COS-8 manufacturing licenses are issued by State Licensing Authorities under Rules 23–30 of the Cosmetics Rules 2020, not CDSCO. This page covers the application process, Seventh Schedule GMP requirements, retention obligations, and the interface between state licensing and CDSCO import registration.
State licensing is the foundation of lawful cosmetics manufacturing in India. Under the Cosmetics Rules 2020, the authority to license a manufacturing facility does not sit with CDSCO — it sits with the State Licensing Authority (SLA), administered by the State Drugs Controller of each state. Rule 4(2) establishes this directly: the state drugs controller, by whatever name called, shall be the State Licensing Authority and the competent authority for enforcement of these rules in matters relating to manufacture for sale or distribution of all categories of cosmetics. Rule 3(o) defines a licence as one granted by the State Licensing Authority under Rule 25. The COS-8 manufacturing license is the instrument of that authority.
This page covers the COS-8 application process, GMP requirements under the Seventh Schedule, retention obligations, inspection framework, and the critical interface between state-licensed manufacturers and CDSCO's import licensing system.
The Cosmetics Rules 2020 create a deliberate bifurcation of regulatory authority. CDSCO, operating at the central level, administers import licensing — COS-1 and COS-2 — under Rules 12 through 22. The State Licensing Authority administers manufacturing licensing under Rules 23 through 34.
This is not a shared jurisdiction. A manufacturer operating in Maharashtra applies to the Maharashtra State Drugs Controller. A manufacturer in Karnataka applies to the Karnataka State Drugs Controller. CDSCO has no role in granting or renewing the COS-8 license. The SLA has no role in import registration.
The two systems intersect only in one scenario: where an Indian manufacturer's facility is the intended fill site for bulk cosmetics imported under a COS-1 or COS-2 license. In that case, the importer's CDSCO application must include documentation from the state-licensed manufacturer. That interface is addressed in a dedicated section below.
Rule 25 specifies the instrument: a license or loan licence to manufacture cosmetics for sale or distribution shall be granted in Form COS-8 and loan licence in Form COS-9. The COS-8 authorises the manufacture of cosmetics for sale or distribution within India. It is product-category specific — the license covers the categories listed at the time of application and any subsequent endorsements.
A loan licence (COS-9) is available to entities that do not own a manufacturing facility but contract production to a licensed manufacturer. The COS-9 holder takes regulatory responsibility for the product; the COS-8 holder remains responsible for manufacturing compliance.
Applications are governed by Rule 23. The statutory framework is as follows:
Step 1: Online Application in Form COS-5
Rule 23(1) and (2) require all applications to be made through the identified online portal in Form COS-5, accompanied by the fee specified in the Third Schedule and documents specified in Part II of the Second Schedule.
Step 2: Compile the Document File
Part II of the Second Schedule prescribes the mandatory documents. The complete application file includes:
• Manufacturing premises ownership or rental agreement
• Constitution documents: Certificate of Incorporation (companies), partnership deed (firms), or proprietorship declaration
• Site plan and plant layout with dimensions
• List of manufacturing equipment (category-wise, per Seventh Schedule Part II requirements)
• Product list with formulations by category
• Technical staff credentials: qualifications (minimum Diploma in Pharmacy or equivalent), experience certificates, and consent letters from designated technical personnel
• Trademark certificate or brand authorisation
• Fire NOC from the competent authority
• UDYAM registration (for MSME applicants)
• Fee payment receipt
Step 3: Self-Declaration in Form COS-7
Rule 23(4) is unambiguous: the applicant shall furnish a self-declaration in Form COS-7 conforming compliance with Good Manufacturing Practices, requirements of premises, plants and equipment for manufacture of cosmetics as specified in the Seventh Schedule. This declaration is a prerequisite, not a post-grant formality. The Seventh Schedule — not Schedule M — is the applicable GMP standard. Schedule M-II was formally omitted by the Thirteenth Schedule, Clause 22 of the Cosmetics Rules 2020.
Step 4: SLA Review and Grant
Rule 23(5) establishes the statutory obligation: the State Licensing Authority shall grant a licence or loan licence within a period of forty-five days from the date of application after scrutiny of the application and documents if it is of the opinion that requirements of the Act and these rules have been fulfilled. Where requirements are not met, the SLA must communicate deficiencies to the applicant within the same 45-day window. The clock stops on a deficiency notice and restarts on resubmission.
Fees are set in the Third Schedule to the Cosmetics Rules 2020 and apply nationally. State Licensing Authorities do not levy fees beyond this schedule.
Item | Fee
COS-8 grant — up to 10 product items per category | ₹10,000
Each additional product item beyond 10 | ₹500
COS-9 (loan licence) grant | ₹5,000
Retention fee (per 5-year cycle) | ₹10,000 (up to 10 items)
Late retention fee | 2% per month on the retention fee
The Seventh Schedule governs all GMP compliance for cosmetics manufacturing. It applies from the point of application and throughout the license term. Its core requirements span four areas:
Premises and Buildings
The factory must be located in a sanitary environment with hygienic conditions maintained throughout. Premises cannot be used for residential purposes or be interconnected with residential areas. Walls and floors in manufacturing areas must be crack-free, smooth, washable, coved, and designed to permit effective cleaning and disinfection. The facility must be well-ventilated and clean.
Equipment
All equipment must be serviced and calibrated regularly with records maintained. Part II of the Seventh Schedule specifies category-wise equipment requirements. An applicant manufacturing hair care products, for example, must demonstrate equipment capability specific to that category. The product list submitted in Form COS-5 must align with the equipment declared.
Quality Control
A quality control system must be in place to ensure products contain correct materials at specified quality and quantity, manufactured under standard operating procedures. Quality control encompasses sampling, inspection, and testing of raw materials, packaging materials, in-process batches, and finished products.
