COSMETICS REGISTRATION IN INDIA

Table of Content

Introduction

Cosmetics are experiencing rising popularity for their role in cleansing, enhancing beauty, and improving the appearance of the human body. However, there is a growing need to prioritize their quality and safety due to their direct application. To guarantee the safety, quality, and efficacy of imported cosmetics, CDSCO, as a central licensing authority, oversees the importation of cosmetics into India.

The Indian government mandates cosmetics licensing for all businesses involved in the cosmetics industry within the country. This requirement aims to ensure the quality and safety of cosmetics for consumers. Therefore, all cosmetics manufacturers and importers must acquire a cosmetics license.

Before proceeding, let's delve deeper into CDSCO.

CDSCO:The Central Drugs Standards Control Organization (CDSCO), a division of the Ministry of Health and Family Welfare, oversees the regulation of all medical products and cosmetic imports in India. Within CDSCO, the Drugs Controller General of India is tasked with issuing licenses for various products, including Allopathic Drugs, Veterinary Medicines, Medical Devices, Homeopathy, and cosmetics. CDSCO's main objectives are to safeguard and enhance public health. The Drugs & Cosmetics Act of 1940 and its associated rules of 1945 delegate diverse responsibilities to both central and state regulatory authorities for the regulation of drugs and cosmetics.

DIVISIONS OF CDSCO

The Central Drugs Standards Control Organization comprises the following divisions.

New Drugs
Import and Registration
Biologics
Bioavailability/Bioequivalence
Medical Device & Diagnostics
Cosmetics
Clinical Trials
DCC-DTAB

WHAT IS COSMETICS LICENCE?

As per section 3(aaa) of the Drugs and Cosmetics Act, 1940, cosmetics refer to any product designed to be applied to the human body, whether rubbed, poured, sprinkled, or sprayed. They serve purposes such as cleansing, beautifying, enhancing attractiveness, or altering appearance. This definition encompasses any item intended for use as a component of cosmetics.

As per the regulations outlined in the Drugs and Cosmetics Act of 1940 and its associated rules, the production of cosmetics is governed through a process of inspection and licensing conducted by State Licensing Authorities appointed by individual State Governments. Meanwhile, the importation of cosmetics is overseen through a registration system managed by the Central Licensing Authority.

Cosmetics, along with their packaging size, variants, and manufacturing premises, must be registered before importation into India. It is imperative to adhere to the standards specified under the Ninth Schedule of the Cosmetic Rules 2020 or any other applicable quality or safety standard, as well as other provisions outlined in the rules. The Central Licensing Authority issues an import registration certificate under Rule 13 of the New Cosmetics Rules, 2020, for the registration of cosmetics intended for importation and use in India.

The manufacturer, authorized agent of the manufacturer, authorized subsidiary of the manufacturer in India, or any other importer in India may apply for an Import Registration Certificate to import cosmetics products into India. The application for this certificate must be submitted online via Form COS-1 on the SUGAM Portal, along with the necessary fee and documents, to the Central Licensing Authority under the Cosmetics Rules, 2020.

To produce cosmetics in India, manufacturers must secure a cosmetic manufacturing license certificate from state licensing authorities. Cosmetic labels must adhere to cosmetics labeling requirements.

Guidelines on Registration and import of cosmetic products

Launch of National Single Window System (NSWS) Portal

The Central Government has introduced the National Single Window System (NSWS) Portal to simplify approvals for investors, offering a one-stop solution for all necessary authorizations. Invest India, in partnership with TCS, has developed the NSWS portal for CDSCO, with a focus on medical device regulations.

Commencing January 1, 2024, three operations outlined in the Medical Devices Rules, 2017, will be activated on the NSWS portal.

Application for the issuance of a Certificate of Registration for a Notified Body - Form MD-OI.
Application for a manufacturing license for medical devices intended for clinical investigations, testing, evaluation, examination, demonstration, or training - Form MD-12.
Application for an import license for medical devices intended for clinical investigations, testing, evaluation, demonstration, or training purposes - Form MD-16.

