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Cosmetic Regulatory Services in India

India's cosmetic market is one of the fastest-growing in the world, valued at over USD 6 billion and expanding rapidly. With rising consumer demand for personal care, beauty, and wellness products, the Indian market presents tremendous opportunities for both domestic manufacturers and international brands.

However, entering or operating in this market requires strict compliance with India's cosmetic regulations enforced by the Central Drugs Standard Control Organization (CDSCO). Whether you're a foreign brand looking to import cosmetics or an Indian manufacturer seeking licensing, navigating the regulatory landscape demands expertise, precision, and speed.

At Omega QMS, we bring decades of regulatory compliance experience to help you achieve seamless market entry and full regulatory compliance for cosmetic products in India.

Understanding India's Cosmetic Regulatory Framework

Cosmetic products in India are regulated under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. The regulatory authority responsible for cosmetic oversight is the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare.

Key Regulatory Bodies

  • CDSCO (Central Drugs Standard Control Organization): Regulates cosmetic imports, product registration, and enforcement of cosmetic standards. CDSCO operates the SUGAM online portal for registration applications.
  • State Licensing Authority (SLA): Issues manufacturing licenses to domestic cosmetic manufacturers and conducts facility inspections.
  • Bureau of Indian Standards (BIS): Sets technical standards for cosmetic products to ensure quality and safety.
  • Legal Metrology Department: Enforces labeling, packaging, and pricing requirements for cosmetic products.

What is a Cosmetic Product?

Under Indian law, a cosmetic is defined as any article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body's structure or functions. This includes:

  • Skincare products (creams, lotions, serums, sunscreens)
  • Hair care products (shampoos, conditioners, hair oils, dyes)
  • Makeup products (lipsticks, foundations, eye makeup)
  • Oral hygiene products (toothpaste, mouthwash)
  • Personal care products (deodorants, soaps, body washes)
  • Nail care products (polish, treatments)
  • Fragrances (perfumes, body sprays)
  • Baby and children's products (baby oils, powders, lotions)

Comprehensive Cosmetic Regulatory Services We Offer

Omega QMS provides end-to-end regulatory support for cosmetic products entering the Indian market. Whether you're importing or manufacturing locally, we handle every aspect of compliance so you can focus on your business.

For Foreign Brands and Importers

Import Registration (Form COS-1 / COS-2)

Foreign cosmetic manufacturers and brands seeking to import products into India must obtain Import Registration from CDSCO. This involves submitting comprehensive documentation and obtaining a certificate (Form COS-2) that authorizes import and sale in India.

Our Import Registration Services Include:

  • Pre-filing eligibility assessment and product classification
  • Complete documentation preparation and submission via SUGAM portal
  • Liaison with CDSCO officials and response to queries
  • Coordination of product testing at NABL-accredited laboratories
  • Authorized Indian Agent representation (if required)
  • Post-approval support and ongoing compliance management

Timeline: Typically 6-9 months from application to certificate issuance, depending on documentation completeness and CDSCO workload.

Authorized Indian Agent Services

Foreign manufacturers without an Indian office are required to appoint an Authorized Indian Agent to act as their local representative for regulatory matters. Omega QMS serves as your authorized agent, managing all interactions with CDSCO, maintaining compliance documentation, and ensuring timely renewals.

For Indian Manufacturers

Manufacturing License (Form COS-5 / COS-8)

Indian manufacturers of cosmetic products must obtain a Manufacturing License from the respective State Licensing Authority (SLA). This license certifies that your facility meets Good Manufacturing Practice (GMP) standards and is authorized to produce cosmetic products for sale in India.

Our Manufacturing License Services Include:

  • GMP compliance assessment and implementation support
  • Facility layout plan preparation and submission
  • Application preparation and submission to State Licensing Authority
  • Coordination of facility inspections and regulatory audits
  • Post-approval changes (PAC) and additional product permissions
  • License renewal support and compliance monitoring

Timeline: Typically 45-60 days from application to license issuance, subject to facility readiness and SLA processing time.

