India rejects European FTA bloc’s ‘data exclusivity' demand

New Delhi, February 15

India on Thursday said it has rejected the demand of the four European nations EFTA bloc for inclusion of a ‘data exclusivity’ provision in proposed free trade agreements, stating that it always protects the interests of the domestic generic drugs industry.

Commerce Secretary Sunil Barthwal said there is no Free Trade Agreement (FTA) in which India would go against the generic drug industry.

The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland. The bloc is negotiating a trade agreement with India.

“They want that there should be data exclusivity, we rejected their demand. We are with our generic industry.

“There is no fear for Indian generic industry (from this agreement). In fact, it is our very important objective to see that generic drug industry flourishes,” he told reporters here. The secretary said the industry is contributing significantly to India’s exports, which are also growing. “So we are there to protect the interest of the industry,” he added.

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 marketing licence for low-cost versions during the tenure of this exclusivity. India’s generic drug industry is estimated at about $25 billion and the country exports 50 per cent of its produce. — PTI

What’s data exclusivity?

Data exclusivity provides protection to technical data generated by innovator companies to prove usefulness of their products. By gaining exclusive rights over this data, these companies can prevent competitors from obtaining marketing licence for low-cost versions

Stand by our generic drug industry

We are with our generic drug industry. There is no fear for Indian generic industry (from this agreement). It is our key objective to see that generic drug industry flourishes. — Sunil Barthwal, commerce secretary