Chapter 3
Chapter 3
Chapter 3
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
Spurious Cosmetics
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]
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.
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.
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
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.
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]
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,
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.
Validity of license
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.
Manner of labelling
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:
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
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
1940 (23 OF 1940) THE DRUGS AND COSMETICS RULES, 1945 LIST OF
ABBREVIATIONS USED [2021][b])
REFERENCES
[1] Cosmetic-Regulations, Research & Marketing challenges and global compliance: An overview
n.d. https://doi.org/10.31219/osf.io/d8tzu.
[2] CENTRAL DRUGS STANDARD CONTROL ORGANIZATION Guidance Document Guidance document
on Common Submission Format for Import Registration of Cosmetics in India. n.d.
[3] Drugs and Cosmetics Act, 1940 | Bare Acts | Law Library | AdvocateKhoj n.d.
https://www.advocatekhoj.com/library/bareacts/drugsandcosmetics/9.php?Title=Drugs%20and
%20Cosmetics%20Act,%201940 (accessed August 28, 2022).
[4] the Drugs and Cosmetics Act, 1940 n.d. https://indiankanoon.org/doc/1891720/ (accessed
August 28, 2022).
[5] The Drugs and Cosmetics Rules, 1945]. 2013.
[6] CDSCO- SUGAM n.d. https://www.slideshare.net/BiNduXtrEiy/cdsco-sugam (accessed August 28,
2022).
[7] Cosmetic Registration and Approval (Form 42, 43) -CliniExperts n.d.
https://cliniexperts.com/india-regulatory-services/cosmetic/for-importer/cosmetic-registration-
and-approval-form-42-43/ (accessed August 28, 2022).
[8] Singh BM, Jain A, Mishra A. Cosmetic Regulations in India vs. Globally and Challenges in
Harmonization. International Journal of Pharmaceutical Sciences and Drug Research 2018;10.
https://doi.org/10.25004/ijpsdr.2018.100308.
[9] Drugs-and-Cosmetics-2 n.d.
[10] Procedure - Drugs & Cosmetic License Application in India | Lawrbit n.d.
https://www.lawrbit.com/article/procedure-for-applying-drugs-and-cosmetic-license-in-india/
(accessed August 28, 2022).
[11] All India Drugs Control Officers ... vs The Government Of India n.d.
https://indiankanoon.org/doc/191958036/ (accessed August 28, 2022).
[12] Drugs And Cosmetics Act, 1940 n.d. http://www.bareactslive.com/ACA/ACT119.HTM (accessed
August 28, 2022).
[13] Directorate General Of Health Services n.d.
https://dghs.gov.in/content/289_3_CentralDrugsLab.aspx (accessed August 28, 2022).
[14] Fda. FOOD AND DRUG ADMINISTRATION PROGRAM 7329.001 COMPLIANCE PROGRAM
GUIDANCE MANUAL. n.d.
[15] Guidelines on Registration of Import of Cosmetics | Ministry of Health and Family Welfare | GOI
n.d. https://main.mohfw.gov.in/fooddrugs/guidelines-registration-import-cosmetics (accessed
August 28, 2022).
[16] Procedure to Import Cosmetic Products in India | E-StartupIndia n.d. https://www.e-
startupindia.com/learn/procedure-to-import-cosmetic-products-in-india/ (accessed August 28,
2022).
[17] Registration Procedure for Import of Cosmetic Products n.d.
https://aurigaresearch.com/registration-procedure-for-the-import-of-cosmetic-products-in-
india/ (accessed August 28, 2022).