CDSCO Regulated Service

Cosmetic
Registration
in India

End-to-end compliance support — from CDSCO Import Registration and Schedule S reviews to manufacturing licences, BIS certification and label compliance under Cosmetics Rules, 2020.

100%
Approval Rate
200+
Brands Registered
45
Days Min. IRC
15+
Years Experience
Cosmetic products arranged elegantly
Schedule S Cleared1,800+ ingredients reviewed
PASS
📋
IRC ApprovedForm Cos-5 — CDSCO
ACTIVE
🏆
BIS CertifiedBaby & Sun care
ISI Mark
📜
Governing ActD&C Act, 1940
📋
RulesCosmetics Rules, 2020
🏛️
AuthorityCDSCO — MOHFW
📝
Key FormForm Cos-5 (Import)
🖥️
PortalCDSCO Sugam
⏱️
Timeline45 days – 6 months
What We Cover

Cosmetic Compliance Services

From import registration certificates to manufacturing licences, label reviews and safety assessments — complete cosmetic regulatory compliance in India.

Cosmetic import registration
Import Service ⏱ 45–90 days
CDSCO Cosmetic Import Registration (IRC)

Foreign cosmetic brands must obtain an Import Registration Certificate (IRC) from CDSCO before selling in India. We handle Form Cos-5 filing, IRP appointment and Sugam portal submission.

Form Cos-5IRC CertificateIRP AppointmentSugam Portal
Get Started →
Cosmetic manufacturing facility
Manufacturing ⏱ 3–6 months
Cosmetic Manufacturing Licence

Indian manufacturers require a state-level manufacturing licence under Cosmetics Rules, 2020. We assist with GMP compliance, factory preparation and state drug controller applications.

State AuthorityGMP ComplianceFactory InspectionISO 22716
Get Started →
Skincare safety testing
Safety Assessment ⏱ 2–4 weeks
Cosmetic Safety Assessment

A qualified cosmetic toxicologist's safety assessment is mandatory for CDSCO import registration. We coordinate complete assessments covering all ingredients, usage patterns and risk profiles.

Toxicologist ReviewNOAEL / MoSIngredient SafetyCDSCO Format
Get Started →
Cosmetic ingredient analysis
Schedule S ⏱ 5–10 days
Schedule S — Ingredient Compliance

We review every ingredient in your formulation against India's Schedule S prohibited and restricted list — identifying non-compliant ingredients and recommending permissible alternatives.

Prohibited IngredientsRestricted ListFormulation ReviewWritten Report
Get Started →
Cosmetic product labelling
Label Review ⏱ 3–7 days
Labelling & Claims Review

Labels must comply with Cosmetics Rules, 2020 — INCI list, MRP, batch number, expiry, country of origin and more. We review and correct labels before submission to avoid rejection.

INCI FormatMandatory FieldsClaims ValidationMRP Declaration
Get Started →
BIS certification cosmetics
BIS Certification ⏱ 4–9 months
BIS Cosmetics Certification

Baby care and sunscreen products require mandatory BIS certification under IS standards. We manage the complete application, factory audit preparation, product testing and ISI mark licensing.

ISI MarkBaby CareSunscreens SPFFactory Audit
Get Started →
Product Categories

Cosmetic Products We Register

We register all categories of cosmetics defined under the Drugs & Cosmetics Act — skincare, haircare, colour cosmetics, fragrances, oral care and more.

Skincare products
🧴 Skincare
Moisturisers, serums, sunscreens, face washes, toners, anti-ageing creams
Haircare products
💇 Haircare
Shampoos, conditioners, hair oils, dyes, serums, scalp treatments
Colour cosmetics makeup
💄 Colour Cosmetics
Lipsticks, foundations, mascaras, eyeshadows, nail polishes, blushers
Fragrance perfume
🌸 Fragrances
Perfumes, eau de toilette, body mists, deodorants, roll-ons
Oral care products
🦷 Oral Care
Toothpastes, mouthwashes, teeth whitening, dental floss, lip balms
Baby care products
👶 Baby Care
Baby lotions, shampoos, powders, creams — BIS certification required
Body care products
🧼 Body Care
Body washes, soaps, scrubs, body butters, hand creams, foot care
Sun care sunscreen
☀️ Sun Care
Sunscreens SPF 15–50+, after-sun products — BIS certification required
Regulatory Compliance

Schedule S — India's Cosmetic Ingredient Standard

Schedule S lists ingredients that are prohibited or restricted in cosmetics sold in India. Non-compliance means import rejection at customs and legal liability for the importer.

