Standards Handbook - Chapter 5

Handbook on Product Standards and
International Trade
Global Trade Law Series
VOLUME 55
Series Editors
Prof. Ross P. Buckley, King & Wood Mallesons Professor of International Finance Law,
Faculty of Law, University of New South Wales, Sydney, Australia
Prof. Andreas R. Ziegler, Faculty of Law, Criminal Sciences, and Public Administration,
University of Lausanne, Switzerland
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The Global Trade Law Series addresses key issues in international trade law. It covers
a broad range of topics, including WTO dispute settlement, free trade agreements,
investment law and arbitration, export control, and compliance with international
trade obligations.
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The volumes published in this series are aimed at offering high-quality analytical
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2-3 new volumes published each year.
The titles published in this series are listed at the end of this volume.
Handbook on Product Standards and
International Trade
Navigating the Regulatory Landscape in India
Edited by
James J. Nedumpara
Satwik Shekhar
Akshaya Venkataraman
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Editors
James J. Nedumpara
Satwik Shekhar
Akshaya Venkataraman
v
Contributors
Arthur Appleton, JD, PhD; Partner, Appleton Luff – International Lawyers; Adjunct
Professor Johns Hopkins School of Advanced International Studies (SAIS Europe);
Principal, TCube Consulting (India).
Amandeep Kaur Bajwa, Research Fellow, Centre for Trade and Investment Law,
Email: [email protected].
Smrithi Bhasker, Research Fellows, Centre for Trade and Investment Law, Indian
Institute of Foreign Trade, New Delhi.
Aparna Bhattacharya, Senior Research Fellow, Centre for Trade and Investment Law,
New Delhi. Email: [email protected].
Ashish Chandra, Partner, International Trade/WTO Law Practice group at L&L

Partners, New Delhi. Email: [email protected].
Anupal Dasgupta, Associate, International Trade/ WTO Law Practice group at L&L
Partners, New Delhi. Email: [email protected].
Manya Gupta, Senior Research Fellow at Centre for Trade and Investment Law,
Ministry of Commerce and Industry, Government of India. Email: [email protected].
Hari Maya Gurung
Murali Kallummal
Sreelakshmi S. Kurup
Rishabha Meena, Research Fellow at Centre for Trade and Investment Law, Ministry
of Commerce and Industry, Government of India. Email: [email protected].
Trishna Menon, Senior Research Fellow, Centre for Trade and Investment Law, New
Delhi. Email: [email protected].
vii
Contributors
Shiny Pradeep
Ridhish Rajvanshi, Research Fellow, Centre for Trade and Investment Law,
[email protected].
Malvika Shetty
Shailja Singh, Legal Consultant (Associate Professor) at the Centre for WTO Studies,
New Delhi.
Rita Teaotia
Sunanda Tewari, Senior Research Fellow, Centre for Trade and Investment Law,
[email protected].
Apoorva Singh Vishnoi, Research Fellows, Centre for Trade and Investment Law,
Indian Institute of Foreign Trade, New Delhi.
viii
Summary of Contents
Editors v
Contributors vii
List of Figures xxi
List of Tables xxv
Foreword xxvii
Preface xxix
Editors’ Introduction: Handbook on Product Standard and International

Trade – Navigating the Regulatory Landscape in India
James J. Nedumpara, Satwik Shekhar & Akshaya Venkataraman 1
CHAPTER 1
Trade Regulation of Product Standards: An Overview
CHAPTER 2
Technical Regulations and Standards: Lessons Learnt from TBT Disputes
Arthur Appleton 43
CHAPTER 3
Product Regulations: Designing a Development-Friendly FTA – An Indian
Perspective
Shailja Singh 63
ix
Summary of Contents
CHAPTER 4
Standards and the WTO Agreement on Import Licensing Procedures
Aparna Bhattacharya & Trishna Menon 89
CHAPTER 5
Standards Ecosystem and Standardization Activities in India
CHAPTER 6
Conformity Assessment Practices and Procedures
Smrithi Bhasker & Apoorva Singh Vishnoi 143
CHAPTER 7
Mutual Recognition Agreements: An International and Indian Perspective
Manya Gupta & Rishabha Meena 191
CHAPTER 8
Food Safety Ecosystem in India: A Regulator’s View
Rita Teaotia 221
CHAPTER 9
Understanding the SPS Regulatory Framework in the Indian Context
Ashish Chandra & Anupal Dasgupta 249
CHAPTER 10
India’s Initiatives in Addressing Food Safety: The Concerns with
Maximum Residue Levels
Murali Kallummal, Malvika Shetty & Hari Maya Gurung 277
CHAPTER 11
Services Standards: Trends, Gaps and Future Directions
Shiny Pradeep, Trishna Menon & Sreelakshmi S. Kurup 309
CHAPTER 12
Standardisation of Digital Economy: An Indian Perspective
Sunanda Tewari, Amandeep Kaur Bajwa & Ridhish Rajvanshi 347
x
Table of Contents
Editors v
Contributors vii
List of Figures xxi
List of Tables xxv
Foreword xxvii
Preface xxix
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 9
1.2 Development and Enforcement of Standards 11
1.2.1 Types of Standards 12
1.2.2 Standard-Setting Bodies 14
1.2.3 Conformity Assessment Procedures 15
1.3 International Trade Regulation and Standards 16
1.3.1 Agreement on Technical Barriers to Trade 17
1.3.1.1 Scope of Application 17
1.3.1.2 Key Principles of the TBT Agreement 19
1.3.1.2.1 Non-discrimination 19
1.3.1.2.2 Legitimacy of Objective and Trade
Restrictiveness of the Technical Regulation 21
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Table of Contents
1.3.1.2.3 Use of International Standards 22

1.3.1.2.4 Transparency 23
1.3.1.3 The TBT Committee 25
1.3.2 Agreement on SPS Measures 25
1.3.2.1 Scope 26
1.3.2.2 Key Principles 28
1.3.2.2.1 Basic Rights and Obligations under the SPS
Agreement 28
1.3.2.2.2 Harmonisation 29
1.3.2.2.3 Risk Assessment under the SPS Agreement 34
1.3.2.2.4 Transparency and Notification of SPS
Measures 37
1.3.2.3 The SPS Committee 37
1.3.3 PTAs and Other Arrangements 38
1.3.3.1 Different Approaches Within PTAs 38
1.3.3.2 MRAs and the Principle of Equivalence 40
1.4 Conclusion 42
CHAPTER 2
Technical Regulations and Standards: Lessons Learnt from TBT Disputes
Arthur Appleton 43
2.1 Introduction 43
2.2 Lessons Learnt: Scope and Nomenclature 45
2.2.1 Scope 46
2.2.1.1 The TBT Agreement Has Retroactive Application 46
2.2.1.2 The TBT Agreement Does Not Apply to Private
Standards 46
2.2.1.3 The TBT Agreement Is Unlikely to Apply to Many
Import Bans 46
2.2.1.4 The TBT Agreement Applies to Labelling Measures 49
2.2.2 Nomenclature 50
2.2.2.1 Technical Regulations Versus Standards 50
2.2.2.2 International Standardization Body 51
2.3 Lessons Learnt: TBT Disciplines 51
2.3.1 Non-discrimination 51
2.3.2 Necessity 54
2.3.2.1 Technical Regulations 56
2.3.2.2 Conformity Assessment Procedures: Article 5.1.2 57
2.3.2.3 Standards 58
2.3.3 Harmonization 58
2.3.4 Transparency 59
2.4 Conclusion 59
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Table of Contents
CHAPTER 3
Product Regulations: Designing a Development-Friendly FTA – An Indian
Perspective
Shailja Singh 63
3.1 Introduction 64
3.2 International Standardising Bodies and Standards 65
3.2.1 Background 65
3.2.2 Recent FTA Practice 66
3.2.3 The Developmental Perspective: Special Focus on India 68
3.3 Sectoral Annexes, Equivalence and Mutual Recognition 74
3.3.1 Background 74
3.4 Trans-Governmental Network of Regulators 81
3.4.1 Background 81
3.5 Language as a Barrier to Trade 84
3.5.1 Background 84
3.6 Conclusion 87
CHAPTER 4
Standards and the WTO Agreement on Import Licensing Procedures
Aparna Bhattacharya & Trishna Menon 89
4.1 Introduction 89
4.2 Overview of disciplines contained in the WTO Agreement on Import
Licensing Procedures 90
4.3 WTO Jurisprudence on the Intersection Between Standards and the
Import Licensing Agreement 93
4.4 Conclusion 97
CHAPTER 5
Standards Ecosystem and Standardization Activities in India
5.1 Introduction 100
5.1.1 History of Standard-Setting in India 101
5.1.1.1 Phase 1: 1947-1965 102
5.1.1.2 Phase 2: 1965-1980 103
5.1.1.3 Phase 3: 1980-1991 103
5.1.1.4 Phase 4: 1991-Present 104
5.1.2 Overview of India’s Standards Regulatory Landscape 108
5.1.2.1 Policy Rationale for Standards 110
5.1.2.2 Regulations on Product Standards 111
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5.2 Indian National Strategy for Standardization 112

5.2.1 Standards Development 113
5.3 Bureau of Indian Standards 115
5.3.1 Members of BIS 115
5.3.2 Divisions of BIS 116
5.3.3 Standards Formulation Process of BIS 117
5.4 Standards National Action Plan 119
5.4.1 Actions and Measures under SNAP 121
5.4.2 Key Standardization Areas 123
5.5 Standards Developing Organizations 124
5.5.1 Agricultural and Processed Food Products Export Development
Authority (APEDA) 125
5.5.2 Automotive Research Association of India (ARAI) 127
5.5.3 Building Materials and Technology Promotion Council (BMTPC) 127
5.5.4 Central Drugs Standard Control Organization (CDSCO) 128
5.5.5 Directorate of Marketing and Inspection (DMI) 129
5.5.6 Directorate of Standardization (DoS) 129
5.5.7 Food Safety and Standards Authority of India (FSSAI) 131
5.5.8 Ministry of Environment, Forest and Climate Change (MoEFCC) 133
5.5.9 Oil Industry Safety Directorate (OISD) 136
5.5.10 Petroleum and Explosives Safety Organization (PESO) 137
5.5.11 Telecommunication Engineering Centre (TEC) 138
5.6 Conclusion 139
CHAPTER 6
Conformity Assessment Practices and Procedures
Smrithi Bhasker & Apoorva Singh Vishnoi 143
6.1 Introduction to Conformity Assessment Procedures 144
6.1.1 Types of Conformity Assessment Procedures and Conformity
Assessment Bodies 146
6.1.1.1 Types of CAPs 146
6.1.1.1.1 Certification 147
6.1.1.1.2 Testing 147
6.1.1.1.3 Inspection 147
6.1.1.2 Types of CABs 148
6.2 WTO Disciplines 148
6.2.1 CAPs in International Trade 148
6.2.2 TBT Agreement 149
6.2.2.1 Definition of CAPs in the TBT Agreement 149
6.2.2.2 Substantive Provisions of the TBT Agreement 150
6.2.2.2.1 Non-discrimination 151
6.2.2.2.2 Unnecessary Obstacles to International
Trade 153
6.2.2.2.3 Other Procedural Requirements 154
6.2.2.2.4 Harmonisation 155
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Table of Contents
6.2.2.2.5 Transparency and Notification

Requirements 156
6.2.3 The SPS Agreement 156
6.2.3.1 Scope of Article 8 and Annex C 157
6.2.3.2 Undue Delay and Non-discrimination 158
6.2.3.3 Necessity 159
6.2.3.4 Other Obligations 159
6.3 Conformity Assessment in India 159
6.3.1 BIS and Conformity Assessment 159
6.3.1.1 Structure of BIS Conformity Assessment Activities 160
6.3.1.2 BIS Act, 2016 161
6.3.1.3 BIS Rules and Regulations 162
6.3.1.3.1 BIS Rules, 2018 162
6.3.1.3.2 BIS (Advisory Committees) Regulations,
2018 163
6.3.1.3.3 BIS (Conformity Assessment) Regulations,
2018 163
6.3.1.3.4 BIS (Hallmarking) Regulations, 2018 166
6.3.2 Non-BIS Scheme 168
6.3.2.1 S-Mark Scheme 168
6.4 Accreditation in India 169
6.4.1 Quality Council of India 170
6.4.2 National Accreditation Board for Testing and Calibration
Laboratories 172
6.4.2.1 Accreditation Services Provided by NABL 173
6.4.2.2 Accreditation Process 173
6.4.3 National Accreditation Board for Certification Bodies (NABCB) 174
6.4.3.1 Process of Accreditation 177
6.4.4 National Accreditation Board for Education and Training
(NABET) 178
6.4.4.1 Environment Division 178
6.4.4.2 Lean Manufacturing for MSMEs 179
6.4.4.3 FEED Division 179
6.4.5 National Accreditation Board for Hospitals and Healthcare
Providers (NABH) 180
6.4.5.1 NABH Accreditation Programmes 180
6.4.5.1.1 Hospital Accreditation Programme 180
6.4.6 National Board for Quality Promotion (NBQP) 181
6.4.6.1 Registration Schemes under NBQP 182
6.5 International Cooperation 183
6.5.1 CASCO, International Organization for Standardization 184
6.5.2 International Electrotechnical Commission (IEC) 185
6.5.3 International Accreditation Forum (IAF) 185
6.5.4 Asia Pacific Accreditation Cooperation (APAC) 186
6.5.5 International Laboratory Accreditation Cooperation 187
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Table of Contents
6.6 Conclusion 188
CHAPTER 7
Mutual Recognition Agreements: An International and Indian Perspective
Manya Gupta & Rishabha Meena 191
7.2 International Perspectives on MRAs 194
7.3 Regulation of MRAs under WTO Law 196
7.3.1 Agreement on the Technical Barrier to Trade 196
7.3.2 Agreement on the Application of Sanitary and Phytosanitary
Measures 197
7.3.3 General Agreement on Trade in Services 198
7.4 Rationale Behind Negotiating MRAs 199
7.5 Types of MRAs 200
7.5.1 On the Basis of Scope 200
7.5.2 On the Basis of the Parties 202
7.5.3 On the Basis of Covered Sectors 202
7.6 MRAs under Free Trade Agreements 203
7.7 MRAs and the Development Perspective 206
7.8 Indian Perspective on MRAs 207
7.8.1 Bureau of Indian Standards 207
7.8.2 National Accreditation Board of Calibration and Testing
Laboratories 208
7.8.3 National Accreditation Board for Certification Bodies 210
7.8.4 Export Inspection Council of India 211
7.9 MRAs in India’s FTAs 216
7.10 Conclusion 218
CHAPTER 8
Food Safety Ecosystem in India: A Regulator’s View
Rita Teaotia 221
8.2 Transition to ‘One Nation, One Food Law’ 223
8.3 Organizational Structure and Functions 225
8.3.1 The Structure of FSSAI 225
8.3.2 Key Functions of FSSAI 226
8.3.3 FSSAI as the Sole Food Safety Regulator 228
8.3.3.1 Bureau of Indian Standards (BIS) 228
8.3.3.2 Agricultural Produce (Grading and Marking) Act, 1937 229
8.3.3.3 The Export Inspection Council (EIC) 230
8.3.3.4 Agricultural and Processed Food Products Export
Development Authority (APEDA) and Marine Products
Export Development Authority (MPEDA) 230
8.4 Development of Standards in FSSAI 230
8.4.1 FSSAI: Scaling Frontiers 234
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Table of Contents
8.5 Regulation and Enforcement of the Food Safety Standards 235

