Cosmetics Manufacturing License in Maharashtra (COS-8) — Complete Service Guide

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Maharashtra is India’s largest cosmetics manufacturing hub — home to hundreds of manufacturing units across Mumbai, Pune, Nashik, Navi Mumbai, and Thane. If you are setting up a cosmetics manufacturing facility in Maharashtra, one licence is non-negotiable: the COS-8 Manufacturing Licence issued by Maharashtra FDA (Food and Drug Administration). Without it, manufacturing cosmetics for commercial sale or distribution is a legal violation under the Drugs and Cosmetics Act, 1940.

What Is a Cosmetics Manufacturing Licence (COS-8)?

The COS-8 licence is the legal permit to manufacture and sell cosmetic products in India. COS-8 licence is issued by the State Licensing Authority — also known as the State Drug Controller — for manufacturing and sale of cosmetic products in India. In Maharashtra, the State Licensing Authority is Maharashtra FDA (Food and Drug Administration, Maharashtra State).

The process involves two key forms:

Form	Purpose	Stage
Form COS-5	Application for licence to manufacture cosmetics for sale or distribution	Application — submitted to Maharashtra FDA
Form COS-7	Self-declaration of GMP compliance (Seventh Schedule)	Submitted along with COS-5
Form COS-8	Manufacturing Licence — granted after scrutiny/approval by State Licensing Authority	Issued by Maharashtra FDA

In simple terms: COS-5 is your application. COS-7 is your GMP self-declaration. COS-8 is your manufacturing licence. You cannot legally manufacture cosmetics for commercial sale in Maharashtra without a valid COS-8.

Who Needs a Cosmetics Manufacturing Licence in Maharashtra?

Any person or company intending to manufacture cosmetic products in Maharashtra for commercial sale, distribution, or export must hold a COS-8 licence. This includes:

Startups and entrepreneurs setting up a new cosmetics manufacturing unit
Existing beauty brands establishing their own manufacturing facility
Third-party / contract manufacturers offering manufacturing services to other brands
Ayurvedic cosmetics manufacturers (where products fall under cosmetics definition)
OEM manufacturers producing for export markets
Brands transitioning from third-party manufacturing to own facility

Important: Manufacturing or selling cosmetics without a valid licence may attract action under the Drugs and Cosmetics Act, 1940. For general contravention relating to cosmetics, punishment may extend to imprisonment up to one year, or fine up to ₹20,000, or both. In cases involving spurious or adulterated cosmetics, penalties may be higher.

Own Manufacturing Licence vs Loan Licence — Which Is Right for You?

Maharashtra FDA issues two types of manufacturing licences for cosmetics:

Licence Type	Form	Licence Issued	Best For
Own Manufacturing Licence	COS-5	COS-8	Brands with their own GMP-compliant manufacturing facility in Maharashtra
Loan Licence	COS-6	COS-9	Brands that want to manufacture under their own name using another company’s licensed facility

With a Loan Licence (COS-6 → COS-9), you use another company’s licensed facility to manufacture under your brand, while you — the loan licensee — hold the licence. This is a popular option for emerging brands in Maharashtra who want to own the regulatory compliance without investing in a full manufacturing facility immediately.

A third option — third-party / contract manufacturing — does not require you to hold any licence yourself. You tie up with a COS-8 licensed manufacturer who produces under your brand. However, you have no regulatory ownership and are entirely dependent on the contract manufacturer’s compliance status.

Maharashtra-Specific Requirements — What's Different

Maharashtra Pollution Control Board (MPCB) Consent

Unlike many other states, Maharashtra requires a Consent to Establish from the Maharashtra Pollution Control Board (MPCB) before FDA will process your manufacturing licence application. This MPCB consent must be obtained for your manufacturing premises before submitting the COS-5 application to Maharashtra FDA. Failure to have MPCB consent in place is one of the most common reasons for application rejection or stalling in Maharashtra.

