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CHAPTER 3 COSMETIC REGULATION: INDIA

COSMETIC REGULATIONS: INDIA


The cosmetic products in India are regulated under the Drugs and
Cosmetics Act 1940 and Rules 1945 The cosmetic products in India are
regulated under the Drugs and Cosmetics Act 1940 and Rules 1945 and
Labelling Declarations by the Bureau of Indian Standards (BIS). BIS sets
the standards for cosmetics for the products listed under Schedule ‘S’ of
the Drugs and cosmetics Rules 1945[1]. BIS has also provided the
specification for Skin Creams and Lipstick in the Indian Standards (IS)
6608:2004 and 9875:1990 respectively.

Fig.19 Logo of CDSCO

As per section 3(aaa) of the 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.[2]

The Drugs and Cosmetic Act, 1940 also describes some cosmetics as
misbranded and some as spurious cosmetics as well:

Misbranded Cosmetics

A drug is defined as misbranded if:[3]

a) it contains a color which is not prescribed; or

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b) it is not labelled in the prescribed manner; or


c) the label or container or anything accompanying the cosmetic bears
any statement which is false or misleading in any particular.

Spurious Cosmetics

A drug is defined as spurious if:

it is imported under a name which belongs to another cosmetic; or

if it is an imitation of, or is a substitute for, another cosmetic or


resembles another cosmetic in a manner likely to deceive or bears upon it
or upon its label or container the name of another cosmetic, unless it is
plainly and conspicuously marked so as to reveal its true character and
its lack of identity with such other cosmetic; or

the label, or container bears the name of an individual or a company


purporting to be the manufacturer of the cosmetic which individual or
company is fictitious or does not exist; or

if it purports to be product of a manufacture of whom it is not truly a


product.[4]

As per Rule 129 of Drugs and Cosmetic Rules, 1945 No cosmetic shall be
imported into India unless the product is registered under the rules by
the licensing authority appointed by the Central Government under rule
21 or by any person to whom such powers may be delegated under rule
22. Any article falling within the definition of cosmetic (Section 3aaa of
D&C Act, 1940) is required to be registered along with pack size and
manufacturing premises before import into the country.[5] An application
for issue of a Registration Certificate for cosmetics intended to be
imported into India shall be made online in Form 42 on SUGAM [6]Portal
of CDSCO either by the manufacturer himself or by his authorized agent
or importer in India or by the subsidiary in India authorized by the
manufacturer to the Licensing Authority under the Act i.e., Drugs
Controller General (I), CDSCO (HQ). The purpose of this document is to
provide guidance for submission of online application in Form 42 [7]to
CDSCO for obtaining Registration Certificate for import of cosmetics in
India.[8]

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Features of Drugs and Cosmetic Act, 1940

1. To regulate drugs and cosmetics through licensing.


2. The process of manufacture, distribution, and sale of drugs and
cosmetics to be done only by qualified persons.
3. To maintain the high standards in medical treatments.
4. To establish the Drugs Technical Advisory Board, Drugs Consultative
Committees for Allopathic and allied drugs, and cosmetics.
5. The punishment ranges with the penalty of life imprisonment and a
fine of Rs. 10 Lakhs, or 3 times the value of the confiscated goods.
Some offenses can be considered cognizable and non-bailable.
6. The prosecution can be done by Drug Controller’s officers, also gazette
officers.
7. There are designated courts for the offences covered under this Act.[9]

AUTHORITIES, OFFICERS AND LABORATORY

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.

Delegation of powers of Licensing Authorities.

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
Organization not below the rank of Assistant Drugs Controller.

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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. [10]

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.

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.[11]

Controlling officer

Any officer not below the rank of Assistant Drugs Controller, by whatever
name called, shall be the controlling officer to supervise and give
instructions to any officer subordinate to such controlling officer 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.[12]

Government Analyst.

The Central Government or a State Government may appoint by


notification in the Official Gazette, the Government Analyst for the
purpose of these rules as provided in section 20 of the Act and rules
made thereunder.

Functions of Government Analyst.

1. The Government Analyst shall cause to be analyzed 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 analyses 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

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research with a view to their publication at the discretion of the


Central Government.

Powers, duties and functions of Inspectors specially Authorized to


inspect manufacture and sale of cosmetics.

