COS-8 manufacturing licenses are issued by the State Licensing Authority under Rule 23(1) of the Cosmetics Rules, 2020. This page covers the application process, Seventh Schedule GMP requirements, fees, validity, and the 2025 amendments.
Every cosmetics manufacturer operating in India requires a license before production begins. The authority for that license does not sit with CDSCO — it sits with the State Licensing Authority (State Drugs Controller) of the state in which the facility is located. The governing instrument is the Cosmetics Rules, 2020, notified under the Drugs and Cosmetics Act, 1940, which replaced all prior cosmetics manufacturing provisions and established the current licensing framework in full.
This page covers the complete COS-8 licensing process: the applicable rules, documents, GMP obligations under the Seventh Schedule, fees, timelines, and the 2025 amendments that have materially changed enforcement powers.
Chapter IV of the Cosmetics Rules, 2020 governs domestic cosmetics manufacturing. Rule 23(1) states the position directly: "Any person who intends to manufacture cosmetics shall make an application for grant of a licence or loan licence to manufacture for sale or for distribution to the State Licensing Authority."
Two license types exist under this chapter:
COS-8 — standard manufacturing license, issued to the manufacturer operating their own facility
COS-9 — loan license, issued where a manufacturer produces on behalf of another party using their own facility
CDSCO has no role in issuing manufacturing licenses. Its mandate covers imports, registration certificates (COS-1, COS-2), and central coordination. State Licensing Authorities hold full jurisdiction over manufacturing premises, compliance, inspection, and enforcement within their state.
Applications for COS-8 are submitted in Form COS-5 through the state's designated online portal. Most states route applications through the SUGAM portal or their own State Drugs Control department system. Paper submissions are not accepted.
Part II of the Second Schedule to the Cosmetics Rules, 2020 prescribes the document set. An application must include:
1. Fee receipt corresponding to the Third Schedule fee schedule
2. Approved layout plan of the manufacturing premises
3. Proof of possession or ownership of the premises
4. List of machinery and equipment with specifications
5. Constitution of the firm (partnership deed, certificate of incorporation, or equivalent)
6. Qualifications and appointment details of competent technical staff
7. List of cosmetics proposed for manufacture, with formulas and specimen labels
8. Trademark registration documents where applicable
9. Form COS-7 — a self-certificate of GMP compliance, signed by the applicant
The Form COS-7 self-certificate is not a formality. Under Rule 23(9), if a post-grant inspection finds that the self-certificate contained false information, the State Licensing Authority may cancel the license after issuing a show-cause notice. Manufacturers must ensure the facility meets Seventh Schedule requirements before filing.
The applicant must demonstrate that competent technical staff are in position at the facility. Accepted qualifications include a Diploma in Pharmacy or an equivalent qualification recognised by the State Licensing Authority. This requirement applies at the time of application, not after license grant.
Rule 23 sets a 45-day processing window from receipt of a complete application. If the application and documents satisfy all requirements, the State Licensing Authority grants COS-8 within this period.
Within 30 days of license grant, the Authority must conduct a site inspection to verify the GMP claims made in Form COS-7. Rule 23(8) contains a deemed-validity provision: if the Authority fails to inspect within the 30-day window, the license is deemed valid for all purposes. This does not exempt the manufacturer from GMP compliance — it is a procedural default provision, not a compliance waiver.
Following initial grant, regular inspections are conducted at minimum once every three years.
The Seventh Schedule to the Cosmetics Rules, 2020 sets out Good Manufacturing Practices and Requirements of Premises, Plants and Equipment for Manufacture of Cosmetics. It replaced Schedule M(II) of the Drugs and Cosmetics Rules, 1945, which was explicitly omitted under Clause 22 of the Thirteenth Schedule to the 2020 Rules. Any reference to Schedule M as a current GMP standard for cosmetics is incorrect.
