If you are a manufacturer or importer of skincare products then you must understand the license required For skincare products in India. If you are a manufacturer then you have to obtain a license of COS 8 and for the Importers COS 1 license is required.
Skincare products fall under cosmetic products as per the Drug and Cosmetics Act, 1940, and Rules, 2020. To establish your brand in the cosmetic industry successfully, the manufacturer must meet the regulatory requirements, ensuring high-quality standards of products.
The application for a grant of manufacturing license for skincare products is submitted in Form COS-5 and granted in Form COS-8. This guide will walk you through essential steps to help you get started on your journey in skincare product manufacturing.
What Are Skincare Products?
According to the Drug and Cosmetic Act, of 1940, skincare products fall under the category of cosmetic products. Where cosmetics are defined as any article that is intended to be rubbed, poured, sprinkled, or applied to the human body for cleansing, beautifying, and promoting attractiveness. However, if any product claims to treat or manage skin diseases such as acne, it might be classified as a drug depending on the intended use. Some of the examples of skincare products are listed below:
- Moisturizer
- Sunscreen
- Face wash
- Anti-ageing cream
- Skin toner
- Skin serum
- Face masks
What Is a COS-8 License?
COS-8 license is the legal requirement for manufacturing cosmetics for sale and distribution in India under the Drug and Cosmetic Act, 1940, Rules, 2020. The State Licensing Authority issues this license. For manufacturing skincare products, a manufacturer must obtain a COS -8 license ensuring the manufacturer meets safety and high-quality standards for producing skincare products or any other cosmetic products.
Who Can Apply To Obtain a Manufacturing License For Skincare Products?
Below are the entities or individuals who can apply for a COS-8 license to manufacture cosmetics skincare products:
- If you are a manufacturer, you can apply for a COS-8 license to manufacture skincare products.
- Any individual who wants to start a skincare products business or manufacture skincare products can apply for a COS-8 license.
Documents Required For Obtaining Manufacturing License For Skincare Products
Below are some important documents required to be submitted for the grant of a manufacturing license under Form COS -8:
- Cover letter
- Proof of ownership of premises or facilities
- Memorandum of associate or certificate of incorporation
- Product information
- GMP certificate
- Few receipts
- Plant layout or blueprint
- List of equipment and machinery
- Details of qualified person or staff
- List of skincare products to be manufactured
- Understanding of product compliance as per Cosmetic Rules, 2020
What Is The Procedure To Obtain Manufacturing License For Skincare Products In India?
Following are some crucial steps that shall be followed by the applicant for obtaining a manufacturing license for skincare products:
- Visit the SUGAM portal and register yourself.
- Fill in the COS-5 application.
- Upload all the required documents as mentioned in part II of the second schedule of Cosmetic Rules, 2020, ensuring compliance with the regulatory framework.
- Applicable fees must be paid as mentioned in the third schedule of Cosmetic Rules, 2020.
- Submit the application to the State Licensing Authority, which will review the submitted application.
- After the application is reviewed and documents are verified successfully without any query, the State Licensing Authority grants the manufacturing license within 45 days of document verification.
- After the grant of the manufacturing license, get ready for audit inspection within 30 days of obtaining the license, ensuring the product compliance with Good Manufacturing Practice (GMP).
What Is The Validity Of Manufacturing License For Grant Under Form COS-8?
The validity for the manufacturing license of skincare products is for 5 years from the date of issue and the manufacturer shall pay the fees after every 5 years for license renewal.
Why Choose ELT Corporate For Obtaining a Manufacturing License For Skincare Products?
At ELT corporate, we are experts in assisting in granting manufacturing licenses for skincare products with our deep regulatory expertise. From preparing and submitting applications to ensuring compliance with regulatory standards, we provide comprehensive support and make the process smooth. Let’s be regulatory partners in achieving your goals.
Our offerings include:
- Overall documentation support
- In-depth review of queries
- Submission of application form
- Complete compliance support
- Assistance in obtaining a skincare products manufacturing license
FAQs
Which License Is Required For Skincare Products?
To manufacture skincare products, a manufacturing license is required under Form COS 8, issued by the State Licensing Authority, under Cosmetic Rules, 2020.
Can ELT Corporates Help, If My Previous Application Got Rejected For a Manufacturing License?
Yes, we provide assistance in the complete review of the application to identify the issue and resolve it with our expertise. If the rejected application cannot be processed further, we can help you in re-submitting the application with the necessary corrections.
Is It Mandatory To Comply With Good Manufacturing Practice (GMP)?
Yes, compliance with GMP is mandatory for obtaining a manufacturing license for skincare products, ensuring quality and safety standards.
