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Cosmetics Rules, 2020

(Updated in 2025) As Amended by G.S.R. 513(E)., dt. 29/07/2025 - Amendments in Rule 3(w), Rule 6, Rule 9, Rule 11(1), Rule 26(c)(ii), Rule 26(f), Rule 26(h), Rule 26(m), Rule 31(2), Rule 31A, Rule 34(10), Rule 49(1), Rule 49(3), Rule 53(2), Rule 60(1), Rule 60(2), Rule 60(3), Rule 61, Rule 62(e), Rule 63, Rule 69(2), First Schedule MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 15th December, 2020 G.S.R. 763(E).--Whereas a draft of the Cosmetics Rules, 2018, was published, with a view to codify separately and to update the rules relating to cosmetics,by the Central Government in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 1153(E), dated the 29thNovember, 2018, in the Gazette of India, Extraordinary, Part II, Secti

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S.Rule 59 Further application after rejection.--

If within a period of six months from the rejection of an application for approval, the applicant informs the State Licensing Authority that the conditions laid down have been satisfied and deposits inspection fee as specified in the Third Schedule, the State Licensing Authority may, after a further inspection being carried out and on being satisfied that the conditions for grant of approval have been complied with, grant the approval in Form COS-23.


S.Rule 60 Validity of licence.--

(1) 1[An approval issued] in Form COS- 23 shall remain valid, if the licensee deposits 2[approval retention] fee referred in the Third Schedule before the completion of period of five years from the date of its issue, unless, it is suspended or cancelled by the State Licensing Authority.

(2) The 3[approval] retention fee referred in sub-rule (1) shall be equivalent to the fee required for grant of such 3[approval] as specified in the Third Schedule.

(3) If the 3[approval] fails to pay 3[approval] retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay 3[approval] retention fee along with a late fee calculated at the rate of two per cent of the 3[approval] fee for every month or part there of up to six months, and in the event of nonpayment of such fee, the 3[approval] shall be deemed to have been cancelled.


S.Rule 61 Inspection for verification of compliance.--

The 1[approved premises] in the manner specified in these rules shall be inspected jointly by Inspector appointed by the Central Government and State Government to verify compliance with the conditions of 2[approval] and provisions of the Act and these rules at least once in three years based on risk based approach.


S.Rule 62 General conditions after approval.--

An approval in Form COS-23, shall be subject to the following general conditions:--

(a) The laboratory that has been approved under this chapter for carrying out tests and analysis shall provide and maintain an adequate staff and adequate premises and equipment as specified in the Eleventh Schedule.

(b) The approved institution shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.

(c) The approved institution shall maintain records of tests carried out on all samples of cosmetics and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in case of substances for which an expiry date is assigned for a period of two years from the expiry of such date and in case of other substances, for a period of six years.

(d) The approved institution shall allow the Inspector appointed under t

S.Rule 63 Withdrawal and suspension of approval.--

(1) The State Licensing Authority may, after giving the approved laboratory an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons therefore, withdraw an approval granted under this 1[Chapter] or suspend it for such period as considered appropriate either wholly or in respect of some of the categories of cosmetics to which it relates, if in his opinion, the approved institution has failed to comply with any of the conditions of the approval or with any provisions of the Act or Rules made thereunder.

(2) Any approved laboratory whose approval has been suspended or withdrawn, may within three months of the date of the order, appeal to the concerned State Government which shall dispose of the appeal in consultation with a panel of competent persons appointed by it in this behalf and notified in the Official Gazette.


S.Rule 64 Exemption of cosmetics.--

(1) Cosmetics as may be specified in the Twelfth Schedule shall be exempted from the provisions of Chapter III and Chapter IV of the Act and the rules made thereunder to the extent and subject to the conditions specified in that Schedule.


S.Rule 65 Voluntary recall of cosmetics.--

(1) If a manufacturer or authorised agent, as the case may be, considers or has reasons to believe that a cosmetics, which has been imported, manufactured, sold or distributed, is likely to pose risk to the health of a user during its use and therefore may be unsafe, such manufacturer or authorised agent shall immediately initiate procedures to withdraw the cosmetics in question from the market, indicating reasons for its withdrawal and inform the State Licensing Authority or Central Licensing Authority, as the case may be, of the details relating thereto.

(2) A manufacturer or authorised agent, as the case may be, shall immediately inform the State Licensing Authority or Central Licensing Authority, as the case may be, and co-operate with them, if there are reasons to believe that a cosmetic which has been placed in the market, may be unsafe for users.

(3) The manufacturer or importer or authorised agent, as the case may be, shall inform the State Licensing Authority

S.Rule 66 Fees for examination of samples.--

(1) The fee for test and analysis in respect of samples under sub-section (1) of section 25 of the Act shall as specified in the Fifth Schedule.

(2) The fees to be paid by a person submitting to the Government Analyst under section 26 of the Act for test or analysis of a cosmetic purchased by him shall be those specified in the Fifth Schedule.


S.Rule 67 Mode of payment of fee.--

(1) The fees prescribed under these rules, in case of application made to the Central Licensing Authority, shall be paid through challan or by electronic mode, in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch of Bank of Baroda, or any other bank, notified by the Ministry of Health and Family Welfare in the Central Government, to be credited under the Head of Account "0210- Medical and Public Health, 04-Public Health, 104-Fees and Fines.

(2) Where the fee specified is payable to the State Licensing Authority, the same shall be paid through a challan or by electronic mode as may be specified by the State Government concerned.


S.Rule 68 Applicability in case of inconsistency.--

If there is any inconsistency between these rules and any other rules made under the Act, the provisions of these rules shall prevail over such other rules.


S.Rule 69 Debarment of applicant.--

(1) Whoever himself or, any other person on his behalf, or applicant submits misleading, or fake, or fabricated documents, may, be debarred by Licensing Authority for such period as deemed appropriate in the facts and circumstances of the case after giving an opportunity to show cause as to why such an order should not be made.

(2) Where an applicant is aggrieved by an order made by the 1[Licensing Authority] under sub-rule (1), such applicant may, within thirty days from the receipt of the order, make an appeal to the Central Government or the State Government, as the case may be, and the Central Government or the State Government, may, after such enquiry as it considers necessary, and after affording an opportunity of being heard, pass such orders in relation thereto as considered appropriate.


S.Rule 70 Digitalisation of Form.--

The Forms prescribed under these rules may be suitably modified by the Central Drugs Standard Control Organisation for the purpose of digitalisation and such conversion into digital forms modification shall be deemed legally valid for all purposes.


