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CDSCO Releases Draft Guidance for Industry Version 1.2 for Stakeholders' Comments

Written by : Aishwarya Sarthe

April 19, 2024

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The draft Guidance for Industry, Version 1.2, primarily focuses on streamlining the processes related to submitting clinical trial applications and requirements for new drug approvals.

In recent developments, the Central Drugs Standard Control Organisation (CDSCO) has unveiled a revised Guidance for Industry Version 1.2 draft to enhance the regulatory framework concerning clinical trial applications and new drug approvals. 

This initiative aligns with the New Drugs and Clinical Trials (NDCT) Rules, 2019, and the Sugam application process, reflecting India's evolving landscape of pharmaceutical regulation.

According to the CDSCO, the draft guidance addresses crucial aspects related to submitting clinical trial applications, requirements for new drug approvals, and preparing quality information for drug submissions, particularly focusing on biotechnological and biological products.

Sharing insights, Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), said, "The updated guidance underscores our commitment to ensuring the safety and efficacy of pharmaceutical products in the Indian market."

He further elaborated on the document's objectives, highlighting the need for adherence to Good Clinical Practice (GCP) guidelines and statutory provisions. 

"Sponsors must maintain a robust Quality Assurance system to ensure compliance with protocol and regulatory requirements," Raghuvanshi added.

Stakeholder Engagement & Feedback

In an inclusive approach, CDSCO has invited feedback from stakeholders regarding the draft guidance. 

Encouraging active participation from industry experts, Raghuvanshi said, "We welcome suggestions, comments, or objections, which will be considered when finalizing the draft guidance."

Stakeholders have been given a 15-day window to submit their feedback to the regulator. This collaborative effort reflects CDSCO's commitment to ensuring transparency and accountability in the regulatory process.

Emphasis on Compliance & Reporting

The revised guidance document emphasizes the importance of compliance with regulatory requirements throughout the clinical trial process. Sponsors must submit periodic status reports to the Licensing Authority and promptly report any serious adverse events.

Furthermore, the document outlines requirements for submitting applications for clinical trials under the NDCT Rules, 2019. It provides detailed guidance on preparing chemistry and pharmaceutical information for biological products, aligning with international standards while ensuring compliance with Indian regulations.

Focus on Quality & Safety

In addition to the draft guidance for clinical trials, CDSCO released a draft guidance document on Good Distribution Practices (GDP) for pharmaceutical products. This initiative underscores the regulator's commitment to upholding the quality and safety of pharmaceutical products circulating in the market.

The GDP guidelines, inspired by the framework outlined in the WHO Technical Report Series, aim to prevent the circulation of substandard and counterfeit products in the healthcare system. 

The guidelines establish stringent procedures for storing, transporting, and distributing pharmaceutical products, reinforcing CDSCO's efforts to safeguard public health.

The release of the draft Guidance for Industry Version 1.2 by CDSCO signifies a proactive approach towards enhancing the regulatory framework governing pharmaceuticals in India. 

By engaging stakeholders and inviting feedback, CDSCO aims to ensure that the guidelines align with international standards while addressing the unique requirements of the Indian pharmaceutical industry. 


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