Label Compliance and Review

Cosmetic labels must comply with Rule 34 of the Cosmetics Rules, 2020, BIS standards, and Legal Metrology requirements. Non-compliant labeling can result in product seizure, penalties, and damage to brand reputation.

Our Label Compliance Services Include:

  • Comprehensive label review for regulatory compliance
  • Ingredient list formatting as per Indian standards
  • MRP declaration and Legal Metrology compliance
  • Manufacturer/importer address and contact information verification
  • Claims substantiation and advertising compliance
  • Multi-language labeling support (if required)

Product Testing and Safety Assessment

CDSCO requires product testing to ensure safety, quality, and compliance with Indian standards. Testing must be conducted at NABL-accredited laboratories or BIS-recognized international labs.

Our Testing Coordination Services Include:

  • Identification of applicable test requirements based on product category
  • Coordination with NABL-accredited laboratories for testing
  • Review of test reports for completeness and compliance
  • Heavy metal testing and microbiological analysis
  • Stability testing and shelf-life determination

Omega QMS also manufactures and supplies testing equipment for cosmetic laboratories, providing integrated solutions for manufacturers seeking in-house testing capabilities.

Post-Approval and Lifecycle Management

Cosmetic registration and licenses require ongoing compliance, renewals, and updates for product changes. We provide comprehensive post-approval support to ensure your business remains compliant throughout the product lifecycle.

Our Post-Approval Services Include:

  • License and registration renewals (every 5 years for import registration, periodic for manufacturing licenses)
  • Post-Approval Changes (PAC) for formula modifications, manufacturing site changes, and label updates
  • Additional product variant registrations
  • Regulatory intelligence and updates on changes to cosmetic regulations
  • Market surveillance and compliance monitoring

Regulatory Pathways and Process

Import Registration Process (For Foreign Brands)

The import registration process for cosmetic products involves several stages and requires meticulous documentation and coordination with CDSCO.

Step-by-Step Process:

  1. Registration on SUGAM Portal: Create an account on CDSCO's online SUGAM portal and obtain login credentials.
  2. Document Compilation: Prepare all required documents including manufacturing license, Free Sale Certificate, product formula, test reports, label artwork, and GMP certificate.
  3. Online Application Submission: Upload documents and complete Form COS-1 application through the SUGAM portal.
  4. Generate and Submit Form COS-1: Generate the form through the portal and upload the signed original.
  5. CDSCO Review and Query Response: CDSCO conducts technical evaluation. Respond promptly to any queries or requests for clarification.
  6. Certificate Issuance: Upon approval, Form COS-2 (Import Registration Certificate) is issued, valid for 5 years.

Government Processing Time: 180 days (approximately 6 months), though delays are common if documentation is incomplete.

Manufacturing License Process (For Indian Manufacturers)

Indian manufacturers must obtain a state-level manufacturing license before commencing commercial production of cosmetic products.

Step-by-Step Process:

  1. GMP Compliance Assessment: Ensure facility adheres to Good Manufacturing Practices as per Seventh Schedule of Cosmetics Rules 2020.
  2. Layout Plan Preparation: Prepare detailed facility layout showing manufacturing, testing, storage, and quality control areas.
  3. Application Submission: Submit Form COS-5 (application) to the State Licensing Authority along with required documents.
  4. Facility Inspection: SLA officials conduct an inspection to verify GMP compliance and facility readiness.
  5. License Issuance: Upon satisfactory inspection, Form COS-8 (Manufacturing License) is issued.

Typical Timeline: 45-60 days from application submission, subject to facility readiness and inspection scheduling.