S.Rule 71 Amendments in the Drugs and Cosmetics Rules, 1945.--

The Drugs and Cosmetics Rules, 1945 is amended in the manner as specified in the Thirteenth Schedule.


S.Rule 72 Savings.--

(1) Notwithstanding the non-applicability of the Drugs and Cosmetics Rules, 1945, the approvals or permissions or licenses or certificates issued under the provisions of the Act and the said rules in respect of cosmetics prior to commencement of these rules, shall be deemed to be valid for all purpose still its expiry or for a period of eighteen months from the date on these rules are notified, whichever is later, under the corresponding provisions of said rules;

(2) Any things done or any action taken or purported to have been done or taken, including any rule, notification, inspection, order or notice made or issued or any appointment or declaration made or any operation undertaken or any direction given or any proceedings taken or any penalty, punishment, forfeiture or fine imposed under the Drugs and Cosmetics Rules, 1945 shall, be deemed to have been done or taken under the corresponding provisions of these rules and shall always remain valid for all purposes.


S.First Schedule

First Schedule
[See rule 12(3)]
Authorisation from manufacturer
(To be authenticated in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by an equivalent authority through apostille) Authorisation to accompany an application for issuance of import registration certificate

I ............................working as ......................................... authorised to sign this Authorisation on behalf of manufacturer M/s ......................................... (Full addressor telephone number, e-mail) having manufacturing site at ......................................... (Full address, telephone no., e-mail), hereby delegate the Authorisation to M/s .....................


S.Second Schedule


S.Third Schedule

Third Schedule
[See rules 12(5), 12(9), 13(5), 23(2), 23(10), 28, 30(1), 32(1), 55(3), 55(4), 59, 60(1) and 60(2)]
Fee payable for licence, permission and registration certificate.

Serial

Number

Subject

In rupees(INR) except where specified in dollars

1.

Registration Certificate

(a) Fee for the grant or retention of registration certificate for each category of cosmetic

1000 Dollars

Fourth Schedule

[See rule 12 (6)]



List of categories of cosmetics for import
Serial number
Category
1.
Face care products other than face mask
2.
Face mask
3.
Eye contour products
4.
Lip care products
5.
Hand care products

6.

Foot care produ

S.Fifth Schedule

Fifth Schedule

[See rule 12(8), 66(1) and 66(2)] Fee for test or analysis by the Central cosmetics laboratories or by the state laboratories.

1.

Fees for Physical tests

Rupees

(i)

Adhesion Strength

150

(ii)

Ash Content

100

(iii)

Bleed Number

150

(iv)

Blush Time

150

(v)

Cleaning Efficiency

100

(vi)

Cloud Point

100


S.Sixth Schedule

Sixth Schedule
(See rule 17(1))

Undertaking for the import of cosmetics to be submitted by the importer with application form for Import Registration Number.

I/We............................................................S/o or D/o................................................................ having

premises in the name of M/s. ...................................................... at

(address)..................................................................................................................................... aged about

.......... do hereby undertake that,-

1.    I am the importer of........................(Name of the Cosmetics) from......................(Name and address and

country of a company from whom the cosmetics are imported)...............................................................

which are manufactured by the manufactur

S.Seventh Schedule

Seventh Schedule
[See rules 23(4), 26(b)]

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

I. General requirements

(A)    Location and surroundings.-. The factory shall be located in a sanitary place any hygienic conditions shall be maintained in the premises. Premises shall not be used for residence or be interconnected with residential areas. It shall be well ventilated and clean.

In the manufacture of cosmetic products overall control and monitoring is essential to ensure that the consumer receives products of specified quality.

(B)    Buildings.-. The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of inse

S.Eighth Schedule

Eighth Schedule

[See rules 26(f)]

I.    Particulars to be shown in the manufacturing records:

(1)    Serial number.

(2)    Name of the product.

(3)    Lot or Batch size.

(4)    Lot or Batch number.

(5)    Date of commencement of manufacture and date when manufacture was completed.

(6)    Names of all ingredients, quantities required for the lot/batch size, quantities actually used.

(7)    Control reference numbers in respect of raw materials used in formulation.

(8)    Reference to analytical report numbers or unique code.

(9)    Actual production and packing particulars indicating the size and quantity of finished packings.

(10)    Date of release of finished packing for distribution or sale.

(11)  &

S.Ninth Schedule

Ninth Schedule

(See rules 34(7), 39(1), 48)
Standards for cosmetics

Standards for cosmetics in finished form.-The following cosmetics in finished form shall conform to the Indian Standards specifications laid down from time to time by the Bureau of Indian Standards (BIS).

1.    Skin Powders IS :3959

2.    Skin Powder for infants IS :5339

3.    Tooth Powder IS :5383

4.    Toothpaste IS :6356

5.    Skin Creams IS :6608

6.    Hair Oils IS :7123

7.    Shampoo, Soap - based IS :7669

8.    Shampoo Specification IS : 7884

9.    Hair Creams IS :7679

10.    Oxidation hair dyes, Liquid IS :8481

11.    Cologne IS :8482

12.    Nail Polish (Nail Enamel) IS :9245

13.    After

S.Tenth Schedule


S.Eleventh Schedule

Eleventh Schedule

[See rule 62(a)]

Good laboratory practices and requirements of premises and equipment

1. General Requirements:

(a) The laboratory or the organisation of which it is a part must be an entity that is legally authorised to
function and can be held legally responsible.

(b) It is the responsibility of the management to ensure that the laboratory carry out its testing, calibration,
validation, and all other technical activities in such a way as to meet Good Laboratory Practices (GLP)
requirements.

(c) Laboratory management shall have a qualified individual to be known as quality manager or technical
manager for carrying out all technical acti










S.Twelfth Schedule

Twelfth Schedule

[See rule 64(1)]


Class of cosmetics

Extent and conditions of exemption

1. Cosmetics

The provisions of Chapter IV of the Act and Rules made thereunder, which require them to be covered by a licence for the sale, provided that the cosmetics sold, if of Indian origin, are manufactured by licensed manufacturers.

2. Hair Fixers, namely mucilaginous preparations containing gums, used by men for fixing beard.

The provisions of Chapter IV of the Act and the rules thereunder.

3. The following categories of cosmetics:-

(i) Cosmetics in bulk for repackaging for 100%
export to other countries.

(ii)

S.Thirteenth Schedule

Thirteenth Schedule

(See rule 71)

1. In the Drugs and Cosmetics Rules 1945 (hereinafter to be referred as said rules) in sub-rule (1) of rule 1 the words -and cosmetics" shall be omitted.

