Archive for May, 2012

31 New Drugs Approved for Marketing in India Without Clinical Trials

May 29th, 2012 | by

In a random scrutiny, the Parliamentary Standing Committee on Health has found that as many as 33 drugs were approved without clinical trial on Indian patients by the Drug Controller General of India (DCGI), during the period of January 2008 to October 2010. (Source:


“According to information provided by the Ministry, a total of 31 new drugs were approved in the period January 2008 to October 2010 without conducting clinical trials on Indian patients. The figure is understated because two drugs 29 (ademetionine and FDC of pregabalin with other ingredients) were somehow not included in the list. Thus there is no scientific evidence to show that these 33 drugs are really effective and safe in Indian patients,” said the report which is likely to create ruckus in the coming days.

In order to scrutinize new drug approvals, the Committee sought details [sponsors; pre-approval phase III clinical trials; overseas regulatory status in US, Canada, Britain, Australia and European Union; indications; names of experts if consulted and Post-Marketing Safety Update Reports (PSURs)] in respect of randomly selected 42 medicines from the list of new drugs uploaded by CDSCO on its website. Of these, 38 drugs were approved in the years 2004 to August 31, 2010; one drug had been approved earlier in 2001. Three drugs had been approved earlier in mid 90s. In all DCGI had approved 2,167 drugs in the period January 2001 to 30-11-2010. Thus the sample size for random scrutiny was less than 2 percent, said the panel headed by Brajesh Pathak report said.

“Out of 42 drugs picked up randomly for scrutiny, the Ministry could not provide any documents on three drugs (pefloxacin, lomefloxacin and sparfloxacin) on the grounds that files were non-traceable. All these drugs had been approved on different dates and different years creating doubt if disappearance was accidental. Strangely, all these cases also happened to be controversial drugs; one was never marketed in US, Canada, Britain, Australia and other countries with well developed regulatory systems while the other two were discontinued later on. In India, all the three drugs are currently being sold. It is not possible to monitor if manufacturers are abiding by the conditions of approval viz. indications, dosage, contraindications, precautions etc. Updation of product monographs and safety information in the light of recent developments is also not possible putting patients at risk. Before being withdrawn, major changes in safety profile, including Black Box Warnings (meant to draw attention to serious side effects), were incorporated to the prescribing guidelines of the two drugs sold in the United States but later withdrawn from the market,’’ the report said.

Excerpts from the Report:

7.14 On scrutiny of 39 drugs on which information was available, the Committee found the following shortcomings:

• In the case of 11 drugs (28 per cent) phase III clinical trials mandated by Rules were not conducted. These drugs are i, Everolimus (Novartis), ii. Colistimethate (Cipla), iii. Exemestane (Pharmacia), iv. Buclizine (UCB), v. Pemetrexid (Eli Lilly), vi. Aliskiren (Novartis), vii. Pentosan (West Coast), viii. Ambrisentan (GlaxoSmithKline), ix. Ademetionine (Akums), x. Pirfenidone (Cipla), and xi. FDC of Pregabalin, ethylcobolamine, Alpha Lipoic Acid, Pyridoxine & Folic Acid (Theon);

• In the case of 2 drugs (Dronedarone of Sanofi and Aliskiran of Novartis), clinical trials were conducted on just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients;

• In one case (Irsogladine of Macleods), trials were conducted at just two hospitals as against legal requirement of 3-4 sites;

• In the case of 4 drugs (10 per cent) (Everolimus of Novartis; Buclizine of UCB; Pemetexid of Eli Lilly and FDC of Pregabalin with other agents), not only mandatory phase III clinical trials were not conducted but even the opinion of experts was not sought. The decision to approve these drugs was taken solely by the non-medical staff of CDSCO on their own.

• Of the cases scrutinized, there were 13 drugs (33 per cent) which did not have permission for sale in any of the major developed countries (United States, Canada, Britain, European Union nations and Australia). None of these drugs have any special or specific relevance to the medical needs of India. These drugs are: i. Buclizine for appetite stimulation (UCB); ii. Nimesulide injection (Panacea); iii. Doxofylline (Mars) iv. FDC of Nimesulide with Levocetirizine (Panacea); v. FDC of Pregabalin with other agents (Theon); vi. FDC of Tolperisone with Paracetamol (Themis); vii. FDC of Etodolac with 28 Paracetamol (FDC); viii. FDC of Aceclofenac with Thiocolchicoside (Ravenbhel); ix. FDC of Ofloxacin with Ornidazole (Venus), x. FDC of Aceclofenac with Drotaverine (Themis); xi. FDC of Glucosamine with Ibuprofen (Centaur); xii. FDC of Diclofenac with Serratiopeptidase (Emcure) and xiii. FDC of Gemifloxacin with Ambroxol (Hetero).

