Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder, the manufacture of cosmetics in India is regulated under a system of inspection and licensing by the State Drug Control Department while the import of cosmetics is regulated under a system of registration by the Central Drugs Standard Control Organization (CDSCO), who is the main authority to regulate activities relating to cosmetics and promulgate corresponding regulations.

Cosmetics that have been tested on animals are prohibited from import into India. Besides, cosmetics with Hexachlorophene, Lead or Arsenic compounds and mercury compounds are prohibited to be manufactured and imported.

Part 1 Regulatory Framework and Competent Authority

1 Existing Main Cosmetic Regulations in India

2 Competent Authority

The organizations for Drugs Control exist at two levels: Central and State Government level.

The Central Drugs Standard Control Organization (CDSCO) is the main authority to regulate activities relating to cosmetics and promulgate corresponding regulations. Under CDSCO, the Drugs Controller General (India) (DCGI) is established as the executive sector to deal with operations such as application for registration or license.

Exact functions of CDSCO include:

1. Amendment of Drugs & Cosmetic Rules, 1945 with respect to registration of import of Cosmetic products.

2. Scrutiny of applications relating to registration of cosmetic products for import into the country as per the requirements of Drugs and Cosmetics Act 1940 and Rules, 1945 thereunder.

3. Scrutiny of various applications for NOC/Clarification relating to import of cosmetic products.

4. Preparation of draft replies to RTI, VIP references and Parliament Question related to cosmetics.

5. Replying to Government correspondences/BIS as and when required.

6. Handling of public enquiries/hearings related to cosmetic import registration process and providing guidance thereto.

7. Handling of public/NGOs/Consumer forums complaints/grievances regarding standards of cosmetic products.

8. Pre-screening of applications received by the applicant with respect to registration of the import of the cosmetic.

9. Amendment of pre-screening checklist and preparation of SOP as per the present working procedures on evaluation of applications for import and registration of cosmetics.
   

The State Drug Control Department deals with licensing of both manufacturing and sales premises of cosmetics. Its most important mandate is to ensure the supply of quality drugs at the price fixed by GOI (NPPA) to the people of the State.

Besides, the Bureau of Indian Standards (BIS) provides specifications of certain cosmetics, and issued lists for prohibited/allowed ingredients used in cosmetics.

Part 2 Cosmetic Products

1 Definition

According to the Drugs and Cosmetics Act and Rules, cosmetics in India are defined as any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the 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.

2 Classification

3 Manufacture Licensing

According to the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder, the manufacture of cosmetics is regulated under a system of inspection and licensing by each state drug control department. The application for a license is submitted though the website of each state in India. Specific procedures vary from state to state.

The required documents in Maharashtra State are as follows, for example:

• Application in form 31 (for cosmetics)

• Challan of fees paid to be upload in MFW module

• Specific power of attorney in favor authorized signatory for submitting application on behalf of the company

• List of competent technical staff, with their qualification, registration, experience, previous FDA approvals, etc.

• Appointment/acceptance letter of competent technical staff of manufacturing section

• Appointment/acceptance letter of competent technical staff of testing section

• Section wise list of plant and machineries

• Plan layout of the premises approved by the licensing authority

• Consent to establish & consent to operate from Maharashtra State Pollution Control Board

• Noc of department of industrial safety & health

• Details of manufacturing process, process flow chart (for bulk drug)

• AHU installation and validation certificate (wherever necessary)

• Water system installation and validation certificate (wherever necessary)

After the application is accepted, the state Drug Control Department will conduct an on-site examination to see if the applicant complies with the following conditions:

1) The manufacture shall be conducted under the direction and personal supervision of a competent technical staff consisting of at least one person who is a whole time employee and who possesses any one of the following qualifications:

• holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948), or

• is registered under the Pharmacy Act, 1948 (8 of 1948), or

• has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the Licensing Authority as equivalent to it.

2) The factory premises shall comply with the requirements and conditions specified in Schedule M-II of Drugs and Cosmetics Rules, 1945.
3) The applicant shall either

• provide and maintain adequate staff, premises and laboratory equipment for testing the cosmetic manufactured, and the raw materials used in the manufacture; or

• make arrangements with some institution approved by the Licensing Authority under Part XV (A) of these rules for such tests to be regularly carried out in this behalf by the institution

The license will be granted if they are satisfied with the examination results. The license is valid for five years. if the application for renewal of a license in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired, if application for its renewal is not made within six months of its expiry.

4 Registration of Importing Cosmetics for Sale

In India, all cosmetics that are imported for sale need to be registered with the CDSCO as defined under Drug and Cosmetic Rules 1945.

