Under Section 3 (aaa) of the Drugs & Cosmetics Act, 1940, Cosmetic is defined as any article intended to be poured, sprayed, rubbed on/introduced into/otherwise applied to the human body/any part thereof for beautifying, cleansing, promoting attractiveness or changing the appearance & includes any article intended for use as a component of Cosmetic.
Currently, the Cosmetic industry is expanding rapidly everywhere in India, from TVs to social media sites. People from all over the world use cosmetics, whether they are males or females. As we already know, power comes with responsibility, so the Cosmetic Industry has attracted the Government's attention due to its massive demand. Cosmetics manufactured in India are regulated by SLA (State Licensing Authorities) across all States or Union Territories of India. Under the Drugs and Cosmetics Act of 1940, Licenses and Registrations regarding the manufacturing of Cosmetics and the Renewal of Cosmetics Manufacturing Licenses have been granted by the Respective State Licensing Authority.
According to IS 6608:2004, if all the raw materials requiring tests for heavy metals have been so tested and comply with the requirements, then the manufacturer may not test the finished cosmetic for heavy metals and arsenic. The Rule 134 of Drugs and Cosmetics Rules has laid down restrictions on the use of cosmetics containing dyes, colors, and pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part 1 as amended) and Schedule Q. The Rule 145 of the Drugs and Cosmetics Rules prohibits the use of lead and arsenic compounds in cosmetics for the purpose of coloring. Rule 135 prohibits the import of cosmetics in which a lead or arsenic compound has been used for coloring purposes. Rules 145 D and 135 A prohibit manufacturing and importing cosmetics containing mercury compounds.
Requirement of CDSCO Cosmetic Manufacturing Documents
Following are some vital Documents required for cosmetics manufacturing license application:
- List of Directors, Partners, and Trustees along with ROC copy registered Partnership Deed, Trust Deed.
- Application Form COS-5 is required.
- Specific Power of Attorney in favor of authorized signatory for submitting Application on behalf of the company.
- Covering Letter
- Self-attested copies of documents pertaining to the possession of premises like Rent or Register Ownership or Lease Allotment Letter or Possession Letter (Documents should be registered with appropriate Authority).
- Acceptance or Appointment Letter of Competent Technical staff of the manufacturing section (Not Mandatory).
- Section-wise list of plant and machinery.
- Details of the manufacturing process, the process of a flow chart.
- Site Master File.
- Constitution details of firms.
- List of SOPs.
- Challan of fees paid.
- Constitution details of firms.
- Copy of draft label.
- Site Plan and layout of the building with the name, address, scale, and measurements of the area.
- List of Competent Technical Staff along with their qualification, experience, registration, previous FDA Approvals, etc.
Procedure for Obtaining Permission for Cosmetic Compliance
- Filling Of Application: At First, you need to file an application in COS-5 for Cosmetics Manufacturing License and our experts will help you in filing & drafting the Application on your behalf without any hassle.
- Submit Your Documents: After filing the Application, you need to submit all the vital documents to us via email and we will arrange all the documents along with the application form and submit it to the authority.
- Examination: Once we submit the Application and documents to the respective Authority, then they will examine the same.
- Issuance Of License: Once the Licensing Authority is satisfied with all the documents and Applications, they will issue the Cosmetic Products License in Form COS-8 and we will mail you the same.
Cosmetic Registration and Certification Process for Obtaining a License
The manufacturers of cosmetics or cosmetic importers can apply for the manufacturing license for Costmetic Products or apply online for cosmetics manufacturing license by following the below process:
- Visit the SUGAM portal.
- Click on the ‘Login/Sign Up’ button and click on the ‘Sign Up Here’ option.
- Select the registration purpose as ‘For Cosmetic Registration’ and click on the ‘Submit’ button.
- Enter the details, upload the documents (ID proof of the authorized signatory, undertaking, and company address proof), and click the ‘Submit’ button.
- A verification link will be sent to the registered email ID. Upon clicking on the verification link, the application will be sent for approval to the concerned authority, i.e. CDSCO officials.
- The authority will send the approval of registration to the email ID.
- After receiving the approval, log in to the portal by entering the user and password.
- Select the department and type of form in the form submission section.
- Select the type of application to be submitted.
- After submission of the application, click on the ‘continue’ button.
- Preview the page and click on the ‘Save and Continue’ button.
- The ‘Checklist’ page will open. On this page, click on each point to upload documents and click on the ‘Submit’ button.
- The payments page will open. Fill out the form and click on the ‘Submit’ button.
- The preview page will open. Click on the ‘PDF’ button to generate the PDF of the filled application form, and click on the ‘Submit’ button.
- On the next page, upload the application form downloaded as a PDF and click on the ‘Submit’ button.
- The online application form will be forwarded to the respective designated officer for issuing the license.
After the license application form is sent to the designated officer, the designated officer will review and verify the form and documents. If the application form is found to be satisfactory, it will be forwarded for approval by the licensing authority. Once the licensing authority approves the form, the approval letter will be available in the applicants’ SUGAM dashboard.
When the application form is not found to be unsatisfactory, the designated officer informs the applicant of the discrepancies in the application on the SUGAM portal. Once the applicant complies with the discrepancies, it will be processed for approval.
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