Cosmetics – Regulation in India
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Content
➢ Definition of Cosmetic products
➢ History
➢ Requirements of Labeling of Cosmetics
➢ Regulatory Provisions relating to import of cosmetics
➢ Misbranded cosmetics
➢ Spurious cosmetics
➢ Offences & Penalties
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Definition
➢ As per Drugs and Cosmetics Act 1940 , cosmetics are defined in
➢ Section 3 (aaa)] ―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.
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History – Drugs and Cosmetics Act 1940 &
Rules 1945
➢ This act was originally known as the Drug Act and was passed in
1940.
➢ The original act was prepared in accordance to the
recommendations of the Chopra Committee formed in 1930.
➢ The Drugs and Cosmetics Act, 1940 (23 of 1940) was passed by
the India’s Parliament on dated 10th April, 1940 .
➢ Since 1940, the act has undergone several amendments and is now
known as the Drugs and Cosmetics Act, 1940.
➢ An Act to regulate the import, manufacture, distribution and sale of
drugs and cosmetics;
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➢ The primary objective of the act is to ensure that the drugs and
cosmetics sold in India are safe, effective and conform to state
quality standards.
➢ It consist of 5 Chapters and 38 Sections
➢ Chapter- I- Introductory
➢ Chapter II- The Drugs Technical Advisory Board (DTAB), the
Central Drugs Laboratory(CDL) and the Drugs Consultative
Committee(DCC)
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➢ Chapter III -Import of Drugs and Cosmetics
➢ Chapter IV – Manufacture, Sale and Distribution of Drugs and
Cosmetics
➢ Chapter IV A – Provisions relating to Ayurvedic Siddha and Unani
Drugs
➢ Chapter V -Miscellaneous
➢ The related Drugs Rules was passed in 1945.
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List of Amending Acts and Adaptation
Orders
➢ The Drugs (Amendment) Act, 1955
➢ The Drugs (Amendment) Act, 1960
➢ The Drugs (Amendment) Act, 1962
➢ The Drugs and Cosmetics (Amendment) Act, 1964
➢ The Drugs and Cosmetics (Amendment) Act, 1972
➢ The Drugs and Cosmetics (Amendment) Act, 1982
➢ The Drugs and Cosmetics (Amendment) Act, 1995
➢ The Drugs and cosmetics (Amendment) Act, 2008.
➢ The Drugs and cosmetics (Amendment) Act, 2010.
➢ The Drugs and cosmetics (Amendment) Act, 2016.
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Amending Act & Rules related to Import of
Cosmetics
➢ The Government of India has issued a Gazette Notification G.S.R
426(E), dated 19th May 2010 for amending the Drugs &
Cosmetics Rules, 1945 providing for registration of import of
cosmetics into the Country.
➢ The above provision came into effect from the 1st April, 2011.
➢ But, in view of the various possible difficulties apprehended by the
stakeholders, its implementation has been deferred till the 31st
March, 2013.
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Amending Act & Rules related to
Manufacture of Cosmetics for Sale or
Distribution
➢ Gazette notification G.S.R 510(E) , dt. 26-7-1982 for providing
Standards for cosmetics in finished form under Schedule S.
➢ Gazette notification G.S.R 723(E) , dt. 11-8-1992 for providing
requirements of factory premises for manufacture of cosmetics
under schedule M-II.
➢ Gazette Notification G.S.R. 811(E) , dated 14.11.1994. for
providing list of dyes, colours and pigments permitted to be used in
cosmetics and soaps as given under is : 4707 under Schedule Q.
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Cosmetic Products
The following cosmetic products are regulated under Drugs and
Cosmetics Act & Rules,1945
1.Skin Powders.
2. Skin Powder for infants.
3. Tooth Powder.
4. Toothpaste.
5. Skin Creams.
6. Hair Oils.
7. Shampoo, Soap-based.
8. Shampoo, Synthetic-Detergent based.
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9. Hair Creams.
10. Oxidation hair dyes, Liquid.
11. Cologne.
12. Nail Polish (Nail Enamel).
13. After Shave Lotion.
14. Pomades and Brilliantines.
15. Depilatories Chemical.
16 .Shaving Creams.
17. Cosmetic Pencils.
18. Lipstick.
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19. Toilet Soap.
