I. INTRODUCTION
India’s drive for ensuring quality and safety in goods and services has intensified over the last decade, and at the centre of this evolution stands the Bureau of Indian Standards (“BIS”). As the national standards body of India, BIS plays a pivotal role in promoting the culture of quality, setting benchmarks, and mandating compliance under a structured legal framework.
The recent changes in BIS’s enforcement under the Bureau of Indian Standards Act, 2016 (“Act”) and the growing list of products under mandatory certification through Quality Control Orders (QCOs) underscore the urgent need for businesses, especially manufacturers and importers, to understand and adapt to the BIS compliance ecosystem.
While BIS certification is largely voluntary, it becomes mandatory when the Central Government notifies specific products under QCOs or includes them in the Compulsory Certification list. Notably, even goods imported for captive consumption or self-use may fall within the purview of the BIS regime if so notified.
This article breaks down the BIS legal framework and recent regulatory developments to provide clarity on what Indian and foreign businesses must do to remain compliant.
II. THE BIS LEGAL FRAMEWORK:
1. The Act replaced the earlier BIS Act of 1986 to modernise the statutory framework. The BIS operates under the aegis of the Ministry of Consumer Affairs, Food and Public Distribution, and functions through its headquarters in New Delhi and a wide network of regional and branch offices. The Act empowers BIS to:
i. Establish Indian Standards for goods, services, processes, and systems
ii. Grant licenses and certification for conformity
iii. Enforce mandatory certification through QCOs issued by various ministries
iv. Conduct surveillance, testing, and enforcement through raids, penalties, and prosecution.
2. Under the Act, and the BIS (Conformity Assessment) Regulations, 2018 (“Conformity Regulations”), BIS operates a range of such schemes for both mandatory and voluntary certification, including certification for domestic manufacturers, foreign manufacturers, management systems, and hallmarking, among others. These schemes are structured mechanisms through which BIS evaluates and certifies whether a product, process, service, or system complies with applicable Indian Standards. These schemes are also essential for ensuring quality, safety, reliability, and performance of goods and services in the Indian market.
3. The key legal provisions of the Act mandating BIS certification include:
i. Section 16 – Mandatory Use of Standard Marks:
Section 16 of the Act empowers the Central Government to mandate the use of the Standard Mark on goods, systems, or services in the public interest. An order under Section 16, typically published in the Official Gazette, directs that such goods or articles must conform to specified Indian Standards and carry a Standard Mark under a BIS licence or conformity certificate.
ii. Section 17 – Prohibition Without Certification:
The Section 17 of the Act imposes a strict prohibition on the manufacture, import, sale, or distribution of goods covered under a notified order unless they bear a valid Standard Mark, and/or they conform to the relevant Indian Standard. These provisions effectively mean that any product falling under a QCO, or compulsory certification notification cannot legally be dealt with in India without BIS approval.
iii. Section 29 – Penalties for Non-Compliance
The violation of BIS mandates under the Act can attract penalties, including monetary fines, seizure of goods, and in some cases, imprisonment under Section 29 of the Act. These penalties aim to ensure strict adherence to quality standards and protect consumer interests by deterring the circulation of substandard or non-compliant products.
III. QUALITY CONTROL ORDERS (QCOS): THE ENFORCEMENT PILLARS
QCOs are statutory instruments issued by various ministries that mandate compliance with specific Indian Standards. Once a QCO is in effect, no person or entity can manufacture, import, distribute, sell, or store the listed product without BIS certification. Some of the key recent QCO Developments include:
1. Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024 (“Safety Order”): The Safety Order is a QCO issued under Scheme-X of Schedule-II of the Conformity Regulations. It is a relatively unique QCO that covers a wide range of machinery and equipment, while imposing multi-level BIS compliance requirements generally not found in other QCOs, also introducing mandatory safety standards for machinery and electrical equipment.
2. Chemicals QCOs (2023–24): In order to address concerns around consumer safety, product labelling, and manufacturing quality, the Ministry of Commerce and Industry has notified QCOs covering textiles, apparel, and footwear products.
These include notifications issued in 2020, 2023, and 2024. These regulations mandate compliance with Indian Standards on composition, durability, shrinkage, and labelling, targeting both domestic manufacturers and importers. E-commerce retailers are also required to ensure that listed products bear valid BIS marks.
3. Steel and Alloy QCOs: Various grades of steel (stainless, structural, electrical) are covered under QCOs by the Ministry of Steel. These ensure product integrity in critical infrastructure and automotive sectors.
4. Textiles and Footwear QCOs: The Ministry of Commerce implemented QCOs to mandate labelling, product composition, and performance conformity for textiles ensuring consumer protection.
5. Petrochemical and Fertilizer QCOs: The Ministry of Petroleum and Natural Gas, along with the Ministry of Agriculture, has issued QCOs that now cover polymers, petrochemical derivatives, fertilizers, micronutrients, and bio-stimulants. These QCOs have been issued progressively since 2020, with further updates and extensions in 2023, 2024, and 2025.
6. Battery and Electronic Goods QCOs: The QCOs for Battery and Electronic Goods, specifically Safety of Household, Commercial and Similar Electrical Appliances, will come into force on March 19, 2026. This QCO, notified by the DPIIT, applies to a wide range of electrical appliances with voltage ratings up to 250V for single phase and 480V for other appliances, including DC and battery-operated ones. It excludes products already covered under separate QCOs or mandatory BIS certification. These QCOs also aims to bring e-waste, lithium-ion battery packs, and critical power products under formal quality control.
IV. PRACTICAL IMPACT: WHEN IS BIS CERTIFICATION MANDATORY?
1. While BIS certification is voluntary for some products, it becomes mandatory when items are notified under QCOs issued by relevant ministries or departments or are listed under Compulsory Certification published by the BIS.
2. When a product is covered under the BIS mandates, the manufacturer, importer, or seller must obtain BIS certification prior to its sale, distribution, or import. Notably, the scope of BIS certification extends well beyond finished consumer goods such as:
i. Components, spare parts, and accessories intended for use in certified products must also comply if individually notified under a QCO.
ii. BIS mandates are not limited to goods sold in the market as products for self-use or captive consumption is not a valid exemption. A key notification issued by the Ministry of Commerce and Industry in 2004 (Notification No.29 (RE-2004) / 2002-2007) clarified that importers and industrial users must obtain BIS certification if the following conditions are met: a) Items are required for captive consumption, and b) Items are required on continuous basis, and c) Items are procured from pre-identified sources.
3. The BIS framework therefore imposes significant compliance responsibilities not just on manufacturers and importers, but also on businesses involved in assembling, integrating, or internally consuming notified goods. Also, the failure to comply may result in Penalties for Non-Compliance under the Act.
V. BIS CERTIFICATION PROCESS: A SNAPSHOT
1. The BIS certification process, in brief, involves the following key steps:
i. Application Filing (online via the BIS portal)
ii. Submission of Technical Documents (drawings, test reports, quality protocols)
iii. Factory Audit (domestic or overseas)
iv. Product Testing (in BIS-approved labs)
v. Grant of License/Registration
vi. Affixation of the BIS Mark and product release
vii. Post-Certification Surveillance, including inspections, sample collection, and testing.
2. For importers, it is critical to ensure products have BIS approval before they arrive at Indian ports as customs clearance is typically denied for uncertified goods listed under QCOs and covered under BIS mandates.
*Please note the content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
For any enquiry please contact
Kapil Mahajan
Kapil.mahajan@lexajia.com
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