India CDSCO Guidance: Subject Expert Committee (SEC), What Pharma and Clinical Trial Teams Need to Know

The Central Drugs Standard Control Organization (CDSCO) under India’s Ministry of Health & Family Welfare has released a detailed Guidance Document for Subject Expert Committees (SECs) in 2025. This document aims to bring greater clarity, transparency, and scientific rigor to the evaluation of new drug applications, clinical trial protocols, investigational medical devices, and other regulatory submissions in India.

What is the Subject Expert Committee (SEC)?

The Subject Expert Committees (SECs) are panels of independent experts formed to advise the Drugs Controller General (India) on a wide range of regulatory proposals — from new drug approvals and clinical trials to biological products, vaccines, and investigational medical devices.

Each SEC typically consists of eight experts, including at least one pharmacologist and specialists from fields such as oncology, cardiology, endocrinology, neurology, infectious diseases, and more. These experts are drawn from reputed research institutions, medical colleges, regulatory agencies, and other academic bodies, ensuring decisions are based on science and public health needs.

Importantly, the SECs are advisory in nature. While they make recommendations, the final regulatory decision lies with CDSCO, which considers SEC advice alongside other regulatory criteria.

How Does the SEC Review Process Work?

The guidance describes the SEC review process in clear, structured steps:

1. Application Submission: Applicants upload electronic submissions via the Sugam portal or MD Online, including all required scientific data and protocols.

2. Preliminary Evaluation: CDSCO checks the completeness and compliance of documents.

3. Referral to SEC: Applications that need expert evaluation are referred to the relevant SEC based on therapeutic area.

4. Meeting Notice: CDSCO sends meeting invitations at least 5 days in advance.

5. SEC Meeting: The applicant presents data; SEC members ask questions and deliberate.

6. Recommendation: SEC makes a documented recommendation, which may be:

   • Approval

   • Approval with minor changes

   • Approval with major changes (requiring further review)

   • Rejection

   • Request for more data and re-deliberation

7. CDSCO Decision: CDSCO issues the final decision after considering the SEC’s recommendation.

To ensure fairness, the SEC must have at least four members (including one pharmacologist) present to form a quorum. For vaccine proposals, a pediatrician and immunologist must also be present.

The guidance also explains scenarios where clinical trial waivers or bioequivalence (BE) study waivers may be granted. For example, drugs classified under BCS I & III might be exempt from BE studies.

Other scenarios include new drugs:

• Intended for orphan diseases

• Gene or cellular therapies

• Needed during a pandemic

• Developed for defense use

• Representing significant therapeutic advance

For these, local trial waivers may apply if the drug is approved in specified countries (USA, UK, EU, Japan, Australia, Canada).

Applicants must:

• Prepare clear, scientific presentations (20–25 slides) covering product overview, mechanism of action, clinical data, protocols, and justifications for waivers.

• Share these with CDSCO at least 5 days before meetings.

• Maintain data integrity, respond promptly to queries, and ensure post-approval compliance.

SEC Members are responsible for:

• Rigorous scientific evaluation of applications

• Asking relevant questions

• Ensuring ethical and safety standards

• Providing clear, written recommendations

• Staying updated on regulatory and scientific developments

CDSCO Moderators help guide discussions, keep meetings on track, brief experts, and coordinate with applicants.

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