Stakeholders are encouraged to utilize the NSWS for submitting applications, as the current cdscomdonline portal will be deactivated starting January 15, 2024. For further details, please visit the NSWS portal.

Cosmetic Registration for Importers and Manufacturers of Cosmetics

A manufacturer producing goods in another nation and seeking to market their products in India must acquire a cosmetic importer license. The procedure for obtaining a cosmetics Import Registration Certificate and cosmetic manufacturing license is outlined below:

Documentation:The Cosmetics Registration process initiates with document preparation, which may differ at various stages. Initially, we gather and organize all essential documents according to the licensing authority's specifications. Subsequently, we conduct label verification for all proposed products.

Application & Documents Submission:After ensuring all essential paperwork is prepared, we'll generate login credentials on the Sugam portal and register for application submission. Upon successful login, we'll proceed to submit the application. Following submission, we'll upload all required documents as per the checklist to advance the process.

Payment:Payment for further processing will be completed once the application and all pertinent documents are submitted. Fees for payment may differ based on the number of categories and manufacturing sites involved.

Submission of form 42:Upon uploading Form 42 on the Sugam portal, the RC application will be considered successfully submitted. Subsequently, the online application will be forwarded to the designated officer as necessary.

Review of Application:The designated officer will assess the application along with the necessary documents to ensure compliance. If the application meets all requirements, it will be sent to the licensing authority for approval. In case of any inadequacies, the discrepancies will be communicated to the applicant via the SUGAM Portal, and we will address them accordingly. Once the discrepancies are resolved, the application will proceed for approval.

Inspection of the Premises:For Indian manufacturers, premises inspection may be conducted by State Licensing Authorities. However, no inspection will occur for foreign manufacturers or importers.

Grant of import license for cosmetics: Upon approval by the licensing authority, the approval letter (Cosmetic License) will be issued. Subsequently, the importer will be authorized to distribute their registered cosmetic products in the Indian market upon receipt of an import registration certificate.

List of CDSCO PRODUCTS REGISTRATION

Documents Required for Cosmetics Registration

The documents needed for Cosmetics registration are as follows:

Product specifications and testing methods for cosmetics testing, along with the Certificate of Analysis.
Manufacturing license, registration, or marketing authorization.
Comprehensive test report encompassing all necessary tests, including heavy metal (Hg, Pb, and As) and microbiological testing.
Authorization documentation from the manufacturer.
List of ingredients/composition along with their respective percentage contents.
Labels for the proposed products.
Free Sale Certificate and any other pertinent documents, if applicable.

Cost for Cosmetics Registration

As per the Third Schedule of Cosmetics Rules, 2020, a fee of 1,000 USD or its equivalent in Indian Rupees is mandatory for the issuance or continuation of a Registration Certificate for each cosmetics category. Additionally, there is a charge of USD 500 for registering each manufacturing site, USD 50 for each variant, and USD 1,000 for obtaining or maintaining a Registration Certificate for an extra cosmetics category.

License	Forms	Govt. Fees
Import License	Application: Form COS-1 Registration Certificate: Form COS-2	500 USD per manufacturing site. 1000 USD per category 50 USD per variant
Manufacture License	Application: Form COS-5 License: Form COS-8	INR 10000 for up to ten items of each category of cosmetics INR 500 each additional item of the category of cosmetic.
Import Registration Number	Application: Form COS-4 Import Registration Number: Form COS-4A	NA

Validity of Cosmetics Registration Certificate

A Cosmetics Registration Certificate remains valid for a period of five years starting from the issuance date, provided the registration certificate retention fee is paid, unless revoked or suspended by the Central Licensing Authority.

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FREQUENTLY ASKED QUESTIONS

What constitutes cosmetics?

Cosmetics include any substance applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance, including those intended for use as cosmetic components.

Who can import cosmetics to India?

Potential importers include:
- Any Importer
- Registered Manufacturer of Cosmetics
- Subsidiary Agent of Manufacturer
- Indian Representative of Foreign Manufacturer