Local rules for the management of traditional Chinese medicine formula granules are implemented!

On July 27, the Hainan Provincial Food and Drug Administration and other four departments jointly posted the "Implementation Rules for the Management of Hainan Traditional Chinese Medicine Formula Granules (Trial)" (hereinafter referred to as "Implementation Rules"), which will be implemented on November 1, 2021
.

This means that after the four ministries and commissions including the State Food and Drug Administration and the National Medical Insurance Administration issued the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" (hereinafter referred to as the "Announcement"), local provinces and cities began to issue detailed implementation rules

Fully liberalize access and establish the only procurement channel

According to the "Announcement", Hainan Province requires in the "Implementation Rules" that enterprises that produce granules of traditional Chinese medicine should obtain the "Drug Production License" and have the scope of production of Chinese medicine decoction pieces and granules
.

Enterprises should have complete production capacity of Chinese medicine processing, extraction, separation, concentration, drying, and granulation, and a production scale corresponding to the number of varieties produced and sold

What attracts people’s attention is that Hainan’s practice is to set up a traditional Chinese medicine formula granule section on the provincial drug procurement platform, formulate and publish the corresponding tender rules
.

The "Implementation Rules" require that the Chinese medicine formula granules used in public hospitals should be purchased through the provincial drug centralized procurement platform, online transactions, offline transactions, and purchases of enterprises and varieties that have not been filed by the Provincial Food and Drug Administration

On this designated procurement platform, medical institutions should sign quality assurance agreements with manufacturers of traditional Chinese medicine formula granules
.

For TCM formula granules produced by manufacturers of TCM formula granules from other provinces to enter the medical institutions of Hainan Province, the manufacturers and their varieties that have not been filed shall not be purchased or traded on the Hainan Province centralized drug procurement platform

According to requirements, starting from November, Chinese medicine formula granules shall not be sold outside medical institutions
.

That is to say, the hospital channel will be the only use channel of Chinese medicine formula particles
.

Since the state issued the "Interim Regulations on the Management of Chinese Medicine Formula Granules" in 2001, the market for Chinese Medicine Formula Granules has developed rapidly

The new round of beach-hunting competition, the trend of the strong will be preliminarily determined

If Hainan Province is in the forefront of issuing the "Implementation Regulations," then, according to the "Announcement", other provinces will also implement the implementation regulations in the last three months
.

It can be concluded that soon the entire Chinese medicine formula granule market will enter a comprehensive differentiation stage

Taking Hongri Pharmaceutical as an example, Shandong Shanghe's intelligent manufacturing base for traditional Chinese medicine formula granules with an annual output of 3,000 tons started construction in June, making it one of the most concerned beachheads during the New Deal window period
.

Hongri Pharmaceutical has established automated production bases of traditional Chinese medicine formula granules in 7 provinces (cities) including Beijing, Hebei, Hubei, Chongqing and Gansu

According to the 2020 financial report of Hongri Pharmaceutical, there are more than 600 kinds of Kangrentang traditional Chinese medicine formula granule products
.

In 2020, the sales revenue of traditional Chinese medicine formula granules and decoction pieces will be 2.

For Chinese medicine formula granule companies, there are also opportunities and challenges: on the one hand, the New Deal clarifies that Chinese medicine formula granules can be used in all medical institutions, which is optimistically expected to benefit the entire industry; on the other hand, as the industry is officially opened, more manufacturers enter While the industry continues to grow at a high speed, competition will become more intense, which will test the company's supply chain capabilities
.

In the face of this systemic competitive landscape, even China Traditional Chinese Medicine and China Resources Sanjiu, the leading companies in traditional Chinese medicine formula granules, dare not slacken in the slightest
.
The focus of Chinese traditional medicine selection is to form a relatively complete industrial chain of raw materials, research and development, production, circulation and terminal through the forward and backward integration of internal and external development
.

The focus is on integration
.
Among the first batch of 6 independent R&D enterprises of Chinese medicine formula granules in China, Chinese Medicine Holdings has 2 companies: Tianjiang Pharmaceutical and Guangdong Yifang Pharmaceutical
.
In recent years, China Traditional Chinese Medicine has completed the preparation process and quality standard research of more than 600 traditional Chinese medicine formula granules.
It has jointly carried out the clinical and pharmacodynamic comparative study of "separate decoction" and "combined decoction", and established the quality standard system and quality standard of Chinese medicine formula granules.
The safety index limit standard of traditional Chinese medicine formula granules
.
At present, Yifang Pharmaceutical has established 11 major production bases, distributed in Shandong, Gansu, Zhejiang, Jiangxi, Hunan, Shaanxi, Guangxi and other regions
.
From the perspective of regional distribution, the income from the pharmaceutical granules business is mainly distributed in East China, South China and North China, accounting for nearly 70%
.

