prescription for

1
prescription for
death
health
Devinder Pal
Catalyst Pharma Consulting
2
Prescription for Health Or Death?

• Flow of Presentation
• Backdrop Indian Pharma Industry
• and Applicable Drug Laws
• Various Counterfeit Drugs Definitions
  resulting confusion?
• What is the Extent of the Menace?
• What are the Key Contributing Factors?
• Which are the Target Products Markets?
• What needs to be done and by whom?

3
Serendipity
4
Serendipity Growth Of Indian Pharma Industry

• As a serendipitous gain
• Indian Pharma Industry has witnessed
• a Phenomenal growth.
• In spite of
• Or rather because of the Red tape and bureaucracy
  
• that
• respected only Process Patents,
• Imposed import restrictions
• and capacity constraints on multinationals.

Incidentally these restrictions are already
out-dated in todays Global India
5
India-from Zero To Hero

• When India won Independence in 1947, it depended
  entirely on imports
• Now about 20 of finished generics OTC drugs in
  the US come from India
• India has the largest number of US FDA approved
  plants outside US some plants, I dare say, are
  superior to some in the US.
• Indias exports exceed domestic consumption
• India exported 800 million worth of APIs and
  formulations to the US in 2006 (China 675
  million)
• India Pharma Industry is 4th largest in the World
  in terms of volume , but 13th in value
• US FDA is evaluating options of opening its
  offices in India
• By 2012 Indias export s will be double of its
  domestic sale

6
The Top 10 Now Where They Came From
Now only 3 MNCs in top 10 - Despite Mergers. 7
are Indian!
GlaxoBWSKB Biddle Swayer
Once upon a time Almost all of the Top 10 were
MNCs (Sarabhai Alembic)
HMRRousselRPR
Abbott Boots
7
The next 10 now where they came from
From Hero to Villain
Sandoz Ciba
PfizerWarner PD
8
India From Hero To Villain

• India is now accused of being the world leader in
  counterfeit drugs trade!
• Some say 30 - 35 of the Indian Pharma turnover
  is of spurious drugs (Highest in Bihar, UP,
  west Bengal)
• Perhaps exaggerated numbers
• perhaps not
• I will revert on this later.
• First a brief introduce to the applicable
  Indian Laws

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India -Non Uniformity Of Enforcement Of Drug Laws
Is A Reality

• In India implementation of the Drugs Cosmetic
  Act 1940 is the concerned States responsibility
• Unfortunately the quality of enforcement in many
  States has been far from satisfactory.
• Non-uniformity in the interpretation of the
  provisions of the laws, their implementation, and
  the varying levels of competence of the
  regulatory officials are the main reasons for
  this less than satisfactory performance.

10
India - Punishment As Per The Drugs Act

• Manufacturer of a spurious/counterfeit drug can
  be punished with life imprisonment.
• Unfortunately no one has been awarded this
  punishment so far !!!
• We all know there is no greater deterrent than a
  severe, sure and swift punishment.-
• Unhappily, Indian legal system cannot claim
  swiftness as its virtue

11
Indian FDAs handicaps

• Indian Regulatory bodies have not been able to
  keep pace with the phenomenal growth and
  developments in Indian Pharma space
• The Mashelkar Committee concluded that the
  problems in the regulatory system in the country
  were primarily due to inadequate or weak drug
  control infrastructure at the State and Central
  level,
• Inadequate testing facilities
• Insufficient Inspectors, non-uniformity of
  enforcement, lack of specially trained cadres for
  specific regulatory areas,
• Virtually, non-existence of data bank.
• Yet, despite many handicaps the Indian FDA has
  been doing a commendable job
• So much for the backdrop of the Indian Pharma
  industry
• Lets now define Counterfeit drugs since there
  seem be more than one definitions
• First the US FDA definition.

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Definition of Counterfeit DrugsUS-FDA

• The Food and Drug Administration, USA defines
  counterfeit drug as
• A drug which, or the container of which, or
  labeling of which, without authorization, bears
  the trademark, trade name, other identifying
  mark, imprint or device or any likeness there of
  , a drug manufacturer, processor, packer, or
  distributor, other than the person, or persons
  who in fact manufactured, processed, packed, or
  distributed such drug and which thereby falsely
  purports, or is represented to be the product of,
  or to have been packed or distributed by such
  other drug manufacturer, processor, packer, or
  distributor.
• Please note Sub-standards are not included ,
• nor is IPR violations due to smuggling from
  across country

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FDA Warns Consumers about Counterfeit Drugs from
Multiple Internet Sellers May 1, 2007

• Internet is perhaps one of the largest route of
  selling counterfeit drugs.
• I am sure like me, you get any number of offers
  to get cheap drugs through the net. My last count
  was 21 sites
• USFDA does not permit this, but has been by and
  large helpless except cautioning the public
• The Food and Drug Administration (FDA) has
  cautioned U.S. consumers about dangers associated
  with buying prescription drugs over the Internet.
  
