If you are a manufacturer or Importer and you want to manufacture legally and sell cosmetic products in India then a Cos-8 license is mandatory to obtain. For all the cosmetic products falling under the Drug and Cosmetics Act, of 1940, the manufacturing license is important for sale and distribution. The application for a grant of manufacturing license is submitted in Form COS-5 and issued in Form COS-8.
What Are Cosmetics?
As per Cosmetic Rule, 2020, under the Drug and Cosmetic Act, of 1940, cosmetic is defined as any article intended to be rubbed, sprayed, sprinkled on, or introduced into the body of human beings or applied on any part of the body for cleaning and enhancing the beauty. Cosmetics include products like skin creams, perfume, antiperspirants, lotion, hair products, facial makeup, etc.
What Is a COS-8 License?
Cos-8 License is a cosmetics regulatory requirement for the cosmetics industry or products. It is mandatory, particularly in markets like the European Union and parts of Asia. It ensures that the cosmetics products are safe for human use. This license is a pat of broader regulations designed to protect consumers from harmful substances.
To obtain this license require manufacturers to adhere to strict guidelines regarding ingredient safety and product efficacy. By following these guidelines, businesses not only ensure compliance but also build consumer trust. A product without this license may raise red flags among consumers, leading to scepticism about its safety.
Why Is the Cos-8 License Important?
When a manufacturer obtains a COS-8 License it indicates that your products in safe to use for the consumers. It assures customers that the products they use have been thoroughly tested for harmful ingredients.
Who Can Apply For COS-8 License?
Following are the entities or individuals who can apply for a COS-8 license:
- If you are a manufacturer then you can apply for a COS-8 license.
- Existing license holders can apply for COS-8.
- Individual who wants to start cosmetic business can apply.
Who Issues The COS-8 License For Cosmetics?
COS-8 license is issued by the State licensing authority also known as the State Drug Controller for manufacturing and sale of cosmetic products in India. The State Drug Controller is an authorized person responsible for granting of COS-8 license.
What Are The Essential Documents Required For a COS-8 License?
To obtain a manufacturing license under Form COS -8, the following documents are required to be submitted to the licensing authority:
- Ownership of premises or facilities
- Memorandum of associate or certificate of incorporation
- GMP compliance of product
- Fee receipts
- Plant layout.
- List of equipment and machinery.
- List of cosmetic products.
- Undertaking of product compliance as per Cosmetic Rules, 2020.
Fastest Procedure To Obtain COS-8 License In India
Following are the steps that must be taken by the applicant to obtain the license as fast as possible:
- Visit the SUGAM portal and register yourself.
- Fill in the COS-5 application.
- Gather all the required documents as mentioned in part II of the second schedule of Cosmetic Rules, 2020, ensuring compliance with the regulatory requirements.
- Fees must be paid as mentioned in the third schedule of Cosmetic Rules, 2020.
- Submit the application to the state licensing authority for review of an application.
- Once the application is reviewed and documents are verified successfully without any query, the State Licensing Authority will grant the license within 45 days of document verification.
- After the grant of a license, be ready for audit inspection within 30 days of obtaining the license, confirming the product compliance with Good Manufacturing Practice (GMP).
- Lastly, after obtaining a license upload it on the CDSCO website for clear transparency.
What Is The Validity Of Manufacturing License Under Form COS-8?
Validity for a cosmetic manufacturing license is for a lifetime unless it is cancelled by the licensing authority and the manufacturer shall pay the fees after every 5 years to maintain validity.
What Is The Timeline For Obtaining Cosmetic Manufacturing License?
The timeline for granting of manufacturing license depends on the company or organization. However, ELT corporate is committed to ensuring prompt submission of documents on time.
Contact Us, ELT Corporate For a Better Experience
We, ELT corporate with deep industry knowledge and expertise can help you in granting of manufacturing license for your organization. Let’s collaborate for a smooth and seamless process of obtaining a manufacturing license and to drive your success and meet regulatory compliance.
What Types of Products Require a Cos-8 License?
All cosmetic products, including skincare, haircare, and makeup items, typically require a Cos-8 license to ensure safety and compliance.
How can I verify if a product has a Cos-8 license?
You can usually check the product packaging for the license number or consult the manufacturer’s website for certification details.
Why Do I Need a Manufacturing License In India?Â
To ensure your company products comply with the Indian regulations, safeguarding public health and safety.
Is the Cos-8 license recognized worldwide?
While the Cos-8 license is mainly recognized in certain regions, compliance with international safety standards can help your products gain acceptance globally.
Can small businesses obtain a Cos-8 license?
yes, If a small business is related to cosmetics then it can easily obtain a Cos-8 license. Any cosmetic product must comply with safety regulations, regardless of the company’s size.
What should I do if I find a product without a Cos-8 license?
If you encounter a cosmetic product without a Cos-8 license, it’s best to avoid using it and report it to local regulatory authorities.