20. Liquid Toilet Soap.
21. Baby Toilet Soap.
22. Shaving Soap.
23. Transparent Toilet Soap.
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Part XV – Labelling, Packing and
Standards of Cosmetics
➢ R.148. Manner of labelling
➢ R.148A. Prohibition against altering inscriptions on containers,
labels or wrappers of cosmetics.
➢ R.148B – Prohibition against false or misleading claims
➢ R.149. Labelling of Hair dyes containing Dyes, Colours and
Pigments.
➢ R.149A. Special provisions relating to toothpaste containing
fluoride.
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➢ 148. Manner of labelling.–Subject to other provisions of the rules,
a cosmetic shall carry.–
➢ (1) on both the inner and outer labels;
➢ (a) the name of the cosmetic,
➢ (b) the name of the manufacturer and complete address of the
premises of the manufacturer where the cosmetic has been
manufactured.
➢ Provided that if the cosmetic is contained in a very small size
container 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.
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➢ (2) On the outer label.– A declaration of the net contents expressed
in terms of weight for solids, fluid measure for liquids, 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.
➢ (3) On the inner label, where a hazard exists–
➢ (a) adequate direction for safe use,
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➢ (b) any warning, caution or special direction required to be
observed by the consumer,
➢ (c) a statement of the names and quantities of the ingredients that
are hazardous or poisonous.
➢ (4) 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”
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➢ Provided that this clause shall not apply to any cosmetic containing
10 grams or less if the cosmetic is in solid or semi-solid state, and
25 millilitres or less if the cosmetic is in a liquid state:
➢ Provided further that in the case of soaps, instead of the batch
number, the month and year of manufacture of soap shall be given
on the label.
➢ (5) Manufacturing licence number, the number being preceded by
the letter ‘‘M’’.
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➢ (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) 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 60
ml of liquid and30 gm of solid and semi-solids.
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➢ (8) Labeling requirement, if any, specified in the relevant Indian
standard as laid down by the “Bureau of Indian Standards” for the
cosmetics covered under Schedule S.
➢ 148A. Prohibition against altering inscriptions on containers,
labels or wrappers of cosmetics.-
➢ 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
licensing authority.
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➢ 148B – 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.
➢ 149. 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 direction should first be made.
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➢ This product should not be used for dyeing the eye-lashes or eye-
brows; 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
quantity of the hair dye as prepared for use to the area and allow it to
dry.
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➢ 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 eye- brows or eye-lashes
as severe inflammation of the eye or even blindness may result.
➢ 149A. Special provisions relating to toothpaste containing
fluoride.-
➢ (i) Fluoride content in tooth paste 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.
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Part XIII – Import and Registration of
Cosmetics
➢ R.129. Registration of cosmetic products imported into the country.
➢ R.129A. Form and manner of application for Registration
Certificate.
➢ R.129B. Registration Certificate for the import of cosmetics
manufactured by one manufacturer.
➢ R.129C. Grant of Registration Certificate.
➢ R.129D. Duration of Registration Certificate.
➢ R.129E. Suspension and Cancellation of Registration Certificate
➢ R.129F. Prohibition of import of certain cosmetic.
➢ R.129G. Standard for imported cosmetics.
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➢ R.129H. Labeling and Packing of Cosmetics
➢ R. 131. Procedure for the import of cosmetics.
➢ R.132. Exemption of cosmetics
➢ R.133. Import through points of entry
➢ R.134. Cosmetic to contain Dyes, Colours and Pigments
➢ R.134-A Prohibition of import of cosmetic containing
Hexachlorophene.
➢ R.135. Import of cosmetic containing Lead or Arsenic compound
prohibited.
➢ 135-A. Import of cosmetics containing mercury compounds
prohibited.
➢ 135-B. Prohibition of import of cosmetics tested on animals.
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➢ 129. Registration of cosmetic products imported into the
country.- 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.
➢ 129A. Form and manner of application for Registration
Certificate.- (1) An application for issue of a Registration
Certificate for cosmetics intended to be imported into India shall be
made in Form 42 either by the manufacturer himself or by his
authorized agent or importer in India or by the subsidiary in India
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authorized by the manufacturer and shall be accompanied by a fee
of 250 US dollars or its equivalent to Indian rupees for each brand
of cosmetic.
