Officials Mull Half-Hearted Data Exclusivity Reform

August 2006 | Market Trend Analysis

The regulatory bodies in India are struggling to introduce a data exclusivity system that will provide the required legal protection for clinical data, yet will not cause major harm to the domestic industry. One way of achieving this, which is being considered, is to implement data protection only for New Chemical Entities (NCE's) whose patent expiry is after 2014. If the government sticks to this policy, only 58 molecules will have the chance to obtain full data exclusivity in India, leaving many hundreds still

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