8.5.1 Inspections and Checks by Regulatory Officials 237
8.5.2 Third-Party Ecosystem 238
8.5.3 Self-Compliance 239
8.5.4 Strengthening the State Machinery 241
8.6 Food Testing Ecosystem 241
8.6.1 Primary Laboratories 241
8.6.2 Referral Food Laboratories (RFLs) 242
8.6.3 National Reference Laboratories (NRLs) 242
8.7 Import Compliance with Food Safety Standards 243
8.8 Capacity Building of Food Businesses 244
8.9 Eat Right India: A Novel Approach Toward Ensuring Food Safety, Health
and Sustainability 245
8.10 Conclusion 247
CHAPTER 9
Understanding the SPS Regulatory Framework in the Indian Context
Ashish Chandra & Anupal Dasgupta 249
9.2 The SPS Agreement: At a Glance 252
9.2.1 What Is Harmonization? 253
9.2.2 What Is ‘Risk Assessment’ under the SPS Agreement? 254
2.3 What Is Equivalence? 255
9.2.4 Requirement to Notify SPS Measures 255
9.3 SPS Standard-Setting and Implementation: The Indian Regulatory
Landscape 255
9.3.1 FSSAI 256
9.3.1.1 How Does the FSSAI Regulate Food Imports? 257
9.3.1.2 What Does the NCC and the NCCP Do? 259
9.3.2 AGMARK 260
9.3.3 APEDA 260
9.3.4 MPEDA 262
9.3.5 EIC 263
9.3.6 BIS 264
9.4 Systemic Issues and Regulatory Overlaps in India’s SPS Ecosystem 264
9.4.1 Regulatory Overlaps and Conflicts Between State and Central
Agencies 265
9.4.2 Multiple Standard Development Organizations (SDOs) 265
9.4.3 Over or under Regulation in Certain Sectors 266
9.4.4 Lack of Accessible Information 266
9.4.5 Lack of Effective Utilization of Mutual Recognition Agreements
(‘MRAs’) 267
9.5 Insights into Select Sectors and Issues 267
9.5.1 Avian Influenza and Poultry Products 268
9.5.2 Foot and Mouth Disease in Bovine Meat 269
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Table of Contents
9.5.3 Maximum Residue Limits (MRL) of Insecticides, Pesticides and

Preservatives 271
9.5.3.1 Shrimp (Ethoxyquin) 272
9.5.3.2 Basmati Rice (Tricyclazole) 273
9.5.3.3 Banana (Imazalil) 273
9.5.3.4 Grape (Mancozeb) 273
9.6 Conclusion and Recommendations 274
CHAPTER 10
India’s Initiatives in Addressing Food Safety: The Concerns with
Maximum Residue Levels
Murali Kallummal, Malvika Shetty & Hari Maya Gurung 277
10.2 The History of MRL Negotiations: SPS Agreement 280
10.2.1 Countries Implementing Measures More Stringent Than Codex
MRLs 280
10.2.2 Lack of International Standards 282
10.2.3 Private Standards 283
10.2.4 Technical Assistance and Special and Differential Treatment 283
10.3 Discussions on Maximum Residuals Limits under WTO: A Balancing Act 284
10.3.1 Maintaining Market Access in Agriculture and Allied Products 284
10.3.2 Practical Access to Plant Protection Tools: Recent Harmonisation
Efforts 285
10.4 Global Institutions for Fixation of MRLs 287
10.4.1 Codex Alimentarius Commission (CAC) 287
10.4.2 Institutions Governing MRLs in India 289
10.4.2.1 Central Insecticides Board and Registration Committee
(CIB-RC), Ministry of Agriculture and Farmers Welfare 289
10.4.2.2 FSSAI Scientific Panel on Pesticides Residue 289
10.4.2.3 Pesticides Management Bill, 2020 290
10.5 Concerns with Rising Usage of SPS-Based MRLs 290
10.5.1 Growing Challenge of Information Asymmetry 292
10.5.2 Increased Role of Private Consultancy Firms and MRLs 293
10.5.3 Increase in Non-transparent MRLs 295
10.5.4 Lower Tariffs Versus Stringent MRLs 297
10.5.5 Pitfalls of the Proposals on MRLs and Other Related Issues 300
10.6 Conclusion 301
CHAPTER 11
Services Standards: Trends, Gaps and Future Directions
Shiny Pradeep, Trishna Menon & Sreelakshmi S. Kurup 309
11.1.1 Standards Development in Services 311
11.1.2 The Role of International Standard-Setting Organisations 311
11.1.3 International Trade and Technical Standards in Services 312
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Table of Contents
11.2 The Development of Services Standards in India 314

11.2.1 Development of Services Standards by BIS 314
11.2.1.1 Published Standards 315
11.2.1.2 The BIS’s Ongoing Work on Services Standardisation 316
11.2.1.3 Cooperation with International Agencies 317
11.2.2 Standards Applicable to Selected Important Services Sectors 318
11.2.2.1 Information Technology and Information
Technology-Enabled Services 318
11.2.2.1.1 ISO/IEC Joint Technical Committee on
Information Technology 318
11.2.2.1.2 Organization for the Advancement of
Structured Information Standards 320
11.2.2.1.3 The Electronics and IT Department of the
BIS 321
11.2.2.1.4 National Association of Software and
Service Companies 321
11.2.2.2 Accounting and Finance Services 322
11.2.2.2.1 Accounting Standards 322
11.2.2.2.2 Auditing Standards 324
11.2.2.2.3 Cost Auditing Standards 326
11.2.2.3 Banking, Financial Services and Insurance 328
11.2.2.3.1 ISO Technical Committee 68 328
11.2.2.3.2 Financial Stability Board 329
11.2.2.3.3 BFSI National Regulators 330
11.2.2.3.4 BIS Technical Committee on Banking and
Financial Services 330
11.2.2.3.5 Industry Organisations 331
11.2.2.4 Tourism and Hospitality Services 332
11.2.2.5 Medical Value Services 334
11.2.2.5.1 Accreditation Standards: Yoga and
Naturopathy 336
11.2.3 Evolving Sectors 336
11.2.3.1 Telehealth Services 337
11.2.3.2 Environmental Services 338
11.2.3.3 Management and Consulting Services 339
11.2.3.4 Communication Services 340
11.2.3.5 Education Services 342
11.2.3.6 Legal Services 344
11.3 Conclusion 345
CHAPTER 12
Standardisation of Digital Economy: An Indian Perspective
Sunanda Tewari, Amandeep Kaur Bajwa & Ridhish Rajvanshi 347
12.1.1 Need for Standardising the Data 349
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Table of Contents
12.2 Digital Standards and International Developments 350

12.2.1 Digital Standards 350
12.2.2 Data Security Standards 351
12.2.3 Data Privacy Standards 351
12.2.4 Digital Standards Issued by International
Platforms/Organisations 352
12.2.5 Laws/Regulations of Different Countries Acting as De Facto
Digital Standards 354
12.2.5.1 European Union 354
12.2.5.2 Development in Other Countries 356
12.3 Digital and Data Standards in India 362
12.3.1 Digital Standards in India 363
12.3.1.1 National e-Governance Plan 363
12.3.1.2 Institutional Mechanism for Standards Formulation 364
12.3.1.3 Technical Standards for Interoperability Framework 365
12.3.1.4 India Enterprise Architecture Framework 366
12.3.1.5 Metadata and Data Standards 367
12.3.1.6 Standards for Data Preservation 367
12.3.1.7 Digital Service Standards 368
12.3.1.8 Standard and Specifications for e-Authentication 369
12.3.1.9 Localisation and Language Technology Standards 370
12.3.2 Standards for Data Security in India 371
12.3.2.1 Biometrics 372
12.3.2.1.1 Fingerprint Image and Minutiae Data
Standard for e-Governance Application in
India (November 2010) 372
12.3.2.1.2 Face Image Data Standard for
e-Governance Applications in India
(November 2010) 373
12.3.2.1.3 Iris Image Data Standard for e-Governance
Applications in India (March 2011) 373
12.3.2.2 Health Services and Documents 373
12.3.2.3 Financial Services and Documents 374
12.3.2.4 Mobile Applications 375
12.3.3 Standards for Data Privacy in India 376
12.3.3.1 Information Technology Act, 2002 (ITA, 2008) 377
12.3.3.2 Aadhar (Targeted Delivery of Financial and Other
Subsidies, Benefits and Services Act, 2016 (Aadhar
Act, 2016) 377
12.3.3.3 Privacy Standards: A Collation of Key Sectors in India 378
12.3.3.3.1 Financial Sector 378
12.3.3.3.2 Telecommunication Sector 380
12.3.3.3.3 Health Sector 380
12.3.3.3.4 E-Commerce Sector 381
12.4 Conclusion 382
xx
List of Figures
Figure 1.1 Types of Standards as per OECD

Figure 1.2 Types of Standards as per CEN
Figure 1.3 Conformity Assessment Procedures
Figure 1.4 Difference Between Technical Regulations, Standards and
Conformity Assessment Procedures
Figure 1.5 Snapshot of the TBT IMS
Figure 1.6 Elements for Determining Scope of the SPS Agreement
Figure 1.7 Key elements under Article 2 of the SPS Agreement
Figure 1.8 Comparison of the Harmonisation Choices
Figure 1.9 Factors Relevant to the Assessment of $isks
Figure 1.10 Rules on Risk Assessment under the SPS Agreement
Figure 1.11 Snapshot of SPS IMS
Figure 3.1 Select Country Participation at the ISO Technical Committee*
Figure 3.2 Number of Active Secretariats Held by Select ISO Member
Bodies
Figure 5.1 Snapshot of Some of the Standard-Setting, Conformity Assess-
ment and Accreditation Bodies in India
Figure 5.2 Goals under the ‘Standards Development’ Pillar of the INSS
Figure 5.3 Process of Standard Formulation by BIS
Figure 5.4 Objectives of Standards National Action Plan
Figure 6.1 Overview of TBT Provisions on CAPS
Figure 6.2 Article 5.1.2. Analysis by the AB
Figure 6.3 Hierarchy of CAP Activities of BIS
Figure 6.4 BIS Standard Mark
Figure 6.5 BIS Registration Mark
xxi
List of Figures
Figure 6.6 BIS Standard Mark for Management System

Figure 6.7 BIS Mark
Figure 6.8 Process of Receiving Safety Inspection Certification
Figure 6.9 Objectives of QCI
Figure 6.10 Constituent Boards of QCI
Figure 6.11 Types of CABs and the Relevant International Standards for
Conformity Assessment
Figure 6.12 Procedure for NABL Accreditation
Figure 6.13 Process of Accreditation of CAB by NABCB
Figure 6.14 Verticals of NABET
Figure 7.1 Traditional and Enhanced MRAs
Figure 7.2 Examples of Different Types of Recognition Provisions Used in
FTAs
Figure 8.1 Acts and Orders Repealed by FSS Act
Figure 8.2 Structure for Standards and Enforcement
Figure 8.3 Food Safety Enforcement Machinery in the State
Figure 8.4 Procedure for Development of Food Safety Standards
Figure 8.5 List of Horizontal and Vertical Scientific Panels under FSSAI
Figure 8.6 Scientific Work at FSSAI
Figure 8.7 Status of FSSAI License/Registration (as on 30.06. 2021)
Figure 8.8 Hygiene Rating Logo, FSSAI
Figure 8.9 Trans Feet Free Logo, FSSAI
Figure 8.10 Status of Food Testing Ecosystem Developed by FSSAI
Figure 8.11 Eat Right India Initiative on Demand Side, Supply Side, and
Sustainability Initiatives
Figure 8.12 Eat Right India Scorecard (as on 31 January 2021)
Figure 9.1 Risk Assessment Criteria under the SPS Agreement]
Figure 9.2 USFDA Data on Indian Shipment Rejections]
Figure 10.1 Global Agricultural Trade Balance (Income Category-Wise) –
USD Bn
Figure 10.2 European Union’s Thirty-Three Thousand MRLs and Codex
(2015)
Figure 10.3 United States Thirty-Nine Thousand MRLs and Codex (2019)
Figure 10.4 Thirty-Five Agricultural Products and the EU Market Access
Bound and MRL Stringencies
Figure 10.5 Yearly EU’s MRL Directives
Figure 10.6 Agricultural and Allied Products and MRLs at the Level of De-
tection (LOD)
xxii
List of Figures
Figure 10.7 Thirty-Five Agricultural Products and the US Market Access

Bound and MRL Stringencies
Figure 11.1 The JTC 1’s Scope of Standards Development
Figure 11.2 The Areas of Work of the Sub-committee JTC 1/SC 40
Figure 11.3 The ASB’s Standard-Setting Process
Figure 11.4 Objectives of the AASB
Figure 11.5 The CASB’s Standard-Setting Process for Cost Accounting
Standards
Figure 11.6 Objectives of the FSB
Figure 12.1 Digital Standards Issued by ISO
Figure 12.2 Data Standards Covered under GDPR
Figure 12.3 Laws Governing Data Privacy in US
Figure 12.4 Requirements under China’s Cybersecurity Law and Stan-
dards
Figure 12.5 Regulations and Ordinance in Brazil Governing Data Privacy
Figure 12.6 Key Features of South Africa’s Data Privacy Laws
Figure 12.7 Institutional Mechanism for Standard Formulation by National
e-Governance Standards Division
xxiii
List of Tables
Table 1.1 Notification and Publication Requirements under the TBT Agreement
Table 1.2 Table of PTA Provisions and Their Approach to Regulating Standards
Table 3.1 Recent FTAs Referencing the TBT Committee Decision
Table 3.2 Recent FTAs Mentioning Specific ISBs
Table 3.3 Participation of ISO Members in Technical Committees (TCs)
Table 3.4 Select Indian FTAs and Approach Toward/ ‘International Standards’
Table 3.5 Recent FTAs and Sectoral Annexes
Table 3.6 Select Indian FTAs and Their Approach Towards Sectoral Annexes
Table 3.7 Recent FTAs Referring to the Trans-Governmental Regulatory Net-
works for SPS/TBT
Table 3.8 Select Indian FTAs and the Language Requirements Therein
Table 5.1 The Four Phases in Evolution of Standards Ecosystem in India
Table 5.2 Number of Notifications by India Before the WTO TBT Committee
Table 5.3 Number of Notifications by India Before the WTO SPS Committee
Table 5.4 Key Activities Undertaken by BIS
Table 5.5 Sectors in Which BIS Engages in Formulation of Indian Standards
Table 5.6 Actions and Measures under SNAP
Table 5.7 ‘Priority’ Subject Areas for Standardization under SNAP
Table 5.8 Rules under Explosives Act, 1884 and Petroleum Act, 1934
Table 6.1 Difference between CAP and Accreditation
Table 6.2 Classification of CAPs
Table 6.3 Overview of Key Provisions of Article 5.2
Table 6.4 NABCB Accreditation Schemes
Table 6.5 Examples of CAPs Related Standards Developed by CASCO
xxv
List of Tables
Table 8.1 India’s Food Standards Scorecard

