Key facts
- Chinese regulators have disqualified more than 10 drug and medical-device companies from national bulk-procurement programs.
- The disqualifications are due to serious production or quality-management defects.
- Shandong Beida Gaoke Huatai Pharmaceutical Co. was recently disqualified.
- The company's production line for amiodarone hydrochloride injection was found to have serious deficiencies.
- The production line has been suspended.
Chinese regulators have disqualified more than 10 drug and medical-device companies from national bulk-procurement programs this year. These actions stem from serious production or quality-management defects, highlighting growing safety concerns within a system designed to reduce healthcare costs for patients.
The most recent case involved Shandong Beida Gaoke Huatai Pharmaceutical Co. According to a notice from the Shandong provincial drug regulator on June 9, the company's production line for amiodarone hydrochloride injection was found to have significant deficiencies, leading to its suspension.