From fitness trackers to medical devices: Where India draws the regulatory line

A decade ago, a wearable told you how many steps you had taken. Today, the same form factor in the shape of a watch, a ring, a patch or an earbud provides estimated heart rate variability, flags possible atrial fibrillation, tracks skin temperature and menstrual cycles, monitors blood oxygen saturation, and, increasingly, reads glucose levels without a single finger-prick. The global wearables market is projected to keep growing at a rapid pace through the rest of this decade and India with its large smartphone base, rising lifestyle-disease burden, and appetite for preventive health, is one of its fastest-growing markets.