➢ The application shall be accompanied by a treasury challan as
specified in sub-rule (3) along with the information and undertaking
as specified in Schedule D (III) duly signed by or on behalf of the
manufacturer or by his authorized agent or importer in India or by
the subsidiary in India authorized by the manufacturer.
➢ (2) 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 such an equivalent authority.
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Who can apply for Registration of Import
of Cosmetics / who can be an importer:
➢ The Manufacturer himself having registered office in India.
➢ The Authorized Agent of the Manufacturer
➢ The Subsidiary of the Manufacturer
➢ Any other importer
➢ A “Manufacturer” means a person or entity in a Country other than
India who owns the trade name of the brand of the cosmetic product
for which registration has been applied for and who / which
manufactures such product at his / its own manufacturing site or at a
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➢ site owned by another manufacturer in the trade name of his / its
brand.
➢ An “Authorized Agent” means a person or entity in India authorized
by the manufacturer. The authorized agent will be responsible for
the business activities of the manufacturer in India including
compliance to the provisions of the Act in all respects.
➢ Subsidiary” means an entity in India owned by the manufacturer.
➢ “Any other importer” means any person or entity purporting to
import cosmetic products other than the manufacturer, its authorized
agent and its subsidiary.
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➢ A “Brand” will not mean the trade name of any product of a
manufacturer or the manufacturer himself / itself.
➢ A “Brand” for the purpose of these rules will mean each category of
cosmetic products
➢ Ex: Face care products other than face mask ,Eye contour products,
Lip care products, Hand care products, Foot care products, Body
care products, Soap products, Bath / shower products, Make-up
remover products, Shaving products etc..
➢ A “Brand” will include all variants of a product e.g. colour, shades,
pack sizes, etc.
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➢ 129B. Registration Certificate for the import of cosmetics
manufactured by one manufacturer.-
➢ A single application may be made and a single Registration Certificate
in Form 43 may be issued in respect of import of one or more than
one cosmetics manufactured by the same manufacturer: Provided that
the cosmetics are manufactured at one factory or more than one
factory functioning conjointly as a single manufacturing unit.
➢ 129C. Grant of Registration Certificate.-
➢ (1) On receipt of an application for Registration Certificate in the
form and manner specified in rule 129A, the licensing authority shall,
if satisfied, issue a Registration Certificate in form 43 subject to the
conditions of the registration certificates in form 43:
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➢ Provided that if the application is complete in all respects and
information specified in Schedule D III is in order,
Schedule D (III) -Information and undertaking required to be
submitted by the manufacturer or his authorized
importer/distributor/agent with the application form for a
Registration Certificate.
1.Particulars of the manufacturer and manufacturing
premises.-
➢ (a) Name and address of the manufacturer and manufacturing
premises to be registered along with telephone numbers, Fax
numbers and e-mail address.
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➢ (b) Name(s) and address of the Partners/Directors.
➢ (c) Name and address of the authorized importer/distributor/agent in
India, responsible for the business of the manufacturer.
➢ (d) A brief profile of the manufacturer ‘s business activity, in domestic
as well as global market.
2. Particulars of the Cosmetics to be Registered under
Registration Certificate.-
(a) Names of cosmetics along with their brands name, category,
pack sizes and variants to be registered and meant for import into
and use in India.
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➢ (b) Particulars of the manufacturing licenses/registration/marketing
authorizations (if any) under which the cosmetics are being
manufactured in the country of origin along with the copy of the
licenses/ marketing authorization/registration issued by the
Regulatory Authority of that country.
➢ (c) List of countries where marketing authorization or import
permission for the said cosmetic has been granted.
3. Chemical Information of Cosmetics.-
➢ (a) Name(s) of ingredients in the nomenclature of standard
references, along with percentages contained in the cosmetic.
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➢ (b) Specification and testing method for testing of the cosmetic(s).
➢ (c) Manner of labelling as per Drugs and Cosmetics Rules, 1945.
➢ (d) Package insert (if any).
4. Undertaking to declare that.-
➢ (a) We shall comply with all the conditions imposed on the
Registration Certificate for the import of cosmetics as required
under the provisions of Drugs and Cosmetics rules, 1945.
