INDEX

A. Problem Statement B. Pharma Scenario in India - Poverty Amidst Plenty & How doctors are used as an instrument 3-4 5-13

1. Prescription by brand name 2. Prescription of non essential drugs 3. Irrational Prescriptions

C. Aggressive Drug Promotion 14-23

1. 2. 3. 4. 5. 6. 7. 8. 9.

Influencing Doctors Lack of objective drug information False evidence based medical practice Promotion of hazardous, banned and bannable drugs Doctors as Key Opinion Leaders Biased clinical trials Disease Mongering Direct to consumer advertising Influencing Government Policies 24-25 26-28 Adoption of Essential Drug List Use of standard treatment guidelines
2. Availability of low cost drugs at govt. run medical shops

D. Implications of unethical promotion E. The Solution

1. Rational use of drugs Prescription by generic name

F. Chittorgarh Model G. Concept Note on generic drugs H. Frequently Asked Questions Annexures Alphabetical List of 570 low cost generic medicines Comparative list of 300 low cost ethical drugs List of 54 IV fluids List of 142 surgical items
Documentation by Dr. Samit Sharma Collector & District Magistrate Chittorgarh (Rajasthan)

29-31 32-33 34-35

(This also contains excepts from "A Lay Person's Guide to Medicines" by S. Srinivasan)

PROBLEM STATEMENT
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Huge gap in access to drugs

With a population of nearly 100 crores, India accounts for 16 per cent of the global population. Sizeable population lives below the poverty line and 48 per cent of the people are illiterate. India accounts for huge morbidity & mortality burden due to large number of deprived & extremely poor people. WHO says that 65% of the population still lacks regular access to essential medicines. With the rise in health care cost, over 23 % of the sick dont seek treatment because they are not having enough money to spend. A study by World Bank shows that as a result of single hospitalization 30 % of people fall below poverty line. Over 40% of those hospitalized, need to borrow money or sell their assets. Healthcare costs are high and are increasing further. Expenditure on drugs constitutes about 50 % of the health care cost which increases up to 80 % in rural areas. (In fact expenditure on health care is the second most common cause for rural indebtedness in India) Where does the money for health expenditure (in India) come from? Private out of pocket 79% expenditure State govt. 14% Central govt. 4% Private investment 3% Private insurance 0 1% India accounts for 22 per cent of the global illness with only 2 per cent of the global drug production of which only 0.7 per cent are essential drugs. Yet 1.3 per cent are non essential, profit-oriented formulations which are highly priced, irrational or useless. Crores of our people, living in abject poverty, can barely afford a square meal a day, can they afford to spend on costly medicines. People are being pushed further into poverty, disability and death because of these costs. Completely irrational drugs, which do nothing but waste peoples money, are widely sold. More and more drugs flood our markets every year. There are over 20,000 pharmaceutical units in the country producing over 1,00,000 (one lakh) formulations of drugs. It is paradoxical that while essential and life-saving drugs are in short supply, more and more drugs which are not therapeutically more effective, irrational and may be even dangerous, are being produced and pushed in the market with absolute disregard to the country's health needs. The problem becomes more acute in developing countries where resources for the purchase of drugs are scarce. In the pharmaceuticals sector, the cost of manufacturing a drug is relatively low, compared to the price it is sold at. By selling drugs at inflated prices, big companies and retailers pocket a large share of the money paid out by the consumer. Retail prices of drugs show complete arbitrary variation between brands. There are abnormally high trade margins with wasteful, unregulated and unethical drug promotion. There is a nexus between drug companies, stockists, retailers, Medical Representatives (M.R.) & some medical practitioners which disproportionately inflates the cost of medicines & the overall treatment. Each

gains down the line, the only loser being the poor patient for whom the drugs become unaffordable. TOP Issue of Research Cost Recovery The life cycle of a drug has four phases: 1. 2. 3. 4. Research Development Patentee commercialization Generic commercialization

