Handbook on Product Standards and International Trade

Name: Handbook on Product Standards and International Trade | Navigating the Regulatory Landscape in India
Brand: Wolters Kluwer
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Navigating the Regulatory Landscape in India

James J. Nedumpara Satwik Shekhar Akshaya Venkataraman(Herausgeber*in)

Wolters Kluwer (Verlag)

Erschienen am 5. November 2021

432 Seiten

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Inhalt

Intro
Half-Title Page
Title Page
Copyright Page
Editors
Contributors
Summary of Contents
Table of Contents
List of Figures
List of Tables
Foreword
Preface and Acknowledgement
Editors' Introduction: Handbook on Product Standard and International Trade - Navigating the Regulatory Landscape in India
CHAPTER 1 Trade Regulation of Product Standards: An Overview
1.1 Introduction
1.2 Development and Enforcement of Standards
1.2.1 Types of Standards
1.2.2 Standard-Setting Bodies
1.2.3 Conformity Assessment Procedures
1.3 International Trade Regulation and Standards
1.3.1 Agreement on Technical Barriers to Trade
1.3.1.1 Scope of Application
1.3.1.2 Key Principles of the TBT Agreement
1.3.1.2.1 Non-discrimination
1.3.1.2.2 Legitimacy of Objective and Trade Restrictiveness of the Technical Regulation
1.3.1.2.3 Use of International Standards
1.3.1.2.4 Transparency
1.3.1.3 The TBT Committee
1.3.2 Agreement on SPS Measures
1.3.2.1 Scope
1.3.2.2 Key Principles
1.3.2.2.1 Basic Rights and Obligations under the SPS Agreement
1.3.2.2.2 Harmonisation
1.3.2.2.3 Risk Assessment under the SPS Agreement
1.3.2.2.4 Transparency and Notification of SPS Measures
1.3.2.3 The SPS Committee
1.3.3 PTAs and Other Arrangements
1.3.3.1 Different Approaches Within PTAs
1.3.3.2 MRAs and the Principle of Equivalence
1.4 Conclusion
CHAPTER 2 Technical Regulations and Standards: Lessons Learnt from TBT Disputes
2.1 Introduction
2.2 Lessons Learnt: Scope and Nomenclature
2.2.1 Scope
2.2.1.1 The TBT Agreement Has Retroactive Application
2.2.1.2 The TBT Agreement Does Not Apply to Private Standards
2.2.1.3 The TBT Agreement Is Unlikely to Apply to Many Import Bans
2.2.1.4 The TBT Agreement Applies to Labelling Measures
2.2.2. Nomenclature
2.2.2.1 Technical Regulations Versus Standards
2.2.2.2 International Standardization Body
2.3 Lessons Learnt: TBT Disciplines
2.3.1 Non-discrimination
2.3.2 Necessity
2.3.2.1 Technical Regulations
2.3.2.2 Conformity Assessment Procedures: Article 5.1.2
2.3.2.3 Standards
2.3.3 Harmonization
2.3.4 Transparency
2.4 Conclusion
CHAPTER 3 Product Regulations: Designing a Development-Friendly FTA - An Indian Perspective
3.1 Introduction
3.2 International Standardising Bodies and Standards
3.2.1 Background
3.2.2 Recent FTA Practice
3.2.3 The Developmental Perspective: Special Focus on India
3.3 Sectoral Annexes, Equivalence and Mutual Recognition
3.3.1 Background
3.3.2 Recent FTA Practice
3.3.3 The Developmental Perspective: Special Focus on India
3.4 Trans-Governmental Network of Regulators
3.4.1 Background
3.4.2 Recent FTA Practice
3.4.3 The Developmental Perspective: Special Focus on India
3.5 Language as a Barrier to Trade
3.5.1 Background
3.5.2 Recent FTA Practice
3.5.3 The Developmental Perspective: Special Focus on India
3.6 Conclusion
CHAPTER 4 Standards and the WTO Agreement on Import Licensing Procedures
4.1 Introduction
4.2 Overview of disciplines contained in the WTO Agreement on Import Licensing Procedures
4.3 WTO Jurisprudence on the Intersection Between Standards and the Import Licensing Agreement
4.4 Conclusion
CHAPTER 5 Standards Ecosystem and Standardization Activities in India
5.1 Introduction
5.1.1 History of Standard-Setting in India
5.1.1.1 Phase 1: 1947-1965
5.1.1.2 Phase 2: 1965-1980
5.1.1.3 Phase 3: 1980-1991
5.1.1.4 Phase 4: 1991-Present
5.1.2 Overview of India's Standards Regulatory Landscape
