A brief description about adulteration and misbranding of Pharmaceutical and other substance with punishments and fines according to FDA

1. ADULTERATION &
MISBRANDING

2. CONTENTS

ADULTERATION OF DRUGS
i.
Definition
ii.
Conditions for adulterine drugs
iii.
Types of adulterants
iv.
Acts regulating adulteration

MISBRANDING
i.
Definition
ii.
Acts

Incidents

penalties

3. ADULTERATION OF
DRUGS

Definition : Adulteration is the practice of
substituting the original crude drug either
partially or wholly with other similar looking
substances but the adulterated drug is free of or
inferior to the parent drug in chemical and
therapeutic properties

4. ADULTERATION OF
DRUGS

Adulteration involves different conditions:

Deterioration – It results in impairment in quality of drugs.

Admixture – Addition of one article to the other due to
ignorance, carelessness or accidentally.

Sophistication – It is done intentionally or deliberately.

Substitution – In this a completely different substance is
added in place of original drug.

Inferiority – A substituted drug is added.

Spoilage- Micro organisms attack the drug product

5. ADULTERATION OF
DRUGS

Types of adulterants:
1.
Substitution with substandard commercial
varieties(.Examples: Capsicum minimum replaced
by Capsicum annuum. Indian sennareplaced by Arabian
senna or Dog senna.)
2.
Substitution with superficially similar inferior
drugs(Examples: Bees wax is adulterated with Japan wax.
Mother cloves and clove stalks are mixed with
cloves.Saffron is adulterated with flowers of Carthamus
tinctorius.)
3.
Substitution with artificially manufactured substance.
(Examples: Compressed chicory is used instead of coffee.
Paraffin wax is made yellow and used instead of Bees wax.)

6. ADULTERATION OF
DRUGS
4.
Substitution with exhausted drug: (Examples:
Exhausted Gentian is made bitter with Aloes.
Exhausted Saffron is artificially coloured)
5.
Use of synthetic chemicals to enhance natural
character(Examples: citral is added to citrus oils like
lemon and orange oils.)
6.
Presence of vegetative matter of same plant.
(Examples: Moss, liverworts, epiphytes growing on bark
portion is mixed with Cascara and Cinchona . Stem
portions are mixed with leaf drugs like
Stramonium, Lobelia and Senna.)

7. ADULTERATION OF
DRUGS
7.
Harmful adulterants(Examples: Pieces of amber
coloured glass is added to Colophony Limestones
in Asafoetida. white oil in coconut oil.rodent
faecal matter to cardamom seeds, which is
harmful.)
8.
Adulteration of powders(. Examples: dextrin is
added in ipecacuanha, exhausted ginger
in ginger, red sanders wood in capsicum powder
and powdered bark adultered with brick
powder.)

8. ACTS REGULATING
ADULTERATION

Federal food , drug & cosmetic act- early 1800’s

Pure food and drug act-1906

FFDCA-1938

Section 501 (a)(2)(B) Specifically declares that a drug is
adultered unless it is manufactured in accordance with Cgmp

Section 301 FDA-adulteration and misbranding of drugs in
interstate commerse

FDA-controls

-procedure and production results in proper identity , strength ,
quality and purity of drug

-identity deficiency

-ensure correction of deficiencies , sees for sub potency ,
particulates , lack of content uniformity , dissolution failures.

9. MISBRANDING

Section 502 of the FFDCA contains provisions on misbranding
and false or misleading labelling. A drug is misbranded if:

Its labelling is false or misleading in any particular:

It is in package form and its label fails to contain the name and
place of business of the manufacturer, packer, or distributor;
and an accurate statement of the quantity of the contents in
terms of weight, measure, or numerical count.

Its label does not bear adequate directions for use; including
warnings against use in certain pathological conditions; or by
children where its use may be dangerous in health; or against
unsafe dosage, or methods, or duration of administration or
application;

It is dangerous to health when used in the dosage or manner or
with the frequency or duration prescribed, recommended or
suggested in the labelling; or

It does not comply with the colour additives provisions listed
under Section 706 of the Act.

10. 
If the device's established name (if it has one) its name in an official
compendium, or any common or usual name is not prominently printed in type
at least half as large as that used for any proprietary name

If the establishment is not registered with FDA as per Section 510, has not
device listed as per section 510(j), or obtained applicable premarket
notification clearance as per Section 510(k)

If the device is subject to a performance standard and it does not bear the
labeling prescribed in that standard

If there is a failure or refusal to comply with any requirement prescribed under
the FFDCA, Section 518 on notification and other remedies, or failure to furnish
any materials or information requested by or under Section 519 on reports and
records or under Section 522; or

If there is any representation that created an impression of official approval
because of the possession by the firm of an FDA registration number.

