USTR calls for data exclusivity in India

27 April 2008

The United States Trade Representative is "lobbying hard" for India's Ministry of Health to adopt data exclusivity rules which local commentators argue would harm the local generic drug industry. The issue is the degree of protection offered to patent holders by the Indian government, which incorporated the World Trade Organization's Trade-Related aspects of Intellectual Property rights (TRIPs) into the 2005 Indian Patent Act.

DG Shah, secretary general of the Indian Pharmaceutical Alliance, told The Times of India: "India is not obliged to grant data exclusivity under TRIPs. Protecting the originators' data against 'unfair commercial use' is agreed by all sections of the industry. So why are attempts being made to get it (data exclusivity) back?"

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