When the product is in the research mode, a research institution invents a new drug. Then a patent application is filed to preserve rights. When the institution starts pre-clinical and clinical testing of the drugs, the development phase begins. In the patentee commercialization phase, the innovator (patent holder) begins selling in at least one country. In this process, doctors, patients, hospitals, public health agencies and insurers get involved. Generic commercialization commences when the patent expires in any given country and generic companies start to sell the drug at lower prices. Intellectual property is a vital factor for discovery of new drugs. Without patents, research and development would be reduced. Without generics, access to medicine would be impaired. Thus, we have to strike a balance between encouraging research and development of new drugs and the drugs which are already discovered should be affordable and accessible to the entire mankind. All research should be carried out with the intention of improving the health of the crores of people of this world and not with the intention of getting more and more money out of their pocket. Studies suggest that the money spent on research is just 2 20% of the total turnover, but huge profits are reaped in the name of recovering research expenditure. During the patent period cost should be such so as to recover R & D cost and not in form of monopoly pricing. And after the expiring of patents the cost of generic version should be a reasonable profit added to cost of manufacturing the drug. Drugs which are similar to their predecessors are invented just by making some minor change in the original drug chemical and are then patented and aggressively promoted Me too drugs (higher priced alternatives of a parent drug without a clear therapeutic advantage). In contrast to the breakthrough drugs, they have no significant treatment benefit, but are just created to continue to enjoy the patent protection (ever greening of patents) and thereby reap huge profits after anyhow convincing the doctors to prescribe them. The country where 3 out of 4 children & every other woman are anemic & iron defensive anemia is the most prevalent public health problem; the drug companies are free to sell the iron preparation at any cost which comes to about five to ten times in certain cases. Do we really want to help our anemic children? So, whether it is about the patented drugs or about the out of patent (generic) drugs the story is the same, drug industry is operating with the motive of making huge profits rather than the intention of serving the sick and the needy. The ultimate aim of drug production should be, to make drugs affordable and accessible to all so that people of the world can be cured of their diseases. The pharma industry has to sub serve human goals of promoting health, and that industry cannot operate in a manner that just helps the business elite. Should we allow commercial interests to dominate us so completely?

Pharma Scenario in India - Poverty Amidst Plenty

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India has a vast pharma market, and is rightly celebrated in international circles for making medicines very affordable and low-priced. As of 2003, Indian industry was supplying 20 percent of the worlds drugs and is currently one of the largest pharma industries in the world. At least 60 manufacturing plants in India have US Federal Drug Administration (FDA) approval, second only to the Unites States. Currently a dozen top Indian companies are major suppliers to the US and European market as well as China. India has one of the best developed pharmaceutical industries among the developing countries with over 20,000 units producing between 60,000 to one lakh formulations. The drug industry has a total annual turnover of approximately Rs 52,000 crores. Nevertheless, the booming Indian pharma market coming to the rescue of generic world over, especially by making low priced antiretroviral, is a good part of the story. The not so good part is that the Indian pharma scenario, as far as the ordinary poor consumer is concerned, is a failure of the market. As a result of this extreme market failure of regulation in the absence of well-functioning markets, the drug (medicines) availability situation in India is one of the poverty amidst adequacy there is inadequate access and supply of even essential drugs to the poor despite adequate drug production. Adding to this misery is the poorly functioning public health system. While the sales of Indian pharma companies are increasing steadily, drugs are getting away from the people, more so for the poor. Share of drugs to total treatment costs can vary from 50 to 80 percent depending on rural / urban locations and inpatient / out patient treatment. All-India figures for per capita annual drugs and other medical expenditure (rural) is Rs. 294 out of Rs. 380 for health as a whole. Although there are over 20 thousand drug companies & over 1 lac formulations are sold in the drug market, medicines are out of reach of millions of people, because they are unaffordable. The large scale production has not had any significant improvement in the availability of drugs to meet the country's needs. One of the major reasons for this situation is that, as we have noted before, most of the formulations produced are unnecessary, unaffordable, irrational and very costly. The fact is that the no. of active pharmaceutical ingredients (APIs) is just 550. When the actual number of ingredients is so small the large numbers of pharmaceutical products are just to confuse the doctors & exploit the ignorance of the patients. It has been estimated that barely 20 per cent of the medicines available today are necessary to treat over 80 per cent of the prevailing diseases. About 70 - 80 per cent of the output of some major MNCs in India consists of simple household remedies like cough syrups and vitamin preparations. But lifesaving drugs account for only 20-30 per cent of the total value of the formulations sold by these companies. It is paradoxical that essential & life saving drugs are inaccessible & unaffordable & newer drugs which have no therapeutic advantages , irrational & even dangerous are being produces & marketed at very high prices with utter disregard to country's health requirements. In 1975, the Hathi Committee which was appointed by the Government of India to analyze the Indian drug industry, recommended a restricted list of essential drugs