Cosmetic ingredient testing laboratory
Schedule S Status Legend
Prohibited — completely banned
Restricted — concentration limits
Limited — product-type specific
Permitted — no restriction

📋 What is Schedule S?

Schedule S under the D&C Act lists cosmetic ingredients that are either completely banned in India, restricted to certain concentrations, or permitted only in specific product types. It mirrors EU Cosmetics Regulation with India-specific additions.

Covers Annexures I (prohibited) and II (restricted with conditions)
Updated by Gazette notifications — we track all changes
Applies to both imported and domestically manufactured cosmetics
Non-compliant products are rejected at port or seized from market

Common Issues We Identify & Resolve

● Prohibited
Hydroquinone
Banned in cosmetics — only in prescription drugs
● Prohibited
Mercury Compounds
Found in mascaras from some markets
● Restricted
Kojic Acid
Max 1% in face creams only
● Restricted
Salicylic Acid
2% rinse-off / 0.5% leave-on limit
● Limited
Retinol
Restricted in leave-on face products
● Prohibited
Certain UV Filters
Some EU/US-approved filters banned in India
Step-by-Step

Our 6-Step Registration Process

A structured approach that achieves CDSCO cosmetic registration with zero rework and maximum speed — backed by 200+ successful registrations.

Product & Formulation Assessment
Cosmetic vs. drug classification, Schedule S pre-check, product category identification and regulatory roadmap.
Week 1
🔬
Safety Assessment & Schedule S Review
Full ingredient review against Schedule S. Safety assessment coordinated with qualified cosmetic toxicologist.
Week 1–3
🏷️
Label & Claims Compliance Review
Mandatory field verification, INCI format check, MRP declaration, and no-drug-claims confirmation.
Week 1–2
👤
Indian Responsible Person (IRP) Setup
IRP appointment, Sugam portal registration, and manufacturer authorisation letter preparation.
Week 2
📋
Form Cos-5 Application on Sugam
Complete Form Cos-5 filing on CDSCO portal, document upload, fee payment and status tracking.
Week 3–4
IRC Grant & Post-Registration Support
Receive IRC certificate. Label update coordination, product additions, renewal tracking and ongoing compliance.
Approval + ongoing
Regulatory assessment
STEP 1 OF 6

Product & Formulation Assessment

We determine whether your product qualifies as a cosmetic under Indian law, identify the product category, conduct a preliminary Schedule S scan, and create a full regulatory roadmap with timeline and fee estimate — all before you commit to anything.

Cosmetic vs. drug classification under D&C Act
Product category identification
Preliminary Schedule S ingredient scan
BIS requirement check (baby care, sunscreen)
Regulatory roadmap with timeline and fees
1 wk
Duration
₹0
Govt. Fee
Free
Consult
Label Compliance

Mandatory Cosmetic Labelling Requirements

Cosmetics Rules, 2020 specifies exactly what must appear on all cosmetic product labels sold in India — imported and domestic alike. Incorrect labels are the #1 reason for IRC rejection.

Cosmetic product labels
🏷️

India-Compliant Label — Mandatory Fields

As per Cosmetics Rules, 2020

📦Product NameHydraGlow Face Cream 50gRequired
🏭Manufactured ByXYZ Cosmetics GmbH, BerlinRequired
📥Imported By (IRP)ABC Beauty India Pvt Ltd, DelhiRequired
💰MRP₹1,299 (Incl. all taxes)Required
🔢Batch NumberB2024-1122Required
📅Mfg. / Expiry DateNov 2024 / Nov 2026Required
🧪Ingredients (INCI)Aqua, Glycerin, Niacinamide…Required
📋IRC NumberCOS/IRC/2024/XXXXXRequired
🌍Country of OriginMade in GermanyRequired

Our label review catches every non-compliance before you file — saving weeks of back-and-forth with CDSCO. Here's what we verify:

1
INCI Ingredient List

Complete ingredient list in INCI (International Nomenclature of Cosmetic Ingredients) in descending order of concentration — a strict Cosmetics Rules, 2020 requirement.

2
MRP Declaration

"MRP ₹XX (Incl. all taxes)" must be printed or stickered. Missing MRP is a Legal Metrology Act violation carrying serious penalties.

3
IRC Number on Label

The CDSCO Import Registration Certificate number must appear on every pack before commercial import — customs will reject shipments without it.

4
Importer (IRP) Details

Full name and address of the Indian Responsible Person (importer) must appear on label or an adhesive sticker affixed before customs clearance.

5
No Drug Claims

Claims like "treats acne," "cures dandruff," or "reverses ageing" reclassify your product as a drug — we review all claims and marketing copy for compliance.

