CDSCO’s Revised Guidance on Post Approval Changes in Biological Products

The guidance primarily targets Marketing Authorization (MA) holders intending to make changes to already approved biological products

The Health Master

March 4, 2024

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Last Updated on March 13, 2024 by The Health Master

Biological Products

Biological Products: In the dynamic landscape of pharmaceuticals, regulatory bodies play a pivotal role in ensuring the safety, quality, and efficacy of medical products.

The Central Drugs Standard Control Organisation (CDSCO) has recently released a draft of a revised guidance document aimed at the industry for Post Approval Changes in Biological Products

Download guidance for Post Approval Changes in Biological Products

This document specifically focuses on post-approval changes (PACs) in biological products, aligning them with global standards, including those of the World Health Organisation (WHO).

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A Science-Based Approach

The upcoming guidance document underscores the importance of a science-based and risk-based approach in assessing the quality, safety, and efficacy of biological products.

This shift towards a more scientific evaluation is a significant step forward, bringing CDSCO in line with international best practices.

Soliciting Stakeholder Input

CDSCO encourages active participation from stakeholders by soliciting suggestions, comments, and objections within a 45-day window from the date of issuance.

This collaborative approach ensures that the final guidance incorporates diverse perspectives from industry experts, manufacturers, and other concerned parties.

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Target Audience

The guidance primarily targets Marketing Authorization (MA) holders intending to make changes to already approved biological products.

It serves as a valuable tool to assist MA holders in classifying changes effectively for products approved by CDSCO, either for import or local manufacturing and marketing in India.

Classifying Changes – The Four Levels

The guidance document introduces a classification system for PACs, dividing them into four distinct levels. Each level corresponds to the magnitude and potential impact of the changes on the product.

Level I – Supplement Changes (Major Quality Change)

The first level addresses supplement changes, indicating major quality modifications that can substantially affect the identity, strength, quality, purity, or potency of the biological product.

Extensive documentation and in-vivo studies support these changes, requiring a thorough risk assessment by CDSCO.

Level II – Notifiable Changes (Moderate Quality Change)

This level involves notifiable changes that have a moderate potential to adversely affect the product’s identity, strength, quality, purity, or potency.

CDSCO approval is essential for implementing changes falling under this category.

Level III – Annual Notification (Minor Quality Change)

Annual notifications cover minor quality changes with minimal potential to affect the product.

Unlike Level I and II, MA holders can implement Level III changes without prior CDSCO review, except for alterations in shelf life.

Level IV – Quality Only Changes

Changes falling into this category are not expected to adversely impact the strength, quality, or other factors of the drug products.

MA holders can implement these changes without prior CDSCO review, adhering to Good Manufacturing Practices.

Detailed Documentation Requirements

The guidance emphasizes the need for comprehensive documentation supporting each level of change.

Submission formats defined by CDSCO or Common Technical Documents (CTD) should be followed.

his ensures clarity and uniformity in the information provided.

Administrative Product Labelling Information Changes

Certain changes, labeled as administrative product labelling information changes, are deemed not to affect the safe and efficacious use of the biological product.

CDSCO aims to review and approve these changes within a timeframe of around 30 days from the date of submission.

Post-Approval Change Management Protocol (PACMP)

The guidance introduces the Post-Approval Change Management Protocol (PACMP), offering a structured plan for implementing quality changes.

This protocol includes specified tests and acceptable limits, ensuring the absence of negative effects on the product’s quality, safety, or efficacy.

Expedited Review/Reliance Pathway

CDSCO acknowledges the need for an expedited review or reliance pathway, particularly for biological products addressing priority diseases.

This approach facilitates the treatment of serious or life-threatening illnesses in public health emergencies or during shortages, including orphan products.

Similar Biotherapeutic Products (SBP)

Post-approval, Similar Biotherapeutic Products (SBP) are considered independent from the reference product, with their own life-cycle.

However, any major change in clinical use necessitates CDSCO consideration on a case-by-case basis, ensuring ongoing safety and efficacy.

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