The Central Drugs Standard Control Organisation (CDSCO) has released the Subject Expert Committees (SECs) Guidance Document Version 1.0, establishing a comprehensive framework for India's drug and medical device regulatory approval process. Released on July 17, the guidelines aim to enhance scientific rigor, transparency, and efficiency in the evaluation of new drugs, biologics, clinical trials, and investigational medical devices.
Enhanced SEC Structure and Member Qualifications
The new guidelines define stringent criteria for SEC membership, requiring experts to demonstrate a proven research track record with a minimum of 10 publications and a citation ratio of at least 2:1. Members must be affiliated with reputable government or academic institutions to minimize conflicts of interest and serve three-year terms with regular performance monitoring.
SEC meetings require a quorum of at least four experts, including one pharmacologist, and must be notified at least five days in advance. The guidelines emphasize that SEC members are distinguished scientists, clinicians, and regulatory experts drawn from premier institutions across India, providing specialized reviews for various applications including new drugs, biologics, clinical trials, investigational medical devices, vaccines, and fixed dose combinations.
Streamlined Review Process and Timeline Requirements
The document outlines a clear sequence of application submission, review, expert deliberation, and final recommendation. SECs must prepare meeting minutes on the same day and share final minutes with stakeholders within seven working days of the meeting. The guidelines specify that SECs should adhere to seven-day timelines for finalization of recommendations to expedite the approval process and application reviews.
Core responsibilities of SECs include rigorous and comprehensive scientific evaluation, guidance and support to applicants on protocol and data generation, and maintaining standardized evaluation across different therapeutic areas with fairness and predictability in the review process.
Clinical Trial Waiver Clarifications
The guidelines provide explicit criteria for clinical trial waivers, particularly for orphan drugs, pandemic treatments, and therapies approved in countries including the USA, UK, Japan, Canada, Australia, and the EU. SEC recommendations for clinical trial waivers must be stated as either "Yes" or "No" and supported by detailed justification that complies with NDCT Rules 2019 and Medical Devices Rules 2017.
The document emphasizes that once clinical trial parameters such as objective, design, eligibility criteria, and safety and efficacy assessment criteria are decided for a specific drug product, they should remain consistent for subsequent applicants conducting similar studies to maintain data comparability and regulatory efficiency unless scientifically justified.
Enhanced Applicant Requirements
Applicants must now submit focused and well-structured briefing documents limited to 20-25 slides, which must be forwarded to SEC experts five days in advance along with presentations. The briefing material should include a comprehensive overview of the product, mechanism of action, claims, indication, dosage and administration, adverse effects, contraindications, precautions, and warnings.
The guidelines require applicants to provide summarized non-clinical and clinical safety and efficacy data, adverse drug reaction data analysis, and complete clinical trial or bioavailability/bioequivalence study protocols. Applicants must ensure effective communication, query resolution, clear presentations, data integrity, transparency, and post-approval compliance including pharmacovigilance and regulatory updates.
Decision-Making and Consistency Standards
The guidelines establish that SECs should reach scientifically sound decisions based on consensus among committee members. Subsequent SECs cannot overrule previous decisions unless there is strong justification. In cases of conflicting recommendations, CDSCO may refer matters to the Technical Committee for final decision.
The document specifies that topics unrelated to product safety, efficacy, or quality, such as pricing, should not be addressed during committee deliberations. SEC members must manage conflicts of interest by declaring potential conflicts and recusing themselves from discussions when necessary, while maintaining confidentiality and continuing education to stay current with scientific advancements and regulatory updates.
