spurious drug s
TRANSCRIPT
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PROBLEM OFSPURIOUS/COUNTERFEIT
DRUGS
BY
DR. D. ROYC.D.S.C.O., MINISTRY OF HEALTH, GOVT. OF INDIA.
Website : www.cdsco.nic.in
Email : [email protected]
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The overall objective of a Drug Regulatory
Authority (DRA) is to ensure that medicinal
products are of acceptable quality andmanufactured and distributed in ways which
ensure their quality until they reach the
patient/consumer, and their commercial
promotion is accurate.
Consumer have the right to expect that Drug
Administration will not just protect the public
health by keeping unsafe drug off the market but
facilitate the availability of safe and effectivedrug.
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Unsafe drugs could be.
Spurious/counterfeit drugs,
Sub standard, sub therapeutic,
unlicensed drugs Drugs manufactured under improper
condition (non compliance of GMP)
improperly stored drugs,
Having unfavorable benefit riskprofile
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The production, distribution and sales of counterfeit
medicines have shown dramatic rise in recent years,involving medicines for life threatening diseases with
high mortality.
WHO and partners organizations consistently
advocate and provide supports for combating
counterfeit medicines. However, more efforts are
needed at country and inter country levels to fightthe production, distribution and sales of these
products.
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Drug Regulatory System
Drugs
&
Pharmaceutical
Safety
Efficacy
Quality
Regulatory
Policies &
Procedures
Advances in Sciences
& TechnologiesPublic Concerns
International
HarmonizationProcess
Nature of
Products
Country specific
political and
administrative
Scenario
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DRUGS CONTROLLER (INDIA)
HEAD QUARTERSUB ZONAL
OFFICE (3)
ZONAL
OFFICE (4)
LABORATORY
(6)
PORT OFFICE
(7)
New Drugs
CLLA
Imports
DTAB
I.P.
Parliament
Misc.
GMP Audits
Coordinationswith States
GMP Audits
Coordinationswith States
Import
ExportTesting of drug
Samples
Validation of
Test protocol
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Indian Pharmaceutical Industry
Global ranking in volume terms 4th , Value
terms 13th
Amongst top 3 worldwide API productioncenters
Products sold to over 100 countries
World Class quality products
Most competitive prices in the world ~ 8-10%of international prices
Recognized international base for process
chemistry Applied research focus
Largest spender on R&D across industries
Largest number of USFDA approved site out
side USA
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DEFINATION OF SPURIOUS DRUGS
Spurious drugs are mainly the products which are
deliberately and fraudulently mislabeled so as to
conceal their identity and source of manufacture to
cash-on the popularity of fast moving brands. It mayor may not contain the active ingredients mentioned
on the label.
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WHO DEFINITATION:A medicine,which is deliberately and fraudulentlymislabeled with respect to identity and/ or source.
Counterfeiting can apply to both branded andgeneric products and counterfeit products may
include products with the correct ingredients or with
the wrong ingredients, without active
ingredients,with insufficient active ingredients orwith fake packaging
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Spurious Drugs
Measures taken by Government of India The subject of spurious drugs and drug
adulteration has been discussed many times at
the joint meetings of Central Council of Health(CCH) which consists of Union Health Ministeras Chairman and the State Health Ministers asmembers.
A committee was set up under thechairmanship of DGHS in 2001 by Govt. ofIndia on Spurious Drugs.
A two-day workshop was arranged by CDSCOinvolving all stakeholders during December
2001 at Delhi.
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Honorable Union Health Ministerfocused CMs attention on matters
relating to spurious drugs in October2002.
A committee was formed under thechairmanship of Dr. R.A. Mashelkar
for a comprehensive examination ofdrug regulatory issue including theproblem of spurious drugs.
Based on the recommendation ofMashelkar committee, a bill has beenplaced in the parliament to amend theD&C Act.to make the punishment
more deterrent.
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Penalty For Manufacture, Sale etc.of Spurious Drugs
Imprisonment for a term which shallnot be less than 5 years but which
may extend to a term of life forspurious drug likely to cause death orgrievous heart.
Three years but which may extend tofive years with fine for any otherspurious drug.
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Spurious Drugs
Number of spurious drugs detectedduring last 4 years.
2004-2005 144/49,287
2003-2004 118/40,862
2002-2003 129/43,138
2001-2002 96/38,824
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GLOBAL SCENARIO
The counterfeit medicines trade is amulti-billion dollar trade thought to berun by criminal gangs.
Most severe problems occur in countrieswith ineffective drug regulatory system.
Counterfeit drug problem must be
treated as a threat to national securityin each country and resources tocombat the problem should become aninternational priority
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Focused efforts
Intensified surveillance in high risk areas
( market places, borders areas, rural areas etc).
Rapid alert mechanisms Inter country among focal points
In country among stakeholders and
general public
Advocacy to policy makers, providers andgeneral publics
Improved collaboration with law enforcement
agencies
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