Central Drugs Standard Control Organization (CDSCO) has released the Subject Expert Committee (SEC) Guidance Document – Version 1.0 (2025). This new guideline provides a framework for the operation, composition, responsibilities, and decision-making processes of SECs, which are crucial to India’s regulatory approval ecosystem for drugs and investigational medical devices.
What Are SECs and Why Are They Important
Subject Expert Committees (SECs) are panels of distinguished scientists, clinicians, and regulatory experts drawn from premier institutions across India. These experts provide specialized reviews of applications involving:
- New drugs and biologics
- Clinical trials (CTs)
- Investigational medical devices (IMDs)
- Vaccines and fixed dose combinations
- Bioequivalence and bioavailability studies (BA/BE)
Their scientific assessments form the backbone of CDSCO’s decisions on approvals, amendments, and waivers.
Key Highlights of the New SEC Guidelines
Streamlined Review Process
The document outlines a clear sequence of application submission, review, expert deliberation, and final recommendation. SEC meetings must be notified at least five days in advance and must have a quorum of at least four experts, including one pharmacologist.
Defined Member Criteria
SEC members are now required to have a proven research track record (minimum 10 publications and a citation ratio of at least 2:1) and be affiliated with reputed government or academic institutions to minimize conflicts of interest. Members serve a 3-year term, with regular performance monitoring.
Clarity on Waivers
The guideline also clarifies when clinical trial or bioequivalence study waivers may be granted — particularly for orphan drugs, pandemic treatments, and therapies approved in countries like the USA, UK, Japan, Canada, Australia, and the EU.
Applicant Responsibilities Strengthened
Applicants must now submit focused and well-structured briefing documents — limited to 20–25 slides — five days ahead of meetings. The new norms emphasize data transparency, ethical conduct, and post-approval compliance including pharmacovigilance and regulatory updates.
With these guidelines, CDSCO reinforces its commitment to scientific integrity, transparency, and patient safety. As India’s role as a global pharma and medtech hub grows, such initiatives will play a pivotal role in aligning with international standards while catering to domestic healthcare needs.