(b) We declare that we are carrying on the manufacture of the
cosmetics mentioned in this Schedule, at the premises specified
above, and we shall from time to time report any change of
premises on which manufacture will be carried on and in cases
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➢ where manufacture is carried on in more than one factory any
change in the distribution of functions between the factories.
➢ (c) We shall comply with the provisions of Part XIII of the Drugs
and Cosmetics Rules, 1945.
➢ (d) Every cosmetic manufactured by us for import under the
Registration Certificate into India shall conform to the
specifications given in the Drugs & Cosmetics Rules, 1945 as
amended from time to time.
➢ (e) We shall inform to the licensing authority, within 30 days in the
event of any change in variants or in category or in manufacturing
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location or in labelling or in documentation of any of the cosmetic
pertaining to the certificate to be granted to us.
We shall from time to time report for any administrative action
taken due to adverse reaction, viz. market withdrawals/regulatory
restriction, or cancellation of authorization and/or ―not of standard
quality report of any cosmetic pertaining to the Registration
Certificate declared by any Regulatory Authority of any country
where the cosmetic is marketed/sold or distributed. The dispatch
and marketing of the cosmetic in such cases, shall be stopped and
the licensing authority shall be informed immediately.
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➢ (g) We shall comply with such further requirements, if any, as may
be specified, by the Government of India, under the Act and the
Rules, made there under.
➢ (h) We shall allow the licensing authority or any person authorized
by him in that behalf to take samples of the cosmetics for testing if
considered necessary by the licensing authority.
➢ 129D. Duration of Registration Certificate.-
➢ A Registration Certificate, unless it is sooner suspended or
cancelled, shall be valid for a period of three years from the date of
its issue: Provided that if application for a fresh Registration
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Certificate is made within six months before the expiry of the said
certificate, the existing Registration Certificate shall be deemed to
continue to remain in force until orders are passed on the
application.
➢ 129E. Suspension and Cancellation of Registration Certificate.-
➢ If the manufacturer fails to comply with any of the conditions of
the Registration Certificate, the licensing authority may after giving
him an opportunity to show cause why such an order should not be
passed, by an order in writing, stating the reasons therefor, 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:
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➢ Provided that a person who is aggrieved by the order passed by the
licensing authority under this rule may, within thirty days of the
receipt of the order, appeal to the Central Government and the
Central Government may after such enquiry into the matter as it
considers necessary and after giving the said appellant an
opportunity of being heard pass orders as it thinks fit.
➢ 129F. Prohibition of Import of certain Cosmetic.-
➢ No cosmetic, the manufacture, sale or distribution of which is
prohibited in the county of origin, shall be imported under the same
name or under any other name except for the purpose of
examination, test or analysis.
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➢ 129G. Standard for Imported Cosmetics.-
➢ No cosmetic shall be imported unless it complies with the
specifications prescribed under Schedule S and Schedule Q 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 Schedule S, it shall meet with specifications under the rules
and standards applicable to it in the country of origin.
➢ 129H. Labeling and Packing of Cosmetics.-
➢ No cosmetic shall be imported unless it is packed and labeled in
conformity with the rules in Parts XV. Further 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.
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131. Procedure for the import of cosmetics.
➢ (1) If the officer appointed at the post 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. If on examination of the
sample defects are noticed the officer shall advise the Collector of
Customs for further action to be taken.
➢ 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. The consignment of the said cosmetic shall be detained till such
time that the test report on such sample is received from the Director of
the said laboratory or any other officer of the laboratory empowered by
him in this behalf with the approval of the Central Government:
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132. Exemption of cosmetics
➢ Cosmetics as may be specified in Schedule D shall be exempted from
the provisions of Chapter III of the Act and the Rules made thereunder
to the extent and subject to the conditions specified in that Schedule.
133. Import through points of entry
➢ No cosmetic shall be imported into India except through the points of
entry specified in rule 43A.
➢ In respect of drugs imported by rail across the frontier with Pakistan. –
Freozepore Cantonment and Amritsar Railway Stations
➢ In respect of drugs imported by rail across the frontier with Bangladesh
– Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna
Bazar and Agartala in Tripura :
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134. Cosmetic to contain Dyes, Colours and Pigments.-
➢ No Cosmetic shall contain Dyes, Colours and Pigments other than
those specified by the Bureau of Indian Standards (IS:4707 Part 1 as
amended) and Schedule Q.
