CDSCO Releases Detailed Guidance for Subject Expert Committees (SECs)

The Central Drugs Standard Control Organisation (CDSCO) has published SEC Guidelines Version 1.0 on July 17, clarifying roles and processes for Subject Expert Committees (SECs). The document outlines the responsibilities of SEC members and applicants, the review process, and expected timelines. SECs must conduct rigorous scientific evaluations, provide expert guidance, ensure consistency across therapeutic areas, and document meeting minutes within seven days. Clinical trial waiver decisions must be clearly stated with justifications and align with NDCT Rules, 2019 or Medical Devices Rules, 2017. Applicants must submit concise briefing materials and presentations, free from promotional content, five days in advance. Presentations should include product overviews, safety and efficacy data, and clinical protocols. SEC discussions must remain focused on scientific and regulatory issues—excluding topics like pricing. The guidance emphasizes transparency, query resolution, and maintaining data integrity, ensuring a fair, predictable, and scientifically grounded evaluation process for drug and device approvals in India.

27-07-2025