Through interviews with a large number of pharmaceutical enterprises and related organizations, we learned that there were many problems in the 2013 Guangzhou Basic Drug Supplement.
In the previous report "What happened to Guangdong based drugs when a boss was shot by five companies. Some drugs are not prescribed by the state as the first drug, and even the national controlled drug tramadol is also included in the list.
Among them, the enterprises involved include Changbaishan Pharmaceutical Co., Ltd., Jiangxi Shangao Pharmaceutical Co., Ltd., Shanghai Kaibao, Kang'enbei, Jilin Pharmaceutical and other enterprises.
Opioid drugs as base drugs
Compared with the above or involved pharmaceutical enterprises, the following pharmaceutical enterprises have more obvious violations.
"It is a basic principle that when entering the list of basic drugs, you must first comply with the relevant provisions of the state on basic drugs.". The above secretary of the board of directors of Southern Pharmaceutical said to 21st Century Network.
It is understood that the Opinions on Consolidating and Improving the Essential Drug System and the New Mechanism for Grass roots Operation (GBF [2013] No. 14) of the General Office of the State Council also stipulates that the selection and adjustment of the national basic drug catalogue should be "based on the principles of necessary prevention and control, safety and effectiveness, reasonable price, convenient use, and equal emphasis on Chinese and western drugs", One of the fundamental principles is to comply with the basic principles of national basic drug selection, which also includes the provisions not included in the selection scope of the national essential drug directory:
（1） Containing medicinal materials of endangered wild animals and plants of the state;
（2） It is mainly used for nourishing health care and is easy to abuse;
（3） First choice for non clinical treatment;
（4） Due to serious adverse reactions, the national food and drug administration clearly stipulates to suspend production, sales or use;
（5） Violating national laws and regulations, or failing to meet ethical requirements;
（6） Other situations stipulated by the National Essential Drugs Working Committee.
According to a data provided by a senior expert of a top three hospital in Guangzhou to 21Century. com, 10 of the 278 new varieties of drugs in the List of Essential Drugs Supplemented in Guangdong Province (2013 Edition) involve many enterprises, including Changbaishan Pharmaceutical Co., Ltd., Jiangxi Shangao Pharmaceutical Co., Ltd., Shanghai Kaibao, Kang'enbei, Jilin Pharmaceutical, etc, The drugs involved are non preferred or contain drugs prohibited by the state, and the drugs controlled by the state.
According to the data provided by the above senior experts, in the 2013 supplement of basic drugs in Guangzhou, Cefepime, Tobramycin, Ligustrazine, Papaverine, Shenqi Shiyiwei Granules (capsules, tablets), Shexiang Tongxin Dropping Pills, Qishen Capsules, Shexiang Haima Zhuifeng Cream, Kangai Injection, etc. are non preferred or contain national banned drugs, The analgesic tramadol includes three dosage forms involved: (hydrochloride) sustained-release capsules, (hydrochloride) tablets and (hydrochloride) injections, which are all controlled by the state, rather than basic drugs.
For example, the Shexiang Tongxin Dropping Pill in the category of blood stasis removing agent in the 2013 Guangdong Supplementary List of Basic Medicines is a drop pill with a specification of 35mg per pill. After consulting the State Food and Drug Administration, 21Century.com found that this product is still one of the youngest drugs in this supplementary list. The drug approval date is January 30, 2013, and there is only one corresponding manufacturer, That is, Inner Mongolia Kang'enbei Pharmaceutical Co., Ltd. Shenglong Branch. According to the official website of Kang'enbei, the company is a pharmaceutical enterprise under Zhejiang Kang'enbei Pharmaceutical Co., Ltd.
In 2013, Qishen capsule in the Guangdong supplementary catalogue was 0.3g per capsule. 21st Century found from the State Food and Drug Administration that the product was only owned by Henan Xinyi Pharmaceutical Co., Ltd., which involved the listed company Shanghai Kaibao.
The above medicine is not the first choice, and the above medicine containing musk is also the medicine with great controversy on safety.
In addition, according to a clinician who has been practicing medicine for many years, tramadol is an opiate, mainly used as an analgesic, which can relieve ordinary to severe pain, and can be addictive if abused. It is a national controlled drug. However, it appeared in the 2013 supplement list of basic drugs.
Guangdong based medicine supplement is not good?
Shi Lichen, senior medical partner of the Zongheng Pharmaceutical Industry Center of Peking University, believes that the reason for the above phenomenon is that the types of diseases in different provinces are different, and the national basic drug catalog should not be fully included. The positioning of China's basic drug catalog and the strategy of allowing provinces to supplement themselves have led to many problems in the actual operation of the selection and application of China's basic drug catalog, There are opportunities for the supplement of basic drugs in each province. In addition, whether the country has unified norms and standards for the supplement of basic drugs in each province, a series of chaos has emerged in the supplement of basic drugs in each province, which also increases the opportunity for corruption of rights.
As for whether the above drugs are likely to be kicked out, Shi Lichen told 21st Century. com that they will not be kicked out unless it is verified that the drug companies have paid bribes in the supplement of basic drugs. Other provinces will consider the increase proportion of some varieties, especially exclusive varieties or product specifications, especially those involving pharmaceutical enterprises. As for the number of supplements, many factors can not be balanced in each province, and the number of supplements in each province will not be less than 200.
In fact, the relevant departments have also stipulated that drugs will be transferred from the national essential drugs list: the drug standards have been canceled; The State Food and Drug Administration revokes the drug approval certificate; Serious adverse reactions occur; According to pharmacoeconomic evaluation, it can be replaced by varieties with better risk benefit ratio or cost benefit ratio; And other situations that the National Essential Drugs Working Committee thinks should be transferred out.
Gan Rongfu, a senior consultant of Sinopharm Holdings and a senior expert in the pharmaceutical industry, told the media that in general, each province has a database of drug selection experts. Every time when it is necessary to adjust the medical insurance category B directory and the local basic drug directory, the health management departments of each province will randomly select some experts to hold a seminar, and then publicly solicit opinions.
However, this supplement of basic drugs in Guangdong did not seek public opinions in advance. It was introduced quickly and there were many exclusive varieties, which caused external discussion.
Niu Zhengqian, vice president of the China Pharmaceutical Enterprise Management Association, also said that the supplementary list of basic drugs in Guangdong Province "basically abolished the national basic drug list.
