CDSCO Cosmetic Manufacturing License Overview

In India right now, the cosmetics sector is booming everywhere from TVs to social media platforms. Whether they are male or female, people use cosmetics all around the world. Because of the enormous demand for cosmetics, which has drawn government attention because we already know that with great power comes great responsibility. Cosmetics are governed by the CDSCO (Central Drugs Standard Control Organization) in India, and CDSCO Cosmetic Manufacturing Licenses are governed under the Drugs and Cosmetics Act, 1940. Before 2013, there was no such requirement, but starting in 2013, all imported cosmetics for sale had to register with the DCGI (Drug Control General of India).

Customers these days are curious about the items' constituents and use that information to decide which ones are worth purchasing. Therefore, you must first obtain a CDSCO Cosmetic Manufacture License in order to launch a new cosmetics company and carry out product manufacturing, selling, and distribution. After that, registered cosmetics must attach a distinctive label bearing the Registration Certificate Number.

Different Classes of Cosmetic Products

Deodorant soaps

01. Hair colourants

02. Hair setting products

03. Lips product

04. Skin-whitening products

05. Face masks

06. Toilet soaps

07. Emulsions, creams, lotions, oil & gels for the skin

08. Make-up powders

09. Face masks

10. Deodorants and Antiperspirants

11. Products for waving, fixing hair, and straightening

12. Mouth & teeth products

13. Anti-wrinkle products

14. Shower & bath preparations such as salts, foams, oils, and gels

15. Hairdressing products such as lacquers, lotions, brilliantine

16. Make-up and products removing make-up

17. Products for external intimate hygiene

18. Sunbathing products

19. Depilatories

20. Hygienic powders

21. After-bath powders

22. Tinted bases (pastes, liquids, powders)

23. Shaving products (lotions, creams, foams)

24. Toilet waters, perfumes and eau de Cologne

25. Make-up powders.

26. Deodorant soaps

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Regulatory Authority for CDSCO Cosmetic Manufacturing License in India

The Central Drug Standard Control Organisation is the principal regulating body for CDSCO Cosmetic Manufacturing License in India (CDSCO). All cosmetic licences and medications are governed by the CDSCO. This body must coordinate with and regulate all requirements for the CDSCO Cosmetic Manufacturing License. The Drug & Cosmetic Act Of 1940 And Rules, 1945 is the law that governs the cosmetic sector in India. For CDSCO Cosmetic Manufacturing License in India, the BIS or Bureau Of Indian Standards publishes a number of standards in addition to CDSCO. These organisations also control the ingredients used 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:

  • Powders
  • 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
  • Depilatories
  • Preparations used for eyes
  • Aerosol
  • Tooth powder and toothpaste
  • Toilet soaps.
 

A licence issued by a Licensing Authority that the State Government designates is necessary to produce any of the products on the previously mentioned list. Form-31 must be used to submit the application, fee, and inspection charge. Additionally, the producer must make sure that the production is carried out in the presence of trained technical staff, at least one of whom must meet the following educational 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.
 

Therefore, the Licensing Authority must visit the entire site where the operation will be conducted before granting or denying the licence, and the inspector must be chosen in accordance with the Act. The licencing authority will decide whether or not to give the licence after receiving the inspection officer's report.

Labelling Requirements for Manufacturers
 

The following are some labelling specifications outlined by the 1945 Drugs & Cosmetic Rules :

01. The ingredients used to manufacture the product should be listed on the outside label

02. The manufacturing batch must be identified on the label by the letter M, and a separate batch number beginning with the letter B

03. If the container is small in size, the principal position and the pin code are sufficient, but the product name should be clearly stated on both the inner and exterior labels

04. The inner label must include any essential warnings and instructions for usage

Documents Required for CDSCO Cosmetic Manufacturing License

The following important papers are needed to obtain a CDSCO Cosmetic Manufacturing License:

01. Form-32 for cosmetics manufacture

02. Challan with fee deposited

03. A site plan and key plan blueprint

04. In the case of renting, ownership confirmation of the property

05. Justification for holding of the property

06. a certified copy of the firm's certificate of incorporation

07. Form of Declaration

08. Statement of non-conviction of partners, directors, or proprietorship under the 1940 Drugs and Cosmetics Act

09. A letter of affidavit from a licenced pharmacist or other qualified professional stating that they would work full-time for the business, duly attested by a notary

10. Biodata form

11. A certified copy of the registration certificate, experience certificate, and qualification certificates for registered pharmacists or skilled workers

12. If an employee, a letter appointing a registered pharmacist or competent, qualified person in charge.

Procedure for Obtaining CDSCO Cosmetic Manufacturing License

According to the Drugs and Cosmetic Act & Rules, import licences in Form 10 and registration certificates in Form 21 are needed for the import of certain medical devices into India. Medical device manufacturing facilities and sites must be registered with Indian Drug Regulatory, or the Central Drugs Standards Control Organization, in order to import medical equipment (CDSCO).

How to Apply for a Medical Device Import License from CDSCO

Step 1: Filling Of Application : First, you must submit an application for a cosmetic manufacturing licence. We will draught the application for you and assist you in submitting it without any problem.

Step 2: Submit Your Documents : After submitting your application, you must email us with all of the necessary supporting documentation so that we may build and submit your form under CDSCO.

Step 3: Examination : CDSCO will evaluate the application and documentation when we have submitted them.

Step 4: Issuance Of License : The department will issue the licence after being satisfied with all of the application materials, and we will ship the licence to you.

FAQ
 

Is it compulsory to obtain a Cosmetic Manufacturing License in India?

Yes, it is required.

What are the primary functions of the Central Drug General of India?

It’s an executive body above the CDSCO and this body executes all the functions regarding the compliance of cosmetics & drugs in India.

How does cosmetic registration work?

When someone wishes to create a product that deals with skin washing or beauty, they must register their business.

How is the manufacturing of cosmetics regulated under the provision of the Act?

The State Licensing Authority, which is chosen by the individual State Governments, controls the manufacturing of cosmetics through a system of inspection and licencing.

Which form is needed to obtain an Indian cosmetic manufacturing licence?

A License on Form-32 is issued to produce, sell, or distribute cosmetics in accordance with the Drugs & Cosmetics Act of 194o.

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