2. In the said rules, in sub-rule (1) of rule 45 the words -and cosmetics" shall be omitted.

3. In the said rules, in rule 48 the words -or cosmetic" shall be omitted.

4. In the said rules, in rule 52 the words -or cosmetics" shall be omitted.

5. In the said rules, in sub-rule (1) of rule 52 the words -or cosmetics" shall be omitted.

6. In the said rules, in sub-rule (4) of rule 52 the words -or cosmetics" shall be omitted.

7. In the said rules, in rule 54A the words -or cosmetics" wherever they occur shall be o












S.Form COS- 1

Appendix

Form COS- 1

[See rule 12(2), and 12(7)]

Application for issue of registration certificate for import of cosmetics into India





I/We*__________________________________________ (Name and full address) hereby apply for the
grant of registration certificate to the manufacturer, M/ s __________________ (full address with telephone
number, fax and e-mail address of the foreign manufacturer) for his manufactured cosmetics meant for
import into India.


1. Names of cosmetics along with their brand name and pack size(s) and variants for registration.

Serial
number
Product or brand of
cosmetic

S.Form COS- 2

Form COS- 2

[See rule 13(1) and 13(4)]

Import registration certificate to be issued for import of cosmetics into India
Registration Certificate No. __________________________ Date ____________________________________
M/s ______________________________________________________ (Name and full address of registered office) having factory premises at _______________________________________ (full address) has been registered under rule 13 as a
manufacturer and is hereby issued this Registration Certificate.

2. Name (s) of cosmetics, along with their brand names and pack size(s) and variants which may be imported under this registration certificate.



 

Serial


S.Form COS- 3

Form COS- 3

[See rule 13(3), 23(3), 32(2) and 32(3)]
Permission to import or manufacture new cosmetics in India

Number of the permission and date of issue…………….M/s………………………….having
address………………………is hereby permitted to import or manufacture the following new cosmetic
under rule 32 of the Cosmetics Rules, 2020.

1. Name of the cosmetic

2. Category or intended use

3. Composition of the product

4. Any special instruction

Dated:














Signature:
Name and Designation of


S.Form COS- 4

Form COS- 4

[See rule 17(1)]

Application for issue of Import Registration Number for Import of already registered cosmetics.
I/We*______________________________________________________________________________________________________________(Name and full address of importer) hereby
apply for the grant of registration number for Import of already registered cosmetics, meant for import into India.

1. Detail of cosmetics


Serial
number
Name of
cosmetic
(Name of manufacturer
and address)
Pack sizes

S.Form COS- 4A

Form COS- 4A

[See rule 17(2)]
Import Registration Number to be issued for import of already registered cosmetics into India
Import Registration No.: ___________________ Date _______________________

1. M/s ________________________________________________________ (Name and full Address of importer) has been registered
under rule 17 as an importer and is hereby issued this Import Registration Number for import of already registered cosmetics into India.


2. Detail of cosmetics


Serial
number
Name of cosmetic(s) Pack size(s) Name and address of manufacturer

S.Form COS- 5

Form COS- 5
[See rule 23(2)]
Application for grant of a license to manufacture cosmetics for sale or for distribution
1. I/We .................................of..............................hereby apply for the grant of a License to manufacture on
the premises situated at ..................... the following cosmetics:

2. Details of cosmetic products:

Serial
Number
Name of
cosmetic
Name of
ingredients
Specifications or Standards or Grade of ingredients
Percentage

S.Form COS- 6

Form COS- 6
[See rule 23(2)]
Application for grant of a loan license to manufacture cosmetics for sale or for distribution
1. I/We .............................of..................................................hereby apply for grant of a loan license to manufacture cosmetics, for sale, on the Premises situated at .....................C/o.............................the following cosmetics:

2. Details of cosmetic products:

Serial
Number
Name of
cosmetic
Name of
ingredients
Specifications o

S.Form COS- 7

Form COS- 7
[See rule 23(4) and 23(7)]
Self-certificate of compliance of Good Manufacturing Practices (GMP) for manufacture of cosmetics

(To be given by the applicant along with Form COS- 5 or Form COS- 6 at the time of application for manufacturing licence or loan licence)

1. I/We ................................... of..............................hereby applied for the grant of a License to manufacture at premises situated at……………… the following cosmetics.

1.…………

2. …………

3. …………

2. I/We hereby declare that the above premises

S.Form COS- 8

Form COS- 8
[See rule 25, 26(g), 27(1), 28 and 30(1)]
License to manufacture cosmetics for sale or for distribution
Number of license and date of issue..................................

1.............................is hereby licensed to manufacture on the premises situated at ..................... the following
cosmetics under the supervision of the following technical staff

(a) Details of cosmetic products:

Serial
Number
Name of
cosmetic
Name of
ingredients
Form COS- 9
[See rule 25, 26(g), 27(1), 27(3), 28 and 30(1)]
Loan license to manufacture cosmetics for sale or for distribution

1. Number of license and date of issue............................

2. ......................... of .................................... is here by granted a loan license to manufacture the following
cosmetics on the premises situated at . . . . . . . .. . . . . . . . . . . .C/o. ................. under the direction and
personal supervision of the following technical staff :

a. Names of the technical staff............................

 

b. Details of cosmetic products

S.Form COS- 10

Form COS- 10
[See rule 26(i) and 44(1)]
Intimation to person from whom sample is taken
I have this day taken from the premises of ............................. situated at................................................. samples of the cosmetics specified below for the purpose of test or analysis.

Date.......................

Inspector…………

Details of samples taken

Date.......................

Inspector…………


S.Form COS- 11

Form COS- 11
[See rule 26(k) and 62(i)]
Form in which the inspection book shall be maintained

A. The cover of the Inspection Book shall contain the following particulars, namely :

1. The name and address of the licensee ...............................
2. License number and the date up to which the license is valid ...............

B. (i) The pages of the Inspection Book shall be serially numbered and duly stamped by the Licensing Authority. The pages, other than the first and the last pages, shall have the following particulars:-

Name and designation of the Inspector who inspects the premises of the licensee:-

Date of Inspection ....................

S.Form COS- 12

Form COS- 12
[See rule 32(1)]
Application for grant of permission for new cosmetics for obtaining import registration certificate or
manufacturing license

I/We*_________________________________________ (Name and full address) hereby apply for the grant of permission to import or manufacture a new cosmetics in India. The necessary information or data is given below:--

1. Particulars of new cosmetic:-

a. Name of the cosmetic

b. Category of cosmetic/intended use

c. Composition of the product

d. Test protocols/specification of the raw materials and finished product

2. Assessment of the safety for human health o

S.Form COS- 13

Form COS- 13

[See rule 40]
Application from a purchaser for test or analysis of a cosmetic under Section 2 6 of the Drugs and Cosmetics Act, 1940

1. Full name and address of the applicant ...................................................................................................................

