prescription for Devinder Pal Catalyst Pharma Consulting Devinder

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

Prescription for Health Or Death? 1) 2) 3) 4) 5) 6) 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? Devinder Pal - Catalyst Pharma Consulting

Devinder Pal - Catalyst Pharma Consulting

Serendipity & Growth Of Indian Pharma Industry As a serendipitous gain s n Indian Pharma Industry hasctwitnessed io i n r t a Phenomenal egrowth. s i r ted e s ofda In spite e h utt a i y d l o Or rather because of the Red tape and l n a y I t ad l n a bureaucracy e e b d r i o l l c a n G I are that s ’ y a Process Patents, d respected tonly o Imposed import restrictions and capacity constraints on multinationals. Devinder Pal - Catalyst Pharma Consulting

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

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

The next 10 now & where they came from o r F o r e H m to Sandoz + Ciba Pfizer+Warner +PD n i a l l i V Devinder Pal - Catalyst Pharma Consulting

India – From Hero To Villain v. India is now accused of being the world leader in counterfeit drugs trade! v. Some say 30 - 35 % of the Indian Pharma turnover is of spurious drugs (Highest in Bihar, UP, & west Bengal) v. Perhaps exaggerated numbers – perhaps not … v I will revert on this later. v. First a brief introduce to the applicable Indian Laws Devinder Pal - Catalyst Pharma Consulting

India -Non Uniformity Of Enforcement Of Drug Laws Is A Reality v. In India implementation of the Drugs & Cosmetic Act 1940 is the concerned State’s responsibility v. Unfortunately the quality of enforcement in many States has been far from satisfactory. v. 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. Devinder Pal - Catalyst Pharma Consulting

India - Punishment As Per The Drugs Act v. Manufacturer of a spurious/counterfeit drug can be punished with life imprisonment. v. Unfortunately no one has been awarded this punishment so far !!! v. We all know there is no greater deterrent than a ‘severe’, ‘sure’ and ‘swift’ punishment. v. Unhappily, Indian legal system cannot claim ‘swiftness’ as its virtue Devinder Pal - Catalyst Pharma Consulting

Indian FDA’s handicaps v Indian Regulatory bodies have not been able to keep pace with the phenomenal growth and developments in Indian Pharma space v 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, v Inadequate testing facilities v Insufficient Inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, v Virtually, non-existence of data bank. v Yet, despite many handicaps the Indian FDA has been doing a commendable job v So much for the backdrop of the Indian Pharma industry v Let’s now define Counterfeit drugs – since there seem be more than one definitions v First the US FDA definition. Devinder Pal - Catalyst Pharma Consulting

Definition of Counterfeit Drugs US-FDA v 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` Devinder Pal - Catalyst Pharma Consulting

FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers May 1, 2007 v Internet is perhaps one of the largest route of selling counterfeit drugs. v I am sure like me, you get any number of offers to get cheap drugs through the net. My last count was 21 sites v USFDA does not permit this, but has been by and large helpless – except cautioning the public v The Food and Drug Administration (FDA) has cautioned U. S. consumers about dangers associated with buying prescription drugs over the Internet. v 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. v None of the capsules ordered off the Web sites contained , the active ingredients. v Some other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. v Though, as placebo effect some counterfeit Viagara, that contained no active worked well with some! Devinder Pal - Catalyst Pharma Consulting

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

Counterfeit & Substandard Medicines WHO v WHO recognizes that: Ø 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. v A substandard product may also be counterfeit. v Though, all substandard products are not necessarily counterfeits v A counterfeit product may or may not be Substabdard – though more often than not, it is so Devinder Pal - Catalyst Pharma Consulting

What is a Counterfeit drug? Wikipedia v A counterfeit drug is a medication which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. v 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. v Fake medicines and generic drugs which are deliberately mislabeled in order to deceive consumers are therefore counterfeit Devinder Pal - Catalyst Pharma Consulting

