Schedule M Cosmetics India: Why It No Longer Applies and What Does

Schedule M-II governed cosmetics manufacturing GMP in India for decades under the Drugs and Cosmetics Rules 1945. As of 15 December 2020, it does not exist. The Cosmetics Rules 2020, notified under G.S.R. 763(E), omitted Schedule M-II through an explicit legislative act — Thirteenth Schedule, Clause 22 — and replaced it with the Seventh Schedule as the sole GMP standard for cosmetics manufacturing in India.

Any manufacturer, consultant, or auditor applying Schedule M-II to a cosmetics facility today is working from a superseded and legally inapplicable framework. This page states the current legal position and what the Seventh Schedule actually requires.

The Legal Position: Schedule M-II Is Omitted

The Thirteenth Schedule of the Cosmetics Rules 2020 lists all provisions omitted from the Drugs and Cosmetics Rules 1945. Clause 22 reads:

"In the said rules, the SCHEDULE M(II) shall be omitted."

This is not an amendment or a partial replacement. It is a complete omission. From the commencement date of the Cosmetics Rules 2020, Schedule M-II ceased to have any legal force over cosmetics manufacturing. No CDSCO circular or transition guidance is required to give this effect — the gazette notification itself is the operative instrument.

The confusion persists because Schedule M (Part I) continues to govern pharmaceutical GMP under the Drugs and Cosmetics Rules 1945, and large portions of the internet conflate Schedule M with Schedule M-II, or treat them interchangeably. They are distinct instruments with distinct scopes. Schedule M (drugs) remains in force. Schedule M-II (cosmetics) is omitted.

What Governs Cosmetics GMP Now: The Seventh Schedule

The Seventh Schedule of the Cosmetics Rules 2020 is the current and exclusive GMP standard for cosmetics manufacturing in India. Its applicability is established by two rules:

• Rule 23(4): An applicant for a COS-8 manufacturing license must submit Form COS-7 — a self-declaration of compliance with the Seventh Schedule — at the time of application.
• Rule 26(b): The Seventh Schedule is a standing condition of every COS-8 license. Breach of Seventh Schedule compliance is grounds for suspension or cancellation under Rule 23(9).

The State Licensing Authority inspects manufacturing premises against the Seventh Schedule at the time of license grant (within 30 days per Rule 23(7)) and at every three-year periodic inspection under Rule 9(i).

Structure of the Seventh Schedule

The Seventh Schedule is structured in two parts.

Part I — General Requirements covers eleven areas:

• (A) Location and surroundings — Factory must be in a sanitary location, maintained in hygienic conditions, not used for residence or interconnected with residential areas.
• (B) Buildings — Construction must prevent entry of insects, rodents, and flies. Walls and floors in manufacturing areas must be crack-free, smooth, washable, and coved to a height of six feet from the floor. Testing laboratories must be physically separated from production areas.
• (C) Personnel — Adequate number of personnel with experience and capabilities relevant to their assigned function. Specific Competent Technical Staff qualifications are set by Rule 26(a), not the Schedule itself.
• (D) Water supply — Adequate supply for manufacturing operations.
• (E) Disposal of waste — Provision for waste disposal systems.
• (F) Health, clothing and sanitary requirements — Staff hygiene and protective clothing requirements.
• (G) Medical services — On-site or accessible medical provision.
• (H) Maintenance — All equipment must be serviced and calibrated regularly; records must be maintained where required.
• (I) Testing and release — A quality control system must be established to ensure products contain correct materials and are manufactured per standard operating procedures. Each batch of raw material or finished product need not be individually tested if approved under a documented parametric release procedure — except for eye products, lipstick, and dental products, for which parametric release is prohibited.
• (J) Working benches — Requirements for work surface standards.
• (K) Washing and drying facilities — Hygiene infrastructure requirements.

Part II — Requirements of Plant and Equipment specifies category-specific equipment lists, minimum floor areas, and safety requirements across twelve product categories: Powders, Skin Powder for Infants, Creams and Emulsions, Nail Polishes, Lipsticks, Depilatories, Eye Preparations, Aerosols, Alcoholic Fragrance Solutions, Hair Dyes, Tooth Preparations, and Toilet Soaps.

Category-Specific GMP Requirements

The Seventh Schedule does not apply a uniform standard across all cosmetics. Requirements vary materially by product category.

Minimum floor areas are prescribed per category. Toilet Soaps require a minimum of 100 square metres. Other categories have their own specified minima.

Special safety infrastructure is mandatory for specific categories. Nail polishes and nail lacquers require a flameproof exhaust system and must be situated in an industrial area, given the flammable solvent content.

Sterilisation requirements apply to eye preparations. Kajal requires sterilisation of the base at 150°C and carbon black powder at 120°C — requirements that reflect the specific risk profile of products applied to the ocular area.

Parametric release restriction — as noted above — prohibits batch-level QC bypass for eye products, lipstick, and dental products. These categories require individual batch testing and release.

A manufacturer producing across multiple categories must meet the Seventh Schedule requirements for each category independently. A single facility producing both nail lacquers and kajal must comply with the flameproof and sterilisation requirements simultaneously.

Personnel Qualifications: Rule 26(a), Not the Seventh Schedule

A common misreading of the Seventh Schedule is to treat its personnel provision — "adequate number of personnel having experience and capabilities relevant to their assigned function" — as the complete qualification requirement. It is not.

Rule 26(a) sets the Competent Technical Staff conditions as a license condition separate from the Seventh Schedule. These include specific qualifications in pharmacy or cosmetic technology. The Seventh Schedule provision describes the workforce structure requirement; Rule 26(a) defines the minimum qualification threshold for the technically responsible person.

This distinction matters for COS-8 applications and audits: personnel documentation must satisfy both Rule 26(a) qualification evidence and the Seventh Schedule's staffing adequacy standard.

Documentation: The Seventh Schedule and the Eighth Schedule

The Seventh Schedule establishes the requirement for a quality control system and standard operating procedures. Detailed batch documentation obligations — batch manufacturing records, in-process control records, finished product testing records — are governed by the Eighth Schedule under Rule 26(f).

For a complete documentation compliance picture, both schedules must be addressed. The Seventh Schedule governs the QC system and premises; the Eighth Schedule governs batch-level documentation. An audit that reviews only one will miss the other.

COS-8 Application: The Seventh Schedule Compliance Pathway

For a manufacturer applying for a COS-8 license, Seventh Schedule compliance operates as follows:

1. Before submitting the COS-8 application, the applicant conducts a self-assessment of the manufacturing facility against all applicable Seventh Schedule requirements — general requirements and the category-specific plant and equipment provisions.
2. Form COS-7 is completed, certifying Seventh Schedule compliance, and submitted as part of the COS-8 application under Rule 23(4).
3. The State Licensing Authority inspects the premises within 30 days of grant.
4. The license is issued subject to Rule 26(b) — the Seventh Schedule compliance condition is a continuing obligation, not a one-time pre-license requirement.
5. Periodic inspections occur every three years under Rule 9(i). Non-compliance identified at inspection triggers the Rule 23(9) show-cause procedure, which can lead to suspension or cancellation.

There is no grace period or transition arrangement for manufacturers previously certified under Schedule M-II. Seventh Schedule compliance is required from the date of application.

Cosmetics Consultants India provides COS-8 license preparation including Seventh Schedule gap assessment, Form COS-7 preparation, and pre-inspection compliance verification. Contact us to begin.