SEC – Special Expert Committee, Medical Devices

SEC – Special Expert Committee, India Update:

In the process of obtaining CDSCO regulatory approval for medical devices in India, understanding the role of Subject Expert Committees (SECs) is very important. This article provides an overview of the CDSCO’s comprehensive evaluation process, which includes scrutiny from SECs at multiple stages—from the early clinical development to post-marketing surveillance for both drugs and medical devices. The CDSCO handles various application types, including Investigational New Drug (IND) applications, new and subsequent drugs, fixed dose combinations, recombinant DNA (rDNA) products, vaccines, global clinical trials, bioavailability and bioequivalence studies (BA/BE), and new medical devices.

Role of Subject Expert Committees in CDSCO Application Review and Approval Process

Subject Expert Committees (SECs) in various therapeutic areas, such as Oncology & Hematology and Cardiology & Nephrology, assist the Central Drugs Standard Control Organization (CDSCO) in evaluating applications across different divisions. These SECs offer advisory recommendations, with CDSCO making final decisions based on these inputs and regulatory provisions. Applications can vary, aimed at conducting clinical trials, obtaining marketing authorizations, or reviewing Phase IV clinical trial protocols, with their nature and category affecting requirements, processing times, and prioritization. Initially, applications are processed by the respective CDSCO division, which determines whether to forward them to the appropriate SEC. If further data or clarification is needed after SEC review, the division reassesses the applicant’s response and may refer it back to the SEC for more detailed review. Decisions on these referrals are managed by the Expert Committee Coordination Cell of CDSCO, coordinating further deliberations at SEC meetings.

Briefing Materials for CDSCO Application Evaluations

Introduction to Briefing Materials: Briefing materials are critical documents prepared by applicants and refined by CDSCO divisions, which summarize essential data and information relevant to the application being reviewed. These documents play an important role in the evaluation process by providing Subject Expert Committees (SECs) with the necessary insights to assess the safety, efficacy, and regulatory compliance of new drugs, medical devices, or clinical trial proposals. Well-prepared briefing materials ensure that SECs have a clear understanding of the application, facilitating informed and efficient deliberations.

Preparation of Briefing Materials:

Initial Submission: Applicants must submit initial briefing materials to the respective CDSCO division, which will then refine these for the Subject Expert Committee (SEC)’s deliberation.
Content Variation: The content of briefing materials may vary depending on the application type and evolve from one meeting to another based on the issues discussed.

Content of Briefing Materials:

Data Summary: Materials should succinctly summarize non-clinical and clinical data on safety and efficacy, regulatory status, clinical trial and BA/BE study protocols, product claims, and dosage.
Risk Management: Include potential adverse effects, contraindications, precautions, and warnings.
Waivers: Provide a detailed justification for any requested waivers from local clinical trials or BA/BE studies.
Relevance: Clearly outline the issues for deliberation, focusing on the proposal’s relevance to the meeting’s objectives.
Inappropriate Content: It is important to avoid including irrelevant or inappropriate statements and language.

Briefing Packets Should Include:

Product Description: A general description, including the mechanism of action.
Safety and Efficacy Data: Summarized data on non-clinical and clinical safety and efficacy.
Adverse Reactions: Details of any observed adverse drug reactions.
Data Analysis: Written discussions or analyses relevant to the safety and efficacy data of the proposal.
Study Protocols: Clinical trial or BA/BE study protocols, including justifications for sample sizes.
Package Inserts: Proposed package insert information such as indications, dosage, and safety warnings.
Regulatory Status: Information on the product’s regulatory status in other countries, including approval documents and foreign package inserts.
SEC Observations: Previous SEC observations or recommendations if it’s a case of re-deliberation.
Presentation Slides: The applicant’s presentation slides for the meeting.
Regulatory Provisions: Applicable regulatory provisions from the New Drugs and Clinical Trials Rules, 2019, and the Medical Devices Rules, 2017, alongside relevant guidance documents.
Literature References: Copies of significant literature references.

Streamlined Procedures for SEC Meetings in CDSCO Evaluations:

To ensure efficient and effective deliberations during Subject Expert Committee (SEC) meetings, the following structured procedures are implemented:

Question Development: Relevant CDSCO divisions prepare balanced, regulatory-based questions for committee deliberation. These questions are approved by the Deputy or Joint Drugs Controller of India to ensure they meet regulatory standards and address pertinent issues.
Material Distribution: Prior to the meeting, briefing materials and the developed questions are distributed to SEC members and the Expert Committee Coordination Cell. This ensures all parties are well-prepared and familiar with the topics to be discussed.
Applicant Preparation: To facilitate transparency and the effectiveness of proposal presentations, questions are shared with applicants well in advance of the meeting. This allows applicants to prepare detailed responses and tailor their presentations to address specific regulatory concerns directly.
Agenda Management: Once the agendas are prepared by the relevant divisions, they are compiled and forwarded to SEC members and the Drugs Controller General of India (DCGI) by the Coordination Cell. This ensures that all participants are aware of the meeting’s flow and can prepare accordingly.
Meeting Notifications: The Coordination Cell issues detailed meeting notices and invitations to experts and applicants, guaranteeing that all participants are well-informed about the meeting details, thereby facilitating informed participation and discussion.

