Cosmetic License

What is COSMETIC License?

Cosmetics are those products that are intended to be rubbed, poured, sprinkled or sprayed on or otherwise applied to the human body for cleansing, beautifying, improving the appearance, and promoting attractiveness. The Drugs and Cosmetics Act of 1940 manages the import, production, distribution and sale of drugs and cosmetics in India. The primary intention of the act is to make sure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. After April 13, it became compulsory for all the imported cosmetics for sale to get registered with Central Drugs General (DCGI).

Types of Cosmetic License issued in India?

There are different types of Cosmetic License, They are:

Cosmetic Manufacturing License
Cosmetic Import License
Cosmetic Loan License

Currently there is no licensing for the sale of cosmetic products. Maharashtra Food and Drug Administration (FDA) has submitted a proposal to the state Government to make it mandatory for retailers selling cosmetic products to apply for licenses. Once approved, Maharashtra will be the first state to start licensing retailers of cosmetic products.

1. Cosmetic Manufacturing License

Cosmetic Manufacturing License is required when a person or a firm manufactures cosmetic products in India. Customers are now interested to know the ingredients in products and make decisions which one to buy. Hence to start a new business for cosmetic production one need to obtain Cosmetic Manufacturing License. The given licenses are required for cosmetic production and market in India as per the Drug and Cosmetic Act, 1940.,

License on Form 32 is issued for manufacture or sale distribute of cosmetics. (Application is filled in Form 31)
License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs or cosmetics or raw material used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs or cosmetics. (Application is filled in Form 36)

2. Cosmetic Import License

Import of cosmetics in India are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules 1945. Import of cosmetics in India needs to be regulated to ensure quality and safety of cosmetics being imported in India and safety of consumers using these cosmetics. For the import of cosmetics in India, it is needed to be registered with the Central Drugs Standards and Control Organization by submitting an application in Form 42 to obtain registration certificate in Form 43. The manufacturer himself or the authorized agent of the manufacturer or the subsidiary of the manufacturer or any other importer can be an applicant for the issuance of registration certificate for import of cosmetics to India.

3. Cosmetic Loan License

As per Drug and Cosmetic Act, the Loan License means a license which a licensing authority may issue to an applicant who do not possess its own arrangement of manufacturing but who wish to benefit himself of the manufacturing facilities of licensee. License in Form 32 – A is issued for loan license for manufacturing cosmetics for sale or for distribution. The application is filled in Form 31-A.

What are the forms required for Cosmetic License?

Form 31: is needed to be filled for applying Cosmetic Manufacturing License.

Form 32: The manufacturing License is issued for manufacture or sale of cosmetics.

Form 31-A: is needed to be filled for applying Cosmetic Loan License.

Form 32-A: The Cosmetic Loan License is issued in Form 32-A for manufacturing cosmetics for sale or for distribution.

Form 42: is an application for issue of a registration certificate for import of cosmetics into India.

Form 43: Form 43 is a registration certificate to be issued for import of cosmetics into India.

What are the documents required for Cosmetic License Registration?

Documents required for Cosmetic Manufacturing License:

Form 31 duly filled.
Challan of fee deposited.
Declaration form.
Key plan (Blue Print)
Site plan (Blue Print)
Basis of possession of the premises.
Proof of ownership of premises, if rented.
Proof of constitution of the firm.
Affidavit of non-conviction of proprietor or partners or directors under Drugs and Cosmetics act, 1940.
Certified copy of registration certificate of Delhi Pharmacy Council or experienced certificate of the pharmacist or competent person and qualification certificates.
Bio data form.
Affidavit of registered pharmacist or competent person regarding fulltime working with the firm duly attested by notary.
Appointment letter of registered pharmacist or competent person in charge, if employed person.
List of machines installed for manufacturing.
List of laboratory equipment.
NOC from pollution control board.
Certificate of free sale, marketing authorization letter.

Documents required for Cosmetic Import License:

Original copy of power of attorney
Form 42 duly filled and signed.
Covering letter.
Schedule D III
List of ingredients.
Labels of proposed products.
Specification and testing method for testing of cosmetics.
Authenticated copy of manufacturing licenses or marketing authorization for the applied products issued by Regulatory Authority from country of origin.
Pack insert, if any.
Original free sale certificate issued by National Regulatory Authority of country of origin for the applied products.
Non animal testing declaration.
Declaration for heavy metal and hexachlorophene content.

Documents required for Cosmetic Loan License:

Form 31-A duly filled and signed.
Covering letter.
Challan for required amount under the head of account.
Statutory forms: Form fees.
Declaration of the proprietor or partners or directors etc., in affidavit-I along with attested copies of partnership deed or memorandum of articles.
Affidavit-II attested by Notary regarding the name, address and other details of the person responsible to the day to day affairs of company and for the conduct of business along with his photograph duly attested.
Copy of ration card or passport or electoral ID etc., in support of residential address of responsible person.
Consent letter from the parent firm declaring the facilities available and the details of the licenses possessed indicating the category of drugs and number of loan licenses already held.
Declaration of technical staff for manufacture and for analysis.
Declaration to the effect that whether the firm is already having any manufacturing license of their own unit or loan license and if so, the details of such licenses and declaration stating the same formulations now applied were not earlier permitted on the same brand name or under any other brand names.

What is the procedure for applying for Cosmetic License?

Determine if your product requires registration.
Appoint an authorized Indian agent. (For foreign manufacturers)
Submit all the regulatory documents.
Obtain registration certificate.

What if you violate the law?

Penalty for the import of spurious cosmetic or cosmetic containing any ingredient harmful for use: The person will be liable to a penalty of imprisonment for term of 3 years which may extends to 5 years with fine of 5000 rupees.
Penalty for the import of cosmetic whose import is prohibited under section 10-A: The person will be liable to a penalty of imprisonment for term of 3 years which may extends to 5 years with fine of 5000 rupees.
Penalty for the repeated offense of above two: The person will be liable to a penalty of imprisonment for term of 5 years and fine which may extend to 10000 rupees.
Penalty for sale or manufacture of cosmetic which is not of standard or misbranded cosmetic: The person will be liable to a penalty of imprisonment for term of 3 years which may extends to 5 years with fine of 5000 rupees.

Conclusion

Being the manufacturer or importer of cosmetic products in India, one must possess the Cosmetic License. It is required for them to strictly follow the rules and regulations of the Drugs and Cosmetic Act. Failing to comply with these will lead to punishable offenses under the act