IS 4011:2018 · NABL Accredited · Dermatologist Supervised Full Cosmetics Testing Scope →

Clinical Safety Testing for Cosmetics

Mandatory human safety studies required before launching cosmetics in India — HRIPT, skin irritation, cumulative irritation, and eye irritation tests conducted under IS 4011:2018 with trained dermatologist supervision.

4 Safety Studies Up to 200 Volunteers IS 4011:2018 GCP Protocol

Available Safety Studies

All studies conducted at our NABL-accredited facility in accordance with IS 4011:2018.

Human Repeat Insult Patch Test

IS 4011:2018

NABL

200 Volunteers

TAT: 90 Days Days

IS 4011:2018

The gold standard for cosmetology safety. A patch containing the test material is applied and re-applied over multiple exposure cycles on 200 healthy volunteers to identify sensitisation potential and repeated-dose irritation. Mandatory for CDSCO cosmetics registration under IS 4011:2018.

Dermatologist supervised · GCP compliant
NABL ISO/IEC 17025:2017 accredited lab
Accepted by CDSCO, BIS, and export regulators

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Skin Irritation Test

IS 4011:2018

NABL

24 Volunteers

TAT: 24 Days Days

IS 4011:2018

Evaluates whether a cosmetic product induces primary (acute) cutaneous irritation when applied under a semi-occlusive patch for 24 hours. Conducted on 24 volunteers by a qualified dermatologist, this test is a prerequisite for BIS product certification and export compliance.

Dermatologist supervised · GCP compliant
NABL ISO/IEC 17025:2017 accredited lab
Accepted by CDSCO, BIS, and export regulators

Order This Test

Cumulative Irritation Patch Test

IS 4011:2018

NABL

24 Volunteers

TAT: 45 Days Days

IS 4011:2018

Assesses the cumulative irritation potential of leave-on and rinse-off cosmetics after repeated daily applications over several weeks on 24 volunteers. Required for moisturisers, sunscreens, and other products with prolonged skin contact that need BIS or CDSCO clearance.

Dermatologist supervised · GCP compliant
NABL ISO/IEC 17025:2017 accredited lab
Accepted by CDSCO, BIS, and export regulators

Order This Test

Eye Irritation Test

IS 4011:2018

NABL

24 Volunteers

TAT: 21 Days Days

IS 4011:2018

Ophthalmological safety assessment conducted under dermatologist and ophthalmologist supervision on 24 volunteers. Determines ocular tolerance of eye-area cosmetics (kajal, eyeliner, mascara, eye cream) in compliance with IS 4011:2018 and export market requirements.

Dermatologist supervised · GCP compliant
NABL ISO/IEC 17025:2017 accredited lab
Accepted by CDSCO, BIS, and export regulators

Order This Test

Why These Tests Matter

Clinical safety testing is not optional — it is a regulatory requirement for cosmetics sold and exported from India.

CDSCO Registration Required

Under the Cosmetics Rules 2020 (Drugs & Cosmetics Act), a safety dossier including clinical safety data is mandatory for CDSCO cosmetics import and manufacturing registration. IS 4011:2018 studies form the cornerstone of this dossier.

BIS IS 4011:2018 Standard

BIS-certified cosmetics (lip care, eye care, skin lightening, sunscreen) must demonstrate human safety compliance per IS 4011:2018 — the Indian standard specifying test protocols, volunteer numbers, and dermatologist sign-off requirements.

Export Market Compliance

GCC countries, Southeast Asia, and African markets increasingly demand human safety data aligned with ISO and GCP standards. Our IS 4011:2018 reports are framed alongside international equivalents, supporting multi-market export registrations from a single study.

Accreditations & Approvals