Cosmetics manufactured in India are regulated under the Drugs and Cosmetics Act, 1940, and the Cosmetics Rules, 2020, for sale or distribution. This regulatory framework covers manufacturing, quality, safety, labelling, and licensing of cosmetics. The State Licensing Authority (SLA) grants the manufacturing licence for domestically manufactured cosmetics. It’s written in the Cosmetics Rules, 2020.
Let’s look into the working of CDSCO and state licensing authorities for providing manufacturing licences in India.
Understanding CDSCO for Cosmetic Regulations in India
The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory body. Under the Directorate General of Health Services and the Ministry of Health and Family Welfare, it takes care of pharmaceuticals, medical devices, and cosmetics regulations. The Drugs and Cosmetics Act, 1940, and the Cosmetics Rules, 2020, are the stated cosmetic regulatory framework.
The State Licensing Authority (SLA) grants the manufacturing licence. Applicants submit applications for a manufacturing licence or loan licence. They need to fill out the Form COS-5 or Form COS-6, respectively, to the concerned State Licensing Authority.
CDSCO continues to have a central regulatory role under the Cosmetics Rules. It includes functions relating to the Central Licensing Authority and other regulatory provisions. However, the COS-8 manufacturing licence for domestically manufactured cosmetics is issued by the State Licensing Authority rather than directly by CDSCO.
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Key Requirements for Cosmetic Manufacturing Licences in India
Manufacturers must employ competent technical personnel to oversee manufacturing operations and comply with the applicable requirements for premises, plants, equipment, testing, and documentation. Applicants must also provide the information and documentation required under the Cosmetics Rules, 2020, for the proposed manufacturing activities.
Cosmetic manufacturers also need to comply with applicable cosmetic labelling requirements and the relevant quality and safety standards. Under the licensing conditions, each batch or lot of raw materials used in manufacturing and each batch of the final cosmetic must be tested, with the applicable test records maintained as required by the rules. Specific safety and effectiveness data requirements also apply where the product is classified as a new cosmetic under the Cosmetics Rules, 2020.
Also Read: CDSCO Registration Process for New Cosmetics in India
Cosmetic Manufacturing Facility Compliance Requirements
Such a facility must adhere to the Seventh Schedule of the Cosmetics Rules, 2020. The applicant must provide a self-declaration using Form COS-7. It confirms compliance with Good Manufacturing Practices and the requirements for premises, plants, and equipment specified in the Seventh Schedule.
Within thirty days of licence or loan licence issuance, the State Licensing Authority or a designated subordinate officer inspects the site to verify the information provided in the self-declaration Form COS-7. If the authority does not carry out the inspection within the prescribed period, the licence or loan licence is deemed valid for all purposes under Rule 23.
Separately, licensed manufacturing premises are subject to inspection for verification of compliance not less than once every three years or as needed under a risk-based approach, as provided under Rule 31.
Manufacturing Licence for Cosmetics in India
The application for a manufacturing licence is submitted using Form COS-5 to the State Licensing Authority. Where a loan licence is sought, the application is made in Form COS-6. The manufacturing licence is granted in Form COS-8, while a loan licence is granted in Form COS-9.
The State Licensing Authority is mandated to grant a manufacturing licence or loan licence within forty-five days from the date of application after scrutinising the submitted application and documents. If not, they should communicate the reasons as well.
If cosmetics are manufactured at more than one premises, a separate application must be submitted and a separate licence obtained for each premises.
Also Read: CDSCO Cosmetics Registration in India for Importation
Application Process For Obtaining Manufacturing Licence For Cosmetics In India
Here’s the application process to get a cosmetic manufacturing licence in the country:
Application Submission
Prepare and submit the application in Form COS-5 for a manufacturing licence. Form COS-6 is for a loan licence. Along with the form, submit the required documents and fee. Also, complete the Form COS-7 self-declaration to the concerned State Licensing Authority. You’ll need a separate application and licence for every premise if cosmetics are manufactured at more than one premises.
Regulatory Scrutiny
The State Licensing Authority scrutinises the application. They check the supporting documents, fee, and self-declaration to ensure the fulfillment of all laid-down requirements of the Act and Cosmetics Rules, 2020.
Grant of Licence
If the requirements are satisfied, the State Licensing Authority grants the manufacturing licence in Form COS-8 or the loan licence in Form COS-9 within the prescribed 45-day period.
Post-Grant Inspection
Within 30 days of granting the licence or loan licence, the State Licensing Authority or an authorised subordinate officer inspects the manufacturing site and verifies the information provided in Form COS-7.
Ongoing Compliance
After licensing, the manufacturer must continue to comply with the conditions of the licence, applicable GMP requirements, testing requirements, record-keeping obligations, labelling requirements, and other provisions of the Cosmetics Rules, 2020.
Licence Retention
A COS-8 or COS-9 licence remains valid in perpetuity, subject to payment of the applicable licence retention fee before completion of each five-year period and subject to the licence not being suspended or cancelled.
Also Read: CDSCO Registration of Multiple Product Variations of Cosmetics in India
Key Updates Under the Cosmetics (Amendment) Rules, 2025
The Cosmetics (Amendment) Rules, 2025, were notified on July 29, 2025. It introduced several changes relevant to cosmetic manufacturers. One important change concerns manufacturing records and testing. Licensees must maintain records of each manufactured cosmetic batch and the raw materials used, either in hard copy or electronically, for three years or six months after expiry of the batch, whichever is later.