5.1.2.1 Policy Rationale for Standards
5.1.2.2 Regulations on Product Standards
5.2 Indian National Strategy for Standardization
5.2.1 Standards Development
5.3 Bureau of Indian Standards
5.3.1 Members of the BIS
5.3.2 Divisions of the BIS
5.3.3 Standards Formulation Process of the BIS
5.4 Standards National Action Plan
5.4.1 Actions and Measures under SNAP
5.4.2 Key Standardization Areas
5.5 Standards Developing Organizations
5.5.1 Agricultural and Processed Food Products Export Development Authority (APEDA)
5.5.2 Automotive Research Association of India (ARAI)
5.5.3 Building Materials and Technology Promotion Council (BMTPC)
5.5.4 Central Drugs Standard Control Organization (CDSCO)
5.5.5 Directorate of Marketing and Inspection (DMI)
5.5.6 Directorate of Standardization (DoS)
5.5.7 Food Safety and Standards Authority of India (FSSAI)
5.5.8 Ministry of Environment, Forest and Climate Change (MoEFCC)
5.5.9 Oil Industry Safety Directorate (OISD)
5.5.10 Petroleum and Explosives Safety Organization (PESO)
5.5.11 Telecommunication Engineering Centre (TEC)
5.6 Conclusion
CHAPTER 6 Conformity Assessment Practices and Procedures
6.1 Introduction to Conformity Assessment Procedures
6.1.1 Types of Conformity Assessment Procedures (CAPs) and Conformity Assessment Bodies (CABs)
6.1.1.1 Types of CAPs
6.1.1.1.1 Certification
6.1.1.1.2 Testing
6.1.1.1.3 Inspection
6.1.1.2 Types of CABs
6.2 WTO Disciplines
6.2.1 CAPs in International Trade
6.2.2 TBT Agreement
6.2.2.1 Definition of CAPs in the TBT Agreement
6.2.2.2 Substantive Provisions of the TBT Agreement
6.2.2.2.1 Non-discrimination
6.2.2.2.2 Unnecessary Obstacles to International Trade
6.2.2.2.3 Other Procedural Requirements
6.2.2.2.4 Harmonisation
6.2.2.2.5 Transparency and Notification Requirements
6.2.3 The SPS Agreement
6.2.3.1 Scope of Article 8 and Annex C
6.2.3.2 Undue Delay and Non-discrimination
6.2.3.3 Necessity
6.2.3.4 Other Obligations
6.3 Conformity Assessment in India
6.3.1 BIS and Conformity Assessment
6.3.1.1 Structure of BIS Conformity Assessment Activities
6.3.1.2 BIS Act, 2016
6.3.1.3 BIS Rules and Regulations
6.3.1.3.1 BIS Rules, 2018
6.3.1.3.2 BIS (Advisory Committees) Regulations, 2018
6.3.1.3.3 BIS (Conformity Assessment) Regulations, 2018
6.3.1.3.4 BIS (Hallmarking) Regulations, 2018
6.3.2 Non-BIS Scheme
6.3.2.1 S-Mark Scheme
6.4 Accreditation in India
6.4.1 Quality Council of India
6.4.2 National Accreditation Board for Testing and Calibration Laboratories
6.4.2.1 Accreditation Services Provided by NABL
6.4.2.2 Accreditation Process
6.4.3 National Accreditation Board for Certification Bodies (NABCB)
6.4.3.1 Process of Accreditation
6.4.4 National Accreditation Board for Education and Training (NABET)
6.4.4.1 Environment Division
6.4.4.2 Lean Manufacturing for MSMEs
6.4.4.3 FEED Division
6.4.5 National Accreditation Board for Hospitals and Healthcare Providers (NABH)
6.4.5.1 NABH Accreditation Programmes
6.4.5.1.1 Hospital Accreditation Programme
6.4.6 National Board for Quality Promotion (NBQP)
64.6.1 Registration Schemes under NBQP
6.5 International Cooperation
6.5.1 CASCO, International Organization for Standardization
6.5.2 International Electrotechnical Commission (IEC)
6.5.3 International Accreditation Forum (IAF)
6.5.4 Asia Pacific Accreditation Cooperation (APAC)
6.5.5 International Laboratory Accreditation Cooperation
6.6 Conclusion
CHAPTER 7 Mutual Recognition Agreements: An International and Indian Perspective
7.1 Introduction
7.2 International Perspectives on MRAs
7.3 Regulation of MRAs under WTO Law
7.3.1 Agreement on the Technical Barrier to Trade
7.3.2 Agreement on the Application of Sanitary and Phytosanitary Measures
7.3.3 General Agreement on Trade in Services
7.4 Rationale Behind Negotiating MRAs
7.5 Types of MRAs
7.5.1 On the Basis of Scope
7.5.2 On the Basis of the Parties