Table 10.1 Introduction of New MRL Notifications by Region – 2013 to 2020
Table 10.2 Agricultural Products with Level of Detection (LOD) MRLs
Table 11.1 Published Services Standards
Table 11.2 Key Standardisation Areas in Services
Table 11.3 Kinds of Banking, Financial and Insurance Services
Table 11.4 Regulators of NBFEs in India
Table 11.5 Recently Published Standards by TSDSI
xxvi
CHAPTER 5
Standards Ecosystem and Standardization
Activities in India
James J. Nedumpara, Satwik Shekhar & Akshaya Venkataraman
The process of standard-setting in India involves a complex mesh of multiple

bodies/entities (governmental as well as non-governmental) which operate
individually as well as jointly in formulating and implementing standards in
the country. Agencies such as the Bureau of Indian Standards (BIS), Food
Safety and Standards Authority of India (FSSAI), Research Design and
Standards Organisation (RDSO), the Telecommunication Engineering Centre
of India, the Central Drugs Standard Control Organisation, the Petroleum and
Explosives Safety Organisation, Agricultural and Processed Food Products
Export Development Authority, etc., are examples of such bodies that set
standards in specialized products and sectors and fields in India. Since 2014,
India has undertaken a targeted exercise to modernize and harmonize its
standard-setting activities and the revamped BIS Act 2016 was the first major
milestone in this process. With the adoption of the Indian National Strategy
for Standardization (INSS), India’s systems and institutions for standards
and standardization are increasingly aligned with international best prac-
tices. This chapter recounts the evolution of the new regulatory landscape, and
the various strategies and initiatives that the governments (both at the central
and state) have adopted to streamline and build India’s standardization
activities. The chapter proceeds to lay out the broad contours and structures of
the legal regime governing and implementing standards in India. This chapter
is intended to serve as the context within which the specific issues discussed in
the following chapters can be understood.
99
5.1 INTRODUCTION
As the Indian economy continues to grow, the demand for safe and high-quality
products and services has increased, with consumer preference being primarily driven
by performance, quality and reliability of products. To ensure that India becomes a hub
for the global manufacturing industry, the safety of consumers and workers has
become increasingly relevant. India has committed itself to the sustainable develop-
ment goals (SDGs) and is on a path toward meeting its targets by protecting its
environment, flora and fauna, natural resources and wildlife.
Standards are tools to achieve these goals while also facilitating business
interactions. They enable companies to comply with relevant laws and regulations,
accelerate the introduction of innovative products in the market and provide interop-
erability between new and existing products, services and processes. The World Trade
Organization (WTO) Secretariat noted in its report as part of 7th Trade Policy Review
of India that as of March 2018 there were 19,294 Indian standards, 27.3% of which
were harmonized with international standards.1 WTO Members recognize the need to
develop a harmonized, effective, dynamic and robust standards framework. India too
has realized the importance of developing a well-functioning regime for administering
standards and conformity assessment procedures. Since 2018, there has been a further
push toward creating, harmonizing and consolidating Indian standards through policy
proposals such as the Indian National Strategy for Standardization (INSS) and the
Standards National Action Plan (SNAP). While countries may adopt different types of
standards, increasing globalization and closer economic ties underline the need to
harmonize these standards and thereby reduce the barriers to international trade.
India’s standards landscape currently, however, is a complex mesh of multiple bodies
and entities (governmental as well as non-governmental) which operate individually
as well as jointly.
The purpose of this chapter is to provide an overview of this landscape and lay
out how different standard-setting bodies with similar roles, overlapping scope of
functions and driven by the same essential public policy motivations come together to
cohesively create quality standards for the Indian economy. This chapter first looks at
a historical evolution of standards in India to understand how this multi-agency
process of standard-setting came into being. A review of this history also provides
valuable insights into the policy rationales that drive the multitude of laws and
regulations governing standards in India. Thereafter, the chapter examines the INSS to
understand the Indian Government’s approach toward standardization and standard-
setting. The remaining sections of this chapter trace the functions of the foundational
pillars of the process of standard-setting in India – the entities and organizations that
develop standards. By identifying the structure and functions of these entities, this
chapter hopes to provide the reader with a clearer picture of how to navigate the Indian
regulatory landscape for product standards.
1. Report by the Secretariat, Trade Policy Review of India, WT/TPR/S/403, 25 November 2020.
100
Chapter 5: Standards Ecosystem and Standardization Activities in India
5.1.1 History of Standard-Setting in India
By the time India joined the WTO, nearly 3,500 Indian standards had already been
harmonized with international standards (ISOTEC and EC standards or regulations).
This development of standards ecosystem in the 1990s occurred through several
phases of Indian economic history. What is now considered an ‘Indian Standard’,2 is
the result of several changes in regulatory framework and progressive integration with
the world economy. The creation of standards began through the Institutions of
Engineers which created the first draft of a constitution for a formal entity with a
responsibility to set up standards at a national level.3 This led to the creation of Indian
Standards Institution (ISI) in 1947. To provide the advantages of standardization to
common consumers, the ISI started operating the Certification Marks Scheme under
the Indian Standards Institution (Certification Marks) Act, 1952. Under this Scheme, ISI
granted licences to manufacturers who produced goods in conformity with Indian
Standards and applied the ‘ISI Mark’ on their products. Despite the certification process
being undertaken by ISI under the Scheme, ISI’s process of standard-setting and other
relevant processes on creation of standards remained unregulated. On 26 November
1986, a bill was brought in the Indian Parliament to create an organization, namely, the
Bureau of Indian Standards (BIS) to achieve the above objectives.4 Since then, the BIS
has operated as India’s national standards body which creates, recognizes, and adopts
product standards that are applied at the national level. With the promulgation of a
new BIS Act in 2016, BIS was recognized as the National Standards Body and its
functions expanded. The structure, powers, functions, and standardization process of
BIS, and its role within India’s standards ecosystem are covered under section 5.3 of
this chapter.
India’s standards ecosystem that developed gradually since India’s independence
in 1947 can be broadly classified under four economic phases.5 A study of this
historical evolution provides key insights into the existing regulatory landscape on
standards. In particular, this changing approach to standardization, as witnessed
through India’s economic history, provides necessary context to the decentralized
2. Section 2(17), Bureau of Indian Standards Act, 2016 defines ‘Indian Standards’ as: the standard
including any tentative or provisional standard established and published by the Bureau, in
relation to any goods, article, process, system or service, indicative of the quality and specifica-
tion of such goods, article, process, system or service and includes –
(i) any standard adopted by the Bureau under sub-section (2) of section 10; and any
standard established and published, or recognized, by the Bureau of Indian Standards
which was in force immediately before the commencement of this Act.
3. Origin of BIS, Bureau of Indian Standards, https://bis.gov.in/index.php/the-bureau/origin-of-

bis/ (last visited 14 October 2020).
4. Id.
5. Indo-German Working Group on Quality Infrastructure, Overview of India’s Quality Infrastructure
– A Guide to Standardisation, Conformity Assessment, Accreditation, Market Surveillance, and
Metrology, Knowledge Series 1, 14 (2018), https://www.gpqi.org/preview_studies/overview-of
-india-s-qualityinfrastructure.html?file=files/upload/india/documents/2018-12_Overview%20
of%20the%20Indian%20Quality%20Infrastructure_GPQI-India.pdf [hereinafter Overview of In-
dia’s Quality Infrastructure].
101
system of standard-setting prevalent in India and how that is now being harmonized
under umbrella policy frameworks.
Table 5.1 presents the economic phases and the key developments in the
standards ecosystem.
Table 5.1 The Four Phases in Evolution of Standards Ecosystem in India
Economic Phase Key Developments in Standards Ecosystem

1947-1965 State-owned institutions established to cater
Phase 1: Establishment of to standards development, metrology, testing,
institutions and legal frameworks export quality, essential technical regulations
enacted.
1965-1980 Spread of government supported product
Phase 2: Era of licensing and low certification, setting standards in food and
economic growth agriculture.
1980-1991 Introduction of global standards through
Phase 3: Partial liberalization and automotive tie-ups, adoption of quality
decontrol management systems by industry.
1991-present Setting up of national accreditation boards,
Phase 4: Institutional reforms and setting up operations by foreign certification
integration into the world bodies, increase in technical regulations.
economy
Source: Indo-German Working Group on Quality Infrastructure. Overview of India’s Quality Infra-
structure, Knowledge Series 1 (New Delhi: Deutsche Gesellschaft für Internationale Zusammenarbeit
(GIZ) GmbH, 2018).
5.1.1.1 Phase 1: 1947-1965
The first phase of evolution of standards ecosystem coincided with the creation of a
strong public sector, especially in iron and steel, capital goods and heavy industry, and
basic physical infrastructure sectors. The creation of the ISI was swiftly followed by the
establishment of the National Physical Laboratory (NPL) in 1950 as India’s National
Metrology Institute.6 NPL, which continues to be one of the ‘premiere research labs in
the field of physical sciences in India’ as CSIR-NPL, was responsible at that time for the
‘realization, establishment, upgradation, maintenance and dissemination of standards
at par to international level through R&D and latest technology.’7 NPL aided the
development of a testing infrastructure across sectors. One of India’s earliest technical
regulations, the Prevention of Food Adulteration Act was enacted in 1954 and is now
subsumed within the Food Safety and Standards Act, 2006. In 1956, India passed the
6. Id. at 14.
7. National Metrology, CSIR-National Physical Laboratory, https://www.nplindia.in/national-
metrology (last visited 19 December 2020).
102
Standards of Weights and Measures Act, which incrementally introduced the metric
system, making metric weights and measures mandatory in the country.8
5.1.1.2 Phase 2: 1965-1980
During the second phase of economic growth, the government took greater control of
industrial activities through tools like licensing of private enterprises. This era of
government control on private industries, often termed the ‘license raj’, required
private enterprises to obtain licenses and permits for almost all industrial activities,
including starting new businesses, expanding existing businesses, producing now
products, expanding production capacity, etc. State-owned institutions such as the ISI
and NPL operated within a controlled environment, leading to developmental stagna-
tion in the standardization ecosystem.9 The abovementioned Certification Mark
Scheme (‘ISI Mark’) is regarded as the only noteworthy progress of this phase. Another
significant development was the creation of a ‘food and agriculture division’ at ISI to
facilitate growth in the agriculture sector through standardization of equipment,
machinery, and processed foods. This complimented the growth in agriculture sector
which was backed by the ‘Green Revolution’ of the late 1960s.
5.1.1.3 Phase 3: 1980-1991
Reforms in the direction of liberalization by relaxing government control over indus-

trial activities began during the third phase. Foreign investments, primarily from Japan
in the automobile sector saw technical collaborations with their Indian counterparts.
The advent of technology and expansion of telecommunications sectors steered the
introduction of high standards in automotive and telecommunication industries, two
major sectors of the economy.10 The creation of the BIS in 1986 marked the advent of
a more centralized mechanism for standard-setting. Through this Act, the Indian
government laid a robust legal framework regulating standards development and
product certification.11 A key objective was to enable the adoption of international
standards and promote certification. The growth of the automotive and engineering
sectors, coupled with the development of the ISO 9001 series12 of standards influenced
the introduction of overseas conformity assessment bodies and launch of certifications
beyond product certification.13
8. Overview of India’s Quality Infrastructure, supra note 5, at 14.

9. Id., at 15.
10. Id.
11. Id.
12. First introduced in 1987 by the International Standards Organization and subsequently updated
in 2015.
13. Id.
103
5.1.1.4 Phase 4: 1991-Present
In the year 1991, India initiated its major macroeconomic reforms, opening the
economy to trade and foreign direct investment. India’s economic reforms were in line
with the mantra of ‘liberalization, privatization and globalization’ which signalled
India’s broad acceptance of neo-liberal economic policies and its slow integration with
the global markets. Important policies were introduced which led to relaxation of the
licensing requirements, reduced regulation of foreign investment and technology
importation, and introduction of floating exchange rates.14 India’s Information Tech-
nology (IT) sector developed at a fast pace and India became an important player in the
global economy. India also became a powerhouse in providing various categories of
skilled services, especially IT services.
This phase saw an accelerated push toward creation of a robust standards
regulatory regime primarily since India became more engaged in the global trading
network. The introduction of the ‘Compulsory Registration Scheme (CRS) for Elec-
tronic and IT Products’ in 2012 is believed to be a ‘turning point’ in the use of technical
regulations in India.15 The scheme regulates products such as video games, wireless
keyboards, mobile phones and laptops.16 In addition to the advent of electronic and IT
products, the increase in importance of steel, specifically in the defence sector led to a
sudden rise in formulation of standards for these products since 2012.17 One of the
main developments during this phase was the unprecedented collaboration between
the Central Government and the three main national industry associations in India –
the Confederation of Indian Industry (CII), the Federation of Indian Chambers of
Commerce and Industry (FICCI), and the Associated Chambers of Commerce and
Industry of India (ASSOCHAM). These industry associations jointly set up the Quality
Council of India (QCI) in 1997.18 This development was a critical milestone in India’s
progress toward creating a formalized structure of accreditation and conformity
assessment in the country. The National Accreditation Board of Certification Bodies
(NABCB) became the first agency to be set up under the QCI. Two more boards were
set up in 2007, the National Accreditation Board for Education and Training (NABET),
and the National Accreditation Board for Hospitals (NABH).
The National Accreditation Board for Testing and Calibration Laboratories
(NABL) (formerly National Coordination of Testing and Calibration Facilities) and
NABCB signed Mutual Recognition Agreements (MRAs) and Multilateral Recognition
Agreements (MLAs) with regional accreditation bodies like the Asia Pacific Laboratory

15. Observer Research Foundation. Quality Rules in India: Trade, Technical Regulations and
Consumer Protection, Issue No. 245 4 (June 2018) https://www.orfonline.org/wp-content/
uploads/2018/06/ORF_IssueBrief_245_Trade_Regulations.pdf [hereinafter Quality Rules in
India].
16. Id.
17. Id., at 4.
18. About QCI, Quality Council of India, https://www.qcin.org/qci.php (last visited 19 December
2020).
104
Accreditation Cooperation (APLAC), the International Laboratory Accreditation Coop-

eration (ILAC), Pacific Accreditation Cooperation (PAC), and the International Ac-
creditation Forum (IAF).19 NABCB began accrediting certification bodies in India since
the year 2000. The Central Government also provided various incentives for promoting
certification bodies. The Ministry of Micro, Small and Medium Enterprises (MSMEs)
announced subsidies for ISO 900120 certification to MSMEs that was backed by NABCB
accreditation. QCI’s National Board for Quality Promotion (NBQP) promotes applica-
tion of quality management standards and statistical quality tools with an objective of
enabling industry to improve their competitiveness with a specific focus on the MSME
sector.
In 2016, the Government of India enacted a new BIS Act by replacing the BIS Act
of 1986. The new legislation revised and expanded the functions of the BIS, specifically
in relation to development of product standards and conformity assessment proce-
dures. Most notably, the 2016 Act positions the role of BIS as the national standards
body of India. The scope of the new Act applies to articles, processes, and services as
well, (and not just products) and includes conformity assessment procedures within
the functions of BIS. The new Act also includes provisions to ensure that BIS is the only
body vested with the ability to recognize and issue ‘Indian national standards’. Section
5.3 of this chapter delves into the standard-setting processes of BIS in further detail.
Separately, Chapter 6 also introduces the distinct functions of BIS in relation to
conformity assessment procedures.
The Food Safety and Standards Authority of India (FSSAI) was established in
2006 to create food standards, grant certification for food safety, control food-based
hazards such as adulteration, presence of the toxic substances, limit the use of food
additives, crop contaminants, pesticide residues, ‘pharmacological active’ substances,
develop food-labelling standards, promote and coordinate guidelines for risk assess-
ment, provide training in food safety and standards, etc.21 This was a major step in the
direction of ensuring high nutrition diet, improved public health and protection of
public morals by adopting not just product standards, but also standards for proper
treatment of environment and plant and animal life. The role of FSSAI in the creation
of standards based on scientific analysis, and certification of organic food led to a
consistent increase in the number of food and related products to be mandatorily
certified since 2010.22 FSSAI and BIS today share a complementary relationship in the
development and enforcement of Indian Standards related to food and food products.
While both are statutory bodies independent of each other, they operate in tandem for
the creation of food standards and their certification. Since the recognition of BIS as the

20. ISO 9001 belongs to the ISO 9000 family of standards of quality management. ISO 9001 sets out
the criteria for a quality management system and companies, organizations, their products and
processes are certified to ISO 9001. It can be used by any organization, large or small, regardless
of its field of activity. This standard is based on a number of quality management principles
including a strong customer focus, the motivation and implication of top management, the
process approach and continual improvement.
21. See section 16 of the Food Safety and Standards Act, 2006.
22. Quality Rules in India, supra note 15, at 4.
105
national standardization body, it has been vested with Food Safety Management
Scheme, and the power to conduct audits for certain food standards developed by
FSSAI. These schemes are examined in section 5.5.7. Given the important role of food
standards in consumer welfare and public interest, Chapter 8 of this Handbook covers
the role, functions, and operations of FSSAI in detail.
During this Phase 4, there has also been a marked attempt at harmonising the
standards regime with international trade rules developed on standards. The establish-
ment of the WTO in 1995 facilitated the existence of a common platform for countries
to harmonize their standards and technical regulations. As Chapter 1 of this Handbook
examined, the Agreement on Technical Barriers to Trade (TBT) and the Agreement on
Sanitary and Phytosanitary (SPS) Measures of the WTO require Members to, regularly
and promptly, notify their domestic standards and technical regulations.
Between 1995 and 2020, India’s has made 226 TBT notifications.23 Table 5.2
shows the periodic increase in these notifications. A closer look at the sectors regulated
show that at the beginning, the notifications predominantly dealt with the primary
sectors relating to essential goods. Most of the notifications made during 1995–2008
concerned with four categories of industries: the food and beverage industry (pre-
packaged foods, food ingredients, materials in contact with food and beverages),
medical equipment (stents, protective gear, thermometers and medical tools), vehicles
(petrol, vehicle parts, machinery, nuts and bolts, electric vehicles), and daily use
commodities (plastics, protective equipment, housing parts and iron and steel prod-
ucts). Since then, the focus has shifted to products and goods broadly related to the
maintenance of human health and safety, related quality requirements, environmental
protection, prevention of deceptive trade practices and reducing barriers to trade
(specifications for the usage of metals, IT products, technological products, chemicals
and medical equipment and tools). However, specifications relating to food and articles
of food as well as the medical sector have attracted greater focus than other sectors in
the last twenty years of implementation of the TBT Agreement.
Table 5.2 Number of Notifications by India Before the WTO TBT Committee
Years No. of Notifications