Documents Required for Cosmetic Registration

For Import Registration (Foreign Manufacturers):

  • Manufacturing license of the foreign manufacturer (from country of origin)
  • Free Sale Certificate (or Certificate of Pharmaceutical Product - CoPP)
  • Complete product formula and composition
  • Product specifications as per BIS standards (if applicable)
  • Label artwork (inner and outer labels) in compliance with Indian requirements
  • Test reports from NABL-accredited or BIS-recognized laboratories
  • Heavy metal declaration and test results
  • GMP certificate of the manufacturing facility
  • Power of Attorney (if appointing an authorized agent in India)
  • Claims substantiation data (if making specific product claims)
  • Safety assessment report (if required for specific product categories)

For Manufacturing License (Indian Manufacturers):

  • Proof of business registration (GST certificate, incorporation documents)
  • Facility ownership or lease agreement
  • Detailed facility layout plan
  • List of machinery and equipment
  • Details of technical and quality control staff (qualifications and CVs)
  • Standard Operating Procedures (SOPs) for manufacturing and quality control
  • Product formulations and manufacturing process flowcharts
  • Source of raw materials and supplier details
  • Environmental clearances and pollution control certificates (if applicable)

Important Regulatory Requirements and Compliance Points

Prohibited and Restricted Ingredients

Cosmetic products must not contain ingredients listed as prohibited or restricted under Indian regulations. Common restrictions include limits on preservatives, colorants, heavy metals, and certain chemical compounds.

Key Points:

  • Review product formulations against prohibited and restricted ingredient lists
  • Ensure compliance with concentration limits for restricted ingredients
  • Provide safety data and justification for novel or borderline ingredients

Animal Testing Ban

As per Rule 39(7) of the Cosmetics Rules 2020, animal testing for cosmetic products is prohibited in India. Products and ingredients must be tested using alternative methods, and no animal-tested cosmetics can be imported or sold in India.

Labeling Requirements

Cosmetic labels must include the following mandatory information:

  • Name and address of manufacturer/importer
  • Product name and description
  • List of ingredients in descending order of concentration
  • Net quantity (volume or weight)
  • Batch number and manufacturing date
  • Expiry date or "Best Before" date
  • Country of origin (for imported products)
  • Maximum Retail Price (MRP) inclusive of all taxes
  • Customer care contact information

Good Manufacturing Practices (GMP)

All cosmetic manufacturers must comply with GMP requirements as specified in the Seventh Schedule of the Cosmetics Rules 2020. Key requirements include:

  • Adequate premises, equipment, and sanitation
  • Qualified and trained personnel
  • Standard Operating Procedures for all manufacturing and quality control processes
  • Proper documentation and record-keeping
  • Quality assurance and product testing protocols
  • Hygiene and contamination control measures

Why Choose Omega QMS for Cosmetic Regulatory Services?

At Omega QMS, we have built a reputation as one of India's most experienced regulatory consultancy firms. While cosmetic regulatory services represent a natural extension of our core expertise, we bring the same rigor, precision, and client-first approach that has made us leaders in BIS certification, product licensing, and regulatory compliance across multiple industries.

Our Unique Strengths

  • Proven Regulatory Expertise: With decades of experience in navigating India's complex regulatory landscape, our team includes former BIS officers and technical experts who understand government processes inside and out.
  • End-to-End Support: We manage the entire compliance journey from initial consultation to post-approval lifecycle management, so you can focus on your business.
  • Strategic Location in New Delhi: Our presence in India's regulatory capital ensures direct access to CDSCO, SLAs, and other government authorities, enabling faster query resolution and smoother approvals.
  • Integrated Testing Solutions: As manufacturers and suppliers of laboratory testing equipment, we offer unique integrated solutions for companies seeking in-house testing capabilities alongside regulatory compliance.
  • Transparent Communication: We provide clear timelines, regular progress updates, and honest assessments of your application status. No surprises.
  • Multi-Industry Experience: Our work across electronics, chemicals, steel, textiles, and other sectors gives us a broad perspective on Indian regulatory compliance, which we apply to cosmetic services.

Our Commitment to Your Success

We understand that entering the Indian cosmetic market requires speed, precision, and regulatory confidence. Our consultants work closely with you to:

  • Minimize approval timelines through proactive documentation and query management
  • Reduce compliance risk through thorough pre-filing review and gap analysis
  • Provide strategic market entry guidance tailored to your product portfolio
  • Ensure ongoing compliance throughout your product lifecycle

Whether you're a global beauty brand looking to enter India or an Indian manufacturer scaling up production, Omega QMS is your trusted partner for cosmetic regulatory compliance.