The rules also require testing of each batch or lot of raw materials used in manufacturing and each batch of the final product, with the corresponding records or registers retained for the prescribed period. The amendment also clarifies that these particular requirements do not apply to soap manufacturing where the raw-material testing procedure and records are governed by the procedure approved by the Licensing Authority.
Another important change is the insertion of Rule 31A, which gives the State Licensing Authority express powers to suspend or cancel a licence for non-compliance with licence conditions or the Act and Rules, after providing the licensee an opportunity to show cause and be heard. A licensee whose licence is suspended or cancelled may appeal to the State Government within 90 days of the order.
Conditions for Obtaining a Cosmetic Manufacturing Licence in India
The manufacturer needs to comply with the CDSCO and state requirements after obtaining approval for the manufacturing licence. The CDSCO has implemented rigorous criteria for securing a manufacturing licence.
1. Technical Staff Qualifications
Manufacturing must be conducted under the direction and personal supervision of competent technical staff. It includes at least one whole-time employee meeting one of the prescribed qualification criteria.
- Hold a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948.
- Be registered under the Pharmacy Act, 1948.
- Have passed the Intermediate Examination with Chemistry as one of the subjects, or an equivalent examination recognised by the Licensing Authority.
- Hold a bachelor’s degree in Cosmetic Technology from a recognised university.
2. Compliance with Factory Premises Requirements
The factory premises must comply with the specifications that are in the Seventh Schedule.
3. Laboratory Facilities
The manufacturer must either provide and maintain adequate staff, premises, and laboratory equipment for testing the cosmetics and raw materials. Or, they should make arrangements with a laboratory approved by the State Licensing Authority and accredited by the National Accreditation Board for Testing & Calibration Laboratories (NABL) for conducting tests.
4. Documentary Evidence
The applicant must maintain documentary evidence that concerns the following:
- Premises ownership or occupation
- Firm constitution
- Any other documents required for verification by the Licensing Authority
5. Compliance with Regulations
The licensee must adhere to the provisions of the Act and the rules made thereunder, along with any further requirements specified in future rules under Chapter IV of the Act.
6. Record Keeping
The licensee must maintain records of each batch of cosmetic manufactured and the raw materials used, according to the particulars specified in the Eighth Schedule. Under the 2025 amendment, these records may be maintained in hard copy or electronic form and must be retained for three years or six months after expiry of the batch, whichever is later.
7. Inspection and Sampling
The licensee must allow inspectors to enter the premises, inspect products, take samples, and access all registers and records as per the Act and rules.
8. Notification of Changes
The licensee must inform the Licensing Authority in writing within 30 days of any change in labelling, composition, testing, specifications, or documentation relating to cosmetics covered by the licence, together with the required undertaking regarding compliance with applicable BIS standards.
9. Change in Constitution
The licensee must inform the Licensing Authority in writing of any change in the constitution of the firm. Where the constitution changes, the existing licence remains valid for a maximum of six months from the date of the change unless a fresh licence is obtained in the name of the firm with the changed constitution.
10. Change in Manufacturer Name or Address
Where the manufacturer’s name or address changes after grant of the licence or loan licence, an application for amendment must be submitted for prior approval in accordance with Rule 26(m), within 60 days from the date of the change.
CDSCO Fees for Processing Cosmetic Manufacturing Licence Applications in India
The Third Schedule of the Cosmetics Rules, 2020, has the cosmetic manufacturing licence fees.
- Form COS-8 manufacturing licence = ₹10,000 for up to 10 items in each category of cosmetics
- Additional ₹500 for each additional item in a category
- A fee of ₹10,000 applies for 10 items in each additional category.
The Third Schedule also specifies separate fees for Form COS-9 loan licences and applicable retention fees. Because the prescribed fees and regulatory requirements can be amended, applicants should verify the applicable fee in the current Cosmetics Rules and with the concerned State Licensing Authority before submitting an application.
Manufacturing Licence vs Prior Permission for a New Cosmetic
A manufacturing licence and prior permission for a new cosmetic are separate regulatory requirements.
A manufacturer applies to the State Licensing Authority for a manufacturing licence. It does so under Chapter IV of the Cosmetics Rules, 2020. However, the applicant needs to first get prior permission from the Central Licensing Authority in Form COS-3 where the product qualifies as a new cosmetic under the rules. They should apply in Form COS-12 with the required fee and safety and effectiveness data.
The prior permission in Form COS-3 must then be furnished with the application for the manufacturing licence for the new cosmetic.
Therefore, manufacturers should determine whether a proposed product falls within the regulatory definition of a new cosmetic before applying for its manufacture.
Conclusion
Focus on producing quality cosmetics while we handle the licensing formalities. Get your cosmetic manufacturing licence support in India hassle-free – talk to our experts today.
FAQs
Who issues a cosmetic manufacturing licence in India?
The State Licensing Authority (SLA) issues the manufacturing licence for cosmetics manufactured domestically for sale or distribution in India. The application is submitted in Form COS-5, and the licence is granted in Form COS-8.
Is a cosmetic manufacturing licence in India valid for five years?
No. A cosmetic manufacturing licence is valid in perpetuity, subject to payment of the applicable licence retention fee before completion of each five-year period and continued compliance with the Cosmetics Rules, 2020.
Is a separate approval required for a new cosmetic in India?
Yes. If a product qualifies as a “new cosmetic” under the Cosmetics Rules, 2020, prior permission from the Central Licensing Authority is required before applying for its manufacturing licence. The manufacturer must obtain the required permission in Form COS-3 and submit the prescribed safety and effectiveness data.