What is a Counterfeit drug (contd. )? From Wikipedia v Counterfeit drugs can generally be classified by the following characteristics: v Re-labeled drugs that were previously expired, defective or otherwise deemed unfit. O for use; H W is fraudulently o v Drugs wherein the active ingredient t r a l i diluted; sim n – r o e i v Drugs whereinlu the ingredient is adulterated; cidactive t d i n n i u f y e r d a v Drugs wherein the active ingredient is substituted; V d n a t s s composition t v Falsely-labeled substances of any b i e u f s r s e e t wherein the active d ingredient n is completely u u l o c in and C misrepresented; v Falsely-labeled substances whose combined active ingredients meet one or more of the preceding criteria. Devinder Pal - Catalyst Pharma Consulting

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

Definition of Spurious Drugs Indian Drugs Act v A drug shall be deemed to be spurious if it is manufactured under a name which belongs to another drug, or v If it is an imitation of, or is substitute for, another drug, or resembles another drug in a manner likely to deceive, or v 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 v 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 v If it has been substituted wholly or in part by another drug or v Substance, or v If it purports to be the product of a manufacturer of whom it is not Devinder Pal - Catalyst Pharma Consulting

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

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

Extent of Spurious Drugs - No Validated Data Mashelkar committee report Nov. 2003 v The reported extent ranged widely between 0. 5% (based on the cases analyzed and 35% (ascribed to WHO Studies). v 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’. v 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. v The Mashelkar Committee came to the conclusion, after examining all the data and reports at hand: Ø ‘there was an absence of a scientifically and statistically designed investigation, which could give a realistic estimate of the menace of spurious drugs’. Devinder Pal - Catalyst Pharma Consulting

Yet another set of numbers! v. Deputy Drugs Controller India for West Zone (he has since moved to number one post in FDA) has said: ØHis office had taken over 4000 samples of eight to nine brands ØOut of which only two were found counterfeit. v. He added that the percentage of counterfeiting was as low as 0. 01 % in West zone Devinder Pal - Catalyst Pharma Consulting

Estimates (Guess)Estimates and Statistics v RecentØ sting operation by a TVare channel in India Statistics and estimates like concluded: Bikinis; Ø 30 % of all drugs sold in India were spurious!!! ØWhat they reveal is on interesting… Ø This conclusion was based the clandestine operations unearthed them. but whatbythey hide is vital Ø The TV showed of a cough syrup ØSome arebottles uncharitable enough to being filled … one bottle at a time… by using a funnel & a beaker… no say: machine! are lies, (‘light damn lies, and v At this ‘There rate I guess heartedly’ speaking) the whole of adult Indian population may be needed Statistics’. to produce what might constitute 30 % of We all know, one can use statistics to country’s consumption! prove anything, by selecting sample v Yet a man in the street now believes the 30 % and source` numbersize that has resurfaced on the popular channel that is usually responsible in reportage. Devinder Pal - Catalyst Pharma Consulting

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

Estimates of Anti-counterfeiting group (including Substandard) v According to the anti-counterfeiting group, counterfeit drugs constitute 6 % of world-wide drug sales in 2000 v The group estimated the following figures for some countries: v Brazil: 20%, v Nigeria 60 -70%, v Indonesia: 25%, v Senegal: 10 times the regular market; v India: 20%, v Pakistan: 20 -50%, v China: the largest producer of sub-standard drugs in the world Devinder Pal - Catalyst Pharma Consulting

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

To Sum it up Estimates Vary Widely v We have seen estimates counterfeit drugs vary from a ØYet others of also include: fraction of 1 % to 50 % Ø IPR violations, or v Additional complicating factors are: ØTrademark violations Ø Some numbers are based only on ‘Counterfeits” ØEven sounding Ø Others also include. Similar sub-standard drugs Brand names § Products not complying with the label claims: ü Intentional : lowerthese end the (95% v Even though mayrange be due to to 105%) cross border smuggling – from a ü Unintentional ‘potency or bioavailability or other country producing the product as storage or key parameters effected’ due to bad transportation due to undetected variation in per applicableorlaws. quality of the inputs or cause process v This is root of ü Ignorance (diethyl glycol), conflicting numbers! Devinder Pal - Catalyst Pharma Consulting