➢ 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 calculated as arsenic trioxide.
➢ (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.
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134-A Prohibition of import of cosmetic containing
Hexachlorophene.
➢ No cosmetic containing hexachlorophene shall be imported.
135. Import of cosmetic containing Lead or Arsenic compound
prohibited.
➢ No cosmetic shall be imported in which a Lead or Arsenic
compound has been used for purposes of colouring.
135-A. Import of cosmetics containing mercury compounds
prohibited.
➢ No cosmetic shall be imported which contains mercury compounds.
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135-B. Prohibition of import of cosmetics tested on animals.
➢ No cosmetic that has been tested on animals after the commencement
of the Drugs and Cosmetics (Fifth Amendment) Rules, 2014 shall be
imported into the country.
136. 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 bona fide use of the passenger; and
➢ (ii) The cosmetics shall be declared to the Customs authorities, if they
so direct.
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The documents are required to be
submitted for grant of registration
certificate:
➢ Covering letter by the applicant
➢ Form 42
➢ Treasury Challan
➢ Power of Attorney
➢ Schedule D III
➢ Original or a copy of the Label.
➢ Free Sale Certificate (FSC)/Marketing Authorization
letter/Manufacturing License, if any
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➢ Product specification and testing protocol.
➢ List of countries where Market Authorization or import permission
or registration was granted.
➢ Pack insert, if any
➢ Soft copies of the information about the brands, products and
manufacturer
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Conditions of the Registration Certificate.
➢ The Registration Certificate shall be produced by the authorized
importer/distributor/agent as and when required by the licensing
authority/regulatory authority.
➢ The manufacturer or his authorized importer/distributor/agent in
India shall inform the licensing authority forthwith in the event of
any administrative action taken namely, market withdrawal,
regulatory restrictions, or cancellation of authorization, and/or not
of standard quality report of any cosmetic pertaining to this
Registration Certificate declared by the Regulatory Authority of the
country of origin or by any Regulatory Authority of any other
country, where the cosmetic is marketed/sold or distributed.
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➢ The dispatch and marketing of the cosmetic in such cases shall be
stopped immediately, and the licensing authority shall be informed
immediately. Further action in respect of such stopped marketing of
drug shall be followed as per the direction of the licensing authority.
In such cases, action equivalent to that taken with reference to the
concerned cosmetic in the country of origin or in the country of
marketing shall be followed in India also, in consultation with the
licensing authority. The licensing authority may, however, direct
any further modification to this course of action, including the
withdrawal of the cosmetic from Indian market within 48 hours
time period.
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➢ The manufacturer or his authorized agent/importer/distributor or
subsidiary in India shall inform the licensing authority within 30
days in writing in the event of additional variants/additional
cosmetic category/additional manufacturing location or any change
in labeling or in testing, or in documentation of any of the cosmetic
pertaining to this Registration Certificate.
➢ In such cases, where there shall be additional variants/additional
cosmetic category/additional manufacturing location, as the case
may be, at the discretion of the licensing authority, the manufacturer
or his authorized agent/importer/distributor/subsidary in India shall
apply for necessary approval within 30 days by submitting a
separate application along with the registration fee.
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➢ The manufacturer or his authorized agent in India shall inform the
licensing authority immediately in writing in the event of any
change in the constitution of the firm and / or address of the
registered office / factory premises operating under this Registration
Certificate. Where any such change in the constitution of the firm
and/or address takes place, the current Registration Certificate shall
be deemed to be valid for a maximum period of three months from
the date on which the change has taken place unless, in the
meantime, a fresh Registration Certificate has been taken from the
licensing authority in the name of the firm with the changed
constitution of the firm and/or changed address of the registered
office or factory premises.
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Chapter III -Import of Drugs and
Cosmetics
➢ S.9C. Misbranded cosmetics.
➢ S.9D. Spurious cosmetics.
➢ S.10. Prohibition of import of certain drugs or cosmetics.
➢ S.10A. Power of Central Government to prohibit import of drugs
and cosmetics in public interest.