7.5.3 On the Basis of Covered Sectors
7.6 MRAs under Free Trade Agreements
7.7 MRAs and the Development Perspective
7.8 Indian Perspective on MRAs
7.8.1 Bureau of Indian Standards
7.8.2 National Accreditation Board of Calibration and Testing Laboratories
7.8.3 National Accreditation Board for Certification Bodies
7.8.4 Export Inspection Council of India
7.9 MRAs in India's FTAs
7.10 Conclusion
CHAPTER 8 Food Safety Ecosystem in India: A Regulator's View
8.1 Introduction
8.2 Transition to 'One Nation, One Food Law'
8.3 Organizational Structure and Functions
8.3.1 The Structure of FSSAI
8.3.2 Key Functions of FSSAI
8.3.3 FSSAI as the Sole Food Safety Regulator
8.3.3.1 Bureau of Indian Standards (BIS)
8.3.3.2 Agricultural Produce (Grading and Marking) Act, 1937
8.3.3.3 The Export Inspection Council (EIC)
8.3.3.4 Agricultural and Processed Food Products Export Development Authority (APEDA) and Marine Products Export Development Authority (MPEDA)
8.4 Development of Standards in FSSAI
8.4.1 FSSAI: Scaling Frontiers
8.5 Regulation and Enforcement of the Food Safety Standards
8.5.1 Inspections and Checks by Regulatory Officials
8.5.2 Third-Party Ecosystem
8.5.3 Self-Compliance
8.5.4 Strengthening the State Machinery
8.6 Food Testing Ecosystem
8.6.1 Primary Laboratories
8.6.2 Referral Food Laboratories (RFLs)
8.6.3 National Reference Laboratories (NRLs)
8.7 Import Compliance with Food Safety Standards
8.8 Capacity Building of Food Businesses
8.9 Eat Right India: A Novel Approach Toward Ensuring Food Safety, Health and Sustainability
8.10 Conclusion
CHAPTER 9 Understanding the SPS Regulatory Framework in the Indian Context
9.1 Introduction
9.2 The SPS Agreement: At a Glance
9.2.1 What Is Harmonization?
9.2.2 What Is 'Risk Assessment' under the SPS Agreement?
9.2.3 What Is Equivalence?
9.2.4 Requirement to Notify SPS Measures
9.3 SPS Standard-Setting and Implementation: The Indian Regulatory Landscape
9.3.1 FSSAI
9.3.1.1 How Does the FSSAI Regulate Food Imports?
9.3.1.2 What Does the NCC and the NCCP Do?
9.3.2 AGMARK
9.3.3 APEDA
9.3.4 MPEDA
9.3.5 EIC
9.3.6 BIS
9.4 Systemic Issues and Regulatory Overlaps in India's SPS Ecosystem
9.4.1 Regulatory Overlaps and Conflicts Between State and Central Agencies
9.4.2 Multiple Standard Development Organizations (SDOs)
9.4.3 Over or under Regulation in Certain Sectors
9.4.4 Lack of Accessible Information
9.4.5 Lack of Effective Utilization of Mutual Recognition Agreements ('MRAs')
9.5 Insights into Select Sectors and Issues
9.5.1 Avian Influenza and Poultry Products
9.5.2 Foot and Mouth Disease in Bovine Meat
9.5.3 Maximum Residue Limits (MRL) of Insecticides, Pesticides and Preservatives
9.5.3.1 Shrimp (Ethoxyquin)
9.5.3.2 Basmati Rice (Tricyclazole)
9.5.3.3 Banana (Imazalil)
9.5.3.4 Grape (Mancozeb)
9.6 Conclusion and Recommendations
CHAPTER 10 India's Initiatives in Addressing Food Safety: The Concerns with Maximum Residue Levels
10.1 Introduction
10.2 The History of MRL Negotiations: SPS Agreement
10.2.1 Countries Implementing Measures More Stringent Than Codex MRLs
10.2.2 Lack of International Standards
10.2.3 Private Standards
10.2.4 Technical Assistance and Special and Differential Treatment
10.3 Discussions on Maximum Residuals Limits under WTO: A Balancing Act
10.3.1 Maintaining Market Access in Agriculture and Allied Products
10.3.2 Practical Access to Plant Protection Tools: Recent Harmonisation Efforts
10.4 Global Institutions for Fixation of MRLs
10.4.1 Codex Alimentarius Commission (CAC)
10.4.2. Institutions Governing MRLs in India
10.4.2.1 Central Insecticides Board and Registration Committee (CIB-RC), Ministry of Agriculture and Farmers Welfare
10.4.2.2 FSSAI Scientific Panel on Pesticides Residue
10.4.2.3 Pesticides Management Bill, 2020
10.5 Concerns with Rising Usage of SPS-Based MRLs
10.5.1 Growing Challenge of Information Asymmetry
