Cosmetics legislation and product registration in India

India

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.

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

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

Authorized Representative Appointment - Local agent appointed

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

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

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

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

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.

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

We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced.

Carol, Switzerland

Alpure

We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services.

Lena and Clay, USA

IBP

We didn't have any knowledge about the registration process for cosmetics in EU and were very concerned about this, but we met CE.way and they gave us whole packages of consultation and support. It was really helpful and we could do the registration without any problem. We will definitely ask CE.way again when we have new product to register in EU.

Masa, Japan

Nash Corporation

We used Tadej and CE.way for EU compliance with our products. He was very helpful and worked directly with our lab which made the process much easier for us. Tadej worked with me directly on all of our products to make sure I had the right documents. I really liked the attention to detail and how I could work with the owner of the company directly. I would highly recommend their services.

Steve, Canada

Curly Hair Solutions

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Natalia, USA

Hi Tadej, Thank you for your highly professional approach, extremely helpful information and advice on getting our product registration under way and completed in record time! What we thought to be a very tiresome and laborious task was made quick and simple. Thank you again! The Thermitek Team.

Rene, Greece

Funkitup

It's been our first time lodging an application for EU Compliance. Although a big task, Tadej from CE.way made it as painless as possible. His patience and help were invaluable. He was so responsive and was available at all times to work with myself and my manufacturers. We now have our first round of product successfully assessed and notified. I will be placing our next round asap for notification, I can't recommend CE.way highly enough, thanks Tadej - Heather Spierings Eye of Horus Cosmetics.

Heather, Australia

RA Cosmetics

CE.way offers professional and reliable service. The team is diligent and extremely helpful throughout the whole process. We are very satisfied the way the work was executed. We definitely recommend CE.way to others.

Tamar, USA

Nuvision

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James, USA

Eufora

This is a major investment for a small business like ours and it took me a few years to find a company (CE.way) that I felt comfortable working with! That speaks volume to my appreciation of the quality of your communications with me.

Vivian, USA

VB cosmetics

Our company had a great experience with CE.way. They were very organized and provided us with a detailed roadmap of exactly what we needed to gather on our end for them to put together our Product Information File and complete the notification process for the EU. They continued to help us along the way, providing quick feedback on any changes we needed to make to a document for it to work and reminders on what we still needed to provide. They are organized, knowledgeable, fast, and attentive; I would absolutely recommend them to any companies looking to get their products approved in the EU.

Cyrus, USA

SBBM

CE.way's assistance was tremendous, helping our company navigate the EU cosmetic regulation and efficiently get products to market.

Mike, USA

Inverness

Our cooperation with Tadej and his team at CE.way Consultants aimed to assist us to launch our products in UK for the first time. Tadej is a very hands on and always quick with his responses. The process was smooth and beyond our expectations in terms of cost savings and the speed with which we accomplished our goal. We look forward to working with them again.

Ruta, UK

Art de Parfum

We are really appreciate your speedy replies and clear and understandable guide. As there are a lot of differences in cosmetic regulations between Japan and EU first we thought that it would be hard to make all necessary procedures for our products compliance with EU laws, but thanks for your prompt support, all procedures were made smoothly. And now we are successfully selling MT Metatron in EU. We also thinking to expand our other brands in EU and when we start - definitely will ask your company for assist again.

Olga, Japan

MT Cosmetics, Inc.

After a less than pleasurable experience with another company, we found CE.way and we can honestly say that it could not be more beneficial for our brand. The whole notification process is made as easy as possible. The people at CE.way are all very accessible, knowledgeable and always ready to answer questions. CE.way is a great asset to our company and we are grateful for all the help and support we receive. Navigating through all rules and regulations alone is impossible, with the team at CE.way, we have the best support that we could ask for. Highly recommended in all aspects from their support to their reliable service!

Daniel, USA

NCLA