| 任晓明.印度仿制药产业现状及发展策略浅析[J].全球科技经济瞭望,2013,28(2):10~15 |
| 印度仿制药产业现状及发展策略浅析 |
| Current Situation and Development Strategy of India’sGeneric Drug and Biosimilars Industry |
| 投稿时间：2013-01-24 修订日期：2013-01-24 |
| DOI：10.3772/j.issn.1009-8623.2013.02.002 |
| 中文关键词: 印度；专利药；化学仿制药；生物仿制药 |
| 英文关键词: India; brand-name drugs; generic drugs; biosimilars |
| 基金项目: |
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| 中文摘要: |
| 印度制药业充分利用本国专利法和国家药品政策，以及国际上相关的药品法规的不完善，抓住发展机遇，实现了从单纯仿制到仿研结合、自主研发的转变。从 20 世纪 80 年代末，印度制药企业大量制造仿制药，至 2000 年前后，印度药品 50% 以上（大部分为仿制药）供出口，成为全球药品出口大国。印度生物制药企业能够生产生物仿制药 40 余种，2012 年，其生物仿制药市场达到 5.8 亿美元。印度仿制药产业的成功带给我们诸多启示，如：应注重国际知识产权游戏规则的研究；应有效利用外包，以提升自主研发的能力，等等。 |
| 英文摘要: |
| Benefiting from the domestic patent law and preferential medicine policies, India’s pharmaceutical
industry enjoys significant development by taking advantage of the defectiveness in relevant international
pharmaceutical legislation. It opens up a new road to development, from simple copy via combination of copy
& research and finally to independent R&D. From the end of 1980s, India pharmaceutical companies started the
mass-manufacture of generic drugs and India became a dominant medicine exporter with its 50% of total outputs
( majority being generics） for international market in 2000. Indian pharmaceutical enterprises can produce more
than 40 kinds of bio-similars. In 2012, the market value of Indian bio-similars reached 580 million USD. The
success achieved by Indian pharmaceutical industry can give us some inspirations, such as, pay attention to the
research on game rules of international intellectual property；take full advantage of outsourcing to enhance the
ability of independent research and development, and so on. |
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