• In the case of 25 drugs (64 per cent), opinion of medically qualified experts was not obtained before approval.

• In those cases (14 out of 39 drugs), where expert opinion was sought, the number of experts consulted was generally 3 to 4, though in isolated cases the number was more. In a country where some 700,000 doctors of modern medicine are in practice such a miniscule number of opinions are hardly adequate to get diverse views and come to a well considered rational decision apart from the possibility of manipulation by interested parties. As against this, to review just the dose of popular pain-killer paracetamol, the United States Food and Drug Administration (US FDA) constituted a panel of 37 experts drawn from all over the country. After extensive debate 20 members sought ban on the combination of paracetamol with narcotics (17 opposed), 24 members sought reduction of dose from 500mg to 325mg (13 opposed) and 26 members advised to make high dose (1000mg) formulation a prescription only medicine (11 opposed). The voting pattern shows independent application of mind by each member. The opinions and decisions are in public domain (website of US FDA) so that anyone is free to scrutinize, offer comments and give suggestions. In India, every discussion and document is confidential away from public scrutiny. This matter needs to be reviewed to ensure safety of patients, fair play, transparency and accountability.

7.15 Unless there is some legal hitch, the Committee is of the view that there is no justification in withholding opinions of experts on matters that affect the safety of patients from public. Consideration should be given to upload all opinions on CDSCO website.

7.16 According to information provided by the Ministry, a total of 31 new drugs were approved in the period January 2008 to October 2010 without conducting clinical trials on Indian patients. The figure is understated because two drugs 29 (ademetionine and FDC of pregabalin with other ingredients) were somehow not included in the list. Thus there is no scientific evidence to show that these 33 drugs are really effective and safe in Indian patients.

7.17 The Ministry explained that under the rules, DCGI has the power to approve drugs without clinical trials in “Public Interest.” No explanation is available as to what constitutes Public Interest. How can approvals given to foreign drugs without testing on Indians be in Public Interest? Some of the reasons given for irregular approvals are: “Serious disease” (all the more reason to conduct clinical trials to ensure that patients in India really benefit from such imported, exorbitantly expensive drugs), “Rare disease status according to United States Food and Drugs Administration” (How can US FDA decide which is rare disease in India?), “Orphan drug status in Europe and USA” (There is no provision in Indian laws to give special treatment to such foreign drugs).

7.18 When asked about the reasons for approving New Drugs without clinical trials, the Health Secretary, during the course of oral evidence, stated that approval of new drugs without phase-III clinical trials in “public interest” was being done with the support of technical advice. Explaining about the basis for deciding to waive off the condition of local clinical trials for manufacture/import of new drugs, the Ministry stated that the Drugs and Cosmetics Rules do not prescribe specific situation under which clinical trial exemption can be granted due to “public interest”. However, the DCGI can abbreviate, defer or omit the toxicological and clinical data requirements for drugs meant for life-threatening/serious diseases and diseases of special relevance to Indian health scenario. It was further claimed that in such cases status of regulatory approval of the said drug in other countries and opinion from the medical specialists of the relevant field is obtained for taking decision. Further, the marketing approval is conditional to applicants submitting post-marketing surveillance data.

7.19 In cases where foreign drugs were approved without clinical trials in the country, the Ministry offered the following explanation: “Most of the drugs are approved in other countries based on multinational clinical trials…. on various ethnic/racial populations” implying that Indians would be included and hence conducting trials in India was not necessary. However, this presumptive remark is not accompanied by 30 any evidence. The interest is in those ethnicities that live in India, not Slavs, Caucasians, Hispanics and Negroes. The information in the Status Note on the very first drug of a total of 31 in the list of new drugs permitted in “public interest” without clinical trials, daptomycin, shows that pre-approval studies conducted by the American innovator recruited just 558 patients in United States, South Africa, Europe, Australia and Israel. There is absolutely no evidence of major ethnic groups of India being enrolled in these small trials.