and that measures be implemented to ensure their production, that a gradual shift be made from brand names to generic names, that price control measures be effected with the aim of making life-saving drugs and essential drugs affordable, that public sector play a leading role in drug production and certain drugs be reserved to encourage the growth of Indian drug companies. The Committee also recommended elimination of irrational drugs. The situation assumes menacing proportions when the manufacture, import, distribution and sale of drugs continue in our country although they are banned, withdrawn or restricted in other countries, including the country of the parent company in the case of MNCs. Despite knowledge of the ban, many pharmaceutical companies continue to market the banned drug, making false claims regarding their safety and efficacy. For example, the ban order on estrogen-progesterone drugs was challenged by certain drug companies and a stay was obtained in 1982 on technical grounds. Anabolic steroids were marketed as appetite stimulants for growing children in the developing countries. Drugs which have a sizeable stake in our country are not marketed by MNCs in their countries, e.g. cough expectorant, pain killers, growth tonics, appetite stimulants and anti-inflammatory containing phenyl- and oxyphenbutazone. Another such drug that has now acquired some notoriety is analgin and analgin-based drugs like Novalgin, Baralgan, etc. It is banned in Germany, parent country of Hoecsht, and in several countries of the West but marketed in India (Baralgan has since been banned in India by an order of the Supreme Court).
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How doctors are used as an instrument to promote these unhealthy & unethical practices of pharmaceutical industry? Once their medical education is over, the doctors largely depend on MRs for information about drugs. MRs knows that for most of the doctors the cure of the patient is of utmost importance. Thus, doctors are made to believe that although a particular brand is a bit costly but it is of the best quality and is the most effective one in the market, which will definitely cure the patient. They are also introduced to so called latest discoveries which will lead to a magical cure, but which are in fact minor chemical alterations in the parent drug & are just introduced with the sole purpose of ever greening of patent and to enjoy monopoly pricing & are non essential drugs. Similarly with utter disregard to patients health needs drugs which are neither indicated nor required for a disease are promoted just to increase the sales figure of the company. Unfortunately most doctors highly depend on MRs for updation of their medical knowledge and their prescription pattern is largely

influenced by them. Unsuspecting doctors fail to understand that the person coming to them has been hired by a drug company to promote its sale and make profits. TOP Thus, unknowingly doctors help the drug companies and adversely harm the patients in three different ways. 1. Prescription by brand name 2. Prescription of non essential drugs 3. Irrational Prescriptions 1. Prescription by brand name In India there are 72 salts which come under drug price control order (DPCO). It means that the selling price of these drugs is under control & decided by the NPPA (National Pharmaceutical Pricing Authority). This also means that for all the remaining drugs, the drug companies are free to decide the selling price (MRP). Although it is said that in free market economy, market forces will decide the price to the consumer but in case of drugs it is not so. The reality is that the same salt is being marketed by different companies under different brand names but the selling price is to the extent of 10 times to its cost price, which means 1000% profit is reaped. This is made possible using a marketing strategy of employing Medical Representatives, who using various means persuade the doctors to prescribe medicines by brand name of the company & the unsuspecting patient has no choice except to buy that particular brand even when less costly alternatives are available in the market. So, due to brand names artificial monopolies are created in the pharmaceutical market which prevents price competition amongst the same product and consequently all the brands are sold at high prices. For example:Amikacin Drug Name given Salt name of Rate at which drug Rate at which manufacturing by medicine is purchased by the drug is sold to company company (Generic chemist (Stockiest the customer (Brand Name) price) (Printed MRP) Name) One Injection Cadila Amistar Amikacin 500 8.00/70/500 mg German Amee 500 Amikacin 500 8.00/70/Remedies mg Wockhardt Zekacin Amikacin 500 9.90/70/500 mg Alembic Amikanex Amikacin 500 8.22/64.25/500 mg Intas Kami 500 Amikacin 500 8.13/60/mg Unichem Unimika Amikacin 500 7.80/72/500 mg Ranbaxy Alfakim 500Amikacin 500 8.50/70/mg Cipla Amicip 500 Amikacin 500 7.42/72/mg