2. Occupation.....................................................................................................................

3. Name of cosmetic purporting to be contained in the sample ..........................................................................

4. Name and full address of the concern where the cosmetic was purchased……………

5

S.Form COS- 14

Form COS- 14
[See rule 40]


Report of test or analysis by Government Analyst under Sec tion 26 of the Drugs and
Cosmetics Act, 1940

1. Name of person from whom sample received ......................................2. Date of receipt ................................................................................

3. Name of cosmetic purporting to be contained in the sample .....................................

4. Opinion of the Government Analyst-The sample referred to above is/is not of standard quality as defined in the Drugs and Cosmetics Act, 1940 and Rules thereunder.

Date : ........................

Government Analyst........................

S.Form COS- 15

Form COS- 15

(See rule 42)

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

The stock of cosmetics for records, registers, documents or material objects detailed below has / have this day been seized by me under the provisions of clause (c) or clause (cc) of sub-section (1) of section 22 of the Drugs and Cosmetics Act. 1940 (23 of 1940) from the premises of .......................................situated at............................................................

Date...........................

Inspector.................................

Details of cosmetics, records, registers, documents or material objects

S.Form COS- 16

Form COS- 16

[See rule 44(2)]
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

To ...................................

Whereas I, this............... day of ......... 20..........., have taken from the premises of…….. situated at................................ samples of cosmetics as specified below:-

Details of Samples…………………………

And whereas I had offered to pay you rupees ...................... as the fair price of the samples of cosmetics taken:

And whereas, you have refused to accept the fair p

S.Form COS- 17

Form COS- 17

[See rule 45(1)]


Memorandum to Government Analyst

Serial No. of Memorandum ...............................
From:
To
The Government Analyst,
…………………………
…………………………
The portion of sample or container described below is sent herewith for test or analysis under the provisions of clause (i) of sub-section (4) of Section 23 of the Drugs and Cosmetics Act, 1940.

The portion of sample/container has been marked by me with the following mark.

Details of portion of sample or container with name of cosmetic which it purpo

S.Form COS- 18

Form COS- 18

(See rule 46)
Order under section 22 (1)(c) of the Drugs and Cosmetics Act, 1940 requiring a person not to dispose of stock in his possession

Whereas, I have reasons to believe that the stocks of cosmetics in your possession, detailed below contravene the provisions of section 18 of the Drugs and Cosmetics Act, 1940;

Now, therefore, I hereby require you under clause (c) of sub-section (1) of section 22 of the said Act not to dispose of the said stock for a period of .................. days from the date of this order.

Date..........................

Inspector..................

Details of stock of cosmetics

Date...................

S.Form COS- 19

Form COS- 19

[See rule 48]


Report of tests or analysis of cosmetics by the Government Analyst.

1. Name of the officer or Inspector from whom received.................................

2. Serial number and date of the Officer‘s/Inspector‘s memorandum........................

3. Number of sample...............................

4. Date of receipt...............................

5. Name of the cosmetic purporting to be contained in the sample.........................

6. Condition of seals on the packet or on portion of sample or container...

7. Results of test or analysis:-


S.Form COS- 20

Form COS- 20
See rule 49(1) and 49(3)]
Memorandum to the Director, Central Cosmetic Laboratory

Serial Number .............................

To the Director, Central Cosmetic Laboratory ..........................................

From.................................

I send herewith, under the provisions of section 25 (4) of the Drugs and Cosmetics Act,1940, sample(s) of a cosmetic purporting to be ....................for test or analysis and request that a report of the result of the test or analysis may be supplied to this Court.

2. The distinguishing number on the packet is .......................................

3. Parti

S.Form COS- 21

Form COS- 21

(See rule 51)


Report of test or analysis by the Central cosmetic laboratory

Certified that the sample bearing number ............................................ ……………….. purporting to be a
sample of........................................................ received on .................... with memorandum No
..........................................................................dated.........................................from........................................ ............
has been tested or analysed and that the result of such test or analysis is as stated below.


2. The condition of the seals on the packet on receipt was as follows: --

S.Form COS- 22

Form COS-22

[See rule 55(1)]

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

1. *I/We..............................….of………………………….hereby apply for the grant of approval for carrying out tests on the following items of cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of cosmetics.

2. Items of cosmetics:

(1) .....................................

(2).....................................

(3).....................................

3. Name, qualifi

S.Form COS- 23

Form COS- 23

(See rule 56(1), 56(2), 58(1), 59, 60(1) and 62)

Approval for carrying out tests on cosmetics and raw materials used in their manufacture on behalf
of licensees for manufacture for sale of cosmetics

1. Number of approval and date of issue:.....................

2. Approval is hereby granted to...........................................................…….for carrying out tests for identity, purity and quality on the following items of cosmetics and the raw materials used in t he manufacture thereof on the premises situated..........................................................................

Items of cosmetics

(1) ..........................................

S.Form COS- 24

Form COS- 24

[See rule 62(f)]
Report of test or analysis by approved institution

1. Name of manufacturer from whom sample received together with his manufacturing licence number under the Act and under the rules made thereunder.

2. Reference number and date of the letter from the manufacturer under which the sample was forwarded

3. Date of receipt of the sample.

4. Name of cosmetic/raw material purporting to be contained in the sample.

5. Details of raw material/final product in bulk/final product (in finished pack) as obtained from the manufacturer:

(a) Original manufacturer's name in the case of raw materials repacked.

(b) B

S.Cosmetics (Amendment) Rules, 2025 All Amendments incorporated at appropriate place

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 29th July, 2025

G.S.R. 513(E).-- Whereas a draft of certain rules to amend the Cosmetics Rules, 2020 was published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 371 (E), dated the 15th May, 2023, published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section (i), date

S.Rule 1 Short title.--

(1) These rules may be called the Cosmetics Rules, 2020.

(2) They shall come into force on the date of their publication in the Official Gazette.


S.Rule 2 Application.--

These rules shall be applicable to the cosmetic as defined in clause (aaa) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).


S.Rule 3 Definitions.--

In these rules, unless the context otherwise requires,--

(a) "Act" means the Drugs and Cosmetics Act, 1940 (23 of 1940);

(b) "Actual manufacturer" in relation to import of cosmetics, means a person who manufactures cosmetics at his own manufacturing site in a country other than India approved by National Regulatory Authority or any authorised competent authority in that country for that purpose, by whatever name called.

