2. Devinder Pal - Catalyst Pharma Consulting prescription for Devinder Pal Catalyst Pharma Consulting

3. Devinder Pal - Catalyst Pharma Consulting Prescription for Health Or Death? Flow of Presentation 1)Backdrop – Indian Pharma Industry and Applicable Drug Laws 2)Various Counterfeit Drugs’ Definitions & resulting confusion? 3)What is the Extent of the Menace? 4)What are the Key Contributing Factors? 5)Which are the Target Products & Markets? 6)What needs to be done… and by whom?

4. Devinder Pal - Catalyst Pharma Consulting

5. 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 today’s Global India

6. Devinder Pal - Catalyst Pharma Consulting 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.  India’s 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 4 th largest in the World in terms of volume, but 13 th in value  US FDA is evaluating options of opening its offices in India  By 2012 India’s export s will be double of its domestic sale

7. Devinder Pal - Catalyst Pharma Consulting The Top 10 Now & Where They Came From Now only 3 MNCs in top 10 - Despite Mergers. 7 are Indian! Once upon a time Almost all of the Top 10 were MNCs (Sarabhai & Alembic) Glaxo+BW+SKB+ Biddle Swayer HMR+ Roussel +RPR Abbott + Boots

8. Devinder Pal - Catalyst Pharma Consulting The next 10 now & where they came from Pfizer+Warner +PD Sandoz + Ciba From Hero to Villain

9. Devinder Pal - Catalyst Pharma Consulting 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

10. Devinder Pal - Catalyst Pharma Consulting India -Non Uniformity Of Enforcement Of Drug Laws Is A Reality  In India implementation of the Drugs & Cosmetic Act 1940 is the concerned State’s 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.

11. Devinder Pal - Catalyst Pharma Consulting 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

12. Devinder Pal - Catalyst Pharma Consulting Indian FDA’s 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  Let’s now define Counterfeit drugs – since there seem be more than one definitions  First the US FDA definition.

13. Devinder Pal - Catalyst Pharma Consulting Definition of Counterfeit Drugs US-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`

14. Devinder Pal - Catalyst Pharma Consulting 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!

15. Devinder Pal - Catalyst Pharma Consulting 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

16. Devinder Pal - Catalyst Pharma Consulting 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

17. Devinder Pal - Catalyst Pharma Consulting 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.medication  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. active ingredients  Fake medicines and generic drugs which are deliberately mislabeled in order to deceive consumers are therefore counterfeitgeneric drugsconsumers

18. Devinder Pal - Catalyst Pharma Consulting 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

19. Devinder Pal - Catalyst Pharma Consulting Spurious & Counterfeit  The Indian Drugs Act does not use the word Counterfeit!  It uses the word “Spurious” Drugs  Here is the definition

20. Devinder Pal - Catalyst Pharma Consulting 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

21. Devinder Pal - Catalyst Pharma Consulting Counterfeit is not defined… but  Even though the word Counterfeit is not defined, the Indian Drugs Act’s definition of spurious drug is wide enough to cover Counterfeit drugs.

22. Devinder Pal - Catalyst Pharma Consulting Prescription for Health Or Death? What is the Extent of the Menace?

23. Devinder Pal - Catalyst Pharma Consulting Extent of Spurious Drugs - No Validated Data Mashelkar 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 World’s 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’.

24. Devinder Pal - Catalyst Pharma Consulting 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

25. Devinder Pal - Catalyst Pharma Consulting 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 country’s 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`

26. Devinder Pal - Catalyst Pharma Consulting 50 : 50 One Chicken One Horse

27. Devinder Pal - Catalyst Pharma Consulting 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

28. Devinder Pal - Catalyst Pharma Consulting Estimates…Estimates!!!  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

29. Devinder Pal - Catalyst Pharma Consulting 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!

30. Devinder Pal - Catalyst Pharma Consulting 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!

31. Devinder Pal - Catalyst Pharma Consulting S erious 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

32. Devinder Pal - Catalyst Pharma Consulting Prescription for Health Or Death? What are the Key Contributing Factors?

33. Devinder Pal - Catalyst Pharma Consulting 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.

34. Devinder Pal - Catalyst Pharma Consulting 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

35. Devinder Pal - Catalyst Pharma Consulting 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

36. Devinder Pal - Catalyst Pharma Consulting 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 field’s day.  Lack of coordinated preventive actions – not even at country level, leave alone at International level

37. Devinder Pal - Catalyst Pharma Consulting We forgot that An 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 child’s 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

38. Devinder Pal - Catalyst Pharma Consulting Prescription for Health 6. What needs to be done… and by whom?

39. Devinder Pal - Catalyst Pharma Consulting 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

40. Devinder Pal - Catalyst Pharma Consulting What needs to be done?  Multi-pronged approach at country’s 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

41. Devinder Pal - Catalyst Pharma Consulting 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

42. Devinder Pal - Catalyst Pharma Consulting 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

43. Devinder Pal - Catalyst Pharma Consulting 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

44. Devinder Pal - Catalyst Pharma Consulting 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 Doctor’s responsibility  The Doctor says it is the manufacturer's responsibility Manufacturers say it is Govt’s 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

45. Devinder Pal - Catalyst Pharma Consulting Generic Description Of Anti-counterfeiting Measures Protection High Packaging determined by features of the product Level 5 Level 4 Level 3 Level 2 Level 1 Legal Protection Features Permits manufacturers to track & trace any form of brand attack Features that require consume involvement to confirm genuineness Visual Identification feature – invites consumer to participate in protecting himself

46. Devinder Pal - Catalyst Pharma Consulting Giving a Counterfeit to a sick person is akin to sentencing him to death It is no brainer

47. Devinder Pal - Catalyst Pharma Consulting 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 Culprit All Stake holders must play their role  Unfortunately there is no perfect bullet

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

49. Devinder Pal - Catalyst Pharma Consulting Devinder Pal www.CatalystPharmaConsult.com consult@DevinderPal.com