India CDSCO Notice: Draft Notification on Post-Approval Changes (PAC) in Drugs

India’s Central Drugs Standard Control Organization (CDSCO) has released a draft notification dated 09 March 2026 proposing amendments to the Drugs Rules, 1945 to establish a structured framework for managing post-approval manufacturing changes.

This draft notification introduces clear regulatory requirements for notifying authorities when manufacturers make changes to manufacturing processes, excipients, packaging, shelf life, specifications, testing procedures, or documentation. The goal is to strengthen regulatory oversight while maintaining product quality and patient safety.

Post-approval changes are common during the lifecycle of pharmaceutical products as manufacturers improve processes, optimize formulations, or update manufacturing controls. However, such changes can potentially affect a drug product’s identity, strength, quality, purity, or potency.

The proposed amendments aim to ensure that regulatory authorities are informed of such changes and can assess their potential impact before implementation when necessary. The draft rules also introduce a risk-based classification system to determine the level of regulatory review required.

Purpose of the Draft Rules

The primary objective of this notification is to create a transparent and structured approach for handling manufacturing changes after product approval.

Specifically, the proposed rules aim to:

• Ensure consistent regulatory oversight of manufacturing changes

• Prevent adverse impacts on drug quality or safety

• Align India’s regulatory practices with global regulatory approaches for post-approval changes

• Improve traceability and reporting of manufacturing modifications

Classification of Manufacturing Changes

Under the proposed amendments, CDSCO plans to categorize manufacturing changes into three levels based on their potential impact on product quality.

Level I – Major Quality Changes

Major changes refer to modifications that have a substantial potential to affect the identity, strength, quality, purity, or potency of a drug product.

Examples may include significant changes to the manufacturing process or critical formulation components. Manufacturers must obtain prior approval from the licensing authority before implementing such changes.

Level II – Moderate Quality Changes

Moderate changes are those that have a moderate potential to impact product quality attributes.

Although the risk level is lower than Level I changes, manufacturers are still required to obtain prior approval from the licensing authority before implementing these changes.

Level III – Minor Quality Changes

Minor changes are those with minimal potential to impact product quality.

In such cases, manufacturers may implement the change without prior approval, except when the change involves the shelf life of the drug substance or drug product.

Instead, these changes must be reported annually to the licensing authority during the first quarter of the calendar year.

Notification Requirements for Manufacturing Changes

The draft notification specifies that manufacturers must inform the licensing authority in writing within 30 days whenever changes occur in areas such as:

• Manufacturing processes

• Excipients or formulation components

• Packaging materials

• Shelf life or stability data

• Product specifications

• Testing methods

• Documentation or quality systems

These requirements ensure that regulators remain informed about changes that could affect product quality or compliance.

As this is a draft notification, the Central Government has invited objections and suggestions from stakeholders within 30 days of publication in the Official Gazette.

The feedback received during this consultation period will be reviewed before finalizing the amendments to the Drugs Rules.

📌 Reference

For full details, click this LINK to the official CDSCO draft notification: