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, Tooth paste, 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.

  Rule 149A:

  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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Comments 37 comments

Siddharth 5 years ago

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.

But we request you to please let us know that manufacturing of NAIL POLISH REMOVER is required any license or comply any special standard.


Tintin25 profile image

Tintin25 5 years ago Author

check the latest list of schedules, if any, issued by govt of India.


Rahul 4 years ago

thanks a ton :)


tanya 3 years ago

what license and permissions are required to manufacture a shampoo in India


kopale 2 years ago

what license and permission are required to manufacture a shampoo in india?


Tintin25 profile image

Tintin25 2 years ago Author

The best is to go to a contract manufacturer you will find it you will find address in any pharmaceutical index like MIMS or CIMS, you can use their manufacturing license number and other approvals.


Ankita 2 years ago

Does home made scrub require any license to launch in the retail market


Tintin25 profile image

Tintin25 2 years ago Author

No, not in India!


mahendra 2 years ago

Sir, plz confirm whether I need a manufacturing or repacking license even if I pack pure henna powder in 70 gms packing under my label when bought from bulk suppliers/processors. To make clear, on my pouch I may not write- for sole use on hair. If luckily NO, then do I fall under someone else monitoring. Plz reply. Thanks. maha_indr@yahoo.com


Tintin25 profile image

Tintin25 2 years ago Author

You don't need anything to repackage henna!


rhea 2 years ago

what license and permissions are required to manufacture hair dye/hair colour products in India


AYUSH 2 years ago

Thanks A Lot For Helping Me Guys!!


Mohit Kumar Monga 2 years ago

I want to manufacture shampoo , washing powder.From where I could get licence.


Tintin25 profile image

Tintin25 2 years ago Author

Don't manufacture it, go to a known manufacturer, get it made under your brand and market it. This way it will be economical, risk free and you do not need manufacturing licence.


xyz 2 years ago

What licensing and permission required for lipstick


shreya 2 years ago

Its Really amazing to know that which ingredients will be used or not

I Want to know about manufacturing license and permission

of cosmetics product


ajeet Singh 22 months ago

Want manufacture ayurvedic hair oil... Do I need any kind of licence?


Tintin25 profile image

Tintin25 22 months ago Author

Manufacturing license number is required from local FDA.


soapgirl 21 months ago

Do we need cosmetic license for selling hand made soaps and creams in India?


Monika Kesharwani 21 months ago

I have manufactured herbal ayurvedic hair oil and i m seliing it from 3 months . its effective as well as i done a lot of research on it. i want to make it official and want to take a product manufacturing licence and want to do product registration so that i can expand my business. so please guide me where can i get licence. any proccess for it . can i get help of any agent? and tell me abt documentation becz i hav no idea abt licence proccess .


virender 20 months ago

I want to start manufacturing SHAVING FOAM in delhi what licence i required??


Urmila 20 months ago

I have grown myself organic termaric. I want to launch by packing n selling as for bridal use n medication. Which all licence i need to take


saurabh bhatt 18 months ago

I want a manufacturing certificate


Jyotika Kapoor 18 months ago

Hi!I want to know about starting a buisness in homemade skin and hair care products.Do i need a license if want to launch in the market as they r homemade..


sameer bisaria 17 months ago

iwant to manufacturer multani based lotion, do ineed a licence for herbal product.m-9897088975


Natu bhai L. Patel 17 months ago

FDA registration for plain Handwash is required in India or not ?

FDA registration for antibacterial or antimicrobial Handwash is required in India or not ?


shashank 17 months ago

What permission and licences would be required to make the product of Razor in india


Shivam 16 months ago

I want to know the procedure for obtaining product manufacturing licence and also want to do product registration for Herbal Cosmetics?

Also, is FDA registration for plain Handwash is required in India or not ?

FDA registration for antibacterial or antimicrobial Handwash is required in India or not .

8282842007


Praveen Kirsur profile image

Praveen Kirsur 16 months ago

I want to sell Ayurvedic hair oil (manufactured at home using some available herbal ingredients).

I want info on:

1. procedure for obtaining product manufacturing licence

2.Which govt body I have to visit (in Pune) and any website for online registration of the my prod?

3. What licenses i have to get?

4. Should I be a doctor(BAMS) or medical practitioner to sell ayurvedic hair oil ?

thanks


Praveen Kirsur profile image

Praveen Kirsur 16 months ago

Manufacturing process: I am not boiling or doing anything special, just adding some required ingredients in appropriate weights, for hair growth and sustaining.


Natu Patel Mob - 09909994055 15 months ago

Plz inform me whether FDA registration is required for handwash with no antibacterial substances, Toilet Cleaner, Floor cleaner, Glass cleaner, pine oil phenyl, Fabrice liquid soap or not?


Hitesh 15 months ago

Hi

I have been making lip balms at home, and want to sell it online/retail stores, can you tell me if any mfg license or extra permissions are required in order to sell hand made lip balms/lotions and soaps.

Look forward to your response.

8860363340


shivani 10 months ago

what permission and licences wouyld be required to make a product kajal?


amit 8 months ago

is any manufacturing licence required for massage oil


Karthik N 6 months ago

I need to know the detailed procedures for getting hair oil manufaturing license.

karthikn.1995@gmail.com


anusree 2 months ago

What permissins are required to make washing powder


Richard Brookes 8 weeks ago

Hi tintin25

How can I contact you for advice and guidance of hand made soap manufacturering. Thanks.

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