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Date: 2022-12-23 Category: Extra Ordinary State: Union Government Country: India

Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022.

Issued by Ministry of Environment, Forest and Climate Change · Hazardous Substances Management Division

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Executive Summary & Key Takeaways

Okay, I'm ready to analyze the provided policy text and generate the report. **Report: Analysis of the Hazardous and Other Wastes Management and Transboundary Movement Second Amendment Rules, 2022** **1. Executive Summary:** This report analyzes the "Hazardous and Other Wastes Management and Transboundary Movement Second Amendment Rules, 2022," which amends the 2016 rules of the same name. The core purpose of this amendment is to modify regulations related to the import and reuse of certain high-end medical equipment classified under Basel No. B1110. The key finding is that the amendment aims to facilitate the import of "High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment" for reuse, specifying conditions for import and delegation to the Ministry of Health and Family Welfare for defining applicable equipment. **2. Introduction:** This report provides an informative overview and analysis of the "Hazardous and Other Wastes Management and Transboundary Movement Second Amendment Rules, 2022" based solely on the text provided in the official notification. The report aims to inform affected industries about the specific changes introduced by this amendment and its potential implications. **3. Policy Overview:** * **Original Policy:** Hazardous and Other Wastes Management and Transboundary Movement Rules, 2016. * **Core Objective(s):** The original policy's objective (inferred from the amendment's context) is the management and regulation of hazardous and other wastes, including transboundary movement. The amendment focuses on specific aspects of this broad objective, namely the import of certain used medical equipment. **4. Background and Rationale:** This amendment appears to address a specific aspect of the original policy related to the import and reuse of medical equipment. The rationale likely involves a desire to allow for the import and reuse of high-end medical equipment (excluding critical care equipment) to potentially reduce healthcare costs, promote resource efficiency, or address specific medical equipment needs. The amendment seeks to clarify and streamline the import process for such equipment, potentially balancing environmental concerns with the benefits of equipment reuse. **5. Key Provisions / Changes:** This amendment focuses on Schedule III, Part B, specifically Basel No. B1110 of the Hazardous and Other Wastes Management and Transboundary Movement Rules, 2016. * **Specific Part Changed:** Schedule III, Part B, Basel No. B1110 * **New Rule/Provision:** * The following entry is inserted: "High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment for re use note the related entry in Schedule VI, B1110". * The following text is inserted before "Note": "Import permitted in the country by actual user or by Original Equipment Manufacturers OEM or Indian Subsidiary of OEM or Trader on behalf of actual user; High End and High Value Medical Equipment is such medical equipment as specified by the Ministry of Health and Family Welfare from time to time.". * **Difference/Effect of the Change:** * The amendment now *explicitly* allows the import of "High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment" for reuse, provided it falls under Basel No. B1110 and is not critical care equipment. * The import is restricted to specific entities: actual users, Original Equipment Manufacturers (OEMs), Indian Subsidiaries of OEMs, or traders acting on behalf of actual users. * The Ministry of Health and Family Welfare is given the authority to define what constitutes "High End and High Value Medical Equipment," providing flexibility and allowing for adaptation to evolving medical technology. **6. Target Audience and Stakeholders:** Based on the provided text, the directly affected stakeholders include: * **Hospitals and Healthcare Providers (Actual Users):** Those who directly utilize medical equipment. * **Original Equipment Manufacturers (OEMs):** Companies that manufacture the medical equipment. * **Indian Subsidiaries of OEMs:** Local branches of the manufacturing companies. * **Traders:** Entities involved in the import and distribution of medical equipment. * **Ministry of Health and Family Welfare:** Responsible for defining “High End and High Value Medical Equipment." * **Ministry of Environment, Forest and Climate Change:** Regulatory oversight **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** The Ministry of Environment, Forest and Climate Change is responsible for the overall enforcement of the rules. The Ministry of Health and Family Welfare is responsible for defining "High End and High Value Medical Equipment." * **Timelines/Procedures:** The amendment came into force on the date of its publication in the Official Gazette (December 23, 2022). Specific procedures for import would likely involve compliance with existing customs regulations and potentially requiring certification or approval from the Ministry of Health and Family Welfare based on their definition of applicable equipment. * **Amendment-Specific Implementation:** Implementation will require the Ministry of Health and Family Welfare to establish and communicate criteria for defining "High End and High Value Medical Equipment." Customs and regulatory bodies will need to be informed of these criteria to properly process imports. **8. Expected Outcomes / Impact of Changes:** The likely intended outcomes of these specific changes are: * **Increased Availability of Used Medical Equipment:** Making "High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment" available for reuse within the country. * **Potential Cost Reduction in Healthcare:** By allowing the import of used equipment, healthcare providers might have access to more affordable options. * **Resource Efficiency:** Promoting the reuse of valuable medical equipment, aligning with circular economy principles. * **Flexibility and Adaptability:** The involvement of the Ministry of Health and Family Welfare allows for a dynamic definition of "High End and High Value Medical Equipment," ensuring that the regulations remain relevant as technology advances. **9. Conclusion:** The "Hazardous and Other Wastes Management and Transboundary Movement Second Amendment Rules, 2022" introduces a specific change to the existing regulations, facilitating the import and reuse of certain categories of high-end medical equipment under defined conditions. The amendment delegates definitional authority to the Ministry of Health and Family Welfare and aims to balance environmental concerns with the potential benefits of medical equipment reuse. This amendment is significant as it may impact the availability and cost of medical equipment in the Indian healthcare sector.