For example if doctor has to treat a patient of blood cancer, he may advice the salt Imatinib by various brand names. If he has prescribed brand Glivec a months course will cost Rs.1,14,400/- to the patient. Whereas, the same anti cancer drug, but with a different brand name Veenat costs just Rs.11,400/-. And Cipla supplies the generic equivalent of this drug (@-imitib) at Rs. 8,000/- only, also Gelnmark supplies it for Rs. 5,720/-! All these brands contain the same salt Imatinib, in the same quantity, conform to the same quality standards and are equally effective. TOP

See an example where the same company markets the same salt by different brand names and use differential pricing policy. Drug Name Salt name of Rate at which Rate at manufacturin given by medicine drug is which drug is g company company (Generic Name) purchased by sold to the (Brand the chemist customer Name) for 10 Tablets (Printed (Stockiest price) MRP) Cipla Alerid Cetrizine 10 mg 28.85/37.50/ Cipla Cetcip Cetrizine 10 mg 1.88/33.65/ Cipla Okacet Cetrizine 10 mg 1.84/27.50/ -

If you dont believe this then see the list below.

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MRP Printed on the pack Stockist Price

Brand name also violates the right of the patient to choose a product as per his pocket condition. If doctors prescribe by salt name instead of brand name then various products can be compared & the one with the lowest price can be offered to the patients which are at times even 5-10 % of the MRP. Even oldest of the drugs like paracetamol, iron, etc for which there is no patent protection and anybody can manufacture and sell it continues to be marketed at high prices. This is done by appending a brand name to these out of patent drugs. The same salt is being marketed by different companies under different brand names but the selling price is to the extent of 10 times to its cost price, which means 1000% profit is reaped. This happens because the Medical Representatives of the company persuade the doctors to prescribe medicines by brand names & the patient has no choice except to buy that particular brand even when less costly alternatives are available in the market. BRAND MONOPOLY ELIMINATES PRICE COMPETITION
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There are a number of reasons why the prices of drugs in India, indeed all over the world, are so high. One of them is the business of branding. In many developing countries, consumers buy the same drug marketed by several different producers under different brand names, not realizing that they are all the same product. Paracetamol, for example, is the generic name, for a painkiller. It is available under more than 20 brand names -- Crocin, Calpol, Metacin, Pyrin - all of which are paracetamols. The consumer, however, is not aware of this. Drug companies and doctors may swear that one particular drug is more effective than the other, although this cannot be so as they all contain the same ingredient and conform to the same quality control standards. Similarly, metronidazole is sold by the name of Amivan, Flagyl, Aristogyl, etc.

The

same

with

different

names

Thus, by branding a drug and advertising it, the drug company plays on a consumer's psyche and brings about an increase in the price of the drug. For example, it costs around 15 paise to produce one tablet of paracetamol. Pharmaceutical companies sell the same drug for around 80-90 paise under the brand name Crocin. That branded drug is sold to consumers through advertisements; companies spend huge amounts of money on television advertisements and other kinds of marketing techniques. Brands compete with each other in the market and the cost is passed on to the consumer. This is the reason why drugs are so expensive. The pharmaceutical sector thus earns profits at the cost of the poor and ignorant consumer. The creation of brand names, leading invariably to high prices, monopolies by big companies and the vulnerability of consumers, are all aspects related to profiteering in the

pharmaceutical sector. This monopolisation of the market by the drugs industry is one of the main reasons why drugs are so costly.

