China bans GSK from drug procurement activities through April 2024
Following an inspection of GSK’s CDMO Poznan, Poland-based site that identified questionable practices, China has decided to ban the company from participating in its centralized drug procurement program through April 29, 2024, according to an English translation of a recent government posting.
The plant in question is a GSK contract manufactrurer’s, which supplies the urinary retention drug dutasteride, and China’s State Food and Drug Administration found the company did not conduct batch-by-batch and full-item inspections of the products exported to China, as well as identified deficiencies in the prevention and control of microbial contamination risks.
GSK sold the manufacturing site to French CDMO Delpharm in Oct. 2020 as the British drugmaker sold other assets too. Commenting on the latest disruption, GSK said in a statement:
GSK’s volume-based procurement agreement with China for the supply of Avodart (dutasteride) expired on 30 October. Due to a review of manufacturing processes following an inspection of our contract manufacturer, supply of Avodart to China is currently on hold. For this reason, GSK will not be eligible to take part in the next volume-based procurement agreement for this product. This exclusion only applies to Avodart – no other GSK products are supplied to China through a volume-based procurement programme.
China’s SFDA said it suspended the import, sale and use of GSK dutasteride soft capsules, and all drug import ports in China have suspended the issuance of import customs clearance forms.
GSK acquired the Polish site in 1998 and, according to a 2018 report, spent around $500 million there over 20 years, with the production of 8.7 million tablets and 1.3 million capsules every day for 130 countries.
In March 2019, the drugmaker announced plans for a financial hub in Poznań, which will stay in GSK’s hands moving forward, the company said in a release. The hub employs between 200 and 300 employees, GSK said previously.
“The comprehensive assessment of the production quality management of this variety does not meet the requirements of China’s ‘Good Manufacturing Practice for Drugs’ (revised in 2010). On October 31, 2022, the State Drug Administration issued an announcement to suspend the import, sale and use of this product from now on,” China’s SMPA wrote on its website.
The decision to ban GSK came after the collective deliberation of the relevant members of the state-organized Drug Joint Procurement Office, with the SMPA writing that the company’s qualification to participate in the centralized drug procurement activities organized by the state from today to April 29, 2024, will be suspended.
“In view of the fact that the procurement cycle of dutasteride ends at the end of October, and the replacement procedure will no longer be initiated, all localities are requested to pay attention to the supply of this drug in the follow-up work after the procurement cycle expires, and do a good job in connection work to ensure a stable drug supply,” the government added, according to an English translation.