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 Categories

Requirements by product category

Key compliance requirements for different product types

Electronics & Electrical

  • BIS Certification
    ISI mark for scheduled electrical products
  • WPC Approval
    Equipment Type Approval for wireless devices
  • E-Waste Compliance
    RoHS and EPR registration

Medical Devices & Pharmaceuticals

  • CDSCO Registration
    Medical device registration (Class A-D)
  • Import License
    For drugs and medical devices
  • Local Representative
    Authorized Indian representative required

Food & Beverages

  • FSSAI License
    Import license for food products
  • Product Approval
    For novel foods and additives
  • Labeling Requirements
    Bilingual labels (English and Hindi)

Automotive & Components

  • Type Approval
    TAC for vehicles, CTA for components
  • AIS Compliance
    Automotive Industry Standards
  • Emission Standards
    Bharat Stage (BS) emission norms
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.

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)
Stay Updated

Recent regulatory updates

Latest changes and important announcements affecting India

BIS Certification 2024-2025

Expanded Mandatory BIS Certification

BIS has expanded the list of products requiring mandatory certification (CRS scheme). Recent additions include LED lamps, power banks, and various electronic accessories. Manufacturers must ensure compliance before market entry.

Medical Devices 2023-2024

Medical Device Rules Updates

CDSCO continues to strengthen medical device regulation with updated registration requirements and quality management system expectations. Class C and D devices face enhanced scrutiny.

E-Waste & EPR Ongoing

Strengthened E-Waste Management

The government has tightened E-Waste Management Rules with stricter EPR targets and enhanced enforcement. Electronics manufacturers must register and meet collection targets.

Stay Updated on India Regulations

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