6
Batch Number & Dates

Batch/lot number, month & year of manufacture, and "Best Before" or "Use Before" date are all mandatory per Cosmetics Rules, 2020.

Documentation

Documents Required by Registration Type

Required documents vary by registration type. Select a category below to see the complete checklist for your specific application.

🏭
Manufacturer Documents
From foreign manufacturer
📋
Manufacturing licence / GMP certificate from country of origin● Mandatory
📋
Free Sale Certificate (FSC) — product approved in origin country● Mandatory
📋
Authorisation letter appointing Indian Responsible Person (IRP)● Mandatory
📋
Undertaking on quality and Schedule S compliance● Mandatory
📋
ISO 22716 (Cosmetics GMP) certificate● Recommended
🧪
Product & Formula Documents
Per product / SKU
📄
Complete INCI ingredient list with % concentrations● Mandatory
📄
Product specification / technical data sheet● Mandatory
📄
Safety assessment by qualified cosmetic toxicologist● Mandatory
📄
Stability / shelf-life study data● Mandatory
📄
Challenge / preservative efficacy test report● If applicable
🏷️
Product label artwork — India compliant with all mandatory fields● Mandatory
🏗️
Premises & Infrastructure
State Drug Controller requirements
📋
Factory plan with manufacturing, QC and storage areas● Mandatory
📋
Ownership / lease agreement of factory premises● Mandatory
📋
NOC from local authority / fire department● Mandatory
📋
List of plant and machinery with capacity● Mandatory
📋
Water quality test report (BIS standards)● Mandatory
👩‍🔬
Personnel & Quality Documents
GMP compliance
📄
Qualified person certificate (B.Pharm / M.Sc Chemistry / relevant degree)● Mandatory
📄
GMP / ISO 22716 compliance declaration● Mandatory
📄
Product master formula list● Mandatory
📄
Standard Operating Procedures (SOP) list● Recommended
📄
QC laboratory equipment list● Mandatory
🏆
BIS Application Documents
For baby care & sunscreens
📋
BIS application form (online) with product details● Mandatory
📋
Product test report from BIS-approved laboratory● Mandatory
📋
Manufacturing licence (state or home country GMP)● Mandatory
📋
Factory layout and QMS documentation● Mandatory
📋
Indian Authorised Representative letter (foreign mfr)● Foreign mfr
🧫
Product Testing Documents
IS Standard compliance
📄
Product test report against applicable IS standard● Mandatory
📄
SPF test data (for sunscreen products)● Sunscreens
📄
Dermatological / ophthalmological test data● Baby products
📄
Preservative efficacy test (PET) / challenge test● Mandatory
📄
Stability data at accelerated and real-time conditions● Mandatory
🔬
Safety Assessment Content
By qualified toxicologist
📄
Toxicological profile of each ingredient (NOAEL data)● Mandatory
📄
Margin of Safety (MoS) calculation per ingredient● Mandatory
📄
Usage pattern — product type, skin contact area, frequency● Mandatory
📄
Overall product safety conclusion by toxicologist● Mandatory
📄
Toxicologist CV and qualification certificate● Mandatory
📊
Supporting Scientific Data
Ingredient-level evidence
📑
CIR (Cosmetic Ingredient Review) assessments● If available
📑
SCCS (Scientific Committee on Consumer Safety) opinions● EU ingredients
📑
Sensitisation / skin irritation test reports● New ingredients
📑
Dermatological testing (HRIPT) if efficacy claims made● If claims
📑
Phototoxicity / photosensitisation data for UV products● Sunscreens
Mandatory for all
Conditional
Recommended
Government Fees & Timelines

Registration Fees & Approval Timelines

Government fees for cosmetics are relatively modest. Timelines depend on application completeness and CDSCO workload.

Service TypeAuthorityApprox. Govt. FeeValidityTimelineKey Form
Import Registration (IRC)CDSCO CentralUSD 100–500 / product3 years45–90 daysForm Cos-5
Manufacturing LicenceState Drug Controller₹ 3,000 – ₹ 25,0005 years3–6 monthsState Form
BIS — Baby CareBureau of Indian Standards₹ 20,000 – ₹ 75,0001–2 years4–9 monthsBIS Licence
BIS — SunscreensBureau of Indian Standards₹ 20,000 – ₹ 75,0001–2 years4–9 monthsBIS Licence
IRC RenewalCDSCO CentralUSD 50–250 / product3 years30–60 daysRenewal Application
Variation / AmendmentCDSCO CentralUSD 50–100Per change30–45 daysAmendment Form
Schedule S ReviewInternal / GuidanceNo govt. feePer submission5–10 working daysCompliance Report
ℹ️
Fees shown are approximate government fees only. For imports, fees are per product/SKU — multiple SKUs require separate registrations. Contact us for a bundled quote if registering multiple products. Professional service fees are separate and quoted based on scope and number of products.
Why Choose Us

Why RegPath for Cosmetic Registration?

