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Dr.
Chandra M. Gulhati,
Editor, MIMS.
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Regulatory framework
(CDSCO) exists in India to deal with Fake and Substandard drugs.
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Production and sale of
fake drugs is essentially a criminal act.
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Production and sale of
substandard drugs can be deliberate or due to negligence.
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Fault can also lie with
distributors and retailers with regard to storage of temperature
sensitive items that can render standard into substandard products e.g.
Insulin.
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Every now and then the
mass media both in India and abroad carries stories on manufacture and
sale of huge number of fake drugs in India.
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Figures quoted range
from 20 to 25%
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Implication: Every 5th,
if not 4th medicine being sold in over 600,000 retail chemist shops is
fake.
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Based on this
assumption, the total fake market business should be at least Rs. 6,500
crores every year!
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“One widely quoted WHO
statistic places India as the leader, with as much as 35% of world’s
production (of fake drugs)”: news item in the Lancet, 2 June 2001.
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As part of the
“evidence” the case of narcotic analgesics being smuggled by Uzbek
carriers but seized at New Delhi airport was quoted.
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The fact: the narcotic
analgesics were illegally produced for smuggling but were NOT
FAKE.
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Despite repeated
denials by WHO, this misinformation continues to be repeated by the
media even today.
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In India, the
descriptions fake, spurious and counterfeit convey the same meaning.
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However as per WHO
definition counterfeit drugs are those that have “been deliberately and
fraudulently mislabelled with respect to identity and/or source.”
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Despite such a wide
definition between 2002 and 2004, not a single case of counterfeit case
was reported to WHO.
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In America counterfeit
drugs include genuine, foreign medicines/brands not approved by the
United States Food and Drug Administration (USFDA).
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No wonder according to
USFDA, “Up to 25% of all drugs consumed in poor countries are thought
to be counterfeit or substandard.”
(Ref:
The Lancet, Vol. 362, 22 November 2003).
WHO “Fact Sheet”
Without Data, Without Proof:
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“There has been no full
international survey but estimates from
WHO and the pharmaceutical industry suggest
that at least 5% of medicines in
circulation (worldwide) may be counterfeit” (Ref: The Lancet, 5 October
2002)
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“Counterfeiting in
Peru is as high as 80% according to Merck, Sharp, and Dohme.” How come
everyone is alive!
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“In 2002, India’s
pharmaceutical companies suggested that
in India’s major cities, one in five medicines sold was a fake. They
claimed a loss in revenue of between 4% and 5% annually. The industry
also estimated that
illegal drugs had grown from 10% to 20% of the total market.”
Ref:
WHO Fact Sheet revised, 14 November 2006.
Figures Don’t
Tally:
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If fake drugs are so
much in abundance in India, then why does the industry claim that their
“loss of revenue” is between 4 and 5%?
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It should be more like
20% or even more.
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It can be less ONLY if
fake drugs fall overwhelmingly in the cheaper range.
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But why cheap fake
drugs should be manufactured and sold since the profits are not be
worth the trouble and risk.
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Bulk paracetamol costs
Rs. 180 per kg (1000g).
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Cost of active
ingredient in one dose comes to just 9 paise.
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The production cost of
a strip of 10 tablets (without active ingredient) comes to Rs. 1.50.
Thus production cost is higher than cost of medicine.
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Sale price varies from
Rs. 4 to 10 per strip.
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Bulk ceftriaxone costs
over Rs. 11,000 per kg.
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Cost of active
ingredient in one dose (1g) vial comes to Rs. 11.20.
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The production cost
without active ingredient is Rs. 4.40.
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Sale price is over Rs.
70
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Will fake drug maker
produce paracetamol or ceftriaxone?
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Profits lie in
expensive products with large market.
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In India, Fake is a
commonly used word that means “Not Genuine.” This word is not
specifically mentioned in our laws governing medicines.
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“Spurious”, as defined
in the Drugs and Cosmetics Act (Section 17B) is not limited to fake
products but also includes other cases such as products that use
unauthorized names, manufacturers etc.
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Implication: A strip of
10 pure and genuine paracetamol tablets will be deemed to be “spurious”
if it uses the name Crocin without permission from trade mark holder
GSK.
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In many raids where the
aggrieved informer is a manufacturer of the original product, primarily
and at least initially the issue relates to unauthorized use of brand
names.
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Thus manufacturers use
the legal definition to their commercial benefit even when public
health may or may not be at stake.
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How many of the
“spurious” products were found to be fake as well?
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Is the definition
exaggerating the figures of really fake drugs?
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Should the definition
of Spurious drugs be amended?
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Large drug industry
associations (IDMA, OPPI) provide estimated percentage figures of fake
drugs.
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Methodology and
conclusions are neither listed nor supported with evidence.
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Concrete examples are
often not given.
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Why should the drug
companies shy away from giving specific details?
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Recently duplicate
copies of a popular and very widely used cough remedy flooded certain
markets in eastern India.
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The company found that
its product’s sale was either stable or going up all over the country
except certain markets in eastern India.
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The Company took action
with local police help but did not involve drug controller.
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The reason? Media
coverage of the existence of duplicate products would have led to
boycott of the brand by patients and doctors all over India!
Conclusion:
Urgent Need of Credible, Correct Data:
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Currently fake drugs
are discovered through random sample collections by state drug
inspectors.
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On receipt of
complaints by aggrieved manufacturers.
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Rarely by patients.
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These are inadequate
measures to determine the correct prevalence of the problem.
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National level
scientifically structured large sample collection and testing is
urgently required. CDSCO has probably already started the process.
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