CDSCO Issues Comprehensive SEC Guidance Document For Consistent Regulatory Evaluation

To strengthen the technical evaluation process that supports regulatory decisions and to bring formal structure to the functioning of Subject Expert Committees (SECs), the Central Drugs Standard Control Organization (CDSCO) has released a first-of-its-kind guidance document. These committees play a key advisory role in evaluating applications related to clinical trials, marketing authorization, and post-marketing regulatory actions for new drugs, biological products, vaccines, investigational medical devices (IMDs), and more. While CDSCO retains final decision-making authority under applicable regulations, SEC recommendations are also highly influential.

The guidance formalizes SEC roles under a framework, detailing composition, qualifications, independence, and responsibilities of committee members. It institutionalizes the SEC system, previously functioning without formal codification, thereby enhancing transparency, consistency, and scientific rigor. The