A look at the growing list of branded drugs also emphasises monopolies in the market. Take the case of Ciproflaxacin -- an antibiotic used to fight typhoid. Almost half the Ciproflaxacin sold in the market comes from one company; effectively this drug is the brand leader as well as the price leader. Being a brand leader, a company, whether it be Cipla, Alembic or Glaxo, is able to control the market using various marketing strategies and offering huge margins to retailers and doctors. This way, even if prices are kept high, people will continue to buy the drug. It is assumed that market forces promote competition. In a free market the competition results in lowering and more importantly, levelling the prices. But this may be true in generic drug market but not in proprietary (branded) drug market like that exists in India. Monopolies are created artificially by means of brand names. In India the prescription and dispensing of medicines is mostly by brand names. This is in fact the Trade Secret of the pharma business. Different companies manufacture the same salt by different brand names. The companies allure doctors (via M.R.s ) and induce them to write a particular brand. The patient has no option but to buy the brand at the M.R.P. which the company has decided to print. Besides this, the consumers/patients have no choice as they do not select the medicines like in other consumer goods. The doctors or chemists decide it. Thus, even when so many companies are manufacturing the same salt there is virtually no price competition in the market. And all brands are sold at very high rates. The same salt of equal potency is made by different companies and marketed under different brand names for different prices (MRP)
2. Promotion of Non essential drugs NON ESSENTIAL
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DRUGS

There are a total of 354 drugs in the National List of Essential Medicines (NLEM), which are adequate to take care of the majority of the health needs of the For the Patient population. But when we analyze the sales of top 300 brands only 38% of brands are of the drugs mentioned in the NLEM. The other 62% brands comprise drugs For the that are higher priced alternatives without a clear therapeutic advantage and Patient many are unnecessary, irrational and even hazardous.

Doctor should act as FILTER

ESSENTIAL DRUGS

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This indicates that contrary to what is advocated by WHO & as adopted in our national health policy, the drugs which are most useful & cost effective for the treatment are not being prescribed & the non costlier & irrational drugs are sold more often (The government of Rajasthan has directed that at least 85% of the drugs prescribed should be from EDL) TOP Top 300 Brands and their Relation to the National Essential Medicines List The moving annual total (MAT) from the retail sales of top 300 brands alone is Rs. 18,000 crores. Some of the top-selling Brands in India as per ORG-Nielsen Retail Audit Brand name Corex Becosules Liv-52 Neurobion Nise Dexorange Uses and Remarks Moving Annual Total in rupees crore (Oct 2003) Cough suppressant. Abused as drug of 88.18 addicition because of presence of codeine Multivitamin, unnecessary preparation 79.74 Ayurvedic liver preparation 62.67 Irrational Multivitamin preparation 60.27 Hazardous drug for pain relief 58.31 Irrational preparation for anemia 57.65

Top Selling Drugs Outside the NLEM include: (i) Higher priced brand of either the same drug or a higher priced alternative to a lower cost essential drug Example: Cifran brand of ciprofloxacin is the largest selling antibiotic, whereas it is the costliest among the ciprofloxacins. Other brands of ciprofloxacin (e.g. Zoxan) although three times cheaper, sell five times lesser than Cifran. (ii) Irrational combinations of drugs, which only add cost but are of no therapeutic value, are touted as effective remedies and promoted aggressively. In our country about 75 % of the children & 50 % of the women suffers from Anemia and iron deficiency anemia is responsible for 1/3 of all maternal deaths. But the most popular prescription is of fancy multivitamin formulations instead of iron and folic acid preparations. The sales figures reflect the fact that in India, drugs which are not considered essential sell more than rational & essential drugs, that costlier drugs most often sell more than cheaper alternatives (even those made by well known manufacturers), and downright irrational and hazardous drugs are among the topsellers. The majority of sales are coming from the sales of drugs not considered relevant by experts for inclusion into an essential medicines list, and not considered important by the government for regulation of their price. Brief analysis of the top 300 brands suggests that the Indian doctors are prescribing drugs without adequate

