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CDSCO Releases Revised Guidelines on Post-Approval Changes in Biological Products

Written by : Aishwarya Sarthe

March 6, 2024

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Additionally, CDSCO has invited stakeholders to provide suggestions, comments, and objections within 45 days of issuance.

The Central Drugs Standard Control Organisation (CDSCO) has unveiled a draft of revised guidance for the industry concerning quality, safety, and efficacy documents for Post Approval Changes (PACs) in biological products. 

This move aims to align standards with international guidelines, including those set by the World Health Organisation (WHO) and current global regulatory practices.

The guidance document highlights the importance of adopting a science-based and risk-oriented approach to assessing biological products' quality, safety, and efficacy. 

Additionally, CDSCO has invited stakeholders to provide suggestions, comments, and objections within 45 days of issuance, emphasizing a collaborative effort in finalizing the guidance.

Classification of Post-Approval Changes

The guidance document categorizes PACs into four levels, each addressing varying degrees of impact on the biological product:

Level I-Supplement (Major Quality Change): These changes represent significant alterations with the potential to adversely affect the product's identity, strength, quality, purity, or potency. They require thorough documentation and assessment, including in-vivo studies, to ensure safety and efficacy.

Level II - Notifiable Changes: Moderate quality changes that could have a moderate adverse effect on the product's characteristics.

Level III - Annual Notification or Minor Quality Changes: Changes with minimal potential to impact the product's attributes, allowing implementation by Marketing Authorization (MA) holders without prior regulator review, except for shelf life alterations.

Fourth Level - Quality Only Changes: Changes that do not fall into the previous categories and are unlikely to affect the product's key attributes. MA holders can implement these changes without prior CDSCO review, provided they adhere to good manufacturing practices.

Documentation Requirements & Processes

The guidance outlines detailed documentation requirements for each level of change, emphasizing the submission of comprehensive data in formats defined by CDSCO or Common Technical Documents (CTD). It also establishes timelines for submission, with annual notifications due in the first quarter of each calendar year.

Additionally, the document addresses administrative product labeling information changes, with a streamlined review and approval process expected within 30 days of submission.

Moreover, CDSCO introduces the Post-Approval Change Management Protocol (PACMP), offering a structured framework for implementing quality changes. This protocol includes predefined tests and acceptable limits to demonstrate the absence of negative effects on product quality, safety, or efficacy.

Expedited Review & Reliance Pathway

The guidance acknowledges the possibility of expedited review and reliance pathways for biological products, particularly in addressing priority diseases, public health emergencies, or shortages. It also considers orphan products under these provisions.

Regarding Similar Biotherapeutic Products (SBP), the guidance clarifies that an SBP is independent of the reference product and follows its own life cycle once approved. However, changes in clinical use or labeling information must align with updates to the reference product unless proven irrelevant to the SBP.

Comprehensive Regulatory Guidelines for Drug Quality Surveillance

In another development, CDSCO initiated the transition to an online submission process for Period Safety Update Reports (PSUR) concerning the marketing authorization of new drugs and others. This digitalization effort aims to modernize regulatory procedures, streamline submissions, and enhance efficiency within the pharmaceutical sector.

Furthermore, CDSCO recently unveiled comprehensive regulatory guidelines for sampling drugs, cosmetics, and medical devices. These guidelines aim to standardize and streamline the sampling process while ensuring a centralized approach to maintaining data on product quality.

In line with these initiatives, the CDSCO also initiated plans to establish a Digital Drugs Regulatory System (DDRS) to serve as a unified digital ecosystem, simplifying regulatory activities for drugs, medical devices, cosmetics, and more.

The DDRS is expected to improve trust and confidence in the quality of healthcare products domestically and globally. To support this initiative, the CDSCO has invited Expressions of Interest (EoI) from Software Services Providers (SSPs) to facilitate the digital transformation of CDSCO, IPC, and NIB, with an expected duration of eight to ten years.

The system aims to be modular, accommodating various aspects of regulatory oversight, including end-to-end product management, stakeholder integration, real-time information capture, supply chain tracking, and monitoring of vigilance and enforcement activities.


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