Chinese regulators are probing the quality of domestically produced generic drugs following public outcry over their effectiveness and safety. The investigation highlights tensions in China’s cost-cutting healthcare reforms, which prioritize domestic medications but have raised concerns from doctors, patients, and international pharmaceutical companies.
The investigation, led by the National Healthcare Security Administration (NHSA), comes after prominent doctors voiced complaints about domestic drugs’ poor efficacy. In a rare public statement submitted to Shanghai’s municipal legislature, a group of 20 senior medical professionals led by Zheng Minhua, a surgeon at Shanghai’s Ruijin Hospital, warned that some generics fail to deliver expected results even at higher doses. They cited issues such as hypertension drugs not reducing blood pressure effectively, laxatives failing to induce bowel movements, and anaesthetics leaving patients awake during surgeries.
“Questionable drug efficacy poses the greatest safety risk to patients,” the doctors wrote, calling for greater flexibility in the bidding process to allow western brand-name drugs to be covered by insurance.
China’s pharmaceuticals market, the world’s second-largest after the US, recorded sales of $239 billion in 2023. However, rising healthcare costs have prompted policymakers to overhaul the system. In 2018, China introduced a centralized drug procurement scheme to replace its fragmented hospital-based negotiation system. While the program reduced drug costs—some by more than 50%—it also resulted in a shift toward cheaper domestic generics, replacing more expensive off-patent drugs from global companies such as AstraZeneca and GSK.
Patients and healthcare professionals have increasingly raised concerns about the unintended consequences of these reforms. One Shanghai nurse reported that domestic medical devices often fail during critical procedures, and cases of patients waking up mid-surgery have fueled public alarm. A 35-year-old lecturer in Shanghai, identified as Jumbo, described how a domestic antiviral drug failed to treat her chickenpox effectively, forcing her to self-prescribe a higher dose after researching foreign alternatives.
While patients can purchase foreign drugs online, these are not covered by insurance, and doctors typically do not recommend non-approved medications. In last month’s procurement process for Shanghai’s public health system, international pharmaceutical giants like Pfizer, Bayer, and MSD submitted bids for 32 off-patent drugs, but none were selected.
Foreign pharmaceutical companies have also expressed frustrations with the procurement system, which they say prioritizes cost over quality and clinical outcomes. The European Union Chamber of Commerce in China urged for reforms, warning that the current system undermines product safety and patient trust. Michael Hart, president of the American Chamber of Commerce in China, noted that if foreign companies cannot operate profitably in the country, they may withdraw their products, harming the overall healthcare market.
The NHSA’s probe underscores China’s sensitivity to healthcare safety issues, particularly after past scandals involving tainted infant formula and contaminated blood transfusions. Public outrage has often been sparked by perceived regulatory failures in ensuring product quality.