1. Subject to the instructions of the controlling officer, it shall be the


duty of an Inspector appointed under section 21 of the Act by the
State Government, authorized to inspect the manufacture of
cosmetics,
a) to inspect not less than once in three years, all premises licensed to
manufacture cosmetics within the area allotted to him to satisfy
himself that the conditions of the license and provisions of the Act and
Rules thereunder are being observed;
b) to send a detailed report after each inspection to the controlling officer
indicating the conditions of the license and provisions of the Act and
rules thereunder which are being observed and the conditions and
provisions, if any, which are not being observed;
c) to institute prosecution in respect of breach of the Act and Rules
thereunder.
d) take samples of cosmetics manufactured or imported for sale, or
stocked or exhibited for sale in respect of which the inspector has
reason to suspect contravention of the provisions of the Act or these
rules and send them for test or evaluation;
e) maintain a record of all inspections undertaken, drawing of samples,
seizure of stocks and action taken by inspector in exercise and
performance of duties and to furnish copies of such record to the
Central Licensing Authority or the state Licensing Authority, as the
case may be;
f) make such enquiries and inspections as may be necessary to detect
the manufacture or sale of cosmetics in contravention of any provision
of the Act and these rules;
g) investigate any complaint made in writing relating to cosmetic to the
inspector or any other senior officer in accordance with the direction
of the controlling officer;
h) review technical dossier of cosmetic furnished with the application
under these rules or any other duties assigned by the Central

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Licensing Authority or state Licensing Authority, as the case may be,


related to these rules:
2. Without prejudice to the duties and functions assigned to the
Inspector appointed by the State Government under sub-rule (1) such
duties and function may, as and when directed by Central Licensing
Authority or Drugs Controller General of India or controlling officer
shall be discharged by the Inspector appointed by the Central
Government under section 21 of the Act.

Establishment and functions of the Central Cosmetics Laboratory.

1. The Central Government may, by notification, establish Central


Cosmetics Laboratory for the purpose of,[13]
a) to analyses or test 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) to carry out any other function as may be specifically assigned to it.
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 headed by a Director who
shall be appointed or designated by the Central Government.

IMPORT AND REGISTRATION 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. [14]
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

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himself or by his authorized agent or the importer in India or by the


subsidiary in India authorized by the manufacturer.
3. An authorization 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 specified in
Part I of the Second Schedule:
Provided also that in the event of application for import of bulk finished
formulation ready to fill, the following additional documents shall also
require to be furnished:
i) a valid manufacturing license for the finished formulation of the
cosmetic ready to fill in finished form from the State Licensing
Authority; and
ii) details of registered brand owner of the finished product in India;
5. The application for registration in accordance with sub-rule (2) shall
be accompanied by a copy of the receipt of fee having been deposited
as specified in Third Schedule.
6. The fee shall be such for each category of cosmetic along with each
manufacturing site with additional fee for each category of cosmetic
and variant specified in the Fourth Schedule.
7. Till such time, the online portal becomes operational for this purpose,
offline application in Form COS- 1 may be made either by the
manufacturer himself or by his authorized agent or by the importer in
India or by the subsidiary in India authorized by the manufacturer for
registration of a cosmetic referred to in sub-rule (1).
8. The applicant shall be liable to pay testing fees directly to the testing
Laboratory approved by the Central Government referred in rule 11,
for examination, test and analysis of imported cosmetics in respect of
cosmetics identified for such examination as specified in the Fifth
Schedule.
9. The applicant shall pay the fee as specified in the Third Schedule in
connection with the expenditure to be incurred for inspecting or
visiting the manufacturing premises of cosmetics approved in the

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foreign countries by officers authorized by Central Licensing


Authority, as considered necessary.[15]

Permission for import or manufacture of new cosmetic

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.

1. 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.
2. 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.
3. 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.[16]

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. [17]
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 one or more
cosmetics manufactured by the same manufacturer

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Provided that the cosmetics are manufactured at one factory or more


than one factory functioning conjointly as a single manufacturing unit for
cosmetic intended for registration.

5. A fee as specified in the Third Schedule shall be paid for a duplicate


copy of the registration certificate, if the original is defaced, damaged
or lost.[18]

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.[19]

Suspension and cancellation of Registration Certificate.

If the manufacturer or authorized 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. 17.

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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, 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 import
registration number for such period as it thinks fit.

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.[20]

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

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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.