1995–2000 45
2001–2005 11
2006–2010 30
2011–2015 11
2016–2020 129
23. Search TBT Notifications, Technical Barriers to Trade Information Management System, http:/
/tbtims.wto.org/en/Notifications/Search?page=9&sortBy=DistributionDate&sortDirection=
desc&NotifyingMember=India&DoSearch=True (last visited 1 February 2021); WTO Informa-
tion Centre, Bureau of Indian Standards, https://bis.gov.in/other/WTOTBTEnquiryPoint.htm
(last visited 23 October 2020).
106
India’s notifications during the 2016-2020 period shows a clear indication of the
Indian Government to address the previously prevalent problem of under-notification.
With 129 notifications during 2016–2020, India has notified more measures during the
past five years than it had notified in the preceding twenty years (1995-2015).
India has also increased the number of WTO notifications of its measures under
the SPS Agreement. Table 5.3 shows that there has been a steep rise in notifications in
the last five years – almost three times when compared to the previous corresponding
period and roughly twice that of the last decade. The notifications during 1996–2005
have broadly dealt with agricultural products such as plant products, animals and
animal products including livestock, poultry, bovine and ovine and processed foods.24
A more scientific focus can be seen by way of notifications on Biological agents and
other beneficial organisms (since 2006), food additives and its limits (since 2006) and
usage of pesticides and maximum limits (since 2008). Since 2015 however, a more
specific approach was taken with notifications dealing with specific products and
goods such as pulses, honey, caffeine, additives, carbonated drinks, chocolates, milk
and milk products, frozen foods and rice bran and other oils. Few notifications have
also exclusively dealt with Carbide gas, additives, metal residue levels and healthy
dietary levels for children – all dealing with restrictions and quantities that are
considered to be accepted levels.
Table 5.3 Number of Notifications by India Before the WTO SPS Committee
Years No. of Notifications

1996 – 2000 8
2001 – 2005 30
2006 – 2009 43
2010 – 2015 57
2016 – 2020 140
The sharp rise in the number of TBT and SPS notifications by India can be said to
be a result of notifying measures which were earlier not notified as well as continuous
push toward creation of new standards and revising obsolete ones. The following
sections of this chapter attempt to provide a snapshot of how these new standards are
created.
24. Search Notifications, Sanitary and Phytosanitary Information Management System, http://
spsims.wto.org/en/Notifications/Search?DoSearch=True&NotifyingMember=India&Notificat
ionFormats=1&NotificationFormats=7&NotificationFormats=200&NotificationFormats=201
&NotificationFormats=202&NotificationFormats=203&NotificationFormats=8&NotificationF
ormats=9&DisplayChildren=true (last visited 18 December 2020).
107
5.1.2 Overview of India’s Standards Regulatory Landscape
The process of standard-setting in India involves a complex mesh of multiple

bodies/entities (governmental as well as non-governmental) which operate individu-
ally as well as jointly in formulating and implementing standards in the country.
Agencies such as the BIS, FSSAI, Research Design and Standards Organisation (RDSO),
the Telecommunication Engineering Centre of India, the Central Drugs Standard
Control Organisation, the Petroleum and Explosives Safety Organisation, Agricultural
and Processed Food Products Export Development Authority, etc., are examples of
such bodies that set standards in different sectors and fields in India. Once the
standards have been laid down, the role of accreditation bodies becomes relevant. The
setting up of QCI in 1997 and bringing NABCB, NABET, NABH and NBQP under its
oversight led to a formalized structure for testing, certification and conformity assess-
ment within the quality ecosystem. Chapter 6 of this Handbook examines the role of
accreditation bodies in conformity assessment procedures and certification in further
detail. Figure 5.1 provides a snapshot of some of the key bodies involved in standard-
setting in India.
Figure 5.1 Snapshot of Some of the Standard-Setting, Conformity Assessment and

Accreditation Bodies in India
WTO/TET
Enquiry Point
DCA
Department of IEC ISO
Consumer Affairs QCI
BIS−National Standards JTCI Quality Council of India
Body of India
Bureau of Indian
Standards
NABL NABCB NRBPT
Weights and Measures National Accreditation National National NOC
Board for Testing & Accreditation Registration National
Calibration Laboratories Board for Board for Quality
TRAI Certification Personnel and Campaign
MOC Telecom Regulatory STQC Bodies Training
Ministry of Authorities India Standardization, Testing
Communications
–
and Quality Certification
and Information
Technology DOT National Institute of Training
Department of CCA for Standardization
Telecommunication Controller of Certifying
Authorities
DEA BARC KEY

Department of Bhabha Atomic Research Codex
Atomic Energy Centre Alimentarius
International Indian
Standardization Standards
MOHFW FSSAI NCC Bodies Bodies
Ministry of Health Food Safety and Standards National Codex
and Family Welfare Authority of India Committee
Arcreditation WTO
Bodies Enquiry
MOA WTO/SPS Points
Ministry of Enquiry Point
Agriculture
In the context of India, the process of standard-setting involves three different

types of approaches:
108
(a) standard-setting by the government;

(b) standard-setting bodies; and
(c) industry standards.
At first glance, these three approaches would indicate the existence of a clear
delineation between standards that are set by government departments, those set by
agencies or organizations vested with this specific purpose, and those developed by the
industry. However, a deeper look into the actual mechanisms employed in develop-
ment of standards in these three approaches shows that there is extensive consultation
among different entities and bodies, including government entities, regulatory bodies,
autonomous bodies, industry representatives and experts. While government depart-
ments, standards development organizations (SDOs) and industry bodies are capable
and empowered to develop standards independently, the process typically requires
collaboration.
For example, a government department like the Ministry of Road Transport and
Highways (MRTH) can specify standards through an order published in the Official
Gazette under the Motor Vehicles Act, 1988 or by submitting a proposal to a
standard-setting body. A standard-setting body like the BIS on the other hand, may
receive a proposal for standard development either from the government (such as the
MRTH) or may receive a proposal from an interested party/stakeholder. The process of
adoption of that standard by the standard-setting body, regardless of who makes the
first proposal, would depend on the process set out in the governing law of such body
(for example, the BIS creates standards under the BIS Act, 2016). Distinct from the
government and the standard-setting bodies approach, an industry standard is adopted
through collaboration among the industry, manufacturers, processors and trade asso-
ciations. A recent example is the Indian Standards for Soybean being drafted by the
Soybean Processors’ Association (SOPA), the apex body of soybean processors units,
along with the Indian Institute of Soybean Research and Solidaridad Regional Expertise
Centre.25 While several industrial standards exist in the Indian market, such standards
will be considered an ‘Indian standard’ and have national application, only if they are
recognized under section 10(2)(b) of the BIS Act, 2016.26
Unpacking this complex mesh of regulations, processes and approaches to
standards development in India, therefore, requires a study of the entities that are
responsible for the development of standards. In other words, understanding who sets
the standard is crucial for understanding how these standards are set. The following
sections of this chapter attempt to create a map to navigate the regulatory processes for
standards in India. Despite the differences in the governing legislations, and everyday-
processes that are involved in standard-setting as carried out by different entities in
25. SOPA Developing Industry Norms for Sustainable Soya, Financial Express (17 December 2019
1:23 AM), https://www.financialexpress.com/market/commodities/sopa-developing-industry-
norms-for-sustainable-soya/1795771/.
26. Section 10(2)(b), The BIS Act, 2016, which states that –
(2) The Bureau may […] adopt as Indian Standard, any standard, established by any other
Institution in India or elsewhere, in relation to any goods, article, process, system or
service in such manner as may be prescribed.
109
India, common motivations and public policy goals drive and underpin the work of
these bodies. This section 5.1.2 first attempts to locate and highlight the various policy
rationales that drive the creation of standards in India. Subsequently, section 5.1.2.2
provides a bird’s eye view of the various legislations, borne out of these policy
ambitions, which ultimately form the backbone of standard-setting in India.
5.1.2.1 Policy Rationale for Standards
The standardization process in India follows a set of central Acts, rules, regulations and
orders. Although the Constitution of India does not expressly mention product
standards and the standardization process, the objectives laid down under the Consti-
tution – promotion of public health, nutrition levels, standard of living, protection of
environment, flora and fauna, etc. – remain the key policy objectives which the Central
Government aims to realize through setting up standards under various laws, Acts,
rules and regulations.
Any policy step toward improving public health and preserving plant, animal and
human life should ensure the safe consumption of products. Regulation of the chemical
content in food items or residue limits in fertilizers or food products is important to
ensure safe consumption. Food safety has a direct effect on public health and India has
recognized its duties as a welfare state to provide improved levels of nutrition and
standard of living to its people. Article 47 of the Constitution expressly directs the State
(India) to fulfil this duty. Standards mandating certain quality and safety parameters of
various food products and health supplements, including concentration of additives
and preservatives in foods, fall under this duty of the government to protect public
health.
Protection of environment is another major policy goal. India is a signatory to the
Paris Agreement (21st Conference of the Parties to the UN Framework Convention on
Climate Change, or UNFCCC, held at Paris in 2015) or COP21 and endeavours to meet
the targets thereunder for creation of a sustainable environment by reducing green-
house emissions and protecting/preserving its forests and wildlife. However, prior to
COP21, India had resorted to standards to regulate industry activities and production
processes in favour of protecting environment and public health. Article 48A of the
Constitution lays down the principle of safeguarding forests and wildlife of the country.
Protection of environment directly affects human health and any industrial activity in
India must not be detrimental to the environment, forests, plants and wildlife. An
example of a standard formulated to achieve this aim is the Eco Mark Scheme of the BIS
which was introduced for labelling of environment friendly products.27
India has also a legislative and administrative framework to regulate the trading
of any product which is deemed to be harmful to public health or against public
interest. For example, manufacture or import of drugs like amidopyrine, phenacetin
and fixed combinations of vitamins with anti-inflammatory agents and tranquilizers,
27. Operation of Eco Mark Scheme, Bureau of Indian Standards, https://bis.gov.in/index.php/

product-certification/operation-of-eco-mark-scheme/ (last visited 19 December 2020).
110
and certain other chemicals is either banned or restricted on strict approval basis in
India.28 Likewise, in order to protect wildlife, import of wild animals (including their
parts and products) as defined in the Wild Life (Protection) Act, 1972 is prohibited and
the list of such animals and their products is maintained and notified by the Directorate
General of Foreign Trade. These powers of the Central Government to restrict trade of
certain products and impose high levels of standards for their suitability for public
interests and morals can be said to be derived from Article 302 of the Constitution of
India.
5.1.2.2 Regulations on Product Standards
Product standards in India have been regulated since the creation of Indian Standards
Institution (ISI) in 1947. ISI carried out standard-setting as well as certification
processes in India, the functions which have now been expanded through the BIS Act
2016. As the national standards body, the BIS formulates Indian Standards covering all
areas other than those mentioned in Agricultural Produce (Grading and Marking) Act,
1937 and the Drugs and Cosmetics Act, 1940. While the Agricultural Produce Act of
1937 empowers the Central Government for fixing and marking grades on agricultural
and other produce, the Drugs and Cosmetics Act of 1940 prescribes laying of standards
for drugs to be done by the Central Drugs Standards Control Organization (CDSCO),
which is the central drugs authority under the Ministry of Health and Family Welfare.
All the rules and regulations under these Acts also form an integral part of the
standardization process in India.
The Ministry of Consumer Affairs, Food and Public Distribution is the main
central government department dealing with product standards, although each minis-
try or department also has its own system of framing and publishing product standards.
There are several legislations (sector-specific as well as general) which govern
standard-setting processes. A list of the key legislation, rules and regulations that have
contributed to evolution of the standards regulatory framework in India include, but
are not limited to:
(a) The BIS Act, 2016;

(b) Agricultural Produce (Grading and Marking) Act, 1937;
(c) Drugs and Cosmetics Act, 1940;
(d) Prevention of Food Adulteration Act, 1954;
(e) Export (Quality Control and Inspection) Act, 1963;
(f) The Cigarettes and Other Tobacco Products (Prohibition of Advertisement and
Regulation of Trade and Commerce, Production, Supply and Distribution) Act,
2003;
(g) The Petroleum and Natural Gas Regulatory Board Act, 2006;
(h) The Food Safety and Standards Act, 2006;
28. See Notification No. GSR NO. 578(E), 3 July 1983; Notification No. GSR NO. 578(E), 23 July
1983.
111
(i) Explosives Act, 1984;

(j) Environment Protection Act, 1986; and
(k) All the rules and regulations framed under these Acts, including the BIS Act.
In recent times, India has introduced a number of mandatory certification

requirements for the electronics and IT sector, steel, and agro-based industries. These
mandatory certification requirements are implemented through various BIS schemes.
For instance, the ISI Mark Scheme includes products ranging from Sulphate Resisting
Portland Cement,29 Electric Irons and Stoves,30 skimmed milk-powder,31 tubes for
pneumatic tyres32 to LPG gas containers for automotive use.33 These standards under
the ISI Mark Scheme, being mandatory standards, are notified in the Gazette of India –
either through quality control orders, sectoral legislations, or rules under such legisla-
tion (e.g., see footnotes 30 – 34). The most regulated sectors, until at least a decade ago,
were cement and electronics, presumably in view of consumer safety objectives.34
The existence of several such laws, rules and quality control orders governing
standards development has meant that there is a need to harmonize these regulations
domestically. The adoption of the INSS by India’s Ministry of Commerce and Industry
in 2018 is the latest attempt to build an effective standards-setting process and
harmonize the standards framework.35 The INSS notes that in the seventy years that
preceded its introduction, more than 20,000 Indian Standards were developed, half of
which were product standards.36 Despite these efforts, the INSS observed that stan-
dards in India did not often account for unique domestic requirements and were
typically adopted as is from international standards, or there were large product and
sectoral gaps where standards were absent. The INSS sought to address the gaps in
standard-setting, as well as other pressing needs such as the development of service
sector standards.
5.2 INDIAN NATIONAL STRATEGY FOR STANDARDIZATION
The INSS was prepared by the Department of Commerce, Ministry of Commerce and
Industry after undertaking consultations from 2014 through 2017 through national and
regional standards conclaves and dialogues. The INSS sought to represent the ‘broad
29. Notified through Cement (Quality Control) Order, 2003 S.O. No. 191(E), 17 February 2003.
30. Electrical Wires, Cables, Appliances and Protection Devices and Accessories (Quality Control)
Order, 2003 No. 189(E), 17 Feb 2003 (amended several times subsequently, and most recently
through S.O. 2604 (E), dated 19 October 2010).
31. Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011 under the
Food Safety and Standards Act 2006.
32. Pneumatic Tyres and Tubes for Automotive Vehicles (Quality Control) Order, 2009 S.O. No.
2953(E), 19 November 2009.
33. Gas Cylinder Rules, 2016 under the Explosive Act, 1884.
34. Quality Rules in India, supra note 15, at 3.
35. Indian National Strategy for Standardization, (2018) Ministry of Commerce and Industry,
Government of India https://commerce.gov.in/wp-content/uploads/2020/02/MOC_636655449
469105249_INSS_Booklet_2018.pdf [hereinafter INSS]. .
36. Id. at 9.
112
consensus’ arrived at as a result of these consultations with government bodies,

industry, regulatory bodies, other standard-setting and conformity assessment bodies,
academia.37
The INSS ‘provides direction for India’s political and executive leadership on how
best to use standardization, technical regulations, quality infrastructure and related
activities to advance the interests and well-being of Indians in a global economy.’38 The
INSS is based on considerations around positioning standards as a key driver of all
economic activities relating to goods and services. In other words, the INSS is an
attempt to develop a comprehensive network of standardization in India. As men-
tioned in the previous section of this chapter, harmonization of standards, adopting
best practices of conformity assessment and accreditation makes the quality ecosystem
of a country effective and benefits the manufacturers and traders. INSS lays down a
roadmap to create an integrated quality infrastructure at par with the international best
practices.
By the creation of a robust standardization system in India and improving the
applicable standards, INSS envisions India to play an active role and take leadership
positions in international and regional fora in standard-setting. Conformity assessment
bodies under QCI (like NABL and NABCB) are members of international and regional
accreditation bodies such as International Laboratory Accreditation Cooperation
(ILAC) and Asia-Pacific Accreditation Cooperation (APAC). An important aim of INSS
is to create a response mechanism to global developments on standards, technical
regulations and conformity assessment that impact market access of Indian goods and
services in other countries.
The INSS proposes an implementation plan to undertake the strategy over a
five-year period (2018-2023).39 The plan is being monitored by a high-level committee
(with quarterly reviews). The importance of INSS lies in the fact that it is a strategy
adopted by the Government of India which would shape the standard-setting processes
in the country, which have so far remained scattered.
5.2.1 Standards Development
The INSS aims to develop ‘a dynamic, relevant and priority-driven standards ecosys-
tem that will drive development across sectors, promote competitiveness of Indian
products and services, and foster India’s eminence among the global leaders in
standardization’.40 With this mission statement, the Government of India has high-
lighted eight goals which it aims to achieve by 2023, thereby creating a robust and an
organized approach to development of standards. The eight goals which have been
envisioned under the INSS are mentioned in Figure 5.2.
37. National Policy, Directorate of Standardisation, Department of Defence Production, https://

ddpdos.gov.in/standards/national-policy (last visited 19 December 2020).
38. INSS, supra note 35, at 7.
39. Id.
40. INSS, supra note 35, at 8.
113
Figure 5.2 Goals under the ‘Standards Development’ Pillar of the INSS
Goal 1 Convergence of all standards development activities in India.
Setting up a dynamic mechanism for new standards identification,