11. TYPES OF MISBRANDING

False or Misleading labelling(sec.502(a))

Habit forming drugs(502)

Established names of drugs(502(e))

Adequate directions for use(502(f))

Imitation drugs(502(i)(2))

Batch certification(502)

12. LOOK ALIKE DRUGS(LOOK-ALIKE
BRAND NAMES, DIFFERENT, GENERIC NAMES,
DIFFERENT MANUFACTURER
(CATEGORY I))
Brand name
Generic name
manufacturer
Tibitol
Etambutol
PCI
tobitil
tonixicam
Ranbaxy
PRONIM
Nimesulide
Unichem lab ltd
PRONIL
flouxeetine
PIL pharmacia india
ltd.
celib
Celecoxib
Unichem lab ltd.
celin
Vitamine C
Glaxo smithkline

13. LOOK-ALIKE BRAND NAMES, DIFFERENT, GENERIC
NAMES, DIFFERENT MANUFACTURER
(CATEGORY II
Brand names
Generic names
Manufaturer
PD-Mox
Amoxicilline
Parenteral
PD-Mox
Roxithromycine
Parenteral
Colmine
Clomipramine
PIL
Clozine
Clomipramine
PIL
Bioclox
Clarithromycine
Biochem
biodoxi
Doxycylline
Biochem
)

14. IDENTICAL BRAND NAMES, ONE WITH AN
ADDITIONAL LETTER, SAME GENERIC NAME IN
DIFFERENT COMBINATION, SAME MANUFACTURER
(CATEGORY III)
Brand name
Generic name
Manufacture
Acnesol
Erythromycine
Systopiclab ltd
Acnesol-T
erythromycine+treti Systopic lab ltd
noin
Novolid
Nimesulide
Novolid-s
Nimesulide+serratio Brown and bruk
peptidase
pharm ltd
Aamin
Amlodipine
Aamin-A
Amlodipine+atenolo Targof pure drug ltd
l
Vrown and vurk
pharm ltd
Targof pure drugs
ltd

15. IDENTICAL BRAND NAMES, SAME GENERIC NAME,
DIFFERENT MANUFACTURERS, DIFFERENT
DOSAGE FORMS (CATEGORY IV)
Brand names
Generic names
Manufaturer
Oflorin(tablet)
Ofloxacin
Indoco Remedies
Ltd.
Ofllorin(eye drops)
Ofloxacin
Warren Pharma Pvt.
Ltd.

16. INCIDENTS

Contaminated heparin from china 2007-2008,149 deaths

In panama,2006,many more disabled after receiving cough
syrup prepared with incorporation of diethylene glycol
masquerading as the proper and more costly excipient
glycerin

In 2008, significant portions of China's milk supply were found
to have been contaminated with melamine. Infant
formula produced from melamine-tainted milk killed at least
six children and were believed to have harmed thousands of
others

In 2012, a study in India conducted by the Food Safety
Standards Authority of India (FSSAI) across 33 states found
that milk in India is adulterated with detergent, fat and
evenurea, as well diluted with water.

17. INCIDENTS

In gujarat state-total brands=19367
misbranded drugs=367
S.A.L.A brands=3847

In maharastra state-total brands=18630
Misbranded drugs=201
S.A.L.A brands=2582

18. PENALTIES

Any person who violates a provision of section
301(prohibition act) shall be imprisoned for not more
than one year or fined not more than $1,000, or both.

if any person commits such a violation after a conviction
of him under this section has become final, or commits
such a violation with the intent to defraud or mislead,
such person shall be imprisoned for not more than three
years or fined not more than $10,000 or both.

knowingly distributing drugs in violation of section 503(e)
(2)(A),shall be imprisoned for not more than 10 years or
fined not more than $250,000, or both.

19. PENALTIES

Violation of SEC. 301(t)be subject to the following civil
penalties:

(A) A civil penalty of not more than $50,000 for each of
the first two such violations resulting in a conviction of
any representative of the manufacturer or distributor in
any 10-year period.

(B) A civil penalty of not more than $1,000,000 for each
violation resulting in a conviction of any representative
after the second conviction in any 10-year period

If a person provides information leading to the institution
of a criminal proceeding against, and conviction of, a
person for a violation of section 301(t) ), such person
shall be entitled to one-half of the criminal fine imposed
and collected for such violation but not more than
$125,000

20. CONCLUSION

Detecting adulteration and misbranding is
important to avoid damage to the consumers like
loss of healthy life

In some cases death May occur hence it is a
important study to control those activities.

21. REFERENCE

WWW.GOOGLE.COM

FDA OFFICIAL SITE

Government of india (ministry of health of health
and family welfare) drugs and cosmetic act 1940

22. THANK YOU