If you're planning to manufacture cosmetics in India, obtaining a Manufacturing Licence is mandatory under the Cosmetics Rules, 2020, governed by the Drugs and Cosmetics Act, 1940. This guide outlines the step-by-step process, required documents, timelines, and departmental procedures to help you successfully apply for the licence.

At Satori One Click Solutions LLP, we assist businesses and entrepreneurs throughout this process to ensure compliance and timely approvals.

Why is a Manufacturing Licence for Cosmetics Required?

Under the Drugs & Cosmetics Act, 1940, and the Cosmetics Rules, 2020, any business involved in the manufacturing or sale of cosmetics must obtain a Manufacturing Licence (Form COS-5/COS-6) from the respective State Drugs Control Authority.

This ensures compliance with safety, quality, and hygiene standards, protecting consumers from substandard products.

Step-by-Step SOP for Obtaining a Cosmetics Manufacturing Licence

1. Mandatory Documents Required

To apply for a cosmetics manufacturing licence, the following documents must be submitted:

Application Form – Form COS-5 (for manufacturing) or COS-6 (for loan licensing).
Registration Fee – ₹10,000 per category (covers up to 10 products). Additional products cost ₹500 each.
Constitutional Details – Proof of business type (Proprietorship/Partnership/LLP/Company/Trust/Society).
Premises Ownership Proof – Municipal or local authority documents.
Approved Building Plan – Layout of the manufacturing unit.
Technical Staff Details – Qualification and experience certificates of manufacturing/testing staff.
Product Details – Master Formula Records (MFR), SOPs, specimen labels, and test reports.
Lab Testing Agreement (if applicable) – Consent letter from an approved laboratory.

2. Application Process

For Applicants:

1. Submit Online – Apply via the ONLDS Portal (Online Drug Licensing System).
2. Document Verification – The Drugs Controller’s office reviews the application.
3. Licence Approval – If compliant, the licence is issued within 45 days.
4. Post-Licensing Inspection – A Drugs Inspector conducts a site inspection within 30 days of approval.

For Approvers (Drugs Control Department):

• The application is forwarded to the Assistant Drugs Controller.
• Verification of documents and compliance with Cosmetics Rules, 2020.
• Licence granted within 45 days if requirements are met.
• Post-approval inspection conducted.

3. Fee Payment Process

• Fees must be paid via e-Treasury.
• ₹10,000 for up to 10 products per category.
• ₹500 per additional product beyond 10.

4. Timeline for Approva

• 45 days from the date of application submission.
• 30 days for post-licence inspection.