Goal 2
development and their revision.
Inclusive participation of all stakeholders in standards

Goal 3
development including States and MSMEs.
Goal 4 Harmonizing standards with international standards.
Goal 5 Identifying sectors where India could pioneer standardization work.
Systematic and continuous participation in international and

Goal 6
regional standardization work.
Goal 7 Development of Service Sector Standards.
Creating an ecosystem to meet the challenges from Private

Goal 8
Sustainability Standards.
Converging standards developing activities in India is a priority target that INSS

aims to achieve by 2023. This goal takes particular precedence to address systemic
issues in the fragmentation of standard -setting activities in India. Streamlining the
various regulations and bodies which form a part of the Indian standards ecosystem
and setting up a mechanism which accommodates these diverse functions, is critical
for the future that INSS envisages. As noted earlier in this chapter, the standard-setting
process in India involves extensive consultation among the various standard-setting
bodies and stakeholders. The INSS sets out ambitions for furthering and streamlining
participation of all stakeholders (including MSMEs) in the standard-making process
and leveraging India’s role in standard-setting process globally.
It is expected that the INSS will govern all future standard-setting processes in
India, whether the standards are formulated by the government, the standard-setting
bodies or industry associations. India’s standards-setting process has been led thus far
the BIS. The role of BIS as the apex national standards body in India has been
reaffirmed in the INSS. The BIS will continue to oversee the harmonious development
of standardization activities under its own umbrella as well as through memoranda of
understanding with the other SDOs.41
The following sections of this chapter provides a detailed explanation of the
functioning of various standard-setting agencies in India.
41. Id.
114
5.3 BUREAU OF INDIAN STANDARDS
The central objective of BIS as noted in the BIS Act of 2016 is the ‘harmonious
development of activities of standardization, marking and quality certification of goods
and for matters connected therewith or incidental thereto’.42 BIS is headquartered in
New Delhi and its five Regional Offices (ROs) are at Kolkata (Eastern), Chennai
(Southern), Mumbai (Western), Chandigarh (Northern) and Delhi (Central). The BIS
has also various branch offices in several other cities in India.43
BIS has been established to cater to the interest of consumers as well as the
industry stakeholders. Table 5.4 lays out the various activities which BIS has been
involved in.
Table 5.4 Key Activities Undertaken by BIS
Standards Formulation Product Certification Scheme

Compulsory Registration Scheme Foreign Manufacturers Certification
Scheme
Hall Marking Scheme Laboratory Services
Laboratory Recognition Scheme Sale of Indian Standards
Consumer Affairs Activities Promotional Activities
Training Services (National and Information Services
International)
5.3.1 Members of BIS
BIS consists of 25 members representing both Central and State governments, Members
of Parliament, industry, scientific and research institutions, consumer organizations
and professional bodies; with Union Minister of Consumer Affairs, Food and Public
Distribution as its President and with Minister of State for Consumer Affairs, Food and
Public Distribution as its Vice-President. The representatives from industry associa-
tions or federations, namely the Confederation of Indian Industry (CII), Federation of
Indian Chambers of Commerce and Industry (FICCI) and the Associated Chambers of
Commerce and Industry of India (ASSOCHAM) are also members of BIS.44 In addition,
the scientific and research institutions, technical, educational and professional organi-
zations, regulatory authorities or bodies and national accreditation boards or bodies
are also represented at the BIS.
42. About BIS, Bureau of Indian Standards, https://bis.gov.in/index.php/the-bureau/about-bis/

(last visited 19 December 2020).
43. Id.
44. Bureau Members, Bureau of Indian Standards, https://bis.gov.in/index.php/the-bureau/
organization-2/bureau-members/ (last visited 23 December 2020).
115
5.3.2 Divisions of BIS
Once a proposal to formulate a standard is received, the BIS utilizes its impressive
organization setup of Technical Departments, Division Councils, Technical Commit-
tees, Sectional Committees and Standardization Cells (in other organizations). Several
consultation and coordination among all the stakeholders, including government
bodies, private entities, industry associations, consumer organizations and experts. BIS
prepares and updates detailed Work Programme for each Division Council and
Sectional Committee. While the Work Programme provides scope of the Division
Council and Sectional Committees, it also contains details of status of enforced
standards and the stage of preparation at which draft standards have reached (like
preliminary, wide circulation and finalized draft standards).45
At present, there are 335 Sectional Committees functioning within the BIS. These
consist of over a thousand experts from government bodies, regulatory bodies,
industries, consumer boards, scientists, technologists and testing agencies.46 These
committees work to develop consensus based voluntary National standards with
stakeholder consultations.
Table 5.5 enlists the sectors, each of which has a Technical Department and a
Division Council.47 In addition, each Technical Department consists of Technical
Committees which operate within the mandate of the Technical Department they fall
under. The sectors are:
Table 5.5 Sectors in Which BIS Engages in Formulation of Indian Standards
Chemicals Metallurgical Engineering Mechanical

Engineering
Civil Engineering Petroleum Coal and Management and
Related Products Systems
Electronics and Information Production and General Medical Equipment
Technology Engineering and Hospital
Planning
Electrotechnical Services Sector Textile
Department
Food and Agriculture Transport Engineering Water Resources
45. Process of Standards Formulation, Bureau of Indian Standards, 1 https://bis.gov.in/index.php

/standards/standard-formulation/process-of-setting-standards/ (last visited 19 December 20
20).
46. Review of BIS Annual Report 2018-19, Bureau of Indian Standards, https://bis.gov.in/wp-
content/uploads/2020/03/ReviewStatementofBISAR201819.pdf (last visited 13 October 2020).
47. Technical Departments, Bureau of Indian Standards, https://www.services.bis.gov.in:8071/php
/BIS_2.0/dgdashboard/committee_sso (last visited 7 October 2020).
116
The structure of Technical Departments for each of the above sectors includes
Technical Committees, Sub-Committees, Working Groups and Panels.48 Each of these
teams has a defined scope with respect to products and sectors and experts (including
scientists) are members of these teams. Depending on the primacy and priority of the
products and sectors, the number of Technical Committees under the Technical
Departments could be as high as 45.
5.3.3 Standards Formulation Process of BIS
The process of standards formulation at BIS may include establishing a new standard
or revising, amending or cancelling an established standard. Written proposals are
accepted by BIS from stakeholders and interested parties, which could be either
government entities or private corporations. In addition to external proposals, mem-
bers of BIS as well as members of the Technical Committees also submit proposals for
BIS to take requisite action.49 Once the proposal is received, the proposal is analysed in
a structured manner with these steps followed meticulously:
The Figure 5.3 lays out the steps BIS adopts for formulation of standards.
48. Id.
49. Process of Standards Formulation, supra note 45.
117
Figure 5.3 Process of Standard Formulation by BIS
Step 1: Proposals
Proposals are received from interested parties like governments, consumer organizations and industry bodies. BIS
internal Committees too can submit proposals
Step 2: Satisfaction of Division Council on 'necessity' for standardization
Division Council conducts investigation and consultation to establish necessity for standardization
Step 3: Assignment to Technical Committee
On satisfaction, Division Council assigns the task of formulation of standard to the appropriate Technical Committee
Step 4: Informing the proposer
If the proposal is not accepted, the Division Council informs the proposer of the decision
Step 5: Preparation of a draft standard

Draft Standard is prepared and approved by the Technical Committee and widely circulated for not less than one
month for review and suggestions. Circulation can be waived if urgent
Step 6: Finalizing the standard and its adoption

Comments/suggestions are considered and the draft standard is finalized. Sectional Committee approves and the
Chairman of the Division Council adopts the final standard
Step 7: Periodic review

Periodic review is conducted by Sectional Committee at least once in five years to determine need to revision or
withdrawal. If no amendment, standard is reaffirmed
It must be noted that while deliberating and consulting over the proposed
standard, BIS gives special attention to multidisciplinary areas such as energy conser-
vation, environmental protection, rural development and safety.
The process of formulation of standards is documented on the BIS website.
Details of proposals received, and their status are publicly available.
BIS follows internationally accepted good standardization practices while con-
tinuing to comply with the WTO-TBT Code of Good Practice for preparation, adoption
and application of standards.50 As seen from above, BIS provides all interested
stakeholders with a neutral platform to come together and work toward common
agreements to develop national standards. It must be noted that the fifteen Division
Councils of BIS formulate Indian Standards covering all areas under the scope of the
BIS Act. Though BIS is the national standard-setting body in India, there are other
industries and professional bodies which formulate sector-specific standards. These
bodies are referred to as SDOs. The standards developed by the SDOs are recognized by
the BIS as relevant standards to be applicable at a national level. The statutory
provisions under section 10(2)(c) of the BIS Act and section 30 of the BIS Rules, 2018
(enforced under the BIS Act) confer upon BIS, powers to recognize any SDO in India for
50. Review of BIS Annual Report, supra note 46, at 1.
118
development of standards. Section 5.5 of this chapter looks at certain key SDOs in India
and how they operate.
Standard-Setting by SDOs
Standards Developing Organizations (SDOs) are bodies recognized by the BIS as
having sector-specific knowledge and serve an important function of formulating
sector-specific standards. When an SDO develops a standard, it is required to
then get it recognized as an Indian Standard by the BIS51 in line with India’s ‘One
Nation, One Standard’ policy.
BIS specifies certain criteria that must be met when SDOs develop standards,
such as a mandatory public consultation. Once an SDO standard is prepared, it
must apply for the recognition of the standard, and must provide details to BIS
regarding the standard and its formulation process, the technical committee
involved in formulation, details of consultations, etc. If BIS is satisfied that its
requirements for standards formulation have been met, the appropriate BIS
Technical Committee must consent to the SDO Standard being formulated as an
Indian Standard. The draft is then published on the BIS website for public
comment for at least a month, and any comments received are directed back to
the SDO. Once resolved, the SDO standard is adopted as an Indian Standard by
the BIS.
Being the national standards body in India, BIS had the responsibility to further
the aims and objectives of the INSS. BIS, therefore, released the Standards National
Action Plan (SNAP) in 2019 which provides a framework of actionable and measurable
standardization priorities in India.
5.4 STANDARDS NATIONAL ACTION PLAN
Recognizing that standardization supports economic growth, enhances competitive-

ness, fosters technological development and supports innovation, the BIS developed
the 2019 SNAP.52 The SNAP is a direct result of the strategies and goals identified under
the INSS with an emphasis on standardization activities. Through the SNAP, BIS
intends to ensure a synergy of the standardization activities taking place in India such
that national standards development is aligned with the technological, economic and
social priorities of the country. The Action Plan notes that:
51. Rule 8, Bureau of Indian Standards’ Scheme for Recognition of Standards Developing Organi-
zations (SDOs), available at https://www.services.bis.gov.in:8071/php/BIS_2.0/sdo/sdonew/
SDO-recognition-scheme-document.pdf.
52. Standards National Action Plan, 2019, Bureau of Indian Standards (2019) https://bis.gov.in/
wp-content/uploads/2019/03/SNAP-Documents.pdf.
119
Standardization activities in BIS are to be based on strong foundation and systems

that are aligned to meet the current and anticipated standardization needs and
priorities, coordinated to remain effective and to be able to address emerging
standardization issues.53
The five key issues identified by BIS, in consultation with stakeholders like regulators,
industry associations and research bodies, are:
(a) Gap between the products needed to be standardized and the actual number
of products covered by standards and subjects/topics to be taken up for future
standards development;
(b) Evolving mechanism for regular feedback on standards and standardization
needs;
(c) Constraints faced in participation in standardization work both at national
and international level;
(d) Difficulties faced in implementation of standards; and
(e) Capacity building needs of stakeholders for effective participation in stan-
dards development.
On the basis of inputs from policymakers, regulators and industry and industry
associations, BIS assessed national socio-economic requirements through a process of
secondary research against the ISO guidelines. With these considerations, SNAP was
developed with the objectives as highlighted in Figure 5.4.
53. Id., at 18.
120
Figure 5.4 Objectives of Standards National Action Plan
Identification of standardization needs and enhancing stakeholder

involvement
Standards National Action Plan
Making standardization processes efficient and fast
Ensuring harmonious standardization activities in the country
Increased participation and involvement in international standardization

activities
Increasing awareness and implementation of standards
The SNAP details multiple action plans which the BIS has indicated to undertake
to achieve the above objectives. The actions proposed to be undertaken will be
implemented within defined timeless set by BIS by 2022. The progress will be
monitored periodically in terms of the measures identified against each action.54 BIS
has earmarked certain measures which it intends to assume to realize the five broad
objectives. To implement this action, BIS intends to conduct at least six sector-wise
programmes held every year.
5.4.1 Actions and Measures under SNAP
The SNAP establishes the intention, purpose, actions and timelines for BIS to follow in
its standardization process with an emphasis on widespread stakeholder consultation,
capacity building, sector-wise awareness programmes and UN Sustainable Develop-
ment Goals. The SNAP consists of 42 ‘actions’ which the BIS intends to perform to fulfil
its five objectives.55 As mentioned earlier, BIS proposes a measure to adopt or enact for
each of the 42 action points. Few of the select important actions (and their respective
measures) under SNAP have been enlisted in Table 5.6.
54. Id., at 34.

