NDCT Rules Draft Amendment 2026: Key Regulatory Changes Proposed Under G.S.R. 97(E) and G.S.R. 98(E): Explained

NDCT Rules Draft Amendment 2026: Key Regulatory Changes Proposed Under G.S.R. 97(E) and G.S.R. 98(E): Explained

Introduction

The Ministry of Health and Family Welfare (MoHFW) has issued two important draft notifications, namely G.S.R. 97(E) and G.S.R. 98(E), proposing amendments to the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) under the Drugs and Cosmetics Act, 1940.

The proposed NDCT Rules Amendment 2026 reflects India’s continued effort to strengthen the clinical trial regulatory framework, improve regulatory compliance for pharmaceutical manufacturers, and enhance operational clarity for stakeholders such as drug manufacturers, CROs, and ethics committees.

Overview of G.S.R. 97(E): Post Approval Changes Under NDCT Rules, 2019

The Draft Notification G.S.R. 97(E) introduces a structured mechanism for handling post approval changes in drugs approved under the NDCT Rules, 2019. These changes apply to manufacturing process, excipients, packaging, shelf life, specifications, testing, and documentation.

Classification of Quality Changes

The amendment classifies changes into three levels based on their potential impact on drug identity, strength, quality, purity, or potency:

1. Major Quality Changes (Level I)

Any change having a substantial potential adverse impact on drug quality requires prior approval from the licensing authority. This ensures tighter control over critical variations in drug manufacturing.

2. Moderate Quality Changes (Level II)

Changes with a moderate potential impact on drug quality also require prior regulatory approval, ensuring continued compliance with CDSCO regulations.

3. Minor Quality Changes (Level III)

Minor quality changes with minimal risk may be implemented without prior approval, except in cases involving shelf life changes of the drug substance or drug product. However, these changes must be reported through annual submission to the licensing authority during the first quarter of each calendar year.

This classification brings India closer to global best practices in pharma regulatory compliance and post approval change management.

Amendments to Rule 77 and Rule 82 of NDCT Rules

The notification inserts new clauses under Rule 77 and Rule 82, making it mandatory for manufacturers or their authorized agents to inform the licensing authority in writing about any change in manufacturing or quality-related parameters.

This provision strengthens regulatory oversight while allowing flexibility for innovation and operational efficiency in drug manufacturing changes.

Overview of G.S.R. 98(E): Ethics Committee Registration Simplified

The second draft notification, G.S.R. 98(E), focuses on simplifying the ethics committee registration process under Rule 17 of the NDCT Rules, 2019.

Key Changes Introduced

• Substitution of sub-rule (4) of Rule 17, enabling direct final registration of ethics committees upon satisfactory scrutiny

Under the amended provision, upon receiving an application in Form CT-01, the designated authority will examine the submitted documents and, if compliant, grant final registration in Form CT-03. If the requirements are not met, the application may be rejected with reasons recorded in writing.

This amendment reduces procedural delays and enhances ease of compliance for ethics committees involved in clinical trials in India.

For Pharmaceutical Manufacturers

• Clear guidance on post approval changes under NDCT Rules 2019
• Reduced ambiguity regarding prior approval requirements
• Improved predictability in regulatory approval for drug manufacturing changes

For Ethics Committees

• Faster operational readiness for clinical trial oversight

For CROs and Sponsors

• Greater regulatory clarity supports smoother clinical trial regulatory compliance
• Reduced administrative bottlenecks

Alignment with India’s Clinical Trial Regulatory Framework

The proposed amendments demonstrate the government’s intent to:

• Enhance quality assurance in pharmaceuticals
• Strengthen regulatory scrutiny of applications
• Promote ease of doing research while maintaining patient safety

These changes are significant for professionals dealing with NDCT compliance checklists, pharma regulatory training, and clinical trial regulatory updates in India.

Conclusion

The NDCT Rules Amendment 2026, through G.S.R. 97(E) and G.S.R. 98(E), marks a crucial step in refining India’s drug and clinical trial regulations. By introducing a risk-based approach for post approval changes and simplifying ethics committee registration, the amendments balance regulatory control with operational efficiency.

Pharmaceutical companies, ethics committees, and clinical research organizations must closely monitor these development and align their internal compliance systems to ensure smooth adaptation once the rules are finalized.

Note:
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