Maharashtra FDA Online Portal

All COS-5 applications in Maharashtra are submitted through the Maharashtra FDA’s online licensing portal. Physical submissions are not accepted for new licence applications. Ensure your Digital Signature Certificate (DSC) is ready before initiating the online application process.

Seventh Schedule GMP Compliance

Your manufacturing facility must comply with Seventh Schedule GMP requirements of the Cosmetics Rules, 2020 — the Good Manufacturing Practice (GMP) standard for cosmetic manufacturers. In Maharashtra, FDA inspectors are thorough in their Seventh Schedule GMP requirements assessment — particularly for smaller units and startups. The facility must be ready before the inspection, not during it.

Seventh Schedule Compliance Declaration (COS-7)

The applicant shall furnish a self-declaration in Form COS-7 confirming compliance with Good Manufacturing Practices, premises, plant, and equipment requirements as specified under the Seventh Schedule of the Cosmetics Rules, 2020.

Complete Documents Checklist for COS-5 Application in Maharashtra

Business and Premises Documents

Covering letter addressed to Maharashtra FDA — State Licensing Authority
Certificate of Incorporation / Partnership Deed / Proprietorship proof
List of Directors / Partners / Trustees along with ROC copy or Registered Partnership deed / Trust deed (as applicable)
PAN Card of entity
GST Registration Certificate
Premises ownership proof — registered ownership document, rent/lease agreement, allotment letter, or possession letter with Tax Receipt (registered with appropriate authority)
Consent to Establish from Maharashtra Pollution Control Board (MPCB) — Maharashtra-specific mandatory requirement
Site plan and layout of the building — with name, address, scale, and measurements perSeventh Schedule GMP requirements for cosmetics

Technical and Manufacturing Documents

List of cosmetic products intended to be manufactured (with category-wise details)
Plant layout — showing manufacturing areas, storage, quality control, change rooms, utilities
List of equipment and machinery with specifications
Site Master File — manufacturing site details and process description
Form COS-7 — Self-declaration of compliance with GMP and Seventh Schedule requirements (signed by authorised signatory)
GMP compliance declaration / affidavit
Undertaking for product compliance as per Cosmetics Rules, 2020

Technical Staff Documents

List of competent technical staff with qualifications, experience, and registration details
Proof of qualification of the qualified technical person — minimum one of:
- Diploma in Pharmacy — registered with Pharmacy Council of India under Pharmacy Act, 1948
- Intermediate examination passed with Chemistry as one of the subjects
- Or equivalent qualification recognized by the Licensing Authority
Appointment letter and designation of technical staff

Fee and Additional Documents

Fee payment receipt — as per Maharashtra FDA fee schedule (see fee table below)
Authorization letter — if a regulatory consultant or authorized representative is applying
Digital Signature Certificate (DSC) of authorized signatory — for online portal submission
Previous FDA approvals (if any) — for existing businesses

Government Fee Structure — Cosmetics Manufacturing Licence Maharashtra

The Government charges a fee of ₹10,000 for the grant of licence in Form COS-8 for manufacturing cosmetics for sale and distribution of ten items of each category of cosmetic. Additionally:

Fee Component	Amount	Notes
COS-5 application (minimum — up to 10 items per category)	₹10,000	Per Third Schedule, Cosmetics Rules 2020
Additional items beyond 10 per category	Additional fee applicable	Fee varies per item per category
Additional government charges, if any	As applicable	Should be verified from the applicable State FDA portal/fee challan at the time of filing
Loan Licence (COS-6 → COS-9)	Separate fee schedule	Lower than own manufacturing licence
Retention fee (every 5 years)	As prescribed	Must be paid to maintain lifetime validity

Note: Fee structures are subject to revision by Maharashtra FDA. Verify current applicable fees before submitting application.

Step-by-Step Process to Obtain COS-8 Licence in Maharashtra

1. Set Up Your Manufacturing Facility

Identify and establish your manufacturing premises in Maharashtra. The facility must be located in a sanitary place, not connected to residential areas. Layout must comply with Seventh Schedule GMP requirements — including segregated manufacturing areas, quality control lab, storage areas, change rooms, and utilities. Have your site plan drawn to scale before proceeding.