15+ years of cosmetic regulatory expertise, a 100% IRC approval rate, and deep Schedule S knowledge — India's most trusted cosmetic compliance partner.

Cosmetic regulatory expert consultation
100%
IRC Approval Rate
200+
Brands Registered

100% Cosmetic Approval Rate

Every cosmetic product we've filed for CDSCO IRC has been approved — driven by thorough pre-submission checks and zero-defect applications.

🔬

Deep Schedule S Expertise

We've reviewed thousands of formulations for Schedule S compliance. Our ingredient database is updated with every MOHFW Gazette notification.

🌐

Global Brand Experience

Registered brands from France, South Korea, Japan, USA and Germany in India — expert at bridging EU CPSR and FDA formats to CDSCO requirements.

Fastest IRC Turnaround

Pre-built Cos-5 dossier templates and established CDSCO relationships mean we consistently achieve IRC certificates faster than the statutory 90-day timeline.

📊 Our Track Record (2009–2024)
Import Registration (IRC)100%
Manufacturing Licence98%
BIS Certification95%
Schedule S Pass Rate100%
Frequently Asked Questions

Cosmetic Registration FAQs

Answers to the most common questions from cosmetic brands, importers and manufacturers about CDSCO registration in India.

Is my product a cosmetic or a drug under Indian law?
+
The distinction is determined by intended use claims on the label. Products claiming to "treat," "cure," or "prevent" any condition are drugs — even if sold as cosmetics elsewhere. An anti-dandruff shampoo with zinc pyrithione above certain limits, or a cream claiming to "treat hyperpigmentation," can be reclassified as a drug. We assess every product before filing.
Do I need a separate IRC registration for each product variant?
+
Generally yes — each distinct formulation requires its own IRC. Different sizes (50ml vs 100ml) of the same formulation can often be covered under one IRC. Different shades of lipstick with different pigments typically require separate registrations. We advise on the most cost-effective grouping strategy for your product range.
What is the validity of a CDSCO Cosmetic IRC?
+
The CDSCO Import Registration Certificate for cosmetics is valid for 3 years. We track renewal dates for all clients and initiate renewals 6 months before expiry. Post-renewal you receive a fresh IRC certificate for another 3-year period.
What happens if my cosmetic has a Schedule S prohibited ingredient?
+
CDSCO will reject the IRC application. Products already in market with prohibited ingredients are liable for seizure and the importer faces prosecution. This is why our pre-submission Schedule S review is critical — we identify and resolve issues before filing, advising on permissible substitutes that maintain the product's performance.
Which cosmetic products require mandatory BIS certification?
+
Currently, baby cosmetic products (baby shampoos, baby powders, baby lotions) and sunscreen products above SPF 15 require mandatory BIS certification under specified IS standards. These products cannot be sold without the ISI mark. BIS registration is separate from the CDSCO IRC and must be obtained in addition to it.
Can claims say "reduces wrinkles" or "whitens skin"?
+
"Reduces the appearance of wrinkles" is generally acceptable as a cosmetic claim (improving appearance). However "eliminates wrinkles" or "reverses ageing" crosses into drug territory. Skin whitening/fairness claims are heavily restricted. We review all claims and marketing materials to ensure compliance and avoid drug reclassification.
Can I import cosmetics for testing before getting IRC?
+
Yes — a small quantity can be imported for testing and evaluation without full IRC, but a Test Import Permission may be required. This is used by brands wanting to conduct market research, stability testing, or consumer trials before committing to full registration. We handle Test Import Permissions as a separate service.
Is the IRC transferable if I change my Indian importer?
+
No — the IRC is linked to the specific IRP named in the application. If you change your Indian importer, a variation application must be filed with CDSCO to update the IRP details. The product registration itself remains valid; only the IRP details change. We handle IRP change applications as a post-registration service.

Register Your Cosmetic Brand in India

Book a free 30-minute consultation. We'll assess your products, check Schedule S compliance, and give you a clear registration roadmap — at no cost.

📍
New Delhi, IndiaConnaught Place — 110001
✉️
info@regpathcdso.inResponse within 24 hours
🕐
Mon – Sat9:00 AM – 6:30 PM IST