An Overview of Cosmetic Manufacturing License
Under Section 3 (aaa) of the Drugs & Cosmetics Act, 1940, Cosmetic is defined as any article intended to be poured, sprayed, rubbed, or sprayed on/introduced into/otherwise applied to the human body/any part thereof for beautifying, cleansing, promoting attractiveness or changing the appearance & includes any article intendedfor use as a component of Cosmetic.
Currently, the Cosmetic industry is expanding rapidly everywhere in India, from TVs to social media sites. People from all over the world use cosmetics, whether they are males or females. As we already know that power comes with responsibility, so the Cosmetic Industry has attracted the Government due to its massive demand. Cosmetic Manufactured in India is regulated by SLA (State Licensing Authorities) across all States or Union Territories of India. Under the Drugs and Cosmetics Act 1940, Licenses and Registrations regarding the manufacturing of Cosmetics and Renewal of Cosmetic Manufacturing License have been granted by the Respective State Licensing Authority.
Regulatory Authority for Cosmetic Manufacturing License in India
Under the Drugs & Cosmetics Act, 1940 & Rules made thereunder, the manufacture of Cosmetics is regulated under a system of inspection & licensing by the State Licensing Authorities appointed by the State Governments, while the import of cosmetic products is regulated under a Registration System by the CLA or Central Licensing Authority appointed by the Central Government.
List of Cosmetic Products
- Deodorant soaps;
- Hair colourants;
- Hair setting products;
- Lips product;
- Skin-whitening products;
- Face masks;
- Toilet soaps;
- Emulsions, creams, lotions, oil & gels for the skin;
- Make-up powders;
- Face masks;
- Deodorants and Antiperspirants;
- Products for waving, fixing hair, and straightening;
- Mouth & teeth products;
- Anti-wrinkle products;
- Shower & bath preparations such as salts, foams, oils, and gels;
- Hairdressing products such as lacquers, lotions, brilliantine;
- Make-up and products removing make-up;
- Products for external intimate hygiene;
- Sunbathing products;
- Hygienic powders;
- After-bath powders;
- Tinted bases (pastes, liquids, powders);
- Shaving products (lotions, creams, foams);
- Toilet waters, perfumes and eau de Cologne;
- Make-up powders.
Categories of Cosmetics
Under the Drugs & Cosmetic Rules, 1945, Schedule M-II categories cosmetics into 11 product categories:
Regulations Regarding Cosmetic Manufacturing License in India
Before granting the Cosmetic Manufacturing License, the State Licensing Authority (SLA) will conduct an in-depth inspection of the entire premises. The inspection officer will submit a detailed report to the Licensing Authority, which will decide whether to issue the Cosmetic Manufacturing License or not. Cosmetic manufacturers must comply with the below regulations as prescribed under the Rules.
- Qualification Criteria for Working Staff in a Cosmetic Manufacturing Unit:
Moreover, the manufacturer needs to keep check that the production is done in the presence of skilled technical staff and a minimum of one of the staff people should possess the following education requirements:
- Must be registered under the Pharmacy Act, 1948 or;
- Must acquire a diploma in pharmacy by the Pharmacy Council of India under the Pharmacy Act, 1948;
- Has passed the intermediate exam with chemistry as one of the subjects or any education as the Licensing Authority may consider fit.
- Products Labelling Requirements for Manufacturers
Following are some labelling requirements as laid down under the Drugs & Cosmetic Rules, 1945:
- The outer label should clearly show the ingredients that are used in the product manufacturing;
- A separate batch number started with the letter B and the manufacturing batch with M must be mentioned on the label;
- The product name should be clearly mentioned on both the inner & outer labels and in case the container is small in size & then the principal place and the pin code are fine;
- The inner label must contain the direction for use and warning that may be necessary.
Note: BIS Checks The Product Quality From Time To Time And Also Revises The Indian Standard.
Documents Required for Cosmetic Manufacturing License
Following are some vital documents required for Cosmetic Manufacturing License:
- Application Form COS-5 is required;
- Specific Power of Attorney in favour of authorised signatory for submitting Application on behalf of the company;
- List of Directors, Partners, Trustees along with ROC copy registered Partnership Deed, Trust Deed;
- Covering Letter
- Acceptance or Appointment Letter of Competent Technical staff of manufacturing section (Not Mandatory);
- Section wise list of plant and machinery;
- Details of the manufacturing process, the process of a flow chart;
- Site Master File;
- Constitution details of firms;
- List of SOPs;
- Challan of fees paid;
- Constitution details of firms;
- Copy of draft label;
- Site Plan and layout of the building with the name, address, scale, and measurements of the area;
- Self-attested copies of documents pertaining to the possession of premises like Rent or Register Ownership or Lease or Allotment Letter or Possession Letter (Documents should be registered with appropriate Authority);
- List of Competent Technical Staff along with their qualification, experience, registration, previous FDA Approvals, etc.
Procedure for Obtaining Cosmetic Manufacturing License
Step 1: Filling Of Application: First, you need to file an application in COS-5 for Cosmetic Manufacturing License and our experts will help you in filing & drafting the Application on your behalf without any hassle.
Step 2: Submit Your Documents: After filing the Application, you need to submit all the vital documents to us via email and we will arrange all the documents along with the application form and submit it to the authority.
Step 3: Examination: Once we submit the Application and documents to the respective Authority, then they will examine the same.
Step 4: Issuance Of License: Once the Licensing Authority is satisfied with all the documents and Applications, they will issue the Cosmetic Manufacturing License in Form COS-8 and we will mail you the same.
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Validity of Cosmetic Manufacturing License
A Cosmetic Manufacturing License issued in Form COS-8 shall remain valid in perpetuity, subject to payment of license retention fee as specified in the 3rd Schedule before completion of the period of 5 years from the date of its issue, unless it is cancelled or suspended by the State Licensing Authority.
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Corpbiz has been proved to be the best legal firm in complying and providing the Cosmetic Manufacturing License in India with minimal price. If you have any queries related to Cosmetic Manufacturing License, feel free to contact us.
Frequently Asked Questions
This registration is required when an individual wants to manufacture a product that deals with skin cleansing or beautification.
Yes, it is mandatory.
It’s an executive body above the CDSCO and this body executes all the functions regarding the compliance of cosmetics & drugs in India.
As per the Drugs & Cosmetics Act, 194o, a License on Form-32 is issued to manufacture or sell or distribute cosmetics.
The manufacturing of cosmetics is regulated under a system of examination and licensing by the State Licensing Authority appointed by the respective State Governments.
If any rule or provision under the Act regarding cosmetics is not complied with, imprisonment up to 1 year or maybe more or a fine up to Rs. 1000/- will be imposed. Both can be imposed on 1st conviction and in the subsequent conviction, imprisonment can be further extended to 2 years and a fine up to Rs. 2000/-.