On February 24, the State Food and Drug Administration issued the “Guiding Opinions on the Principles for the Application of Paragraph 2 of Article 117 of the Drug Administration Law of the People’s Republic of China”. Formula granules take the first step from strict supervision.
This document with a very mouth-watering name is actually a sentence at its core: Chinese medicine formula granules are industrial products of uniform quality produced according to the prescribed standards and processes, and should meet the requirements of the drug standards. Regulation.
The management of TCM formula granules as medicines, rather than TCM decoction pieces, is a qualitative decision of the State Food and Drug Administration, which will have a profound impact on the industry.
In February 2021, multiple departments of the state jointly issued the “Announcement on Ending the Pilot Work of TCM Formula Granules”, loosening restrictions on the production and use of TCM formula granules. It is generally believed in the industry that TCM formula granules are not included in centralized procurement, are not limited by the proportion of drugs, do not implement the two-invoice system, and enjoy price bonuses, and are the best “risk-averse varieties” in the pharmaceutical industry.
Just when many companies are preparing to launch a “big fight”, the State Food and Drug Administration reminded the industry that the supervision of traditional Chinese medicine granules may be strengthened in the future.
Traditional Chinese herbal decoction pieces can be discussed, but Chinese herbal formula granules cannot be discussed.
According to the second paragraph of Article 117 of the new version of the “Drug Administration Law”, if the production and sale of Chinese herbal medicine pieces do not meet the drug standards and does not affect the safety and effectiveness, order the Make corrections within a time limit and give a warning; You can impose a fine of not less than 100,000 yuan but not more than 500,000 yuan.
In the new version of the “Drug Administration Law” with a total of 155 provisions, the one related to “Chinese herbal decoction pieces” is only a warning, which can be fined or not.
For Chinese medicine tablets, it is not contradictory that “it does not meet the drug standards and does not affect the safety and efficacy”. Chinese herbal decoction pieces are derived from naturally grown Chinese herbal medicines. Depending on the origin, the size and surface color may not meet the requirements of the drug standards, but the safety and effectiveness of the herbal medicines will not be affected.
It is for this reason that the penalties for non-compliance of TCM decoction pieces are lighter.
On December 10, 2021, the People’s Court of Gulou District, Fuzhou City heard the China’s first dispute over the punishment of Chinese herbal decoction pieces under the new version of the Drug Administration Law. A pharmaceutical company in Fujian purchased Chinese herbal decoction pieces Gualou and sold them to the outside world. The local market supervision and administration bureau found abnormalities during random inspection and sent them for inspection. The final inspection result was “not in compliance with the regulations”, and the company in Fujian was fined 110 million.
But if the substandard products sold are Chinese medicine formula granules, it may be another matter.
According to this guidance, TCM formula granules are no longer regarded as decoction pieces of traditional Chinese medicine, but are treated according to drug standards. After all, the common properties of TCM decoction pieces, such as size, surface color, etc., as well as moisture, ash, and impurities in drug chips, cannot be checked for TCM formula granules.
Managed according to drug standards, which means that as long as it does not meet the drug standards, it will be identified as counterfeit and inferior drugs, and will be punished accordingly, which is obviously better than traditional Chinese medicine pieces. stricter.
After the promulgation of the new Drug Administration Law and the liberalization of the production and use of traditional Chinese medicine granules, the management of this type of product must be put on the agenda. This determination by the Food and Drug Administration is the first step in the next step to systematically standardize traditional Chinese medicine formula granules.
Traditional Chinese medicine formula granules, regulatory tightening will be on the line
Traditional Chinese medicine formula granules will face more stringent regulatory standards, which is an inevitable trend under the conditions of comprehensive liberalization.
In clinical use, TCM formula granules and TCM decoction pieces can basically be substituted for each other. Therefore, while promoting the inclusion of TCM decoction pieces in medical insurance, TCM formula granules are also considered. The medical insurance bureaus in Fujian, Anhui, Hebei and other places have publicly solicited opinions on relevant matters. Recently, the Beijing Municipal Medical Insurance Bureau issued a notice for the purchase of Chinese herbal decoction pieces and Chinese herbal formula granules on the Internet.
Before the licenses were released, only 6 enterprises in China, namely Guangdong Yifang, Jiangyin Tianjiang, Beijing Kangrentang, China Resources Sanjiu, Sichuan New Green and Peili Pharmaceutical, had the authority to produce and sell traditional Chinese medicine granules. . After the release of the production license, coupled with the continuous favorable policies of traditional Chinese medicine formula granules, many traditional Chinese medicine companies have entered the market one after another. More than 30 Chinese medicine companies, including Essence Pharmaceuticals, Taiji Group, Jiuzhoutong, Xiangxue Pharmaceuticals, etc., have all stated that they will deploy Chinese medicine formula granules.
One of the reasons why countless Chinese medicine companies have joined the queue of Chinese medicine formula granules is that industrial production has reduced the difficulty of production, and at the same time, compared with chemical drugs, they are favored by policies. .
However, reasonable support and standardized management are the basis for the healthy development of the industry. Now the Food and Drug Administration has clarified the regulatory rules for Chinese medicine decoction pieces in the “Drug Administration Law”, and the exclusion of Chinese medicine formula granules alone may mean that industrialized Chinese medicine formula granules may be different from common chemical drugs. Like drugs, they are subject to stricter regulatory rules. and under stricter requirements, it is necessary to filter out some speculative Chinese medicine companies that do not meet the standards.
The current highest-level laws and regulations on traditional Chinese medicine formula granules in China are the “Interim Regulations on the Administration of Traditional Chinese Medicine Formula Granules” promulgated by the State Food and Drug Administration in 2001. open, so the regulations are still in use today. The current industry situation has changed, and legislative work should indeed be put on the agenda.
During the National People’s Congress in 2018, Du Yanan, deputy to the National People’s Congress and then mayor of Bozhou City, submitted a proposal, hoping to issue the “Administrative Measures for Chinese Medicine Formula Granules” as soon as possible. However, the relevant laws have not yet been formed.
However, many regions have begun to explore, such asYunnan, Anhui, Guangdong and other places have tried to implement the management rules related to traditional Chinese medicine granules in 2021. Presumably, it is not too far away for the laws related to traditional Chinese medicine formula granules at the national level, and the industry management will inevitably be tightened by then.
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