Traditional Chinese herbal injection: Current status and future perspectives

Abstract Traditional Chinese herbal injection, frequently referred to as TCM injection, has evolved over 70 years as a treatment modality that parallels injections of pharmaceutical products. As the market reach has not been analyzed systematically in the past literature this article performed a descriptive analysis of various aspects of TCM injections based on the following data sources: (1) information retrieved from website of drug registration system of China, and (2) regulatory documents, annual reports and ADR Information Bulletins issued by drug regulatory authority. As of December 31, 2017, 134 generic names of TCM injections from 224 manufacturers were approved for sale. Only 5 of the 134 TCM injections are documented in the present version of Ch.P (2015). Most TCM injections are documented in drug standards other than Ch.P. The formulation, ingredients and routes of administration of TCM injections are more complex than conventional chemical injections. Ten TCM injections are covered by national lists of essential medicine and 58 are covered by China's basic insurance program (2017). ADR reports related to TCM injections accounts for >50% of all ADR reports related to TCMs and the percentages have been rising annually. Making traditional medicine injectable might be a promising way to develop traditional medicines. However, many practical challenges need to be overcome by further development before a brighter future for injectable traditional medicines can reasonably be expected.