India

IndiaCosmetics testingCosmetics testing

Applicable legislation

Cosmetic products sold in India are regulated by the following legislations:

Primary Regulatory Laws

Drugs and Cosmetics Act, 1940 - Governs safety, import, distribution, and sale of cosmetics.

Cosmetics Rules, 2020 - Specifically codifies cosmetics compliance, registration, labelling, and import requirements.

International servicesInternational services

What type of products are cosmetics?

Under Indian CDSCO law, a cosmetic is defined as any article intended to be: “Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.”

Examples include:

Skincare products (creams, lotions, serums)

Makeup & colour cosmetics (lipsticks, foundations)

Haircare products (shampoos, conditioners)

Fragrances & perfumes

Bath products (soaps, shower gels)

Nail & personal grooming products

Examples of Non-cosmetic items in India

Products with claim to treat, cure, prevent disease or affect body function

Anti-acne treatment creams (claiming cure acne)

Hair regrowth / anti-baldness products

Anti-dandruff products with treatment claims

Skin whitening products claiming melasma or pigmentation treatment

Sunscreens claiming prevention of skin cancer

Anti-eczema, anti-psoriasis creams

Anti-fungal or anti-bacterial skin creams

Pain relief balms / gels

Medicated shampoos (ketoconazole, zinc pyrithione with treatment claims)

Requirements

Cosmetic registration and compliance in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act and Rules. All imported cosmetics must be registered with CDSCO before they can be marketed in India, while domestically manufactured products must comply with applicable licensing and labelling requirements. The process involves submission of product details, ingredient lists, safety data, labels, and supporting documents such as Free Sale Certificate and GMP. In addition, products must comply with Indian labelling rules, Legal Metrology requirements, and ingredient restrictions to ensure safety, quality, and consumer protection before entering the market.

Indian Manufacturers

Indian manufacturers must obtain a State Manufacturing License before producing cosmetics.

Importers & Foreign Brands

No cosmetic can be imported into India unless it is registered with the Central Licensing Authority (CLA).Registration must be done online via the CDSCO SUGAM portal.

Local Representative / Responsible Person

If the manufacturer is based outside of India, a local agent or a subsidiary company of the manufacturer registered in India must be authorized by the manufacturer to handle regulatory compliance (Authorized Indian Agent) and communication with authorities. This agent:

Acts as the responsible person for regulatory compliance in India

Files registration applications

Manages post-market obligations including market withdrawals and recalls if needed

Note: Authorization must be authenticated either in India before a magistrate or in the country of origin.

Registration Requirements

To register and import cosmetics, the following are key requirements:

Documentation

Typical documents in a COS-1 application include:

Manufacturer's name, address, and contact details

Authorized agent/importer details

List of products/brands and variants

Manufacturing license from country of origin

Free Sale Certificate from the country of origin

Product formulation and specifications

Testing methods and safety reports

Labelling Requirements

Imported cosmetics must be labelled in compliance with Indian rules as per CDSCO.

Quality & Safety Compliance

Imported products must:

Comply with safety specifications under the Ninth Schedule or equivalent standards

Meet testing requirements for heavy metals, microbiological load, and other quality criteria

Avoid prohibited ingredients or formulations that are banned in India

Process Overview

1

Initial Classification & Review - Determine if product is a cosmetic under Indian law

2

Authorized Representative Appointment - Local agent appointed

3

Documentation Preparation - Gather formulation, test reports, and required certificates

4

COS-1 and COS-2 Submission - Submit application, pay fees, and upload documents

5

Regulatory Review & Approval - CDSCO reviews application and may request clarifications

6

Issuance of Registration Certificate - Product approved for import and sale in India

International servicesInternational services

Timelines

Standard Process

Complete registration (with required documents): 60 working days

Additional laboratory testing (if needed): 20 working days

Notes

Registration approval is subject to India CDSCO

Delays may occur due to changes or updates in the processing system

In summary, registering cosmetic products in India requires compliance with extensive safety and regulatory requirements, proper documentation, and adherence to timelines set by the authorities.

International servicesInternational services

Services offered

Product classification

Formula review

Labelling review

Product registration to CDSCO

Testing services

Responsible person service

Legal meteorology certifications.

And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

Mena, Egypt

Pharmaplast

Testimonials

We use cookies that, through the use of statistics, help us make your experience here one of the best. If you don't like them, you can disable them or find out more about them in our Cookies Policy. If you continue to browse this page without changing any settings, we will interpret that as your complete consent to the use of cookies.

Need help with the cosmetics regulations and testing?