• This alert was issued (May 1, 2007) based on
  information the agency received showing that 24
  apparently related Web sites may be involved in
  the distribution of counterfeit prescription
  drugs .
• None of the capsules ordered off the Web sites
  contained , the active ingredients.
• Some other samples of drug product obtained from
  two of the Internet orders were composed of only
  talc and starch.
• Though, as placebo effect some counterfeit
  Viagara, that contained no active worked well
  with some!

14
WHO Definition

• According to WHO a counterfeit medicine is one
  which, is deliberately and fraudulently
  mislabeled with respect to identity and/or
  source.
• Counterfeiting applies to both branded and
  generic products.
• Counterfeit products may include products
• With correct ingredients Or
• With wrong ingredients, Or
• Without active ingredients, Or
• With insufficient active ingredient, Or
• With fake packaging.
• This definition is wider as sub-standards get
  included

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Counterfeit Substandard Medicines WHO

• WHO recognizes that
• Counterfeit medicines are a part of the broader
  phenomenon of substandard pharmaceuticals
  medicines manufactured below established
  standards of quality and therefore dangerous to
  patients health and ineffective for the
  treatment of diseases.
• A substandard product may also be counterfeit.
• Though, all substandard products are not
  necessarily counterfeits
• A counterfeit product may or may not be
  Substabdard though more often than not, it is
  so

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What is a Counterfeit drug?Wikipedia

• A counterfeit drug is a medication which is
  produced and sold with the intent to deceptively
  represent its origin, authenticity or
  effectiveness.
• A counterfeit drug may be one which does not
  contain active ingredients, contains an
  insufficient quantity of active ingredients, or
  contains entirely incorrect active ingredients
  (which may or may not be harmful), and which is
  typically sold with inaccurate, incorrect, or
  fake packaging.
• Fake medicines and generic drugs which are
  deliberately mislabeled in order to deceive
  consumers are therefore counterfeit

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What is a Counterfeit drug (contd.)?From
Wikipedia

• Counterfeit drugs can generally be classified by
  the following characteristics
• Re-labeled drugs that were previously expired,
  defective or otherwise deemed unfit for use
• Drugs wherein the active ingredient is
  fraudulently diluted
• Drugs wherein the active ingredient is
  adulterated
• Drugs wherein the active ingredient is
  substituted
• Falsely-labeled substances of any composition
  wherein the active ingredient is completely
  misrepresented and
• Falsely-labeled substances whose combined active
  ingredients meet one or more of the preceding
  criteria.

Very lucid - similar to WHO definition
includes sub-standard under Counterfeits
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Spurious Counterfeit

• The Indian Drugs Act does not use the word
  Counterfeit!
• It uses the word Spurious Drugs
• Here is the definition

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Definition of Spurious Drugs Indian Drugs
Act

• A drug shall be deemed to be spurious if it is
  manufactured under a name which belongs to
  another drug, or
• If it is an imitation of, or is substitute for,
  another drug, or resembles another drug in a
  manner likely to deceive, or
• Bears 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 lack of identity with
  such other drug, or
• If the label or container bears the name of an
  individual, or
• Company purporting to be the manufacturer of the
  drug,
• which individual or company is fictitious or does
  not exist, or
• If it has been substituted wholly or in part by
  another drug or
• Substance, or
• If it purports to be the product of a
  manufacturer of whom it is not

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Counterfeit is not defined but

• Even though the word Counterfeit is not defined,
  the Indian Drugs Acts definition of spurious
  drug is wide enough to cover Counterfeit drugs.

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Prescription for Health Or Death?

• What is the Extent of the Menace?

22
Extent of Spurious Drugs - No Validated
DataMashelkar committee report Nov.2003

• The reported extent ranged widely between 0.5
  (based on the cases analyzed and 35 (ascribed
  to WHO Studies).
• However, WHO itself had written in response to a
  query from the Indian Government that
• There is no actual study by WHO, which concludes
  that 35 of Worlds spurious drugs are produced
  in India.
• Some estimation of the quantum of spurious drugs
  in the market quoted is available based on the
  cases detected in selected pockets and regions in
  the country. Validation of the claims made by
  several agencies was not available as concrete
  and authenticated evidence.
• The Mashelkar Committee came to the conclusion,
  after examining all the data and reports at hand
• there was an absence of a scientifically and
• statistically designed investigation, which could
  give a realistic estimate of the menace of
  spurious drugs.

23
Yet another set of numbers!

• Deputy Drugs Controller India for West Zone (he
  has since moved to number one post in FDA) has
  said
• His office had taken over 4000 samples of eight
  to nine brands
• Out of which only two were found counterfeit.
• He added that the percentage of counterfeiting
  was as low as 0.01 in
• West zone

24
Estimates (Guess)Estimates and Statistics

• Recent sting operation by a TV channel in India
  concluded
• 30 of all drugs sold in India were spurious!!!
  
