The Central Drugs Standard Control Organisation (CDSCO) has decided to waive local clinical trials for certain drugs approved in select ICH markets, expediting access to advanced therapies in India. This change aims to reduce delays and costs, making treatments like orphan drugs and gene therapies more accessible. The waiver applies under specific conditions, including no major safety issues and a commitment to post-marketing trials. This policy aligns India with global practices and addresses urgent healthcare needs.
