SUBMITTED BY-
VIDHI SHARMA
M.PHARM (PHARMACEUCTIS)1ST
YEAR
SUBMITTED TO-
DR.HIMMAT SINGH CHAWDA SIR


LOAN LISCENCE
OFFENCES &
PENALTIES


 The Government of India through the Drug and Cosmetic
act 1940 and rules 1945 has made stringent provisions
regarding import, Manufacturing, Sale and Distribution of
Cosmetics.
 These provisions mainly cover the licensing for the
import, manufacturing of cosmetics and also the GMPs
for the manufacturing of cosmetics.
 These guidelines have also listed the 28 cosmetics whose
import is allowed only on to the conformance to the
Indian standards.


 These guidelines have also covered the offences and penalties in case of
contravention of the provisions of the Drug and Cosmetic Act 1940.
 Bureau of Indian standard sets the standard for cosmetic products
listed under the schedule S of the Drugs and Cosmetics Act 1945.
 The Government of India in Feb 2007, the Ministry of Health and
Family Welfare has bring amendment in Drug and Cosmetic Rule, 1945
according to which a cosmetic to be imported into the India has to be get
registered under Rule 129D by licensing authority appointed by Central
Government under Rule 21.


 Usually Drug controller General of India is the Licensing Authority. There
should be a single Application made for one or more cosmetic which are
manufactured by same manufacturer.
 The registration Certificate which is provided is valid for 3 years if it is
not cancelled.
 The application for the registration should be made either by manufacturer
or his agent or importer in India.


Application
form no 31A Fees 3500/- State regulatory
authority
• A person not having his own manufacturing facility can get cosmetic manufacture
form a license cosmetic manufacture under loan license system.
• Application for loan license is prescribed form no 31A along with the fees of
3500/- together with other documents should be submitted to the state regulatory
authority.


• A qualified person can make sure use of approved facility of
manufacturing provided by any other person obtain a loan license for
manufacturing of drugs other than C, C1 and X.


Here are some offences and penalties which are important aspect of regulatory
provision for cosmetic in India-
• For Spurious, adulterated cosmetic imprisonment up to 3 years and fine.
• For not keeping records for cosmetic properly imprisonment up to 3 years
and fine up to 5000/- for manufacture and wholesaler.


CONTRAVENTION IN
BRIEF
PENALTY
Import of spurious cosmetic or
cosmetic containing any ingredient
which harmful for use.
Imprisonment for term of 3 years which
may extends to 5 years with fine of five
thousand rupees.
Import of cosmetic whose import is
prohibited under section 10-A.
Imprisonment for term of 3 years which
may extends to 5 years with fine of five
thousand rupees.
Repeated offence of above two. Imprisonment for term of 5 years and
fine which may extend to 10 thousand
rupees


CONTRAVENTION IN
BRIEF
PENALTY
Sale/manufacture of cosmetic
which is not of standard or
misbranded cosmetic
Imprisonment for term of 3 years which
may extends to 5 years with fine of five
thousand rupees.


1. Sharma P.P, Cosmetic formulation manufacturing and quality
control, 3rd Edition, Nirali Prakashan: P.13-33.
2. Vediclifesciences.com/pdfs/New Regulations in Cosmetics.pdf.
3. en.wikipedia.org/wiki/Cosmetics.
4. URL:http://www.cdcsco.nic.in/writereaddata/G_S_R_%2069(E).pdf
.