Explanation.-- for the purpose of this clause, person includes a company or a unit or a body corporate or any other establishment.

(c) "Appendix" means the appendix appended to these rules;

(d) "Authorised agent" means a person in India authorised by the manufacturer. The authorised agent shall be responsible for the business activities of the manufacturer in India including compliance to the provisions of the Act and rules made thereunder.

Explanation.-- For the purpose of this clause, person includes a company

S.Rule 4 Licensing Authorities.--

(1) The Central Licensing Authority shall be the competent authority for enforcement of these rules in matters relating to,--

(i) import of all categories of cosmetics;

(ii) co-ordination with the State Licensing Authorities.

(2) The state drugs controller, by whatever name called, shall be the State Licensing Authority and the competent authority for enforcement of these rules in matters relating to,--

(i) manufacture for sale or distribution of all categories of cosmetics;

(ii) sale, stock, exhibit or offer for sale or distribution of all categories of cosmetics.

(iii) grant of approval to the laboratory which applies for carrying out tests on cosmetics and their raw materials under Chapter VIII.


S.Rule 5 Delegation of powers of Licensing Authorities.--

(1) The Central Licensing Authority, may with the prior approval of the Central Government, by an order in writing, delegate all or any of its powers to any other officer of the Central Drugs Standard Control Organisation not below the rank of Assistant Drugs Controller.

(2) The officer to whom the powers have been delegated under sub-rule (1) shall exercise the powers of the Central Licensing Authority under its name and seal.

(3) The State Licensing Authority may, with the prior approval of the State Government, by an order in writing, delegate all or any of its powers to any officer not below the rank of Assistant Drugs Controller or equivalent under its control.

(4) The officer to whom the powers have been delegated under sub-rule (3) shall exercise the powers of the State Licensing Authority under its name and seal.


S.Rule 6 Controlling officer.--

Any officer not below the rank of Assistant Drugs Controller, by whatever name called, shall be the 1[Controlling Authority] to supervise and give instructions to any officer subordinate to such 1[Controlling Authority] to exercise powers and functions under these rules for areas and purposes specified, by an order, of the Drugs Controller General of India or the Drugs Controller, by whatever name called, of the State respective.


S.1[Rule 7 Government Analyst.--

The Government Analyst appointed under section 20 of the Act (23 of 1940) shall be the Government Analyst for the purposes of these rules.]


S.Rule 8 Functions of Government Analyst.--

(1) The Government Analyst shall cause to be analysed or tested such cosmetics as may be sent to him by an Inspector or any person under the provisions of Chapter IV of the Act and shall furnish reports of the results of test or analysis in accordance with these rules within a period of sixty days of the receipt of the sample:

Provided that where it is not possible to test or analyse the sample within the specified period, the Government Analyst shall seek extension of time from the concerned Government giving specific reasons for delay in such testing or analysis.

(2) A Government Analyst shall, from time to time, forward to the Central Licensing Authority, reports giving the result of analytical work and research with a view to their publication at the discretion of the Central Government.


S.Rule 9 Powers, duties and functions of Inspectors specially Authorised to inspect manufacture and sale of cosmetics.--

(1) Subject to the instructions of the 1[Controlling Authority], it shall be the duty of an Inspector appointed under section 21 of the Act by the State Government, authorised to inspect the manufacture of cosmetics,--

(i) to inspect not less than once in a three year, all premises licensed to manufacture cosmetics within the area allotted to him to satisfy himself that the conditions of the licence and provisions of the Act and Rules thereunder are being observed;

(ii) to send a detailed report after each inspection to the 1[Controlling Authority] indicating the conditions of the licence and provisions of the Act and rules thereunder which are being observed and the conditions and provisions, if any, which are not being observed;

(iii) to institute prosecution in respect of breach of the Act and Rules thereunder.

(iv) take samples of cosmetics manufactured or imported for sale, or stocked or exhibited for sale in respect of which th

S.Rule 10 Prohibition of disclosure of information.--

Except for the purposes of official business or when required by a court of law, an Inspector shall not, without the sanction in writing of his official superior, disclose to any person any information acquired by him during the course of his official duties.


S.1[Rule 11 Central Cosmetics Laboratory and its function.--

(1) The Central Drugs Laboratory established under the Act shall function as the Central Cosmetics Laboratory for the purposes of,

(a) analysing or testing such samples of cosmetics as may be sent to it under sub- section (2) of section 11 or under sub-section (4) of section 25 of the Act; or

(b) functioning as an appellate laboratory; or

(c) carrying out any other function as may be specifically assigned to it by the Central Government.]

(2) Without prejudice to sub-rule (1), the Central Government may also designate or notify any laboratory under its control and the Director of such laboratory having facility for carrying out test and evaluation of cosmetics as Central Cosmetics Laboratory for the purposes specified in sub-rule (1):

Provided that no Laboratory shall be so designated unless it has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.

(3) The Central Cosmetic Laboratory shall be he

S.Rule 12 Import of cosmetics.--

(1) No cosmetic shall be imported into India unless the product has been registered in accordance with these rules by the Central Licensing Authority or by any officer to whom such powers may be delegated under sub-rule (1) of rule 5.

(2) An application for registration of a cosmetic product intended to be imported into India shall be made through the online portal of the Central Government in Form COS-1 either by the manufacturer himself or by his authorised agent or the importer in India or by the subsidiary in India authorised by the manufacturer.

(3) An authorisation by the manufacturer to his agent in India shall be duly authenticated either in India before a first class Magistrate or in the country of origin before the authority competent under the laws of that country or by an authority specified in the First Schedule.

(4) The applicant referred to sub-rule (2) above shall furnish along with the application such other information and documents as specifie

S.Rule 13 Grant of import registration certificate.--

(1) After examination of documents furnished with the application under sub-rule (2) of rule 12 the Central Licensing Authority may, on being satisfied, grant import registration certificate in Form COS- 2 or may reject such application for which reasons shall be recorded in writing within a period of six months from the date of application.

(2) In the event of rejection, the applicant may appeal to the Central Government within a period of forty-five days and that Government, may, after such enquiry into the matter, as considered necessary, pass orders in relation thereto within a period of ninety days from the date of appeal.

(3) In case of a new cosmetic, the applicant shall obtain prior permission in Form COS- 3 as provided in Chapter V from the Central Licensing Authority before registration of import of new cosmetic into India.


(4) A single application may be made and a single registration certificate in Form COS-2 may be issued in respect of import of

S.Rule 14 Validity of import registration certificate.--

(1) A registration certificate granted under rule 13 shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Third Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the Licensing Authority.

