ADULTERATION OF DRUGS
Conditions for adulterine drugs
Types of adulterants
Acts regulating adulteration
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
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
Types of adulterants:
Substitution with substandard commercial
varieties(.Examples: Capsicum minimum replaced
by Capsicum annuum. Indian sennareplaced by Arabian
senna or Dog senna.)
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
Substitution with artificially manufactured substance.
(Examples: Compressed chicory is used instead of coffee.
Paraffin wax is made yellow and used instead of Bees wax.)
Substitution with exhausted drug: (Examples:
Exhausted Gentian is made bitter with Aloes.
Exhausted Saffron is artificially coloured)
Use of synthetic chemicals to enhance natural
character(Examples: citral is added to citrus oils like
lemon and orange oils.)
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.)
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
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
Federal food , drug & cosmetic act- early 1800’s
Pure food and drug act-1906
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
-procedure and production results in proper identity , strength ,
quality and purity of drug
-ensure correction of deficiencies , sees for sub potency ,
particulates , lack of content uniformity , dissolution failures.
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
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.
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.
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))
LOOK ALIKE DRUGS(LOOK-ALIKE
BRAND NAMES, DIFFERENT, GENERIC NAMES,
Unichem lab ltd
PIL pharmacia india
Unichem lab ltd.
IDENTICAL BRAND NAMES, ONE WITH AN
ADDITIONAL LETTER, SAME GENERIC NAME IN
DIFFERENT COMBINATION, SAME MANUFACTURER
erythromycine+treti Systopic lab ltd
Nimesulide+serratio Brown and bruk
Amlodipine+atenolo Targof pure drug ltd
Vrown and vurk
Targof pure drugs
IDENTICAL BRAND NAMES, SAME GENERIC NAME,
DIFFERENT MANUFACTURERS, DIFFERENT
DOSAGE FORMS (CATEGORY IV)
Warren Pharma Pvt.
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
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
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.
In gujarat state-total brands=19367
In maharastra state-total brands=18630
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.
Violation of SEC. 301(t)be subject to the following civil
(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
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.
FDA OFFICIAL SITE
Government of india (ministry of health of health
and family welfare) drugs and cosmetic act 1940