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Yesterday evening, the Joint Procurement Office of the National Organization for Pharmaceuticals issued an announcement
on the cancellation of the eligibility of GlaxoSmithKline (Ireland) Limited (hereinafter referred to as GSK) dutasteride capsules and the inclusion of the company in the violation list.
Source: Shanghai Sunshine Pharmaceutical Purchasing Network
According to the announcement, the drug regulatory authorities recently inspected the fifth batch of selected drugs dutasteride capsules in the centralized procurement of drugs organized by GSK, and found that the company's products exported to China were not inspected batch by batch and all in accordance with the registration standards, and there were deficiencies in the prevention and control of microbial contamination risks, and the comprehensive assessment of the production quality management of this variety did not meet the requirements
of China's "Good Manufacturing Practice" (revised in 2010).
On October 31, 2022, the State Medical Products Administration issued an announcement suspending the import, sale and use of the product
from now on.
Suspension of eligibility for participating countries for one and a half years
Suspension of eligibility for participating countries for one and a half yearsAccording to the announcement, in accordance with the spirit of the "Opinions of the General Office of the State Council on Promoting the Normalization and Institutionalization of the Centralized and Quantitative Procurement of Drugs" (Guo Ban Fa [2021] No.
2), after the collective review of relevant members of the National Organization Joint Procurement Office for Drugs, GSK violated the commitments made in the declaration materials and violated the relevant provisions of the National Centralized Drug Procurement Document (GY-YD2021-2), and the Joint Procurement Office decided to cancel the qualification of GlaxoSmithKline dutasteride capsules.
At the same time, GSK was included in the "violation list", and the company's application qualification
to participate in the centralized drug procurement activities organized by the state from October 31, 2022 to April 29, 2024 was suspended.
In addition, in view of the fact that the procurement cycle of dutasteride ends at the end of October and no substitute procedure is initiated, all localities need to 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 of bridging work to ensure the stable
supply of drugs.
Three domestic enterprises were approved
Three domestic enterprises were approvedAccording to GBI
SOURCE Global Drug Database, dutasteride is a specific competitive inhibitor of 5α-reductase type I and II isoenzymes, which inhibits the supply of testosterone to dihydrotestosterone (
DHT)
, reduce the content of DHT in the prostate, and then achieve the treatment purpose
of reducing the volume of the prostate and improving the symptoms of the lower urinary tract.
Developed by GSK, the original research dutasteride was approved for marketing in the United States in November 2001 and approved for import into China
in April 2011.
At present, the domestic enterprises approved for the drug include Sichuan Guowei Pharmaceutical, Hengrui Pharmaceutical and Qilu Pharmaceutical
.
In the fifth collection, GSK and Hengrui Pharmaceutical's dutasteride softgels won the bid, and the relevant information is as follows:
Strict supervision, price reduction does not reduce quality
Strict supervision, price reduction does not reduce qualityIn January this year, Premier Li Keqiang presided over an executive meeting of the State Council, which decided to normalize and institutionalize the centralized procurement of drugs and high-value medical consumables to further reduce the medical burden on
patients.
"Strengthening supervision to ensure that the price reduction of selected products does not reduce quality" is one of
the key points emphasized by the National Standing Committee.
It is worth noting that since the launch of national procurement, it is not an isolated case that enterprises have been punished for product quality or supply problems in collective procurement, GBI previously reported:
In March 2020, the State Food and Drug Administration issued an announcement that the second batch of national selected varieties Abraxane (paclitaxel for injection (albumin-bound type)) of American Celgene Company carried out overseas production site inspections of drugs and found that some key production facilities of the product did not meet the basic requirements of China's drug production quality management, so it decided to suspend the import, sale and use of the product
from the announcement date.
In August 2021, North China Pharmaceutical, the selected enterprise of the third batch of domestically sourced ibuprofen sustained-release capsules, failed to supply the agreed purchase quantity in Shandong Province, was included in the "violation list" by the State Joint Procurement Office, and was disqualified
from participating in the national centralized procurement from August 11, 2021 to May 10, 2022.
On September 17, 2021, North China Pharmaceutical was again punished by Shandong Province, deciding to assess its untrustworthy rating as "serious", suspending its eligibility for ibuprofen sustained-release capsules for 3 years, and canceling its eligibility
to participate in collective procurement in Shandong Province from August 11, 2021 to May 10, 2022.
In February 2022, the Guizhou Provincial Drug Administration issued the "Notice on the Results of Drug Production Supervision and Inspection in 2021", because the unannounced inspection found that Shengjitang Pharmaceutical had serious defects in plant maintenance, equipment cleaning, stability inspection, etc.
, it decided to suspend the production and sales of its second batch of national centralized procurement selected products glimepiride tablets in accordance with the law, included Shengjitang Pharmaceutical in the "violation list", and suspended the application qualification of participating in national procurement from January 29, 2022 to July 28, 2023
。
In June 2022, the Shanghai Municipal Drug Administration issued a notice that the drug regulatory department found that the "loss on drying" project of some batches of bicarutamide tablets produced by India Sun Pharmaceutical, the fifth batch of selected products from the state, did not meet the registration standards for
imported drugs.
After deliberation, the Joint Purchasing Office decided to disqualify
the selection of bicalutamide tablets from Sun India.
The incident of pharmaceutical companies being fined for product quality and supply problems not only reflects the state's supervision of selected products in centralized procurement, but also rings the alarm for the industry - under the situation of "normalization, institutionalization and accelerated expansion" of centralized procurement, the entry of products into centralized procurement is only the beginning, and how to ensure the quality and supply of selected drugs in the follow-up is also a top priority
.
