CDSCO Post Approval Changes

The CDSCO post-approval changes refer to any alteration made to a drug, medical device, or cosmetic that has already been granted regulatory approval by the Central Drugs Standard Control Organisation. These approvals are issued in accordance with specified technical, manufacturing, safety, and quality parameters and any deviation outside the approved scope is considered a post-approval change as per the regulations.

These changes may occur due to operational demands such as manufacturing optimisation, supplier replacement, business growth, regulatory changes, or improvements in product quality. The changes are not limited to formulation or process modifications but may also include changes in packaging materials, labelling information, testing methods, shelf life, or details of the manufacturing site. Even minor modifications may affect product performance, stability, or traceability, which is why CDSCO pays closer attention to it.

The regulation on post-approval changes aims to ensure that products sold in India meet the same safety, efficacy, and quality standards on which the original approval was granted. Failure to secure approval or to inform CDSCO, where required, may result in suspension or cancellation of licenses, product withdrawal, or legal action under the Drugs and Cosmetics framework.

These Post-approval changes are controlled to ensure that all the approved drugs, medical devices, and cosmetics continue to meet established safety, quality, and performance standards. Regulatory approvals are issued under certain conditions, and any alteration beyond that approved scope should be reconsidered to safeguard public health and maintain legal compliance.

• Ensuring Product Safety: CDSCO approval ensures that post-approval changes do not add new risks or jeopardise the safety of the patients or consumers. Even small changes may influence performance, stability, or biocompatibility, which is why it is necessary to regulate such changes before implementation.
• Maintaining Approved Quality Standards: Regulatory review is to ensure that the quality parameters approved at the time of licensing are not compromised. CDSCO determines the consistency and reliability of manufacturing, material and process changes and reliability throughout the product lifecycle.
• Preserving License Validity: Licenses are granted on particular structures and circumstances. The unauthorised license can nullify the existing license. CDSCO approval assists firms in balancing continuous legal rights to manufacture, import or sell their goods.
• Supporting Regulatory Traceability: CDSCO needs to have proper records of approved products to conduct inspections, audits, and investigations of adverse events. Post-approval change guarantees that regulatory databases are updated with product information.
• Ensuring Compliance with Applicable Laws: CDSCO provides that post-approval changes comply with the Drugs and Cosmetics Act, Medical Devices Rules, and other applicable guidelines, minimising the chances of enforcement actions or fines.

CDSCO categorizes post-approval changes according to the potential effect of these changes on product safety, efficacy and quality. This classification signifies the need of prior approval or whether post-change notification is required.

1. Major Changes: Major changes are those that can have a serious impact on the performance of a medical device, its quality, safety, or effectiveness. Such modifications alter the terms upon which the initial approval was granted and, as a result, they are subject to stringent regulation. Major post-approval changes are:

• Modification in the material of construction of the medical device.
• Changes in design that affect the quality or performance of products 
• Change in intended use or indication for use.
• Change in the sterilization method or validation approach
• Change in the approved shelf life or expiry period
• Change in the name or address of the manufacturer or licensee
• Labeling changes, excluding font type, font size, colour, or graphic design
• Changes in manufacturing processes, equipment, or testing methods affecting quality
• Change in primary packaging material in direct contact with the device

2. Minor Changes: Minor changes are the ones that do not affect the quality, safety, or performance of the medical device or its stability in any way. These alterations are usually those that relate to operational or administrative changes and they are not subject to a complicated regulatory procedure. Minor post-approval changes include:

• Design changes that do not affect device quality, specifications, performance, intended use, or stability
• Adjustments to manufacturing, equipment or testing procedures, which do not affect the quality of the product.
• Modification of packaging specifications, which do not include primary packaging material.

The minor changes usually need to be reported to the licensing authority within the specified time with supporting documentation. Though this prior approval may not be compulsory requirement, manufacturers and importers are required to keep the proper records and keep themselves subject to the regulatory standards.

The post-approval requirements vary depending on the type of product, regulatory frameworks and risk. The CDSCO implements particular regulations for drugs, medical devices and cosmetics to maintain their safety, quality, and compliance, and meet the unique characteristics and risk profiles of each type.

