The six-flavored yellow instruction manual was changed to affect more than 500 pharmaceutical companies

Pharmaceutical Network February 19th, another large variety, the manual was revised today, the State Drug Administration issued a notice, respectively, the six-flavored yellow preparation prescription drugs and over-the-counter drugs (including pills, capsules, tablets, adhesives, omelettes, granules) instructions "adverse reactions", "taboos" and "precautions" to carry out a unified revision.
The revision requirements of prescription drug instructions for hexa-yellow preparations: First, the "adverse reactions" item should be increased: monitoring data show that hexa-yellow preparations have diarrhea, abdominal pain, bloating, nausea, vomiting, gastrointestinal discomfort, loss of appetite, constipation, itching, rash, headache, palpitations, allergies and other adverse reactions reported.
, taboo items should include: allergic to this product and the ingredients contained in the disabled.
, "Precautions" items should include: 1. Avoid spicy, difficult to digest food.
2. Cold patients use it with caution.
Six-flavored yellow preparation over-the-counter prescription drug instructions revised requirements: First, the "adverse reactions" item should include: monitoring data show that hexa-yellow preparations have diarrhea, abdominal pain, bloating, nausea, vomiting, gastrointestinal discomfort, loss of appetite, constipation, itching, rash, headache, palpitations, allergies and other adverse reactions reported.
, taboo items should include: allergic to this product and the ingredients contained in the disabled.
, "Precautions" items should include: 1. Avoid spicy, difficult to digest food.
2. Cold patients use it with caution.
3. When the above adverse reactions occur during taking the drug, the drug should be stopped, if the symptoms are not alleviated should go to the hospital.
. People with severe blood pressure, heart disease, liver disease, diabetes, kidney disease, etc. should take it under the guidance of a physician.
. Children, pregnant women and lactating women should take them under the guidance of a physician in accordance with the usage.
6. Take the drug for 2 to 4 weeks symptoms are not alleviated, should go to the hospital.
7. Allergic physiques should be used with caution.
Affects the efficacy of more than 500 pharmaceutical companies six-flavored yellow preparation is to nourish the kidneys, the main treatment of kidney losses, composed of cooked yellow, wine meat, peony skin, yams, hazelnelia, is an over-the-counter Class B drug.
security, in addition to drugstores can be sold in supermarkets, hotels, department stores and so on.
, of course, these ordinary commercial enterprises need approval from the appropriate drug regulatory authorities to sell Class B over-the-counter drugs.
six-flavored yellow preparation as a supplement class of old Chinese medicine, the market favor is very high.
the Data of the State Drug Administration, it can be found that the revision of the drug instructions related to drug batch number 778, involving 555 manufacturers.
the market, according to Minet data show that in 2019 sales of six-flavored yellow preparations reached 620 million, although the growth rate of sales in recent years is declining, but has been growing at an annual growth rate of about 50 million yuan in stable growth.
the competitive landscape of enterprises, its market concentration is relatively high, Zhongjing Wanxi Pharmaceuticals, Beijing Tongrentang Technology Pharmaceuticals, Jiangsu Kangyuan Sunshine Pharmaceuticals accounted for more than half of the market share.
(data source: mi-net) (data source: milnet) to promote the rational use of Chinese medicine, it is imperative that the drug description contains the most important and basic information of the drug, is the main basis for the doctor's clinical rational drug use, but also the important guidelines for pharmacists and patients to use drugs, if the important instructions of the drug manual is not revised and perfected, it is not reasonable to know the clinical application of Chinese medicine.
And the instruction manual of Chinese medicine because of the particularity of Chinese medicine, there have been certain loopholes, such as the description of adaptive disorders is not clear, the time of use of drugs is not accurate, etc. , in the adverse reactions, taboos and precautions in the past many descriptions are not clear, and even with "not clear" a piece, even if some drugs have been applied when the adverse reactions.
The State Drug Administration this time on the six-flavored yellow preparation specification of adverse reactions, taboos and precautions to revise, is a solution to the past problems, in addition to the specification modification of the taboo item supplement for allergy patients banned, the original application of this type of drug population has little impact, mainly the specification is more standardized than in the past, to a certain extent, also reflects the National Drug Administration more and more attention to the normative issues of the manual.
In fact, in addition to the six-flavored yellow preparations, since 2021, the State Drug Administration has issued 15 instructions for revision of the announcement of 8 chinese medicine-related, and involved quick-acting heart-saving pills, blood-to-blood preparations and other drugs.
According to the State Drug Administration recently issued the "State Drug Administration on promoting the implementation of innovation and development of Traditional Chinese medicine heritage", the State Drug Administration on the release of "Chinese medicine formula particle quality control and standard-setting technical requirements" notice (No. 16 of 2021) can be seen that the state will strongly support the improvement of the quality of Chinese medicine, high-quality development of the Chinese medicine industry.
Drug Instructions are only part of these initiatives, and the state has made a lot of efforts to improve the quality of Chinese medicine, such as the centralized treatment of the quality of Chinese medicine tablets in 2019, and the number of reports of adverse reactions to Chinese medicine is decreasing year by year.
shows the country's determination to standardize the Chinese medicine market and eliminate the fuzzy area of Chinese medicine.
Standardization of the Chinese medicine market is conducive to the patient's drug safety, but also the only way for the Chinese medicine market can be further expanded, I believe that in the future, the more standardized high standards of enterprise market share will be greater, the development potential is higher, take the national development of Chinese medicine good fast train, to the second best survival space will be squeezed.