Check the slices in JiaLie define embarrassment

ShaoQiuLian zhejiang haining food and drug administration

China's traditional Chinese medicine reported

        Recently, haining food and drug administration to a hospital within the jurisdiction of the use of Chinese medicine yinpian fumaric the sampling inspection, the inspection results is not in conformity with the provisions, detection "gold amine O" (also named alkali, salt and tender yellow O weak yellow, salt and huai yellow, alkaline huai yellow), inspection conclusion for "the product according to the China pharmacopeia (2010 edition a and state food and drug administration drug inspection added testing method and testing project approval a 2010006 test, the result is not in conformity with the provisions".

        But the afore-mentioned unqualified drug qualitative, law enforcement personnel produces different opinions.

        The first kind of ideas that should be qualitative for inferior drugs. According to the pharmaceutical administration law of the second paragraph of article 49 "the drugs with content not comply with the national drug standard for the inferior drugs" regulation, the drug for the inferior drugs. And, for a gold amine O dye, according to the pharmaceutical administration law of the third paragraph of article 49 "has one of following state, according to the drug inferior drugs to punish" fifth "add colorants, antiseptic, without authorization, spices, taste masking agent and accessories" regulation, the inferior drugs according to punish. Comprehensive consideration of the two non-conformity, the drug should be inferior drugs.

        The second kind of ideas that should punish as fake. Reason is gold amine O is a toxic colorings, according to the pharmaceutical administration law of the third paragraph of article 48 "has one of following state, as fake drugs punish" (4) "contaminated" regulation, should punish as fake.

        The China pharmacopoeia (2010 edition) in the first film, fumaric processing provisions "remove impurities, clean, dry, cut thick slices or used when the beat," visible, dyeing is not allowed.

        The author thinks that, that the problem of gold amine O the point is that the qualitative. The pharmaceutical administration law of the provisions shall be the medicinal colorants, even without authorization is add colorants also should be medicinal. However, gold amine O is toxic, applicable to the silk, acrylic, tannin mordant dyeing of the cotton fiber dyeing etc, as a kind of industrial use toxic colorings, should not be medicinal colorants range. This is the pollution of drugs, not only can't ensure pharmaceutical due curative effect, also may endanger human body health. It should be considered contaminated drugs, punish as fake.

        But, because of the pharmaceutical administration law of the third paragraph of article 48 of the fourth "contaminated" say no authority of the more detailed interpretation of law, gold amine is used for drug banned O the colorants also needs to be fastidious. So, will contain gold amine O fumaric as fake to punish all the absence of strong legal support, eventually, law enforcement personnel have to err and inferior drugs to qualitative case.

        The author holds that the pharmaceutical administration law in legal practice, part to define the specific terms, difficult to application, this does not favor the pharmaceutical supervisory and department of market regulation, which objectively to weaken the sales JiaLie drug enforced. So urgently need to be revised in the pharmaceutical administration law of further when materialize, and publish corresponding judicial explanation, forming a more rigorous and drug parent law, in order to grassroots and drug workers operation, enhance the legal authority, reduce the legal provisions for ambiguity caused by the administrative reconsideration, and administrative litigation.