• This conclusion was based on the clandestine
  operations unearthed by them.
• The TV showed bottles of a cough syrup being
  filled one bottle at a time by using a funnel
  a beaker no machine!
• At this rate I guess (light heartedly
  speaking) the whole of adult Indian population
  may be needed to produce what might constitute 30
  of countrys consumption!
• Yet a man in the street now believes the 30
  number that has resurfaced on the popular channel
  that is usually responsible in reportage.

• Statistics and estimates are like Bikinis
• What they reveal is interesting but what they
  hide is vital
• Some are uncharitable enough to say
• There are lies, damn lies, and Statistics.
• We all know, one can use statistics to prove
  anything, by selecting sample size and source

25
50 50
One Chicken
One Horse
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Estimates of Anti-counterfeiting group
(including Substandard)

• According to the anti-counterfeiting group,
  counterfeit drugs constitute 6 of world-wide
  drug sales in 2000
• The group estimated the following figures for
  some countries
• Brazil 20,
• Nigeria 60-70,
• Indonesia 25,
• Senegal 10 times the regular market
• India 20,
• Pakistan 20-50,
• China the largest producer of sub-standard drugs
  in the world

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EstimatesEstimates!!!

• Precise data on extent of counterfeit medicines
  is difficult to obtain.
• So we have Estimates or shall we say
  (Guess)estimates
• As is obvious, some of the reasons for wide
  variation in numbers are
• Huge differences between regions,
• Dramatic variations within a country i.e. city
  versus rural areas, city versus city
• Counterfeiting is greatest in those regions where
  the regulatory and legal oversight is weakest.
• The above is certainly true for India I have
  every reason to believe that this is
  universal truth

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To Sum it up Estimates Vary Widely

• We have seen estimates of counterfeit drugs vary
  from a fraction of 1 to 50
• Additional complicating factors are
• Some numbers are based only on Counterfeits
• Others also include sub-standard drugs
• Products not complying with the label claims
• Intentional lower end the range (95 to 105)
• Unintentional potency or bioavailability or
  other key parameters effected due to bad
  storage or transportation or due to undetected
  variation in quality of inputs or process
• Ignorance (diethyl glycol),

• Yet others also include
• IPR violations, or
• Trademark violations
• Even Similar sounding Brand names
• Even though these may be due to cross border
  smuggling from a country producing the product
  as per applicable laws.
• This is the root cause of conflicting numbers!

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Perception Reality

• There are significant gaps between Perception and
  reality
• There are differences in definition
• This is bound to throw up
• different numbers, and
• send us barking up the wrong tree!
• No doubt everyone is looking at the Elephant
• Some are looking at the Tusk,
• Some others at the Tail
• And yet some others at the legs of the Elephant
• No wonder there are differences in perceptions!

30
Serious Cause for Worry

• Whatever the age
• High or low percentage counterfeit spurious
  drugs are serious cause for worry
• The US based Centre for Medicines predicts that
  counterfeit drug sales will reach US 75 billion
  globally in 2010, an increase of more than
  90 from 2005
• Other predictions forecast 10 of World market
  will be Counterfeit drugs

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Prescription for Health Or Death?

• What are the Key Contributing Factors?

32
Counterfeiting of commercial products has been in
exisitence ever since!

• Greed is a common human weakness not confined
  to any religion or region
• The problem of spurious and counterfeiting is
  universal
• Since consumers and doctors are unable to
  independently assess the quality, safety and
  efficacy. the consequences of ineffective
  regulatory oversight can be deadly to patients.

33
What are the key factors contributing to
proliferation?

• Very remunerative trade
• Weak penal action tardy court proceedings
• Availability of improved printing technology
  that makes
• counterfeiting easier.
• Lack of coordination between various agencies
• Inadequate cooperation between stakeholders
  bordering on callousness (Law and Order?)
• Lack of control by importing/exporting countries
• Wide spread corruption and conflict of interests
• Non-uniformity of enforcement standard followed
  by the drug control authorities within a country,
  and country to country variations.
• Large scale sickness in small scale
  pharmaceutical industry
• Apathy to anti-counterfeiting measures

34
What are the Target Products Markets?

• Only a handful of top selling brands are
  attractive targets
• fast moving and high margins are the key words
• The production of counterfeit drugs does not
  occur in large infrastructures or facilities. The
  majority of the counterfeiters apprehended so
  far, carried out their activities in ordinary
  households, small cottage industries, or in
  backyards.
• Trade in fake medicines is more prevalent in
  countries
• with weak drug regulation and enforcement, Or
• scarcity or erratic supply of basic medicines,
  Or
• unregulated markets Or
• unaffordable prices, Or
• poor law enforcement