Key Entities Referenced

Ministry of Environment, Forest and Climate Change: The ministry issuing the notification. New Delhi: Location of the notification and ministry. A city and union territory of India. Environment Protection Act, 1986: The act under which the powers are conferred to make the rules. Hazardous and Other Wastes Management and Transboundary Movement Rules, 2016: The rules being amended by this notification. Hazardous and Other Wastes Management and Transboundary Movement Second Amendment Rules, 2022: The title of the rules introduced by this notification. Schedule III: Schedule of the Hazardous and Other Wastes Management and Transboundary Movement Rules, 2016 being amended. Part B: Part of Schedule III being amended. Basel No. B1110: Basel number in Schedule III, Part B that is being amended. High End and High Value Used Medical Equipment: The type of equipment to which the amendment applies. Used Critical Care Medical Equipment: Exception to High End and High Value Used Medical Equipment. Original Equipment Manufacturers OEM: One of the entities by which Import is permitted. Ministry of Health and Family Welfare: The ministry responsible for specifying High End and High Value Medical Equipment. Mayapuri, New Delhi: Location of the Dte. of Printing (Directorate of Printing). Delhi: Location of the Controller of Publications.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एxलx.x-GअID.-E2xx4x1 22022-241373 CG-DL-E-24122022-241373 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (i) PART II—Section 3—Sub-section (i) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 803] नई ददल्ली, िुक्रवार, ददसम्ब र 23, 2022/पौष 2, 1944 No. 803] NEW DELHI, FRIDAY, DECEMBER 23, 2022/ PAUSA 2, 1944 पयाावरण, वन और िलवाय ु पररवतना मत्रं ालय अजधसचू ना नई ददल् ली, 23 ददसम् बर, 2022 सा.का.जन. 900(अ).—केन्‍द रीय सरकार, पयाावरण (सरं क्षण) अजधजनयम, 1986 (1986 का 29) की धारा 6,8 और 25 द्वारा प्रदत्त िजियों का प्रयोग करते हुए, उक्त जनयमों के जनयम 5 के उप-जनयम (3) के खंड (क) के अधीन नोरिस की अपेक्षा को समाप् त करत े हुए िन-जहत म ें पररसंकिमय और अन्‍द य अपजिष्ि (प्रबंधन और सीमापारीय संचलन) जनयम, 2016 का और संिोधन करने के जलए जनम्न जलजखत जनयम बनाती ह,ै अथाात्:- 1. (1) संजक्षप् त नाम और प्रारंभ (1) इन जनयमों का संजक्षप् त नाम पररसंकिमय और अन्‍द य अपजिष्ि (प्रबंधन और सीमापारीय संचलन) जद्वतीय सिं ोधन जनयम, 2022 ह।ै (2) ये रािपत्र म ेंअपन े प्रकािन की तारीख को प्रवृत् त होंगे। 2. पररसंकिमय और अन्‍द य अपजिष्ि (प्रबंधन और सीमापारीय संचलन) जनयम, 2016 के अनुसचू ी III म,ें भाग ख म,ें- (क) बेसल स.ं ख 1110 के संदभ ा म,ें स्ट् तंभ (2) म,ें प्रजवजियों के पश् चात, जनम्न जलजखत अतं :स्ट्थ ाजपत दकया िाएगा, अथाात:्- ‘’पुन: उपयोग के जलए प्रयुक् त गंभीर देखभाल के जलए बन े जचदकत् सा उपकरण के अलावा हाई एंड और उच् च मल्ू य प्रयुक् त जचदकत् सा उपकरण (अनसु ूची VI, ख 1110 म ें संबंजधत प्रजवजि पर ध् यान दें)**’’; (ख) रिप् पण स े पूव,ा जनम्न जलजखत अतं :स्ट् थाजपत दकया िाएगा, अथाात ् :- ‘’**वास्ट् तजवक उपयोगकत् ताा द्वारा या मलू उपकरण जवजनमााता (ओईएम) या वास्ट् तजवक उपयोगकत् ता ा की और स े ओईएम या रेडर की भारतीय सब् सीडेरी द्वारा दिे म ेंआयात की अनुमजत; 8622 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] हाई एंड और उच् च मल्ू य वाल े जचदकत् सा उपकरण ऐसे जचदकत् सा उपकरण ह ैं िो समय-समय पर स्ट् वास्ट् ् य और पररवार कल् याण मंत्रालय द्वारा जनर्ददष् ि दकए िाते ह।