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on august 30, the national health insurance administration issued an announcement stating thatatomoxetine hydrochloride capsules from dr. reddy's laboratories, indiathere are defects in raw materials, process validation, quality control, etc., which do not meet the requirements of china's pharmaceutical production quality management standards. the state food and drug administration has taken measures to suspend the import, sales and use of this product.

imported generic drugs are very enthusiastic about participating in centralized procurement, but the existing quality issues deserve in-depth investigation by the competent authorities.

atomoxetine hydrochloride capsules are used to treat attention-deficit/hyperactivity disorder in children and adolescents. november 2023,the drug was included in the ninth batch of national drugscentralized procurement. dr. reddy of indialaboratory productsselected at nt$31.5 per boxthe specification is 25mg*30 tablets, and it is supplied to beijing, hebei, shanxi, jiangsu, shandong, hubei, chongqing, gansu and qinghai.

the national healthcare security administration has suspended dr. reddy's laboratories' qualification to participate in the national centralized procurement from august 30 this year to february 28, 2026, which is similar to the previous punishment conclusion for similar incidents. according to the relevant regulations of the national centralized procurement, the national joint procurement office has initiated the replacement procedure.

dr. reddy's laboratories is india's thirdgeneric drugsenterprise, and is also among the top ten in the world. it is worth mentioning that sun pharmaceutical, previously india's top generic drug company, was also disqualified from being selected in my country's centralized procurement due to drug quality issues.

grabbing the market with low prices but failing on quality

atomoxetine hydrochloride is the first drug approved by the fda for the treatment of adhd. eli lilly's original product was launched in the united states in july 2002, and its core patent expired in may 2017.butoriginal drug2016just enteredchina market,soin chinabasically, it is original research drugs andgeneric drugsthe situation of competing on the same stage.

last year, the national healthcare security administration announced that atomoxetine hydrochloride was included in the ninth batch of national centralized procurement. at that time, the industry believed that it would be one of the most competitive varieties in that batch of national procurement.

at the quotation site for the ninth batch of national procurement in november 2023, india's dr. reddy's laboratory quoted a price far lower than that of domestic drugs.discussions at the scene:indian enterpriseshow to cover costs?

dr. reddy's laboratories has actually been involved in china's centralized drug procurement for a long time. as early as the 4+7 expansion phase, dr. reddy's laboratories' olanzapine tablets were selected as a product, and received a large number of orders from the chinese market, with sales growing rapidly. the company's then ceo publicly stated,we will take advantage of the favorable policies of national drug procurement and strive to make the chinese market a major growth driver.

having tasted the sweetness of centralized procurement, dr. reddy's laboratories hopes to use the low-price strategy again to expand its market share in china. however, the cross-border flight inspection of the china national drug administration found problems with the company: dr. reddy's laboratories' atomoxetine hydrochloride capsulesapidoes not meet the requirements for chinese registration，process validation,quality controlthere are defects in other aspectsthe production quality management of this product does not meet the requirements and its import, sales and use will be suspended from now on.

this is not the first time that dr. reddy’s laboratories has had product quality issues. in april 2018, the state food and drug administration announced thatruidr. dee's laboratoryofthe current production process, production site and batch of quetiapine fumarate are inconsistent with the registered approval content., which did not meet the requirements of china's pharmaceutical production quality management standards, and the product was suspended from sale in china. it was not resumed until june 2023, when quetiapine fumarate had already been included in the third batch of national procurement, and dr. reddy's laboratories missed the opportunity.

despite repeated product quality problems, dr. reddy's laboratories is still among the top ten generic drug companies in the world. in 2023, the company achieved total revenue of us$3.285 billion, with the us market accounting for 47%, followed by india and emerging markets, accounting for 17%-18% respectively.

after the sale of atomoxetine hydrochloride is stopped, the national medical insurance administration will initiate the alternative procedure. it is worth mentioning thatsince the national drugcentralized procurementprice competition, eli lilly's original productalreadysupply in china to cease in january 2024。

indian pharmaceutical companies have repeatedly run into problems, but regulators have a "zero tolerance" policy

india is the world's largest producer of generic drugs, butdata fraud, extensive management, cost compression, etc.the problem has not been solved for a long time.

the health bureau found that in 2018,ambroxol hydrochloride from supa pharmaceuticals ltd. of india, imipenem and cilastatin sodium for injection from sun pharmaceutical industries ltd. of indiaall of them were found to have quality problems during spot inspections by the china food and drug administration and their sales were suspended.

in recent years, the state food and drug administration has organized multiple rounds of cross-border inspections, and problems have been found almost every time.relatively speaking, the problem of problems in domestic drug inspections is not prominent.，there are also many quality problems in foreign pharmaceutical production.

the national medical insurance administration has publicly stated many times that national drug procurement will gradually shift the focus of competition among companies from competing in relationships and marketing tostrive for quality and efficiency to create a clean and healthy environment, which will help promote the high-quality development of the industry. although the prices of the drugs purchased through centralized procurement are low, quality and safety are the lifeline. most domestic companies have formed this awareness, so the quality of most drugs purchased through centralized procurement is guaranteed.

as national drug procurement has become normalized, the linkage mechanism among medical insurance, drug supervision, health and other departments has become more mature, and many issues such as drug quality and safety, online prices and clinical use have been fully implemented, striving to serve the overall coordinated development of drug procurement and the "three medical linkages".

the inspection level of chinese medicines, equipment and consumables is gradually catching up with international standards.some foreign products that lag behind chinese standards will gradually be eliminated and will not be able to pass the review of regulatory authorities and enter the chinese market.。

written by lei gong

editor: jiang yunjiating

operation｜twenty thirteen

illustration｜visual china

disclaimer: this is original content from jianshiju. please do not reprint without permission.

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