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concern for evidence of their efficacy, safety and cost. This is because of poor access to unbiased information on drugs, aggressive and often misleading drug promotion by the drug industry. The result is increased health care costs, irrational use of drugs and exposure of patients to the risk of unsafe drugs. Vitamins and Tonics These are some of the most highly selling and highly priced products in India. Vitamin and tonics are in many cases a mixture of Vitamin B-complex or vitamins in solutions of sugar and alcohol. Among the top-selling 25 medicines in India are Becosules, Neurobion and Dexorange; the first two are irrational and / or unnecessary multivitamin preparations and the last is an irrational iron tonic. Vitamins deficiency should be treated with specific vitamins in dry tablet form. Tonics are hazardous when substances like caffeine, leptazol, are combined with vitamins. Regular intake of Vitamin A and D can be excessive and hence hazardous. Bangladesh had banned tonics, enzyme mixture / preparations and restorative product because such products flourish on consumer ignoranceand of no therapeutic value. The United Kingdom does not recognize tonics as drugs. The production of the high-potency or Forte preparations of multivitamins is a sheer economic waste. It is a drain on the consumers and government dispensaries. High-potency preparations are also a drain on the countrys foreign exchange as most of the raw materials have to be imported. The table below shows that the sale of these rarely required tonics is in hundred of crore rupees. TOP S.N . 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Brand Name Becosules Revital Polybion Zincovit Cobadex Forte Methycobal Zincovit Neogadine Riconia R.B. Tone A to Z M2tone Supradyn Becadexamin Raricap Becosules-Z Optineuron Total Moving crores) Annual Total (rupees

79.74 47.64 40.85 32.26 26.10 21.87 21.65 21.52 20.78 20.21 19.07 18.22 15.25 14.63 13.89 12.03 11.97 437.68

It shows: According to the Pharmaceutical Industry, Most Common Public Health Problem of India is Not Anemia, but B-Complex Deficiency!

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3. Irrational Prescriptions

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Ideally use of drugs should be only when there is an appropriate indication, but this is not in the interest of the drug industry which is more interested in sales promotion. Higher the sales, higher the profit. Therefore doctors under constant persuasion of MRs sometimes follow what is being promoted by the brochures of drug companies instead of prescribing what they have read in their standard medical text books. For example: -> A one year old with low body weight for age is seen in the OPD, because the parents noticed a pot belly. This is due to under nutrition. The family is poor but the child has not been weaned and given solid foods. Should the child receive advice on feeding or an alcohol-based 'multi-vitamin tonic'? -> A computer professional has low-backache because of long hours of sitting at the desk in a faulty posture on a faulty chair. Should he receive long term painkillers like indomethacin, valdecoxib, tramadol, etc (all of which have well known serious side effects) or advice on posture, exercise and a proper chair which supports lower back? -> A chronic smoker comes with cough off and on, especially in the morning. There is no shortness of breath. The clinical examination is normal. Should he receive a cough suppressant, an antibiotic or advice and support for stopping smoking? Reasons for Irrational Prescribing: 1. 2. 3. 4. 5. 6. The MR said so. The latest is the best (latest antimalarials, antibiotics, analgesics, etc.) Costlier the drug, the better it is. The more I write the more I earn. Availability of Irrational Drugs in the Market The patients demand it (or, I will lose my practice).

