This article on cosmetics regulation in India is written by Anumeha Karnatak, a student of National Law School of India University, Bangalore during her internship with iPleaders.     

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. Cosmetics is also a sector that needs to be strictly regulated. Presently the governing legislation in case of cosmetics in India is the Drugs & Cosmetics Act, 1940 which defines a ‘cosmetic’ as “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.”

How to apply for license to manufacture cosmetics?

The procedure to be followed in order to manufacture cosmetics in India has been laid down under the Drugs and Cosmetics Rules, 1945. Schedule M-II classifies cosmetics into 11 broad  product categories: 1) Powders, 2) Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams, hairoils etc., 3) Nail Polishes and Nail Lacquers, 4) Lipsticks & Lip Gloss etc., 5) Depilatories, 6) Preparations used for eyes, 7) Aerosol, 8) Alcoholic Fragrance Solutions (Cologne), 9) Hair Dyes, 10) Tooth Powders and Tooth Pastes etc., 11) Toilet Soaps.  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 alongwith a license fee of Rs. 2500 and an inspection fee of Rs. 1000. 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:

• Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
• Is registered under the Pharmacy Act, 1948; or
• Has passed the intermediate examination with Chemistry as one of the subjects or any other examination as recognized by the Licensing Authority as equivalent to it.

Before granting or refusing the license, the Licensing Authority is required to order inspection of the whole premises where the operations are to be carried out. The inspectors are appointed under the Act. They are then required to submit a detailed report to the Licensing Authority which can then decide whether to grant the license or not.

What are the requirements for factory premises?

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 required that the area in which the factory/manufacturing facility is located and the vicinity are hygienic with proper sanitary conditions. No operations should take place within or around a residential locality.  
• Building: The building in which the operations are to be carried out must be free from rodents, insects etc. The rooms of the building should be at least 6 feet from the floor in height. It should also be smooth, waterproof and capable of being kept clean. With respect to floors the same should be smooth, washable, even and dust-free.
• Disposal of used water: Suitable arrangements should be made for careful and proper discharge or disposal of waste water.  
• Staff: The appointed staff persons should not be suffering from any communicable or infectious disease. It is also important that they are provided with the necessary tools such as hand gloves, masks, uniforms etc. as and when required. First aid facility should also be available inside the factory premises.

What are the requirements pertaining to labelling of products?

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.

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