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Abstracts: The menace of spurious /
counterfeit drugs is escalating every day, endangering
life of innocent ailing human beings. This burning
problem for the health care providers, may be
un-intentional or deliberate, yet it remains dynamic
inspite of stringent penal provisions under the Indian
legislation for cases of detection of
spurious/counterfeit drugs. Counterfeiting of medicines
is a world wide phenomenon and India is not an exception
to it. As the lust of money is increasing, we are
deviating from our moral values/ethics &
responsibilities. Right to health, which includes right
to quality medicine has been considered as a fundamental
right in our constitution, therefore, the state is duty
bound to provide quality medicines to its people.
The
Drug and Cosmetic Act 1940 and Rules 1945, a central
legislation regulating the manufacture, sale, and
quality of drugs and formulations in India provide
definition of 'Spurious Drug' under its section 17-B.
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If it is manufactured under a name which belongs to
another drug; or
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If it is imitation of, or is a substitute for,
another drug or resembles another drug in a manner
likely to deceive or bears upon it or upon its label
or container the name of another drug unless it is
plainly and conspicuously marked so as to reveal its
true character and its lacks of identity with such
other drug; or
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If the label or container bears the name of an
individual or company purporting to be manufacturer
of the drug; which individual or company is
fictitious or does not exist; or
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It has been substituted wholly or in part by another
drug or substance or
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If it purports to be the product of manufacturer of
whom it is not truly a product.
Counterfeit drugs are an upcoming social evil. According
to WHO estimates about 25% of the medicines consumed in
developing countries are believed to be counterfeit.
However, no systematical and scientifical study data is
available on the extent of this menace. 'Counterfeit
drug' is one which is deliberately and fraudulently
mislabeled with respect to identity and / or source, as
per WHO. Counterfeiting can apply to both branded and
generic drug products and counterfeit medicines may
include products with the correct therapeutically active
ingredients but fake packaging; with the wrong
ingredients; without active ingredients or with
insufficient active ingredients. In developed countries,
counterfeiters generally target newer, costly and top
selling drugs like hormones, steroids, antihistamines,
psychiatric medicines and anticancer drugs. In
developing countries, drugs used to treat life -
threatening conditions such as malaria, tuberculosis and
HIV / AIDS are generally counterfeited.
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