These procedures are designed to enhance the effectiveness of SEC meetings, ensuring that discussions are focused, regulatory compliance is maintained, and decision-making is streamlined.

Optimizing Presentation and Interaction in SEC Meetings

Focus on Prepared Queries: Applicants are expected to present their cases to the Subject Expert Committee (SEC), specifically addressing the queries that were provided beforehand. This targeted approach ensures that discussions remain relevant and directly address the regulatory considerations.
Engagement During Presentation: SEC members will actively engage with the applicant during the presentation. The goal is to clarify and delve deeper into specific questions related to the proposal, ensuring a thorough understanding of each aspect presented.
Committee Meeting Efficiency:

Clarity and Balance: Applicants must deliver clear, balanced, and transparent presentations that are scientifically valid. This facilitates a straightforward evaluation by the committee.
Comprehensive Discussions: The committee is expected to comprehensively understand the scientific and regulatory dimensions relevant to the proposals. Full engagement from both sides enriches the decision-making process.
Professional Conduct: All interactions and discussions should maintain a professional tone and strictly adhere to the established agenda. This discipline helps in managing time and focus during the meeting.
Allocated Time for Deliberations: Sufficient time must be allocated for committee deliberations. This ensures that discussions are focused and that all relevant issues are thoroughly covered, allowing for well-rounded decision-making.

These guidelines are designed to enhance the efficiency and effectiveness of SEC meetings, ensuring that every proposal is assessed with the highest level of scrutiny and expertise.

Recommendation of the SEC

After the presentation and interaction, all SEC members participate in an in-depth deliberation, ensuring diverse expert insights are considered. Discussions center on specific queries about the proposal to comprehensively address critical aspects. The SEC issues recommendations on the same day, detailing the reasons for their decisions to maintain transparency and efficiency. This streamlined process ensures that SEC decisions are timely, transparent, and based on a thorough evaluation.

Key Questions for Effective SEC Meeting Discussions

Efficacy Assessment:

What specific efficacy data is required for evaluating the drug’s intended treatment?
Should clinical trials include active comparator arms to assess efficacy?
Is a placebo-controlled trial sufficient for evaluating the drug’s efficacy?

Safety Evaluation:

What safety data is necessary for assessing the drug’s risk for the specified indication?
If existing data are insufficient, what additional data is needed?
Is a placebo-controlled trial adequate for safety assessment.

Data Adequacy and Approval Considerations:

Do the presented data justify approval of the drug, vaccine, medical device, or new indication?
Do the benefits to patients outweigh the risks according to the available safety data?
Do local clinical trial results, supplemented by international data, support the drug’s efficacy and safety for treatment?

Regulatory and Clinical Trial Design:

Should data from international non-clinical and clinical studies justify a waiver for local clinical trials?
Is the proposed clinical trial design adequate to ensure safety and efficacy for approval?

Further Considerations for Drug Development:

Are the non-clinical and clinical data sufficient to support the proposed indication change?
Do the non-clinical and clinical studies’ evidence support the safety of trial subjects as per the global clinical trial protocol?
Is the drug’s design, rationale, and pharmacokinetic/pharmacodynamic interactions adequately supported for its clinical development?

These questions are designed to facilitate balanced and effective discussions between SEC members and applicants, ensuring comprehensive evaluations of drug proposals based on scientific and regulatory standards.

Conclusion:

In conclusion, the blog outlines the essential processes for streamlining CDSCO approval in India, emphasizing the pivotal role of Subject Expert Committees (SECs). It details the steps for thorough application evaluations and efficient SEC meeting protocols. For medical device manufacturers and importers aiming to meet these regulatory requirements effectively, Morulaa offers support, guiding companies through the CDSCO’s detailed evaluation framework to ensure compliance and successful market entry. Understanding and utilizing tools like the SUGAM portal is essential for efficient regulatory processes. Morulaa also provides expertise in adhering to MD-14 standards, ensuring all documentation meets Indian regulatory requirements for successful registration. Registration of medical devices in India requires a comprehensive understanding of the SUGAM portal, which facilitates the entire process. Compliance with MD-14 is crucial, and Morulaa ensures that your registration process is seamless and efficient. For more information on how Morulaa can help you adapt to these regulatory changes, reach out to us at [email protected] or click here to learn more.