Why TCM Concentrated Formula Granules Should Be Promoted
TCM concentrated formula granules are a reform of the dosage-form of Chinese-medicine yinpian (sliced raw herbs). In our country, trial production began in 1992; small-scale trial use in 1993; trials in Beijing in 1999. At present six firms are producing them at industrial scale nationwide, and they are in use across roughly ten thousand healthcare institutions. In June 2002 the Beijing Drug Administration issued a document expanding the clinical pilot for TCM formula granules "beyond the four original pilot hospitals to all medical institutions Grade II-A and above in Beijing, and to TCM specialty institutions" — promoting their wider use to a real extent.
Now, however, the Beijing Drug Administration has issued document Jingyaojianban 2011 No. 33, ruling that from June 1, 2011, only filed medical institutions Grade II and above may trial TCM formula granules. This is a sharp narrowing of the use-range set by the previous policy, and the document offers no persuasive reason for the change. We are concerned that, given Beijing's lead-by-example effect, this restriction will quickly spread nationwide and could even strike down the entire industry that manufactures TCM formula granules.
We hold that TCM formula granules already meet the conditions for promotion — and that this is a matter touching the public welfare and the national interest, deserving high attention. Our reasons follow.
1. TCM formula granules are a dosage-form reform of yinpian. The principal manufacturing process is whole-component water extraction and concentration — a change of physical state. More than a decade of large-scale clinical practice has shown stable efficacy and no adverse reactions. As to the worry that "they have not been co-decocted," in fact pills, powders, pastes, and dan used for over a thousand years are all compounded from raw-herb powders, and their efficacy is established.
2. TCM formula granules have gradually been accepted by clinicians and TCM specialists, and welcomed by the broad public — being especially convenient to carry and take, they are particularly popular among out-of-town and overseas patients.
3. TCM formula granules are an industrial product. Every step — material selection, processing, decoction, extraction — is rigorously tested, and the final product is checked by the most advanced thin-layer chromatography reference testing before leaving the factory. This guarantees a consistency and stability of inner quality that traditional yinpian cannot match — and is favorable to quality control and supervision.
4. The manufacture of TCM formula granules substantially raises the utilization rate of raw materials, saving 20–40% on herbal material. This significantly eases our country's herbal-resource shortage and has strategic significance for protecting Chinese-medicine resources.
5. The production cost of TCM formula granules is controllable. Besides saving raw materials, they save substantially on packaging, warehousing, and transport — an important means for our country to regulate yinpian prices comprehensively, helping to alter, at the root, the passive and chaotic state of yinpian hoarding and price-gouging.
6. TCM formula granules can progressively enable automation of dispensing — sharply shortening fill times, reducing errors, lightening pharmacy workload, and improving the dispensing environment. The State should actively promote research projects and development in this direction.
7. TCM formula granules are easy for physicians to carry. They are particularly useful for doctors going into remote mountainous areas, epidemic zones, and disaster regions; in major outbreaks or natural disasters, they help to contain disease and relieve victims quickly. They also have great potential value for battlefield first-aid.
8. In research and promotion of formula granules, Japan and South Korea got going more than a decade ahead of China; the United States, the EU, Canada, Taiwan, and Hong Kong have long since accepted them. We are behind. With the EU now legislating severe restrictions on the import of Chinese medicine, formula granules are exactly what could break the barrier. Our country has rich resources of raw material for formula granules, and we hold strong competitive ground in both quality and price (Tianjiang Pharmaceutical's Color Atlas of Thin-Layer Chromatography of TCM Formula Granules is a world first; prices in Japan and South Korea are 6–8 times ours). To use this advantage and take ground in the international TCM market — that is what we should be doing.
9. Since TCM physicians may now practice at multiple sites, their prescribing right should not be subject to different restrictions across legally registered medical institutions. Since all legally registered medical institutions hold an equal right to practice medicine, they should not be discriminated against in the medicines they may use. The law is not child's play; government documents at every level must first themselves be legal.
In sum: the use and promotion of TCM formula granules concerns far more than the reform of a dosage-form — it concerns the public welfare and the development of the Chinese-medicine enterprise, and carries major strategic significance. We hope leaders at every level and all sectors of society will take this seriously, and lend strong support to its promotion.