Table of Contents
Cosmetics – How to obtain manufacturing license
Must read articles, click below links
FAQs – on Alcohol (in Pharma Industry)
FAQs on – Cosmetics Rules 2020
FAQs – on Cosmetics (Series-1)
Educational Seminar for Cosmetic Manufacturer on CR 2020
Brainstorming session of Drug Regulators on Cosmetic Rules 2020
Toothpastes and Tooth powders containing Tobacco
Cosmetics under the Garb of Ayurvedic medicines
Understanding Quality Risk Management
Cosmetic definition:
As per Section 3(aaa) of Drugs and Cosmetics Act, 1940 “Cosmetic” means “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.”
Under 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 the State Licensing Authorities appointed by the respective State Governments while the import of cosmetics is regulated under a system of registration by the Licensing Authority appointed by the Central Government.
The Drugs Controller General (India) functions as the Licensing Authority who grants the registration certificate and regulates the import of cosmetics in India.
Cosmetics Rules 2020
List of Schedules of Cosmetics
Following schedules are introduced in Cosmetics Rules 2020
| Sr. No. | Schedule | Description |
| 1 | First Schedule | Authorisation from manufacturer |
| 2 | Second Schedule Part-I | Information and undertaking required to be furnished by the manufacturer or his authorised importer or distributor or agent with the application form for import registration certificate. |
| 3 | Second Schedule Part-II | Information and undertaking required to be furnished by the manufacturer with the application form for grant of manufacturing licence or loan licence |
| 4 | Third Schedule | Fee payable for licence, permission and registration certificate. |
| 5 | Fourth Schedule | List of categories of cosmetics for import |
| 6 | Fifth Schedule | Fee for test or analysis by the Central cosmetics laboratories or by the state laboratories |
| 7 | Sixth Schedule | Undertaking for the import of cosmetics to be submitted by the importer with application form for Import Registration Number |
| 8 | Seventh Schedule | Good manufacturing practices and requirements of premises, plants and equipment for manufacture of cosmetics |
| 9 | Eighth Schedule | Manufacturing and raw material records |
| 10 | Ninth Schedule | Standards for cosmetics (BIS) |
| 11 | Tenth Schedule Part-I | List of colourants allowed for use in cosmetic products as given under IS: 4707 (Part 1) of BIS |
| 12 | Tenth Schedule Part-II | List of colours permitted to be used in soaps |
| 13 | Eleventh Schedule | Good laboratory practices and requirements of premises and equipment |
| 14 | Twelfth Schedule | Extent and conditions of exemption of various class of cosmetics |
| 15 | Thirteenth Schedule | Word “Cosmetics” is omitted from Drugs and Cosmetics Rules 1945 |
Download Schedules
Click the below links to read or download the different schedules of cosmetics
List of Forms for Cosmetics
Following Forms are introduced in Cosmetics Rules 2020
| Sr. No. | Purpose | Form |
| 1 | Application for registration certificate for import of cosmetics in India | Cos-1 |
| 2 | Import registration certificate for cosmetics in India | Cos-2 |
| 3 | Permission to import or manufacture new cosmetics | Cos-3 |
| 4 | Application for Import Registration Number for Import of already registered cosmetics in India | Cos-4 |
| 5 | Import Registration Number for import of already registered cosmetics in India | Cos-4A |
| 6 | Application for grant of a license to manufacture cosmetics for sale or for distribution | Cos-5 |
| 7 | Application for grant of a loan license to manufacture cosmetics for sale or for distribution | Cos-6 |
| 8 | Self-certificate of compliance of Good Manufacturing Practices (GMP) for manufacture of cosmetics | Cos-7 |
| 9 | License to manufacture cosmetics for sale or for distribution | Cos-8 |
| 10 | Loan license to manufacture cosmetics for sale or for distribution | Cos-9 |
| 11 | Intimation to person from whom sample is taken | Cos-10 |
| 12 | Form in which the inspection book shall be maintained | Cos-11 |
| 13 | Application for grant of permission for new cosmetics for obtaining import registration certificate or manufacturing license | Cos-12 |
| 14 | Application from a purchaser for test or analysis of a cosmetic under Section 26 of the Drugs and Cosmetics Act, 1940 | Cos-13 |