Brand

For registration of imported cosmetics, India adopts the concept of "brand" which refers to products in "product" column in above classification list. A "brand" will include all variants of a product e.g. colour, shades, pack sizes, etc. A "brand" will not mean the trade name of any product of a manufacturer or mean the manufacturer himself/itself.

A single application may be made for any number of brands manufactured at one or more locations by a single manufacturer. If the applicant seeks to import the same brand belonging to different manufacturers, he needs to submit separate application for each manufacturer and has to pay separate fees. In any existing valid registration certificate, if the applicant wants to add any further brand of already registered category as mentioned in the above "product" list for the same manufacturer, separate application will need to be submitted by the importer. But no fee will be charged. In such cases additional product permission will be endorsed to the already approved category in a given registration certificate.

Each application will be accompanied by a fee of USD 250 or its equivalent India rupees for each brand.

Who can apply for Registration of Importing Cosmetics?

1. The Manufacturer himself has registered office in India.

2. The Authorized Agent of the Manufacturer

3. The Subsidiary of the Manufacturer

4. Any other importer

An "Authorized Agent" means a person or entity in India authorized by the manufacturer. The authorized agent will be responsible for the business activities of the manufacturer in India, including compliance with the provisions of “Drug and Cosmetic Act in all respects”.  "Subsidiary" means an entity in India owned by the manufacturer. "Any other importer" means any person or entity purporting to import cosmetic products other than the manufacturer, its authorized agent and its subsidiary.

Dossiers required for registration (click here to see the detailed requirements for each document):

• Covering Letter

• Power of Attorney

• Schedule D (III)

• List of Ingredients

• Labels of proposed products

• Specifications

• Pack insert

• Manufacturing Licenses

• Free Sale Certificate

• Non Animal Testing Declaration

• Declaration for Heavy Metal and Hexachlorophene content.

• Other documents (If any).

• Application (Form-42)

• Fee: TR-6 Challan (In Original)

Label for registered imported cosmetics

1. The label of imported cosmetics will bear the registration certificate number of the brand and name and address of the registration certificate holder

2. Stickering of labels containing the registration certificate number of the brand and the name and address of the registration certificate holder may be allowed to be carried out after import at a suitable declared place approved by the Licensing Authority on an application made to the Licensing Authority

3. The Label should also bear the name and address of the manufacturer and name of the country where the product has been manufactured. If the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or the name of the country where it has actually been manufactured as “Made in ........ (Name of country)" should be there on the label.

Exemptions

1. Cosmetic products which are imported into India as bulk for repackaging for 100% export to other countries will not require registration certificate. In such cases the importer has to obtain necessary permission from CDSCO. Importer must give written undertaking that these products are not released for domestic sale.

2. For Import of cosmetics for R&D purposes like packaging trials, consumer studies, shelf life studies and transport studies, registration certificate is not required. In such cases the importer has to obtain necessary permission from CDSCO HQ. Importer must give written undertaking that these products are not released for domestic sale.

Time for issuance and validity

Within 6 months from the date of submission of the application form and submission of the required documents, the registration certificate will be issued.

Registration certificate for import of cosmetics is valid for a period of 3 years from the date of its issuance.

5 General Label Requirements

Legible Original label for proposed products along with their variants (if any) as per Drugs and Cosmetics Rules, 1945 which includes following:-

• Name of Cosmetic

• Name and address of the manufacturer and name of the country where the product has been manufactured. If the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or the name of the country where it has actually been manufactured as “Made in ........ (Name of country)" should be there on the label.

• Further, for very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code.

• Use Before

• Direction for safe use/Caution

• Batch no

• Manufacturing License no.( If any)

• Registration Certificate Number and R.C holders name and address.

• Information (if any) as per Part XV of Drugs and Cosmetics Rules, 1945

In addition, a cosmetic shall carry:

1) on both the inner and outer label

• the name of the cosmetic

• the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured (provided that if the cosmetic is contained in a very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code.)

