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India

India

Access the world's most populous market with BIS certification, WPC approval, and comprehensive regulatory compliance for India's rapidly growing economy.

1.4B

Population

$3.7T

GDP (2023)

5th

Largest Economy

Key Requirements Overview

BIS Certification

Mandatory for regulated products

WPC Approval

Wireless and telecommunications equipment

CDSCO Registration

Drugs, cosmetics, medical devices

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India World's most populous market

India is the world's most populous nation and one of the fastest-growing major economies. With a burgeoning middle class, increasing urbanization, and a government committed to manufacturing growth through initiatives like "Make in India," the country presents massive opportunities for international businesses. However, navigating India's complex regulatory landscape requires careful planning and expert guidance.

Market Advantages

World's largest consumer market with 1.4+ billion people

Rapidly expanding middle class with growing purchasing power

Government incentives for manufacturing and exports

Strategic location for South Asian market access

Regulatory Framework

The Bureau of Indian Standards (BIS) is the primary body responsible for product standards and certification in India. The BIS operates a comprehensive certification scheme covering numerous product categories.

Additional sector-specific authorities regulate telecommunications (WPC/DoT), drugs and cosmetics (CDSCO), food safety (FSSAI), and automotive products (ARAI).

Quick Facts

Official Languages: Hindi, English (22 scheduled languages)
Currency: Indian Rupee (INR)
Market Area: Republic of India (28 states + 8 UTs)
Regulatory Body: BIS, WPC/DoT, CDSCO, FSSAI, ARAI
Standards Organization: Bureau of Indian Standards (BIS)

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Regulations & Requirements

Key India regulations

Understanding the regulatory landscape for product compliance

BIS Certification

Bureau of Indian Standards mandatory certification for regulated products under the CRS scheme.

• ISI mark required for scheduled products

• Factory inspection and surveillance testing

• Indian representative required for foreign manufacturers

WPC Approval

Wireless Planning and Coordination approval for wireless and telecommunications equipment.

• Equipment Type Approval (ETA) for wireless devices

• Testing to TEC standards or international equivalents

• IMEI registration for mobile devices

CDSCO Registration

Central Drugs Standard Control Organization for drugs, cosmetics, and medical devices.

• Import license for drugs and cosmetics

• Medical device registration (Class A-D)

• Local authorized representative required

FSSAI Registration

Food Safety and Standards Authority of India for food products and food contact materials.

• Import license for food products

• Product approval for novel foods

• Compliance with FSS Act and regulations

Automotive (ARAI)

Automotive Research Association of India type approval for vehicles and components.

• Type approval certificate (TAC) for vehicles

• Component type approval (CTA)

• Compliance with AIS and CMVR standards

Environmental Compliance

E-waste management, RoHS compliance, and environmental clearances.

• E-Waste Management Rules for electronics

• RoHS compliance (E-Waste Rules 2016)

• Extended Producer Responsibility (EPR)

Product Requirements

Requirements by product category

Understand which authority regulates your products and compliance requirements

Electronics (CRS)

BIS CRS Registration

Electrical safety, insulation, EMC, thermal performance testing. BIS-recognised lab tests required. BIS CRS certificate mandatory.

Electrical & Gas Appliances

BIS Certification (ISI Mark)

Safety, thermal performance, pressure resistance, durability testing. BIS-recognised labs. ISI marking and BIS License required.

Telecommunications Equipment

BIS + TEC/DoT Approval

Safety, EMC, thermal performance testing. Wireless/RF products need TEC/DoT approval. BIS CRS certificate required.

Food & Beverages

FSSAI Registration

Microbiological, chemical, safety testing at FSSAI-recognised labs. Nutrition labels, GMP/HACCP evidence, FSSAI License required.

Medical Devices

CDSCO Registration

Biocompatibility, safety, performance testing. Class A self-declared. Class B/C/D need CDSCO approval and license.

Cosmetics

CDSCO Registration (Imports)

Safety, microbiology, heavy metals testing. Imported: CDSCO approval. Domestic: GMP self-declaration. INCI lists required.

