cosmetics regulation

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 regulation license

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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38 COMMENTS

  1. Hi, like others are asking I want to start home made products and sell online. Please advice me what certificate and licence are required. Please contact me back.

  2. Hi i want to know, how can I apply for a license for herbal n natural cosmetic products which are handmade. My production level at starting will be 200 to 500 units per product. Can I start from my home? Or do I need to rent a commercial space with requirements which may help me to get a license. How long will it take to get a license? Also how can I market my products till I get a license. Can I sell among local public. Pls help me. M keen to start a business in a systematic way very soon

  3. what if i want to sell a toothpaste which is manufactured by third party.. do I have to apply for drug license? what is the procedure and do i need to apply for FSSAI license as well??

  4. Hello,
    If any company is willing to give job work for there cosmetic product manufacturing we are ready to manufacture,As our company have cosmetic& drug licence so if any requirement plz contact us regarding
    thanks…
    Rajanikanth
    09703539566
    [email protected]

  5. Hi , I am in the process of manufacturing of natural and herbal products such as Sugar scrub, facial cleanser etc. I need to know what are the requirements to start the manufacturing of these products. Also if someone can contact me to this regard to help comply the required formalities. We will pay the necessary fees/charges for the services provided.my contact no is 7700921327
    Thanks and best regards
    Rio Lobo

    • tO START WITH GET IT MANUFACTURED BY THIRD PARTY. AND ONCE YOU FEEL THAT YOUR PRODUCTS COULD SUSTAIN WELL IN THE MARKET,,,THEN GO FOR YOUR OWN FACILITY…

  6. I am planning to open a beard oil production company please explain me about essential requirements to open the company .
    The product we are making is purely natural
    We are adding only natural items pls help me to start this business

  7. I made Fully home made natural cosmetis products with organic. Can i need liesence to sell this products by online. If need where can i apply st chennai

  8. Where can i get certificate at chennai to sell by online my home made natural cosmetics produts like lip balm face wash soap ..

  9. Hi this is Ravi and I am planning to buy a established cosmetic manufacturer company along with there brand and product, so can I know what are the thing to be check with present owner of company and list of license required.

  10. does it mandetory to get a cosmetic licence to manufacture hand made soaps for small companies . if yes what are the requirments to get licence .

  11. Hi.m also making organic fruits flowers and lots of herb packs for face hair n body.ryt now i dnt hv a big set up but in future m planning.so if any one require my products plz whatsapp on 9540420088.my products are 100% pure.its my believe.regards shipra

  12. Thanks for the Info.
    I would like to know do I require a license to sell alcohol based spray perfumes. If yes what is the procedures and can you please explain me in detail.

    Best Regards

  13. hi,
    marketing is part of my project. i am manufacturing a nail polish. what is the license I require, and is there any certified mark like ‘fssai’ for food products??

  14. Does this apply for homemade and handmade soaps and cosmetics as well? I make cold process soaps and cosmetics which are prepared using natural and safe ingredients in very small batches. What license do i require to sell them in stores or expand the manufacturing?

  15. thanks,
    its really authentic and informatively,
    my question for you is i need alcohol based spray perfume manufacturing license,
    what is the procedure of that and how will do ?

    • hellow sir ,
      i had also same buisness as for your working ,
      can i know that which brand name you have used to sell your products ?

  16. Does this apply for homemade and handmade soaps and cosmetics as well? I make cold process soaps and cosmetics which are prepared using natural and safe ingredients in very small batches. What license do i require to sell them in stores or expand the manufacturing?

  17. Hi,

    I want to do home made soap manufacturing through saphonication process. please let me know where and what license i should take

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