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
cosmetic without the consent of the Commissioner of Customs and to
return the consignment or such portion thereof as may be required,
the Commissioner of Customs may, make over the consignment to the
importer.[21]
4. If the importer who has given an undertaking under proviso to sub-
rule (1) is required by the Commissioner of Customs to return the
consignment or portion thereof, he shall return the consignment or
portion thereof within ten days of receipt of the notice.
5. If the Director of the Laboratory established for the purpose by the
Central Government or any other officer of the laboratory empowered
by him in this behalf with the approval of the Central Government,
reports to the Commissioner of Customs or to the officer mentioned in
sub-rule (1) that the sample of any cosmetic in a consignment
contravenes provisions of Chapter III of the Act or rules made
thereunder and that the contravention is such that it cannot be
remedied by the importer, the Commissioner of Customs shall
communicate the report forthwith to the importer who shall within

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two months of receiving such communication either send back all the
cosmetic of that description in the consignment to the country in
which it was manufactured or to the country from which it was
imported or hand it over to the Central Government which shall cause
it to be destroyed: Provided that the importer may, within thirty days
of receipt of the report, make a representation against the report to
the Commissioner of Customs who shall forward the representation
with a fresh sample of the cosmetic to the Central Licensing Authority,
who shall if necessary, after obtaining the report of the Director of the
Central Cosmetics Laboratory, pass orders thereon which shall be
final.
6. If the Central Licensing Authority or any other officer empowered by
the said authority in this behalf with the approval of the Central
Government, reports to the Commissioner of Customs after inspection
of the sample of the cosmetic and where necessary, after obtaining a
test report thereon, that the sample of the said cosmetic contravenes
any provision of the Act or the rules made thereunder and that
contravention is such that it can be remedied by the importer, the
Commissioner of Customs shall communicate the report forthwith to
the importer and permit him to import the cosmetic on his giving an
undertaking in writing not to dispose of the cosmetic without the
permission of the officer authorized in this behalf by the Central
Government.[22]

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.[23]

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.

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MANUFACTURE OF COSMETICS FOR SALE AND DISTRIBUTION

Application for grant of license or loan license to manufacture cosmetics


for sale or for distribution.[24]

1. Any person who intends to manufacture cosmetics shall make an


application for grant of a license or loan license 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 license or in Form COS-6 for loan
license 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
license or in Form COS- 6 for loan license 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 license to manufacture any cosmetic shall be
granted by the State Licensing Authority without such permission.
4. In addition to the documents specified in part II of the Second
Schedule, the applicant shall furnish a self-declaration in Form COS-7
conforming compliance with Good Manufacturing Practices,
requirements of premises, plants and equipment for manufacture of
cosmetics as specified in the Seventh Schedule.
5. On receipt of the application under sub-rule (1) accompanied such fee
and such documents as provided in sub-rule (2) and (3), for grant of a
license or loan license, the State Licensing Authority shall grant a
license or loan license within a period of forty-five days from the date
application after scrutiny of application and documents it is of the
opinion that requirements of the Act and these rules have been
fulfilled: Provided where the State Licensing Authority considers that
the applicant has not fulfilled the requirement of the Act and these
rules, the same shall be conveyed to the applicant within forty-five
days from the date the application has been made. [25]
6. On receipt of the license or loan license referred in sub-rule (5), the
applicant may manufacture cosmetics for sale or distribution, after

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uploading a copy of such license on the website of the Central Drugs


Standard Control Organization.
7. The State Licensing Authority within thirty days from the date of grant
of license or loan license, shall inspect or authorize any other officer
subordinate to such authority to inspect the site and verify the
information given in self-certificate in Form COS-7 referred in sub-
rule (4).
8. Where the State Licensing Authority or any other officer authorized to
do so fails to inspect and verify the site of the license or loan license
within the period referred in sub-rule (7), the license or loan license
shall be deemed to be valid for all purposes.
9. In case, it is found at the time of inspection that the self-certificate
contained any false information, the Licensing Authority may, after
giving the licensee an opportunity to show cause, the license or loan
license may be cancelled.
Provided that where the State Licensing Authority is of the view that
deficiencies can be removed, the said authority may issue the directions
to the holder of the license or loan license to stop the manufacturing till
the requirements are complied with, and when it is complied with, it shall
be informed to Licensing Authority by the applicant and the Licensing
Authority if satisfied may issue the directions to restart the
manufacturing within five working days of receipt of such compliance.
10. In case, the original license or loan license is defaced, damaged or
lost; a duplicate copy of the license or loan license may be requested
for from the State Licensing Authority on payment of fee as specified
in the Third Schedule.[26]

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.

Form of license or loan license to manufacture cosmetics for sale or


distribution.

