How to Get a Cosmetic Manufacturing License in India: Requirements, Documents, Process, and Compliance

Introduction

For cosmetic manufacturers, brand owners, and regulatory teams operating in India in 2026, obtaining the appropriate cosmetic manufacturing licence is a key regulatory requirement for manufacturing cosmetics under the Cosmetics Rules, 2020. The Rules established a dedicated regulatory framework for cosmetics under the Drugs and Cosmetics Act, 1940, with domestic manufacturing licences administered by the State Licensing Authority (SLA), while the Central Licensing Authority handles import registration and permissions for new cosmetics.

For domestic manufacturing, an application is made in Form COS-5 and the licence is granted in Form COS-8. Under the loan-licence route, the application is made in Form COS-6 and the licence is granted in Form COS-9. These licences remain valid in perpetuity, subject to payment of the applicable retention fee every five years and continued compliance with the Cosmetics Rules, 2020.

Scope of the Guide

This guide answers the applicant's question directly. What requirements, documents, facility conditions, technical personnel, application steps, and ongoing compliance obligations must manufacturers meet to obtain and maintain a cosmetic manufacturing licence in India? It walks through licence routes (manufacturing, loan, new cosmetics permission), Seventh Schedule premises/plant/equipment/technical staff requirements, GMP and testing laboratory obligations, Second Schedule Part II documentation, applicable online application process prescribed by the relevant State Licensing Authority, scrutiny/inspection/grant timelines, and post-licensing compliance covering labelling per BIS Ninth Schedule, retention fees, and audit cycles.

Table of Contents

• Introduction
• Why a Cosmetic Manufacturing License Matters for India in 2026
• What a Cosmetic Manufacturing License in India Is and Why It Matters
• Licence Routes COS-5 COS-6 and COS-3 Permission for Cosmetic Manufacturing in India
• Premises Plant Equipment and Technical Staff Requirements for Cosmetic Manufacturing in India
• Testing Laboratory GMP and Quality Control Requirements
• Documents Required for a Cosmetic Manufacturing License in India
• Cosmetic Manufacturing Licence Application Process
• Inspection GMP Audit Labelling and Post-Licensing Compliance for Cosmetic Manufacturing in India
• Conclusion

1. Why a Cosmetic Manufacturing License Matters for India in 2026

Four drivers make disciplined cosmetic manufacturing licensing a strategic priority for cosmetic manufacturers and brand owners in 2026.

1.1 Legal Requirement

A cosmetic manufacturing licence is required under the Cosmetics Rules, 2020 for the commercial manufacture of cosmetics in India. Manufacturing cosmetics without the applicable licence can lead to regulatory action under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020, including action against non-compliant products and manufacturing operations.

For manufacturers operating their own licensed premises, the manufacturing licence is granted in Form COS-8. Where an applicant intends to manufacture cosmetics using the facilities of another licensed manufacturer under the loan-licence route, the application is made in Form COS-6 and, if approved, the licence is granted in Form COS-9. The appropriate licensing route should therefore be determined based on the proposed manufacturing arrangement.

1.2 Cosmetics Market Growth

India's cosmetics and personal care market has expanded across mass, masstige, and premium segments, with growing demand across colour cosmetics, skincare, hair care, and men's grooming. D2C brands frequently use private-label and third-party manufacturing arrangements, for which the applicable licensing structure depends on the manufacturing and marketing arrangement.

Global brands entering India may follow domestic manufacturing or import registration routes, depending on their operating model. Market expansion is creating opportunities for both established manufacturers adding capacity and new entrants setting up cosmetic manufacturing operations, making regulatory planning an important part of market entry and expansion.

