Licenses Required For Cosmetics Manufacturing In India
Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under, the manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the respective State Governments, while the import of cosmetics is regulated under a system of registration by the Central Licensing Authority appointed by the Central Government. The Drugs Controller General (India) functions as the Central Licensing Authority who grants the Import Registration Certificate and regulates the import of cosmetics into India vide Gazette notification G.S.R 763(E) under the provisions of Drugs and Cosmetics Act, 1940.
Any article falling within the definition of cosmetic is required to be registered along with pack size, variant(s) and manufacturing premises before its import into the country.
To have a proper understanding please go through the below requirements:
1. What are Cosmetics? What all products are covered under it?
Cosmetic is defined under section 3(aaa) of the Drugs and Cosmetics Act, 1940 as, any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic.
2. What are steps required for acquiring the required licences?
Steps for registration and issuance of licenses are as below:
1. Initial analysis to discuss the format & eligibility for the licenses.
2. Document drafting for application filing.
3. Drafting application for licenses.
4. Online Application filing process.
5. Payment of government fees.
6. Verification by the appropriate authority.
7. Issuance of the licences.
3. What is the list of Licences required for Pan Masala manufacturing?
The list of Licences and other compliances required for Pan Masala manufacturing in India are as below;
1. Licence in Form COS- 8 for manufacture of cosmetics for sale or for distribution up to ten items of each category of cosmetics
2. Loan Licence in Form COS- 9 for manufacture of cosmetics for sale or for distribution up to ten items of each category of cosmetics
3. Prior permission for manufacturing new cosmetic (Form COS 3)
4. Compliances under Good Manufacturing Practices, requirements of premises, plants and equipment for manufacture of cosmetics as under Form COS-7
5. Approval of laboratory in Form COS-23 for test and analysis of cosmetics
6. Fee for test or analysis by the Central cosmetics laboratories or by the state laboratories (fee applicable per product basis)
7. Assistance in Labelling, Packing and Standards for Sale or Distribution of Cosmetics
8. Compliances in relation to good manufacturing practices and requirements of premises, plants and equipment for manufacture of cosmetics
9. Compliance with the standards of cosmetics as under applicable laws
10. GST Registration
11. Shop & Establishment Licence
4. What is the Validity of Licenses issued?
Any licence or loan licence issued in Form COS-8 or Form COS-9 shall remain valid for the period of 5 years from the date of its issue, unless, it is suspended or cancelled by the State Licensing Authority.
5. What is the duration for issuance of Licences?
The filing of applications will take 12-15 days and license will take approx. 6 months for final approval.
6. What are the guidelines for import of cosmetics in India?
No cosmetic shall be imported into India unless the product is registered under the rules by the Central Licensing Authority appointed by the Central Government under rule 3(f) or by any person to whom such powers may be delegated under rule 5. [As per rule 12(1) of the Cosmetic Rules, 2020]
No cosmetic shall be imported or manufactured unless it complies with the specifications prescribed under the Ninth Schedule or any other standards of quality and safety, applicable to it, and other provisions under the rules. In case, the cosmetic is not included under the Ninth Schedule, it shall meet the requirements under these rules and specifications and standards applicable to it in the country of origin. [As per rule 39 of the Cosmetic Rules, 2020]
No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user. [As per rule 36 of the Cosmetic Rules, 2020]
Please feel free to get in touch if you have any doubts or need clarifications.
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