7.20 It would appear that the intention of those who framed the Act and Rules was to leave a small door ajar for entry of new drugs without undergoing trials in serious emergency situations such as epidemic of a new hitherto unknown disease (e. g. SAARS, Bird Flu or Swine flu) where there may not be time enough to test new drugs and there is no alternative but to take calculated risk. None of the 33 drugs fall in this category of emergency treatments. Besides many drugs were launched in overseas markets years ago with ample time to conduct trials in India. The following are some examples:

• Daptomycin (Cubicin) of Novartis was launched overseas on 13-9-2003 and approved in India on 28-1-2008 after a gap of over four years. There was no tearing hurry to approve the drug without trials.

• Pemetrexed (Alimta) of Eli Lilly was approved on 5-2-2004 in the United States. After a gap of more than two years, it was approved by DCGI on 28-6-2006 without trials. There was more than adequate time to conduct phase III trials in India and yet undue favour was shown to the manufacturer.

• Raltegravir (Isentress) of Merk Sharp and Dhome was launched abroad on 12-10-2007 and approved in India on 27-01-2010 without conducting clinical trials even though there was adequate time to conduct mandatory clinical trials.

7.21 Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk. On an average DCGI is approving one drug every month without trials. This cannot be in public interest by any stretch of imagination. Moreover it was stated that in such cases (i) expert opinion is sought and (ii) Post Marketing Surveillance Data is mandatory.

• However a look at the information on approvals given by DCGI shows that expert opinion was sought in only 5 of 33 such out-of- the-way approvals.

• With regard to Post-Marketing Surveillance data, the Ministry failed to provide even one out of randomly selected 4 drugs approved without trials.

7.22 As stated earlier, the very purpose of phase III trials is to determine any ethnic/racial differences in the safety, efficacy and metabolism of drugs. Hence to serve any useful purpose, patients of different ethnicities living in India should be enrolled. For example, the results of a trial conducted only on Indo-Aryans may not be applicable to Mongoloids or Dravidians due to genetic differences.

Beijing Government Requires Hospitals to Report Medical Treatment Information

May 29th, 2012 | by

From middle of June, five hospitals in Beijing are asked to report the medical treatment information of outpatients and emergency patients to the government, the duration of this pilot project is three months. The plan is to expand this action to all the public hospitals in Beijing area later. The reason for this pilot project may be the increasing medical disputes, so supervision department can have a better documentation background.




这五家医院为中日友好医院、北京友谊医院、北京肿瘤医院、顺义区医院、大兴区人民医院。记者注意到,在此次规定中,明确要求试点医院要上报接受各种手术或 有创操作的门诊病例,包括部分日间治疗病例。在急诊方面,相关试点医院须上报在急诊室连续留住观察、检查、治疗24(含)小时以上的病例。

Hospital Guidance Mobile APP Launched in Nanjin

May 29th, 2012 | by

A hospital in Nanjing City offers a new service to their patients, now patients can download a hospital guidance APP in the mobile, scanning the two-dimensional barcode that hospital placed in many spots, e.g. every department, clinical room etc.,ti get the hospital information as well as information of their medical treatment processes.  





2011年5月28日,南京市胸科医院在省内率先推出了卫生行风的第三方评价。一年来,医院本着“患者的满意是我们最大的追求”的服务宗旨,根据第 三方工作组和患者反馈的意见与建议,积极转变服务理念,创新服务方式,并从细节着手,推出了一系列的便民举措,得到了社会各界的一致认可。卫生行风的第三 方评价模式也获得了各级领导的肯定,并在全市卫生系统中进行推广。在第三方评价工作推出即将满一周年之际,该院继续从服务患者出发,推出了一项新型服务 ——“扫描二维码、了解医院信息”。


届时,患者使用智能手机,按照医院提供的说明,下载并安装软件,进行扫描,就可以看到相关信息。即使离开医院,只要拍下二维码,患者就可以享受到相 关信息服务。目前在该院大门、门诊大厅、科室与诊室门口、病历和专家名片上等多处印制了二维码,可以随时随地为患者提供医院、科室、专家信息以及健康保健 知识。下一步,医院将继续加强信息化建设,搭建医院手机网站,深入开发“二维码”更多功能,进一步推出如预约挂号、候诊提示、卫生行风、第三方评价等。届 时,患者就能体验到“二维码”带来的更加便捷的诊疗服务和更多的健康保健知识。

Beijing to Restructure Hospital Price System

May 29th, 2012 | by

Beijing Health Bureau starts a pilot project regarding restructuring price system in five public hospitals. According to it, hospitals will cancel the price adding on the drugs, instead, they could increase the medical service fee which will be reimbursed by the insurance center. The goal is to offer affordable medical treaments and medicines for the public.




