What Is Cos-8 License In Cosmetics?
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Cosmetics Manufacturing License in India
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For all cosmetics product manufacturers, obtaining a Cosmetics manufacturing license in India is mandatory. It is necessary to obtain it because the cosmetic industry in India is flourishing at a high speed due to its high demand. Central Drug Standard Control Organization ( CDSCO) is the governing Indian Regulatory body that plays a key role in maintaining the quality and safety of cosmetic products so that the best quality product reaches the customer.
Under the Drug and Cosmetic Act of1940, the rules of 1945, and revisions made in the year 2020 CDSCO looks after the manufacturing, sales, import, and distribution of cosmetics in India.
What Is a CDSCO Cosmetic Manufacturing License In India?
As per CDSCO, Cosmetic Manufacturing License in India is the legal authorisation needed for manufacturing cosmetic products which is generally issued by State Licensing Authority under the Drug and cosmetic Act,1940. Manufacturing License ensures that cosmetic products meet safety and quality standards for consumers.
Who issues the Cosmetic Manufacturing License in India?
The Cosmetic Manufacturing license in India is issued by the State Licensing Authorities or State Drug Controller appointed by the State Governments of the respective states.
Why Do You Need Cosmetics Manufacturing License?
Cosmetic Manufacturing License is very essential before starting Manufacturing business for the sale and distribution of cosmetic products in India. It helps in maintaining safety and providing quality cosmetic products.
Procedure To Apply Cosmetic Manufacturing License in India
To apply for a cosmetics manufacturing license in India you have to follow the application process first. The process will make your registration seamless. If you are facing any issues in this then you will get expert support also for filing of cosmetics manufacturing license. The steps are as follows:
Fill out the COS-5 and COS-6 Application form:
Pay Registration Charges
Verification and Review
Uploading License on the website
Survey of Manufacturing Premises by State Licensing Authorities
Issuance of COS-8 and COS-9 License Certificate by Authorities
1. Fill out the COS-5 and COS-6 Application form:
Our team possesses deep regulatory knowledge and practical experience in the cosmetics industry.
2. Pay Registration Charges
Make the payment of the application online according to the schedule third of cosmetics rule.
3. Verification and Review
After checking the manufacturing site and all other documents, the State Licensing Authority gives a decision after 45 days from the day applied.
4. Uploading License on the website
Once the certificate is received it must be uploaded for future reference as a record.
5. Survey of Manufacturing Premises by State Licensing Authorities
Within 30 days from the day of filling application form SLA visits the Manufacturing site to check GMP(Good Manufacturing Practices) and other parameters that are discussed in Schedule 7.
6. Issuance of COS-8 and COS-9 License Certificate by Authorities
If the State Licensing Authority finds all the requirements for getting Manufacturing are according to regulatory guidelines then certificate COS-8 is issued in case of own manufacturing premises and certificate COS-9 in case of Loan License.
Requirements for getting a Manufacturing License in India
Here are some requirements that are mandatory to know before applying for a Manufacturing License for cosmetics in India:-
Manufacturing condition and premises
Good Manufacturing Practices (GMP) according to Schedule 7 are followed for manufacturing cosmetic products. All parameters should follow GMP guidelines.
Laboratory Requirements
The lab should follow Good Laboratory Practices (GLP) accredited by the National Accreditation Board for Testing & Calibration Laboratories for the testing of cosmetics.
Qualified Employees and Manufacturers
Manufacturer should hold a Diploma or bachelor’s degree, Intermediate with chemistry as one of the subjects, and must be registered under the Pharmacy Act 1948. Personnel should be maintained by everyone working there.
Documents
All the documents like Manufacturing documents, Lab details, equipment Sops, and Degrees of the manufacturer and employees should be kept securely for future reference and for inspection by SLA and DI.
Record
All records of batches should be kept safely for future reference.
Information about changes
If any changes are made in documentation, premises, address, labelling, or manufacturing details must be submitted to the State Licensing authority.
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List of Documents Required for Cosmetic Manufacturing License in India
For Smooth processing of cosmetic manufacturing license in India, you have to submit all the documents along with application form.The documents are as follows:
Documents of ownership of manufacturing sites or rental documents.
Documents of all staff.
GMP and GLP documents
Premises documents of area etc.
Receipt of fees paid.
Personal details of the manufacturer along with educational details.
List of Equipment along with its SOPs.
Approval Certificate from the Pollution Control Board
Approval Certificate from the Pollution Control Board
List of cosmetic products all with brand name, labeling details, etc.
Fees for Cosmetic Manufacturing License in India
| Service | Fees |
|---|---|
| Grant or Retention of a Manufacturing License or Loan License for Each Category up to 10 Items. | Rs.10000 |
| Grant or Retention of a Manufacturing License or Loan License for Additional Category of Cosmetic | Rs.500 |
Validity of Cosmetic Manufacturing License Certificate in India
The Validity of the Cosmetic Manufacturing Certificate in India is 5 years after that it is renewed. If the license is not renewed on time then a 2%monthly late fee is charged. If not renewed up to 180 days from the last day then the license gets canceled.
How ELT Corporate Will Assist You?
ELT Corporate helps in smooth and efficient cosmetic manufacturing license process and ensures orderly arrangement of documents for easy processing. We help our clients by providing end to end service by adhering to GMP and regulatory standards. Our client can focus on their core business by allowing us to process the legal regulatory work,
Conclusion
A Cosmetic Manufacturing License in India is important for delivering good quality, safe, and effective products to customers. The manufacturer must fulfill the eligibility criteria and regulatory requirements needed for manufacturing license certificate issuance. After getting the certificate Manufacturing Company not only contributes to customer safety usage but also makes their brand promotion and marketing as well as builds customer trust.
FAQ
Cosmetic Manufacturing license is a must before starting the manufacturing process. Manufacturers can apply for licenses by filling out Form COS-5 and COS-6 for loan licenses. The manufacturing license certificate is issued in forms COS-8 and COS-9.
The cosmetic Manufacturing License in India is issued by the State Licensing Authority appointed by the State Government of respective states. The Guideline should be followed according to CDSCO and also the Drug and Cosmetic Rule 1945.
The fee 10000 for grant or retention of Manufacturing License or Loan License for each category of cosmetics (up to 10 items) and fee of 500 for additional category of cosmetic.
COS-8 License certificate is issued by the state Licensing Authority after inspection of the manufacturing site and verification of all the documents.
It takes 45 days to get a Manufacturing License Certificate. Inspection of the manufacturing site is done by licensing authorities within 30 days from the day of filling the application form.
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