Drugs & Cosmetics Act · Cosmetics Rules, 2020
Authority State Drug Controller

Cosmetic
Manufacturing Licence India

Complete end-to-end support for obtaining a Cosmetic Manufacturing Licence — mandatory for every company manufacturing skincare, haircare, colour cosmetics, fragrances and oral care products in India under ISO 22716 GMP compliance.

98%
Approval Rate
150+
Licences
All States
Covered
15+ Yrs
Experience
Cosmetic manufacturing
Manufacturing Licence GrantedACTIVE
State Drug Controller
⚙️ISO 22716 GMP CompliantCERTIFIED
Full mock audit included
🧪Schedule S ClearedVERIFIED
All formulations pre-checked
📜
Governing ActD&C Act, 1940
📋
RulesCosmetics Rules, 2020
🏢
AuthorityState Drug Controller
⚙️
GMP StandardISO 22716
🧑‍🔬
RequirementQualified Person
⏱️
Timeline3 – 9 months
Overview

What is a Cosmetic Manufacturing Licence?

A Cosmetic Manufacturing Licence is a statutory state-level approval permitting a company to legally manufacture and sell cosmetic products in India. No company can commercially produce cosmetics without it.

Cosmetic lab
5 Yrs
Licence Validity
⚖️

Legal Mandate

Manufacturing cosmetics for commercial sale without a valid licence is a criminal offence under the D&C Act. Every facility producing cosmetics — from small artisan studios to large industrial plants — must hold a valid state-issued licence before any commercial production.

⚙️

ISO 22716 GMP Compliance Required

The factory must comply with Good Manufacturing Practice for cosmetics (ISO 22716). The State Drug Inspector verifies premises, equipment qualification, QC systems, documentation and Qualified Person credentials during the site inspection.

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Qualified Person — Mandatory

A Qualified Person (QP) with a relevant degree in pharmacy, chemistry or science with industry experience must be appointed and present during operations. The QP is personally responsible for product release and GMP compliance.

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Category-Based Endorsements

Each cosmetic category — skincare, haircare, colour cosmetics, fragrances, oral care, baby cosmetics — requires a separate licence endorsement. The licence is premises-specific and tied to the physical factory address.

Licence Categories

Types of Cosmetic Manufacturing Licences

From full factory owners to contract brands and importers who repack — we handle every type of cosmetic manufacturing licence across all Indian states.

Full Manufacturing
Full Licence⏱ 3–9 months
// 01
Full Manufacturing Licence — Own Factory

Primary licence for companies with their own GMP-compliant manufacturing facility. Covers all approved cosmetic categories after Drug Inspector site verification. Requires dedicated areas, equipment, QP and complete QMS.

Own FactoryISO 22716All Categories
Apply Now →
Loan Licence
Loan Licence⏱ 3–6 months
// 02
Loan / Contract Manufacturing Licence

Your brand holds the licence; production happens at a licensed contract manufacturer's facility. Ideal for beauty startups, indie brands and D2C companies launching without their own factory investment.

No Own FactoryBrand OwnersStartups
Apply Now →
Repacking
Repacking⏱ 2–4 months
// 03
Repacking & Relabelling Licence

For companies importing bulk cosmetics and repacking into consumer units, or applying Indian labels before distribution. Requires a dedicated repacking area and separate licence endorsement from the State Drug Controller.

Bulk ImportRepackingRelabelling
Apply Now →
AYUSH
AYUSH⏱ 3–6 months
// 04
Ayurvedic Cosmetic Manufacturing Licence

For manufacturing Ayurvedic beauty products under Schedule T GMP norms — issued by the State AYUSH Department. Separate from the allopathic cosmetic licence with distinct qualified person requirements.

AYUSH Dept.AyurvedicSchedule T
Apply Now →
Amendment
Category Add⏱ 2–4 months
// 05
Additional Category Endorsement

Existing licence holders adding new product categories — e.g., adding colour cosmetics to a licence currently covering only skincare. Each category requires dedicated equipment and a separate Drug Inspector verification visit.

Existing LicenceCategory AddAmendment
Apply Now →
Renewal
Renewal⏱ 30–60 days
// 06
Annual Renewal & Amendments

Annual renewal before expiry, Qualified Person change, premises expansion, ownership change. We track all renewal deadlines and file 60 days in advance — zero licence lapses, zero manufacturing interruptions.

Annual RenewalQP ChangeNo Lapse
Apply Now →
Cosmetic GMP factory
// ISO 22716 GMP Standard

"GMP compliance for cosmetics is verified at every factory inspection — no licence without it."

— Cosmetics Rules, 2020 · Govt. of India
GMP Requirements

What the Inspector Checks

Every item below is assessed during the factory inspection. Deficiencies become NCRs that delay your licence — our pre-inspection mock audit eliminates them.

