CDSCO: Updated version of guidance document for Biologicals

DCGI emphasized that the revised guidance reflects extensive stakeholder consultations and incorporates public feedback.

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Guidelines
Guidelines

Last Updated on June 14, 2024 by The Health Master

Guidance

The Indian pharmaceutical industry received a significant update with the Central Drugs Standard Control Organisation’s (CDSCO) release of a revised “Guidance for Industry (Biologicals)”.

This revamped document, after a 16-year gap, aligns with contemporary regulations and online application processes, aiming to expedite approvals for crucial biological products.

Key Highlights of the Updated Guidelines:

Simplified Clinical Trial Applications:

The document provides comprehensive guidance for submitting clinical trial applications (CTA) to assess the safety and efficacy of biological drugs.

This includes clear instructions on completing Form CT-04 and adhering to the New Drugs and Clinical Trials Rules, 2019 (NDCTR 2019).

Fast-Tracked New Drug Approvals:

The guidance streamlines the process for obtaining marketing authorization for new biological drugs.

It outlines the requirements for submitting applications under the NDCTR 2019, paving the way for quicker access to innovative treatments.

Enhanced Quality Information Submission:

Manufacturers can leverage the document’s detailed instructions on preparing high-quality information packages for new drug applications specific to biological products.

This ensures a thorough and efficient review process by regulatory authorities.

Addressing Industry Needs:

Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), emphasized that the revised guidance reflects extensive stakeholder consultations and incorporates public feedback.

It is designed to harmonize with the NDCTR 2019 and the Sugam online application system, fostering a more streamlined and efficient regulatory framework.

Key Requirements for Clinical Trial Sponsors:

  • Submission of a comprehensive CTA through Form CT-04 via the Sugam or National Single Window System (NSWS) portal.
  • Implementation and maintenance of a robust Quality Assurance system to guarantee adherence to Good Clinical Practices (GCP) guidelines and the NDCTR 2019.
  • Documentation of standard operating procedures (SOPs) to ensure compliance with GCP and relevant regulations.
  • Regular submission of status reports on the clinical trial to the Licensing Authority.
  • Prompt communication (within 14 days) of any serious adverse events (SAEs) to the Licensing Authority and participating investigators.
  • Submission of a summary report within 3 months if the trial is prematurely discontinued, outlining reasons for discontinuation and details of patient exposure.

International Alignment:

The guidance document emphasizes that while the specific sections use Indian terminology, the content aligns with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

This ensures international compatibility and recognition of Indian clinical trial data.

Conclusion:

The updated “Guidance for Industry (Biologicals)” represents a significant step forward for the Indian pharmaceutical sector.

By streamlining clinical trial approvals and facilitating faster drug development, this guidance paves the way for accelerated access to life-saving biological treatments for patients in India.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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