Not only has China banned the import and sale of GSK’s Avodart (dutasteride) soft capsules through its national bulk-buy drug procurement program. It has barred the company's participation in the annual volume-based procurement program for 18 months.
The ban begins immediately and extends through April of 2024. It was triggered by an inspection of a plant in Poznan, Poland, which showed that the company did not conduct batch-by-batch and full-item inspections of Avodart sent to China, according to a government filing.
The National Medical Products Administration determined that without proper inspection, the company could not prevent and control potential microbial contamination. The practices did not comply with China’s good manufacturing practice standards.
Avodart is the only GSK drug currently in China’s bulk-buy program, which was established in 2018 to help lower the price of imported generic drugs. The scheme requires manufacturers to go through a bidding process to supply products to public hospitals.
In an email to Fierce Pharma, GSK acknowledged China's action and that it came following an inspection of a contract manufacturer’s plant.
“GSK will not be eligible to take part in the next volume-based procurement agreement for this product,” a spokesperson said. “This exclusion only applies to Avodart—no other GSK products are supplied to China through a volume-based procurement program.”
The company added that Avodart remains available to patients in all other markets.
In 2020, China banned the import of BeiGene’s chemotherapy Abraxane, which the Chinese company licenses from Bristol Myers Squibb. The ban occurred following inspection of contract manufacturer Fresenius Kabi’s plant in Illinois.
As for GSK, the company and China have had a tenuous relationship at times after revelations that the company bribed doctors and hospitals to favor GSK products. The company incurred a hefty fine and fired more 100 employees who participated in the scheme. In addition, Mark Reilly, who ran GSK's operations in the country, was deported.