In pursuance of Sub rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards hereby notifies that Amendments to Indian standards

## Policy Analysis Report: Amendment to Indian Standard ISISO 119794:2008 **1. Executive Summary:** This report analyzes a notification from the Bureau of Indian Standards (BIS) regarding an amendment to Indian Standard ISISO 119794:2008 concerning ophthalmic implants, specifically intraocular lenses. Amendment No. 1, established on April 15, 2025, focuses on the "Labelling and Information" aspect (Part 4) of these lenses. The amendment will be in force until October 14, 2025, after which the standard without the amendment will no longer be valid. This analysis is based solely on the provided Gazette of India notification. **2. Introduction:** This report provides an overview and analysis of the notification regarding Amendment No. 1 to Indian Standard ISISO 119794:2008 concerning ophthalmic implants (intraocular lenses). The analysis aims to inform stakeholders about the changes introduced by this amendment, based on the information available within the notification. **3. Policy Overview:** * **Original Policy:** Indian Standard ISISO 119794:2008 "Ophthalmic Implants Intraocular Lenses Part 4 Labelling and Information." * **Core Objective:** As inferred from the title and amendment information, the core objective of the original standard is to establish guidelines and requirements for the labelling and information provided with intraocular lenses used as ophthalmic implants. The amendment aims to refine or update these specific requirements. **4. Background and Rationale:** The provided text does not explicitly state the rationale behind this specific amendment. However, it can be inferred that the amendment likely addresses a need to update or clarify the existing labelling and information requirements for intraocular lenses. This could be due to changes in international standards, advancements in technology, or identified gaps or ambiguities in the original standard that required clarification or modification for improved clarity for manufacturer labelling. **5. Key Provisions / Changes:** This notification concerns Amendment No. 1 to ISISO 119794:2008. * **Specific Part Changed:** The amendment specifically affects "Part 4 Labelling and Information" of the standard related to intraocular lenses. * **New Rule/Provision:** While the notification establishes the amendment, it *does not contain the specific text of the amendment itself*. It only states that an amendment has been established. Therefore, the specific new rule or provision *cannot be determined* from the provided text. * **Difference/Effect of Change:** Since the specific text of the amendment is not provided, the exact difference or effect of the change cannot be analyzed. However, the change will likely affect the way intraocular lenses must be labelled and the type of information that must be provided with them. **6. Target Audience and Stakeholders:** The primary target audience and stakeholders are: * Manufacturers of intraocular lenses intended for the Indian market. * Importers and distributors of these lenses. * Healthcare professionals involved in ophthalmic surgery and patient care (indirectly). * Bureau of Indian Standards (BIS) as the regulatory body. **7. Implementation Aspects (Inferred):** * **Responsible Agency:** The Bureau of Indian Standards (BIS) is the responsible agency for implementing and enforcing this amendment. * **Timelines:** The amendment was established on April 15, 2025, and will be in force until October 14, 2025. After that date, the original standard without the amendment will no longer be valid, implying that manufacturers must comply with the amended standard after that date. **8. Expected Outcomes / Impact of Changes:** The likely intended outcome of this amendment is to: * Improve the clarity, accuracy, and completeness of labelling and information provided with intraocular lenses. * Ensure that healthcare professionals and patients have access to the necessary information for safe and effective use of these implants. * Harmonize Indian standards with international best practices in the field of ophthalmic implants (though this cannot be definitively stated based on the provided text). * Ensure that the manufacture and labelling of ophthalmic implants is up to date with changing industry. The impact of the amendment will depend on the specific changes introduced. However, manufacturers will likely need to update their labelling processes and documentation to comply with the new requirements. **9. Conclusion:** This report analyzes the notification concerning Amendment No. 1 to Indian Standard ISISO 119794:2008, focusing on "Labelling and Information" for ophthalmic implants (intraocular lenses). The amendment, established on April 15, 2025, will require manufacturers to update their labelling and information practices to comply with the updated standard. The specific details of the changes and their full impact cannot be fully assessed without access to the amendment document itself, but is focused to improve quality in ophthalmic implants and align with current industry standards for better healthcare and safety.

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