55. Id., Annex 1 at 35.
121
Table 5.6 Actions and Measures under SNAP
Objective Action Measure Targeted Benefit

1. Regular and planned One interaction – Availability of
Identification interaction with every quarter timely inputs on
of Ministries or standardization
standardization Regulators or – Identification of
needs and Industry new subjects for
enhancing Associations to standardization.
stakeholder assess – Identification of
involvement standardization relevant experts.
needs, promote use – Enhance the
of standards through implementation
of standards
govt. policies and
regulations and
identify experts for
participation in
standardization
(national and
international)
2. Making Create National Online commenting – Increased partici-
standardization Commenting platform made pation of stake-
processes Platform - online operational holders and tech-
efficient and commenting/ nical committee
fast feedback mechanism members.
on existing – Faster standards
standards/ draft development
documents processes.
3. Ensuring Introduce a Scheme Policy framed and – Coordinated ef-
harmonious for accreditation or scheme launched forts in national
standardization recognition of standardization.
activities in the Standards – Harmonized
country Developing standard devel-
Organizations opment in the
(SDOs) country.
– International
good standard-
ization practices
followed in the
country.
122
Objective Action Measure Targeted Benefit

4. Increased Identify priority – Strategic plan de- Focused and
participation areas of participation veloped for partici- effective
and in ISO and IEC that pation in ISO/IEC participation in
involvement in are of strategic technical work. international
international importance for India, – Relevant guidelines standardization.
standardization identify relevant for participation in
activities experts who would international meet-
participate and draw ings framed and
an annual delegation implemented.
plan – Relevant Technical
committees/
Working Groups of
International Stan-
dardization Bodies
along with the rel-
evant experts iden-
tified.
– Annual delegation
plan developed.
5. Increasing Carry out sector-wise At least six Increased
awareness and awareness sector-wise awareness and
implementation programme for programmes held implementation of
of standards Industry with focus every year standards
on MSME
5.4.2 Key Standardization Areas
The SNAP intends for sustainability, smartness and service standardization to be the
key aspects that will define the future national standardization work of BIS.56 In this
regard, in order to create an extensive action plan for the standardization process, BIS
has also identified ‘key standardization areas’ and ranked them on the basis of their
priority. Few of the standardization areas with a high priority are enlisted in Table 5.7.
Table 5.7 ‘Priority’ Subject Areas for Standardization under SNAP
Sector Field Subject Area

Agriculture Agriculture – Soil Soil Health
Health and Safety Occupational health, safety Safety guidelines for
and management practices laboratories
Manufacturing Industrial Production Anthropometric data for
Indian population
56. Id., at 49.
123
Sector Field Subject Area

Water Resources Water management Water quality management
The areas listed in the above table are those which have been marked with the
highest priority for standardization. However, with varying priority, a total of 176
subject areas under 64 fields spanning across 26 sectors have been identified in which
standardization process under SNAP will be undertaken. Reviewing the standards
development process is an essential part of SNAP. Periodic review of areas in which
standards are developed is expected to be conducted and the requirements in this
regard are proposed to be updated as necessary.57
5.5 STANDARDS DEVELOPING ORGANIZATIONS
In addition to the BIS, there are other regulators, ministerial departments, industries
and professional bodies in India which formulate sector-specific standards, generally
referred to as SDOs. At present, the BIS maintains a list of 48 SDOs which formulate
standards and technical regulations.58 This list consists of ministries/department of the
Government of India, autonomous regulatory bodies, statutory organizations, industry
bodies, professional bodies, export promotion councils/bodies/authorities and re-
search and technical institutions. The statutory provisions under section 10(2)(c) of the
BIS Act and Rule 30 of the BIS Rules, 2018 confer upon BIS, powers to recognize any
SDO in India for development of standards. Accordingly, BIS launched the scheme for
Recognition of SDOs as a part of the ‘One Nation One Standard’ Mission. In June 2021
BIS gave formal ‘recognition’ to the first SDO as a part of this Scheme – the RDSO of the
Indian Railways. This recognition will allow BIS to adopt RDSO standards as ‘Indian
National Standards’ if it deems fit, and will give RDSO the acknowledgement and
recognition that it is compliant with the TBT Agreement Code of Good Practice.
The QCI has also independently developed criteria for formal accreditation of
other bodies as SDOs though no organization has been granted such accreditation
yet.59
India’s institutional framework, with a plethora of governmental, non-
governmental and autonomous bodies working individually and collectively in
standard-setting, carries a possibility of duplication of standards if there is no well-
integrated information system. India has created such an integrated system around
greater harmonization of standards along the lines of national (Indian Standards) as
well as international standards. The TBT Agreement requires every WTO Member State
57. Id., at 34.

58. Organisations/Departments of Government of India Formulating Standards and Technical
Regulations and their area of Activity, Bureau of Indian Standards, https://bis.gov.in/wp-
content/uploads/2018/11/SDOs_information_for_BIS_Website_09-11-18_1704_h-1.pdf (last
visited 10 October 2020) [hereinafter List of SDOs].
59. Accreditation Program for standards Development Organisation, Quality Council of India,
available at https://qcin.org/SDOS.
124
to designate an ‘enquiry point’ for all TBT-related issues. Article 10.1 of the TBT
Agreement states:
Each member shall ensure that an enquiry point exists which is able to answer all
reasonable enquiries from other members and interested parties in other member
countries as well as to provide the relevant documents.
Since BIS is the national standards body, it has been identified as the enquiry
point of all TBT measures/standards notified by other Member States and for notifying
India’s standards.60 Whenever a standard is created and enforced, it must be notified to
the WTO. In addition to the BIS standards, standards which are formulated by other
SDOs are also notified at the WTO. India’s TBT notifications (226 as of 2020) and SPS
notifications (278 as of 2020) include BIS standards and standards developed by other
SDOs. BIS maintains and updates the list of SDOs it recognizes for formulating
standards in India, and this makes communication related to standardization between
BIS and other SDOs convenient. The following section provides an examination of
select SDOs and their roles in India’s standardization process.
5.5.1 Agricultural and Processed Food Products Export Development

Authority (APEDA)
The APEDA was established by the Government of India under the Agricultural and
Processed Food Products Export Development Authority Act, 1985. It has been set up
as an autonomous body under the Department of Commerce (part of the Ministry of
Commerce and Industry). APEDA undertakes the task of export promotion activities
and development of 14 agricultural and processed food product groups listed in the
Schedule to the APEDA Act.61 In addition to this, APEDA has been entrusted with the
responsibility to monitor the import of sugar as well. The key function areas of APEDA
include standards-setting and formulation of specifications for exports, inspection of
meat and meat products in processing plants, storage premises, conveyances, organic
production and systems.
Since BIS does not formulate standards under the Agricultural Produce (Grading
and Marking) Act, 1937, the standards made under this Act (popularly called AGMARK
standards) are referred to by APEDA. Standards of Export Inspection Councils are also
referred to by APEDA. APEDA has published and regularly updated the National
Programme for Organic Production (NPOP) that lays down standards for organic
60. More specifically, the ‘International Relations & Technical Information Services’ Department of
the BIS is the designated enquiry point of India for all queries except Telecom Sector. The
enquiry point for the Telecom Sector is the Telecommunication Engineering Centre (TEC).
61. Agricultural and Processed Food Products Export Development Authority, Department of Com-
merce, https://commerce.gov.in/about-us/autonomous-bodies/agricultural-and-processed-
food-products-export-development-authority-apeda/ (last visited 25 October 2020).
125
production, systems, criteria and procedure for accreditation of certification bodies, the
National (India Organic) Logo and the regulations governing its use.62
The NPOP formulates standards and procedures keeping into consideration
harmonization of national standards with other international standards which regulate
trading of organic products.
In another instance of cooperation between different standard-setting organiza-
tions, APEDA and the FSSAI have collaborated to develop standards for organic food.
The aim behind these standards is to create products of holistic agricultural practices
focusing on biodiversity, soil health, chemical-free inputs, etc., with an environmen-
tally and socially responsible approach. Organic food products which comply with
these standards are labelled ‘organic’ and conformity with these standards is con-
ducted through the Food Safety and Standards (Organic Foods) Regulations, 2017,
which are based on the NPOP standard and Participatory Guarantee System (PGS-
India).
The European Commission and Switzerland have recognized the NPOP stan-
dards as equivalent to their national standards for production and accreditation
system. Likewise, the NPOP CAPs have been granted equivalence by the United States
Department of Agriculture (USDA). Such coordination, recognition and cooperation
with these countries eases the burden of certification for Indian exporters of agricul-
tural and food products. With these recognitions, Indian organic products duly certified
by the accredited certification bodies of India are accepted by the importing countries.
Mutual recognition of equivalent standards is an area of study which presents different
facets of the process of international harmonization of standards. Chapter 7 of this
Handbook takes a deeper look into the various prospects for such equivalency of
standards through mutual recognition agreements.
APEDA also undertakes collection of statistics from the owners of factories or
establishments engaged in the production, processing, packaging, marketing or export
of the scheduled products and publication of these statistics. This helps in the creation
of a system of information readily available to any stakeholder who wishes to access
such information. Clean and hygienic processing and storage of food products (espe-
cially meat and meat products) is also important to ensure food safety and quality.
APEDA ensures this by carrying out inspection of meat and meat products in
slaughter-houses, processing plants, storage premises, conveyances or other places
where such products are kept or handled for the purpose of ensuring the quality of such
products. Inspection of meat processing plants is carried out by a committee of experts.
This committee is inter-departmental in nature, and has members from EPC, FSSAI,
Dept. of Animal Husbandry and Dairying, APEDA and the veterinary department of
state governments. There is a separate expert committee for red meats, with a similar
composition.
62. National Programme for Organic Production, Agricultural and Processed Food Products Export
Development Authority, http://www.apeda.gov.in/apedawebsite/organic/ORGANIC_CONTE
NTS/National_Programme_for_Organic_Production.htm (last visited 25 October 2020).
126
5.5.2 Automotive Research Association of India (ARAI)
The ARAI plays a crucial role in assuring that safe, less polluting and more efficient
vehicles run on the Indian roads. ARAI is an autonomous body – however, it is
affiliated to the Ministry of Heavy Industries and Public Enterprises and is administered
by the Department of Heavy Industries. It finds place under this department’s allotted
business in the Government of India (Allocation of Business) Rules.
The protection of environment and prevention of health risks and diseases are at
the heart of ARAI’s operations. It provides technical expertise in R&D, testing,
certification, homologation and framing of vehicle regulations.63 ARAI functions in
coordination with its members, consumers and the Central Government. It has been
granted ISO 9001, ISO 14001, OHSAS 18001 and NABL accreditations.64 ARAI is
recognized by the international certification authorities of Singapore, Netherlands, and
Australia for carrying out tests as per their standards and regulations.65
The Automotive Industry Standards Committee (AISC) was set up under Central
Motor Vehicles Rules –Technical Standing Committee (CMVR – TSC) by Ministry of
Road Transport and Highways (formerly Dept. of Road Transport and Highways,
MoRT&H) in the year 1997 within ARAI to review safety in the design, construction,
operation and maintenance of motor vehicles in India. ARAI also represents India on
WP29 – World Forum for Harmonization of Vehicle Regulations under UNECE.
5.5.3 Building Materials and Technology Promotion Council (BMTPC)
The erstwhile Ministry of Urban Development (presently Ministry of Housing and

Urban Affairs) had established the Building Materials and Technology Promotion
Council (BMTPC) in 1990 to create a nexus between R&D and large scale application of
new building material technologies.66 It is one of the only two entities which have an
understanding with the BIS for adoption of its standards as Indian Standards.
BMTPC has worked closely to create Indian Standards on cost effective technolo-
gies such as fly-ash bricks, RCC planks and joist, bamboo mat corrugated roofing
sheets, etc. The Council prepares and submits draft standards on innovative technolo-
gies to BIS for formulation of Indian Standards. BMTPC is in consultation with the BIS
for preparation of two draft standards on Rat Trap Bond in Bricks and Filler Slabs.67
Through Performance Appraisal Certification Scheme (PACS), the Council is carrying
out performance evaluation of new and emerging materials, technologies and construc-
tion systems, on which there are no standards available. In the process so far twenty
63. Certification and Standardization, Automotive Research Association of India, https://www.

araiindia.com/services/certification-and-standardisation (last visited 25 October 2020). [here-
inafter Certification and Standardization].
64. List of SDOs, supra note 58, at 25.
65. Certification and Standardization, supra note 63.
66. About Us, Building Materials and Technology Promotion Council, https://bmtpc.org/topics.
aspx?type=sub&mid=19 (last visited 25 October 2020).
67. Building Materials and Construction Technologies, Materials and Technology Promotion Coun-
cil, https://bmtpc.org/topics.aspx?mid=43&Mid1=55 (last visited 25 October 2020).
127
Performance Appraisal Certificates (PACs) have been issued on various innovative

systems and products.
5.5.4 Central Drugs Standard Control Organization (CDSCO)
The CDSCO is the Central Drug Authority for discharging functions assigned to the
Central Government under the Drugs and Cosmetics Act (DCA). CDSCO has six zonal
offices, four sub-zonal offices, thirteen port offices and seven laboratories under its
control. It oversees regulatory control over the import of drugs, ‘approval of new drugs
and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs
Technical Advisory Board (DTAB), approval of certain licenses as Central License
Approving Authority is exercised by the CDSCO headquarters’.68 CDSCO lays down the
standards for Drugs and health care devices or technologies and approve new drugs
under the Drugs and Cosmetics Act.
The Ministry of Health and Family Welfare (MHFW), through Gazette notifica-
tions, has notified certain medical devices to be considered as drugs under section 3 of
DCS.69 At present, 14 medical device and 8 substances are notified and accordingly the
standards of these 14 medical devices are formulated/updated and controlled by
CDSCO through the different provisions of the DCA as given below:
(a) GMP Requirements are specified under Schedule M III of the DCA.
(b) Requirements on Labelling of Medical Devices specified in Rule 109-A of the
DCA.
(c) Standards for Medical Devices are prescribed in Rule 125-A of the DCA.
CDSCO follows a general structure of adoption of product standards for medical

devices. At first, a medical device shall conform to the standards laid down by the BIS
or as may be notified by the MHFW, from time to time. Where no relevant standards of
any medical device have been laid down by BIS or MHFW, such devices shall conform
to the standards laid down by the International Organization for Standardization (ISO)
or the International Electrotechnical Commission (IEC), or by any other pharmacopoe-
ial standards. Last, in case there are no standards specified BIS, MHFW or international
standards bodies, the device shall conform to the validated manufacturer’s stan-
dards.70
68. Introduction, Central Drugs Standard Control Organization, https://cdsco.gov.in/opencms/

opencms/en/About-us/Introduction/ (last visited 25 October 2020).
69. Central Drugs Standards Control Organization, India Standards Portal, http://indiastanda
rdsportal.org/standardbodiecontent.aspx?StandardBodyId=5 (last visited 25 October 2020).
70. R. 7, Medical Devices Rules, 2017.
128
5.5.5 Directorate of Marketing and Inspection (DMI)
The Directorate of Marketing and Inspection (DMI) was set up in 1935 to implement the
agricultural marketing policies and programmes for integrated development of mar-
keting of agricultural and other allied produce in India.71 Later, it became an attached
office of the Department of Agriculture, Cooperation and Farmers Welfare under
Ministry of Agriculture and Farmers Welfare. Safeguarding the interests of farmers and
consumers is at the heart of DMI’s functions.
DMI undertakes standardization, grading and quality control of agricultural and
allied produce. It develops and publishes its ‘AGMARK standards’ in the form of
Grading and Marking Rules of the commodities under the scheme for Promotion of
Standardization and Grading of Agricultural and Allied Produce.72 So far 222 commodi-
ties have been formulated and notified under the Agricultural Produce (G&M) Act
1937.73
Standard-setting in agricultural and allied produce requires consideration of wide
variations in physical and chemical parameters. Standards of agricultural commodities
are framed on the basis of scientific evidence.74 The standards are set on the
agricultural commodities which are of national ‘priority, necessity and demand’. The
physical and chemical parameters to formulate the standard are decided to determine
the quality and purity of the commodity. It is worth noting that the samples are
analysed after being collected from the growing areas. Analytical data is obtained on
statistical analysis on the basis of quality parameters. Since standards harmonization is
the constant aim of standardization process, international standard bodies like Codex
Alimentarius Commission and ISO are also consulted by the DMI. Once the draft rules
are framed and Preliminary Grading and Marking Rules are drafted, these are vetted by
the Ministry of Law and Justice, translated into Hindi and published in the Gazette of
India.
DMI is also implementing the scheme of certification of agricultural commodities
for domestic trade as well as export. It is a voluntary scheme.
5.5.6 Directorate of Standardization (DoS)
DoS determines standards for defence purchases and codification of defence invento-
ries. The DoS was established in 1962 while the Defence Cataloguing Authority was
merged with it in 1965. At present, it operates within the Department of Defence
Production under the Ministry of Defence. DoS coordinates the standardization

