An Overview of CDSCO Cosmetic Manufacturing License
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 attracts Government due to its massive demand. In India, the CDSCO (Central Drugs Standard Control Organisation) regulates cosmetic products and the Drugs and Cosmetics Act, 1940 regulates CDSCO Cosmetic Manufacturing License. After 2013, it became mandatory for all the imported cosmetics for sale to get registered with DCGI (Drug Control General of India); before that, there was no such provision.
Nowadays, customers are curious to know the ingredients in products & make choices which one is good to buy. Therefore, to start a new cosmetic business and conduct manufacturing, selling, and distribution of products, you need to obtain CDSCO Cosmetic Manufacturing License first. Then, registered cosmetics will need to stick a unique label with the Registration Certificate Number on it.
Different Classes 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.
Regulatory Authority for CDSCO Cosmetic Manufacturing License in India
The primary regulatory authority for CDSCO Cosmetic Manufacturing License in India is the Central Drug Standard Control Organisation (CDSCO). The CDSCO regulates all cosmetic licenses and drugs. All the requirements regarding the CDSCO Cosmetic Manufacturing License are required to be liaised and regulated by this body. The law which regulates the cosmetic industry in India is the Drug & Cosmetic Act of 1940 and Rules, 1945. Apart from CDSCO, the BIS or Bureau of Indian Standards brings out various standards for CDSCO Cosmetic Manufacturing License in India. These bodies also regulates the ingredients in cosmetics.
Cosmetic Regulations for CDSCO Cosmetic Manufacturing License in India
Under the Drugs & Cosmetic Rules, 1945, Schedule M-II categories cosmetics into 11 product categories:
- Creams, lotions, milk, shampoos, cleansing, pomade, shaving creams, hair oils etc.;
- Nail polishes and Nail lacquers;
- Alcoholic Fragrance Solutions;
- Hair Dyes;
- Lipsticks and Lip-gloss;
- Preparations used for eyes;
- Tooth powder and toothpaste;
- Toilet soaps.
To manufacture any product from the above-mentioned list, a license is required that has been attained from a Licensing Authority which the State Government appoints. The application has to be submitted on Form-31 along with the fee and inspection fee. Moreover, the manufacturer needs to keep a 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 the chemistry as one of the subjects or any education as the Licensing Authority may consider fit.
Thus, before issuing or refusing the license, the Licensing Authority is required to examine the overall premises where the operation is to be carried out and the inspector is to be appointed as per the Act. The inspection officer shall submit the report to the Licensing Authority, which will decide whether to grant the license or not.
Labelling Requirements for Manufacturers
Following are some labelling requirements as laid down under the Drugs & Cosmetic Rules, 1945:
- The outer label should clearly showed 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 CDSCO Cosmetic Manufacturing License
Following are some vital documents required for CDSCO Cosmetic Manufacturing License:
- Form-32 for manufacturing of cosmetics;
- Fee deposited challan;
- Blueprint of Site Plan and Key Plan;
- Ownership proof of the premises, in case of rent;
- Basis of possession of the premises;
- Certified copy of proof of constitution of the firm;
- Declaration form;
- Affidavit of non-conviction of Partners or Directors or Proprietorship under Drugs and Cosmetics Act, 1940;
- Affidavit letter of a registered pharmacist or competent/skilled person regarding full-time working with the firm duly attested by Notary;
- Bio-data form;
- Certified copy of Registration Certificate or Experience Certificate of the Registered Pharmacists or skilled person and qualification certificates;
- Appointment letter of a registered pharmacist/competent/skilled person in charge, if an employed person.
Procedure for Obtaining CDSCO Cosmetic Manufacturing License
Step 1: Filling of Application: First, you need to file an application for a Cosmetic Manufacturing License and we 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 create your form under CDSCO and submit it.
Step 3: Examination: Once we submit the application and documents to CDSCO, then they will examine the same.
Step 4: Issuance of License: Once the department is satisfied with all the documents and applicantion, then they will issue the license and we will mail you the license.
How will Corpbiz Support You?
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 CDSCO 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/-.