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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 : royd_in2000@yahoo.com

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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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