CDSCO Tightens Regulatory Review for Globally Unapproved New Drugs

The Central Drugs Standard Control Organization (CDSCO) has issued a formal clarification regarding the approval process for new drugs that have not yet received marketing authorization anywhere in the world. As per the directive issued on August 10, 2026, such drugs must undergo a rigorous domestic regulatory review process. This applies particularly to candidates where Phase III Global Clinical Trials are either ongoing or have been completed with Indian subjects.

These applications are now mandated to be processed by the Investigational New Drug (IND) Division at the CDSCO Headquarters in New Delhi. The process must strictly adhere to the New Drugs and Clinical Trials Rules, 2019. This regulatory framework ensures that all safety and efficacy data are thoroughly evaluated within the Indian context before any drug is permitted to enter the domestic market, regardless of its global status.

The primary goal of this move is to strengthen oversight and ensure that patients in India have access to safe and effective medical treatments. By centralizing the review process, the CDSCO aims to maintain high standards of clinical research and drug safety. This policy shift is expected to provide greater clarity to pharmaceutical companies and research organizations regarding the requirements for introducing innovative therapies into the Indian healthcare system.