Basic guidelines for manufacturing Cosmetics in India
Law that Governs Production, Sale and Distribution of Cosmetics in India
Manufacturing, distribution and sale of cosmetic products in India are regulated by provisions under Drug and Cosmetics Act, 1940. Cosmetics were brought within the purview of Drug Act and the name of the act was changed to Drug and Cosmetic Act 1940. However implementation came into effect in the mid 1960, when the rules relating to import and manufacturing of cosmetics were formed by the government of India in 1964.Then rules have been amended from time to time to achieve the intended purpose under the act.
Definition of Cosmetics
Cosmetics means any article intended to be rubbed, poured, sprinkled or spread on or introduced into or applied to human body or any part there of for cleansing, beautifying, promoting attractiveness and altering the appearance and includes any article intended to be used in a cosmetic/s.
Earlier, soap was excluded, but since 1982, toilet soaps have been covered under the definition of cosmetics.
Prohibited Cosmetics in India
Manufacturing and / or sale of certain cosmetics is prohibited under the Drug and Cosmetic act and rules made there under are:
1- Any cosmetic, which is not of standard quality or is misbranded or spurious.
2- Any cosmetic containing any ingredient that may render it unsafe or harmful for use under directions indicated or recommended.
3- Any cosmetic manufactured in contravention of provisions of act or rules made there under.
4- Any cosmetic except toilet soap containing hexa chlorphen.
5- Any cosmetic containing lead or arsenic compounds for coloring purpose.
6- Any cosmetic containing mercury compound.
7- Any cosmetic containing colors other than prescribed ones.
Standard for finished cosmetics were not prescribed under rules for long time. In early 80’sthe standards formed by Indian Standards Institution (ISI) now known as Bureau of Indian Standard (BIS) were adapted standards and more cosmetics were adopted under it.
Now, as many as 20 cosmetics have been placed under the schedule ‘S’ of cosmetics and are required to comply with the prescribed standards. These are:
Skin powders, Skin powders for infants, Tooth powders, Toothpaste, SKIN CREAMS, Hair oils, Shampoos, Soap based shampoos, synthetic detergent based hair creams, oxidation hair dye liquids, Cologne, After shave lotion, Nail polish, pomades and brilliantines, Chemical depilatories, Shaving creams, Cosmetic pencils, lipsticks, toilet soaps, transparent toilet soaps, shaving soaps, liquid toilet soaps, baby toilet soaps, liquid powder hair dye, liquid bincl, kokum powder, henna powder.
How To Label Cosmetic Products
Any of the above cosmetics, which are imported to India, should confirm to Indian Standard Labeling of Cosmetics.
Finished cosmetics should be labeled in manner laid down under rule 148 of Drug and Cosmetic Act. Special provision relating to labeling of hair dye containing coal tar colors and toothpaste containing fluorides are given under rules 149 and 149A.
Manner of labeling as per rule 148 of Drug and Cosmetics act of IPC.
Subject to other provisions of rule, cosmetics should carry-
1- On both inner and outer labels
- Name of cosmetic
- Name of principle place of manufacturing.
2- On outer label, a declaration of net contents expressed in terms of weight for solids, fluids measures for liquid, weight for semisolids, combined with numerical count if content is sub divided should be provided.
3- On inner label where hazards exists.
- Adequate directions for safe use.
- Any warning, caution or special direction required to be observed by consumer.
- Statement of name and quantities of ingredients that are hazardous and/or poisonous.
4- A distinction batch number from which subjects in container are taken are recorded and available for inspection.
Figures representing batch number being preceded by letter “M” provided that this clause shall not apply any cosmetic containing 10gms or less if cosmetic is in solid or semisolid state or 25ml or less if cosmetics is in liquid state.
Further that in case of soaps instead of batch number, month and year of manufacturing of soaps shall be given or label is given.
5- Manufacturing license number being preceeded by “M”.
6- When package of cosmetic has only one label such label shall contain all information required to be shown on both inner and outer labels under this rule.
Labeling of hair dye containing coal tar color as per rule 149 of drug and cosmetic act.
Hair dye containing p-phenylene diamine or other coal tar dye base or coal tar dye intermediates shall be labeled on both inner and outer label in the following manner:
Caution: this product contains ingredients, which may cause skin irritation in certain cases, and so a preliminary test according to the accompanying directions should first be made.
This product should not be used for dying the eyelashes or eyebrows as such use may cause color blindness.
Each package shall also contain instructions for carrying out the test.
This preparation may cause serious inflammation of skin in some cases and so a preliminary test should always be carried out to determined weather or not special sensitivity exists.
To take the test :-
Cleanse small area of skin behind the ear or the inner surface of the forearm using either soap water or alcohol.
Apply a small quantity of hair dye as prepared for use to the area and allow it to dry.
After 24 hours wash the area gently with soap and water. If no irritation or inflammation is apparent it may be assumed that low hypersensitivity to dye exists. The test should be carried out before application. This preparation should on no account be used for eyebrows or eyelashes as severe inflammation of eye or even blindness may occur.
Special provisions relating toothpaste containing fluoride.
1- Fluoride content should not be greater than 100ppm & content of fluoride in ppm shall be given on tube & cartoon.
2- Date of expiry should be mentioned on tube & cartoon.
Rule 134 of Drug and Cosmetic Act
It stipulates that cosmetic shall be imported which contain coal tar color other than that prescribed in schedule “Q” rule and coal tar colors used in cosmetics shall not contain greater than
1- 2ppm as calculated as Arsenic Oxide (AS2O3).
2- 20ppm Lead calculated as Lead.
3- 100ppm of heavy metals other than Lead calculated as total of respective metals.
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