GMP Compliance for Cosmetics Manufacturers

Every cosmetics manufacturing license issued in India — the COS-8 granted by the State Licensing Authority — is conditioned on compliance with the Seventh Schedule of the Cosmetics Rules 2020. Rule 26(b) makes this explicit: factory premises must comply with the requirements and conditions specified in the Seventh Schedule as a standing condition of holding the license. Failure at any point is grounds for suspension or cancellation.

The Seventh Schedule supersedes Schedule M-II, which governed cosmetics GMP under the Drugs and Cosmetics Rules 1945. The Thirteenth Schedule, Clause 22 of the Cosmetics Rules 2020 formally omitted Schedule M-II. Any reference to Schedule M in the context of cosmetics manufacturing is legally incorrect.

This page sets out what the Seventh Schedule requires, how compliance is assessed at the time of COS-8 application, how the State Licensing Authority verifies it post-grant, and what GMP evidence foreign manufacturers must provide for import registration.

The Seventh Schedule: Structure and Scope

The Seventh Schedule is divided into two parts.

Part I — General Requirements covers the operating environment and management systems applicable to all cosmetics manufacturers regardless of product category. It is structured under eleven clauses:

• (A) Location and surroundings — the factory must be situated in clean surroundings free from open drains, latrines, and other sources of contamination.
• (B) Buildings — separate, demarcated areas are required for raw material storage, production, packaging, finished goods storage, and quality control. Walls must be smooth and impervious, floors non-porous, and the facility adequately ventilated and lit.
• (C) Personnel — an adequate number of qualified staff with experience relevant to their assigned function. Specific qualifications for the technically responsible person are set out in Rule 26(a), not the Schedule itself.
• (D) Water supply — potable water for general use; purified water where formulation or cleaning demands it.
• (E) Disposal of waste — effluent, solid waste, and manufacturing by-products must be disposed of in compliance with applicable environmental requirements.
• (F) Health, clothing, and sanitary requirements — protective clothing, restrictions on eating and smoking in production areas, and exclusion of personnel with communicable conditions.
• (G) Medical services — provision for first aid and medical attention on site.
• (H) Maintenance — all equipment must be serviced and calibrated regularly; calibration records must be maintained where required.
• (I) Testing and release of raw materials and finished products — a quality control system must ensure that products are manufactured under proper conditions according to standard operating procedures, and that raw materials and finished goods are tested before release.
• (J) Working benches — adequate, clean working surfaces in production and QC areas.
• (K) Washing and drying facilities — adequate facilities for glass containers where used in production.

Part II — Requirements of Plant and Equipment specifies the minimum floor area (in square metres) and the equipment required for each cosmetics manufacturing category — Categories A through L. The categories span:

• Category A: Powders and talcs
• Category B: Creams, lotions, and emulsions
• Category C: Nail polishes and nail care products
• Category D: Lipsticks and lip products
• Category E: Eye preparations
• Category F: Aerosol products
• Category G: Hair dyes and colourants
• Category H: Toothpastes and oral care products
• Category I: Soaps
• Categories J–L: Additional product-specific categories

The minimum area and equipment specifications vary by category. A manufacturer must satisfy the Part II requirements for every category listed on their COS-8.

Rule 26(a): Personnel Qualifications

The Seventh Schedule states broadly that personnel must have experience and capabilities relevant to their assigned function. Rule 26(a) sets the specific minimum qualification for the person responsible for manufacturing supervision: they must be a whole-time employee and must hold at least one of the following:

1. A Diploma in Pharmacy approved by the Pharmacy Council of India
2. Registration under the Pharmacy Act, 1948
3. Passed the Intermediate Examination (or recognised equivalent) with Chemistry as a subject
4. A Bachelor's degree in Cosmetic Technology from a recognised university

This person must be on site during manufacturing operations and is personally accountable for GMP compliance. A manufacturer who cannot demonstrate the presence of a qualifying technical person fails a basic license condition.

Documentation Obligations Under Rule 26

The Seventh Schedule itself references documentation in Clause I(H) (equipment calibration records) and Clause I(I) (SOPs and testing records). The comprehensive batch documentation obligations sit in Rule 26 and the Eighth Schedule.

Rule 26(f) requires the licensee to maintain records of every batch manufactured, including raw materials used, in the format specified by the Eighth Schedule. These records must be retained for three years after the date of batch expiry — not three years from the date of manufacture.

