Cosmetic Manufacturing License in India: The State Licensing Authority (SLA) Process Explained

The Most Common Misconception in Indian Cosmetic Manufacturing

Many Cosmetic manufacturers, Importers, startups, and international brands entering the Indian market assume that the Central Drugs Standard Control Organisation (CDSCO) is responsible for granting Cosmetic manufacturing licences. However, under the Cosmetics Rules, 2020, this is not the case.

If you are planning to establish a Cosmetic manufacturing unit in India or manufacture through a third-party facility, understanding the role of the State Licensing Authority (SLA) is essential for Regulatory compliance and faster approvals.

Knowing the correct licensing authority can save significant time, prevent unnecessary delays, and ensure your manufacturing facility complies with the legal requirements from the very beginning.

In this article, we explain the complete manufacturing licensing process, applicable forms, Good Manufacturing Practice (GMP) requirements, documentation, inspections, and the approval timeline prescribed under the Cosmetics Rules, 2020.

The Regulatory Architecture: Why State, Not Central?

The Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020 clearly divide regulatory responsibilities between the Central and State authorities.

CDSCO (Central Authority)

CDSCO primarily regulates:

• Registration of Imported Cosmetics through COS-1 and grant of COS-2
• Approval of New Cosmetics under COS-3 and grant of COS-12
• Central-level regulatory oversight for Imported Cosmetic products

State Licensing Authority (SLA)

The State Licensing Authority regulates:

• Grant of Cosmetic manufacturing licences within the respective State
• Inspection of manufacturing facilities
• Verification of GMP compliance
• Issuance of manufacturing and loan licences

Every Cosmetic manufacturing facility in India must obtain its licence from the SLA of the State where the factory is located.

The Application Forms for Cosmetic Manufacturing

Table 1

COS-8 vs COS-9: Which Licence Do You Need? 

COS-8 – Manufacturing Licence

A COS-8 licence is required when a company owns and operates its own cosmetic manufacturing facility.

The licence holder is responsible for:

• Manufacturing operations

• Quality Control

• Product testing

• GMP compliance

• Regulatory compliance at the licensed premises

COS-9 – Loan Licence

A COS-9 licence is issued when products are manufactured through an already licensed Cosmetic manufacturer.

This model is commonly used by:

• International Cosmetic brands entering India

• Start-ups without their own factory

• Brand owners outsourcing manufacturing

• Companies expanding production through multiple manufacturing partners

Under this arrangement, the loan licence holder remains responsible for product formulation, specifications and labelling, while the licensed manufacturer is responsible for manufacturing operations and GMP compliance.

GMP Compliance: The Seventh Schedule Requirements

Good Manufacturing Practices for Cosmetics in India are defined in the Seventh Schedule of the Cosmetics Rules, 2020. GMP compliance is a prerequisite for the SLA to grant a manufacturing license. The Seventh Schedule requirements cover:

Location & Environment: Manufacturing premises must be situated in a clean, hygienic area, separate from residential buildings, with proper sanitation, ventilation, and cleanliness. 

Building Requirements: Buildings should prevent entry of insects and rodents, have smooth, crack-free, washable walls and floors, adequate lighting, ventilation, and separate testing laboratories wherever possible. 

Storage Areas: Raw materials and finished products must be stored in clean, dry, well-lit, and organised storage areas with sufficient space. 

Qualified Personnel: Adequate, trained, and competent personnel should be employed for manufacturing, quality control, and other assigned functions. 

Water Supply: Only potable-quality water should be used during manufacturing. 

Waste Disposal: Disposal of solid, liquid, and gaseous waste must comply with the requirements of the Pollution Control Board. 

Health & Hygiene: Employees must be free from infectious diseases and provided with clean uniforms, masks, gloves, headgear, washing facilities, and first-aid services. 

Equipment Maintenance: Manufacturing equipment should be regularly cleaned, serviced, calibrated (where applicable), and maintenance records maintained. 

Quality Control: A documented quality control system should ensure proper sampling, inspection, testing, approval, and release of raw materials, packaging materials, in-process materials, and finished products according to SOPs. 

Parametric Release: Approved and validated parametric release procedures may replace routine testing for certain raw materials and finished products, except eye products, lipsticks, and dental products, which require batch testing. 

Working Areas: Filling, labelling, and packing operations should be carried out on smooth, washable, impervious work benches to maintain hygiene. 

Overall Objective: The Seventh Schedule ensures that cosmetic products are consistently manufactured under controlled conditions to achieve safety, quality, and regulatory compliance before reaching consumers.

The SLA inspector will review GMP compliance during a physical inspection of the facility before granting COS-8. 

The Layout Plan Requirement

Every COS-5 application must include a detailed layout plan of the manufacturing facility — a floor plan drawing that shows the physical organisation of all manufacturing sections, storage, QC, personnel, and utility areas. The layout plan must be approved by a competent authority (typically a licensed engineer or architect) before submission.

The purpose of the layout plan is to demonstrate that the facility’s physical design supports GMP compliance — that manufacturing and non-manufacturing areas are appropriately separated, that material flow is logical and contamination risk is managed, and that the facility has adequate space for the scale of operations planned.

The Document Checklist for COS-5/COS-6 Submission

1. Completed application form (COS-5 or COS-6) submitted via the SLA portal
2. Ownership documents for the manufacturing premises (ownership deed or registered lease agreement)
3. Approved layout plan of the manufacturing facility
4. List of machinery and equipment with make, model, and capacity
5. List of product range with chemical formulae, composition, labelling, and intended category
6. Details of qualified technical staff — qualifications and experience of the competent person
7. Identity and address proofs of the applicant and technical personnel
8. Certificate of Incorporation, Memorandum of Association, Articles of Association
9. Copy of fee payment receipt
10. Self-attestation declaration of GMP compliance

Approval Timeline 

The Cosmetics Rules 2020 specify a statutory decision timeline of 45 days from the date of complete application submission for the SLA to grant or refuse the manufacturing license. In practice, the timeline depends on the state’s SLA workload, the quality of the submitted application, and whether the inspector raises queries or requires a physical facility inspection before grant.

For new facilities, an SLA inspection is standard before COS-8 is issued. For existing licensed facilities applying for an endorsement or additional product category, the process is typically faster.

Key Takeaways

• Cosmetic manufacturing licenses in India are issued by State Licensing Authorities (SLAs), not by CDSCO
• COS-5 is the application for a Manufacturing License; COS-6 is the application for a loan license
• COS-8 (Manufacturing license) and COS-9 (loan license) are issued by the SLA upon successful review
• GMP compliance under the Seventh Schedule of Cosmetics Rules 2020 is a mandatory prerequisite for License approval
• The statutory decision timeline is 45 days from complete application submission
• The manufacturing license is valid for five years and must be renewed before expiry

How CliniExperts Can Help

CliniExperts supports both Indian and global OEMs through the full SLA manufacturing license process — from GMP gap assessment and layout plan review to COS-5/COS-6 preparation and SLA liaison. We also assist in identifying appropriate contract manufacturing partners for loan license arrangements. Contact us at contact@cliniexperts.com.