Understanding the Deliberations on 16 FDCs by the DTAB Subcommittee

The upcoming meeting on April 5, 2024, serves as a platform for stakeholders to present their perspectives on the identified FDCs

The Health Master

March 30, 2024

112

DTAB Drug Technical Advisory Board — DTAB

Table of Contents

Last Updated on April 11, 2024 by The Health Master

FDCs

In the realm of pharmaceuticals, the evaluation and regulation of Fixed Dose Combinations (FDCs) play a critical role in ensuring public health and safety.

The sub-committee constituted by the Drugs Technical Advisory Board (DTAB) has recently garnered attention for its forthcoming meeting scheduled on April 5, 2024.

This meeting aims to delve into the assessment of 16 FDCs previously flagged as irrational by the esteemed Prof. Kokate Committee. Let’s delve deeper into the significance of this meeting and its implications.

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1. Background of the Issue

1.1 Prof. Kokate Committee Report

The genesis of the current deliberations can be traced back to the recommendations put forth by the Prof. Kokate Committee.

This committee identified 16 FDCs among the 294 under scrutiny, deeming them irrational.

1.2 Regulatory Response

In response to the findings of the Prof. Kokate Committee, the DTAB convened to examine the report and endorsed the need for further evaluation, particularly focusing on the flagged FDCs.

Read and Download Minutes of all meetings of DTAB

2. The Role of DTAB Subcommittee

2.1 Composition

The DTAB sub-committee, led by Dr. Nilima Kshirsagar, comprises experts in clinical pharmacology and regulatory affairs.

Their expertise is instrumental in evaluating the safety, efficacy, and rationality of pharmaceutical combinations.

2.2 Objectives of the Meeting

The upcoming meeting on April 5, 2024, serves as a platform for stakeholders to present their perspectives on the identified FDCs.

It provides an opportunity for comprehensive deliberation before the sub-committee makes further recommendations.

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3. Stakeholder Engagement

3.1 Importance of Stakeholder Participation

Stakeholders, including manufacturers and regulatory bodies, hold valuable insights into the development and usage of FDCs.

Their active involvement enriches the deliberative process and ensures a holistic assessment.

3.2 Call for Participation

The FDC division of the Central Drugs Standard Control Organisation (CDSCO) has issued a call for stakeholders to attend the online meeting and present their viewpoints.

The absence of stakeholders may influence the committee’s decision-making process.

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4. Evolution of Regulatory Oversight

4.1 Historical Context

The scrutiny of FDCs dates back to 2007 when concerns were raised regarding unapproved combinations in the market.

Subsequent regulatory actions, including directives for withdrawal and committee formations, underscore the evolving regulatory landscape.

4.2 Recommendations and Categorization

The categorization of FDCs into rational, requiring further data, and irrational reflects a nuanced approach to regulatory decision-making.

It emphasizes the importance of evidence-based assessments in determining the fate of pharmaceutical combinations.

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5. Future Implications

5.1 Impact on Pharmaceutical Industry

The outcome of the deliberations holds significant implications for manufacturers and marketers of the identified FDCs.

Compliance with regulatory directives and alignment with rationality criteria are imperative for sustained market presence.

5.2 Public Health Considerations

The ultimate objective of regulatory oversight is to safeguard public health interests.

Rationalization of FDCs ensures that medications adhere to safety and efficacy standards, enhancing patient outcomes and confidence in healthcare interventions.

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