Cosmetics Registration in India

Cosmetics are increasingly being used for cleansing, beautifying, and promoting the attractiveness of the human body. However, greater emphasis should be placed on its quality and safety because of its application. So as to ensure the safety, quality, and performance of imported cosmetics, CDSCO, a central licensing authority, regulates imports of cosmetics into India.

The government of India has made cosmetics licensing mandatory for all businesses that deal in cosmetics in India. To ensure that cosmetics are of good quality and safe for the human body, all cosmetics manufacturers and importers are required to obtain a cosmetics license.

Before moving forward, let's first take a closer look at CDSCO.

CDSCO: The Central Drugs Standards Control Organization, which is part of the Ministry of Health and Family Welfare, regulates all medical goods and imports of cosmetics in India. Under CDSCO, the Drugs Controller General of India is responsible for issuing a license for Allopathic Drugs, Veterinary medicines, medical devices, Homeopathy, cosmetics, etc. The primary goals of CDSCO are to protect and promote public health. The Drugs & Cosmetics Act 1940 and rules 1945 have given various responsibilities to central and state regulators for regulating drugs & cosmetics.

DIVISIONS OF CDSCO

The Central Drug Standards Control Organization has the following divisions

1. New Drugs
2. Import and Registration
3. Biologics
4. Bioavailability/Bioequivalence
5. Medical Device & Diagnostics
6. Cosmetics
7. Clinical Trials
8. DCC-DTAB

Cosmetics is defined under section 3(aaa) of the Drugs and Cosmetics Act, 1940, as 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.

According to the provisions of the Drugs and Cosmetics Act 1940 and its implementing rules, the manufacture of cosmetics is regulated by a system of inspection and licencing by the State Licensing Authorities designated by the respective State Governments. The Import of cosmetics is regulated by a system of registration by the Central Licensing Authority.

Cosmetics must be registered, along with its packaging size, variant(s) and manufacturing premises, before its Import into India. You are not permitted to import or manufacture cosmetics unless it complies with the standards prescribed under the Ninth Schedule of the Cosmetic Rules 2020 or any other standard of quality or safety applicable to it and other provisions under 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 manufactured for Import into and used in India.

The manufacturer himself or the Authorized Agent of the Manufacturer or the authorized subsidiary of the manufacturer in India or any other importer in India can apply for the grant of an Import Registration Certificate for importing cosmetics products into India. An application for the issuance of an Import Registration Certificate for cosmetics shall be made online in Form COS-1 on SUGAM Portal with the required fee and documents to the Central Licensing Authority under the Cosmetics Rules, 2020.

To manufacture cosmetics in India, manufacturers are required to obtain a cosmetic manufacturing licence certificate from state licencing authorities. Cosmetics labels should be as per cosmetics labelling requirements.

The National Single Window System (NSWS) Portal has been launched by the Central Government to streamline approvals for investors, creating a one-stop shop for all required authorizations. Invest India, in collaboration with TCS, has developed the NSWS portal for CDSCO, focusing on medical device regulations.

Starting from January 1, 2024, three activities under the Medical Devices Rules, 2017 will go live on the NSWS portal.

1. Application for grant of Certificate of Registration of a Notified Body-Form MD-OI
2. Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training—Form MD-12.
3. Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training —Form MD-16.

Stakeholders are urged to submit applications through NSWS, as the existing cdscomdonline portal will be disabled from January 15, 2024. Access the NSWS portal for more information.

A manufacturer who manufactures in another country and wants to sell his products in India must obtain a cosmetic importer licence. The process of getting a cosmetics Import Registration Certificate and cosmetic manufacturing licence is as follows:

Documentation: Cosmetics Registration process begins with documentation. Documents that need to be uploaded will vary from point to point. First and foremost, we prepare and compile all of the necessary documents as per the requirements of the licencing authority. We will verify the labels of all the proposed products.

Application & Documents Submission: Once we have all the necessary paperwork ready, we will create login credentials on the Sugam portal and sign up for application submission. We will submit the application after a successful login into the portal. Following application submission, we will upload all necessary documents in accordance with the checklist to proceed further.

Payment: Payment will be made for further processing after the application and all relevant documents have been submitted. Payment fees may vary according to the number of categories and manufacturing sites.

Submission of form 42: We will upload Form 42 on the Sugam portal and the RC application will be successfully submitted after Form 42 is submitted. The online application will be forwarded to the appropriate Designated Officer.

Review of Application: The Designated Officer will review the application with the required documents for compliance. If the application is found to be satisfactory in every way, it will be forwarded to the Licensing Authority for approval. If the application is deemed unsatisfactory, discrepancies are communicated to the applicant via the SUGAM Portal. We will respond to any discrepancies. Once the discrepancies are resolved, it is then processed for approval.

Inspection of the Premises: In the case of an Indian manufacturer, an inspection of premises may be done by the State Licensing Authorities. No inspection will be performed in the case of a foreign manufacturer or importer.

Grant of import license for cosmetics: Once the licencing authority approves the application, the approval letter (Cosmetic Licence), will be issued. The importer will be permitted to sell his registered cosmetics products in the Indian market after receiving an import registration certificate.

The following documents are required for Cosmetics registration:

• Product specification & testing method for testing of cosmetics & Certificate of Analysts.
• Manufacturing Licence/ Registration/Marketing Authorization
• Test report with all tests, including heavy metal (Hg, Pb and As) and Microbiological Testing
• Authorization from the manufacturer
• List of Ingredients/composition along with its percentage contents
• Labels of proposed products
• Free Sale Certificate and Other documents (if any).

According to the Third Schedule of Cosmetics Rules, 2020, a fee of 1,000 USD or its equivalent in Indian Rupees is required for the grant or retention of a Registration Certificate for each category of cosmetics, a payment of USD 500 for the registration of each manufacturing site, a fee of USD 50 for each variant, and a fee of USD 1,000 for the grant or retention of a Registration Certificate for an additional category of cosmetics.

Validity of Cosmetics Registration Certificate

A Cosmetics Registration Certificate is valid for five years from the date of issue, subject to payment of the registration certificate retention fee, unless suspended or cancelled by the Central Licensing Authority.

As per cosmetics rule 2020, All cosmetic products must be registered to ensure that they are safe and reliable for customers. However, compliance can be tricky. Obtaining cosmetic license is not as simple as it first seems because it requires cooperation with authorities, documentation, scrutiny, and fulfilling CDSCO requirements. That’s why It is best to seek expert help so that they can handle the entire process and assist you in obtaining a cosmetic registration certificate.

Aleph India is a one-stop solution for all your compliance requirements. Aleph India provides a single window for product testing, training, technical certification, auditing, laboratory setup, and technical compliance services to the manufacturer and importer.Our Expert will assist you in getting cosmetic licence certificate for your product, providing useful insight and advice at every step of the process required for cosmetic registration.