Are you planning to start a manufacturing business of beauty products in Karnataka? Before entering the market, it is essential to learn how to obtain a cosmetic manufacturing license in Karnataka. The Central Drugs | Standards Control Organization manages the supervision as per the Drugs and Cosmetics Act of 1940.
In this article, we shall discuss the complete process of cosmetic manufacturing registration in India, registration, documents needed, validity period, and other detailed instructions.
What Is A Cosmetics Manufacturing License?
A cosmetic manufacturing license is required to manufacture cosmetics in India. This registration assures the safety, efficacy of products manufactured and sold in India. The state licensing authority in Karnataka grants a cosmetic manufacturing license as a statutorily compliant requirement under the Drugs and Cosmetics Act, 1940.
Regulatory Authority For Cosmetics in Karnataka
The certification process in Karnataka is controlled by the Drugs Control Department, the Government of Karnataka, which is responsible to the Ministry of Health and Family Welfare. The DCD is also responsible to the Central Drugs Standard Control Organization (CDSCO), which has jurisdiction concerning the Policies Applicable to drugs and cosmetics (including safety and effectiveness).
Step-by-Step Process For Getting A Cosmetic Manufacturing License in Karnataka
The process of getting a cosmetic manufacturing license in Karnataka consists of various steps as given below: manufacturing license in Karnataka involves various steps as given below:
- Prepare the Application: Submit Form 31 to the Licensing Authority with supporting documents.
- Fee Payment: Pay the government fee and provide the challan or receipt.
- Site Inspection: The Drugs Control Department will conduct a premises inspection.
- Document Review: Your submitted documents and compliance details will be verified.
- License Grant: Upon successful review, the Form 32 or 32-A license will be issued.
Documents Required For CDSCO Compliant Cosmetic Manufacturing
Prepare these documents for an efficient application procedure:
- Complete Form 31
- Receipt or payment slip for government fees
- Layout or blueprint of the manufacturing site
- Lease or ownership documents of the premises
- Proposed products list
- Machinery and equipment details
- Certificates of education and experience of the technical personnel
- GMP Compliance Affidavit
- Descriptive NOC (no objection certificate) from pertinent locals if applicable
Types of Licenses For Cosmetic Manufacturing Units
There are mainly two types of cosmetic licenses:
- Form 32 License (Now COS 8) – This license allows for the manufacture of cosmetic products for sale or distribution.
- Form 32-A License – This license allows for the manufacture of cosmetics only for testing and analysis.
Eligibility Criteria For Obtaining Cosmetic Manufacturing Certification In Karnataka
To obtain a Cosmetics Manufacturing License in Karnataka, the applicant must fulfill certain eligibility conditions:
- The premises must meet cleanliness, structure, and space standards as per the CDSCO special Guidelines.
- The applicant has to engage technical personnel holding degrees or diplomas in pharmacy, chemistry, and other related disciplines.
- The applicant must have machines and devices for manufacturing and conducting quality analysis.
- Disposal of waste materials should have designated areas set aside for storage as well as proper systems.
Validity And Renewal Of The Cosmetics License
Validity of the cosmetic manufacturing license in Karnataka is typically five years and must be renewed before the expiry date.
CDSCO Guidelines For Cosmetic Manufacturers
The CDSCO has provided exhaustive guidelines for all cosmetic manufacturing units to follow, including:
- Products should not contain ingredients that are banned according to the Drugs and Cosmetics Rules.
- Adherence to labeling and packaging requirements.
- Adherence to Good Manufacturing Practices (GMP) is mandatory.
- Regular quality testing of raw materials and finished goods is required.
How ELT Corporate Pvt. Ltd. Can Help?
ELT Corporate Pvt. Ltd. aids in:
- Submission of license application documents, compiling all relevant materials
- Document drafting, compliance with good manufacturing practices, and overall to quality standards
- Interfacing with the Karnataka Drugs Control Department
- Scheduling and managing inspections and approvals
- Reissuing licenses and providing support services after licensing
FAQs
What Are The Requirements To Apply For A Cosmetic Manufacturing Licence in Karnataka?
You must have a compliant facility, employ qualified technical personnel, and be equipped with the essential machinery and comply with GMP.
Can I Manufacture Multiple Products Under One Licence?
Yes, you can manufacture multiple products under one licence.
What Form Do I Use To Apply For A Cosmetic Manufacturing License?
You will use Form 31 in the Drugs and Cosmetics Rules, 1945 (Form COS-5 in the new format).
Do I Need A License To Manufacture Cosmetics For Internal Testing?
Yes, a Form 32-A license is required for test/sample production.