Get Started with Cosmetic Regulatory Compliance Today

Navigating India's cosmetic regulatory landscape requires expertise, attention to detail, and strategic planning. With Omega QMS as your regulatory partner, you gain access to decades of regulatory experience, direct government relationships, and a proven track record of successful approvals across multiple industries.

Ready to bring your cosmetic products to the Indian market? Contact us today for a comprehensive consultation.

Phone: +91-9810047474
Email: info@globalomega.com

Frequently Asked Questions

Yes, cosmetic registration is mandatory for all imported cosmetic products under the Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020.

For Foreign Manufacturers and Importers:

  • Import Registration (Form COS-1/COS-2) is mandatory before any cosmetic product can be imported into India.
  • Products cannot be cleared through customs without a valid CDSCO registration certificate.
  • Selling unregistered imported cosmetics is illegal and subject to penalties including product seizure, fines, and prosecution.

For Indian Manufacturers:

  • Manufacturing License (Form COS-8) is mandatory from the respective State Licensing Authority.
  • Manufacturers cannot legally produce or sell cosmetic products without a valid manufacturing license.
  • GMP compliance and facility inspections are required before license issuance.

Penalties for non-compliance: Manufacturing, importing, or selling cosmetics without proper registration/licensing can result in fines, imprisonment, and permanent business bans.

Omega QMS ensures your products are fully compliant before market entry, protecting your business from legal and financial risk.

The timeline for cosmetic registration in India depends on the type of registration and the completeness of documentation.

Import Registration (Foreign Manufacturers):

  • Official Government Timeline: 180 days (6 months) from submission of complete application
  • Typical Actual Timeline: 6-9 months including documentation preparation, query response, and CDSCO processing
  • Factors affecting timeline: Documentation completeness, test report availability, CDSCO workload, and response time to queries

Manufacturing License (Indian Manufacturers):

  • Typical Timeline: 45-60 days from application submission
  • Key dependencies: Facility readiness, GMP compliance, inspection scheduling by State Licensing Authority

How Omega QMS Expedites Your Application:

  • Pre-filing documentation review to ensure 100% completeness before submission
  • Proactive query management and rapid response to CDSCO questions
  • Direct liaison with CDSCO officials to address issues quickly
  • Parallel processing of testing and documentation to minimize delays

By ensuring perfect documentation from day one, Omega QMS minimizes approval timelines and gets your products to market faster.

Cosmetic registration and manufacturing licenses in India have defined validity periods and require periodic renewal.

Import Registration Certificate (Form COS-2):

  • Validity Period: 5 years from date of issuance
  • Renewal Process: Application for renewal must be submitted 3-6 months before expiry
  • Renewal Requirements: Updated test reports and continued compliance verification

Manufacturing License (Form COS-8):

  • Initial Validity: Typically 1-3 years depending on state regulations
  • Renewal: Must be renewed periodically; renewal intervals vary by State Licensing Authority
  • Inspection: Facility inspection may be required during renewal

Important Compliance Points:

  • Products cannot be imported or sold after license/registration expiry
  • Late renewal applications may result in processing delays
  • Continuous compliance with GMP and quality standards is required throughout the validity period

Omega QMS provides renewal reminders and complete support to ensure your certifications never lapse, protecting your market access and business continuity.

Yes, foreign brands can import cosmetics to India without setting up a local office, but they must appoint an Authorized Indian Agent or work through an Indian importer.

Option 1: Authorized Indian Agent

  • Foreign manufacturers can appoint an authorized representative in India to handle regulatory submissions and compliance
  • The agent acts as the local point of contact with CDSCO and other authorities
  • Power of Attorney is required to authorize the agent to act on behalf of the foreign manufacturer
  • Omega QMS provides Authorized Indian Agent services, managing all regulatory requirements, CDSCO liaison, and ongoing compliance on your behalf

Option 2: Import through Indian Distributor/Importer

  • Foreign manufacturers can partner with an Indian importer who obtains the registration
  • The Indian importer becomes the registration holder and is responsible for compliance
  • This option may be suitable if you have an exclusive distribution partnership in India

Documents Required from Foreign Manufacturer:

  • Manufacturing license from country of origin
  • Free Sale Certificate or Certificate of Pharmaceutical Product
  • GMP certificate of manufacturing facility
  • Product formulation and test reports
  • Power of Attorney (if appointing authorized agent)

Omega QMS simplifies market entry for foreign brands by serving as your authorized agent, handling all regulatory processes, and ensuring seamless compliance without the need for local incorporation.