Rule 26(h) requires separate registers for testing of raw materials and finished products. These registers must be available for inspection by the State Licensing Authority at any time.

The combined documentation system — Form COS-7 self-declaration at application, batch records per the Eighth Schedule, testing registers under Rule 26(h), and calibration records under Schedule VII Clause I(H) — constitutes the minimum documentation framework a COS-8 licensee must maintain.

COS-8 Application: The Self-Declaration Model

The Cosmetics Rules 2020 operate on a self-declaration model at the point of COS-8 grant. Rule 23(4) requires the applicant to submit Form COS-7, which is a self-declaration confirming compliance with the Seventh Schedule — premises, plant, equipment, and the general requirements of Part I.

Rule 23(5) requires the State Licensing Authority to grant or refuse the COS-8 within 45 days of receiving the application, based on document scrutiny. There is no mandatory pre-grant site inspection. The license is issued on the strength of the submitted documents and the Form COS-7 self-declaration.

Post-Grant Inspection Under Rule 23(7)

Verification of the self-declaration occurs after the license is issued. Rule 23(7) requires the State Licensing Authority to inspect the manufacturing site — or authorise another officer to do so — within 30 days of COS-8 grant. The purpose of this inspection is to verify the information given in Form COS-7 against actual site conditions.

If the inspection reveals that conditions do not match the self-declaration, the State Licensing Authority has grounds to suspend or cancel the COS-8 under the applicable provisions of the Rules. Periodic inspections occur every three years for continuing licensees.

The 30-day inspection window means that manufacturers must be in full Seventh Schedule compliance at the point of application — not just at the point of inspection. Remediation between grant and inspection does not cure a false self-declaration.

GMP Requirements for Foreign Manufacturers

For import registration, the Cosmetics Rules 2020 do not impose the Seventh Schedule directly on foreign manufacturing sites. The applicable standard is set by Rule 3(b), which defines an actual manufacturer as one whose site is approved by the National Regulatory Authority or competent authority in the country of origin.

This approval is evidenced through the Second Schedule, Part-I, Clause 2(b), which requires the importer to submit manufacturing licenses, marketing authorisations, or free-sale certificates issued by the regulatory authority of the country of origin. The Rules do not specify WHO-GMP as the required standard; site approval by a recognised national authority is the accepted basis for import registration.

A WHO-GMP certificate issued by a recognised authority and covering the specific manufacturing site is accepted in practice where it constitutes the relevant national regulatory approval. Site-specific coverage is critical — a WHO-GMP certificate that does not name the actual manufacturing facility is insufficient.

Step-by-Step: Achieving and Maintaining GMP Compliance for COS-8

1. Assess the manufacturing site against Part II of the Seventh Schedule for every category on the intended COS-8. Confirm minimum area and equipment requirements are met before application.
2. Review Part I compliance — location, buildings, personnel, water supply, waste disposal, health and clothing protocols, maintenance systems, QC procedures, and working facilities.
3. Appoint a qualifying technical person under Rule 26(a) as a whole-time employee before application.
4. Establish batch record and testing register systems per the Eighth Schedule and Rule 26(h). These must be operational before the Form COS-7 is signed.
5. Complete Form COS-7 — the self-declaration of Seventh Schedule compliance — and attach it to the COS-8 application.
6. Submit the COS-8 application to the State Licensing Authority. The authority must grant or refuse within 45 days under Rule 23(5).
7. Prepare for the post-grant inspection under Rule 23(7). The inspection occurs within 30 days of license grant. Every element of the Form COS-7 self-declaration must be verifiable on site.
8. Maintain ongoing compliance under Rule 26(b). Equipment calibration, batch records, testing registers, and personnel qualifications must remain current. Periodic inspections occur every three years.

GMP Compliance and COS-8 Renewal

Rule 26(b) makes Seventh Schedule compliance a continuing condition, not a one-time requirement at the point of grant. COS-8 renewal requires the same demonstration of compliance. A facility that has allowed its GMP systems to lapse — outdated calibration records, unqualified technical staff, or premises that no longer meet Part II specifications — faces refusal of renewal in addition to potential suspension of the existing license.

Contractors and loan licensees operating under COS-9 are subject to equivalent obligations: the manufacturing facility used must meet Seventh Schedule requirements, and the loan licensee retains responsibility for ensuring those conditions are met.

Cosmetics Consultants India advises manufacturers on Seventh Schedule compliance assessments, Form COS-7 preparation, and COS-8 applications. Contact us to confirm your site meets the requirements before application.