Last Updated on March 19, 2023 by The Health Master
Cosmetics – How to obtain manufacturing license
Must read articles
Click below links:
Alert: Various chemicals in Cosmetics: Must read
Educational Seminar for Cosmetic Manufacturer on CR 2020
Brainstorming session of Drug Regulators on Cosmetic Rules 2020
Understanding Quality Risk Management
Cosmetics under the Garb of Ayurvedic medicines
Toothpastes and Tooth powders containing Tobacco
How Fair is the Business of Fairness Creams
FAQs on Cosmetics
Click below links:
FAQs on – Cosmetics Rules 2020
FAQs – on Cosmetics (Series-1)
FAQs – on Alcohol (in Pharma Industry)
FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries
FAQs-on-Cosmetics-Rules-2020-by-Cosmetic-division-of-CDSCO-dt-06-08-2021
FAQs-by-CDSCO-on-registration-and-Import-of-Cosmetics-into-India
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 |
Area required at a glance
Area required for manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre
| Manufacturing area / section | Area prescribed for basic installations (Square Metre) | Ancillary Area prescribed (Square Metre) | Total Area required (Square Metre) |
| Allopathic drugs | |||
| External Preparations | 30 | 10 | 40 |
| Oral Liquid Preparations | 30 | 10 | 40 |
| Tablets (uncoated) Non-Beta Lactum (Granulation + compression + packaging etc) | 60 | 20 | 80 |
| Coating (Non-Beta Lactum) | 30 | 10 | 40 |
| Tablets (uncoated) Beta Lactum (Granulation + compression + packaging etc) | 60 | 20 | 80 |
| Coating (Beta Lactum) | 30 | 10 | 40 |
| Powders (oral) | 30 | – | 30 |
| Hard Gelatin Capsules (Beta-lactam) | 25 | 10 | 35 |
| Hard Gelatin Capsules (Non Beta-lactam) | 25 | 10 | 35 |
| Ophthalmic Preparation | 25 | 10 | 35 |
| Eye ointment, Eye lotion | 25 | – | 25 |
| Pessaries | 20 | – | 20 |
| Inhalers & Vitrallae | 20 | – | 20 |
| Re-packing of drugs | 30 | – | 30 |
| Parenteral (Small Volume Parenteral) | 150 | 100 | 250 |
| Parenteral (Large Volume Parenteral) | 150 | 150 | 300 |
| Plastic (LVP) by Form-Fill-Seal / Blow, Fill –Seal technology | 250 | 150 | 400 |
| Homoeopathic | |||
| Mother tincture and mother solutions | 55 | – | 55 |
| Potentization section | 20 | – | 20 |
| Trituration, Tableting, Pills and Globules section | 55 | – | 55 |
| Syrups & other oral liquids | 20 | – | 20 |
| Ointments & lotions section | 20 | – | 20 |
| Ophthalmic Preparations | 20 | – | 20 |
| Packing & labelling | 50 | – | 50 |
| Cosmetics | |||
| A. Powders | 15 | – | 15 |
| B. Skin powder for infants | 15 | – | 15 |
| C. Creams, Lotions, Shampoo, Shaving Creams, Hair Oils, Emulsions, Pastes, Cleansing Milk, Pomade | 25 | – | 25 |
| D. Nail Polish and Nail Lacquers | 15 | – | 15 |
| E. Lipsticks and Lipgloss | 15 | – | 15 |
| F. Depilatories used for eyes | 10 | – | 10 |
| G. 1. Eyebrows, Eyelashes, Eyeliners 2. Kajal and Surma | 10 10 | – 5 For base sterilization | 10 15 |
| H. Aerosols | 15 | – | 15 |
| I. Alcoholic Fragrance Solutions | 15 | – | 15 |
| J. Hair Dyes | 15 | – | 15 |
| K. Tooth powders general | 15 | – | 15 |
| L. Toilet Soaps | 100 | – | 100 |
| Blood Bank / Centre | |||
| Blood Bank / Centre (only for Whole Human Blood) | 100 | – | 100 |
| Blood Component | 50 | – | 50 |
| Blood Bank / Centre including Blood Components | 150 | – | 150 |
| Apheresis | 10 | – | 10 |
| Medical Devices |
| Area not prescribed in MDR 2017 for manufacturing of Medical Devices |
| Medicinal Gas |
| Area not prescribed for manufacturing of Medicinal gases |
| Disinfectant |
| Area not prescribed for manufacturing of Disinfectants |
| API (Bulk drug) |
| Area not prescribed for manufacturing of API (Bulk drugs) |
| Empty Capsule Shell |
| Area not prescribed for manufacturing of Empty gelatin Shell |
| Soft Gelatin Capsules |
| Area not prescribed for manufacturing of Soft Gelatin Capsules |
| Cytotoxic substances / Sex hormones |
| Same area required as defined for tablet section |
