India exempts clinical trials for drugs approved in select countries

The government has waived the requirement for clinical trials of certain categories of drugs in India if they are approved in the US, the UK, Japan, Australia, Canada and the European Union.

The waiver only covers five categories -- orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defence purposes and new drugs having significant therapeutic advances over the current standard care.

This waiver would ensure expeditious availability of the latest medicines for treating diseases like cancers, rare diseases like Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMA), and autoimmune conditions in India.