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?
- Cosmetic Manufacturing License
- Cosmetic Import License
- Cosmetic Loan License
1. Cosmetic Manufacturing License
- 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
3. Cosmetic Loan License
What are the forms required for Cosmetic License?
What are the documents required for Cosmetic License Registration?
- 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.
- 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.
- 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.
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