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.
Overview of Cosmetics Registration (CDSCO)
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.
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.
Types of CDSCO Registration
The Central Drug Standards Control Organization has the following divisions
- New Drugs
- Import and Registration
- Biologics
- Bioavailability/Bioequivalence
- Medical Device & Diagnostics
- Cosmetics
- Clinical Trials
- DCC-DTAB
Documents of 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).
Fees
For a customized and attractive quotation, please contact us with your product details to Kapish Laur (+91- 99717 70603) or Rekh Atri (+91 98118 03136) or Manju Laur (+91 9711994042).
Process for Cosmetics Registration
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.