据悉,北京市公立医院改革选择了友谊医院、朝阳医院、同仁医院、积水潭医院和儿童医院5家市属三甲医院作试点。其中,友谊医院、朝阳医院和儿童 医院主要探索法人治理运行机制;友谊医院、朝阳医院、同仁医院和积水潭医院进行医保总额付费的尝试;友谊医院进行医药分开的改革试点。



在本轮改革的讨论中,上世纪80年代开始实行的“以药补医”制度备受诟病,被认为是诸多问题的根源。因此,北京市此次公立医院改革方案的重点也 放在此处。韩晓芳介绍说,北京市将通过财政、医保、价格政策联动,增加财政投入,提高基本医疗保障水平,取消药品加成政策,建立医事服务费制度。


北京市的“多措”包括:首先,在取消药品加成的同时,相应调整医疗服务价格,通过价格调整,使其能充分体现医务人员的劳动价值,提高医务人员的 积极性;其次,通过创新公立医院供应链管理新模式,北京市医院管理局对药品和耗材实行统一采购、物流配送,发挥规模采购优势,引入价格谈判机制,降低采购 价格,减少流通费用,从而降低药费;第三,建立考核奖励资金,将财政补助与试点医院绩效考核结果挂钩,调动医院加强管理、减少抗生素滥用、减少大处方、减 少大检查,提高医务人员规范医疗行为的自觉性;第四,医保部门通过总额预付和按病种服务费制度改革,调动医疗机构加强内部管理的积极性,使医疗机构和医生 主动参与费用控制。






韩晓芳表示,增设医事服务费至少在3方面减少了患者负担:一是占80%以上的普通门诊医保患者,个人支出从3元降为两元;二是取消药品加成使药 品费用直接减少;三是杜绝过度用药、滥用药等带来的间接费用的减少。“我们静态测算,全市医保基金将因此增加投入13亿元,而普通门诊患者每人次将平均减 少支出11.45元。”





韩晓芳表示,医院院长和副院长将由理事会按规定聘任或解聘。逐步推进院长专业化、职业化建设,探索实行公开竞聘和年薪制。北京市医院管理局将成 立监事会,派驻监事对公立医院运行管理和院长履职情况进行监督,建立总会计师制度,向医院委派总会计师。另外,试点医院员工将实行全员聘用、合同管理、按 岗定薪。医师多点执业、医院后勤社会化将被推行。



Medical Test Recognition Agreement in Guangdong

May 16th, 2012 | by

The repeated medical exams in different hospitals has raised a great waste, hence, seven hospitals in Guangdong province have signed a recognition agreements, and from now on, any examine in one of those hospitals can be recognized by other partner hospitals. The aim is to use the resource more effectively and to reduce the public medical expenses.




患者求医换一家医院,就要重复做检查,这无疑增加了患者费用。7日下午在广东省卫生厅召开的全省卫生系统2012年医改工作会议上,广州、深圳、珠海、佛 山、东莞、中山、江门、肇庆、惠州等珠三角9市卫生局签署了检查检验结果互认协议,旨在促进合理、有效利用卫生资源,简化病人就医环节,降低病人医疗费 用。

Public Hospitals are in Debts

May 7th, 2012 | by

According to Taiyuan Health Bureau, all local public hospitals are in debts, most of the liabilities have reached 50% of the hospital’s total assets, and some of them are as high as 70%. Due to the poor hospital price system, hospitals have to make money from drug sales to maintain the operation, whereas patients still have the problem to get access to the medical treatments.


多数公立医院债务缠身 处境堪忧


“债务缠身 处境堪忧”

Fujian Hospitals to Share Medical Information

May 7th, 2012 | by

Fujian province has implemented the program of “one medical card in the whole province”, the medical card can be read in all public hospitals in Fujian, so patients don’t need to register every time when they visit a new hospital. And according to the local official, the new medical card has four main functions: patient identification, connection with social medical insurance, e-payment and e- patient record.