China Resources Sanjiu also produces more than 600 varieties of single-flavor formula granules, but one of its very important "hands" is to vigorously provide high-quality Chinese medicine formula granules and decoction pieces to enhance the competitiveness of the industry chain
.
Facing the new competitive environment that will be brought about by the end of the Chinese medicine formula granule pilot program, the company is also accelerating the layout of the entire industry chain, accelerating the production of new standards for varieties, optimizing the preparation process and continuing to expand the construction of medicinal planting bases to ensure the quality of medicinal materials And the quality is stable, forming an internal control quality standard that meets the production of high-quality Chinese medicine formula granules
.

In contrast, Peili Holdings, which focuses on the market of concentrated Chinese medicine formula particles, is taking another path: In terms of the production of concentrated Chinese medicine formula particles, Peili Holdings also has 600 kinds of single formula particles and more than 130 kinds of classic compound formula particles.
Through a comprehensive and diverse product portfolio, most traditional Chinese medicine prescription applications can be realized
.
The company currently not only operates more than 30 Nongbenfang modern Chinese medicine clinics in Hong Kong, China, but also operates 6 Nongbenfang modern Chinese medicine clinics in Australia.
The product development center will introduce Japan's most advanced technical knowledge to improve product quality and production efficiency, while further expanding its overseas influence
.

From the perspective of competition, six well-known companies, including China Resources Sanjiu, Jiangyin Tianjiang Pharmaceutical, Hongri Pharmaceutical Kangrentang, Peili Pharmaceutical, and Sichuan New Green Pharmaceutical, are in the market for food-sharing traditional Chinese medicine formula granules
.
But after the New Deal is liberalized, there is still a lot of uncertainty about who will be able to feast in the end
.
This uncertainty comes from the A-share listed companies, more than 30 pharmaceutical companies such as Jilin Aodong, Taiji Group, Xiangxue Pharmaceutical, etc.
have deployed or are about to deploy traditional Chinese medicine formula particles
.
Up to now, Xintian Pharmaceutical has obtained 445 TCM formula particles approved for clinical research seven times
.
It seems that the real contest is yet to come
.

Strengthen basic research, control raw material barriers, and improve quality standards

The formulation and granule filing system not only means the full opening of the access mechanism, but also means that the market will usher in a blowout
.

However, if the policy is liberalized, the supervision will be stricter
.
In view of the current situation of unstable quality of traditional Chinese medicine formula granules and statutory standards that have yet to be improved, the national level is also making every effort to promote system construction
.
On April 29, the official website of the National Pharmacopoeia Commission published the first batch of 160 Chinese medicine formula granules national drug standards
.
The promulgation of the national standards for Chinese medicine formula granules will help to fully realize the overall quality control of the safety and effectiveness of Chinese medicine formula granules
.

In traditional Chinese medicine formula granules, stable production of different batches of the same product has always been the focus of attention
.
Some experts have said bluntly a few days ago, "Encourage the liberalization of the quality standards of formula particles, and emphasize the quality view with enterprises as the main body
.
For example, enterprises can make preparations for modern quality control such as infrared fingerprint spectroscopy in advance
.
In view of this, pharmaceutical companies should strengthen research and formulate The key to standards is to strengthen basic research, optimize processes, and maximize the advantages of formula particles
.
"

In fact, the key to traditional Chinese medicine formula granules is to control the raw material.
The problems of authenticity, artificial cultivation and wildness are also crucial
.
Ensuring the quality and quality of traditional Chinese medicine formula granules requires quality control throughout the entire process, and it is not a single indicator that can be controlled
.
Experts say that the core issue of formula granules is standard and quality problems, and standard decoction is a standard reference for measuring the clinical efficacy of formula granules
.

Difficulties such as the problems of multi-base raw medicinal materials, the inconsistency of processing technology, the problem of single co-decoction, and the incomplete quality standards of traditional Chinese medicine formula granules need to be solved urgently
.
Establish a quality standard system with standard decoctions as the core, and compare traditional Chinese medicine formula granules with standard decoctions to ensure the consistency of the quality of the two
.
The quality control index of formula granules is not equal to the quality control index of the national standard for medicinal materials or decoction pieces, and the same standard decoction should be used as the standard
.
At present, formula granules are facing the status quo of uneven quality.
When making evaluation standards, we must face up to the differences in quality.
Products of the same company and the same brand must pursue uniformity and stability.
It is the formula granules to achieve high quality and good price through brand building.
Way out
.