India to waive clinical trials for drugs approved in U.S, elsewhere

Moving to give patients faster access to new medicines, the Indian Health Ministry will waive a requirement that new drugs undergo clinical trials in India if they have already been approved in certain other markets.

The New Drugs and Clinical Trials Rules, released in March, apply to pharmaceuticals already approved in the United States, the United Kingdom, the European Union, Japan or Australia, provided trials included Indian patients. The new rules are expected to shorten the time it takes to bring new drugs to market. But they have met resistance from some patient advocates, who argue they could encourage the sale of pharmaceuticals that have not been sufficiently tested on the Indian population.