If you are a manufacturer or Importer and want to manufacture legally and sell cosmetic products in India, then Form Cos-5 in Cosmetics is an application for obtaining the manufacturing license. 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 a license is 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 Form COS-5 Application?
Form COS-5 in Cosmetics is the application for a grant of permit to manufacture cosmetic products for domestic sale or for export from India. This Cosmetics manufacturing license is issued by the State Drug Controller, ensuring the products meet quality and safety standards. The license is issued after a successful evaluation of the COS-5 application along with the audit inspection of the manufacturing site.
Who Can Apply For Form Cos-5 In Cosmetics?
Following are the entities or individuals who can apply for a COS-5 application for a grant of manufacturing license:
- If you are a manufacturer then you can fill and apply Form COS-5 for a manufacturing license.
- Existing license holders can apply for COS-5.
- Individual who wants to start cosmetic business can apply.
Who Issues Manufacturing Licenses for Cosmetics?
The manufacturing license is issued by the State licensing authority also known as the State Drug Controller for manufacturing cosmetic products for domestic sale in India or export purposes. The State Drug Controller is an authorized person responsible for the evaluation of COS-5 applications and the grant of manufacturing licenses.
What Are The Essential Documents Required For Application Form COS-5 In Cosmetics?
To submit an application for a manufacturing license under Form COS -5 in Cosmetics, the following documents are required to be submitted to the licensing authority:
- Cover letter.
- Manufacturing site details.
- Site master file.
- Cosmetic products list intended to be manufactured.
- Proof of qualified technical staff.
- GMP compliance of the product.
- Fee receipt.
- Plant layout.
- Undertaking for product compliance as per Cosmetic Rules, 2020.
Procedure To Obtain a Manufacturing License Form Cos-5 In Cosmetics
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 the license upload it on the CDSCO website for clear transparency.
What Is The Validity Of Manufacturing License?
The 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.
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. FAQs
Frequently Asked Questions
What Is The Importance Of Site Master File In Form COS-5?
The site master file provides details about the manufacturing premise, quality control measures, and ensuring compliance with Good Manufacturing Practices (GMP).
What Happens If COS 5 Application Rejected?
If your application for Form COS-5 is rejected, then the licensing authority will provide you with the reason for the application rejection. You can identify the problem and reapply it.
Why Do I Need a Cosmetics Manufacturing License In India?
To ensure your company products comply with the Indian regulations, safeguarding public health and safety.