🏗️

Premises & Layout

Dedicated zones for manufacturing, QC, warehouse, quarantine and utilities. Controlled access, airlock systems, HVAC and pest control to prevent contamination between product categories.

Dedicated zonesHVACAirlockPest control
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Equipment Qualification

All manufacturing and QC equipment must be qualified (IQ/OQ/PQ), calibrated with valid in-date certificates and maintained under a preventive maintenance programme.

IQ/OQ/PQCalibrationPM programme
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Qualified Person & Staff Training

QP must hold relevant degree with experience. All production and QC staff must have documented GMP training records with regular refresher training.

QP qualificationGMP trainingTraining records
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SOPs & Batch Records

SOPs for every critical operation, current and approved by QP. Batch Manufacturing Records (BMR) completed in real-time. Change control, deviation management and CAPA systems in place.

SOPsBMRChange controlCAPA
Step-by-Step

How to Get a Cosmetic Manufacturing Licence

Our 6-step process takes your factory from gap analysis through GMP inspection to licence grant — with mock audits, SOP library and full NCR support included.

01
Site Assessment
Week 1–2
02
Document Prep
Week 2–5
03
GMP Readiness
Month 1–3
04
Application Filing
Week 3–4
05
Inspector Visit
Month 2–6
06
Licence & PMS
Ongoing
Step detail
STEP 01 / 06
Site & Gap Assessment

We review your cosmetic factory against ISO 22716 GMP requirements — identifying infrastructure, equipment, personnel and documentation gaps before any filing. Prevents rejection at the inspection stage and gives you a clear corrective action plan.

Factory layout vs. ISO 22716
Equipment and calibration review
QP qualification check
SOP and documentation review
QC lab adequacy check
Written gap report + action plan
1–2 wks
Duration
₹0
Govt. Fee
Free
Consult
Documentation

Documents Required for the Licence

A cosmetic manufacturing licence dossier covers company, factory, personnel and technical documents. Select a tab to view the complete checklist.

🏢
Business Registration
Mandatory for all applicants
01
Certificate of Incorporation / Partnership Deed / Proprietorship proof● Mandatory
02
GST registration certificate and PAN card of firm● Mandatory
03
Factory ownership deed or registered lease agreement● Mandatory
04
Municipal / Panchayat NOC for factory use● Mandatory
05
Pollution Control Board — Consent to Operate (CTO)● Mandatory
06
State-specific cosmetic manufacturing application form● Mandatory
07
Government licence fee payment receipt● Mandatory
08
Affidavit — no previous drug / cosmetic licence cancellation● Mandatory
📋
Compliance Declarations
Schedule and GMP declarations
01
List of cosmetic products and categories proposed for manufacture● Mandatory
02
Declaration of GMP (ISO 22716) compliance signed by QP● Mandatory
03
Schedule S compliance declaration for all proposed formulations● Mandatory
04
Undertaking to comply with Cosmetics Rules, 2020 labelling requirements● Mandatory
05
Self-inspection checklist against ISO 22716 (signed by QP)● Strongly recommended
🏗️
Premises & Layout
ISO 22716 infrastructure documents
01
Factory layout plan with area dimensions and room labels● Mandatory
02
Floor plan — manufacturing, QC, warehouse, quarantine, utility areas● Mandatory
03
HVAC / ventilation system diagram and specifications● Mandatory
04
Water supply quality test reports (potable / purified water)● Mandatory
05
Photographs of manufacturing areas, QC lab and warehouse● Recommended
⚙️
Equipment & Instruments
Manufacturing and QC equipment
01
List of manufacturing equipment with make, model and capacity● Mandatory
02
QC lab instrument list (pH meter, viscometer, balance, microscope etc.)● Mandatory
03
Valid calibration certificates for all measuring instruments● Mandatory
04
Equipment qualification records (IQ/OQ/PQ) for critical equipment● Recommended
05
Preventive maintenance programme for all production equipment● Recommended
🧑‍🔬
Qualified Person (QP)
Head of Quality — mandatory
01
Degree certificate — B.Pharm / M.Pharm / B.Sc / M.Sc Chemistry or equivalent● Mandatory
02
Cosmetics / personal care industry experience certificate (2+ years)● Mandatory
03
State Pharmacy Council registration (if B.Pharm / M.Pharm holder)● Mandatory
04
Appointment letter and employment contract from company● Mandatory
05
ISO 22716 GMP training certificate for the QP● Strongly recommended
06
Passport-size photograph of QP and proprietor / director● Mandatory
👥
Organisation & Staff
Supporting personnel documents
01
Organisation chart showing QP and all key technical staff roles● Mandatory
02
GMP training records for all production, QC and warehouse staff● Recommended
03
Personal hygiene policy and medical fitness records● Recommended
04
All directors' / partners' ID proof and address proof● Mandatory
🧪
Technical & Product Documents
Per product category proposed
01
Master formulae for each cosmetic product proposed for manufacture● Mandatory
02
Product specification sheets for each cosmetic category● Mandatory
03
SOP index and 30+ key critical SOPs covering all GMP areas● Mandatory
04
Schedule S compliance screening report for all formulations● Mandatory
05
Stability testing protocol and shelf-life data for key products● Recommended
06
Batch Manufacturing Record (BMR) template for each product type● Mandatory
📋
QMS & GMP System
ISO 22716 quality management evidence
01
Quality Manual — GMP policy and quality management system overview● Mandatory
02
Raw material specification sheets and approved supplier list● Mandatory
03
Finished product release protocol and QC testing procedures● Mandatory
04
Market complaint and product recall SOP● Recommended
05
ISO 22716 third-party GMP certificate (if already obtained)● Strengthens application
Mandatory for all
Conditional / recommended
Fees & Timeline

