COS-8 License Requirements

Requirement 1: Qualified Technical Person

This is one of the most stringent — and most commonly inadequate — requirements for new applicants. The manufacturer must employ at least one full-time qualified technical person who meets one of the following educational criteria:

This technical person must be actually employed at your manufacturing unit — not just named on paper. State licensing inspectors specifically verify their presence and credentials. Appointment letter, qualification certificates, and (for D.Pharm holders) Pharmacy Council registration proof are mandatory documents.

Requirement 2: GMP-Compliant Manufacturing Premises (Schedule M-II)

Your manufacturing facility must comply with Schedule M-II of the Cosmetics Rules, 2020 — the Good Manufacturing Practice (GMP) standard for cosmetic manufacturers. This is the single most physically demanding requirement. Key infrastructure that must be in place:

Manufacturing Area

Clearly demarcated, separate manufacturing zones per product category — preventing cross-contamination. Must not be connected to residential areas.

Quality Control Laboratory

Adequate in-house lab equipment for testing raw materials and finished products — OR formal arrangements with a NABL-accredited laboratory approved by the Central Authority.

Segregated Storage

Separate storage for raw materials, finished goods, packaging materials, rejected goods, and quarantine items — with proper labelling and FIFO systems.

Personnel Hygiene Facilities

Change rooms, handwashing facilities, and documented hygiene procedures for all production personnel.

Utilities

Adequate water supply (purified water where product formulations require it), ventilation, lighting, and waste disposal systems.

Documentation Systems

Batch manufacturing records, SOPs, raw material records, QC test records — maintained and accessible for inspection at all times.

Important: The factory must be located in a sanitary place and must not be connected to residential zones. This is explicitly assessed during site inspection — a home-based or shared residential-commercial premises will not qualify.

Requirement 3: Testing Facility

The manufacturer must either:

• Provide and maintain adequate staff, premises, and laboratory equipment for in-house testing of cosmetics and raw materials, OR
• Make arrangements with a laboratory approved by the Central Licensing Authority and accredited by the National Accreditation Board for Testing and Calibration (NABL)

Both options are acceptable — but the arrangement with the external laboratory must be documented and formalised before the application is submitted, not after.

Key standards for cosmetic testing in India:

• IS 4011:2018 — Methods of test for safety evaluation of cosmetics (microbiological, heavy metals, stability, dermatological)
• IS 4707 (Part 1 and 2) — Lists of permitted colours, dyes, pigments, and restricted ingredients
• IS 4707 (Part 2): 2025 — Updated GNRAS and restricted ingredients list (published August 2025)
• IS 4707 (Part 3): 2025 — New permitted preservatives standard (published September 2025)

Requirement 4: Ingredient Compliance (IS 4707 Standards)

Every ingredient in your formulations must comply with India’s cosmetic ingredient standards. As of 2025, the relevant standards are:

India also explicitly prohibits or restricts the manufacture and importation of cosmetics containing hexachlorophene, lead, arsenic, or mercury compounds, as directed by the Cosmetics Rules, 2020. Verify your complete formulation against the updated 2025 IS 4707 standards before any application is filed.

Requirement 5: Label Compliance

Label artwork must be submitted with your COS-5 application. According to Rule 34 of Cosmetics Rules 2020, every manufactured cosmetic must display:

• Product name and brand name
• Name and address of manufacturer
• Manufacturing Licence Number (Mfg. Lic. No.) — your COS-8 number once issued
• Batch number
• Date of manufacture and best before / expiry date
• Net weight or volume in metric units
• Complete ingredient list in INCI nomenclature — descending order of concentration
• Directions for use and necessary precautions
• MRP inclusive of all taxes (as per Legal Metrology Rules)
• “Country of origin: India” or “Made in India”
• Customer care details (name, address, phone/email)

Claims compliance: Avoid drug-like or therapeutic claims — “treats acne disease”, “cures dandruff permanently”. These cross the cosmetic-drug regulatory boundary and can result in your application being flagged or your products being classified as drugs requiring different licences.