A license or loan license to manufacture cosmetics for sale or distribution


shall be granted in Form COS- 8 and loan license in Form COS- 9.[27]

Conditions of license or loan license for manufacture of cosmetics

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A license in Form COS- 8 shall be subject to the conditions stated


therein and to the following other conditions, namely:[28]

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 recognized 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) provide and maintain adequate staff, premises and laboratory
equipment for testing the cosmetics manufactured, and the raw
materials used for manufacture in such cosmetics, or
ii) make arrangements with a laboratory approved by the Central
Licensing Authority under the rules and accredited by National
Accreditation Board for Testing & Calibration Laboratories (NABL) for
carrying out such tests.[29]
d) The applicant shall maintain documentary evidence for the following﹘
i) documents in respect of the ownership or occupation on rental or other
basis of the premises, specified in the application for license or in the
license granted,
ii) constitution of the firm, or
iii) any other document that may be required for verifying the correctness of
the statements made by the applicant or the licensee, while applying for
or after obtaining the license as the case may be.
e) The licensee shall comply with the provisions of the Act and the rules
made thereunder and with such further requirements, if any, as may be
specified in any rules to be made hereafter under Chapter IV of the Act.

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f) The licensee shall keep record of the details of each batch of cosmetic
manufactured by him and of the raw materials used therein as per
particulars specified in the Eighth Schedule and such records shall be
retained for a period of three years after the date of expiry of the batch.
g) A license in Form COS- 9 shall be deemed to have been cancelled or
suspended, if the license issued, in Form COS- 8, in respect of
manufacturing facilities is cancelled or suspended.[30]
h) The licensee shall test each batch or lot of the raw materials used for
manufacturing the cosmetics and also each batch of the final product
and shall maintain records or registers showing the particulars in respect
of such tests. The records or registers shall be retained for a period of
three years from the date of manufacture.
i) The licensee shall allow an Inspector appointed under the Act to enter
with or without prior notice any premises where the manufacture of a
substance in respect of which the license is issued, is carried on, to
inspect the premises and to take samples of the manufactured products
for which a receipt shall be issued in Form COS- 10.
j) The licensee shall allow an Inspector to inspect all registers and records
maintained under these rules and shall supply to the Inspector such
information as he may require for the purpose of ascertaining whether
the provisions of the Act and rules made thereunder have been complied
with.
k) The licensee shall maintain an Inspection book in Form COS-11 to
enable an Inspector to record his impression and the defects noticed;
The manufacturer shall inform the Licensing Authority within thirty
days, in writing, in the event of change in labelling or composition or
testing, or specification or in documentation of any of the cosmetic
pertaining to this license along with an undertaking that the products
comply with standards laid down by the Bureau of Indian Standards as
referred in the Ninth Schedule.[31]
l) the licensee shall inform the Licensing Authority in writing in the event of
any change in the constitution of the firm operating under the license.
Where any change in the constitution of the firm takes place, the current
license shall be deemed to be valid for a maximum period of six months
from the date on which the change takes place unless, in the meantime,

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CHAPTER 3 COSMETIC REGULATION: INDIA

a fresh license has been taken from the Licensing Authority in the name
of the firm with the changed constitution.
m) In case of change in name or address of a manufacturer, after grant of
license or loan license under sub-rule (5) of rule 23, an application for
amendment shall be made to state Government for prior approval from
Licensing authorities for the said changes in manufacturing license
within a period of sixty days from the date of such change

Provided that clauses (c) and (d) shall not apply to the manufacture of
soap and the procedure for testing of raw materials and the records to be
maintained by a manufacturer of soap shall be such as are approved by
the ―Licensing Authority.

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 license 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. [32]

Further application for license or loan license after rejection.

Within a period of six months from the rejection of an application for a


license or loan license, 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
license or loan license have been complied with , issue a license in
Form COS-8 or Form COS- 9.[33]

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CHAPTER 3 COSMETIC REGULATION: INDIA

Validity of license

1. A license or loan license issued in Form COS- 8 or Form COS- 9 shall


remain valid in perpetuity, subject to payment of license or loan
license 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 license or loan license retention
fee on or before the due date as referred to in sub-rule (1), the license
or loan license holder shall, in addition to the license or loan license
retention fee, be liable to pay a late fee calculated at the rate of two
per cent. Of the license or loan license 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 license shall be
deemed to have been cancelled.[34,35]

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 license
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 controlling officer 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.[35]

LABELLING, PACKAGING AND STANDARDS FOR SALE AND


DISTRIBUTION OF COSMETICS

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.

