Editorial: drug deterrent "blacklist" still need to improve

Release date: 2013-10-16

Source: southern daily

        On the "blacklist" focuses on the content, the form of a "blacklist", is only for drug firms out of the time, ugly, and no bone, so nobody CARES about.

        According to the guangdong food and drug administration recently issued announcement, in the second quarter of this year, guangdong province on 102 of the 1238 pharmaceutical producing enterprises, pharmaceutical trading enterprises and 418 medical institutions to sample 886 varieties of 4509 batches of drug, of which 81 varieties 197 batches of unqualified, 71 varieties of 185 batches product inspected as "substandard", 10 varieties 10 batches of product is a "fake".

        And from the point of drug classification, cold treatment drugs listed "substandard", most common amoxicillin capsules, radix isatidis particle, infantile dipper tea particle, ageratum upright wandeng drugs on the list. Products including well-known domestic pharmaceutical companies, including daughter pharmacy of department of gynaecology daughter and talc pharmaceutical hemp apricot cough pills, bezoar bolus of tong ren tang palace was found hyodeoxycholic acid project is unqualified, san-jiu medicine cold spirit particles are on the list.

        Drug safety affects the heart, the announcement, market an uproar. In fact, for some drug companies, this is not the first time appear problem, in recent years well-known drug firms to be product unqualified phenomenon is not uncommon, and even some drug companies several times in a year on the list. For drug firms are public goods is unqualified, media use "HeiBang" or be included in the "blacklist" to describe, but was listed in the "blacklist", really have a deterrent for drug firms? It is questionable.

        In August 2012, the state food and drug administration has issued the regulations for the drug safety "black list" (try out) ", due to a serious breach of drugs and medical equipment management laws, regulations and rules by administrative penalty operators, and responsible for the production of relevant information through the government website, set up "blacklist" database query for society, and adopt measures to increase inspection and sample frequency and so on the key regulatory; Dealing with drugs and medical devices, a contrast relevant administrative licensing matters to review the information in the "blacklist", etc. The rules shall be implemented as of October 1, 2012 has.

        Through the "blacklist" system, as it were, all kinds of unscrupulous businesses of unscrupulous behavior exposure, for those illegal producers or marketers have deterred, for illegal business practices can have the necessary punishment and deterrent. Such a "blacklist" but also to strengthen supervision of the competent department to prevent pharmaceutical production and sales enterprise loss of moral bottom line, but also conducive to the public supervision, enhance the public's confidence in drug safety. However, from the point of practical effect, play a role in the "blacklist" is limited.

        For the "blacklist" why not its proper role, has been blamed on the following points, first of all, still belong to afterwards supervision issued a "blacklist", has its passivity, at this point the damage already produce for consumers, and the criminals have a profit; Secondly, to some extent, the form of a "blacklist" focuses on content, on the "blacklist", ugly for drug firms is just out of the time, and no bone, so nobody CARES about. In my opinion, the drug safety "black list" system to show the power, to scare, scare others seem to be very necessary. Is not only to let the public know these companies did a bad thing, let its reputation, more important, regulators should pass punishment to pay a heavy price.

        In some countries, the enterprise on the blacklist, won't be able to participate in government tender, life always difficult for examination and approval of new drugs, and tougher regulation. It is worth our using for reference. Companies' illegal business behavior should not only linked to drug manufacturing, inspection, etc, and basic drug bidding, government procurement, the registration of new drugs and other industry business activities, with industrial and commercial registration (mot), the price for approval, the enterprise credit, financial credit and other industries outside supervision, in order to improve the illegal cost and opportunity cost into the "black list", due for those price. Offenders, for their part, fear is "blacklist" attached disciplinary content, is the price on the "blacklist", if the punishment is too small, the blacklist will be looked down upon.

        At the end of the day, "blacklist" is just a form of drug firms frequent quality problems, is reflected in the deeper issues of industry. Pharmaceutical industry researcher Guo Fan li pointed out, this mainly includes two aspects: on the one hand, is the enterprise own loophole in terms of product quality management system, each link has not been effective inspection; On the other hand is China's drug administration attaches great importance to the final product inspection results, only in the production of lack of effective supervision, should be to perfect enterprise production by industry standards. To this, the author deeply convinced. To build a "blacklist" system is only the first step, in the future, hope that regulators can step forward, made regulatory intervention when it for production, make the counterfeiters have no empty to drill. At the same time, the author also hopes to strengthen drug companies on product quality management system construction, do a conscience.

        Zhao hui