risks of this type of drug.