CDSCO releases draft Guidelines for Clinical Trial in India

April 16, 2024

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Last Updated on April 23, 2024 by The Health Master

Clinical Trial

The Indian pharmaceutical industry is poised for a significant boost with the Central Drugs Standard Control Organisation’s (CDSCO) release of a revised guidelines for Industry document (Version 1.2) for Clinical Trial in India.

Read or download CDSCO Guidance dt 10-04-2024 for Industry on Clinical Trial

This document, developed in consultation with stakeholders, aims to streamline the clinical trial approval process for biotechnology and biological products.

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Key Focus Areas of the Revised Guidelines

Alignment with Latest Regulations:

The guidelines ensures compliance with the New Drugs and Clinical Trials (NDCT) Rules, 2019, and the Sugam application process. This provides clarity and simplifies the application process for sponsors.

Enhanced Safety and Efficacy Evaluation:

The document emphasizes the importance of submitting a comprehensive clinical trial application (Form CT-04) that outlines the plan for evaluating the safety and efficacy of the new drug.

Streamlined Quality Information Submission:

Specific guidelines are provided for preparing quality information related to biotechnological and biological products. This ensures a thorough review process and protects patient safety.

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What Sponsors Need to Know

Application Submission:

Sponsors must submit applications for conducting clinical trials in India electronically through the Sugam or National Single Window System (NSWS) portal. This eliminates unnecessary paperwork and expedites processing.

Quality Assurance System Implementation:

Sponsors are responsible for establishing and maintaining a robust Quality Assurance System. This system ensures the clinical trial adheres to the approved protocol, Good Clinical Practice (GCP) guidelines, and relevant regulations.

Regular Status Reporting:

Sponsors are required to submit status reports to the Licensing Authority at regular intervals. These reports provide an update on the progress of the trial and ensure transparency.

Adverse Event Reporting:

Any serious adverse events (SAEs) encountered during the trial must be promptly communicated (within 14 days) to the Licensing Authority and participating investigators. This ensures patient safety and allows for timely intervention.

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Focus on Biological Products

While the overall clinical trial conduct requirements remain aligned with the NDCT Rules, 2019, the revised guidelines provides specific details regarding the chemistry and pharmaceutical information required for biologicals.

This caters to the unique needs of these complex products.

International Alignment and Flexibility

The guidelines document, though tailored for the Indian context, adheres to International Council for Harmonisation (ICH) requirements.

This ensures international recognition of Indian clinical trial data. Additionally, the document clarifies that new regulations, if published, will supersede the guidelines.

This ensures the industry remains adaptable to evolving regulations.

Conclusion

The CDSCO’s revised guidelines for Industry represents a significant step forward in streamlining the clinical trial approval process for biotechnology and biological products in India.

By promoting clarity, efficiency, and international alignment, this guidelines is expected to accelerate the development of innovative new drugs for patients in India and around the world.

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