1.3 Regulatory Modernisation

• Cosmetics Rules 2020 (notified by MoHFW) replaced the fragmented cosmetics provisions of Drugs and Cosmetics Rules 1945 with a consolidated framework
• Licence validity moved from periodic renewal to perpetual with 5-year retention fees (Rule 30)
• The Cosmetics Rules provide for applications through an identified online portal, while the applicable filing mechanism should be verified with the relevant State Licensing Authority
• Ninth Schedule specifies applicable Indian Standards for listed cosmetic categories
• Seventh Schedule harmonises GMP premises/plant/equipment requirements across states
• New cosmetic permissions formalise pre-market approval for novel formulations

1.4 Export and Global Alignment

Indian cosmetics exports increasingly go to demanding markets (EU, US, ASEAN, Middle East, Africa) requiring documented cosmetic manufacturing compliance India credentials. ISO 22716:2007 (international GMP standard) alignment with Cosmetics Rules 2020 Seventh Schedule GMP simplifies dual compliance. Buyers request COS-8 licence copies, GMP certificates, and Ninth Schedule BIS test reports as supplier qualification proof. Cosmetic manufacturers holding disciplined licences with clean audit histories access export opportunities that unlicensed or non-compliant peers cannot.

2. What a Cosmetic Manufacturing License in India Is and Why It Matters

Understanding what a cosmetic manufacturing license in India is and why it matters begins with placing it within the Cosmetics Rules 2020 regulatory architecture.

2.1 Definition and Legal Basis

A COS-8 license is the legal permit issued by the State Licensing Authority under Rule 26 of the Cosmetics Rules 2020 authorising a manufacturer to formulate, fill, pack, label, and sell cosmetic products from a specified manufacturing facility. Cosmetics Rules 2020 notified by the Ministry of Health and Family Welfare (MoHFW) draw their statutory authority from the Drugs and Cosmetics Act 1940. Rule 2(i) defines a cosmetic as any article intended to be applied to the human body for cleansing, beautifying, enhancing attractiveness, or altering appearance.

2.2 Regulatory Architecture

2.3 Why Licensing Discipline Matters

• Cosmetics manufacturing regulations India impact multiple business dimensions
• Market access - unlicensed products cannot be legally sold retail or online
• Buyer qualification - modern trade, D2C platforms, and export buyers demand licence proof
• Liability protection - licence provides defensible compliance position
• Business continuity - suspended/cancelled licences halt operations immediately
• Brand credibility - documented compliance builds consumer trust and press positioning

3. Licence Routes COS-5 COS-6 and COS-3 Permission for Cosmetic Manufacturing in India

Understanding licence routes COS-5 COS-6 and COS-3 permission for cosmetic manufacturing in India is the first strategic decision. The right route depends on premises ownership, product novelty, and whether import is involved.

3.1 Manufacturing Licence Route (COS-5 to COS-8)

• COS-5 application to the State Licensing Authority for grant of a manufacturing licence in Form COS-8
• For manufacturers operating their own premises with own plant, equipment, technical staff, and testing arrangements
• Applies to greenfield facilities and existing facilities adding cosmetic categories
• Premises must comply with Seventh Schedule (premises, plant, equipment, GMP requirements)
• Fee schedule per Third Schedule of Cosmetics Rules 2020

3.2 Loan Licence Route (COS-6 to COS-9)

• Cosmetic loan license (Form COS-6 application, Form COS-9 licence) for entities without own manufacturing premises
• Brand owner (loan licensee) uses another COS-8-licensed manufacturer's premises for production
• Loan licensee holds the licence in their own name while manufacturing physically occurs at the host facility
• Manufacturing agreement between loan licensee and COS-8 holder documenting scope and responsibilities
• Host facility retains COS-8 licence; loan licensee gets COS-9 for the specific products
• Common route for D2C brands, private label startups, and companies awaiting own facility completion

3.3 New Cosmetic Permission (COS-12 to COS-3)

• New cosmetics require prior Central Licensing Authority permission through Form COS-12, with approval granted in Form COS-3
• Form COS-12 application to Central Licensing Authority with safety data, formulation, labelling
• Permission granted in Form COS-3 before manufacturing licence can cover the new cosmetic
• Safety evaluation per IS 4011:2018 methods of test for safety evaluation of cosmetics
• Timeline varies with completeness of safety data - can extend project timeline meaningfully
• Cosmetics that do not fall within the regulatory definition of a “new cosmetic” do not require this separate COS-3 permission route

3.4 Route Selection

4. Premises Plant Equipment and Technical Staff Requirements for Cosmetic Manufacturing in India

Understanding premises plant equipment and technical staff requirements for cosmetic manufacturing in India covers the Seventh Schedule of Cosmetics Rules 2020 - the operational backbone of any cosmetic manufacturing facility.