Premises must be sanitary, hygienic, well-ventilated, and clean. They must not be used for, or interconnected with, residential areas. Walls and floors must be smooth, washable, coved, and free from cracks or open joints that could accumulate dust or allow entry of insects and rodents. Walls must be tiled or suitably finished to a minimum height of six feet from the floor.
For small-scale manufacture of toilet soaps specifically, the Schedule recommends a minimum area of 100 square metres. No equivalent minimum is prescribed for other categories, though the general space requirements must accommodate all process areas without cross-contamination risk.
An adequate number of personnel with relevant experience must be employed. All workers must be free from contagious diseases, wear clean uniforms, masks, headgear, and gloves appropriate to their role, and have access to washing and first-aid facilities.
Water used in manufacture must be of potable quality as defined under applicable standards. Sewage and effluents must be disposed of in conformity with Environment Pollution Control Board requirements.
All equipment must be serviced and calibrated at regular intervals. Working benches must have smooth, impervious surfaces capable of being washed and disinfected. Equipment materials must be non-reactive with the cosmetic formulations being processed.
A quality control system must be established covering sampling, inspection, and testing of raw materials, in-process materials, and finished products. Batch testing must be conducted either in-house or through a NABL-accredited laboratory.
The Eighth Schedule prescribes the records that manufacturers must maintain. Under the 2025 amendments, these records must be maintained batch-wise in digital or manual form for a minimum of three years.
License Type | Items | Fee
COS-8 grant or retention | Up to 10 items, single category | Rs. 10,000
COS-8 — additional items | Per item within same category | Rs. 500
COS-8 — additional category | Up to 10 items per additional category | Rs. 10,000
Fees are paid at the time of application. The same fee schedule applies to the five-yearly retention payment.
Under Rule 30(1), a COS-8 license remains valid in perpetuity, subject to payment of the retention fee as specified in the Third Schedule before the completion of each five-year period from the date of issue.
Failure to pay the retention fee on time does not result in immediate cancellation. A late fee of 2% per month applies for up to 180 days. If the retention fee and accumulated late fees remain unpaid beyond 180 days, the license is deemed cancelled by operation of Rule 30.
This is a common compliance failure among manufacturers managing multiple product categories: the perpetual validity of COS-8 creates an assumption that no active renewal action is needed. The five-yearly retention obligation is mandatory — missing it triggers the deemed-cancellation clock.
The Cosmetics (Amendment) Rules, 2025, notified on 29 July 2025, introduced material changes to manufacturing licensing enforcement:
State Licensing Authorities now have explicit statutory authority to suspend or cancel a COS-8 license via show-cause notice, without requiring central approval. This formalises enforcement powers that were previously exercised under general provisions and removes procedural ambiguity.
Manufacturers must now maintain batch-wise records in digital or manual form for a minimum of three years. This applies to both production and quality control records. The amendment updates the Eighth Schedule documentation requirements and has immediate compliance implications for manufacturers whose record-keeping systems do not currently capture data at batch level.
The 2025 amendments refined the criteria for approved testing laboratories, with updated references to NABL accreditation and the process for SLA-approved external labs.
Manufacturers holding existing COS-8 licenses are required to bring their record-keeping and documentation practices into conformity with the amended Rules. The 2025 amendments do not require re-application for the license itself.
Cosmetics Rules, 2020 establishes the national framework, but processing timelines, portal systems, and inspection scheduling vary by state. The 45-day statutory timeline applies uniformly; in practice, high-volume states may take longer on the inspection scheduling side. Manufacturers operating facilities in multiple states require a separate COS-8 from each State Licensing Authority — there is no national manufacturing license and no cross-state recognition mechanism.
Manufacturing cosmetics in India without a COS-8 license is a violation of Rule 23(1) of the Cosmetics Rules, 2020. The license is issued by the State Licensing Authority, governed by the Seventh Schedule GMP framework, and maintained through five-yearly retention payments. Cosmetics Consultants India manages the complete COS-8 application process — from document preparation and GMP gap assessment to submission and post-grant compliance. Contact us to begin.
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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