Transnat.Organized Crime 1

1. C O U N T E R F E I T I N G
I N T H E
P H A R M A C E U T I C A L
I N D U S T R Y -
A N A N A L Y S I S
A P R E S E N TAT I O N B Y KO PA L T E WA RY
R O L L N O - 1 7 1 5 5

2. 1. WHAT ARE COUNTERFEIT
MEDICINES?
• medicines which are deliberately and fraudulently
mislabelled with respect to identity and/or source, and
also which may include products with correct
ingredients or with the wrong ingredients, without
active ingredients, with insufficient or too much active
ingredient, or with fake packaging.
• In 2017, WHO analysed drug samples and found that
10.5 percent of pharmaceutical drugs in low and
middle-income countries are fake or substandard
WHO categorizes counterfeit drugs
into 6 categories based on type and
prevalence:
• No active ingredients (32.1%).
• Incorrect amounts of active
ingredients (20.2%).
• Incorrect ingredients (21.4%).
• Correct quantities of active
ingredients but fake packaging (15.6%).
• An original product that has been
copied (1%).
• High levels of impurities and
contaminants (8.5%).

3. 2. STRATEGIES TO OVERCOME THE
ISSUE OF COUNTERFEIT MEDICINES
Raising Public
Awareness
Anticounterfe
it Labels
Packaging
Techniques
Operation
Panagea-
INTERPOL
Developing
Stricter Laws
WHO Member
State
Mechanism
WHO Surveillance
and Monitoring
System
3. The Response of World
Health Organization

4. 4. DEFINITION UNDER THE DRUG AND
COSMETICS ACT, 1940
• No official definition for counterfeit drugs
• Section 17-B of Drugs and Cosmetics
Act,1940 has defined spurious drugs - "A
drug shall be deemed to be spurious if it is
manufactured under a name which belongs
to another drug, if it is an imitation of
another drug or if it has been substituted
wholly or partly by another drug or if it
wrongly claims to be the product of
another manufacturer.
• Central Drugs Standard Control
Organization (CDSCO) has categorised not
of standard quality (NSQ) products in three
categories A, B and C
Category
A
• conceal the real identity
of the product or
formulation and be similar
to some well-known brand
Category
B
• include grossly substandard drugs in
which product fails the
disintegration or dissolution test
and where active ingredient assay
get below 70% and 5% of
permitted limit
Category
C
• involved products
with minor defects
like emulsion cracking,
change in formulation
colour, small variation
in net content,
sedimentation in clear
liquid

5. 5. STEPS TAKEN BY INDIA
Mandatory
Barcoding
Blockchain
Technology
• August 2003- special committee -objective of
taking speedy action against the menace of
spurious drugs
• Recommended stiffer penalties for violating
India's drug laws.
• In December 2003- the death penalty
approved for the sale or manufacture of fake
medicines that cause grievous harm or death;
• Minimum prison term increased from five to
ten years.
• The committee also recommended- a)
improvements to the nation's drug regulatory
infrastructure- b) central drug administration
to control the licensing of all drugs, , c) greater
surveillance, d) increasing the number of drug
inspectors .