Consistency evaluation "counter attack"? 25 over 100 million products dongyangyao, xinlitai, qilufili

Since December 2014, Shanghai Pharmaceutical Institute has carried out three batches of centralized drug volume procurement Among them, the first batch has 3 varieties, the second batch and the third batch have 7 and 19 varieties respectively Since the implementation of volume procurement, the bid winning enterprises have changed from contract renewal to bid dropping, and the purchase price has changed from contract renewal with bid winning price to increase, which is very remarkable Bid winning results of three batches of drugs purchased in volume in Shanghai On October 11, 2019, Shanghai Sunshine pharmaceutical purchase network announced the results of the selection of four varieties of the third batch of drugs purchased with volume, including fluconazole tablets, bisoprolol fumarate tablets, glimepiride tablets and ambromide hydrochloride tablets Among them, only the fluconazole tablets of Kelun pharmaceutical continued to be purchased, and other varieties were replaced by the winning enterprises It is worth noting that the products of the enterprises selected this time are all drugs that pass the consistency evaluation The price of fluconazole tablets in Kelun pharmaceutical industry is 185% higher than that of the original ones, the price of ambroxol hydrochloride tablets in Hengrui pharmaceutical is 172% higher, and the price of bisoprolol fumarate tablets in Yuandong biology and glimepiride tablets in Xinhua Pharmaceutical is slightly lower than that of the original ones Selection results of 4 varieties Suntech's simvastatin tablets are the second batch of centralized purchase varieties, but at the end of the purchase cycle, the varieties failed to pass the consistency evaluation, while Hanhui pharmaceutical has passed the consistency evaluation with the same generic name and specification On August 19, 2019, after inquiry and purchase, Hanhui pharmaceutical accepted the bidding price and successfully replaced Sandoz to supply simvastatin throughout Shanghai Nimesulide dispersible tablets are the second batch of centralized procurement varieties in Shanghai The selected enterprise is Shubang pharmaceutical, and Kangzhi pharmaceutical actively applies for the procurement qualification by winning the bid price of volume procurement On January 3, 2019, Shanghai Pharmaceutical bureau announced that Kangzhi pharmaceutical proposed to cancel its procurement qualification and continue to purchase the winning varieties of Shubang pharmaceutical due to its inability to continue to supply at the original purchase price due to the rising cost On October 26, 2018, Shanghai Pharmaceutical bureau announced that the second batch of valaciclovir hydrochloride tablets (area B) of the bid winning drug Beite Pharmaceutical Co., Ltd has completed the agreed purchase volume, and the enterprise proposed that it would not continue to supply any more, so as to settle the bid Therefore, the purchase volume of valaciclovir hydrochloride tablets (area B) shall be supplied by Xinyi, the selected enterprise of area A On December 22, 2017, Shanghai Pharmaceutical bureau announced that the second batch of lisinopril tablets of the winning drug Great Wall Pharmaceutical Co., Ltd were purchased in a centralized way and the agreed purchase volume was completed, and the enterprise put forward an application for no renewal of the contract for bid dropping At the same time, the supply area of lisinopril tablets (area a) in the charge of Great Wall Pharmaceutical Co., Ltd is transferred to Zhongfu Pharmaceutical Co., Ltd., the selected enterprise in another supply area (area B) On May 31, 2018, after inquiry and purchase, Lizhu group was responsible for the supply of lisinopril capsules in area a; Zhongfu pharmaceutical continued to be responsible for the supply of lisinopril tablets in area B, and the bid price increased from 2.62 yuan / (10mg * 14 tablets / box) to 3.65 yuan Shanghai's volume purchasing is the national wind vane, and the implementation has accumulated valuable experience for the industry From the above changes, it is not difficult to find that consistency evaluation and cost control have become the core elements of enterprise products participating in bidding procurement After winning the bid, pharmaceutical enterprises face the risk of being replaced by the products of the evaluated enterprises if they have not been evaluated at the end of the procurement period; enterprises that have not done a good job in cost control can only give up the market to their competitors At the same time, from the rise of the bid price, we also see the loosening of the tendency of "only low price is taking" in drug procurement Over evaluation of three batches of drugs purchased in volume in Shanghai There are 27 general-purpose drugs purchased in three batches in Shanghai According to the data of minenet, the terminal sales of 27 generic drugs in public medical institutions in China totaled more than 40 billion yuan in 2018 Among them, the sales of 25 drugs exceeded 100 million yuan, and the sales of 11 products exceeded 1 billion yuan In terms of drug subclasses, most of the drugs purchased are psychoactive drugs and systemic antibacterials, with 4 in each category; in terms of blood lipid lowering drugs, diabetes drugs, systemic antiviral drugs, systemic antifungal drugs and drugs acting on renin-angiotension system, there are 2 in each category Sub categories of drugs purchased in three batches in Shanghai According to the past evaluation, 10 of the 27 generic drugs failed to pass the consistency evaluation Among them, aripiprazole tablets, glipizide tablets, alfacalcohol soft capsules and other three varieties of enterprise consistency evaluation are under review It is worth noting that the enterprise of Enhua Pharmaceutical Co., Ltd., which was selected from aripiprazole tablets as a mental tranquilizer, has not applied for conformity assessment, and there are two conformity assessments of product specifications of the Chinese and Western medicine of Shangyao Pharmaceutical Co., Ltd in the trial According to the data of mienei.com, in 2018, the sales volume of aripiprazole in China's public medical institutions was 1.078 billion yuan, an increase of 18.39% year on year Among them, Sinopharm accounts for 19.87% and Enhua pharmaceutical accounts for 2.72% Sinopharm is expected to regain Shanghai regional market if it has been evaluated Consistency evaluation of three varieties under review Previously, the announcement of Shanghai Pharmaceutical Bureau mentioned that: for the drugs that failed to pass the consistency evaluation, and the same generic name and specification of the original research and less than 3 enterprises that passed the consistency evaluation, the original research and consistency evaluation enterprises of the same product specification will be inquired with the bid price, and if the enterprise accepts the bid price, the original bid winning drugs will be replaced to supply within the city and a one-year purchase agreement will be signed According to the statistics of mienei.com, among the drugs that pass the consistency evaluation, only one of the 8 drugs has been evaluated, and the evaluated enterprises are not selected in the volume purchase After the expiration of the purchase period, these enterprises that have purchased drugs with volume are expected to purchase and replace the selected enterprises through inquiry, such as clarithromycin tablets of dongyangguang pharmaceutical, Loratadine Tablets of xinlitai, risperidone orally disintegrating tablets of Qilu pharmaceutical, lamivudine tablets of Longze pharmaceutical, enalapril tablets of malic acid of Yangtze River, etc.