来源:东南网 作者:医药卫生网

据了解,以往就诊卡都是各医院自行发放,医院之间互不通用,患者每去一家医院就要买一张卡,既花钱又不方便。2009年底,我省启动就诊“一卡通”建设, 总投资近1亿元。如今,五花八门的医院就诊卡已成为历史,标准统一的社保卡作为就诊一卡通,在全省所有医院通行、使用。
省卫生信息中心有关负责人介绍,相比传统就诊卡,“一卡通”具有身份识别、医保(新农合)联网结算、电子钱包医疗支付应用及居民健康个人档案索引等4项优 势功能。其中,作为一卡通载体的IC卡还融合了金融应用,具有电子钱包支付功能,持卡人可以存入小额现金(1000元以内),相当于金融储蓄卡。病人到医 院就诊不用像以往那样在就诊卡中存入预缴金,在诊疗过程中产生的挂号费、检查费、治疗费、药费等需要个人支付的部分,均可由电子钱包支付;通过就诊“一卡 通”,还能查询个人健康信息,包括体检、预防接种、检查、检验、诊断、医嘱等信息,医院之间通过网络共享健康档案信息。“这样可以减少不必要的重复检查, 降低医疗费用。”这位负责人说。

Different Drug Instruction in China and in other Countries

May 7th, 2012 | by

China is in fierce discussion around why the drug instruction standard in China differs from the standard in foreign countries. E.g. the Hepatitis B drug made by Novartis, in the American market, it’s written in the instruction that there’s possible adverse reaction of rhabdomyolysis, which is however not written for the same product in China. People argue that one of the reasons is because different country regulations, US has much stricter regulations in terms of drug safety than China, and the penalties for vi0lation are different. 


作者:戴绪霖 慧聪制药工业网



目前,西方主要国家对于药品不良反应都采取无过错原则进行归责。如德国,在1976年就制定了《药物伤害法》,规定生产有缺陷药物 的生产者应承担法律责任,在1978年施行的新《药品法》进一步对药品生产商限定了严格的责任,一旦发生药品责任诉讼时,不能因为其已获得政府批准或许可 及遵守德国标准药典的规定,而免除其民事或刑事责任;药品生产商不得主张发展风险抗辩,即不得以“药品缺陷是依当时的科技水平所不能发现的”为理由申请免除责任。

而我国对ADR归责原则没有专门的规定,司法实践中依照过错责任来处理此类纠纷的居多,其法律依据主要是《民法通则》第106条第 2款“公民、法人由于过错侵害国家的、集体的财产,侵害他人财产、人身的,应当承担民事责任。”但《产品质量法》第四十一条规定,生产者能够证明产品投入 流通时科学技术水平尚不能发现缺陷存在的,不承担赔偿责任。显然,ADR受害者是很难提供证据证明产品投入流通时的科学技术水平是否能发现缺陷的存在,因 此,ADR事件的民事赔偿在我国遇到了重重阻力,得到赔偿的个案少之又少。当然,ADR受害者也可以依《民法通则》第132条规定,根据公平责任原则求得 赔偿。然而,公平责任是根据公平观念在当事人之间分摊责任,即受害人自己也要承担一定的损害,这可能会使ADR受害者获得救济的程度大打折扣。另外,在司 法实践中,各地法院及不同的法官对公平责任都有各自的把握,ADR受害者能否得到救济仍处于不确定状态。

尽管我国现行的《药品不良反应报告和监测管理办法》第四十五条、第四十九条明确规定了药品生产企业对已确认发生严重不良反应的药品 所应承担的责任,但是,对药品生产企业违反这些规定的处罚却非常轻,仅体现于第五十八条“药品生产企业有下列情形之一的,由所在地药品监督管理部门给予警 告,责令限期改正,可以并处五千元以上三万元以下的罚款。”而且,该条亦未明文提出未按要求修改说明书者将接受何种处罚,因此只能按第七款“其他违反本办 法规定的”进行处罚。

ADR损害具有广泛性、潜伏性和高科技性等特点,在侵权损害赔偿诉讼中要证明加害人的过错是困难重重的。ADR适用无过错责任原则 是一个世界性的趋势,笔者在此建议采用,这不仅解除了ADR受害者的举证之苦,也必会促使企业更主动地监测和报告ADR,完善药品的处方工艺,改善用药方 案。

安全、有效、质量可控是药品的基本质量属性,说明书是指导医生和患者用药的重要文件,属于药品的一个重要组成部分。只有确保说明书 的正确性和完整性,才能指导临床合理用药。用药的目的是治病救人,即使受现有科学技术的限制,需要承担一定的风险,也一定要努力采取一切必要措施降低这种 风险,将其控制在可接受范围内。在说明书上清楚说明可能发生的ADR就是这样的一种措施。