72. Directorate of Marketing and Inspection (DMI) – AGMARK, India Standards Portal, http://www
.indiastandardsportal.org/standardbodiecontent.aspx?StandardBodyId=7 (last visited 25 Octo-
ber 2020).
73. List of all products is maintained by the DMI and available at https://dmi.gov.in/Documents/
listcommodity1937.pdf.
74. Ananta Saikia, AGMARK Grades and Standards, 2 (EEI-NER, Working Paper), http://www.eei
-ner.org/wp-content/uploads/2019/09/AGMARK-Grades-and-Standards.pdf.
129
activities in Defence PSUs viz., BEML, BEL, HAL and shipyards, etc.75 It is the nodal
agency for all the Defence Standards. The DoS constantly undertakes harmonization of
Defence Standards with the Indian Standards.
DoS has endorsed the INSS published by the Ministry of Commerce and Industry
and the SNAP as formulated by BIS. It defines ‘Defence Standardization’ as ‘a means to
provide the use of minimum number of parts to serve the maximum number of
purposes consistent with economical manufacture, minimum whole life cost and the
quality/reliability necessary to ensure maximum fighting effectiveness’.76
The Directorate has adopted two methods of implementing standardization –
Entry control and Variety reduction.
‘Entry Control’ through standardization is planned and implemented for pre-
venting variations in items from entering the Defence supply system. It is primarily
achieved through ‘Codification’ and screening of proposals for availability of
similar/related standards/specifications. When one service wishes to introduce any
item, it shall first refer to the Joint Services Preferred Ranges (JSPR) or Joint Services
Specifications (JSS) issued on similar items. Introduction of the items to the service are
to be selected from the JSPR of the items so that proliferation of the items is checked.
It is always intended to codify the entire current Defence inventory for effective Entry
Control.77
‘Variety reduction’ is a form of standardization consisting of the reduction of the
number of types of products, or materials or parts within a definite range to a lesser
number which is adequate to meet prevailing needs at a given time. Variety reduction
is a preferred method from a logistical and economic point of view. It is believed that
for better war preparedness and fighting fitness, the variety of items purchased,
stocked, transported and used by the Defence Services are intended to be less.78 The
Variety Reduction is achieved through preparation of Joint Services Rationalised List
(JSRL)79 for commodities/equipment/assemblies/sub-assemblies/items for Defence
Services.
In addition to the above documents, Standardization Sub-Committees also
prepare Joint Services Guides (JSG) and Approved Notification (AN) to ensure
Standardization of products and processes. The Standardization Committee generally
adopts BIS Standards where practicable in preference to making departmental specifi-
cations to avoid duplicity and exercise economy of effort. If, it is adopted in full without
any modification, an Approval Notification would be issued by the Directorate.
To sum up, the DoS prepares five types of Standardization documents in respect
of components, assemblies, sub-assemblies, equipment and other Defence Stores:
75. About Us, Directorate of Standardization, https://ddpdos.gov.in/about/about-us (last visited 25

October 2020).
76. Organization Brief, Directorate of Standardization, https://ddpdos.gov.in/about/standardi
sation-profile (last visited 25 October 2020).
77. Id.
78. Id.
79. Joint Services Rationalized List is a list of existing inventory items, arrived at after elimination
of superfluous variety from existing inventory, which is adequate to meet the present require-
ment of users.
130
(a) Joint Services Specification (JSS)

(b) Joint Services Preferred Range (JSPR)
(c) Joint Services Rationalised List (JSRL)
(d) Joint Service Guide (JSG)
(e) Approved Notification (AN) for adoption of Indian Standards
These 5 types of standards prepared by the DoS are available for purchase by
private vendors, firms and traders on the basis of an RFI (Request-for-Information),
RFP (request-for-proposal), a supply order, a development order, or a referral letter
from defence organizations or defence related PSUs. Upon submission of the reason for
purchase, the standards can be purchased.
Therefore, while primarily for non-commercial use, there do appear to be a wide
range of situations, including fairly preliminary stages such as RFIs, in which these
standards might prove valuable for private players as well.
5.5.7 Food Safety and Standards Authority of India (FSSAI)
The FSSAI is governed by the Food Safety and Standard Act, 2006. It has been set up to
create food standards, grant certification for food safety and controls the food-based
hazards like adulteration, presence of the toxic substances. Food Safety Standards are
developed/reviewed taking into account the latest developments in food science, food
consumption pattern, new products and additives, advancement in the processing
technology and food analytical methods, and identification of new risks.80 The
development of standards is undertaken by twenty-one Scientific Panels and a Scien-
tific Committee comprising more than 250 subject independent experts/scientists of
eminence. These divisions function under the supervision of the Food Authority which
has been entrusted with setting standards, policy making and advising the Central
Government on health goals for India. The FSSAI lays down ‘science-based standards
for articles of food and to regulate their manufacture, storage, distribution, sale and
import to ensure availability of safe and wholesome food for human consumption’.81
There are seven regulations under the Food Safety and Standards Act which deal with
quality and safety parameters of various food products:
– Food Safety and Standards (Food Products Standards and Food Additives)
Regulations, 2011.
– Food Safety and Standards (Contaminants, Toxins and Residues) Regulations,
2011.
– Food Safety and Standards (Packaging and Labelling) Regulations, 2011.
80. Food Safety and Standards Authority of India (FSSAI), India Standards Portal, http://www.
indiastandardsportal.org/standardbodiecontent.aspx?StandardBodyId=10 (last visited 25 Oc-
tober 2020).
81. About FSSAI, Food Safety and Standards Authority of India, https://www.fssai.gov.in/cms/
about-fssai.php (last visited 25 October 2020).
131
– Food Safety and Standards (Food or Health Supplements, Nutraceuticals,

Foods for Special Dietary Uses, Foods for Special Medical Purpose, Functional
Foods and Novel Food) Regulations, 2016.
– Food Safety and Standards (Organic Foods) Regulations, 2017.
– Food Safety and Standards (Alcoholic Beverages) Regulations, 2018.
– Food Safety and Standards (Fortification of Food) Regulation, 2018.
FSSAI has currently over 500 standards published for food and food products.
FSSAI also prescribes standards for health supplements and nutraceuticals. FSSAI has
also developed standards for food businesses and processes. FSSAI has adopted the
Food Safety Management System (FSMS) as a tool for ensuring food safety. FSMS is a
systematic approach to controlling food safety hazards within a food business to assure
that food is safe to eat. All businesses are expected to put in place, execute and
maintain an FSMS based on the principles of ‘Hazard Analysis Critical Control Point’
(HACCP). HACCP is a management system in which food safety is addressed through
the analysis and control of biological, chemical and physical hazards from raw material
production, procurement and handling, to manufacturing, distribution and consump-
tion of the finished product. It is a preventive approach to food safety from biological,
chemical, physical hazards and more recently radiological hazards in production
processes that can cause the finished product to be unsafe and designs measures to
reduce these risks to a safe level. HACCP has been recognized internationally as a
logical tool for adapting traditional inspection methods to a modern, science-based,
food safety system.82
Under the Food Safety and Standards (Licensing and registration of Food
Businesses), Regulations 2011, while prescribing hygiene and sanitary conditions as a
prerequisite to both registration and licensing of Food Business Operators (FBOs), it is
also stated that the FBOs are encouraged to go for implementation an HACCP based
system. The Regulation states that:
These are the basic – compulsory requirements for ensuring safety of the food
manufactured in ay premise and FBOs shall continuously try to improve the
sanitary and hygiene conditions at the premises with a goal of attaining India
HACCP standards within a – previously determined period … .
Codex Alimentarius (Codex) Commission had published a ‘Recommended Inter-

national Code of Practice – General Principles of Food Hygiene’83 describing the
controls recognized internationally as essential for safety and suitability of food. In
addition, HACCP is recommended for ensuring enhanced food safety. The Codex
General Practice of Food Hygiene (GPFH) is applicable across the food chain. Since the
Codex GPFH and HACCP are guidance documents and hence, not amenable to auditing
82. Hazard Analysis Critical Control Point (HACCP) Principles & Application Guidelines, available
at https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-
application-guidelines; See also Food and Agricultural Organization, Hazard Analysis And
Critical Control Point (HACCP) System And Guidelines For Its Application, Annex to CAC/RCP
1-1969, Rev. 3 (1997) available at http://www.fao.org/3/Y1579E/y1579e03.htm.
83. Recommended International Code of Practice – General Principles of Food Hygiene, Codex
Alimentarius, CAC/RCP 1-1969, Rev. 4-2003.
132
or certification, the Quality Council of India (QCI), with multi-stakeholder participation

and consultation, has developed an IndiaHACCP Certification Scheme, for enabling
third-party verification of compliance by FBOs through voluntary certification initia-
tive.
IndiaHACCP certification, which can be obtained under the Voluntary Certifica-
tion Scheme for Food Safety operated by Quality Council of India (QCI), is based on
international best practices and global standards to ensure internationally acceptable
certification. This Scheme is intended to provide assurance that food is suitable for
human consumption but also maintain confidence in internationally traded food. The
IndiaHACCP Scheme provides Indian FBOs an alternative to foreign certifications and
outgo of foreign exchange. Thus, FBOs are encouraged to implement IndiaHACCP in
their operations and take certification from certification bodies approved under this
Scheme. On compliance with the requisite conditions, the certification can be obtained
under the IndiaHACCP Scheme which ensures internationally acceptable certification
as the Scheme is based on international best practices and global standards such as
DutchHACCP, Codex General Principle of Food Hygiene and ISO 22000:2005.
FSSAI develops guidance documents, codes of practices, etc., which are used for
upgrading the level of food safety implementation by food business, especially in the
SME sector across the country. A Risk Assessment Cell develops framework for
carrying out risk assessment-based studies. A Scheme of Research and
Development/Food Quality and Safety has also been developed by the FSSAI. The
FSSAI also houses a Quality Assurance Division (QA Division). The QA Division
notifies food laboratories and research institutions accredited by NABL for the pur-
poses of carrying out analysis of samples by the Food Analysts. Notification of food
testing laboratories/referral laboratories including recognition, renewal, suspension,
de-recognition, etc. is also conducted by the QA Division. As per Chapter VIII, section
43 of the Food Safety and Standards Act, 2006, FSSAI fosters an ecosystem for testing
of food at food laboratories for compliance with the food safety standards.
A Scientific Committee framed under the FSS Act is also engaged in constantly
updating the standards either through revision or amendment with the help of 8
Scientific Panels working under it.
FSSAI has had a central role to play in the development of India’s standards
ecosystem in the food sector. In addition to being the domestic regulator for the food
sector, FSSAI is also the enquiry point notified by India under the SPS Agreement. In
view of its role as a key driver of standard-setting in India, Chapter 8 of this Handbook
is dedicated to tracing the history, functions and operations of FSSAI within India’s
standards ecosystem.
5.5.8 Ministry of Environment, Forest and Climate Change (MoEFCC)
The MoEFCC is the nodal agency of the Central Government for planning, promotion,
coordination and overseeing of implementation of India’s environmental and forestry
133
policies and programmes.84 These policies and programmes are guided by the principle
of sustainable development and enhancement of human well-being. MoEFCC creates
standards which are formulated to conserve India’s natural resources including rivers
and lakes, biodiversity, forests and wildlife, ensuring animal welfare, and the preven-
tion and abatement of pollution.85
The Central Pollution Control Board (CPCB), established as a statutory organi-
zation under the Water Act 1974, acts as a technical support organization for the
MoEFCC. Environmental standards of emission and discharge for different industrial
activities, ambient air quality and noise standards developed by the CPCB are notified
by MoEFCC in the respective rules and regulations framed under the Environmental
Protection Act, 1986 (EPA) for mandatory compliance.86 CPCB is entrusted with the
task of development and revision of Environmental Standards. The Board maintains,
revises and upgrades the Comprehensive Industrial Document (COINDS) and guide-
lines for environmental management in various industrial sectors.87 The CPCB has
developed National Standards for Effluents and Emission under the statutory powers of
the Water (Prevention and Control of Pollution) Act, 1974 and the Air (Prevention and
Control of Pollution) Act, 1981. These standards were approved and notified by the
MoEFCC under section 25 of EPA. The environmental standards which have been
notified by CPCB include effluent standards (for 37 categories of industries), emission
standards (for 31 categories of industries), standards for ambient air quality, ambient
noise, automobile and fuels quality specifications for petrol and diesel. Guidelines have
also developed separately for hospital waste management.88 The CPCB has also
established and is operating the National Air Monitoring Programme (NAMP) to
‘determine the present air quality status and trends and to control and regulate
pollution from industries and other source to meet the air quality standards’.89 The
NAMP also provides background air quality data needed for industrial siting and towns
planning.
The CPCB creates standards in the following areas:
(a) Air Quality Standards;

(b) Water Quality Standards;
(c) Vehicular Exhaust;
84. About the Ministry, Ministry of Environment, Forest and Climate Change, http://moef.gov.in/
about-the-ministry/introduction-8/ (last visited 25 October 2020).
86. Ministry of Environment, Forest and Climate Change (MoEFCC), India Standards Portal http://
www.indiastandardsportal.org/standardbodiecontent.aspx?StandardBodyId=13 (last visited
25 October 2020).
87. Central Pollution Control Board (CPCB), India Standards Portal, http://indiastandardsportal.org
/standardbodiecontent.aspx?StandardBodyId=6 (last visited 26 October 2020).
88. Environment Standards in India, EnviroCare Labs, http://envirocare.co.in/environmental-
standards-in-india.htm (last visited 26 October 2020).
89. Central Pollution Control Board (CPCB), Ministry of Environment, Forest and Climate Change
http://moef.gov.in/about-the-ministry/organisations-institutions/boards/central-pollution-
control-board/ (last visited 26 October 2020).
134
(d) Noise Standards – Noise Limits for Vehicles and Airports and Noise Limits for
Generator Sets;
(e) Bio-Medical Incinerators;
(f) Auto Fuel Quality;
(g) Common HW Incinerators;
(h) Generator Set; and
(i) Industry specific standards.
The NAMP has set up a network of operating stations across various cities, towns
and villages in India to constantly monitor identified air pollutants such as SO2 and
CO2, and particulate matter. The aim is to use this data to determine trends in air
quality, and to determine if standards of air quality are being followed. These standards
are the National Ambient Air Quality Standards (NAAQS), notified by CPCB under the
Air (Prevention and Control of Pollution Act, 1981. These standards focus on prescrib-
ing air quality levels that are required for protection of health, and to provide ‘a
uniform yardstick’ for assessment of air quality across the country.90 These are in
addition to air pollution reduction measures such as the prescription of advanced
vehicle emission and fuel quality standards such as Bharat Stage-VI (BS-VI). BS-VI
refers to Indian standards for petrol and diesel, released by BIS.91
CPCB also prepares manuals, codes and guidelines relating to treatment and
disposal of sewage and trade effluents as well as for stack gas cleaning devices, stacks
and ducts. CPCB lays down standards for stream or well in consultation with the State
Governments, and also lays down standards for the quality of air.
Some examples of the key standards prepared by CPCB are:
(a) National Ambient Air Quality Standards (NAAQ);

