GSK hit with 18-month ban from China bulk-buy drug program

Oct. 31, 2022

GSK will lose its eligibility to sell its prostate treatment, Avodart, through China's bulk-buy drug procurement program focused on off-patent medicines until April 2024, after a plant inspection revealed quality issues.

A batch of Avodart — manufactured by GSK's Polish contract manufacturer,  Delpharm — failed a recent quality check, according to reporting from Reuters. Avodart the only GSK product supplied to China through the country's volume-based procurement (VBP) program. The drugmaker is now banned from selling the drug through the program from Oct. 31, 2022 until April 29, 2024.

According to Shanghai's public procurement agency, SMPA, regulatory agencies found that GSK "did not care about the products exported China," noting a failure to conduct batch-by-batch and full-item inspections of exports, as well as deficiencies in the prevention and control of microbial contamination risks.

GSK sold the Poznan, Poland site (and its workers) to French CDMO Delpharm in 2020 and continued using it to manufacture Avodart.