SFDA在2010年诺华制药遭遇首次素比伏争议后不久,就发出第30期药品不良反应通报,指出“横纹肌溶解”是替比夫定和拉米夫定已知的不良反应,建议“相关生产企业……最大程度避免严重药品不良反应的重复发生,保障公众的用药安全”。诺华制药在 说明书中称不可能确切估计发生频率与药品的关系,并没有尽到“最大程度避免严重药品不良反应的重复发生”的义务。建议借鉴美国 Hoffmanv﹒Sterling DrugInc﹒(1973)案和Woodersonnv﹒Ortho Pharmaceutical Corp﹒(1984)案,判企业承担惩罚性赔偿责任。


Chinese Pharmaceutical Firms Face Challenging Financial Situation

May 7th, 2012 | by

It’s reported that Chinese pharmaceutical distributors have cash flow problem (e.g. Zuelllig Pharma), this is mainly caused by the delayed payments from hospitals. The current situation challenges the existing payment system in China, and there must be some improvement in terms of hospital payment.






在这家医药物流公司的GSP仓库内,基药堆满了托盘,每个托盘上,都是小山一样的基药。库管人员介绍说:这些基本药物,都是厂家直发过来的,每个月 都要购进大批的基药,否则厂家就会因为没有完成本月的购进,而取缔公司的基药配送资格。销售人员介绍说:基层医疗单位的采购,品种分散,购进量小,远远达 不到厂家规定的销量要求。财务人员介绍说:从厂家购进的基药,都是现款;医院的回款要在30-90天,公司只能筹措流动资金,以保证基药的配送。公司领导 介绍说:基药占压了公司所有的流动资金,所有的融资渠道都已经努力过,固定资产已经全部抵押,仍然不能满足基药的资金需要。


中投证券研究报告显示:2012年第一季度,基药配送商业企业上市公司的经营性现金流为 -25.12亿元。九州通、华东医药、南京医药、一致药业、国药股份、嘉事堂等基药配送商业企业,每股经营活动现金流量分别为-0.62元、-1.25 元、-0.597元、-0.66元、-1.29元、-0.39元。全国基药配送商业企业上市公司,每股经营活动现金流量为历史上最低值。九州通、华东医药 经营性现金流量净额分别为-8.96亿元、-5.42亿元。



公开资料显示:全国取得基药配送资格的医药商业企业,超过6000家。以每家月均配送基药200万元的最低值,以医院平均60天回款,做保守估计, 全国基药配送商业企业,基药占压流动资金总额超过200亿元。200亿对于我们偌大的国家,也许是个小数字,各省集采平台交易汇总数据,全国基药医院年度 总购进超过1000亿元,月均购进100亿元。也就是说:基药配送商业企业,承载着基药使用量100%的流动资金。


如果把基药比作一架马车,配送商业就是马匹,厂家就是车夫,医院就是目的地。与马匹不同的是,基药配送商业的百万大军,典当了所有家当,换来货物装 在车上,瘦骨嶙峋、衣衫褴褛,绷紧肌肉,躬身、低头,奋力拉拽着;与车夫不同的是:厂家吹着欢快的牧笛,扬鞭催马,空中划过一道鞭影,马的耳畔响起清脆的 鞭声;与目的地不同的是,一路上坎坷无尽,风雨交加,运到地方还要30-90天才给钱。马儿还要做到:装出笑脸,奋力奔跑,一如大佛脚下的三江河水,冰 冷、湍急、日夜不息。



商务部发布的《全国药品流通行业发展规划纲要(2011年—2015年)》提出,到2015年要形成1—3家年销售额过千亿的全国性大型医药商业集 团,20家年销售额过百亿的区域性药品流通企业;中小药品流通企业,通过收购、合并、托管、参股和控股等途径,并入大型药品流通企业。



新版GSP与现行GSP比较,在冷链物流上要求:药品在仓储和配送过程中,温度自动控制设施和设备现代化,配送使用带有GPS的冷藏车,温度数据时 时上传到监管部门;在票据管理上要求:进项发票与购进款一致,销项发票与销售款一致,做到票帐货相符,倒票、挂靠、卖增值税发票等非法营利成为昨日黄花; 在系统管理上要求:系统全流程覆盖,全岗位覆盖,所有的管理通过系统权限实现,所有的流通药品采用电子监管码,进销存数据实时上传到监管部门。