Toys

BIS Certification (IS 9873)

Mechanical/physical safety, chemical safety, flammability testing at BIS labs. Age grading, labeling, BIS License required.

Automotive Parts

BIS Certification

Mechanical strength, chemical composition, thermal, durability testing. BIS-recognised labs. ISI marking and BIS License required.

Building Materials

BIS Certification

Strength, chemical composition, durability, fire resistance testing. BIS/NABL labs. ISI marking and BIS License required.

Textiles

BIS Certification (regulated products)

Tensile, tear resistance, flammability, colourfastness, chemical testing. BIS/NABL labs. Labeling and BIS License where applicable.

Footwear

BIS Certification (certain categories)

Material composition, slip/tensile/adhesion testing. BIS/NABL labs. QMS documentation, labeling, BIS License required.

Furniture

BIS Certification (certain products)

Mechanical strength, stability, load-bearing, flammability, chemical safety testing. BIS/NABL labs. BIS License required.

Batteries

BIS Certification

Electrical performance, capacity, leakage, toxicity, flammability testing. BIS/NABL labs. MSDS, BIS Certificate, environmental approvals.

Machinery

BIS Certification (certain types)

Mechanical performance, load, safety, durability, electrical testing. BIS/NABL labs. Manuals, QMS, BIS License required.

Plastic & Rubber Products

BIS Certification (certain products)

Chemical composition, mechanical strength, thermal resistance, durability testing. BIS/NABL labs. BIS License required.

Food Contact Materials

BIS Certification (IS 14534)

Chemical migration, heavy metals, BPA, phthalates, thermal stability testing. BIS/NABL labs. MSDS, BIS License required.

Metals

BIS Certification

Chemical composition, tensile strength, hardness, corrosion resistance testing. BIS/NABL labs. QMS, traceability, BIS License.

Lubricants

BIS Certification (IS 1448)

Viscosity, flash point, pour point, acid value, toxicity, heavy metals testing. BIS/NABL labs. BIS Certificate required.

Paints & Coatings

BIS Certification

VOC content, heavy metals, flammability, drying time, adhesion testing. BIS/NABL labs. MSDS, environmental approvals, BIS Certificate.

Detergents & Cleaning Products

BIS Certification (IS 4251)

Chemical composition, pH, toxicity, corrosivity, foaming, cleaning efficiency testing. BIS/NABL labs. MSDS, BIS Certificate.

These are the basic requirements, but individual product types and regulatory schemes may have additional requirements.
Please contact SANTIQ for the full requirements that apply to your products.

Compliance Journey

Your India compliance process

Follow these steps to ensure your products meet Indian requirements

1

Product Classification

Identify applicable Indian standards and determine if BIS certification, WPC approval, or other sector-specific registrations are required.

2

Appoint Indian Representative

Foreign manufacturers must appoint an authorized Indian representative to liaise with BIS and other regulatory bodies.

3

Testing & Documentation

Conduct testing at BIS-recognized labs (Indian or international ILAC-accredited) and prepare technical documentation.

4

Certification & Factory Inspection

Submit application to BIS or relevant authority. Factory inspection required for BIS certification. Address any non-conformities.

Labeling & Market Entry

Apply ISI mark and comply with labeling requirements. Maintain surveillance testing and ongoing compliance obligations.

The actual process will vary depending on which authority regulates the specific product. The information provided here is high-level and not intended to be exhaustive. Please contact SANTIQ for the full requirements that apply to your products.

Documentation

Required documentation for India

Essential documents needed for certification and compliance

Technical Documentation

Required technical files for BIS and other certifications:

Product Specifications

Detailed technical specifications and ratings
Test Reports

From BIS-recognized or ILAC-accredited labs
Circuit Diagrams & Drawings

For electrical and electronic products
Quality Manuals

ISO certification and QMS documentation
Bill of Materials

Component details and specifications

Legal & Regulatory Documents

Required legal documents and authorizations:

Authorization Letter

Appointing Indian representative
BIS License

Product registration and ISI mark license
Import Documents

IEC code, customs documentation
Company Documents

Registration, incorporation certificates
Trademark Certificates

Brand registration in India (if applicable)

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