10.5.2 Increased Role of Private Consultancy Firms and MRLs
10.5.3 Increase in Non-transparent MRLs
10.5.4 Lower Tariffs Versus Stringent MRLs
10.5.5 Pitfalls of the Proposals on MRLs and Other Related Issues
10.6 Conclusion
CHAPTER 11 Services Standards: Trends, Gaps and Future Directions
11.1 Introduction
11.1.1 Standards Development in Services
11.1.2 The Role of International Standard-Setting Organisations
11.1.3 International Trade and Technical Standards in Services
11.2 The Development of Services Standards in India
11.2.1 Development of Services Standards by BIS
11.2.1.1 Published Standards
11.2.1.2 The BIS's Ongoing Work on Services Standardisation
11.2.1.3 Cooperation with International Agencies
11.2.2 Standards Applicable to Selected Important Services Sectors
11.2.2.1 Information Technology and Information Technology-Enabled Services
11.2.2.1.1 ISO/IEC Joint Technical Committee on Information Technology
11.2.2.1.2 Organization for the Advancement of Structured Information Standards
11.2.2.1.3 The Electronics and IT Department of the BIS
11.2.2.1.4 National Association of Software and Service Companies
11.2.2.2 Accounting and Finance Services
11.2.2.2.1 Accounting Standards
11.2.2.2.2 Auditing Standards
11.2.2.2.3 Cost Auditing Standards
11.2.2.3 Banking, Financial Services and Insurance
11.2.2.3.1 ISO Technical Committee 68
11.2.2.3.2 Financial Stability Board
11.2.2.3.3 BFSI National Regulators
11.2.2.3.4 BIS Technical Committee on Banking and Financial Services
11.2.2.3.5 Industry Organisations
11.2.2.4 Tourism and Hospitality Services
11.2.2.5 Medical Value Services
11.2.2.5.1 Accreditation Standards: Yoga and Naturopathy
11.2.3 Evolving Sectors
11.2.3.1 Telehealth Services
11.2.3.2 Environmental Services
11.2.3.3 Management and Consulting Services
11.2.3.4 Communication Services
11.2.3.5 Education Services
11.2.3.6 Legal Services
11.3 Conclusion
CHAPTER 12 Standardisation of Digital Economy: An Indian Perspective
12.1 Introduction
12.1.1 Need for Standardising the Data
12.2 Digital Standards and International Developments
12.2.1 Digital Standards
12.2.2 Data Security Standards
12.2.3 Data Privacy Standards
12.2.4 Digital Standards Issued by International Platforms/Organisations
12.2.5 Laws/Regulations of Different Countries Acting as De Facto Digital Standards
12.2.5.1 European Union
12.2.5.2 Development in Other Countries
12.3 Digital and Data Standards in India
12.3.1 Digital Standards in India
12.3.1.1 National e-Governance Plan
12.3.1.2 Institutional Mechanism for Standards Formulation
12.3.1.3 Technical Standards for Interoperability Framework
12.3.1.4 India Enterprise Architecture Framework
12.3.1.5 Metadata and Data Standards
12.3.1.6 Standards for Data Preservation
12.3.1.7 Digital Service Standards
12.3.1.8 Standard and Specifications for e-Authentication
12.3.1.9 Localisation and Language Technology Standards
12.3.2 Standards for Data Security in India
12.3.2.1 Biometrics
12.3.2.1.1 Fingerprint Image and Minutiae Data Standard for e-Governance Application in India (November 2010)
12.3.2.1.2 Face Image Data Standard for e-Governance Applications in India (November 2010)
12.3.2.1.3 Iris Image Data Standard for e-Governance Applications in India (March 2011)
12.3.2.2 Health Services and Documents
12.3.2.3 Financial Services and Documents
12.3.2.4 Mobile Applications
12.3.3 Standards for Data Privacy in India
12.3.3.1 Information Technology Act, 2000
12.3.3.2 Aadhar (Targeted Delivery of Financial and Other Subsidies, Benefits and Services Act, 2016 (Aadhar Act, 2016)
12.3.3.3 Privacy Standards: A Collation of Key Sectors in India
12.3.3.3.1 Financial Sector
12.3.3.3.2 Telecommunication Sector
12.3.3.3.3 Health Sector
12.3.3.3.4 E-Commerce Sector
12.4 Conclusion
Index
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