南方医科大学研究显示:经济发达的广东省,192家县级医院中,没有负债的4家,占总数的2.08%;有188家负债,负债小于100万的一家,负 债在100万-500万的17家,平均负债额度达到4826万,其中118家平均负债达到6213万。最高的一家医院负债超过10亿,主要原因是新盖大 楼。


医院负债严重,在于医疗保险欠费。医保病人出院结算时,只需支付小比例的自负部分,医保报销的医药费完全由医院先行垫付,医保局留10%考核金,每 月扣除违反规定的医药费,成为永久性扣款。这样,医院对医保病人提供了医疗服务,却并不能确保经济利益就一定能流入医院,医院财务账面资产严重背离实际资 产,无法核消,长期挂帐, 形成巨额负债。

医院负债严重,在于人道救助欠费。 “120”、“110”、自然灾害、矿难和群众送到医院的无主病人和重大伤亡事故病人,通过医院绿色通道抢救的急、危、重病人所发生的医药费,形成无法追还的债务;医疗纠纷、债务单位变更和债务人死亡等形成欠费。


























省级集采平台,应划归医保管理。面向全国基药生产企业,通过银行,向基药生产企业直接结算,而不是向基药配送商业企业结算。这样,基药生产企业必须 为产品的质量负责,基药配送商业企业,只需按照订单,配送到指定的医院,即完成配送任务,根本无需为基药占压一分钱的流动资金。


医院自动生成采购计划,基药结算平台自动汇总采购计划,远程传输到基药生产企业,系统本着就近优先的原则,自动分配配送任务到配送商业。配送商业按 照集采中心的配送指令,代替集采中心,验收、入库、养护、配送,上传数据到集采中心,配送商业只承担配送的角色,承担基药在库管理的责任,挣取配送费用和 保管费用。


医院每天上传采购计划,选定基药品种时,本着低价优先的原则,自动选择挂网价格最低的生产企业。生产企业都是具有GMP资质的,生产的药品遵循的都 是药典标准,产品质量应视为相同的。集采平台可以考虑取消招标,开放平台,鼓励生产企业随时修改挂网价格,通过竞价和竞争,挤掉水分,降低基药的用药总金 额。减少财政负担。



China Uses Industrial Gelatin in Medicine Capsules

May 7th, 2012 | by

The use of industrial gelatin in medicine capsules was exposed by state broadcaster China Central Television in mid-April. This form of gelatin contains excessive levels of chromium and is severely hazardous to human health.

The Ministry of Public Security said Sunday that it has confiscated 77 million capsules made from toxic industrial gelatin, arrested nine criminal suspects, detained 54 others and shut down 8 capsule manufacturing lines in Hebei, Zhejiang and Jiangxi provinces.

















基于此,安徽省药监局药品安全监管处处长刘晓琳在26日API China药用辅料论坛上表示,“药监部门正在全国范围内对药品生产流通领域进行地毯式的清查,对所有用到胶囊的生产企业进行抽检,基本上做到全覆盖。”












27日,国家药监局公布药用明胶和胶囊抽检结果。结果显示,对18家药用明胶生产企业抽验了166批明胶,检出1批产品铬超标;对117家药用胶囊 生产企业抽验了941批药用胶囊,检出15家企业74批胶囊铬超标,不合格率为7.9%。其中涉及浙江的9家铬超标药用胶囊企业全部位于胶囊之乡——新昌 县。




对此,郭凡礼表示,在胶囊事件影响下,胶囊行业整合步伐加快,产业集中度得到提升,这会引发两方面的反应。一是品牌建设及产品质量较好的胶囊企业, 其经济效益和社会效益将提升;二是就市场层面而言,胶囊企业可能结成联盟,采取囤货、限量、提价等形式维护自己的既有利益,也不失为既保本又让市场不致失 衡的良好举措。

历史上,我国首例使用假药用辅料造成重大药害的事件,是2006年的“齐二药”事件。企业对于辅料供应审计不严,辅料检验流于形式,误将工业二甘醇 当作丙二醇。这与1937年美国发生的磺胺醑剂事件所涉及的辅料成分相似。而结果是,我国这家企业已经不复存在,美国那位涉案的主任药师因内疚和绝望自 杀。