(2) If the licensee fails to pay the required registration certificate retention fee on or before the due date as referred to in sub-rule (1), the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part thereof within one hundred and eighty days and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been cancelled.


S.Rule 15 Fresh application in case of change in constitution.--

(1) In case of change in constitution of a registration holder or overseas manufacturer, after grant of registration under sub-rule (1) of rule 13, an application shall be made under sub-rule (2) of rule 12 for grant of fresh registration within a period of one hundred and eighty days from the date of such change in constitution:

Provided that the existing registration shall be deemed to be valid till such time, fresh registration is issued or application is rejected by the Central Licensing Authority.

(2) In case of any change in respect of labelling or composition or testing of registered product or its specifications, the Central Licensing Authority shall be informed by manufacturer or by the authorised agent or the importer or the subsidiary in India authorised by the manufacturer within fifteen days along with an undertaking that products comply with standards laid down by the Bureau of Indian Standards as referred in the Ninth Schedule.

(3) In case of chan

S.Rule 16 Suspension and cancellation of Registration Certificate.--

If the manufacturer or authorised agent or importer fails to comply with any of the conditions of the Registration Certificate, the Central Licensing Authority may, after giving him an opportunity to show cause as to why such an order should not be passed, by an order in writing, stating the reasons therefore, suspend or cancel the registration certificate for such period as it thinks fit either wholly or in respect of some of the cosmetics to which it relates:

Provided that a person who is aggrieved by the order passed by the Central Licensing Authority may, within thirty days of the receipt of the order, appeal to the Central Government and that Government may, after such enquiry into the matter as it considers necessary and after giving the said appellant an opportunity of being heard, pass such orders as considered appropriate in the facts and circumstances of the case.


S.Rule 17 Import of cosmetics already registered for import.--

(1) A cosmetic manufactured in a foreign site and already registered under rule 13 for import and sale in India, may be imported by any person or entity by making an application in online portal of the Central Government in Form COS-4 with an undertaking as specified in Sixth Schedule.

(2) After examination of documents furnished with the application under sub-rule (1), the Central Licensing Authority may, on being satisfied, subject to the conditions, grant import registration number in Form COS- 4A, or may reject such application for which reasons shall be recorded in writing within a period of six months from the date of application.

(3) An import registration number granted under sub-rule (2) shall remain valid for a period of three years from the date of its issue, unless it is suspended or cancelled.

(4) If the importer fails to comply with any of the conditions of the Import Registration Number issued in Form COS-4A, the Central Licensing Authority may, a

S.Rule 18 Prohibition of import of certain cosmetic.--

(1) No cosmetic, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.

(2) No cosmetics shall be imported unless the "Use Before or use by' date shown on the label, wrapper or container of the cosmetic is later than six months from the date of import.

(3) No cosmetic containing hexachlorophene shall be imported.

(4) No cosmetic that has been tested on animals after the 12th day of November 2014 shall be imported into the country.


S.Rule 19 Documents to be supplied to the Commissioner of Customs.--

Before any cosmetics are imported, a declaration signed by manufacturer or on behalf of the manufacturer or by importer or on behalf of the importer that the cosmetics comply with the provisions of Chapter III of the Act, and the rules made thereunder, shall be supplied to the Commissioner of Customs.


S.Rule 20 Procedure for import of cosmetics.--

(1) If the officer appointed at the port of entry by the Central Government has reason to believe that any cosmetic contravenes any of the provisions of the Act or the rules made thereunder, he may take sample of the cosmetic from the consignment for inspection.

(2) If on examination of the sample drawn as per sub-rule (1) defects are noticed, the officer shall advise the Commissioner of Customs about further action to be taken.

(3) If the suspected contravention of the provisions of the Act or the rules is such as may have to be determined by test, the officer shall send the sample to the Laboratory established for the purpose for performing such tests and the consignment of the said cosmetic shall be detained till such time, the test report on that sample is received from the Director of the said Laboratory or any other officer of the Laboratory empowered by him in this behalf:

Provided that if the importer gives an undertaking in writing not to dispose of the

S.Rule 21 Import of cosmetic for personal use.--

Small quantities of cosmetics the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions:--

(i) The cosmetics shall form part of a passenger's baggage and shall be the property of and intended for, the bonafide use of the passenger; and

(ii) The cosmetics shall be declared to the Customs authorities, if they so direct.


S.Rule 22 Import through points of entry.--

No cosmetic shall be imported into India except through the points of entry as specified in rule 43A of the Drugs and Cosmetics Rules, 1945.


S.Rule 23 Application for grant of license or loan license to manufacture cosmetics for sale or for distribution.--

(1)Any person who intends to manufacture cosmetics shall make an application for grant of a licence or loan licence to manufacture for sale or for distribution to the state Licensing Authority.

(2) Application under sub-rule (1) shall be made through an identified online portal in Form COS-5 for licence or in Form COS-6 for loan licence accompanied with a fee, as specified in the Third Schedule along with respective documents as specified in Part II of the Second Schedule.

Provided further that till such time the online portal is not operational for this purpose, offline application in Form COS- 5 for licence or in Form COS- 6 for loan licence may be made for manufacturing of cosmetic referred to in sub-rule (2).

(3) In case of a new cosmetic, the applicant shall obtain prior permission in Form COS- 3 as provided in Chapter V from the Central Licensing Authority and no licence to manufacture any cosmetic shall be granted by the State Licensing Authority without

S.Rule 24 Manufacture at more than one premises.--

If cosmetics are manufactured at more than one premises, a separate application for each of such premises shall be made and a separate license obtained for each such premises.


S.Rule 25 Form of license or loan licence to manufacture cosmetics for sale or distribution.--

A license or loan licence to manufacture cosmetics for sale or distribution shall be granted in Form COS- 8 and loan licence in Form COS- 9.


S.Rule 26 Conditions of license or loan licence for manufacture of cosmetics.--

A license in Form COS- 8 shall be subject to the conditions stated therein and to the following other conditions, namely:--

(a) Manufacture of cosmetics shall be conducted under the direction and personal supervision of competent technical staff consisting at least one person who is a whole-time employee and who possesses any one of the following qualifications-

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

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

(iii) has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognised by the Licensing Authority as equivalent to it.

(iv) holds a bachelor degree in Cosmetic Technology from recognized university.

(b) The factory premises shall comply with the requirements and conditions specified in the Seventh Schedule.

(c) The manufacturer shall either--

(i) pr

S.Rule 27 Grant or refusal of license.--

(1) If the Licensing Authority, after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the rules under the Act have been complied with and that the conditions of the license, loan licence and the rules under the Act shall be observed, he shall grant a license in Form COS-8 or Form COS-9 as the case may be.

