China’s drug regulator has blocked the public from accessing drug data after independent analysts found discrepancies in the database.
Chinese doctors from top hospitals recently said bulk buy domestic generic drugs are ineffective compared to imported drugs. The nationwide controversy has led to concerns that the drug regulator’s approval of some generic drugs could be based on fraudulent clinical trial results.
China’s National Medical Products Administration, which is responsible for drug approval, allegedly altered some data on Jan. 24 after analysts found evidence suggesting patent plagiarism in its database. The National Medical Products Administration claimed clerical errors caused the discrepancies.
Later that day, the database became unavailable for downloads. The function remains blocked as of Jan. 29.
The controversy revolves around cheap domestic generic drugs purchased via a bulk buy program called National Volume-Based Procurement (NVBP).
Among the 62 drugs that won the 10th NVBP bid in Shanghai in December 2024, most are domestically produced generic drugs, and no branded drugs were included.
The program was implemented in 2019 to reduce public health care costs. According to Chinese state media, the program has reduced drug costs by half on average. In some cases, branded drugs, such as Pfizer’s antibiotic Linezolid, were replaced with generic drugs that are at least 90 percent cheaper.
A generic drug is a medication that contains the same ingredients and is meant to have the same or similar effect as a branded drug. Generic drugs, which are made and sold after the patents of their branded counterparts expire, cost much less.
Doctors Raise Concerns
The quality of cheap generic drugs has been unreliable, according to Zheng Minhua, director of general surgery at the Ruijin Hospital in Shanghai and a member of the Chinese People’s Political Consultative Conference (CPPCC)’s standing committee in Shanghai.For example, antibiotics have caused allergies, blood pressure medications didn’t lower blood pressure, and anesthetics and laxatives were ineffective, he told Chinese outlet eastday.com on Jan. 15.
Zheng was among the 20 senior doctors (also CPPCC committee members in Shanghai) who submitted a proposal during Shanghai’s municipal-level meetings earlier this month. The proposal suggested ways to improve the quality of drugs under the NVBP framework.
The annual municipal meetings include the CPPCC and China’s rubber-stamp legislature, the People’s Congress, at national and municipal levels.
Zheng advocated for access to branded drugs and urged the state-administered medical insurance system to provide partial coverage for their costs.
Around a week after Zheng’s interview with eastday.com, his account on Chinese social media Weibo disappeared. Netizens said he allegedly deleted it after internet trolls accused him of idolizing everything foreign and pleasing foreigners.
Meanwhile, doctors around the country have echoed Zheng’s concerns about low-quality domestic generic drugs.
Lu Changlin, a CPPCC committee member in Beijing and head of the cardiology department at the capital’s Chaoyang Hospital, also called for including branded drugs or imported generic drugs in the NVBP framework.
According to Chinese media outlets, Lu said in his proposal that patients who used bulk buy versions of oral blood thinners were more likely to suffer a stroke or pulmonary embolism compared to those who used imported versions.
He also noted that bulk buy drugs are more likely to cause side effects or allergies, indicating that there are more impurities in domestic drugs and more issues in the drugs’ manufacturing processes.
On Jan. 25, Bai Jianfeng, deputy head of Jiangsu Province Hospital’s biliary surgery division, said in a video shared on social media that muscle relaxants bought under NVBP lose their effectiveness much faster, which increases the risks of complications during surgery.
