Cosmetics - How to obtain manufacturing license

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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.ScheduleDescription1First ScheduleAuthorisation from manufacturer2Second Schedule Part-IInformation 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.3Second Schedule Part-IIInformation and undertaking required to be furnished by the manufacturer with the application form for grant of manufacturing licence or loan licence4Third ScheduleFee payable for licence, permission and registration certificate.5Fourth ScheduleList of categories of cosmetics for import6Fifth ScheduleFee for test or analysis by the Central cosmetics laboratories or by the state laboratories7Sixth ScheduleUndertaking for the import of cosmetics to be submitted by the importer with application form for Import Registration Number8Seventh ScheduleGood manufacturing practices and requirements of premises, plants and equipment for manufacture of cosmetics9Eighth ScheduleManufacturing and raw material records10Ninth ScheduleStandards for cosmetics (BIS)11Tenth Schedule Part-IList of colourants allowed for use in cosmetic products as given under IS: 4707 (Part 1) of BIS12Tenth Schedule Part-IIList of colours permitted to be used in soaps13Eleventh ScheduleGood laboratory practices and requirements of premises and equipment14Twelfth ScheduleExtent and conditions of exemption of various class of cosmetics15Thirteenth ScheduleWord “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.PurposeForm 1Application for registration certificate for import of cosmetics in IndiaCos-1 2Import registration certificate for cosmetics in IndiaCos-2 3Permission to import or manufacture new cosmeticsCos-3 4Application for Import Registration Number for Import of already registered cosmetics in IndiaCos-4 5Import Registration Number for import of already registered cosmetics in IndiaCos-4A 6Application for grant of a license to manufacture cosmetics for sale or for distributionCos-5 7Application for grant of a loan license to manufacture cosmetics for sale or for distributionCos-6 8Self-certificate of compliance of Good Manufacturing Practices (GMP) for manufacture of cosmeticsCos-7 9License to manufacture cosmetics for sale or for distributionCos-8 10Loan license to manufacture cosmetics for sale or for distributionCos-9 11Intimation to person from whom sample is takenCos-10 12Form in which the inspection book shall be maintainedCos-11 13Application for grant of permission for new cosmetics for obtaining import registration certificate or manufacturing licenseCos-12 14Application from a purchaser for test or analysis of a cosmetic under Section 26 of the Drugs and Cosmetics Act, 1940Cos-13 15Report of test or analysis by Government Analyst under Section 26 of the Drugs and Cosmetics Act, 1940Cos-14 16Receipt 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, 1940Cos-15 17Receipt 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 refusedCos-16 18Memorandum to Government AnalystCos-17 19Order under section 22 (1)(c) of the Drugs and Cosmetics Act, 1940 requiring a person not to dispose of stock in his possessionCos-18 20Report of tests or analysis of cosmetics by the Government AnalystCos-19 21Memorandum to the Director, Central Cosmetic LaboratoryCos-20 22Report of test or analysis by the Central cosmetic laboratoryCos-21 23Application 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 cosmeticsCos-22 24Approval for carrying out tests on cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of cosmeticsCos-23 25Report of test or analysis by approved institutionCos-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.

CategoryCosmeticsArea in Sq.MtrsAPowders15BSkin Powder for infants15CCreams, Lotions, Shampoo, Shaving Creams, Hair Oils. Emulsions, Pastes, Cleansing Milk, Pomade25DNail Polish and Nail Lacquers15ELipsticks and Lipgloss15FDepilatories used for eyes10GEyebrows, Eyelashes Eyeliners10HAerosols15IAlcoholic Fragrance Solutions15JHair Dyes15KTooth powders general and toothpastes etc.15LToilet Soaps100

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

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

Licenses-fee-structure-for-all-licenses

Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of LicensesApplication on FormLicense on FormLicense FeeRenewal / Retention fee (after 5 years)Late fee Per monthFee for duplicate licenseAdditional Item (per item)Sale licensesWhole Sale1920-B 21-B3000/- (1500/- each)Retention fee after 5 years Rs. 3000/-2% (Rs 60/-)300/--Retail sale1920 & 21-do--do--do--do--Homeopathic (Wholesale)19-B20-D250/-20-E50/-150/--Homeopathic (Retail sale)19-B20-C250/-20-E50/-150/--Sch. X (Wholesale)19-C20-G500/-Retention2%150/--Sch. X (Retail Sale)19-C20-F500/-Retention2%150/--Manufacturing licensesManufacturing (Non-Biological)24257500/-Retention2%1000/-300/-Manufacturing (Biological)27287500/-Retention2%1000/-300/-Loan License (B)27-A28-B7500/-Retention2%-300/-Loan License (NB)24-A25-B7500/-Retention2%-300/-LVP27-D28-D7500/-Retention2%-300/-Homeopathic24-C25-C300/-26-C100/-50/-50/-CosmeticCOS 5COS 810,000/-Retention2% 500/-Repacking (NB)24-B25-B700/-Retention2%1000/-100/-Testing licensesLicense for Test / Analysis2930250/-Valid for 3 years and further renewal for 1 year---Cosmetic Testing LaboratoryCOS 22COS 231000/-----Commercial testing Laboratory36377500/-Retention2%--Blood CentreBlood Centre27-C28-C7500/-28-c1000/--300/-Medical Devices manufacturing licensesMedical Devices (Cat A& B)MD-3MD-55000/-Retention2%-500/-Medical Devices (Loan License) (Cat A& B)MD-4MD-65000/-Retention2%-500/-Medical Devices (Cat C& D)MD-7MD-850,000/-Retention2%-1,000/-Medical Devices Loan License (Cat C& D)MD-9MD-1050,000/-Retention2%-1,000/-Medical Devices RegistrationMedical Devices RegistrationMD-41MD-423,000/-Retention2%--

Technical staff

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

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

Documents and undertaking

Documents, undertaking required for a cosmetics manufacturing license, 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 the 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

Procedure for applying for approval of testing laboratory

Procedure for applying for approval of testing laboratory, click below link

Procedure-for-grant-of-approval-for-testing-cosmetics

List of colors permitted

List of Dyes, Colours and Pigments Permitted in manufacturing of cosmetics, Click below link:

List-of-dyes-colours-and-pigments-permitted-in-cosmetics

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 scheduleGMP - Good manufacturing practices and requirements of premises, plants and equipment for manufacture of cosmetics

Download Seventh Schedule for requirements of area and machineries:

Seventh-Schedule-Cosmetics

G.S.R. No. 763(E) dt 15-12-20 - Cosmetics Rules 2020, click below link

G.S.R.-No.-763E-dt-15-12-20-Cosmetics-Rules-2020

Cosmetics Notifications

For notifications of Cosmetics, click below link:

Notifications - Cosmetics
https://thehealthmaster.com/drugs/manufacturing-licenses/cosmetics/