Journal of Medicine Vol 4 - Amrita Institute of Medical Sciences and ...

Amrita Journal of Medicine
Caution! Counterfeit Medicines are on the Rise
3. No medicine as labelled
4. Inappropriate, but harmless ingredient(s) in place of
the labeled medicine(s)
5. Inappropriate as well as potentially harmful
ingredient(s) in place of the labeled medicine(s)
6. Added - unlabeled harmless /potentially toxic / banned
ingredients e.g., steroids with herbals
7. Expired medicines repacked and relabeled
8. Medicines mimicking the original product in package
design and label (fake packaging of legally manufactured
medicine)
THE POOR VICTIMS
The entire human population are aggrieved and their
lives are at risk. Many case of fatalities and morbidity
have been reported from India. Category wise consequences
are given below:
1. Consumers, the primary victims:
May be innocuous
May result in permanent disability
May be fatal
2. Legitimate manufacturers:
Undermine the confidence in their product
Incur loss of sales
3. Government:
Fiscal loss of revenue to purchase
spurious medicines
Lead to collapse of health sector
4. Health care professionals:
Loss of patient’s confidence in their services
Loss of revenue
THE CONCERN
Initially counterfeiting was limited to comparatively
expensive medicines. Today scenario has changed. Prescription,
nonprescription, generic, branded,
over-the-counter, life saving; all are being counterfeited.
Many cases of fatalities have been reported from India
due to the use of counterfeit medicines.
FACILITATING FACTORS FOR COUNTERFEITING
1. High demand for medicines
2. High cost of medicines and price variation
3. Easy for transportation
4. Scarcity and erratic supply of basic
medicines
5. Weak drug regulatory control in the
fields of manufacture and marketing
6. Poor socioeconomic status of the population - easy
prey to corruption
7. Lack of know how and lack of resources for quality
assessment
8. Lack of public awareness and political will
9. Boost in the unscrupulous E- advertising and trading
practices
STRATEGIES TO COUNTER THE MENACE OF COUN-
TERFEITING
1. At the International Level:
a. World Trade Organization’s General Agreement on
Tariffs and Trade - Trade Related Aspects of Intellectual
Property Rights Agreement 1994 (GATT -Trips
Agreement 1994)
All types of Intellectual property rights like patents,
copyright and trademarks are protected globally by
GATT- TRIPS Agreement 1994 signed by all member
countries of the World Trade Organisation (WTO).
This agreement covers all areas of business and sociey
like pharmaceceuticals, software, music, arts etc. The
Agreement details all the rules related to enforcement
of international laws in cases of fraud or
counterfeiting like collection and documentation of
evidence, provisional measures to be adopted in such
cases, penalties to be meted out etc. It is further
agreed that that courts should have the right, under
certain conditions, to order the disposal or destruction
of pirated or counterfeit goods.
b. International Medical Products Anti-Counterfeiting
Taskforce (IMPACT)
International Medical Products Anti-Counterfeiting
Taskforce (IMPACT) has been set up in the United
States of America and many European countries. Development
of Global Anti- Counterfeit Task Force is
on the anvil.
c. Pharmacovigilance systems should be extended to
include reporting of and investigating suspected cases
of counterfeit medicines.
d. Custom Offence
1. Treat willful Counterfeiting of trademark as criminal
offence
2. Enact and implement appropriate legislation to
protect intellectual property right and to counter
the movement of counterfeit and pirated goods
across the border under the clause “custom offence”
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