The decision need to be careful about Chinese medicine yinpian non-conformance

Gao Xudong Xiangshui county in jiangsu province food and drug supervision bureau

China's traditional Chinese medicine to

        A food and drug regulatory authorities in the special Chinese medicine yinpian, to shut a drug retail enterprises within their respective jurisdictions of cortex phellodendri has carried on the sampling inspection, on the basis of "Chinese pharmacopoeia" 2010 version of a test, the results description for: cortex phellodendri, does not conform to the rules. Facing the drug inspection report to the conclusion that in the case of qualitative law enforcement has a different opinion on:

        Some argue that the "drug administration law" in the second paragraph of article 48 specific provision, pharmaceutical ingredients contained in conformity with the required ingredients for the national drug standards; In a drugs masquerading as drugs or with his kind of medicine as such drugs for counterfeit drugs; And (3) according to the six aspects of counterfeit drugs be rules. "Pharmaceutical administration law" the seventy-eighth regulation, notice, the punishments for JiaLie medicine must indicate the pharmaceutical inspection institutions of quality inspection result, except otherwise stipulated by the pharmaceutical administration law. Shut cortex phellodendri cortex phellodendri, in the case in the "Chinese pharmacopoeia" 2010 edition a, closed and cortex phellodendri cortex phellodendri character and identification methods of different, conforming to his drugs masquerading as the drug regulation, therefore, should be in accordance with the pharmaceutical administration law in the second paragraph of article 48 of counterfeit drugs to initiate an investigation, and according to the criminal law amendment (eight) transferred to public security organs to deal with.

        Others believe, cortex phellodendri and cortex phellodendri of the effective component mainly berberine, "Chinese pharmacopoeia" 2010 version a. Though the records, but the two varieties of "sexual flavour and belong to the", "function and attending", "usage" is exactly the same. For thousands of years, Chinese medicine is China's traditional medicine, has its inherent drug habit, does not distinguish between in clinical use, the formulation and cortex phellodendri cortex phellodendri overspending: as the same drug medicine, from the perspective of developing and protection of traditional medicine, should not be directly identified as counterfeit drugs, should be ordered to recall, to correct the name again after sales.

        Under normal circumstances, law enforcement personnel is not in conformity with the provisions in the drug inspection report items of all medicines as a counterfeit drugs, mainly from the following two aspects to determine:

        One's character. Drugs traits include drugs the appearance (color, shape, smell, taste, solubility and physical constants, etc. Under normal circumstances, the chemical properties change and cannot be judged to be fake drugs, such as many drugs when it is heated, illumination, after its appearance will change color. But traditional Chinese medicine or Chinese medicine yinpian such traits do not conform to the rules, decision is more complicated, because some Chinese herbal medicine or Chinese medicine yinpian is falsify or confused as the real thing, the drugs properties structure, function and main composition is totally different from the real thing, can not be used as a medicine cure, therefore, can be directly judging from the character is not in conformity with the provisions of counterfeit drugs, and some are according to the appraisal study of traditional Chinese medicine (TCM) relevant knowledge base of the original (the former plant, animal and mineral) after appraisal, can identify true and false, superior, inferior, and qualitatively according to the China pharmacopoeia are counterfeit or substandard drugs.

        The second is to identify. Is to identify the active ingredients in medicines or qualitative, a particular component is a main method to identify drugs of true and false. In drug inspection, identification of drugs are mainly physical and chemical identification, microscopic identification, identification, TLC identification and thin layer identification, etc., as long as there is a differential item does not conform to the regulations, which should determine the drug for counterfeit drugs. If identified a drug has been spoiled or contaminated, or there is evidence to prove that its accord with the pharmaceutical administration law article 48 in the third paragraph (a) (2) of the circumstances specified in item (5) (6), shall be as according to counterfeit drugs.

        Accordingly, these two views, the former decision criteria and decision basis in accordance with law, which is understandable. The author thinks, Chinese medicine yinpian (material) and chemical drugs, chemical drugs is strictly in accordance with a certain technological process, strictly according to the specific prescription under the GMP production of products, in general, a manufacturer's batch varieties are rather unique. While Chinese medicine yinpian, slices of the same name its producing area is different, its structure, effective component content will be different, and even some Chinese medicine yinpian has multiple aliases, therefore, to decide on, Chinese medicine yinpian non-conformance, law enforcement officers can not sloppy qualitative must consider, carefully analyse the causes of unqualified, then make a legal decision.

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