4.1 Premises Requirements (Seventh Schedule)

• Manufacturing premises must meet Seventh Schedule requirements covering layout, hygiene, and separation of functions
• Location away from open sewers, drains, public lavatories; environment free from dust/smoke/odours
• Separate rooms/areas for raw material storage, weighing/dispensing, manufacturing, filling/packing, finished goods storage, quality control
• Adequate space
• Interior surfaces: smooth, washable walls; flooring resistant to spills; adequate ventilation
• Water supply of potable quality; adequate drainage
• Separate area for change room, hand-wash facilities, protective clothing

4.2 Plant and Equipment

4.3 Technical Staff

• Cosmetic manufacturing must be conducted under the direction and personal supervision of competent technical staff, including at least one whole-time employee meeting the qualifications prescribed under Rule 26 of the Cosmetics Rules, 2020.
• The whole-time technical person must meet at least one of the prescribed qualification routes: hold a Diploma in Pharmacy approved by the Pharmacy Council of India; be registered under the Pharmacy Act, 1948; have passed the Intermediate Examination with Chemistry as a subject or an equivalent examination recognised by the Licensing Authority; or hold a bachelor's degree in Cosmetic Technology from a recognised university.
• Manufacturers should maintain documentary evidence of the technical person's applicable qualifications and employment status for licensing and inspection purposes.
• Additional trained personnel may be deployed for quality control, production, packaging, warehousing, documentation, and other functions based on the scale and complexity of manufacturing operations.
• Applicants should also verify any additional documentation or procedural requirements specified by the relevant State Licensing Authority.

5. Testing Laboratory GMP and Quality Control Requirements

Understanding testing laboratory GMP and quality control requirements for cosmetic manufacturing in India covers Eleventh Schedule GLP obligations and integrated quality systems.

5.1 Testing Laboratory (Eleventh Schedule)

• Testing laboratory requirements per Eleventh Schedule where in-house testing is performed
• Separate lab area with adequate space and lighting, ventilation, air conditioning where applicable
• Chemical testing area for physico-chemical parameters (pH, viscosity, colour, content assay)
• Microbiological testing for products requiring microbial limit tests
• Storage for reagents, standards, retained samples per Ninth Schedule requirements
• Alternatively, the manufacturer may arrange testing through a laboratory approved by the Central Licensing Authority under the Cosmetics Rules and accredited by NABL, with an appropriate scope covering the required tests

5.2 GMP Requirements

• GMP requirements per Seventh Schedule (Cosmetics Rules 2020) with international benchmark ISO 22716:2007
• Documented SOPs for all manufacturing operations, cleaning, sanitation
• Batch manufacturing records with unique batch numbers and traceability
• Change control procedures for formulation, process, or equipment modifications
• Deviation and non-conformance management with root cause analysis
• Complaint handling and product recall procedures
• Personnel hygiene protocols, protective clothing, training records
• Preventive maintenance schedule for equipment and utilities

5.3 Quality Control Testing

• Quality control spans raw material testing through in-process to finished product testing
• Raw material identity and quality verification against approved specifications
• Colorants restricted to IS 4707 Part 1 (Tenth Schedule Part I); soap colours per Tenth Schedule Part II
• Prohibited raw materials per ANNEX A of IS 4707 Part 2 excluded
• In-process controls at critical process steps
• Finished product testing per Ninth Schedule BIS specifications
• Retention samples per product per batch for the shelf-life period
• Certificate of Analysis (CoA) generated per batch signed by QC head

5.4 Cosmetic Product Standards

Ninth Schedule specifies applicable Indian Standards for listed cosmetic categories covering skin creams, skin powders, hair oils, shampoos, soaps, lipsticks, foundations, nail polishes, toothpastes, and others. If a BIS standard exists for the product category, compliance is mandatory; if not, product must meet requirements per Rules and standards from country of origin. Any new BIS standard introduced becomes mandatory 6 months after publication. Cosmetic product standards compliance forms a core part of both licensing and post-market surveillance.