• Post-Approval Changes for Drugs: Post-approval modification for drugs are regulated under the Drugs and Cosmetics Act and Rules, covering formulation, manufacturing processes, shelf life, labeling, and the method of testing. Any major changes must be approved by CDSCO to maintain the valid license.
• Post-Approval Changes for Medical Devices: According to the Medical Devices Rules, 2017, the categories of changes include major and minor depending on the risk and performance effects, safety, or intended use. High-risk changes must be approved beforehand and minor changes may be notified.
• Post-Approval Changes for Cosmetics: Post-approval changes focus on ingredient safety, labeling, claims and compliance to BIS standards. Any alterations in the restricted substances, place of manufacture, or product claims should follow regulatory approval or notification procedure.

Appropriate documentation is vital to CDSCO post-approval change submissions. According to the applicant, the authority assesses change requests on the basis of technical justification, risk assessment, and compliance. Key documents include:

• Covering letter explaining the nature and rationale of the change
• Approved license copy and product permission details
• Change impact assessment and justification report
• Updated technical dossiers or specifications
• Revised labels, artwork, or packaging details (if applicable)
• Stability data or validation reports (where required)
• Declaration of compliance signed by authorised signatory

The regulatory process of post-approval change under CDSCO has a structured course of regulations. Every step can be traced, seen through, and verified by technical validation before changes are adopted or implemented. The following is the step-by-step process:

• Step 1: Identification and Classification of Change: The applicant recognizes the change and classifies it as major or minor according to CDSCO requirements.
• Step 2: Preparation of Technical and Regulatory Documents: All necessary documents, along with risk assessment, and updated records should compiled in prescribed formats.
• Step 3: Online Submission through CDSCO Portal: The change application are made via the relevant CDSCO online portal with the applicable government fees.
• Step 4: Regulatory Review and Query Resolution: CDSCO examines the submission and can have technical or compliance inquiries which need to be clarified.
• Step 5: Approval or Acknowledgement of Change: CDSCO issues approval for major changes or acknowledges minor changes once they have been notified.

The timelines of CDSCO review differ based on the nature and complexity of post approval change. Minor changes provided as notifications are typically recognized sooner, whereas major changes can go through an extensive technical review, including expert committee evaluation. Timelines are also based on product category, documentation completeness and response time to regulatory queries. The delays are usually caused by an inadequate justification or lack of technical data.

Consequences of Non-Compliance with Post-Approval Requirements

Failure to adhere to the CDSCO post approval change requirements can result in severe regulatory and commercial repercussions for the manufacturers and importers, such as:

• Suspension or revocation of approval or license of product.
• Regulatory notices, penalties or prosecution as per the law.
• Product recalls, or market withdrawal orders.
• Importing notices or production restrictions.
• Injury to brand reputation and compliance history.

Best Practices to Manage CDSCO Post-Approval Changes Efficiently

Post-approval changes can only be managed well through proactive planning, regulatory awareness and discipline in documentation. Businesses that incorporate compliance avoid delays and enforcement risks.

• Carry out an internal impact assessment before implementing any change.
• Maintain updated regulatory documentation and version control.
• Seek expert regulatory review for borderline or complex changes.
• Track submission timelines and CDSCO responses on a timely basis.
• Align quality, regulatory and operations departments for consistency.

Corpseed is a top consulting firm providing expert support for manufacturers and importers to manage CDSCO post-approval changes efficiently. We ensure all regulatory requirements are met accurately, minimizing compliance risks and ensuring smooth approvals without operational disruptions.

• Expert Regulatory Guidance: Our professionals have in-depth knowledge of CDSCO rules for drugs, medical devices, and cosmetics, ensuring each change is correctly classified, documented, and aligned with applicable regulatory standards.
• End-to-End Support: We handle the entire process from impact assessment, documentation preparation, portal filing, regulatory follow-ups, and final approval, allowing businesses to focus on operations without compliance stress.
• Compliance Accuracy: Every submission is meticulously prepared to follow CDSCO guidelines, notifications, and license conditions, minimizing errors, reducing rejection risks, and ensuring that post-approval changes are fully compliant.
• Timely Monitoring: We track each application closely, respond promptly to regulatory queries, and provide regular updates to clients, ensuring applications progress smoothly without unnecessary delays.
• Post-Approval Support: Beyond approvals, we assist with future changes, audits, renewals, and ongoing regulatory compliance, helping businesses maintain credibility, prevent violations, and stay market-ready.