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

First-Schedule-Cosmetics

Second-Schedule-Part-I-Cosmetics

Second-Schedule-Part-II-Cosmetics

Third-Schedule-Cosmetics

Fourth-Schedule-Cosmetics

Fifth-Schedule-Cosmetics

Sixth-Schedule-Cosmetics

Seventh-Schedule-Cosmetics

Eighth-Schedule-Cosmetics

Ninth-Schedule-Cosmetics

Tenth-Schedule-Part-I-Cosmetics

Tenth-Schedule-Part-II-Cosmetics

Eleventh-Schedule-Cosmetics

Twelfth-Schedule-Cosmetics

Thirteenth-Schedule-Cosmetics

Click for all other Schedules

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

Form-Cos-1

Form-Cos-2

Form-Cos-3

Form-Cos-4

Form-Cos-4A

Form-Cos-5

Form-Cos-6

Form-Cos-7

Form-Cos-8

Form-Cos-9

Form-Cos-10

Form-Cos-11

Form-Cos-12

Form-Cos-13

Form-Cos-14

Form-Cos-15

Form-Cos-16

Form-Cos-17

Form-Cos-18

Form-Cos-19

Form-Cos-20

Form-Cos-21

Form-Cos-22

Form-Cos-23

Form-Cos-24

Click for all other application forms

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

Click for Licensing procedure for manufacturing of Drugs

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

Click for Procedure to obtain license for manufacturing of Homoeopathic Medicines

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

Click for Procedure to obtain license for manufacturing of Cosmetics

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

Click for Procedure to obtain license for Blood Centre (Blood Bank)

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

Click for Procedure to obtain license for Commercial Testing Laboratories

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

Area requirement for manufacturing

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

Form-Cos-5-Cosmetics

Cos-6: Application for grant of a loan license to manufacture cosmetics for sale or for distribution

Form-Cos-6-Cosmetics

Cos-7: Self-certificate of compliance of Good Manufacturing Practices (GMP) for manufacture of cosmetics

Form-Cos-7-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

Form-Cos-22-Cosmetics

Click for all other application forms

Fee

Fee payable for licence, permission and registration certificate is given in Third Schedule, Click below link:

Fee-for-license-for-manufacturing-and-import-of-cosmetics

License fee structure for all licenses

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	3,000/-	3,000/-	2%	300/-	–
Retail sale	19	20 & 21	3,000/-	3,000/-	2%	300/-	–
Homeopathic (WSDL)	19-B	20-D	2,000/-	–	–	–	–
Homeopathic (RSDL)	19-B	20-C	2,000/-	–	–	–	–
Sch. X (WSDL)	19-C	20-G	500/-	500/-	2%	150/-	–
Sch. X (RSDL)	19-C	20-F	500/-	500/-	2%	150/-	–

Click for Licensing procedure for manufacturing of Drugs

Drug Manufacturing Licenses
Manufacturing (Non- Biological)	24	25	7,500/-	7,500/-	2%	1,000/-	300/-
Manufacturing (Biological)	27	28	7,500/-	7,500/-	2%	1,000/-	300/-
Manufacturing Schedule X	24 F	25 F	7,500/-	7,500/-	2%	1,000/-	300/-
License for Test / Analysis	29	30	250/-	Valid for 3 years. Renewal for 1 year	–	–	–
Loan License (Biological)	27-A	28-B	7,500/-	7,500/-	2%	No	300/-
Loan License (Non- Biological)	24-A	25-B	7,500/-	7,500/-	2%	No	300/-
LVP	27-D	28-D	7,500/-	7,500/-	2%	No	300/-

Click for Procedure to obtain license for manufacturing of Homoeopathic Medicines

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	–	–	–	–

Click for Procedure to obtain license for manufacturing of Cosmetics

Medical Devices Manufacturing Licenses
Medical Devices (A& B)	MD-3	MD-5	5,000/-	5,000/-	2%	–	500/-
Medical Devices (Loan License) (A& B)	MD-4	MD-6	5,000/-	5,000/-	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

Click for Procedure to obtain license for Blood Centre (Blood Bank)

Other Licenses
Blood Centre	27-C	28-C	7,500/-	26-G	1,000/-	No	300/-
Homeopathic Mfg License	24-C	25-C	2,000/- For any no. of single ingredient	–	–	–	200/- Per product of combination
Approval of Commercial testing Lab	36	37	7,500/-	7500/-	2%	–	–
Repacking Non-Biological	24-B	25-B	700/-	700/-	2%	1,000/-	100/-

Compiled by:

Lalit Kr. Goel, DSDC, FDA Haryana

Rakesh Dahiya, SDCO, FDA Haryana

Download fee structure

Click below link to download the fee structure of all types of drug licenses

License fee structure for all licenses

Technical staff

Requirement of technical staff for cosmetics manufacturing license, click below link

Requirement-of-technical-staff-for-cosmetics-manufacturing-license

Documents and undertaking

Documents, undertaking required for cosmetics manufacturing licesnse, click below link

Documents-undertaking-required-for-cosmetics-manufacturing-licesnse

Requirements of plant and equipment

For requirements of plant and equipment to manufacture cosmetics, click below link

Requirements-of-plant-and-equipment-to-manufacture-cosmetics

Procedure for applying cosmetics manufacturing license

Procedure for applying cosmetics manufacturing license, click below link

Procedure-for-obtaining-Cosmetics-manufacturing-license

Validity and retention fee

Validity and retention fee for cosmetics manufacturing license, click below link

Validity-and-retention-fee-for-cosmetics-manufacturing-license

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

Conditions-of-license-for-manufacture-of-cosmetics