6. Documents Required for a Cosmetic Manufacturing License in India

Understanding documents required for a cosmetic manufacturing license in India covers Second Schedule Part II of Cosmetics Rules 2020. Documentation quality directly determines application scrutiny time.

6.1 Application Documents

• Cosmetic manufacturing license documents typically include
• Cover letter on company letterhead addressed to the State Licensing Authority
• Filled Form COS-5 (manufacturing) or Form COS-6 (loan licence)
• Site master file describing facility, processes, equipment, quality systems
• Manufacturing site address proof (ownership deed or lease agreement)
• Plant/factory layout drawings showing zoning of production, storage, QC, staff areas
• List of cosmetic products intended to be manufactured with categories and formats
• List of plant, machinery, and equipment with make, model, capacity
• Qualification proofs of full-time technical/manufacturing staff (degree certificates, experience letters)
• GMP self-declaration/undertaking per Cosmetics Rules 2020
• Product compliance undertaking (Ninth Schedule BIS standards)

6.2 Supporting Documents

• Constitution documents of the applicant (incorporation certificate, partnership deed, proprietorship declaration)
• PAN, GST registration, trade licence
• Fee payment receipt from SUGAM portal per Third Schedule fee structure
• Power of Attorney if application filed through consultant/agent
• Consent to Establish (CTE)/Consent to Operate (CTO) from State Pollution Control Board (per Water Act 1974/Air Act 1981)
• Fire NOC and factory licence (per OSH Code 2020) from relevant authorities
• For loan licence: manufacturing agreement with COS-8-licensed host facility

6.3 Product-Level Documents

• Documentation for each intended product category
• Product formula with complete quantitative composition
• Specification sheet per BIS/internal standards signed by QC head
• Manufacturing method/process narrative with critical parameters
• Draft labelling in triplicate per Rule 34 and Ninth Schedule BIS labelling requirements
• Stability data or protocol for products where applicable
• Safety assessment/data for new formulations

6.4 Documentation Discipline

Documentation quality is the single strongest determinant of application success rate. Common deficiencies triggering queries: incomplete site master file, layout inconsistency with intended products, technical staff qualification gaps, product list not matching plant capability, missing BIS specification citations, incomplete labelling drafts. Preparing an audit-ready document dossier before submission reduces query cycles and shortens grant timeline. State Licensing Authorities publish state-specific checklists - verifying against local SLA checklist before submission avoids state-particular deficiencies.

7. Cosmetic Manufacturing Licence Application Process

Understanding application process scrutiny and licence grant for cosmetic manufacturing in India covers the end-to-end procedural pathway from filing to licence receipt.

7.1 Pre-Application Preparation

• Cosmetic manufacturing license application preparation steps
• Business entity formation and initial registrations (PAN, GST, trade licence)
• Site selection and premises readiness per Seventh Schedule
• Plant and equipment installation and validation
• Technical staff recruitment with required qualifications
• Testing arrangement through an in-house laboratory meeting the applicable requirements or an appropriately approved and NABL-accredited external laboratory, as applicable
• Document compilation per Second Schedule Part II and state-specific checklist
• SUGAM portal registration and applicant profile setup

7.2 Application Filing

• Cosmetic manufacturing license online filing through online portal (state-specific state SLA portals in some states)
• Fill Form COS-5 (manufacturing) or Form COS-6 (loan licence) online
• Upload all supporting documents in specified formats
• Pay fees per Third Schedule (base fee for 10 items per category; additional per-item fees)
• Submit application with digital signature/authentication
• Track application status via SUGAM portal dashboard