Cosmetic Manufacturing Licence — Fees & Timelines

Government fees vary by state, product category and scale. Below is an indicative guide — we provide exact state-specific quotes on request.

Licence / ServiceAuthorityApprox. Govt. FeeValidityTimelineType
Full Manufacturing LicenceState Drug Controller₹ 3,000 – ₹ 25,0005 years3–9 monthsOwn factory
Loan / Contract LicenceState Drug Controller₹ 2,000 – ₹ 15,0005 years3–6 monthsNo own factory
Repacking / RelabellingState Drug Controller₹ 2,000 – ₹ 10,0005 years2–4 monthsEndorsement
AYUSH Cosmetic LicenceState AYUSH Dept.₹ 2,000 – ₹ 12,0005 years3–6 monthsAYUSH Dept.
Annual RenewalState Drug Controller₹ 1,000 – ₹ 10,0005 years30–60 daysBefore expiry
Category EndorsementState Drug Controller₹ 1,000 – ₹ 8,000Co-terminus2–4 monthsAmendment
QP / Premises ChangeState Drug Controller₹ 500 – ₹ 3,000N/A15–45 daysAmendment
ℹ️
Fees vary significantly by state — Maharashtra, Karnataka and Gujarat typically have higher fees. Contact us for a state-specific and category-specific quote. Our professional service fees are quoted separately based on scope and complexity.
Post-Licence

Critical GMP Compliance Areas

Drug Inspectors conduct announced and surprise visits. These 8 areas are most frequently cited in cosmetic factory NCRs — keep them in perfect order at all times.

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SOP Currency

All SOPs must be current, approved by QP and reviewed annually. Expired or unsigned SOPs are the #1 cosmetic factory NCR finding across all states.

📦
Batch Record Completeness

BMR must be completed in real-time for every batch — no post-hoc entries. Incomplete batch records attract regulatory action and product recall orders.

⚖️
Calibration Currency

All QC instruments must be calibrated on schedule. Expired calibration certificates at inspection time lead to immediate NCR and potential product hold.

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In-Process Controls

In-process testing (viscosity, pH, colour, microbial) at defined stages must be conducted and recorded. All results must be within approved specification limits.

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Change Control

Any change to ingredients, suppliers, equipment or processes must go through formal change control. Unauthorised changes invalidate GMP compliance and may void licence conditions.

🌡️
Storage Conditions

Manufacturing and storage areas must maintain appropriate temperature and humidity. Cold chain for temperature-sensitive products. Daily environmental monitoring with documented logs.

🚫
Schedule S Compliance

All products must remain Schedule S compliant after licence grant. New suppliers or formulation changes must be re-screened against the current Schedule S list before production.

📊
Stability Studies

Ongoing stability studies required for all product categories. Shelf-life claims must be supported by real stability data. Retain stability samples from every manufactured batch.

Why RegPath

India's Cosmetic Manufacturing Licence Specialists

150+ cosmetic manufacturing licences granted across every Indian state — from artisan skincare startups to multi-category industrial beauty brands.

Cosmetic regulatory expert
98%
Approval Rate
150+
Licences Granted
🔍

ISO 22716 Mock Audit & GMP Readiness

A complete pre-inspection audit and full mock Drug Inspector visit — closing every gap before the real inspection. Our 92% first-attempt pass rate demonstrates the results of thorough preparation.

📋

60+ SOP Library — Ready to Customise

Our cosmetic GMP SOP library covers manufacturing, QC, warehouse, hygiene and change control. Dramatically reduces documentation prep time — inspector-ready SOPs from day one.

🧴

Schedule S Pre-Compliance for All Formulations

Every formulation is reviewed against current Schedule S before filing. We identify and resolve ingredient compliance issues before they become licence rejection reasons.

🗺️

All-State Drug Controller Knowledge

Maharashtra, Karnataka, Himachal Pradesh, Gujarat, UP, Rajasthan and 22+ more — each state's specific requirements, fees and inspector preferences are built into our process.

