China removes ban on imported calculus bovis in traditional Chinese medicine

China has launched a pilot program allowing the use of imported calculus bovis in traditional Chinese medicine (TCM) production under specified conditions, in an effort to ease the supply shortage of the material, which is used widely in TCM.

Calculus bovis sourced from countries or regions not subject to mad cow disease import bans and compliant with China's customs quarantine and pharmaceutical quality inspection requirements will be permitted for trial use in TCM manufacturing, the National Medical Products Administration (NMPA) and the General Administration of Customs (GAC) said in a joint statement released on Monday.

The pilot program will cover 12 provincial-level regions, including Beijing and Tianjin, and will remain in effect for two years. Upon evaluation of the outcomes of this pilot program, authorities will progressively expand the use of imported calculus bovis nationwide, the statement said.

The program has detailed requirements for the application of imported calculus bovis and relevant processing, storage and production procedures.

Calculus bovis — cattle gallstones — has historically been a critical source for TCM ingredients to treat high fever, convulsion, stroke, among others.

Following the global outbreak of mad cow disease around 2000, China banned the use of imported bovine-derived materials, including natural calculus bovis, in TCM to mitigate public health risks. Over the past five years, the spread of mad cow disease has been brought under control globally, with sporadic reports of atypical cases posing minimal health threats.

To address the surging demand for calculus bovis, the NMPA and GAC conducted thorough evaluations and stakeholder consultations, culminating in this pilot program to alleviate raw material shortages, stabilize TCM production and ensure market supply, according to the statement.