7.3 Scrutiny and Inspection

• SLA scrutinises submitted documents for completeness and compliance with Cosmetics Rules 2020
• Queries raised on SUGAM portal - applicant responds within specified time
• Pre-grant site inspection at SLA discretion - facility readiness verified against Seventh Schedule
• Any deficiencies noted require correction before grant
• Deemed acceptance provisions apply where SLA fails to act within specified timelines

7.4 Licence Grant Timeline

8. Inspection GMP Audit Labelling and Post-Licensing Compliance for Cosmetic Manufacturing in India

Understanding inspection GMP audit and post-licensing compliance for cosmetic manufacturing in India alongside labelling BIS standards and product-level compliance for cosmetic manufacturing in India completes the picture. Licences are perpetual only when compliance is sustained.

8.1 Post-Grant Inspection

• SLA conducts inspection within 30 days of licence grant
• Verification of GMP self-certificate (Form COS-7) claims against actual facility conditions
• If SLA does not inspect within 30 days, the licence is deemed valid for all purposes
• Correctable deficiencies: SLA may direct manufacturer to stop manufacturing until resolved
• False information in GMP self-certificate can trigger licence cancellation

8.2 Ongoing Inspection Cycle

• Inspection by SLA or authorised officers at least once every 3 years for licensed sites
• Form COS-11 inspection book maintained at site for inspector entries
• Drug inspectors may conduct sampling of manufactured cosmetics for testing
• Non-conforming samples can trigger show-cause notices, product recall, licence suspension
• Voluntary GMP audits (ISO 22716) support customer/export requirements alongside regulatory audits

8.3 Labelling Compliance

• Labelling requirements per Rule 34 and Ninth Schedule BIS specifications
• Product name, manufacturer name/address, manufacturing licence number (Mfg. Lic. No.)
• Batch number, manufacturing date, use-before/expiry date
• Net contents (weight/volume)
• Composition/list of ingredients (INCI names) as required
• Directions for use and precautions/warnings where applicable
• Compliance with category-specific BIS labelling requirements per Ninth Schedule
• Common non-compliance: missing Mfg. Lic. No., outdated packaging with old formulations, inadequate warnings

8.4 Retention Fees and Change Notifications

• Licence retention fee per Third Schedule payable before 5-year anniversary of licence issue
• Late fee 2 percent per month applies if retention fee paid within 180 days of due date
• Non-payment for 180 days beyond due date results in deemed cancellation of licence
• Any change in constitution of the firm requires fresh licence within 6 months
• Changes in labelling, composition, testing, specifications, or documentation must be reported to SLA within 30 days
• Change in name or address of manufacturer requires amendment of licence

8.5 Regulatory Compliance

Sustained regulatory compliance requires disciplined ongoing effort. Batch manufacturing records should be maintained in accordance with the Eighth Schedule and retained for the prescribed period, including three years after the expiry date of the relevant batch. Testing records for raw materials and finished products should also be maintained for the period prescribed under the Cosmetics Rules, 2020. Complaint records, recall procedures, product-level quality-control documentation, and applicable change notifications should be maintained as part of the ongoing compliance system.

Manufacturers should periodically review compliance with applicable Seventh Schedule requirements and monitor State Licensing Authority notifications, regulatory amendments, and relevant BIS standard updates. Maintaining appropriate regulatory oversight, whether through an in-house team or external regulatory support, can help sustain compliance throughout the life of the licence.

Conclusion

Obtaining and maintaining a cosmetic manufacturing licence in India requires the correct licence route, compliance with premises, equipment, staff, testing, GMP, documentation and labelling requirements, and timely applications to the relevant State Licensing Authority. Manufacturers must also manage inspections, retention fees, change notifications and ongoing compliance. A perpetual licence therefore still requires continuous regulatory oversight.

Three key priorities are choosing the correct licence route, submitting complete documentation, and maintaining compliance after approval. Own-facility and loan-licence applications follow different routes, while novel cosmetics may require separate CDSCO permission. Strong documentation can reduce application delays, and ongoing inspections, fee payments, notifications and labelling controls remain essential after the licence is granted.