India says no to UK data exclusivity demand to protect generic drug firms
New Delhi: In a move aimed at protecting the domestic generic pharmaceutical sector, India has denied the UK's demand to include a 'data exclusivity' provision in the free trade agreement, announced on May 6, an official said.
During the negotiations, the UK had asked for the inclusion of data exclusivity provision in the trade pact. Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products. In the pharmaceutical sector, drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new medicine.
By gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining a marketing licence for low-cost versions during the tenure of this exclusivity.
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