The different regulatory provision used in the Cosmetics products.

1. REGULATORY PROVISIONS
RELATING TO IMPORT OF COSMETICS
SUBMITTED BY: RAHUL PAL, PRACHI PANDEY SUBMITTED TO: DR. HIMMAT SINGH
CHAWRA
M. PHARM (PHARMACEUTICS), II SEM.
DEPARTMENT OF PHARMACEUTICS, NIMS INSTITUTE OF PHARMACY, NIMS UNIVERSITY, JAIPUR RAJASTHAN.

2. COSMETICS DEFINITION
Drug and Cosmetics Act, 1940, defined “cosmetics” as-
“Any article intended to be rubbed, poured sprinkled or sprayed on or intended into or
applied to any part of the human body for cleansing, beautifying, promoting attractiveness
& altering appearance, and includes any article intended for use as a components of
cosmetics”.
- Generally, cosmetics consisting misbranded, spurious & adulterated cosmetics products.

3. MISBRANDED COSMETICS
 Under Section: 9C & 17C
Contains colour which is not prescribed.
Not labelled in prescribed manner.
Label or container accompanying cosmetic bears an statement which is false or
misleading.

4. SPURIOUS COSMETICS
 Section- 9D & 17D.
Manufacturing under a name which belong to another cosmetics.
Imitation of or substitute (copy).
Label or containers bears name of individual or company purporting to be mfg. of
cosmetics which is fictitious or doesn’t exist.

5. ADULTARATED COSMETICS
 Section- 17E
If it consisting in whole or in part, of any filthy, putrid r decomposed substance.

6. REFULATORY PROVISIONS RELATING TO
MANUFACTURING THE COSMETICS
 A license is required under the Drug and Cosmetic Rules for the manufacture of
cosmetics for sale/distribution. This licence is issued by state regulatory authorities.

7. HOW TO OBTAIN LICENSE
 An application should be accompanied with the following documents (Form No 31)
 It require layout plan of the factory premise.
 A list of equipments and machinery installed.
 A documents about the constitution of the firm.
 The factory premises are inspected by the officers of the state regulatory agency.

8. IMPORT PROCEDURE IN COSMETICS

9. DOCUMENTS REQUIRED FOR IMPORTING

10. THE OFFICER FIND OUT WHETHER
 The applicant has provided adequate space for the manufacturing operations, quality
control & storage of the raw material, packaging material and finished products.
 The applicant has provided adequate equipment and machinery for the
manufactures of the cosmetics which the intended to manufacture.
 The applicant has provided adequate testing facilities for the raw material and after
finished form of the cosmetics.

11. IMPORT OF COSMETICS
Require compulsory registration certificate for importing from DCGI (CDSCO).
Registration procedure: Application of registration on Form- 42 along with requisite
documents submitted to DCGI, CDSCO, FDA office in NEW DELHI.
List of documents:
 Particular or the manufacturer & manufacturing premises.
 Proof of payment of the requested registration, FEES- USD 250.
 Particular of the cosmetics to be registered.

12. IMPORTING OF COSMETICS
 Time line for processing of application: Issuance of registration certificate, with in
the 6 Months from date of submission of application and the required documents.
 Registration certificate validity: 3 Years from date of its issuance.

13. REFERENCE
 https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
 Abdullah B, Hamdard J. A comparative study of cosmetic regulations in different countries of the world
with focus on India. Int J Curr Res Rev 2012;4:130-43.
 Central Drugs Standard Control Organisation. Guidance Document on Common Submission Format
for Import Registration of Cosmetics in India. New Delhi: Central Drugs Standard Control
Organisation; 2007