The Sichuan Provincial Drug Administration has released its second batch of trial standards for traditional Chinese medicine (TCM) granules, effective immediately. The new regulations, covering 21 herbal formulas including Buchengqie (Litsea cubeba fruit) and Dujiaojin (Striga asiatica), mark a significant step toward standardizing the TCM granule market. The two-year trial period underscores the province’s commitment to balancing traditional practices with modern pharmaceutical compliance.
Key Policy Highlights
- 21 Granule Formulas Standardized: The standards specify manufacturing processes, active ingredient concentrations, and quality control metrics for each formula. For example, Buchengqie granules must contain 0.2–1.7 mg of rutin per gram, while Dujiaojin requires a minimum 12% ethanol-soluble extract.
- Dynamic Compliance Framework: Trial standards will automatically expire if national-level regulations are issued during the two-year period, ensuring alignment with overarching Chinese pharmaceutical policies.
- Enhanced Safety Protocols: Rigorous testing for heavy metals, aflatoxins, and chemical markers (e.g., matrine in Dujiaojin) reflects growing consumer demand for transparency in herbal medicine.
Industry Impact: Modernization vs. Tradition
Pharmaceutical firms operating in Sichuan’s TCM sector face heightened compliance costs but stand to gain from reduced regulatory uncertainty. The standards prioritize scientific validation without discarding traditional extraction methods, a delicate balance that could set a national precedent. Analysts estimate the move could streamline supply chains by 15–20% while elevating export credibility.
Global Implications
As China’s TCM exports reached $6.1 billion in 2024, Sichuan’s trial standards may influence international regulatory frameworks. Companies like Yunnan Baiyao and Tong Ren Tang could leverage these benchmarks to meet EU and U.S. pharmacopeial requirements, potentially unlocking $12 billion in untapped overseas markets.
Expert Reaction
“Standardization doesn’t mean sterilizing tradition—it’s about proving efficacy through modern science,” said Dr. Li Wei, director of the Chengdu Institute of TCM. “Sichuan’s approach could become a blueprint for other provinces.”
Looking Ahead
The trial period concludes in April 2027, with a review likely focusing on scalability and industry feedback. Investors should monitor whether national adoption follows, which would accelerate China’s TCM sector toward a projected $250 billion valuation by 2030.
For full regulatory details, see the attached standards document.
Policy Source:http://yjj.sc.gov.cn/scyjj/c103155/2025/4/2/26ab4079c5f049a0b4dbfb8401cbd41b.shtml