ैं ‘’ [फा. सं. 23/104/2022-एचएसएम] नरेि पाल गगं वार, अपर सजचव रिप्प ण : मूल जनयम भारत के रािपत्र, असाधारण, भाग II, खंड 3, उपखंड (i) म ें सा.का.जन. संख यांक 395 (अ), तारीख 4 अप्रलै , 2016 द्वारा प्रकाजित दकए गए थ े और तत्प श् चात ् सा.का.जन. संख यांक 670(अ), तारीख 6 िुलाई, 2016, सा.का.जन. संख यांक 177(अ), तारीख 28 फरवरी, 2017; सा.का.जन. संख यांक 544(अ), तारीख 11 िून, 2018; सा.का.जन. संख यांक 178(अ), तारीख 1 माच,ा 2019; सा.का.जन. 641(अ), तारीख 9 अक्त ूबर, 2020; सा.का.जन. 47(अ), तारीख 27 िनवरी, 2021; सा.का.जन. 798(अ), तारीख 12 नवम् बर, 2021 और सा.का.जन. 593(अ), तारीख 21 िुलाई, 2022 द्वारा संिोजधत दकए गए। MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE NOTIFICATION New Delhi, the 23rd December, 2022 G.S.R.900(E).—In exercise of powers conferred by sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986), the Central Government, after having dispensed with the requirement of notice under clause (a) of sub-rule (3) of rule 5 of the said rule in public interest, hereby makes the following rules further to amend the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, namely: - 1. Short title and commencement. - (1) These rules may be called Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, in Schedule III, in Part B, - (a) against Basel No. B1110, in column (2), after the entries, the following shall be inserted, namely: - “High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment for re- use (note the related entry in Schedule VI, B1110) **”; (b) Before Note, the following shall be inserted, namely: - „„** Import permitted in the country by actual user or by Original Equipment Manufacturers (OEM) or Indian Subsidiary of OEM or Trader on behalf of actual user; High End and High Value Medical Equipment is such medical equipment as specified by the Ministry of Health and Family Welfare from time to time.". [F. No. 23/104/2022-HSM] NARESH PAL GANGWAR, Addl. Secy. Note : The principal rules were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 395(E), dated the 4th April, 2016 and subsequently amended vide number G.S.R. 670(E), dated the 6th July, 2016; number G.S.R. 177(E), dated the 28th February, 2017; number G.S.R. 544(E), dated the 11th June, 2018; number G.S.R. 178(E), dated the 1st March, 2019; number G.S.R. 641(E), dated the 9th October, 2020 ; number G.S.R. 47(E), dated the 27th January, 2021; number G.S.R. 798(E), dated the 12th November, 2021 and number G.S.R. 593(E), dated the 21st July, 2022. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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