According to the Shanghai Sunshine Pharmaceutical Procurement Network, the National Joint Procurement Office for Medicines announced on October 31st the cancellation of GlaxoSmithKline (Ireland) Limited's winning bid qualification for Dutasteride Capsules and the inclusion of the company on the list of violations. The announcement pointed out that recently, drug regulatory authorities conducted inspections on the Dutasteride Capsules of GlaxoSmithKline (Ireland) Limited (hereinafter referred to as "GSK") selected in the fifth batch of centralized procurement organized by the state. It was found that the company did not conduct batch-by-batch, full-item inspections according to the registration standards for products exported to China, and there were deficiencies in the risk control of microbial contamination. The comprehensive evaluation concluded that the production quality management of this variety does not meet the requirements of China’s “Good Manufacturing Practice for Pharmaceutical Products” (2010 Revision). On October 31, 2022, the National Medical Products Administration announced the suspension of importation, sales, and use of this product with immediate effect.
In accordance with the spirit of the "Opinions of the General Office of the State Council on Promoting the Normalization and Institutionalization of Centralized Bulk Procurement of Medicines" (Guo Ban Fa [2021] No. 2), after collective deliberation by relevant members of the National Joint Procurement Office for Medicines, it was determined that the company violated the commitments made in its submission materials and breached relevant clauses of the "National Centralized Medicine Procurement Document (GY-YD2021-2)." The Joint Procurement Office has decided to revoke GSK's winning qualification for its Dutasteride Capsules and include GlaxoSmithKline PLC. on the "List of Violations." The company's eligibility to participate in the submission process for centralized national medicine procurement activities will be suspended from October 31, 2022, to April 29, 2024.
Given that the procurement cycle for dutasteride will end in late October and no replacement process will be initiated, all regions are requested to pay attention to the supply situation of this drug during the subsequent work after the procurement cycle ends. Ensure proper coordination to maintain a stable drug supply.