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

Serious Cause for Worry v Whatever the %age… v. High or low percentage … counterfeit & spurious drugs are serious cause for worry v. 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 v. Other predictions forecast 10 % of World market will be Counterfeit drugs Devinder Pal - Catalyst Pharma Consulting

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

Counterfeiting of commercial products has been in exisitence… ever since! v. Greed is a common human weakness – not confined to any religion or region v. The problem of spurious and counterfeiting is universal v. 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. Devinder Pal - Catalyst Pharma Consulting

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

What are the Target Products & Markets? v Only a handful of top selling brands are attractive targets – Ø fast moving and high margins are the key words v 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. v Trade in fake medicines is more prevalent in countries: Ø Ø Ø with weak drug regulation and enforcement, Or scarcity or erratic supply of basic medicines, Or unregulated markets Or unaffordable prices, Or poor law enforcement Devinder Pal - Catalyst Pharma Consulting

Lack of Foresight of the Industry & Profession! v. Our lack of foresight that Technology & internet will make the task easier. ØOur lack of foresight of developing and using anticounterfeiting measures - to make it difficult if not impossible. ØLack of effective deterrents punishment, combined with poor enforcement - virtually inviting anybody wanting to get rich quickly, to have a field’s day. ØLack of coordinated preventive actions – not even at country level, leave alone at International level Devinder Pal - Catalyst Pharma Consulting

We forgot that An open door tempts even a saint! v We forget Prevention is always better than Cure! What did we do to prevent temptation getting better of unscrupulous elements? v Not enough (Virtually nothing!) Ø We did not foresee that technology will make counterfeiting a child’s play. Ø We have been complacent … Ø We forget that open door tempts even a ‘saints’ … Ø 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! Ø No security guard– not even a lock on the Jewelers store Devinder Pal - Catalyst Pharma Consulting

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

Learning from experience v. CDs, VCD, DVD piracy in India v. Law and Order problem … much like we in Pharma industry are saying v. Industry leaders got together v. Evolved a strategy v. Pooled monetary and other resources v. Hired professional v. Used police help… but the manufacturers were in driving seat Devinder Pal - Catalyst Pharma Consulting

What needs to be done? v Multi-pronged approach at country’s FDA level Ø Strengthen Drug Administration ü Increase sampling & analysis ü Involve Police in investigation ü Coordinate actions of all stakeholders ü Consumer Education Ø Collect intelligence ü Medical Representatives ü Doctors & Hospitals ü Distribution Channels ü Other investigating agencies ü Profile on sick units ü Associations Devinder Pal - Catalyst Pharma Consulting

What needs to be done -2 ? v Creating awareness amongst: Ø Medical profession, and above all Ø Patients & Public at large v Awareness of Ø Menace & consequences Ø Anti-counterfeiting devices (Meaningless unless educated on What? How to? ) v Identifying countries / regions of higher incidence – to permit prioritization of areas needing higher dose of preventive, punitive actions / resources Devinder Pal - Catalyst Pharma Consulting

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

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

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

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

o n r e n i a r b s i It Giving a Counterfeit to a sick person is akin to sentencing him to death Devinder Pal - Catalyst Pharma Consulting

Perfect Murder v. 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 v. To Catch the Culprit All Stake holders must play their role v. Unfortunately there is no perfect bullet Devinder Pal - Catalyst Pharma Consulting

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

Devinder Pal www. Catalyst. Pharma. Consult. com consult@Devinder. Pal. com Devinder Pal - Catalyst Pharma Consulting