If you are a manufacturer or Importer and want to manufacture and sell cosmetic products legally in India, Form COS-5 is an application for obtaining a manufacturing license. The manufacturing license is important for all cosmetic products falling under the Drug and Cosmetics Act of 1940. The application for a grant of a manufacturing license is submitted in Form COS-5, and a license is issued in Form COS-8.
Definition of Cosmetic
As per the Cosmetic Rule, 2020, under the Drug and Cosmetic Act, of 1940, a cosmetic is defined as any article intended to be rubbed, sprayed, sprinkled on, or introduced into the body of human beings or applied to any part of the body for cleaning and enhancing 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?
The 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 out and apply for Form COS-5 for a manufacturing license.
- Existing license holders can apply for COS-5.
- An individual who wants to start a 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 authorised person responsible for the evaluation of COS-5 applications and the grant of manufacturing licenses.
What Are The Essential Documents Required For the Application Form COS-5 In Cosmetics?
To apply 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.
- The cosmetic products list is intended to be manufactured.
- Proof of qualified technical staff.
- GMP compliance of the product.
- Fee receipt.
- Plant layout.
- Undertaking for product compliance as per the Cosmetic Rules, 2020.
Procedure To Obtain a Manufacturing License Form Cos-5 in Cosmetics
The 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.
- 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’s compliance with Good Manufacturing Practice (GMP).
- Lastly, after obtaining the license, upload it to the CDSCO website for clear transparency.
Difference Between COS-5 and COS-8
|
Feature |
Form COS-5 |
Form COS-8 |
|
Purpose |
Application form to obtain a cosmetic manufacturing license |
Actual license issued after successful evaluation of the application |
|
Filed By |
Manufacturer / Applicant |
State Licensing Authority (after approval) |
|
Stage |
Beginning of the licensing process |
End of licensing process |
|
Outcome |
Request to grant permission |
Legal authorisation to manufacture cosmetics |
|
Validity |
One-time submission (until processed) |
Lifetime validity (renewable with a fee every 5 years) |
|
Issued To |
Applicant (manufacturer/business owner) |
Successful applicant, after site audit & compliance verification |
In simple terms, Form COS-5 is your application, while Form COS-8 is your approval. Without COS-5, you cannot start the process, and without COS-8, you cannot legally manufacture cosmetics in India.
What is The Validity Of a 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 every 5 years to maintain validity.
Contact Us, ELT Corporate, For a Better Experience
We, ELT, with deep industry knowledge and expertise, can help you in granting a manufacturing license for your organisation. 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.