2. Obtain Maharashtra Pollution Control Board (MPCB) Consent

Apply to MPCB for Consent to Establish for your manufacturing premises. This is a Maharashtra-specific requirement that must be completed before your FDA application. MPCB consent timelines vary by district and plant category — start this process at least 4–6 weeks before your planned FDA submission date.

3. Hire Qualified Technical Staff

At minimum, one full-time qualified technical person must be in place — holding a Diploma in Pharmacy (registered with Pharmacy Council of India) or equivalent qualification. Prepare appointment letters, qualification certificates, and experience documentation for all technical staff. Maharashtra FDA inspectors specifically verify that qualified technical staff are actually employed — not just named on paper.

4. Prepare Complete Document Dossier

Compile all documents listed in the checklist above — business documents, site plan, product list, equipment list, Site Master File, COS-7 self-declaration, technical staff proofs, MPCB consent, and fee receipt. Every document must be current, accurate, and cross-consistent. Maharashtra FDA scrutinizes applications thoroughly — any inconsistency triggers queries or rejection.

5. Submit COS-5 Application Online to Maharashtra FDA

Submit your complete application through Maharashtra FDA’s online licensing portal using your DSC. Fill Form COS-5 accurately, upload all supporting documents, and pay the applicable government fee online. Keep a record of your application acknowledgement number — you will need it for all follow-up communications.

6. Application Scrutiny and Query Response

Maharashtra FDA scrutinizes the submitted application and documents. If deficiencies are found, a query is raised and you must respond with corrective documentation. Respond completely — partial responses lead to repeat queries and extended timelines. The State Licensing Authority is mandated to grant a Manufacturing Licence within forty-five days from the date of application after scrutinizing the submitted application and documents.

7. Site Inspection by Maharashtra FDA

The licence may be granted after scrutiny of documents and self-declaration. After grant, the authority may inspect the manufacturing premises to verify compliance with GMP, Seventh Schedule GMP requirements, facility layout, equipment details, technical staff availability, and other information submitted by the applicant. Therefore, the manufacturing facility should be fully ready and compliant before filing the application, not after receiving inspection communication.

8. COS-8 Licence Issued — Begin Manufacturing

After obtaining the COS-8 licence, the applicant may begin manufacturing cosmetics for sale or distribution after uploading a copy of the licence on the CDSCO website. The manufacturer must continue to maintain GMP compliance, pay the retention fee every five years, and remain prepared for inspection by Maharashtra FDA.

Licence Validity, Renewal and Ongoing Compliance

Validity: COS-8 licence is valid for lifetime — it does not expire unless cancelled by the Licensing Authority
Retention fee: Must be paid every 5 years to maintain validity — failure to pay can result in licence suspension
Routine inspection: Maharashtra FDA conducts GMP inspection of your facility at least once every 3 years
Post-licence verification: The Licensing Authority may inspect the premises after grant of licence to verify the details submitted in the self-declaration and GMP compliance.
Product additions: Adding new products to your licence requires an amendment application with applicable fees
Facility changes: Significant changes to manufacturing site, layout, or equipment require prior approval from Maharashtra FDA

Common Mistakes That Delay COS-8 Approval in Maharashtra

Mistake	Impact	Prevention
MPCB consent not obtained before FDA application	Application stalled — mandatory Maharashtra requirement	Start MPCB process 4–6 weeks before planned FDA submission
Facility not Schedule M-II compliant at time of application	Inspection failure — re-inspection required	GMP gap analysis before submission — close gaps proactively
Technical staff qualification documents missing	Maharashtra FDA query — mandatory qualified staff required	Appoint qualified technical person and prepare all credential documents before applying
Site plan not drawn to scale or not per Schedule M-II	Query or rejection of application	Engage a professional to prepare compliant site layout plan
COS-7 self-declaration not submitted with application	Incomplete application — Maharashtra FDA returns for resubmission	COS-7 is mandatory at application stage — not post-inspection
Product list not categorized as per Schedule M-II categories	Query on product classification — fee recalculation may be needed	Map all products to Schedule M-II categories before preparing fee calculation
Manufacturing started before COS-8 is issued	Violation of Drugs and Cosmetics Act — legal action possible	Never manufacture for commercial sale without valid COS-8 in hand