(b) Water Quality Criteria;
(c) Standards for Emission or Discharge of Environmental Pollutants from vari-
ous industries (Industry specific standards);
(d) Standards for Treatment and Disposal of Bio-Medical Waste by Incineration;
(e) Emission Standards and Noise Limits for Diesel Engines; and
(f) Emission and Noise Limit of LPG and CNG Generator Sets.
CPCB also formulates the Minimal National Standards (MINAS) for various
categories of industries with regards to their effluent discharge (water pollutants),
emissions (air pollutants), noise levels and solid waste.92 The majority of MINAS were
published under the Environment (Protection) Rules of 1986, while some were
developed or revised thereafter. In addition to having developed a MINAS for the
textiles sector, CPCB has also issued a regulation aiming for facilities to attain a zero
90. National Clean Air Programme Report, Ministry of Environment, Forest and Climate Change, 10,
11, (2019) http://moef.gov.in/wp-content/uploads/2019/05/NCAP_Report.pdf
91. See Indian Standards on Petrol (IS 2796) and Diesel (IS 1460); Sale of BS-VI Norm Vehicles, PIB,
(9 December 2019, 2:25 P.M), https://pib.gov.in/Pressreleaseshare.aspx?PRID=1595507
92. Central Pollution Control Board (CPCB), supra note 77.
135
liquid discharge target, i.e., that no effluents are discharged into environment by the
industries.93 The driving force behind the development of a new MINAS or the revision
of an existing one can be the availability of new technologies for improvement in
prevention, control, and abatement of pollution. The public pressure generated by civil
society organizations or NGOs also plays an important role in raising environmental
issues which could be addressed by revised or new MINAS. The CPCB and MoEFCC
work together to create MINAS standards where the former provides expertise and
recommendations and the latter reviews the work done by CPCB before notifying these
standards. These standards are required to be adopted by State Governments and
Union Territory administrations as minimal standards.
5.5.9 Oil Industry Safety Directorate (OISD)
OISD is a technical directorate under the Ministry of Petroleum and Natural Gas. It
‘formulates and coordinates the implementation of a series of self-regulatory measures
aimed at enhancing the safety in the oil and gas industry in India’.94 Standardization is
one of its major activities. OISD observes and monitors the latest design and operating
practices in the areas of safety and fire fighting in the hydrocarbon processing industry
in the developed countries.95 This is done so as to develop standards and codes that
would be suitable for the conditions prevailing in India. These OISD standards are
periodically reviewed to incorporate the latest technological developments and expe-
riences gained in their implementation to keep them in line with the current interna-
tional practices.
All the activities related to standardization such as framing of new OISD
standards, revision or amendment of existing OISD standards are carried out as per the
requirement of the industry members. Such requirements are duly recorded in the
meetings of the steering committee of the OISD, which are held at least once in a year.
Alternatively, OISD may also take up revision/amendment/reaffirmation with the
approval of Executive Director, OISD.
The OISD had released a document titled ‘Guidelines for Preparation of OISD
Standards’ which directs and provides instructions for preparation of technical safety
standards as well as procedure for updating the standards. The process of standard-
setting under these guidelines starts with identification of topics for standardization
and through a process of consultation with members of a Functional Committee and
panellists, and review of public comments, OISD standards are printed by the Safety
Council of OISD following the approval by the Steering Committee.
93. OECD, India: Procedures to develop comprehensive industry documents and national emission
standards, in Report on Best Available Techniques for Preventing and Controlling Industrial
Pollution: Activity 2 – Approaches to Establishing BAT Around the World, 74, 76 (2018).
95. About Us, Oil Industry Safety Directorate, https://www.oisd.gov.in/about-us (last visited 26
October 2020).
136
5.5.10 Petroleum and Explosives Safety Organization (PESO)
PESO is a statutory authority, entrusted with the responsibilities under Explosives Act,
1884; Petroleum Act, 1934; Inflammable Substances Act, 1952, Environment (Protec-
tion Act), 1986 and the rules framed under these Acts.96 PESO is under the auspices of
the Department for Promotion of Industry and Internal Trade. Presently, PESO is
dealing with the administration of the rules under Explosive Act, 1884 and Petroleum
Act, 1934 as mentioned in Table 5.8.97
Table 5.8 Rules under Explosives Act, 1884 and Petroleum Act, 1934
Rules under Explosives Act, 1884 Rules under Petroleum Act, 1934
Explosives Rules, 2008 Petroleum Rules, 2002
Gas Cylinders Rules, 2004 Calcium Carbide Rules, 1987
Static & Mobile Pressure Vessels Cinematographic Film Rules, 1948
(Unfired) Rules 1981
Ammonium Nitrate Rules, 2012. Inflammable Substance Act, 1952
Notification No. GSR 625 (E) dated
07.08.1983 regarding Acetylene
PESO lays down the technical standards and specifications including safety
standards in activities related to explosives, petroleum and petroleum products,
pipelines, gases, gas cylinders, safety fittings, special electric equipment that have been
specified in relevant section of various rules framed under the Explosives Act, 1884 and
Petroleum Act, 1934.98
Since the Indian Standards formulated by BIS and the standards developed by
OISD cover the products under its scope, PESO takes a leading role in their formulation
and revision. These standards are related to manufacture, refining, processing, storage,
transportation, handling, testing and quality specification of explosives, petroleum,
flammable and non-flammable compressed gases and other hazardous substances and
referred various Indian Standards it its regulations making them mandatory.99 PESO
also undertakes the grant of approval, licences for manufacture, authorization, storage,
import/export, transport by road and packaging for explosives, petroleum, calcium
carbide, gas cylinders, pressure vessels and other hazardous substances.
96. Annual Report 2017-2018, Petroleum and Explosives Safety Organization 5 (2018) http://www
.peso.gov.in/web/sites/default/files/2019-12/AR2017_18.pdf.
97. Objectives PESO, Petroleum and Explosives Safety Organization, https://peso.gov.in/web/
objective (last visited 27 October 2020).
98. Petroleum and Explosives Safety Organization (PESO), India Standards Portal http://www.
indiastandardsportal.org/standardbodiecontent.aspx?StandardBodyId=17 (last visited 26 Oc-
tober 2020).
99. Id.
137
5.5.11 Telecommunication Engineering Centre (TEC)
TEC is a technical body under the Department of Telecommunications of the Ministry

of Communications. It is the WTO-TBT Enquiry Point for India in the Telecommuni-
cation Sector. TEC develops standards and specifications for modern technologies in
telecommunication and related ICT systems to be deployed in India. Specifications
which are published by TEC are categorized into three types – Generic Requirements
(GRs), Interface Requirements (IRs) and Service Requirements (SR). The Centre
promotes development and upgradation of ubiquitous, resilient and state-of-the-art
quality infrastructure by testing and certification.100 At the end of 2020, a total of 624
Technical Specifications have been formulated that includes 523 on GRs, 65 on IRs, 13
on SRs, and 23 Standards.101 TEC has also been associated with international standard-
ization bodies like International Telecommunications Union (ITU) in respect of
developing global standards. National Working Groups in TEC corresponding to
various study Groups of ITU contribute to global standards-making process.
TEC has been entrusted with the power to implement the standard-adoption
process with the help of an institutional framework consisting of Telecom Standards
Advisory Committee (TSCA), Consultative Committee(s)(CC) and task force(s) setup
for the purpose. The standard adopted by TEC is regarded as the National Standard in
India. In this regard, a Standardization Guide was formulated for ratification or
adoption of TSDSI/International Telecom Standards.102
The Standardization Guide has underlined the standards ratification/adoption
process as follows:
(a) Proposal: On receipt of a proposal for ratification/adoption in TEC, the same

is examined to see whether the standard proposed for adoption is duly
approved by General Body/governing body of Telecommunications Stan-
dards Development Society (TSDSI) or Telecom Standards Development
Organization (TSDO) concerned and whether the national requirements have
been represented or taken care of during standardization or transposition.
(b) Telecommunication Standards Advisory Committee (TSAC): The proposal is
then put up to TSAC for examination whether the standard can be adopted as
national standard.
(c) Draft TEC standard: Proposed standard once agreed for adoption as national
standard, becomes draft TEC standard for circulation.
(d) Circulation of draft: The draft standard is thereafter circulated electronically
for inviting public comments.
100. Quality Policy and Objectives, Telecommunications Engineering Centre, https://www.tec.gov

.in/quality-policy-and-objectives/ (last visited 27 October 2020).
101. Telecommunications Engineering Centre (TEC), India Standards Portal, http://www.indi
astandardsportal.org/standardbodiecontent.aspx?StandardBodyId=22 (last visited 27 October
2020).
102. Telecom Engineering Centre. Standardization Guide: Adoption of TSDSI/International Telecom
Standards, Version 1.0.0 (2019) https://www.tec.gov.in/pdf/PMI/Final%20Standardization
%20Guide.pdf.
138
(e) Public comments: The draft standard is normally available for public com-
ments irrespective of its national or international origin. Further, only tech-
nical content or the amendments affecting the technical content of standard
are open for public comments.
(f) Rejection of proposal: If the proposal is not agreed/approved for adoption as
national standards, TSDSI or the source of the proposal may be intimated
accordingly.
(g) Resolution of comments: The comments are compiled and reviewed. If no
comments other than the editorials are received, the draft shall be recom-
mended for ‘identical adoption’ after making editorial changes. If comments
or deviations related to incorporation of national
requirements/parameters/levels are received, the standard is modified ac-
cordingly in a manner consistent with ‘ISO/IEC guide 21’ and submitted for
approval as ‘modified adoption’. Process of seeking comments and discussion
are repeated to resolve all the issues.
(h) Finalization of draft: After completion of the process, the draft is finalized by
the Consultative Committee and submitted for approval.
(i) Notification: Whether the proposal is approved for adoption or not, informa-
tion on the decision is notified and in case of any discrepancy in comments,
procedure is followed for the same.
It is important to note that it is the TSDSI which either develops its own standards
or transposes International Standards to India. However, for these standards to apply
nationally in India, they must be formally adopted by the TEC.
As we can see, SDOs prepare standards in their specific areas or sectors.
However, SDOs cannot claim their standards to be Indian standards. Only BIS is
empowered to set Indian standards. As highlighted above, standards set by SDOs attain
national implementation once BIS recognizes standards set by these SDOs as Indian
Standards. Only two of these bodies – the Building Materials and Technology Promo-
tion Council (BMTPC), and the Automotive Research Association of India (ARAI) –
have an understanding with BIS to get their standards adopted as Indian Standards.103
5.6 CONCLUSION
The current regulatory regime for standardization in India is the culmination of several
decades of phased development of law-making. Since the establishment of the ISI in
1947, the approach to standard-setting and the processes and entities involved in
standard-setting have undergone significant changes.
Today, at the helm of this regulatory landscape sits the BIS which is the apex
national standardization body in India. It creates and enforces standards across several
sectors and classes of products and is responsible for handing the official designation
of ‘Indian standards’. BIS’s work is complemented by standardization organizations
139
(SDOs) which operate in specific sectors. SDOs are important actors in the standard-
setting process in India and contribute to the development of modern technology,
science, research and development, and technical expertise. SDOs may be statutory
bodies such as the FSSAI and CDSO, or in other cases, ministries such as the MoEFCC.
The process of standard-setting in BIS as well as the SDOs involves extensive
stakeholder consultations. The development of a standard in a specific sector may be
initiated either by a stakeholder, a regulator, any interested party or the SDOs.
Technical and expert committees within the SDOs work on such proposals to develop
standards for use. Depending on the mandate and scope of powers of the SDO, such
standards are then published and adopted for use in the sector either mandatorily or on
a best practices basis. For national application and for recognition as an Indian
Standard, a proposal may be submitted to BIS. BIS’s technical divisions will evaluate
these standards and accordingly adopt them as ‘Indian standards’. While standards
may generally be published and notified by the SDO or BIS in any such manner as
prescribed in their governing laws, mandatory standards must be notified in the
Gazette of India to acquire the legal force necessary to ensure their mandatory
application. This is done through quality control orders or rules and regulations under
parent statutes. BIS consolidates mandatory standards under one of its four compul-
sory registration schemes.
The complexity of legislation, processes and interaction among these bodies has
led the Government of India to push for a drive to harmonize and house standard-
setting under a single umbrella framework. The government released the INSS in 2018
to ‘provide direction for India’s political and executive leadership on how best to use
standardization, technical regulations, quality infrastructure and related activities to
advance the interests and well-being of Indians in a global economy.’ The INSS enlists
the aims, roles and functions of a robust quality ecosystem by providing strategies to be
considered in the standardization process. The strategies, aims and priorities formu-
lated under the INSS have been widely accepted as guidelines for standard-setting
process by the BIS as well as the SDOs. The INSS brings all the stakeholders, their
experiences, their legislations/rules/regulations under a single guiding document to
find uncomplicated pathways through the complex regulatory network of standardiza-
tion in India.
The BIS was prompt to release its own action plan under the guidance provided
by the INSS. The SNAP released in 2019 seeks to ensure synergy of the standardization
activities taking place in India. A key issue identified in the INSS is the gap in the
product coverage of the existing regulatory framework on standards in India. Though
there has been a push in favour of standardization and harmonization of India’s
standards with international standards, the BIS has acknowledged the further need to
enforce standards on priority products which are critical for India’s domestic industry
and public health and safety. In this regard, the SNAP details certain actions and
measures which are intended to be adopted by BIS to meet its targets under the Action
Plan. Through SNAP, the BIS lays out a systematic path which it aims to cover, giving
a clear and extensive picture of its standardization process in the future. This provides
a much-needed understanding and clarity to the businesses in India about BIS’s
140
standard-setting process and the relevant divisions of the Bureau which have specified
functions in the standardization process.
This chapter is intended to provide an overview of the landscape of standard-
setting in India. The subsequent chapters provide a comprehensive account of the
individual aspects of standard-setting and implementation in India.
141

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Handbook on Product Standards and

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Printed on acid-free paper.

e-Book: ISBN 978-94-035-3414-5

© 2021 James J. Nedumpara, Satwik Shekhar & Akshaya Venkataraman

Printed in the United Kingdom.

Ashish Chandra, Partner, International Trade/WTO Law Practice group at L&L

Hari Maya Gurung

List of Figures xxi

List of Tables xxv

Editors’ Introduction: Handbook on Product Standard and International

List of Figures xxi

List of Tables xxv

Editors’ Introduction: Handbook on Product Standard and International

1.3.1.2.3 Use of International Standards 22

5.2 Indian National Strategy for Standardization 112

6.2.2.2.5 Transparency and Notification

6.6 Conclusion 188

8.5 Regulation and Enforcement of the Food Safety Standards 235

9.5.3 Maximum Residue Limits (MRL) of Insecticides, Pesticides and

11.2 The Development of Services Standards in India 314

12.2 Digital Standards and International Developments 350

Figure 1.1 Types of Standards as per OECD

Figure 6.6 BIS Standard Mark for Management System

Figure 10.7 Thirty-Five Agricultural Products and the US Market Access

Table 8.1 India’s Food Standards Scorecard

The process of standard-setting in India involves a complex mesh of multiple

5.1.1 History of Standard-Setting in India

3. Origin of BIS, Bureau of Indian Standards, https://bis.gov.in/index.php/the-bureau/origin-of-

Table 5.1 The Four Phases in Evolution of Standards Ecosystem in India

Economic Phase Key Developments in Standards Ecosystem

5.1.1.1 Phase 1: 1947-1965

5.1.1.2 Phase 2: 1965-1980

5.1.1.3 Phase 3: 1980-1991

Reforms in the direction of liberalization by relaxing government control over indus-

8. Overview of India’s Quality Infrastructure, supra note 5, at 14.

5.1.1.4 Phase 4: 1991-Present

14. Overview of India’s Quality Infrastructure, supra note 5, at 16.

Accreditation Cooperation (APLAC), the International Laboratory Accreditation Coop-

19. Overview of India’s Quality Infrastructure, supra note 5, at 16.

Years No. of Notifications

Years No. of Notifications

5.1.2 Overview of India’s Standards Regulatory Landscape

The process of standard-setting in India involves a complex mesh of multiple

Figure 5.1 Snapshot of Some of the Standard-Setting, Conformity Assessment and

DEA BARC KEY

In the context of India, the process of standard-setting involves three different

(a) standard-setting by the government;

5.1.2.1 Policy Rationale for Standards

27. Operation of Eco Mark Scheme, Bureau of Indian Standards, https://bis.gov.in/index.php/

5.1.2.2 Regulations on Product Standards

(a) The BIS Act, 2016;

(i) Explosives Act, 1984;

In recent times, India has introduced a number of mandatory certification

5.2 INDIAN NATIONAL STRATEGY FOR STANDARDIZATION

consensus’ arrived at as a result of these consultations with government bodies,

5.2.1 Standards Development

37. National Policy, Directorate of Standardisation, Department of Defence Production, https://

Goal 1 Convergence of all standards development activities in India.

Setting up a dynamic mechanism for new standards identification,