Discussion on the legal attribute of traditional Chinese medicine formula granules

Traditional Chinese medicine formula granule is a kind of special drug concept From the perspective of drug administration law, whether it belongs to the category of traditional Chinese medicine decoction pieces or preparations (referring to preparations of production enterprises) is still controversial in drug supervision, law enforcement and use practice The author believes that in order to supervise these drugs in accordance with the law, it is necessary to clarify their attributes in the legal sense of drug management The main reason why traditional Chinese medicine formula granules attract people's attention is that they are very popular in the pharmaceutical market According to the statistics of relevant departments, as early as 2009, the output of Chinese herbal formula granules exceeded 10000 tons, accounting for 6% of the annual sales of Chinese herbal pieces, and the annual growth rate was more than 30% But under the appearance of prosperity, there are also potential problems: first, at the level of use and sales For the reason of convenient use of medicine, medical institutions strongly recommend that patients use traditional Chinese medicine formula granules to replace the herbal medicine they have taken At the same time, many websites with or without certificates are also selling traditional Chinese medicine formula granules Second, at the production level Generally speaking, most of the traditional Chinese medicine formula particles used by medical institutions come from the compliant drug manufacturers, while the products sold on some websites are not only from the compliant drug manufacturers, nor even the drug manufacturers, such as the so-called traditional Chinese medicine formula particles produced by "a natural plant raw material factory" Third, in the purchase level of medical institutions Most of the traditional Chinese medicine dispensing granules in medical institutions are purchased from drug manufacturers, but a few of them are purchased from drug wholesalers According to the current regulations, traditional Chinese medicine formula particles can only be produced in pilot production enterprises, and can only be sold to hospitals registered by provincial drug regulatory authorities, and have never been approved to enter the field of drug wholesale and circulation, so drug trading enterprises are not allowed to operate In 2006, the State Food and Drug Administration issued a document reiterating that pharmaceutical enterprises are not allowed to sell traditional Chinese medicine formula granules The laws and regulations for the production and use of traditional Chinese medicine formula granules are based on the Interim Provisions on the management of traditional Chinese medicine formula granules The original intention of the special product launched by the former State Drug Administration in 2001 was to carry out reform experiments on traditional Chinese medicine decoction Because the traditional Chinese medicine dispensing granules can avoid the process of decocting traditional Chinese medicine, which is equivalent to handing over the complicated decocting process from the patient or the decocting hospital to the pharmaceutical factory It has many advantages, such as short mixing time, easy to take, easy to deal with and so on In addition, due to the scientific and large-scale extraction process, it can also save the resources of traditional Chinese medicine So, what is the legal attribute of traditional Chinese medicine formula granules? Does it belong to Chinese herbal pieces or preparations? Judging from the clear statement in the first paragraph of the Interim Provisions on the management of granules of traditional Chinese medicine formula that "in order to promote the implementation of approval number management of Chinese herbal pieces and standardize the pilot study of granules of traditional Chinese medicine formula, granules of traditional Chinese medicine formula will be included in the management of slices of traditional Chinese medicine from December 1, 2001, and the implementation of approval number management", the granules of traditional Chinese medicine formula will be managed as slices of traditional Chinese medicine However, if it is regarded as a piece of Chinese herbal medicine, it is different and has fuzzy attributes First, the production process of traditional Chinese medicine formula granules goes far beyond the processing method of decoction pieces, and has extended to the production process of preparations Its technological process involves medicinal materials, decoction pieces, extracts, intermediates and finished products In the appendix of the Interim Provisions on the administration of granules of traditional Chinese medicine, the seventh "inspection" of the technical requirements for the study of the quality standards of granules of traditional Chinese medicine is as follows: unless otherwise specified, the inspection shall be carried out in accordance with the inspection items specified in the general principles of granules in the appendix of the current volume I of the Chinese Pharmacopoeia Obviously, it is closer to the granule of traditional Chinese medicine than the decoction pieces of traditional Chinese medicine Second, the quality standard of traditional Chinese medicine formula granules shall be determined by each enterprise according to the requirements of Interim Provisions on the management of traditional Chinese medicine formula granules As we all know, according to the drug administration laws and regulations, drugs (especially preparations) must be in accordance with the national drug standards, while Chinese herbal pieces can be in accordance with the national drug standards or provincial processing specifications In this way, traditional Chinese medicine granules are in a special area Third, special management should be carried out for the production and operation of TCM formula granules That is to say, traditional Chinese medicine formula granules must be produced by pilot enterprises, can not enter the field of drug circulation, can only be sold to hospitals, and can only be used by clinical hospitals registered by the provincial drug administration It has been more than 10 years since the promulgation of the Interim Provisions on the administration of granules of traditional Chinese medicine Granules of traditional Chinese medicine are still in the experimental stage If they are regarded as substitutes for pieces of traditional Chinese medicine, they do not need to be strictly controlled as new drugs Because by comparing the relevant provisions of drug management laws and regulations, the control of Chinese herbal pieces is weaker than that of preparations Fourth, there has been a controversy about the efficacy of drugs Some people in the pharmaceutical industry raised doubts from the pharmacological point of view: first, the traditional Chinese medicine formula granules lack the process of "group drug co Decoction", so they do not have all the effective ingredients of decoction pieces; second, the traditional Chinese medicine formula granules are in the pilot research stage, without authoritative national standards, and there are potential risks in safety, effectiveness and quality control More determined opponents believe that traditional Chinese medicine formula granules are not suitable for wide-ranging promotion and use in medical institutions This brings about a problem As a substitute of traditional decoction pieces, traditional Chinese medicine formula granules can not achieve the effect of traditional decoction pieces, which is obviously against the purpose of traditional Chinese medicine decoction reform experiment Therefore, at present, the legal attribute of traditional Chinese medicine formula granules is very vague However, the reality caused by this fuzzy situation is that the legal status of traditional Chinese medicine formula granules has not been fully determined, but the industry is developing rapidly Due to the lack of regulatory regulations and market norms, drug regulatory authorities often have no evidence in law enforcement Recently, the general office of the State Food and Drug Administration issued the notice on issues related to strict processing specifications of Chinese herbal pieces and pilot research management of Chinese herbal formula particles, which made it clear that Chinese herbal formula particles are still in the pilot research The State Food and Drug Administration will promote the pilot research of Chinese herbal formula particles with relevant departments, find problems, summarize experience, and timely Relevant regulations have been issued It is hoped that this regulation will be issued as soon as possible, further clarify the legal attribute of TCM formula particles, improve the regulation of TCM formula particles, and promote the standardized development of TCM formula particles industry.