Cosmetics market in India is growing at a rapid pace. The demand for cosmetics products has been growing, particularly in urban centres owing to several factors such as greater purchasing power because of higher incomes, increasing influence of western culture, desire to look better and more attractive etc. A cosmetic is also a sector that needs to be strictly regulated.
Cosmetic Regulation in India
According to the Drugs & Cosmetics Act, 1940, a ‘cosmetic’ is defined as an article that can be used in any part of the human body. It may be rubbed, poured, sprinkled or sprayed on. Cosmetic is applied to any part of human body to clean, beautify, promote attractiveness, or to alterthe appearance.
The Drugs and Cosmetics Rules, 1945 elaborates the procedure to manufacture cosmetics in India.Cosmetics can be classified, under Schedule M-II, into 11 broad product categories:
- Powders,
- Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams, hair oils etc.,
- Nail Polishes and Nail Lacquers,
- Lipsticks & Lip Gloss etc.,
- Depilatories,
- Preparations used for eyes,
- Aerosol,
- Alcoholic Fragrance Solutions (Cologne),
- Hair Dyes,
- Tooth Powders and Tooth Pastes etc.,
- Toilet Soaps.
Types of Cosmetic License in India
There are two types of license for setting up a cosmetic business in India. The license depends upon the nature of the cosmetic business. Hence, the following are two kinds of cosmetic license in India:
- Manufacturing, and
- Importing.
Requirements for getting License of Cosmetic Business
Submission of Form for the License:
The State Government appoints a Licensing Authority for manufacturing the products. Any individual or company has to obtain a license from the Licensing Authority to manufacture any products.According to Drug and Cosmetics Act, 1940, in India, for the manufacturing of cosmetic product, the following licenses are required:
- License on form 32 is issued for manufacture/ sale distribute of cosmetics and,Form no. 31 should be submitted.
- License on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics, and Form no. 31-A should be submitted.
- License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics, and Form no. 36 should be submitted.
The applicant must submit the required form to get the license. The applicant is also supposed to submit Rs. 2500 as the fee for license and Rs. 1000 as the fee for inspection. The applicant is required to submit the said fee through bank challan. In case, if the application is made through online, the applicant will receive an e-mail.
Requirement of the Technical Stuff:
It is the duty of the manufacturer to assure that a competent and qualified technical staff must present there to observe the process of production. One staff, should be there, whomust possessthe required educational background.
- The stuff should hold a Diploma in Pharmacy which must be approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
- The stuff can be registered under the Pharmacy Act, 1948; or
- The stuff shouldpassthe intermediate examination with Chemistry as one of the subjects or any other examination as recognized by the Licensing Authority as equivalent to it.
Inspection before Granting License:
Before granting or refusing the license, the Licensing Authority is supposed to order forinspecting the whole processof the operations. The appointment of the inspectorsshould be done under the Act. Then the inspectors are supposed to submit a detailed report about the operations to the Licensing Authority. After that, the Licensing Authority will decide whether to grant the license or not.
Requirements for Factory Premises
The essential conditions of the factory premisesfor setting up a cosmetic business have been elaborated underSchedule M-II. The following premises are required:
Location and Surroundings: It is supposed that the areashould be having all the facilities for seating up a cosmetic manufacturing business. The matter of the location should be strongly viewed before starting the construction. The vicinity should be hygienic with proper sanitary conditions. The operationmust not be taken place within or near any residential area.
Building: The building should be free from rodents, insects etc. which can hamper the whole operation or product.There are several conditions for the rooms of the building. The height of the room should not be less than 6 feet from the floor. The rooms should be kept smooth, waterproof and also capable of being kept clean. The floors should also be smooth, washable,¹¹ and dust-free.
Disposal of used water: The stuffs should make proper arrangements and they should also be careful about proper discharge or disposal of waste water.
Staff: The staffs, appointed for the manufacturing, should free from any communicable or infectious disease. The stuffs are required to use the necessary tools such as hand gloves, masks, uniforms etc. The availability of first aid facility inside the factory premises should also be there.
Requirements pertaining to Labelling of Products
The labellingof cosmeticshas been elaborated under the Drugs and Cosmetics Rules, 1945. The rules are as follows:
- Both the inner and the outer labels contain the name of the product and the address of its manufacturing. In case, if the size of thecontainer is small, the Principal place of manufacturing and the pin code is enough according to the cosmetic labelling instruction.
- The outer label should contain and clearly mention the list of ingredients which are being used in the manufacturing of the product.
- To avoid any risk, the ‘Directions for use’, any warning or caution must be specified on the inner label. Manufacturer is also supposed to mention the names and quantities of ingredients which are of hazardous nature.
- According to the Drugs and Cosmetics Rules, the cosmetic labelling instruction says to mention a distinctive batch number preceded by letter “B” and manufacturing batch with “M”,Manufacturing Date, Best Before along with manufacturing license number (if any) on the label.
- In January, 2001, the Indian government has made some compulsion for all the imported cosmetics. The pre-packaged goods must contain all the above features along with its Maximum retail sales price (MRP). All taxes, total transport charges, commission payable to dealers, and all charges towards advertising, delivery and packingshould be included in the MRP.
- 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.
Quality standards in case of the aforementioned categories of products must conform to the Indian standards laid down and revised by the Bureau of Indian Standards (BIS) from time to time.
Requirement forTesting of Cosmetic Sample
According to the Bureau of Indian Standards (BIS) requirements, the testing of cosmetic product should be done. It has to meet all the criteria for imported cosmetic product registration and it shouldsatisfythe manufacturer, buyer and consumer.The sample testing includes the following:
- Physical and chemical analysis of raw materials and active ingredients;
- Safety tests to assess the presence of heavy metals in cosmetics, banned colours and chemicals;
- Microbiological quality check to ensure the absence of microbial counts and pathogens;
- Qualitative and quantitative estimation of active ingredients;
- Physical testing which includes parameters such as viscosity, spread-ability, scratch test, pay-off test;
- Estimation of sun protection factor;
- Skin irritation and sensitivity studies;
- Stability testing, shelf life determination, etc.
Documents required for Cosmetic Registration in India
For the cosmetic registration, the required documents are as follows:
- Original copy of Power of Attorney in case of Importer,
- Certificate of free sale, marketing authorization letter,
- Form 42 duly signed and filed and the list of products to be renewed,
- Fees as mentioned,
- A self-declaration that there are no changes in earlier shred information,
- NOC from Pollution Control Board,
- Plan the layout of the premises,
- Rent agreement in case of rented premises,
- List of laboratory equipment,
- Affidavit of Applicant,
- List of machines installed for manufacturing,
The Importer needs to apply for cosmetic registration products by
- An authorized agent of the manufacturer,
- A Subsidiary of the manufacturer,
- A manufacturer having registered premises in India,
- Any other importer.
It should me remembered that each and every product, that is manufactured or import, should deal with the Drugs and Cosmetics Rules, 1945and the registration is valid for the period of three years.
The Drugs and Cosmetics Act, 1940 is a punitive Act. If any of the provisions or rules under the Act with respect to Cosmetics is/are not complied with, imprisonment upto one year or fine upto Rs. 1000 or both can be imposed on first conviction and on subsequent convictions, imprisonment can be extended to two years and fine to Rs. 2000.
