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And this article on a problem, that is, we are very concerned about the new law penalty amount of the problem, the fake drug 1.5 million start, bad drug 1 million start.
Article 17 Of the penalties for inferior drugs, for Chinese medicine tablets, made the following special provisions: the production and sale of Chinese medicine tablets do not meet the drug standards, not yet affect the safety and effectiveness of the, ordered to correct within a time limit, give a warning;
the key point is: not yet affect security, effectiveness; First look at a group of Chinese medicine tablets industry data, feel the 2018 national sales revenue of Chinese medicine tablets 263.9 billion yuan, net profit margin of about 15%;
and the same period in 2018 the whole year sampling of unqualified Chinese medicine tablets 2385 batches, such as 1 million, the total fine as high as 2.38 billion.
(Note: Up to 2019, 1858 batches of unqualified Chinese medicine tablets, if calculated at 1 million, the total fine is as high as 1.86 billion).
according to the country's 2,200 drink tablets flat, each enterprise fined 1 million yuan.
this fine is not heavy for the Chinese medicine drink ingress industry.
a lot of drinking factories can close directly.
whether Chinese medicine drink tablets should have special treatment Chinese medicine tablets, raw materials Chinese medicine, its agricultural and sideline identity, natural properties are obvious;
at the same time, but also because of natural properties, Chinese medicine, such as insects, mold, can not be avoided.
in this case, the drug management law, the implementation of special treatment of Chinese medicine tablets, is a reflection of respect for objective facts, worthy of praise.
not yet affect security and effectiveness; The understanding of this sentence is directly related to the future implementation of the drug law, directly related to the application of 1 million starting? It's still 100,000 starting.
this issue, the next step for regulators will certainly be to issue specific implementation guidelines, before the introduction, try to talk about the scientific understanding of individuals.
safety: This is relatively good understanding, safety indicators dyeing, weight gain, fumigation, aflatoxin, etc. are related to safety, such as touching, it is not applicable to 100,000 start.
the future may be controversial is the agricultural residues, heavy metals exceed the standard, does not count as affecting safety issues, in theory, agricultural residues, heavy metals belong to the safety indicators, its excess of certainly not applicable to 100,000 start;
Effectiveness: What is effective is the efficacy.
this problem is complex, the difficulty is that, in fact, the current standard of Chinese medicine clear quantitative indicators, are "indicator components."
note that, yes, it is "indicator ingredient" and not "effective component"; What's
? Directly the indicator component as the effectiveness component, non-conformity on behalf of the impact of efficacy? There is clearly a dispute.
I talk about the idea, I think to judge whether the impact of efficacy, or from the overall quality of Chinese medicine to measure.
such as water slightly super, impurities slightly super, tablet slightly irregular point, will not affect the efficacy;
of course, human impurities super too much, artificially caused too much difference, that is another matter.
here can set the guidance standard, grasp the degree of judgment.
, in addition, such as the storage process of insects, mold, in the case of not being sold, can also be classified to not affect the efficacy.
which are the ones that affect the effects? And the key is whether there is man-made intentional behavior.
if it has been extracted, is it deliberately reprocessed with mold? If so, that is, 100,000 start-ups are not applicable.
hey, finally talk about, feel still not straightened out ha;
for this issue, the vast number of peers we can talk about, what do you think? Brainstorming can also serve as a reference for regulators to develop detailed rules for the future.
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