| Laboratory |
| Area for Commercial Laboratory or Laboratory for manufacturing units not prescribed |
Note: Requirement of ancillary area shall not apply to the units registered before 30-06-2005
Compiled by:
Lalit Kr. Goel, DSDC, FDA Haryana
Rakesh Dahiya, SDCO, FDA Haryana
Download area requirement
Click below link to download the requirement for the manufacturing of Drugs, Cosmetics, Homoeopathic and Blood Centre
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
Fee
Fee payable for licence, permission and registration certificate is given in Third Schedule, Click below link:
Download the pdf file for the license fee structure for all licenses under the Drugs and Cosmetics Act 1940 and the Rule framed thereunder. Click below link
Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945
| Types of Licenses | Application Form | License on Form | Fee | Renewal / Retention fee | Late fee | Duplicate license | Fee per item |
| Drug Sale Licenses | |||||||
| Whole Sale | 19 | 20-B & 21-B | 3000/- | 3000/- | 2% | 300/- | – |
| Retail sale | 19 | 20 & 21 | -do- | -do- | -do- | -do- | – |
| Homeopathic (WSDL) | 19-B | 20-D | 250/- | 20-E | 50/- | 150/- | – |
| Homeopathic (RSDL) | 19-B | 20-C | 250/- | 20-E | 50/- | 150/- | – |
| Sch. X (WSDL) | 19-C | 20-G | 500/- | 500/- | 2% | 150/- | – |
| Sch. X (RSDL) | 19-C | 20-F | 500/- | 500/- | 2% | 150/- | – |
| Drug Manufacturing Licenses | |||||||
| Manufacturing (Non- Biological) | 24 | 25 | 7500/- | 7500/- | 2% | 1000/- | 300/- |
| Manufacturing (Biological) | 27 | 28 | 7500/- | 7500/- | 2% | 1000/- | 300/- |
| Manufacturing Schedule X | 24 F | 25 F | 7500/- | 7500/- | 2% | 1000/- | 300/- |
| License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years. Renewal for 1 year | – | – | – |
| Loan License (Biological) | 27-A | 28-B | 7500/- | 7500/- | 2% | No | 300/- |
| Loan License (Non- Biological) | 24-A | 25-B | 7500/- | 7500/- | 2% | No | 300/- |
| LVP | 27-D | 28-D | 7500/- | 7500/- | 2% | No | 300/- |
| Cosmetics Manufacturing Licenses | |||||||
| Manufacturing | COS 5 | COS 8 | 10,000/ | 10,000/- | 2% | – | 500/- |
| Loan License | COS 6 | COS 9 | 10,000/ | 10,000 | 2% | 500/- | |
| Laboratory | COS 22 | COS 23 | 1,000/- | 1,000/- | 2% | 100/- | – |
| Additional Section | – | – | 10,000/ | – | – | – | – |
| Free Sale | – | – | No fee | – | – | – | – |
| Medical Devices Manufacturing Licenses | |||||||
| Medical Devices (A& B) | MD-3 | MD-5 | 5000/- | 5000/- | 2% | – | 500/- |
| Medical Devices (Loan License) (A& B) | MD-4 | MD-6 | 5000/- | 5000/- | 2% | – | 500/- |
| Medical Devices (C& D) | MD-7 | MD-8 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Medical Devices Loan License (C& D) | MD-9 | MD-10 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Registration of Medical Devices Laboratory | MD-39 | MD-40 | 20,000/- | 20,000/- | 2% | – | – |
| Sale License | MD-41 | MD-42 | 3,000/- | 3,000/- | 2% | – | – |
| Free Sale certificate | 1,000/- for each category | ||||||
| Other Licenses | |||||||
| Blood Centre | 27-C | 28-C | 7500/- | 26-G | 1000/- | No | 300/- |
| Homeopathic Mfg License | 24-C | 25-C | 300/- | 26-C | 100/- | 50/- | 50/- |
| Approval of Commercial testing Lab | 36 | 37 | 7500/- | 7500/- | 2% | – | – |
| Repacking Non-Biological | 24-B | 25-B | 700/- | 700/- | 2% | 1000/- | 100/- |
Technical staff
Requirement of technical staff for a cosmetics manufacturing license, click the below link
Documents and undertaking
Documents, undertaking required for a cosmetics manufacturing license, click below link
Requirements of plant and equipment
For requirements of plant and equipment to manufacture cosmetics, click the 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 colors permitted
List of Dyes, Colours and Pigments Permitted in manufacturing of cosmetics, 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:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
