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Encourage appropriate formulation improvements for Tibetan medicine.
Release time:
2017-03-09 14:02
Currently, the review and approval process for Tibetan medicine and ethnic medicines still follows the standards applied to traditional Chinese medicine. Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference and Chairwoman of Tibet Qizheng Tibetan Medicine Group, believes that for the Tibetan medicine industry—and indeed other ethnic medicine industries—with relatively low levels of industrialization—appropriate, differentiated adjustments to the current review and approval policies are needed. We should encourage appropriate innovations in dosage forms for ethnic medicines, and adopt a more nuanced approach rather than applying a one-size-fits-all strategy when reviewing changes to existing dosage forms.
She suggested that, while fully respecting intellectual property rights, appropriate modifications to certain suitable varieties of Tibetan medicine should be encouraged. The reasons are as follows:
First, many Tibetan medicinal products have a long history, proven efficacy, and excellent safety profiles. However, their limited dosage forms have hindered their wider adoption and promotion. Reformulating these products is an essential step toward modernization and gaining access to the mainland Chinese market. Second, the modernization of Tibetan medicine has lagged far behind that of traditional Chinese medicine. Therefore, we cannot apply the same standards to evaluating the reformulation issues of Tibetan medicine and traditional Chinese medicine. The modernization of traditional Chinese medicine can be traced back to the 1980s; in particular, from the late 1990s until before 2005, Chinese pharmaceutical companies seized the opportunity to leverage modern pharmaceutical technologies to address shortcomings in traditional Chinese medicine, making significant improvements and upgrades. As a result, numerous reformulated products received approval, driving a boom in the Chinese medicine market. Third, for a long time, regulatory requirements for topical medications—especially locally applied topical formulations—have been relatively stringent. Consequently, any changes to dosage forms, such as converting oral medications into topical ones, must provide thorough explanations regarding the scientific basis, rationality, efficacy, and safety of such reformulations.
Modifying the dosage forms of Tibetan medicinal products represents an optimal approach that balances inheritance and innovation, while accelerating the secondary development of superior, time-tested Tibetan medicines. These classic Tibetan remedies, having been used for millennia, are the most likely to meet the stringent requirements of proven efficacy and high safety. However, we must further draw on modern scientific methods to conduct more in-depth research into their mechanisms of action, their chemical foundations, and their stability over time. At the same time, during the process of dosage-form modification, we should pay close attention to the selection of appropriate varieties, avoiding excessive or indiscriminate changes. Moreover, Tibetan medicine enterprises should take the lead in this effort to prevent repeating past mistakes. We should tailor our approach to the unique characteristics of Tibetan medicine, treating dosage-form modifications for Tibetan medicines with appropriate distinctions. In particular, we should encourage improvements in the dosage forms of classic Tibetan medicines—especially the development of topical formulations—thereby promoting the market application of Tibetan medicine and fostering the healthy development of regional ethnic economies.
Reporting media: China Journal of Traditional Chinese Medicine
Report link: http://www.cntcm.com.cn/2017-03/09/content_27424.htm
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