NHSA to Investigate Quality Concerns of Generic Drugs in Centralized Procurement Programs

Concerns Arise Over Generic Drug Quality in China's Centralized Procurement Programs

The National Healthcare Security Administration (NHSA) announced plans to send a team to Shanghai to investigate concerns regarding the quality of generic drugs procured through centralized programs. This decision follows concerns voiced by political advisors and medical experts during the ongoing annual sessions of Shanghai's legislative and political advisory bodies.

These concerns center around the efficacy of generic medications whose prices have been significantly reduced through national and regional bulk buy programs. While acknowledging the program's success in reducing financial burdens on patients and public health insurance funds, experts have noted that some generic drugs, particularly those used for high blood pressure, constipation, anesthesia, and antibiotics, have not delivered the expected outcomes or appear inferior to their imported counterparts.

The NHSA team, comprised of officials from health, industry, information technology, and drug regulation, will arrive in Shanghai on Tuesday to gather suggestions on the procurement policy and quality of selected medications. Their focus will be on identifying clues to quality and efficacy problems through clinical data and statistical differences in cure rates, treatment effectiveness, and adverse reactions between original and generic versions. The findings will be shared with drug regulators.

The team will also discuss approaches to further guarantee the efficacy and safety of procurement drugs. These include intensifying regular checks of drug manufacturers, fully publishing drug evaluation results, and establishing feedback channels for medical institutions to submit their comparisons of drug efficacy.

The NHSA emphasizes that there is no policy prohibiting hospitals from procuring imported, original drugs. Companies winning bids in the centralized procurement program have all passed drug efficacy assessments and are subject to random inspections. Additionally, a real-world study researching the use of bulk-buy drugs in 80 major hospitals has been conducted.

The NHSA's investigation demonstrates their commitment to addressing concerns about the quality of generic drugs and ensuring the safety and efficacy of medications procured through centralized programs. This initiative is crucial for maintaining public trust in the healthcare system and ensuring patients receive the best possible care.