What is a Cosmetics License?
We are all well aware of the fact that the Cosmetics market in India is expanding rapidly. As a matter of fact, India has the second largest population in the world and it offers a large market for cosmetic products Nowadays, people from all over the world use cosmetics irrespective of the gender they belong to. In India, cosmetics regulations are governed by the Drugs and Cosmetics Act, 1940 (hereinafter as “the Act”) , wherein the term “Cosmetic” is defined as an “article that intends to be poured, rubbed, sprinkled or sprayed on to the human body or for cleansing, beautifying, promoting attractiveness or altering the appearance of particular part of the body”.
Cosmetics Registration for Manufacturers
Every importer shall apply for a registration certificate to obtain the necessary license for cosmetics in India from the Central Drugs Standard Control Organization (CDSCO).
According to the Act, the list of licenses needed for cosmetic product manufacturing and marketing in India are as follows:
To manufacture/ sale distribution of cosmetics, a license is issued on form 32.
Also, to issue loan licenses for manufacture/ sale distribution form 32-A is used.
A license is issued on Form 37 for grant or renewal of approval for carrying out tests on drugs/ cosmetics or raw material used to manufacture on behalf of licenses issued to manufacture for sale of drugs/ cosmetics.
The list documents required for cosmetics registration areas follows:
Application from of registration
A slip of fee deposited i.e. Challan
A declaration form
Key plan (Blue print)
Site plan (Blue print)
Proof of ownership of the premises, if rented
The basis of possession of the place
A proof of constitution of the firm (Certified copy)
An affidavit stating or declaring non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940
A certified copy of Registration Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent person and qualification certificates
Bio-data form (details of the manufacturer)
An affidavit of a Registered Pharmacist/Competent person working for the firm, it shall be duly attested by Notary
A letter of appointment of Registered Pharmacist/Competent person in charge, if employed person.
It is the duty of the manufacturer to look after that the production is being done in the presence of competent and qualified staff, one of them shall possess a certain level of education required as per the law.
Cosmetics Registration for Importers
The procedure to be followed to obtain cosmetics registration for importers:
The first step is to identify if the product requires registration.
The second step is to appoint an authorized agent in India by the importer, who shall act on their behalf as a point of contact.
The next step is to fill a predefined performs by CDSCO.
It includes details about the manufacturer and the product. The form is accompanied by a list of documents discussed below.
The form shall be duly signed and stamped along with other relevant documents submitted to the DGCI.
The list of documents required for cosmetics registration of importer are as follows:
A cover letter by the applicant
Treasury Challan (a slip of fee paid)
Power of Attorney
Schedule D III
An original or copy of the label of the product
A list of countries where the applicant is authorized to market or import or registration is granted
Pack insert, if any
Free sale certification or Market authorisation letter or Manufacturing license, if any
A soft copy of the information about the brand, product and the manufacturer.
Product specification and testing protocol.
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Registration certificate also known as Form 43 is valid for three years. The Government fees are 2000 USD per category and 50 USD per variant.
Labelling of the Cosmetics Products
The Drugs and Cosmetics Rules, 1945 laid down the procedure of labelling of cosmetics products, every manufacturer or importer should ensure that their cosmetics products have proper labelling. Labelling of the Cosmetic products are divided into two types first ‘inner labelling’ and ‘outer labelling’, procedure as follows:
Labelling of Cosmetics Products
The inner label must contain the name of the product.
The name of the manufacturer.
Full address of the manufacturer where the cosmetics product is manufactured.
Name of the ingredients used in the manufacturing of cosmetics products; it must be noted that name should come according of the percentage of content.
Direction provided for the use of the cosmetic product.
adequate direction for sale use,
Warning or Caution word should be mentioned if the product contains hazardous substances.
The name of the poisons or hazardous must be mentioned on the product.
The batch number preceded by the letter “B”, Provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state, and 25 milliliters or less if the cosmetic is in a liquid state:]
In the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.
Manufacturing license number, the number being preceded by the letter M.
Where a package of cosmetics has only one label such label shall contain all the information required to be shown on both the inner and the outer labels.
A declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, weight for semi-solids, combined with numerical count if the content is subdivided.
The list of ingredients, present in concentration of more than one percent shall be listed in the descending order of weight or volume.
The import of pre-packaged commodities such as raw materials, bulk imports, etc., that need to undergo further processing before they are sold to end consumers are not included under this labelling requirement.
It is compulsory for all pre-packaged goods to contain all the above features along with its Maximum retail sales price (MRP). The MRP includes all taxes, total transport charges, commission payable to dealers, and all charges towards advertising, delivery and packing.
Labeling requirements, if any, specified in the relevant Indian Standards laid down by the Bureau of Indian Standards for the cosmetics covered under Schedule “S”
Note: The Above application should be Apply in Form 43 and get Approval for Cosmetic Labelling in India
What are the penalties imposed for not complying to the rules?
The Drugs and Cosmetics Act, 1940 is a penalty act in which it is clearly stated that if any provision or rules under the Act with respect to Cosmetics is not complied with, imprisonment up to one year or more and fine up to Rs 1000 or both can be imposed on first conviction and in the subsequent conviction imprisonment can be extended to two years and fine to Rs 2000.
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