| 15 | Report of test or analysis by Government Analyst under Section 26 of the Drugs and Cosmetics Act, 1940 | Cos-14 |
| 16 | Receipt for stock of cosmetics for record, register, document or material object seized under section 22 (1) (c) or (cc) of the Drugs and Cosmetics Act, 1940 | Cos-15 |
| 17 | Receipt for samples of cosmetics taken where fair price tendered thereof under sub – section (1) of section 23 of the Drugs and Cosmetics Act, 1940 is refused | Cos-16 |
| 18 | Memorandum to Government Analyst | Cos-17 |
| 19 | Order under section 22 (1)(c) of the Drugs and Cosmetics Act, 1940 requiring a person not to dispose of stock in his possession | Cos-18 |
| 20 | Report of tests or analysis of cosmetics by the Government Analyst | Cos-19 |
| 21 | Memorandum to the Director, Central Cosmetic Laboratory | Cos-20 |
| 22 | Report of test or analysis by the Central cosmetic laboratory | Cos-21 |
| 23 | Application for grant of approval for carrying out tests on cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of cosmetics | Cos-22 |
| 24 | Approval for carrying out tests on cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of cosmetics | Cos-23 |
| 25 | Report of test or analysis by approved institution | Cos-24 |
List of Forms
Click the below links to read or download the different Forms of cosmetics
Categories and area required
Details of categories and area required to manufacture cosmetics under Cosmetic Rules 2020 is as under.
| Category | Cosmetics | Area in Sq.Mtrs |
| A | Powders | 15 |
| B | Skin Powder for infants | 15 |
| C | Creams, Lotions, Shampoo, Shaving Creams, Hair Oils. Emulsions, Pastes, Cleansing Milk, Pomade | 25 |
| D | Nail Polish and Nail Lacquers | 15 |
| E | Lipsticks and Lipgloss | 15 |
| F | Depilatories used for eyes | 10 |
| G | Eyebrows, Eyelashes Eyeliners | 10 |
| H | Aerosols | 15 |
| I | Alcoholic Fragrance Solutions | 15 |
| J | Hair Dyes | 15 |
| K | Tooth powders general and toothpastes etc. | 15 |
| L | Toilet Soaps | 100 |
Requirement for obtaining manufacturing license for Cosmetics
The following application forms are required to obtain license for manufacturing cosmetics, loan license and license to test the cosmetics:
Forms
Download the below pdf files for various Forms which suits your requirement
Cos-5: Application for grant of a license to manufacture cosmetics for sale or for distribution
Cos-6: Application for grant of a loan license to manufacture cosmetics for sale or for distribution
Cos-7: Self-certificate of compliance of Good Manufacturing Practices (GMP) for manufacture of cosmetics
Cos-22: Application for grant of approval for carrying out tests on cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of cosmetics
To download all other forms, click below link
Fee
Fee payable for licence, permission and registration certificate is given in Third Schedule, Click below link:
Technical staff
Requirement of technical staff for cosmetics manufacturing license, click below link
Documents and undertaking
Documents, undertaking required for cosmetics manufacturing licesnse, click below link
Requirements of plant and equipment
For requirements of plant and equipment to manufacture cosmetics, click below link
Procedure for applying cosmetics manufacturing license
Procedure for applying cosmetics manufacturing license, click below link
Validity and retention fee
Validity and retention fee for cosmetics manufacturing license, click below link
Condition of license
Conditions of licenses is to be maintained after obtaining the required manufacturing license for Cosmetics. To download the pdf file for ready reference, click below link
Procedure for applying for approval of testing laboratory
Procedure for applying for approval of testing laboratory, click below link
List of Laboratory Instruments
We have provided list of laboratory instruments, click below link to exploxe:
List of Laboratory Instruments for Pharma & Cosmetics Industry
Seventh schedule – GMP
Seventh schedule
GMP – Good manufacturing practices and requirements of premises, plants and equipment for manufacture of cosmetics
Download Seventh Schedule for requirements of area and machineries:
G.S.R. No. 763(E) dt 15-12-20 – Cosmetics Rules 2020, click below link
Cosmetics Notifications
For notifications of Cosmetics, click below link:
Latest updates:
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