New markets open for Indian drug companies

In a move that could open up markets across continents for the Indian generic pharmaceutical industry, the United States has announced changes in its free trade agreement (FTA) policy that enables faster entry of generic drugs into its partner countries in case of a national emergency.

The changes would be immediately effective in countries like Columbia, South Korea, Peru and Panama, where FTAs are in the final stages of approval. It may also apply to all future FTAs that the US is negotiating with Malaysia and Thailand.

The changes, announced on May 10, will allow generic firms to enter these markets quickly.Generic companies will now be able to use the clinical trial data of the innovative drug manufacturer soon after the data exclusivity "" the copyright on R&D on a patented drug "" date expires. This is irrespective of any patent protection on that drug.

The changes also make clear that the data exclusivity provision will not preclude FTA countries from taking measures to protect public health.