On October 31, the Joint Procurement Office issued an announcement through the Shanghai Sunshine Pharmaceutical Procurement Network that it decided to cancel GSK's qualification for dutasteride capsules, and at the same time put the company on the "violation list", suspending the company's declaration qualification
to participate in the centralized drug procurement activities organized by the state from October 31, 2022 to April 29, 2024.
This also means that GSK will not be able to collect procurement
in the next year and a half.
Dutasteride capsules (trade name: Amfoda) are indications/functional indications: treatment of moderate to severe symptoms
of benign prostatic hyperplasia (BPH).
For patients with benign prostatic hyperplasia with moderate to severe symptoms, reducing the risk of
acute urinary retention (AUR) and surgery.
GSK's product was approved to enter the Chinese market in 2011, successfully won the bid in the fifth batch of national procurement, and was launched
in various places in October 2021.
The Joint Procurement Office said that the procurement cycle of the product ended at the end of October this year, and the replacement procedure will no longer be initiated, and all localities will pay attention to the supply of the drug in the follow-up work after the expiration of the procurement cycle, and do a good job in the connection work to ensure the stable
supply of drugs.
According to Intranet, GSK's global sales of dutasteride in 2021 were about $400 million
.
In the domestic market, in 2021, the sales scale of dutasteride softgels in the three major domestic terminal markets exceeded 3 million yuan, with a growth rate of more than 62%, with great
potential.
It is understood that in addition to the original research enterprises, the current domestic enterprises of dutasteride include Chengdu Shengdi Pharmaceutical Co.
, Ltd.
, Qilu Pharmaceutical, and Sichuan Guowei Pharmaceutical Co.
, Ltd
.
With the suspension of collective procurement by GSK, the industry believes that the other three domestic companies may usher in new opportunities
in the next successive procurement.
For GSK, the impact may not be limited to this, the current collective procurement has tended to be normalized, basically carried out twice a year, the seventh batch of collective procurement in 2022 has now been successively landed in many places, and the eighth batch of collective procurement is also like an arrow
.
GSK's disqualification from collective procurement in the next year and a half means that the company's drugs may miss at least three domestic procurement opportunities and lose the opportunity to enter the
hospital market.
In fact, GSK is not the only company that has been suspended or disqualified from winning bids due to product quality problems
.
For example, at the end of June this year, the United Procurement Office sued India Sun Company that some batches of bicarutamide tablets produced by India Sun Company did not meet the registration standards for imported drugs, and cancelled their qualifications
in the fifth batch of national centralized procurement.
And Zhejiang Hisun Pharmaceutical Co.
, Ltd.
, Shanxi Zhendong Pharmaceutical Co.
, Ltd.
, and Shanghai Zhaohui Pharmaceutical Co.
, Ltd.
will replace the original supply area
of Sun Company.
Earlier, in March 2020, the Joint Procurement Office issued an announcement canceling the qualification
of the second batch of national centralized procurement of paclitaxel (albumin-bound type) for injection of Celgene of the United States Celgene Company.
And by Shiyao Ouyi and Hengrui Pharmaceutical as substitute suppliers
.
Not only multinational pharmaceutical companies, but also local pharmaceutical companies have a similar situation
.
From the perspective of reasons, it is mainly because some enterprises do not meet the good manufacturing practices of drugs, violate the company's commitment to be responsible for drug quality and supply, cannot continue to perform the contract, cannot meet the clinical drug needs of medical institutions, and cancel the qualification of the selection; Some enterprises fail to supply the agreed purchase quantity according to the agreement, and the enterprise independently proposes to waive the qualification for selection, but this will also have an impact
on the rating of untrustworthiness of the enterprise.
From the above cases, although the winning bid of collective procurement can bring market increment to the enterprise by exchanging price for quantity, the winning enterprise does not mean that it is a "winner", and needs to be responsible for the quality and supply of products, otherwise it may lose the qualification of collective procurement and give the opportunity to other manufacturers
.
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