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getting into cosmetics manufacturing business
Cosmetics Regulation in India - the law you need to know
before getting into cosmetics manufacturing business
Posted by: Ramanuj in General February 12, 2014 2.Comments|
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This article 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
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
yes, 7) Aerosol, 8) Alcoholic Fragrance Solutions (Cologne), 9)
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 arca 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 perso
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 Ietter ‘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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