Our Cosmetics Manufacturing Licence Services for Maharashtra

We assist cosmetic manufacturers, startups, and beauty brands across Mumbai, Pune, Nashik, Navi Mumbai, and Thane with end-to-end COS-8 licence support:

Eligibility Assessment

Evaluate your facility, technical staff, and documentation against Maharashtra FDA’s COS-8 requirements before application.

GMP Gap Analysis

Assess your facility against Schedule M-II GMP requirements and identify gaps before FDA inspection — not during it.

MPCB Consent Guidance

Guide you through the Maharashtra Pollution Control Board Consent to Establish process — the Maharashtra-specific step most first-time applicants overlook.

Complete Dossier Preparation

Prepare all documents — COS-5, COS-7, site plan, Site Master File, product list, technical staff documentation, and all supporting documents.

Online Portal Filing

End-to-end COS-5 application submission on Maharashtra FDA’s online portal — accurate, complete, and ready for scrutiny.

Inspection Preparation

Mock inspection against Maharashtra FDA’s Schedule M-II checklist — ensure your facility is ready before the inspector arrives.

Ready to Get Your COS-8 Licence in Maharashtra?

From MPCB consent to GMP compliance to Maharashtra FDA online filing — we manage the entire process so you can focus on building your brand. Get in touch today for a free assessment of your COS-8 eligibility. Get a Free COS-8 Consultation →

Frequently Asked Questions

How long does it take to get a COS-8 licence in Maharashtra?

Maharashtra FDA is mandated to grant the licence within 45 days of a complete application. In practice, including MPCB consent, document preparation, query responses, and inspection scheduling, the total timeline is typically 3–5 months for a complete, well-prepared application. Incomplete applications or facility readiness gaps can extend this to 6–9 months.

Can I manufacture all cosmetic products under one COS-8 licence?

Your COS-8 licence covers the specific products listed in your COS-5 application — organized by Schedule M-II categories. You can list multiple products across multiple categories, with fees calculated per category. To add new products or categories after the licence is issued, an amendment application with applicable fees must be filed.

What is the difference between your own manufacturing licence and loan licence in Maharashtra?

An own manufacturing licence (COS-5 → COS-8) requires you to own or lease a GMP-compliant manufacturing facility in Maharashtra. A loan licence (COS-6 → COS-9) allows you to manufacture under your brand name using another company’s licensed facility — without owning a facility yourself. The loan licensee holds regulatory ownership; the licensed manufacturer provides the manufacturing capability.

Is MPCB consent mandatory for cosmetics manufacturing in Maharashtra?

Yes. Maharashtra Pollution Control Board (MPCB) Consent to Establish is a mandatory Maharashtra-specific requirement for manufacturing licences under Maharashtra FDA. This requirement does not exist in all states — but in Maharashtra, your COS-5 application is not processable without it. Start the MPCB process early as it runs parallel to, not after, your FDA preparation.

Can I also import cosmetics if I hold a COS-8 manufacturing licence?

COS-8 is a manufacturing licence — it does not authorise you to import cosmetics. Import of cosmetics requires a separate COS-2 Import Registration Certificate from CDSCO (the Central Licensing Authority). Many manufacturers in Maharashtra hold both — a COS-8 for domestic manufacturing and a COS-2 for imported products sold under their brand.

Does the COS-8 expire and need renewal?

The COS-8 manufacturing licence has lifetime validity — it does not expire with a fixed date. However, you must pay a retention fee every 5 years to maintain its validity. Failure to pay the retention fee on time can result in licence suspension. Additionally, Maharashtra FDA conducts routine GMP inspections at least every 3 years — non-compliance during inspection can result in licence suspension or cancellation.