Kshirsagar Nilima A, Bachhav Sagar S
National Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR), ESI-PGIMSR MGM Hospital, Parel, Mumbai, India.
Int J Risk Saf Med. 2013;25(4):235-8. doi: 10.3233/JRS-130601.
With globalization and signing of WTO GATT treaty, the market in India has expanded. This has necessitated important regulatory decisions.
This study aims to determine the gap in introduction and withdrawal of drugs in India and EU.
For drugs prohibited for manufacture and sale(withdrawn) in India during 1983-1998 and 1999-2012 periods, data on year of introduction and withdrawal in India and EU/internationally was extracted from Central Drugs Standard Control Organization (CDSCO), European Medical Agency (EMA) websites and Google search engine and compared.
The gap in introduction of drug in India compared to EU/internationally during 1999-2012 period is shorter than 1983-1998 period, while the gap in withdrawal has not changed much.
Regulatory authority in India has approved drugs in recent year more quickly than the past but gap in withdrawal has not shortened, indicating need for strengthening postmarketing studies and review process.
随着全球化以及世贸组织关贸总协定的签署，印度市场得以扩张。这使得做出重要监管决策成为必要。
本研究旨在确定印度与欧盟在药品引入和撤市方面的差距。
对于1983 - 1998年以及1999 - 2012年期间在印度被禁止生产和销售（撤市）的药品，从中央药品标准控制组织（CDSCO）、欧洲药品管理局（EMA）网站以及谷歌搜索引擎中提取印度和欧盟/国际上药品的引入年份和撤市年份数据，并进行比较。
1999 - 2012年期间，印度与欧盟/国际上在药品引入方面的差距比1983 - 1998年期间更短，而撤市方面的差距变化不大。
印度监管机构近年来批准药品的速度比过去更快，但撤市方面的差距并未缩短，这表明需要加强上市后研究和审查流程。
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