2) on the outer label

• a declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, weight for semi-solids, combined with numerical count if the content is sub-divided (provided that this statement need not appear in case of a package of perfume, toilet water or the like the net content of which does not exceed 60 ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30 grams)

3) on the inner label, where a hazard exists

• adequate direction for sate use;

• any warning, caution or special direction required to be observed by the consumer;

• a statement of the names and quantities of the ingredients that are hazardous or poisonous;

• a distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter “B” (provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state, and 25 milliliters or less if the cosmetic is in a liquid state; provided further that in the case of soaps, instead of the batch number, the mouth and year of manufacture of soap shall be given on the label);

• manufacturing license number, the number being preceded by the letter “M”;

• where a package of a cosmetic has only one label, such label shall contain all the information required to be shown on both the inner and the outer labels;

• the list of ingredients, present in concentration of more than one percent shall be listed in the descending order of weight or volume at the time they are added, followed by those inconcentration of less than or equal to one percent, in any order, and preceded by the words “INGREDIENTS”;

• Labeling requirement, if any, specified in the relevant Indian standard as laid down by the "Bureau of Indian Standards" for the cosmetics covered under Schedule S-Standards for Cosmetics.
  

Special label requirement for Hair dyes containing Dyes, Colors and Pigments

Hair dyes containing para-phenylenediamine or other Dyes, Colors and Pigments shall be labeled with the following legend in English and local languages and these shall appear on both the inner and the outer labels.

"Caution -- This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying direction should first be made. This product should not be used for dyeing the eye-lashes or eye-brows; as such a use may cause blindness".

Each package shall also contain instructions in English and local languages on the following lines for carrying out the test:

“This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eye- brows or eye-lashes as severe inflammation of the eye or even blindness may result.”

Special label requirements for toothpaste containing fluoride

1. fluoride content in tooth paste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton

2. date of expiry should be mentioned on tube and carton

Prohibitions

1. no person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic (provided that nothing in this rule shall apply to any alteration, inscription or mark made on the container, label or wrapper of any cosmetic ay the instance or direction or with the permission of the licensing authority)

2. no cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user.

Part 3 Cosmetic Ingredients

1 BIS Set Standards for Cosmetics

The Bureau of India Standards (BIS) issued "Classification of Cosmetic Raw Materials and Adjuncts" to stipulate requirements for ingredients usage in cosmetics.

In the "Classification", it claims that considering the ill effect of spurious cosmetics, in the absence of effective regulations or standards had broadly classified the ingredients for use in cosmetics into two categories:

• Generally recognized as safe (GRAS)

• Generally not recognized as safe (GNRAS)

For dyes pigments and colors, BIS reckon as GRAS ("Generally Recognized as Safe") class and provide a positive list of dyes, colors and pigments which allowed for use in cosmetics (IS: 4707 Part 1); for other ingredients BIS reckon as GNRAS ("Generally not Recognized as Safe") class, and provide a negative list of raw material which shall not form part of the composition of cosmetic products, along with a list of substances which cosmetic products shall not contain except subject to restrictions and conditions laid down (IS: 4707 Part 2).

2 Prohibitions/Restrictions Outlined

To align with the standards that are stipulated by BIS, the "Drug and Cosmetic Act1940 & Rules1945" also outlined several apparently prohibited items in manufacturing and importing cosmetics.

1) Prohibition of manufacturing/import cosmetic to contain Dyes, Colors and Pigments other than those prescribed by BIS

No Cosmetic shall contain Dyes, Colors and Pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part 1 as amended) and Schedule Q.

The permitted Synthetic Organic Colors and Natural Organic Colors used in the Cosmetic shall not contain more than:-

• 2 parts per million of arsenic calculated as arsenic trioxide.

• 20 parts per million of lead calculated as lead.

• 100 parts per million of heavy metals other than lead calculated as the total of the respective metals.

2) Prohibition of manufacturing/import of cosmetic containing Hexachlorophene

No cosmetic containing hexachlorophene shall be imported.

Note: Provided that in the case of soaps Hexachlorophene may be used in concentrations not exceeding one per cent weight by weight. Provided further that the following cautionary note shall be printed and shall appear in a conspicuous manner on the wrapper of package of each soap, namely “Contains Hexachlorophene – not to be used on babies.”

3) Prohibition of manufacturing/ import of cosmetic containing Lead or Arsenic compound

No cosmetic shall be imported in which a Lead or Arsenic compound has been used for purposes of coloring.

4) Regulation of import and manufacture of cosmetics containing mercury. Cosmetics imported into India or manufactured domestically shall contain mercury in the following proportion, namely;

• in cosmetics intended for use only in the area of eye, the level of mercury not exceeding seventy parts per million (0.007 per cent.) of mercury, calculated as the metal, as a preservative;

• in other finished cosmetic products, unintentional mercury shall not exceed one part per million (1 ppm).

5) Prohibition of import of cosmetics tested on animals

No cosmetic that has been tested on animals after the commencement of the Drugs and Cosmetics (Fifth Amendment) Rules, 2014 shall be imported into the country.