(2) If the Licensing Authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a license can be granted or renewed and shall supply the applicant with a copy of inspection report.


S.Rule 28 Further application for licence or loan licence after rejection.--

If within a period of six months from the rejection of an application for a licence or loan licence, the applicant informs the State Licensing Authority that the requirements laid down in the Act and these rules have been fulfilled and deposits a fee as specified in the Third Schedule, the State Licensing Authority may, after causing further scrutiny, and on being satisfied that the requirements for grant of licence or loan licence have been complied with , issue a licence in Form COS-8 or Form COS- 9.


S.Rule 29 Appeal to the State Government.--

Any person who is aggrieved by the order passed by the Licensing Authority refusing to grant a license under this Chapter may within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry as considered necessary, and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.


S.Rule 30 Validity of licence.--

(1) A licence or loan licence issued in Form COS- 8 or Form COS- 9 shall remain valid in perpetuity, subject to payment of licence or loan licence retention fee as specified in the Third Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the State Licensing Authority.

(2) If the licensee fails to pay the required licence or loan licence retention fee on or before the due date as referred to in sub-rule (1), the licence or loan licence holder shall, in addition to the licence or loan licence retention fee, be liable to pay a late fee calculated at the rate of two per cent.of the licence or loan licence retention fee for every month or part thereof within one hundred and eighty days and in the event of non-payment of such fee during that period, the licence shall be deemed to have been cancelled.


S.Rule 31 Inspection for verification of compliance.--

(1) The premises licensed for manufacturing cosmetics shall be inspected by Inspector appointed by the Central Government and State Government to verify the compliance with the conditions of licence and the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach.

(2) The inspectors appointed by the Central Government shall, when so required by the 1[Controlling Authority] or the Central Licensing Authority, carry out special inspection of the identified manufacturing facilities for ensuring compliance with the provisions of this Act and Rules thereunder.


S.1[Rule 31A Cancellation or suspension of licence.--

(1) If a licensee fails to comply with any of the conditions of license or with any provision of the Act or the rules made thereunder, the State Licensing Authority may, after giving the licensee an opportunity to show cause as to why an order for cancellation or suspension of license should not be passed and after giving an opportunity of being heard, by an order in writing, stating the reasons thereof, cancel a licence issued under these rules or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates.

(2) A licensee whose licence has been suspended or cancelled, may, within a period of ninety days from the date of the order, appeal to the State Government which shall, after considering the appeal and after giving an opportunity of being heard to the said appellant for hearing, pass such order as it deems fit which shall be final.]


S.Rule 32 Permission for import or manufacture of new cosmetic.--

(1) Any person who intends to import or manufacture a new cosmetic, shall apply to the Central Licensing Authority in Form COS- 12 along with requisite fee and the data on safety and effectiveness of cosmetic.

(2) If the Central Licensing Authority, after being satisfied that the cosmetic if permitted to be manufactured or imported shall be safe and effective for use in the country, may issue a prior permission in Form COS-3, subject to the condition specified therein.

(3) The prior permission obtained in Form COS-3 shall be furnished along with the application for import under Chapter III or manufacture under Chapter IV of such new cosmetics.

(4) Methods of test or analysis to be employed for safety evaluation of new cosmetic shall be complied by manufacturer as specified in the IS 4011 : 2018 methods of test for safety evaluation of cosmetics, published by the Bureau of Indian Standards as amended from time to time.


S.Rule 33 Prohibition of sale or distribution.--

Subject to the other provisions of the act and these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin, is manufactured by a licensed manufacturer and labelled and packed in accordance with these rules.


S.Rule 34 Manner of labelling.--

(1) Subject to other provisions of the rules, a cosmetic shall carry on both the inner and outer labels:

(a) the name of the cosmetics,

(b) the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic 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:

Provided that if the cosmetic is contained in a very small size container as 30gm or less if the cosmetics are in solid or semi-solid state and 60 ml or less if the cosmetics is in liquid state, 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.

(c) use before or date of expiry (month and year) or use by or expiry date or expiry XX mo

S.Rule 35 Prohibition against altering inscription on containers, labels or wrappers of cosmetic.--

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 at the instance or direction or with the permission of the Central Licensing Authority.


S.Rule 36 Prohibition against false or misleading claims.--

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


S.Rule 37 Labelling of hair dyes containing dyes, colours and pigments.--

Hair dyes containing Para-phenylenediamine or other dyes, colours and pigments shall be labelled 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 directions should first be made. This product should not be used for dyeing the eyelashes or eyebrows; 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

S.Rule 38 Special provisions relating to toothpaste containing fluoride.--

(i) Fluoride content in toothpaste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton.

(ii) Date of expiry should be mentioned on tube and carton.


S.Rule 39 Standards of cosmetics.--

(1) No cosmetic shall be imported or manufactured unless it complies with the specifications prescribed under the Ninth Schedule or any other standards of quality and safety, applicable to it, and other provisions under the rules. In case, the cosmetic is not included under the Ninth Schedule, it shall meet the requirements under these rules and specifications and standards applicable to it in the country of origin.

(2) Raw materials specified in ANNEX A of the Indian Standard IS: 4707 Part 2, as amended from time to time, shall not be added in the cosmetic product.

(3) No Cosmetic shall be imported or manufactured which contains Dyes, Colours and Pigments other than the one specified by the Bureau of Indian Standards (IS: 4707 Part 1 or IS: 4707 Part 2, as amended) and included the Tenth Schedule.

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

(i) 2 parts per million of Arsenic calc

S.Rule 40 Testing of Cosmetic from a purchaser.--

An application from a purchaser for test or analysis of a cosmetic under section 26 of the Act shall be made to the Government Analyst in Form COS- 13 and the report of the test or analysis of the cosmetics made on such application shall be supplied to the applicant in Form COS- 14.


S.Rule 41 Procedure for sampling.--

The Inspector while exercising powers under section 22 of the Act shall follow the procedure provided in section 23 of the said Act.


S.Rule 42 Forms of receipts for seized cosmetic, record register, document or any other material object.--

A receipt for the stock of any cosmetic or for any record, register, document or any other material object seized by him under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be given in Form COS-15.


S.Rule 43 Manner of certifying copies of seized documents.--

The Inspector shall return the documents, seized by him under clause (cc) or produced before him under clause (cca), of sub-section (1) of section 22 of the Act within a period of twenty days of the date of such seizure or production to the person from whom they have been seized or as the case may be, the person who produced them, after copies thereof or extracts therefrom have been signed by the concerned Inspector and the person from whom they were seized or as the case may be, who produced such records.