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CHAPTER 3 COSMETIC REGULATION: INDIA

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 months from manufactured or date of manufacturing or
expiry date.
2.
a) A distinctive batch number, that is to say, the number by reference to
which details of manufacture of the particular batch from which the
substance in the container is taken are recorded and are available for
inspection, the figures representing the batch number being preceded
by the letter “B” or the words “Batch No” or “B. No.” or “Batch” or “Lot
No.” or “Lot” shall carry on the inner or outer labels:

b) Manufacturing license number, the number being preceded by the


letter “M” or “M. L. N” or “Mfg. Lic. No.” shall carry on the inner or outer
labels,

Provided that in case of imported products, if such provision is not


mandatory in country of origin, such cosmetics may be allowed without
mentioning manufacturing license number, subject to fulfillment of other
import regulations.

3. The outer label of the cosmetics shall carry a declaration of the net
contents expressed in terms of weight for solids, fluid measure for

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CHAPTER 3 COSMETIC REGULATION: INDIA

liquids, fluid measure or weight for semi-solids, combined with


numerical count if the content is sub-divided:
Provided that this statement need not appear in case of a package of
perfume, toilet water or the like, the net content of which does not exceed
60 ml or any package of solid or semi-solid cosmetic the net content of
which does not exceed 30 grams.
4. In case of cosmetics; where a hazard exists, every inner label shall
clearly indicate
a) adequate directions for safe use,
b) any warning, caution or special direction required to be observed by
the consumer,
c) a statement indicating the names and quantities of ingredients that
are hazardous or poisonous.
5. In the case of imported cosmetics to be marketed in India, import
registration certificate number shall be mentioned on the label of unit
pack preceded by letter “RC” or “RC No.” or “Reg. Cert. No.” along with
name and address of the importer;
6. Where a package of a cosmetic has only one label, such label shall
contain all the information required to be shown on both the inner
and the outer labels, under these rules.
7. In all cases, the list of ingredients, present in concentration of more
than one percent. shall be listed in the descending order of weight or
volume at the time they are added, followed by those in concentration
of less than or equal to one percent, in any order, and preceded by the
words “INGREDIENTS”.
Provided that this statement need not appear for packs of less than or
equal to 60 ml of liquid and 30 gm of solid and semi-solids.
8. The cosmetic shall comply with labelling requirement, if any, specified
in the relevant Indian standard as laid down by the “Bureau of Indian
Standards” for the cosmetics covered under the Ninth Schedule.
9. No cosmetic shall be imported unless it is packed and labelled in
conformity with these rules and the label of imported cosmetics shall
bear registration certificate number of the product and the name and
address of the registration certificate holder for marketing the said
product in India: Provided further that in cases where the imported

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CHAPTER 3 COSMETIC REGULATION: INDIA

cosmetics require India specific labelling, the same shall be allowed to


be stickered on the unit pack at the bonded warehouses.
10. In case, the cosmetic is meant for export then the labels on
packages or container of cosmetic shall meet the specific requirements
of law of the country to which the cosmetic is to be exported, but the
following particulars shall appear in a conspicuous manner on the
label of the inner most pack of the cosmetic in which the cosmetic is
packed and every other outer covering in which the container is
packed:
a) name of the cosmetic
b) the distinctive batch number or lot number or serial number preceded
by the word “Lot No.” or “Lot” or “Batch No.” or “B. No.” or “Serial No.”
or B”.(Schedule-U. [2020])
c) use before or date of expiry, if any
d) the name and address of manufacturer and address of actual
premises where the cosmetic has been manufactured
e) license number preceded by letters “License No.” or “Lic. No.”
f) internationally recognized symbols in lieu of text, wherever required

Provided that where a cosmetic is required by the consignee to be not


labelled with the name and address of the manufacturer, the labels on
packages or containers shall bear a code number as approved by the
state Licensing Authority.[37]

Labelling of hair dyes containing dyes, colors and pigments.

Hair dyes containing Paraphenylenediamine or other dyes, colors 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:

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CHAPTER 3 COSMETIC REGULATION: INDIA

“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
quantity of the hair dye as prepared for use to the area and allow it to
dry. After twenty-four hours, wash the area gently with soap and water. If
no irritation or inflammation is apparent, it may be assumed that no
hypersensitivity to the dye exists. The test should, however, be carried
out before each and every application. This preparation should on no
account be used for dyeing eyebrows or eyelashes as severe inflammation
of the eye or even blindness may result.”[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.

