Permissions and Licenses Required for Making Cosmetics in India

Making Cosmetics in India
Ganesh Nair
| Updated: Sep 28, 2022 | Category: CDSCO

The cosmetics Industry in India is flourishing. Cosmetic products have seeped both into the urban as well as rural spaces and, in recent times, have created a larger market for themselves by breaking down the gender stereotypes attached to them. In India, the cosmetics sector is governed by the Drugs and cosmetics act 1940 and the Drugs and Cosmetics rules, 1945 to deal with cosmetic registration in India.

Licenses required for making cosmetics in India

A manufacturer requires to obtain the following licenses for making cosmetics in India:

License for Manufacture/sale/ distribution

The Drugs and cosmetic rules state that a manufacturer needs to obtain a license of Form 32 by applying for Form no.31 with state license authority. The manufacturer shall be able to manufacture 10x of all the cosmetics categories mentioned in Schedule M-II of the rules.

Loan License for Manufacturing of cosmetics

The manufacturer has the provision for obtaining a loan license under Form 32-A by applying for an application for a loan as mentioned under Form 31-A, with licensing authority of the state.

License for grant of approval for carrying out tests or cosmetics

The manufacturer has to get approval for conducting tests on cosmetics and raw materials (Form 37). And to obtain this license, the manufacturer must apply for Form 36 with the state licensing authority.

Fee Structure

S.no License Application Fee Inspection Fee
1. Manufacturing cosmetics 2,500 1,000
2. Loan license for manufacturing cosmetics 2,500 1,000
3. License for grant of approval for carrying out tests 1,500

Prerequisites for making cosmetics in India

Making cosmetics in India requires adherence to certain regulations. If the manufacturer fails to comply with these provisions, the license may not be granted.

The eligibility requirements for working staff in a cosmetic manufacturing unit

The manufacturers must ensure that the staff that is employed in the manufacturing process must possess the knowledge and technical know-how and fulfil the following requirements:

  • Diploma in Pharmacy – that is approved by the Pharmacy Council of India under the Pharmacy Act, 1948
  • Must be Registered under the Pharmacy Act, 1948
  • The candidate must have cleared the intermediate examination and have chemistry as one of the core subjects.

Rules for labelling of products

  • Details such as the product’s name, the manufacturer’s name, and the premises’ complete address must be clearly stated on the inner and outer labels.
    • The outer label must clearly specify the ingredients being used in the product’s manufacturing.
    • The inner label must have directions to use, possible hazards and relevant warnings to ensure safety printed over it.
    • The product must contain the Batch number that is preceded with the letter B and the Manufacturing number preceded with the letter M over the label.
    • Other labelling requirements as per the BIS must also be provided.

Requirements of the factory:

The Manufacturing factory must comply with the conditions mentioned in schedule M-II for making cosmetics in India. These are:

  • Location of the factory: it is essential that the area where the manufacturing factory is situated must be kept clean and hygienic. The manufacturer must ensure that the factory does not function near a residential area.
  • Factory Building: The walls of the factory building must able to be washable, dust and dirt free. The rooms in the building must be at least six feet from the floor in height. The factory building must be kept free from rodents, insects etc.
  • Water: The manufacturer must ensure that the factory has proper systems installed for the disposal of the document.
  • Staff: The staff should not be suffering from any infectious disease. The manufacturer must provide its staff with safety equipment such as gloves, masks, and uniforms. Along with this a First Aid facility should also be made available in the factory.

Documents Required for Cosmetic Registration

The documents required for making cosmetics in India are:

  • Proof of ownership of the premises
  • Documents showing the constitution of the firm
  • A Declaration form
  • Blueprint of the site plan
  • Affidavit of partners, directors and proprietor as per the act
  • A copy of Certificate registration from the Pharmacy Council of India[1]
  • A copy of the pharmacist’s experience certificate
  • Copy of qualification of pharmacist and other relevant members
  • Affidavit of registered pharmacist on full-time employment attested by the Notary public
  • Appointment letter of the registered pharmacist
  • Application forms (31,31-A or 36) are downloaded in PDF format.

Process of manufacturer registration for making cosmetics in India

The manufacturer of cosmetics can apply for a licensing process will be as follows:

  • The manufacturer must visit the SUGAM portal
  • Then, the applicant must click on the Login/ signup button
  • On the registration purpose, select the purpose as ‘Cosmetic Registration’ and click on the submit button.
  • The applicants must enter details as prompted. Then upload the documents (ID proof of authorised signatory, Declaration form, letter from the pharmacist)
  • After this, a verification Link will be sent to the registered mail id. Click on the verification Link, and the application shall be advanced for approval from the concerned authority.
  • The authority shall forward the registration approval to the registered email id.
  • After approval, the applicant must re-login to the portal by entering the user id and password.
  • Choose the department and the form type in the form submission section.
  • Select the type of application on the portal.
  • Click on the continue button after submission of the application
  • The portal shall show the preview of the application again, check for any errors and then click on save and continue.
  • After this, the user will be redirected to a checklist page. Here the user has to upload each document individually and hit the submit button.
  • The CDSCO shall grant the registration to the manufacturer for making cosmetics in India.

Conclusion:

For making cosmetics in India, the manufacturer must obtain all the licenses as laid down by the government. Along with this, the manufacturer has to follow labelling rules and maintain factory conditions as per the drugs and cosmetics act. The government has made the process of application for the registration license simple via the SUGAM portal.

Read our Article:Who can apply for CDSCO License?

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Ganesh Nair

Ganesh Nair completed his graduation in law from IP university. He is an ardent researcher who has written various research papers and articles on contemporary legal issues. His keen interest in the field of research made him pursue a career in legal research. His core area of interest include Cyber, IPR and Finance laws.

 

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