➢ S.11. Application of law relating to sea customs and powers of
Customs Officers
➢ S.12. Power of Central Government to make rules
➢ S.13. Offences
➢ S.14. Confiscation
➢ S.15. Jurisdiction
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S.10. Prohibition of Import of certain
Drugs or Cosmetics
➢ No person shall import—
➢ (a) any drug or cosmetic which is not of standard quality;
➢ (b) any misbranded drug or misbranded or spurious cosmetic;
➢ (bb) any adulterated or spurious drug;
➢ (c) any drug or cosmetic for the import of which a licence is
prescribed, otherwise than under, and in accordance with, such
licence;
➢ (ee) any cosmetic containing any ingredient which may render it
unsafe or harmful for use under the directions indicated or
recommended;
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S.10A. Power of Central Government to
Prohibit Import of Drugs and Cosmetics
in Public Interest
➢ Without prejudice to any other provision contained in this Chapter,
if the Central Government is satisfied that the use of any drug or
cosmetic is likely to involve any risk to human beings or animals or
that any drug does not have the therapeutic value claimed for it or
contains ingredients and in such quantity for which there is no
therapeutic justification and that in the public interest it is necessary
or expedient so to do then, that Government may, by notification in
the Official Gazette, prohibit the import of such drug or cosmetic.
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Offences Penalties
S.9D. Spurious cosmetics.—For the S.13. Offences.—(1) Whoever
purposes of this Chapter, a drug himself or by any other person
shall be deemed to be spurious,— on his behalf imports, —
(a) if it is imported under the name (a) any drug deemed to be
which belongs to another cosmetic; adulterated under section 9A or
or deemed to be a spurious drug
(b) if it is an imitation of, or is a under section 9B or any spurious
substitute for, another cosmetic or cosmetic referred to in section
resembles another cosmetic in a 9D or any cosmetic of the nature
manner likely to deceive or bears referred to in clause (ee) of
upon it or upon its label or container section 10 shall be punishable
the name of another cosmetic,
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Offences Penalties
unless it is plainly or conspicuously with imprisonment for a term which
marked so as to reveal its true may extend to three years and a fine
character and its lack of identity which may extend to five thousand
with such other cosmetic; or rupees;
(c) if the label or the container bears
the name of an individual or
company purporting to be the
manufacturer of the cosmetic, which
individual or company is fictitious
or does not exist; or
(d) if it purports to be the product of
a manufacturer of whom it is not
truly a product.
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Offences Penalties
S.9C. Misbranded cosmetics.— S.13. Offences.—(1) Whoever
For the purposes of this chapter, himself or by any other person
a cosmetic shall be deemed to be on his behalf imports, —
misbranded— (b) any drug or cosmetic other
(a) if it contains a colour which is than a drug or cosmetic referred to
not prescribed; or in clause (a), the import of which
(b) if it is not labelled in a is prohibited under section 10, or
prescribed manner; or any rule made under this Chapter,
(c) if the label or container or shall be punishable with
anything accompanying the imprisonment for a term which
cosmetic bears any statement may extend to six months, or with
which is false or misleading in fine which may extend to five
any particular. hundred rupees, or with both;
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Offences Penalties
S.10A. Power of Central S.13. Offences.—(1) Whoever
Government to prohibit import of himself or by any other person
drugs and cosmetics in public on his behalf imports, —
interest (c) any drug or cosmetic in
contravention of the provisions of
any notification issued under
section 10A, shall be punishable
with imprisonment for a term
which may extend to three years,
or with fine which may extend to
five thousand rupees, or with both;
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Offences Penalties
(2)Whoever having been (a) under clause (a) or clause (c) of sub-
convicted of an offence— section (1), is again convicted of an
offence under that clause, shall be
punishable with imprisonment for a term
which may extend to five years, or with
fine which may extend to ten thousand
rupees, or with both;
(b) under clause (b) of sub-section (1), is
again convicted of an offence under that
clause, shall be punishable with
imprisonment for a term which may
extend to one year, or with fine which
may extendwwtow.DoulonMeix.ctohmousand rupees, or62
Offences Penalties
S.11. Application of law relating to (3) The punishment provided by
sea customs and powers of this section shall be in addition to
Customs Officers. any penalty to which the offender
may be liable under the provisions
of section 11.
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References
❖ Drugs and Cosmetics Act 1940 & Rules 1945 published by Ministry
of Health and Family Welfare, Government of India
❖ www.cdsco.nic.in
❖ www.google.co.in
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THANK YOU
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