Definition of Cosmetics
Legal cosmetic manufacturing in India: The first step here is to understand the definition of the term, ‘cosmetic’. 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 alter the appearance.
How to apply for a license to manufacture cosmetics?
Getting the license is one of the major requirements for everyone who wants to legally manufacture cosmetics in India. 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.
Submission of Form for the License: To manufacture any of these products, a license has to be obtained from a Licensing Authority appointed by the State Government. The application has to be submitted in Form 31 along with a license fee of Rs. 2500 and an inspection fee of Rs. 1000.
Requirement of the Technical Staff:
The manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff and at least one of the staff persons should possess the following educational requirements:
- The staff should hold a Diploma in Pharmacy which must be approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
- The staff is registered under the Pharmacy Act, 1948; or
- The stuff should pass the 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 for inspecting the whole process of the operations. The appointment of the inspector should 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. Read our another article: Shareholder Agreements in India: A Detailed Overview
Requirements for Factory Premises
All units engaged in legal cosmetics manufacturing in India will have to fulfill requirements related to factory setup and hygiene. The factory premises needs to comply with certain conditions as laid down under Schedule M-II. Some of the general requirements are as follows:
- Location and Surroundings: It is supposed that the area should 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 operation must 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
Proper labelling ensures compliance with the rules for manufacturing cosmetics legally in India. Following are some of the labelling requirements as laid down under the Drugs and Cosmetics Rules, 1945:
- Name of the product along with the manufacturing address must be mentioned on both the inner and the outer labels. If the container is small in size then the principal place of manufacturing and the pin code are enough.
- The outer label should clearly specify the net contents of the ingredients used in the manufacture of the product.
- The inner label should contain the ‘directions for use’ along with any warning or caution that may be necessary. It should also contain names and quantities of ingredients which are hazardous in nature.
- A distinctive batch number preceded by letter ‘B’ alongwith manufacturing license number preceded by letter ‘M’ must be mentioned on the label.
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.
What may happen if the rules are not complied with?
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.
Requirement for Testing of Cosmetic Sample
Product testing is a key part of manufacturing cosmetics legally in India. 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 should satisfy the 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 be remembered that each and every product, that is manufactured or import, should deal with the Drugs and Cosmetics Rules, 1945 and the registration is valid for the period of three years.
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