In India, new medicines are normally required to undergo a local Phase 3 clinical trial before they can be sold, even if they have already been approved by regulators abroad. In August 2024, India's drug regulator allowed local trials to be waived for drugs already approved in the United States, the United Kingdom, Japan, Australia, Canada or the European Union, in five categories: drugs for rare diseases, gene and cell therapies, drugs for pandemics, drugs for special defence purposes, and drugs that offer a significant advance over existing treatment.