US FDA drug import plans hold promise for Indian pharma

The doors appear to be opening. In what is being seen as a major positive for the Indian pharma industry, the US Food and Drug Administration is working on an action plan to import drugs. Addressing price hikes, the import of drugs is expected to be limited to the drugs that are off-patent, reports The Pharma Letter’s India correspondent.

At the request of US Health and Human Services (HHS) Secretary Alex Azar, FDA Commissioner Scott Gottlieb is reportedly setting up a working group to examine how to safely import prescription drugs from other countries, in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.

Experts insist this is a compelling move for the Indian pharma industry which hosts the highest number of US FDA approved drug manufacturing plants outside the USA. "Indian generic companies have established a strong logistic network and have been marketing several off-patent drugs as well as biosimilars in India and globally. This is an opportunity that domestic drug majors should not miss," said an analyst.