drug and cosmetic act- misbranded and spurious drug

1. Misbranded and
Spurious Cosmetics
Foram Machhar
Mpharm Sem II
Department of Pharmaceutics
Roll no. 05

2. Misbranded Cosmetics
Misbranded cosmetics.- According to the Drug and Cosmetic Act,
1940,
a cosmetic shall be deemed to be misbranded—
(a) if it contains a colour which is not prescribed; or
(b) if it is not labelled in a prescribed manner; or
(c) if the label or container or anything accompanying the
cosmetic bears any statement which is false or misleading in any
particular.

3. Example:
• A bottle claimed to contain 50 grams of drug but was actually
almost less than half than its declared content.
• Here the label on the sample bottles was false or misleading in
particulars regarding net contents and that the statement made
is false and misleading.

4. • Accused wanted to represent to the public that it was a drug
manufactured by the firm at one place. Infact it was
manufactured in another.
• Thus this is a product of one town, being described as the
product of another town, it amounts to a misbrand within the
meaning of section17(h)
• Listing “mica” by itself as an ingredient when cosmetic micas
are used to color the product. (soap making)

5. Spurious cosmetics
Spurious cosmetics.—a cosmetic shall be deemed to be
spurious,—
(a) if it is imported under the name which belongs to another
cosmetic; or
(b) 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 or conspicuously marked so as to
reveal its true character and its lack of identity with such other
cosmetic; or

6. (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.

7. Examples of spurious goods.
They spell alike and look alike.
• Luk for Lux
• Saveena for Sabeena
• Sun max for Super master

8. Incident
• Rs 2.5 crore worth spurious cosmetics seized by FDA
(mumbai).
• Famous brands such as LOreal, Lakme, Nivea, Elle 18 etc, were
manufactured
• The products include Lakme Radiance Compact, LOreal Paris
Banana Treatment Pack, Baby Lips Color (Lip Balm).

9. Offences and penalties related to
import of such cosmetics
Offence Penalty
First Conviction Subsequent Conviction
Import of adulterated
or spurious or
misbranded cosmetics
or drugs containing
any ingredient which
may render it unsafe
or harmful for use
under the directions
recommended.
Imprisonment upto 3
years and fine upto Rs
5,000
Imprisonment upto 5
years OR
Fine upto Rs 10,000
OR
Both

10. Offences and penalties related to
import of such cosmetics
Offence Penalty
First Conviction Subsequent Conviction
Import of any drug or
cosmetic other than
referred above the
import which is
prohibited
Imprisonment upto 6
months
OR
fine upto Rs 500
OR
Both
Imprisonment upto 1
year
OR
Fine upto Rs 1000
OR
Both
Import of any drug or
cosmetic in
contravention of any
notification issued
under section 10A
Imprisonment upto 3 years or fine upto Rs
5,000 OR
Both.

11. Offencesrelatedtomanufactureandsalesofcosmetics
Offence Penalty
First conviction Second conviction
1. Manufacture for sales,
distribution, stocking
a. Spurious cosmetic Imprisonment upto 3 years and fine
b. Any other cosmetic in
contravention of this
chapter or rules
thereunder
Imprisonment upto 1 year or fine upto Rs 1000 or
both
2. Non disclosure of
name of a manufacturer
or place where
manufactured cosmetics
are kept
Imprisonment upto 1 year or fine upto Rs 1000 or
both
3. Not keeping records of
manufacture and sale of
cosmetics in specified
manner
Imprisonment upto 3 years and fine upto Rs 5000

12. References:
• A text book of forensic pharmacy by NK Jain, published by
vallabh prakashan, 6th edition, Chapter 5, page no.54-63
• http://www.cdsco.nic.in/writereaddata/Drugs&CosmeticAct.p
df
• https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsReg
ulations/ucm074248.html
• https://openjurist.org/title-21/us-code/section-
362/misbranded-cosmetics
• https://www.indiatoday.in/pti-feed/story/rs-2.5-crore-worth-
spurious-cosmetics-seized-by-fda-855894-2017-01-12
• https://www.modernsoapmaking.com/the-labeling-mistakes-
i-always-made-are-you-making-them-too/

13. Thank you