India Product Registration & Certification
Important Notes
- CDSCO Registration: All pharmaceuticals, medical devices (since 2020), and (some) cosmetics require import or manufacturing registration with the Central Drugs Standard Control Organization to obtain an import or manufacturing license.
- Local Authorized Agent (Indian Agent): Foreign manufacturers must appoint an Authorized Agent resident in India (Indian citizen or registered company) to submit applications, communicate with CDSCO, and bear joint legal liability.
- New Medical Device Rules & Risk Classification: Per the Medical Devices Rules 2020, devices are classified A-D (low to high risk). Class B, C, D require CDSCO license; Class A only requires notification.
- Bioequivalence (BE) Study Requirement (Generics): Registration of oral generic drugs typically requires a BE study conducted in India or at specified overseas facilities, with data from pre-screened subjects.
- Price Control & DPCO: Drugs listed in the National List of Essential Medicines are subject to the Drug Price Control Order, with price ceilings set by the National Pharmaceutical Pricing Authority.
- Labeling & Language Requirements: Inner labels must contain information in English and a local official language (e.g., Hindi). Outer packaging and leaflets must at least be in English, with key information bilingual.
India Specific Requirements
- "Pharmacy of the World" & Complex Regulatory Transition: As the world's largest generic supplier, its regulatory system is evolving from fragmented to stringent unification, with the new Medical Devices Rules marking a significant shift.
- Extremely Price-Sensitive & Vastly Stratified Market: Low per capita health expenditure makes price the primary competitive factor. The market exhibits multiple dualities: urban/rural, public/private, branded/generic.
- Increasingly Strict Demands for Local Clinical Data: In recent years, requirements for clinical data (including BE studies) for new drugs and complex generics have become more standardized, emphasizing trial ethics and data reliability.
- Powerful Domestic Pharma & Device Industry: Local firms are not only global leaders in low-cost generics but also dominate in devices (e.g., monitors, syringes) and APIs, acting as both partners and competitors.
- Digital Initiatives & Evolving Public Procurement: The "Digital India" drive promotes online licensing and regulatory filings; public procurement is becoming more transparent and favors local manufacturing through the "Make in India" policy.
Medical Devices Registration
Regulatory Requirements
- Medical Device Import Registration Certificate
- Classification Management by Risk Level (Class A, B, C, D)
- Complete Technical Documentation and Test Reports
- Quality Management System Certificate (ISO 13485)
- English Labeling and Instructions for Use
- Free Sale Certificate
- Certificate of Origin
- India Local Test Reports
- Clinical Data (Class C, D devices)
- India Authorized Representative Agreement
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- India Authorized Representative Appointment
- CDSCO Application Submission
- Local Testing Completion
- Import License Acquisition
Registration Timeline
12-24 months
Official Fees
₹150,000 - ₹3,000,000
Service Fees
$18,000 - $55,000
Regulatory System Overview
CDSCO
Central Drugs Standard Control Organization India
Responsible for registration approval, import licensing, quality supervision, and market regulation of medical devices and pharmaceuticals. Operates as the primary regulatory authority under the Ministry of Health and Family Welfare, India.
FSSAI
Food Safety and Standards Authority of India
Responsible for food and health supplement safety regulation, standards development, and license approval. Ensures food safety and compliance.
BIS
Bureau of Indian Standards
Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Indian national standards
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to India Medical Devices Rules (Class A-D)
Technical Documentation Preparation
Prepare complete technical documentation including product specifications, test reports, quality system certificates
India Authorized Representative
Appoint authorized representative in India responsible for registration and regulatory affairs
CDSCO Application Submission
Submit medical device import registration application and all technical documents to CDSCO
Local Testing
Complete mandatory product testing in India NABL accredited laboratories
Cosmetics Registration
Regulatory Requirements
- Cosmetic Import License
- Ingredient Safety Assessment Report
- English Product Labeling
- Good Manufacturing Practice Certification
- Product Information File
- Microbiological Test Reports
- Stability Study Data
- BIS Mandatory Certification (for specific products)
- Heavy Metals and Contaminants Testing
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Import License Application
- Labeling Review Preparation
- BIS Certification Acquisition
Registration Timeline
6-12 months
Official Fees
₹75,000 - ₹600,000
Service Fees
$10,000 - $25,000
Regulatory System Overview
CDSCO
Central Drugs Standard Control Organization India
Responsible for registration approval, import licensing, quality supervision, and market regulation of medical devices and pharmaceuticals. Operates as the primary regulatory authority under the Ministry of Health and Family Welfare, India.
FSSAI
Food Safety and Standards Authority of India
Responsible for food and health supplement safety regulation, standards development, and license approval. Ensures food safety and compliance.
BIS
Bureau of Indian Standards
Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Indian national standards
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with India cosmetic regulations
Safety Assessment Report
Prepare product safety assessment report and technical documentation
Import License Application
Submit cosmetic import license application to CDSCO
Labeling Compliance Review
Ensure labeling complies with India cosmetic labeling regulations
BIS Certification
Obtain mandatory certification from Bureau of Indian Standards for specific product categories
Health Supplements Registration
Regulatory Requirements
- FSSAI License (Food License)
- Ingredient Safety and Quality Proof
- English Product Labeling
- Good Manufacturing Practice Certification
- Nutrition Claims Compliance
- Heavy Metals and Contaminants Testing
- Microbiological Test Reports
- Product Specifications and Purity Proof
- Importer FSSAI Registration
Main Process
- Product Classification Confirmation
- Technical Documentation Preparation
- FSSAI Application Submission
- Labeling Review Preparation
- Importer Registration Completion
Registration Timeline
4-9 months
Official Fees
₹50,000 - ₹300,000
Service Fees
$8,000 - $22,000
Regulatory System Overview
CDSCO
Central Drugs Standard Control Organization India
Responsible for registration approval, import licensing, quality supervision, and market regulation of medical devices and pharmaceuticals. Operates as the primary regulatory authority under the Ministry of Health and Family Welfare, India.
FSSAI
Food Safety and Standards Authority of India
Responsible for food and health supplement safety regulation, standards development, and license approval. Ensures food safety and compliance.
BIS
Bureau of Indian Standards
Responsible for developing mandatory product standards, conducting product certification and testing, ensuring specific product categories comply with Indian national standards
Health Supplements Registration Process
Product Classification Confirmation
Confirm product falls under health supplements category, determine applicable license classification
Technical Documentation Preparation
Prepare complete technical documentation including ingredient analysis, safety evidence, nutritional data
FSSAI Application Submission
Submit license application to Food Safety and Standards Authority of India
Labeling Compliance Review
Ensure labeling fully complies with FSSAI labeling regulations
Importer Registration
Ensure importer completes mandatory registration with FSSAI