// Success Metrics 2009–2024
Full Cosmetic Manufacturing Licence98%
First-Attempt Inspection Pass Rate92%
AYUSH Cosmetic Licence Success97%
Annual Renewal Success Rate100%
FAQs

Cosmetic Manufacturing Licence — FAQs

Answers to the most common questions from cosmetic entrepreneurs, beauty brands, contract manufacturers and startups about the manufacturing licence process in India.

Can I manufacture cosmetics from a home studio without a licence?
+
No. Manufacturing cosmetics for commercial sale from any premises — including home studios or kitchens — without a valid manufacturing licence is a criminal offence under the Drugs & Cosmetics Act. Home premises cannot meet ISO 22716 GMP requirements. You need a GMP-compliant manufacturing facility with a valid state-issued licence. Startups can use a Loan Licence to manufacture at a licensed contract manufacturer's factory without building their own facility.
What is a Loan / Contract Manufacturing Licence for cosmetics?
+
A Loan (Contract Manufacturing) Licence allows your cosmetic brand to hold its own manufacturing licence while producing at a GMP-certified contract manufacturer's facility. Your brand name appears on the product label alongside the contract manufacturer's facility details. Ideal for D2C beauty brands, indie cosmetic startups and international brands entering India who want to launch without the significant capital investment of building their own GMP-compliant factory.
What qualifications does the Qualified Person (QP) need?
+
A Qualified Person for a cosmetic manufacturing licence must hold a relevant degree — typically B.Pharm, M.Pharm, B.Sc or M.Sc in Chemistry, Biochemistry, Microbiology or related life science — with relevant cosmetics or personal care industry experience (typically 2+ years). Unlike drug manufacturing, a single QP can cover both production and QC responsibilities. State-specific requirements vary — we advise on the accepted qualification for your specific state drug controller before filing.
Do I need separate licences for skincare vs. haircare vs. colour cosmetics?
+
Each cosmetic product category requires a separate endorsement on the manufacturing licence. Common categories include: skin care (creams, serums, lotions), hair care (shampoos, conditioners, oils), colour cosmetics (lipsticks, foundations), fragrances (perfumes, deodorants), oral care (toothpastes) and baby cosmetics. Each endorsement requires dedicated equipment for that category and a Drug Inspector verification visit. We advise on the most efficient way to group your product range into categories.
Is ISO 22716 certification mandatory to get the licence?
+
Third-party ISO 22716 certification by an accredited body is not mandatory to obtain the state cosmetic manufacturing licence — but compliance with ISO 22716 GMP principles is mandatory and verified during the Drug Inspector's factory visit. Having ISO 22716 certification significantly strengthens your application, results in a smoother inspection, and is increasingly required by major retail buyers, export markets and premium brands using your contract manufacturing facility. We recommend pursuing it alongside the state licence.
Can I use retinol, AHAs, salicylic acid in cosmetics I manufacture?
+
Yes — within Schedule S concentration limits. Salicylic acid is permitted up to 2% in rinse-off and 0.5% in leave-on products. AHAs (glycolic, lactic acid) are permitted with appropriate concentration and pH limits. Retinol is restricted in leave-on facial products. Making drug-like claims ("treats acne," "reverses ageing") even with permitted concentrations can trigger product reclassification as a drug — requiring a drug manufacturing licence instead. We screen all formulations and product claims before filing.
How long is a cosmetic manufacturing licence valid?
+
Cosmetic manufacturing licences are typically valid for 5 years in most states. Renewal must be filed before expiry — a lapsed licence means all manufacturing must stop immediately. We track renewal deadlines for all our clients and file renewals 60 days in advance to ensure continuous, uninterrupted manufacturing authority. If a licence lapses, a fresh application including a new Drug Inspector factory inspection may be required, which significantly delays your operations.
Do cosmetic manufacturers also need a CDSCO Import Registration (IRC)?
+
No — the CDSCO Cosmetic Import Registration Certificate (IRC / Form Cos-5) is required for importing finished foreign cosmetic products for commercial sale in India. If you manufacture cosmetics in India, you only need the state manufacturing licence from the State Drug Controller. However, if you also import some finished cosmetics from abroad alongside manufacturing your own, those imported products require a separate CDSCO IRC. The manufacturing licence only covers products made at your licensed Indian facility.

Launch Your Cosmetic Brand
— Get Licensed Today

Book a free consultation. We assess your factory, product categories and QP credentials — and give you a clear, transparent roadmap to your licence at zero cost.

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Head OfficeConnaught Place, New Delhi — 110001, India
✉️
Emailinfo@regpathcdso.in — Response within 24 hours
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Call / WhatsApp+91 98100 00000 — Mon–Sat, 9AM–6:30PM IST
Response TimeFree consultation booked within 24 hours