Personnel
Adequate personnel with relevant qualifications and experience must be employed for their assigned functions. The designated technical person — typically a Diploma or Degree holder in Pharmacy, Chemistry, or a related discipline — must be present on the premises during manufacturing operations and bears personal responsibility for GMP compliance.
The State Licensing Authority conducts GMP inspections through its authorised inspectors. Post-grant verification occurs to confirm that the manufacturing facility matches the declarations made in Form COS-7. Where inspection is not completed, the license remains valid, but the SLA retains the right to inspect at any time.
Routine inspections occur on a cycle of approximately every three years under Rule 9. Re-inspection is triggered by complaints, product quality failures, adverse reports, or specific cause communicated to the SLA. The licensee must maintain all records — batch manufacturing records, raw material records, equipment calibration logs — and make them available on demand.
The Cosmetics (Amendment) Rules 2025 (notified 29 July 2025) amended Rule 26(f): batch and raw material records must now be maintained in hardcopy or electronic form for a minimum of three years or six months after the product's expiry date, whichever is later.
Rule 30(1) governs the ongoing validity of the COS-8 license: a licence or loan licence issued in Form COS-8 or Form COS-9 shall remain valid in perpetuity, subject to payment of licence or loan licence retention fee as specified in the Third Schedule before completion of the period of five years from the date of its issue, unless it is suspended or cancelled by the State Licensing Authority.
This structure mirrors COS-2 import licensing under Rule 14 — perpetual validity, not term-based renewal. The license does not expire at the five-year mark; it is deemed cancelled if the retention fee is not paid. Rule 30(2) provides a 180-day cure period with a late fee of 2% per month. Non-payment within 180 days results in deemed cancellation. Reinstatement after deemed cancellation requires a fresh application.
No GMP re-inspection is required solely on account of the retention fee payment cycle. Re-inspection occurs only if the SLA has specific cause.
The COS-8 license becomes directly relevant to CDSCO's import licensing system in one specific circumstance: where bulk cosmetic formulations are imported ready-to-fill and the Indian manufacturer's facility is the designated fill site.
Rule 12(4) addresses this: in the event of application for import of bulk finished formulation ready to fill, the following additional documents shall also be required to be furnished: (i) a valid manufacturing license for the finished formulation of the cosmetic ready to fill in finished form from the State Licensing Authority; and (ii) details of registered brand owner of the finished product in India.
The practical consequence: an importer applying to CDSCO for a COS-1 or COS-2 license to import bulk cosmetics for filling in India must include a valid COS-8 license from the Indian fill-site manufacturer. The SLA-issued document is a mandatory enclosure in the CDSCO application file.
For traders without their own manufacturing site who supply to a licensed manufacturer, CDSCO requires a notarised agreement between the trader and the COS-8-holding manufacturer, plus a copy of the manufacturer's valid COS-8 license. The manufacturer's COS-8 effectively underpins the import chain.
A foreign manufacturer that establishes a manufacturing subsidiary or joint venture in India must obtain a COS-8 from the relevant State Licensing Authority before commencing manufacture for sale. The application process is identical to that for a domestic manufacturer — Form COS-5, Third Schedule fees, Seventh Schedule GMP compliance, Form COS-7 declaration.
The entity must be incorporated in India and the manufacturing premises must be located in India. A foreign parent company cannot hold a COS-8 directly. The Indian legal entity — whether wholly owned subsidiary, joint venture, or otherwise — is the applicant and the licensee.
Once the Indian entity holds a valid COS-8, it can supply products to Indian importers or distributors, and can also serve as the fill-site manufacturer for importers who hold COS-1 or COS-2 licenses for bulk formulations originating from the same foreign parent.
Rule 34(10) provides that labels for export must meet the specific requirements of the destination country. Where a consignee requires that the manufacturer's name and address not appear on the label, Rule 34(10) permits the use of an SLA-approved code number in place of the manufacturer's identity. This provision requires prior approval from the State Licensing Authority before labelling to code.
The Twelfth Schedule (under Rule 64(1)) separately exempts cosmetics in bulk imported for repackaging for 100% export from the Chapter III import registration requirements. This exemption applies on the condition that the cosmetics are not used for domestic sale.
COS-8 is the entry point for any entity manufacturing cosmetics for sale or distribution in India. It is issued by the State Licensing Authority, governed by the Cosmetics Rules 2020, and remains valid in perpetuity subject to 5-yearly retention fees. For manufacturers supplying to importers operating under CDSCO import licenses, the COS-8 is not ancillary — it is a mandatory document in the import application file.
Cosmetics Consultants India advises Indian manufacturers and foreign manufacturers establishing Indian operations on COS-8 applications, Seventh Schedule GMP compliance, and the documentation interface with CDSCO import licensing. Contact us to assess your specific situation.
COS-8 is the manufacturing license required under Rule 23 of the Cosmetics Rules 2020 for any person manufacturing cosmetics for sale or distribution in India. Issued by the State Licensing Authority, it is valid in perpetuity subject to 5-yearly retention fees.
Learn more →The Seventh Schedule of the Cosmetics Rules 2020 is the sole GMP standard for cosmetics manufacturing in India. COS-8 grant and renewal are both conditioned on Seventh Schedule compliance under Rule 26(b). This page sets out what the schedule requires, how the State Licensing Authority verifies it, and what foreign manufacturers must demonstrate for import registration.
Learn more →Schedule M-II was omitted by Thirteenth Schedule, Clause 22 of the Cosmetics Rules 2020. The Seventh Schedule is the current GMP standard for cosmetics manufacturing in India, operative through Rule 23(4) and Rule 26(b).
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