CDSCO requires cosmetic products to undergo testing to ensure safety, quality, and compliance with Indian standards. Testing must be conducted at NABL-accredited laboratories in India or BIS-recognized international laboratories.

Common Tests Required for Cosmetic Products:

  • Heavy Metal Analysis: Testing for lead, mercury, arsenic, and cadmium to ensure compliance with safety limits
  • Microbiological Testing: Total bacterial count, yeast and mold count, pathogen screening (E. coli, Salmonella, Pseudomonas, Staphylococcus)
  • Physicochemical Testing: pH, viscosity, specific gravity, and other product-specific parameters
  • Preservative Efficacy Testing (PET): For products containing water or susceptible to microbial contamination
  • Stability Testing: To determine product shelf life and storage conditions
  • Ingredient Verification: Confirmation that ingredients match the declared formula
  • Claims Substantiation: Testing to support specific product claims (e.g., "SPF 50", "Anti-Aging", "Whitening")

Testing Timelines:

  • Routine testing: 7-15 days per product
  • Stability testing: Can take 3-12 months depending on claimed shelf life
  • Accelerated stability: Shorter timelines available for certain product categories

Omega QMS Testing Support:

  • Coordination with NABL-accredited laboratories across India
  • Guidance on applicable test requirements based on product category
  • Review of test reports for completeness and regulatory compliance
  • Supply of testing equipment for in-house laboratory setup (for manufacturers seeking testing capabilities)

We ensure your products are tested correctly the first time, avoiding delays from incomplete or non-compliant test reports.

Cosmetic product labels in India must comply with Rule 34 of the Cosmetics Rules, 2020, BIS standards, and the Legal Metrology (Packaged Commodities) Rules, 2011. Non-compliant labels can result in product seizure, penalties, and market withdrawal.

Mandatory Information on Cosmetic Labels:

  • Product Name and Description: Clear identification of the product
  • Manufacturer/Importer Name and Address: Complete registered address including country of origin (for imports)
  • Net Quantity: Volume (ml/L) or weight (g/kg) in prescribed format
  • List of Ingredients: All ingredients in descending order of concentration (International Nomenclature of Cosmetic Ingredients - INCI names recommended)
  • Batch Number: Unique identifier for traceability
  • Manufacturing Date: Month and year of manufacture
  • Expiry Date or "Best Before" Date: Shelf life indication
  • Maximum Retail Price (MRP): MRP inclusive of all taxes (mandatory under Legal Metrology Act)
  • Country of Origin: "Made in [Country]" or "Manufactured in [Country]"
  • Customer Care Details: Phone number, email, or address for consumer inquiries/complaints
  • Warnings and Precautions: If applicable (e.g., "For external use only", "Keep out of reach of children")
  • Registration Number: CDSCO registration number (for imported products once registered)

Additional Compliance Requirements:

  • Language: Labels must be in English and/or Hindi; additional regional languages optional
  • Font Size: Minimum font size requirements apply based on package size
  • Claims: All claims (e.g., "dermatologically tested", "organic", "natural") must be substantiated with evidence
  • Prohibited Claims: Medicinal or therapeutic claims are not permitted for cosmetics

Omega QMS Label Compliance Services:

  • Complete label review and compliance assessment
  • Identification and correction of non-compliant elements
  • Guidance on ingredient declaration and INCI nomenclature
  • MRP calculation and Legal Metrology compliance
  • Claims review and substantiation support

Non-compliant labels are a leading cause of product rejection and market delays. Omega QMS ensures your labels meet all regulatory requirements before submission, protecting your brand and accelerating market entry.

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