In order to ensure the quality and safety of drugs, relevant departments have frequently issued policies and strict supervision in recent years to promote the development
of the pharmaceutical industry in a standardized direction.
Among them, Chinese medicine pieces have become "frequent customers"
of relevant departments due to the backward standards of some medicinal materials, unscientific cultivation of traditional Chinese medicine and the difficulty of precise supervision.
On October 28, the Guangdong Food and Drug Administration issued a notice on the results of random inspection of drug quality (Issue 06 of 2022), which involved a total of 1,675 batches of products, of which 4 batches were unqualified, all of which were pieces of traditional Chinese medicine, namely red ginseng, cardamom, fried bran, and raw rehmannia
.
The unqualified items involved are: determination of residues, properties, moisture and content of
other organochlorine pesticides.
For drugs that do not comply with the regulations, the current drug regulatory departments have required relevant enterprises to take risk control measures
such as suspension of sales and use, recall, etc.
On October 25, the website of Jiangsu Provincial Drug Administration issued a notice on the quality of drugs in Jiangsu Province No.
3 in 2022 (No.
23 of 2022).
According to the annual sampling inspection work plan, the Jiangsu Provincial Drug Administration organized random inspections on the production, operation and use of some drugs, of which 4 batches did not meet the regulations
.
The four batches of products are Epimedium, Wheat Dong, Peony Peel and Sand Garden, and the unqualified items involved are traits, moisture and impurities
.
On the same day, in the "2022 No.
3 Drug Quality Sampling Notice" issued by the Shanghai Municipal Drug Administration, there were also 2 Chinese medicine pieces with unqualified quality, namely Yuanzhi and Sanleng, and the unqualified items of drugs were aflatoxin and traits
.
At present, for batches of products that do not meet the regulations, drug regulatory departments at all levels have required relevant enterprises to take risk control measures such as suspension, suspension and recall, and investigate and deal with
relevant enterprises according to law.
Industry analysts believe that in fact, all localities are accelerating the quality sampling activities
of drugs, especially Chinese medicine pieces.
Especially since February 2020, the State Food and Drug Administration issued the "Work Plan for the Special Rectification of Chinese Medicine Pieces", which put forward the overall goals and work points for the special rectification of Chinese medicine pieces nationwide, up to now, many places across the country have successively issued special rectification work plans for Chinese medicine pieces, strengthened the frequency of random inspections, and at the same time named some non-compliant drugs, and increased penalties
.
According to the relevant provisions of the new version of the Drug Administration Law, those who produce and sell inferior drugs will be subject to confiscation of illegal gains, a fine of 2.
5 times the value of illegally produced and sold drugs (if the value of illegally produced and sold drugs is less than 100,000 yuan, it is calculated as 100,000 yuan), and the punishment of confiscation and recall of the
batch of inferior drugs.
Previously, in a notice issued by the Anhui Provincial Food and Drug Administration, a traditional Chinese medicine piece company in Bozhou City was fined nearly 600,000 yuan
for producing and selling chrysanthemums that did not meet the regulations.
Although Chinese medicine pieces still account for the majority of unqualified products in drug sampling, the overall qualification rate of Chinese medicine pieces sampling is also rising
under the background of the continuous efforts of relevant departments and the continuous improvement of the production quality of Chinese herbal medicines.
According to the 2021 National Blue Book of Chinese Medicine Regulation, the control of APIs, production processes and product quality of Chinese medicine pieces have been greatly improved and improved in recent years, and from 2016 to 2021, the overall qualification rate of Chinese medicine pieces has increased from 77.
7% to 98.
4%.
In the future, with the promotion of favorable policies and the continuous increase of supervision of Chinese medicine pieces by drug regulatory departments at all levels, the market of Chinese medicine pieces will accelerate its development
in the direction of high quality.
At the same time, the standards of Chinese herbal medicines, the supervision of planting and other supporting issues will also be stricter, for relevant enterprises, only adhere to compliance is the way
out.
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