Shanghai First Biochemical Pharmaceutical Co., Ltd., which was involved in the "Protamine Out of Stock Storm", is a wholly-owned subsidiary of Shanghai Pharmaceutical Group. Starting from this year, the first biochemical pharmaceutical company terminated its cooperation with the original raw material supplier. The shortage of raw materials directly leads to the shortage of protamine in the market, and many cardiac surgery operations have to be stopped.
Xu Guoxiong told reporters that at present, there are three companies in the country that hold the approval for the production of protamine, but the other two companies stopped producing this variety two or three years ago. At present, only the first biochemical company in China is still supplying.
Low-priced drugs like protamine are not a case. Many life-saving drugs are facing the dilemma of protamine.
Exclusive production and supply are in a hurry.
Protamine is an alkaline protein sulfate extracted from fresh mature sperm of fish. It is used for bleeding and spontaneous bleeding caused by heparin overdose, especially for patients who have adopted cardiopulmonary bypass in heart surgery, and there is no substitute for other drugs.
20 1 1 since the first half of the year, protamine in Nanjing, Wuhan, Nantong and other places has been in a hurry. Due to the shortage of this emergency medicine, some heart operations have to be stopped, and hospitals and patients have no way to seek medical treatment everywhere.
Relevant persons from the State Administration of Pharmaceutical Products said that at present, there are only three domestic enterprises with protamine production approval documents, namely Shanghai No.1 Biochemical Pharmaceutical Co., Ltd., Yuekang Pharmaceutical Group Beijing Hyatt Pharmaceutical Co., Ltd. and Duoduo Pharmaceutical Co., Ltd.. At present, it is out of stock. In addition to coordinating the production of these enterprises, other companies will also urgently handle the production approval requirements and give "green channel" support in the process. At present, among the three enterprises that have been approved to produce protamine, Beijing Yuekang Pharmaceutical Group has started production under the coordination of the drug supervision department.
"Protamine production cycle is about half a month. Our second batch of goods will start production around 16 this month and can be supplied at the end of the month. " A staff member of the sales department of Yuekang Pharmaceutical Group said that the first batch of goods had all been delivered in Beijing.
Why is there a national supply shortage?
"The goods are too concentrated. Only one of our pharmaceutical factories continues to produce this medicine, but since this year we have changed the raw material supplier, which requires a three-month quality stability inspection period, so the supply has been delayed. " Xu Guoxiong told reporters that in the past, the raw materials of the First Biochemical Company were all purchased from a pharmaceutical factory in Qingdao, but this year, for the sake of safety supervision and cost reduction, the First Biochemical Company began to supply its own raw materials. However, according to the new pharmacopoeia standard, the requirements for raw materials and production technology are higher, and there is another three-month investigation period, and the raw material factors are limited, and the first biochemical protamine output drops sharply.
He told reporters that in 20 10, the first biochemical company * * * put 1 0.2 million protamine into the market, but from1to August this year, the total * * * only supplied 200,000 protamine, and the huge gap directly led to an emergency in the market supply.
"Many hospital deans call us to supply, and we are also very anxious." Xu Guoxiong told reporters that although protamine has little profit and is on the verge of profit and loss, the company will not give up production. "After this special period has passed, we can immediately resume the supply of 80,000 to 90,000 pieces per month and produce at full capacity, which can basically meet the needs of the national market."
Embarrassed cheap old medicine
Protamine is an emergency medicine in heart surgery. Why is there only one pharmaceutical factory in China? Is there something else hidden in this?
"This medicine is old medicine. Government pricing has not changed for more than ten years. Enterprises are profit-seeking. If there is no profit, they are definitely not willing to produce. " A person in the pharmaceutical industry admits that the absolute dosage of this drug is not large. For large pharmaceutical companies, the drug price is not high, the profit is too low, and the dosage cannot go up. Logistics costs and raw material prices are rising, which is unbearable for enterprises. "From the market and medical point of view, protamine is a medicine that is not used in large quantities, but must be prepared and really needed in an emergency."
Xu Guoxiong told reporters that the ex-factory price of protamine is 8.5 yuan, and the bidding price is 1 1.5 yuan. The profit of the first biochemical production of this drug is meager. "This medicine was at this price more than ten years ago."
For the other two companies that got the approval, these two companies stopped production as early as three years ago because the drug price was too low. In the past three years, protamine in the national market was all supplied by First Biochemical Company.
It is not uncommon for cheap old drugs to be in short supply or even disappear directly into the market. Previously, chlortetracycline hydrochloride eye ointment produced by Shanghai General Pharmaceutical Co., Ltd. also encountered the dilemma that pharmacies were out of stock and had nowhere to buy.
Lv Jiuhui, deputy general manager of Yuekang Tong Yuan Pharmaceutical, a subsidiary of Yuekang Group, said: "Protamine 10 will arrive in Beijing. There are many examples of such out-of-stock, and many drugs without substitutes are hard to find in the market. Protamine is just a case of media attention. "
In 2009, in the latest round of bidding for Beijing Pharmaceutical, a list of drugs in short supply was specially made and the bidding was organized separately. In this "list of drugs in short supply", in addition to the old faces such as blood products, the most common drugs such as vitamin C Yinqiao tablets, painkillers and erythromycin are all on the list, and the specific drugs for treating nitrite poisoning, protamine and methylene blue, are also impressively listed.
The above catalogue was made by hospitals in Beijing according to the data collected in clinical use in 2008. Most of these varieties are in short supply in China.
Although most of them have been listed in the national list of essential drugs, which reflects the policy inclination, in practice, these drugs are still not easy to sell.
Take erythromycin as an example. In the national list of essential drugs, the highest price of erythromycin for 100 tablets is 17.4 yuan, and the lowest bid price in Gansu is 9. 1 yuan in Anhui. Previously, Dalian Luomei's erythromycin production capacity accounted for about 90% of the country. In 2009, due to the relocation, production was simply stopped, leaving some small and medium-sized enterprises to survive.
Jiangsu, Beijing and other provinces and cities have adopted special bidding channels for cheap and short drugs, but in the context of price reduction, some drugs are still cut off because they are unprofitable.
A negative example is, for example, in 2009, heparin sodium used in combination with protamine was seriously out of stock. In 20 10, the state increased the drug price of this variety by about 40%, and more pharmaceutical companies immediately intervened in the production process.
Xu Guoxiong pointed out that enterprises are also applying for moderate price increases, but "this process is very long." In fact, hospitals and pharmacies are more willing to sell high-priced drugs and use these new products. The relevant links in the whole interest chain can get greater benefits, but patients can only be forced to pay for high-priced drugs.
20 1 1 in March, 2008, officials of the drug price department of the national development and reform commission analyzed the phenomenon of "low-priced out of stock": "enterprises can subsidize these cheap varieties with profitable varieties to achieve a total balance." He also said that "some enterprises choose not to supply, but there are still enterprises to supply, which is a matter of business strategy choice for each enterprise." We conducted a third-party survey on more than 200 kinds of delisted drugs reported in the news from 2002 to 2007, and almost no drugs were delisted for cost reasons. Only 5% is because the replacement has really disappeared from the market, and most of them can still be bought. "