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,
Colors 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 colors
and Natural Organic Colors used in the Cosmetic shall not contain
more than:
i) 2 parts per million of Arsenic calculated as Arsenic Trioxide.

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CHAPTER 3 COSMETIC REGULATION: INDIA

ii) 20 parts per million of lead calculated as lead.


iii) 100 parts per million of Heavy Metals other than lead calculated as
the total of the respective metals.
4. No cosmetic containing hexachlorophene shall be manufactured:
Provided that in case of soaps, hexachlorophene may be used in
concentrations not exceeding one per cent weight by weight: Provided
further that the following cautionary note shall be printed and shall
appear in a conspicuous manner on the wrapper of package of each
soap, namely. “Contains hexachlorophene - not to be used on babies”.
5. Cosmetics imported or manufactured in the country shall contain
mercury in the following proportions, namely,
a) in cosmetics intended for use only in the area of eye, the level of
mercury not exceeding seventy parts per million (0.007 per cent.) of
mercury, calculated as the metal, as a preservative;
b) in other finished cosmetic products, unintentional mercury shall not
exceed one part per million (1 ppm).
6. The use of lead and arsenic compounds for the purpose of coloring
cosmetics is prohibited.
7. No person shall use any animal for testing of cosmetics.(Schedule-S.
[2020]).

SCHEDULES INTRODUCED TO COSMETIC RULES

Table 10. List of schedules and their description[40]

Sr. Schedule Description


No.

1 Schedule First Authorization from manufacturer.

2 Second schedule Information and undertaking required to be


Part I furnished by the manufacturer or his authorized
importer or distributor or agent with the
application form for import registration certificate.

3 Second schedule Information and undertaking required to be


Part II furnished by the manufacturer with the
application form for grant of manufacturing

CHANDIGARH COLLEGE OF PHARMACY, LANDRAN 23


CHAPTER 3 COSMETIC REGULATION: INDIA

license or loan license.

4 Third schedule Fee payable for license, 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 Schedule importer with
application form for Import Registration Number.

8 Seventh schedule Good manufacturing practices and requirements


of premises, plants Schedule and equipment for
manufacture of cosmetics

9 Eighth schedule Manufacturing and raw material records.

10 Ninth schedule Standards for cosmetics (BIS)

11 Tenth schedule List of colorants allowed for use in cosmetic


products as given under IS: 4707 (Part 1) of BIS
Part I

12 Tenth schedule List of colors permitted to be used in soaps


Part II

13 Eleventh Good laboratory practices and requirements of


premises and equipment
schedule

14 Twelfth schedule Extent and conditions of exemption of various


class of cosmetics 14

15 Thirteenth Word “Cosmetics” is omitted from Drugs and


Cosmetics Rules 1945
schedule

FORMS UNDER COSMETIC RULE (GOVERNMENT OF INDIA MINISTRY


OF HEALTH AND FAMILY WELFARE (Department of Health) THE DRUGS
AND COSMETICS ACT AND RULES THE DRUGS AND COSMETICS ACT,

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CHAPTER 3 COSMETIC REGULATION: INDIA

1940 (23 OF 1940) THE DRUGS AND COSMETICS RULES, 1945 LIST OF
ABBREVIATIONS USED [2021][b])

Table 11. List of forms and their purposes

Sr. Purpose Form


NO.

1. 1 Application to obtain cosmetic manufacturing license Cos-5

2. Self- certificate compliance for GMP Cos-7

3. Cosmetic manufacturing license Cos-8

4. Form for Sampling Cos-10

5. Seizure Form Cos-15

6. Fair-price form Cos-16

7. Memorandum to Govt. Analyst Cos-17

8. Non-Disposal form Cos-18

9. Govt. Analyst test report Cos-19

10. Application for Grant of testing of cosmetics Cos-22

11. License for testing laboratory for cosmetics Cos-23

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CHAPTER 3 COSMETIC REGULATION: INDIA

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CHANDIGARH COLLEGE OF PHARMACY, LANDRAN 26


CHAPTER 3 COSMETIC REGULATION: INDIA

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[37] Section 148 in The Drugs and Cosmetics Rules, 1945 n.d.
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[39] Schedule-S n.d.
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CHANDIGARH COLLEGE OF PHARMACY, LANDRAN 28

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