S.Rule 44 Form of intimation of purpose of taking samples.--

(1) When an Inspector takes a sample of a cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in Form COS- 10 to the person from whom he takes the sample.

(2) In cases, where the fair prices tendered is refused by the person from whom sample has been taken, the Inspector shall record the fact in the receipt in Form COS-16.


S.Rule 45 Procedure for dispatch of sample to Government Analyst.--

(1) The portion of the sample or the container sent by an Inspector to the Government Analyst for test or analysis under sub-section (4) of section 23 of the Act shall be sent by registered post or by hand in a sealed packet, enclosed together with a memorandum in Form COS-17.

(2) A copy of the memorandum and a specimen impression of the seal used to seal the packet shall be sent to the Government Analyst separately by registered post or by hand.


S.Rule 46 Form of order not to dispose of stock.--

An order in writing by an Inspector under clause (c) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form COS- 18.


S.Rule 47 Prohibition of sale.--

No person in possession of a cosmetic in respect of which an Inspector has made an order under clause (c) of sub-section (1) of section 22 of the Act shall, in contravention of that order, sell or otherwise dispose of any stock of such cosmetic.


S.Rule 48 Procedure on receipt of sample.--

On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet or on the portion of sample or container with the specimen impression received separately and shall note the condition of the seals on the packet or on portion of sample or container. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate of the result of the test or analysis in Form COS- 19, together with full protocols of the tests or analysis applied.

Explanation.-- It shall be deemed to be full and sufficient compliance of the requirement of the rule in respect of the supply of the "protocol of the tests or analysis applied", if--

(1) for the category of cosmetics for which standards specified in the Ninth Schedule are applicable and followed, a reference to the specific tests or analysis carried out as per standards stipulated therein is given in the report.

S.Rule 49 Dispatch of samples for test or analysis by order of court.--

(1) Samples for test or analysis under sub-section (4) of section 25 of the Act shall be sent by registered post 1[x x x x] or delivered in person in a sealed packet, enclosed, together with a memorandum in Form COS- 20, with the outer cover being addressed to the Director.

(2) The packet as well as the outer cover shall be marked with a distinguishing number.

(3) A copy of the memorandum in Form COS- 20 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post 2[x x x x] to the Director.


S.Rule 50 Recording of condition of seals.--

On receipt of the packet, it shall be opened by an officer authorised in writing in that behalf by the Director who shall record the condition of the seal on the packet.


S.Rule 51 Report of result of test or analysis.--

After test or analysis, the result of the test or analysis, together with full protocols of the tests applied, shall be supplied immediately after completion of such tests or analysis to the sender in Form COS- 21.


S.Rule 52 Issuance of certificates.--

Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorised by the Central Government by Notification in the Official Gazette to sign such certificates.


S.Rule 53 Confiscation of cosmetics, implements, machinery etc.--

(1) Where any person has been convicted for contravening any of the provisions of Chapter IV of the Act or any Rule made thereunder, the stock of the cosmetics in respect of which the contravention had been made, shall be liable to confiscation.

(2) Where any person has been convicted for manufacturing of any cosmetic deemed to be misbranded under clause (a), clause (b) or clause (c) of section 17C of the Act, 1[or spurious cosmetics under section 17D or adulterated cosmetic] under section 17E of the Act, or for manufacture for sale of any cosmetic without a valid licence as required under clause (c) of section 18 of the Act, any implements or machinery used in such manufacture and any receptacle, packages, or coverings in which such cosmetic is contained and the animals, vehicles, vessels or other conveyances used in carrying such cosmetics shall also be liable to confiscation.


S.Rule 54 Procedure for disposal of confiscated cosmetics.--

(1) The Court shall refer the confiscated cosmetics to the Inspector concerned for report as to whether they are of standard quality or contravene the provisions of the Act or the Rules in any respect.

(2) If the Inspector, on the basis of Government Analyst's report, finds the confiscated cosmetics to be not of standard quality or to contravene any of the provisions of the Act or the Rules thereunder, he shall report to the Court accordingly. The Court shall, thereupon, order destruction of such cosmetics. The destruction shall take place under the supervision of the Inspector in the presence of such authority, if any, as may be specified by the Court.

(3) If the Inspector finds that the confiscated cosmetics are of standard quality and do not contravene the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly.


S.Rule 55 Application for grant of approval for testing cosmetics.--

(1) Any laboratory that meets the requirements and has been accredited by National Accreditation Body for Testing and Calibration Laboratories may grant of approval for carrying out testson cosmetics or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of cosmetics, shall be made in Form COS-22 to the State Licensing Authority of the state where such laboratory is to be established:

Provided that the applicant shall furnish to the State Licensing Authority such additional information as may be required in Form COS-22 in connection with the application.

(2) A separate application shall be made for grant of approval for carrying out tests on additional categories of cosmetics including raw materials used in the manufacture of these cosmetics.

(3) The application under sub-rule (1) shall be accompanied with the fee as specified in the Third Schedule.

(4) In case the original approval is defaced, damaged or lost

S.Rule 56 Approval for carrying out tests on cosmetics on behalf of licensees.--

(1) Approval for carrying out such tests on cosmetics as may be required under the provisions of these rules, on behalf of licensee for manufacture of cosmetics, shall be granted in Form COS-23.

(2) Before approval in Form COS- 23 is granted, the following conditions shall be complied with by the applicant.--

(i) The premises where the tests are to be carried out, shall be well lighted and properly ventilated except where the nature of tests of any cosmetic warrants otherwise.

Wherever necessary, the premises shall be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as microbiological tests, etc.

(ii) The applicant shall provide adequate space having regard to the nature and number of samples of cosmetics proposed to be tested:

Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate.

(

S.Rule 57 Inspection before grant of approval.--

(1) Before grant of approval in Form COS-23, the State Licensing Authority shall cause the institution at which the testing of cosmetic is proposed to be carried out to be inspected jointly by the Inspector appointed by the Central Government and the State Government under section 21 of the Act, to examine the premises and the equipment intended to be used for testing of cosmetics and inquire into the professional qualifications of the expert staff to be employed.

(2) The report of the inspection shall be rendered within twenty four hours of the inspection and a copy thereof shall be made available to the laboratory inspected.


S.Rule 58 Procedure of approving authority.--

(1) If the State Licensing Authority, after such further enquiry, if any, as may be considered necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act will be observed, he shall grant an approval in Form COS-23.

(2) If the State Licensing Authority is not so satisfied, the application shall be rejected and the applicant informed of the reasons for such rejection and of the conditions which must be satisfied before an approval could be granted.


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