35
Lack of Foresight of the Industry Profession!

• Our lack of foresight that Technology internet
  will make the task easier.
• Our lack of foresight of developing and using
  anti-counterfeiting measures - to make it
  difficult if not impossible.
• Lack of effective deterrents punishment,
  combined with poor enforcement - virtually
  inviting anybody wanting to get rich quickly, to
  have a fields day.
• Lack of coordinated preventive actions not even
  at country level, leave alone at International
  level

36
We forgot thatAn open door tempts even a saint!

• We forget Prevention is always better than Cure!
  What did we do to prevent temptation getting
  better of unscrupulous elements?
• Not enough (Virtually nothing!)
• We did not foresee that technology will make
  counterfeiting a childs play.
• We have been complacent
• We forget that open door tempts even a saints
  
• In the absence of using anti-counterfeiting
  measures, we are virtually leaving diamonds on
  platter on the roadside, expecting that no one
  will take them way!
• No security guard not even a lock on the
  Jewelers store

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Prescription for Health

• 6. What needs to be done and by whom?

38
Learning from experience

• CDs, VCD, DVD piracy in India
• Law and Order problem much like we in Pharma
  industry are saying
• Industry leaders got together
• Evolved a strategy
• Pooled monetary and other resources
• Hired professional
• Used police help but the manufacturers were
  in driving seat

39
What needs to be done?

• Multi-pronged approach at countrys FDA level
• Strengthen Drug Administration
• Increase sampling analysis
• Involve Police in investigation
• Coordinate actions of all stakeholders
• Consumer Education
• Collect intelligence
• Medical Representatives
• Doctors Hospitals
• Distribution Channels
• Other investigating agencies
• Profile on sick units
• Associations

40
What needs to be done -2 ?

• Creating awareness amongst
• Medical profession, and above all
• Patients Public at large
• Awareness of
• Menace consequences
• Anti-counterfeiting devices
• (Meaningless unless educated on
• What? How to?)
• Identifying countries / regions of higher
  incidence to permit prioritization of areas
  needing higher dose of preventive, punitive
  actions / resources

41
Who are best placed to detect?

• There are only two victims of counterfeit drugs
  consumer and the manufacturer. The rest are not
  real sufferers
• Manufacturers, wholesalers, re-packagers,
  pharmacists and PSRs are in the best position to
  detect counterfeit drugs.
• They should play a proactive role, and be
  required by law to report their suspicions to the
  relevant authorities.
• Unfortunately the main stake holders have done
  precious little so far

42
Strategy Multi-country Coordinated Actions

• Multi-country (WHO - IMPACT?) coordinated attack
  to deal with this menace
• Arrive at a common definition of Counterfeit
  drugs
• Survey to determine
• Extent of problem
• Vulnerable countries
• Vulnerable areas / regions
• Networking for sharing of intelligence
• structured mechanism for sharing information
• Designate a contact persons in regulatory
• agencies and industry
• Multi-pronged coordinated attack to track book
  the culprits

43
Everybody, Somebody, Anybody, Nobody !

• There were four colleagues
• Everybody, Somebody, Anybody, and Nobody
• And there was a job to be done
• Everybody knew how to do it, he was confident
  Somebody will do it
• Somebody was sure Anybody will do it
• Anybody felt Everybody will do it
• The result Nobody did it !!!
• We are behaving no different from this story!
• The Pharmacist says it is Doctors responsibility
• The Doctor says it is the manufacturer's
  responsibility
• Manufacturers say it is Govts responsibility
• Everyone is passing the buck.
• What about poor patient?
  Robert Richter from the Movie
• Pills For Exports only
• Before I end
• Brief generic coverage of Anti counterfeiting
  measures

44
Generic Description Of Anti-counterfeiting
Measures
Level 5
Packaging determined by features of the product
Protection High
Legal Protection Features
Level 4
Permits manufacturers to track trace any form
of brand attack
Level 3
Features that require consume involvement to
confirm genuineness
Level 2
Level 1
Visual Identification feature invites consumer
to participate in protecting himself
45
It is no brainer
Giving a Counterfeit to a sick person is akin to
sentencing him to death
46
Perfect Murder

• Administering counterfeits is akin to a perfect
  crime, because fake medicines look like the real
  thing and evidence is gone because a patient is
  always presumed to have died from the disease,
  rather than the drug. And the mastermind is never
  caught," Ranjit Shahani
• To Catch the CulpritAll Stake holders must play
  their role
• Unfortunately there is no perfect bullet

47

We must do our bit to make it tough for them and
ensure to death by hanging from the nearest
lamp post!
Counterfeiting Offers Red Carpet for Quick buck
48

Thank you

• Devinder Pal
• www.CatalystPharmaConsult.com
• consult_at_DevinderPal.com