Investigation into Generic Drug Quality in China's Centralized Procurement Program

Concerns Raised About Generic Drug Quality in China

The National Healthcare Security Administration (NHSA) announced plans to send a team of officials to Shanghai to investigate concerns about the quality of generic drugs included in centralized procurement programs. This decision follows discussions during Shanghai's annual legislative and political advisory sessions, where concerns were raised about the efficacy of these medications.

Centralized procurement programs involve pharmaceutical companies bidding for large-volume contracts with public hospitals, leading to significant price reductions for generic drugs. While this mechanism has been praised for reducing financial burdens on patients and public health insurance funds, some political advisors have reported that certain generic drugs have not met efficacy expectations or have performed worse than imported alternatives.

The NHSA team will visit Shanghai to collect suggestions on the procurement policy and the quality of selected medications. They will focus on identifying quality and efficacy issues supported by clinical data, such as statistical differences in cure rates, treatment effectiveness, and adverse reactions between original drugs and generic versions. Findings will be submitted to drug regulators.

Discussions will also explore measures to ensure the efficacy and safety of drugs procured through the program, including increasing routine inspections of drug manufacturers, publishing drug evaluation results, and establishing feedback channels for medical institutions to report comparisons of drug efficacy.

The NHSA noted that medications purchased through centralized procurement agreements generally make up 60 percent to 80 percent of the total volume required by medical institutions, which are free to choose brands for the remaining portion. The administration emphasized that there is no policy prohibiting hospitals from procuring imported, original drugs. Additionally, companies winning bids have passed drug efficacy assessments and are subject to random inspections. A real-world study assessing the use of bulk-buy drugs in 80 major hospitals is also underway.