Aggressive Drug Promotion:

There are more than 100,000 formulations (at five products per company for the estimated 20,000 manufacturing units India) in the Indian market, many of which are similar except for different brand names or for a few unnecessary additional ingredients. Pharmaceutical companies therefore indulge in aggressive marketing to promote the sale of their brands. Sometimes, it results in unethical marketing practices. As pharmaceutical business is very profitable, it is hardly any wonder that pharmaceutical companies spend at least 20 percent of their sales revenue on promoting their products. Drug promotion is carried out by means of heavy advertising, frequent visits to private medical practitioners by the medical representatives of pharmaceutical companies with literature on their drugs, free sample of drugs, and even gifts like diaries, posters, calendars, pens and sometimes also invitations to medical conferences held in five-star hotels. The companies also encourage articles in newspapers and magazines, television and radio programs, release promotional materials as news stories about latest developments in medical field and sponsoring television programs. Thus, drug

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promotion is a comprehensive attempt to influence the doctors to suspend their critical judgment and prescribe what is profitable for the manufacturer. 1. Influencing Doctors to prescribe irrational, non essential drugs by brand name Companies prefer to spend more on drug promotion because they recover their expenses by pricing the drug highly. Doctors are influenced into prescribing a particular brand which is often more expensive. The Hathi Committee in its report, made this observation about the multinational drug industry: "High pressure sales techniques coupled with distribution of medical samples on a liberal scale to the medical profession was their (MNC's) forte". According to David Jones, former vice president of Public Affairs for Abbott Laboratories, and former Executive Director of Public and Professional Affairs for Ciba-Geigy, "Prescription drugs are marketed as if they are candy. Claims are made beyond what the product will do. Demand is inflated beyond the medical need. Uses are promoted that are neither healthy nor wise" World over, and in India specially, medicines are promoted by all means fair and foul. Drug industry treats doctors as prescribers and not cares givers. 2.
TOP

Lack

of

Objective

Drug

Information

It is doubtful whether the majority of doctors in India are in the habit of regularly referring to standard textbooks or standard medical journals. In Britain, all practicing doctors are supplied every six months with a copy of the British National Formulary (BNF) which contains reliable, updated information including costs on the preparations on sale in the UK. In the absence of objective information on new drugs, doctors in many Third World Countries, are fully dependent on drug information supplied by the pharmaceutical companies. And owing to the profit-oriented nature of the drug companies, the information provided in its literature is bound to be in favor of the drug. The prescribing information in most publications cannot be relied upon. Some of these journals bring out "Review of New Drugs", which are actually based on unreliable information. These publications even bring out pseudo-scientific reviews of irrational drugs! Doctors in India usually rely on information supplied by medical representatives and drug companies which can be very biased and selective. Also, doctors are led to believe a lot of new products are being marketed every day. Many of these are not new discoveries, which radically alter the course of treatment. 3. False Evidence-based medical practice: The practice of medicine based on scientific evidence is more talked about and less practiced. Some times evidence is selectively quoted or false evidence is produced to promote a drug. For Example:

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Glaxo Laboratories cited the authority of a British medical journal, the Lancet to promote its sales of Ostocalcium B-12 even though there was no such endorsement of the product in the Lancet. Boehringer-Knoll quoted UNICEF and used their logo to promote the use of streptomycin-chloramphenicol combination for diarrhoea treatment, whereas UNICEF promotes simple ORT for most diarrhoea. Franco-Indian Laboratories misquoted Goodman and Gilman to promote their tonic, whereas Vitamin B-12 has no role in ordinary anaemia. S.G. Chemicals (Indian subsidiary of Ciba-Geigy) misquoted Goodman and Gilman and Martindale to promote a combination of two dangerous drugs analgin and oxyphenbutazone, whereas in fact the texts warn against this dangerous combination. There also exist double standards in the information given on drugs by MNCs in the developed and developing countries. In the developing countries, warnings about the side-effects or contraindications are not given; drugs are recommended when their efficacy is not proven and even when its safety is not established fully. For instance, oral contraceptive drugs are not recommended in U.S.A. and Britain for premenstrual tension, menstrual cramps, and menopausal problems and in dysfunction of the female reproductive system.
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Opinions of International Panel on Drugs Advertised in Indian Edition of BMJ Trental 400 (pentoxifylline): The advertisement makes unsubstantiated claims of improvement in mental function. (This drug is marketed only for peripheral vascular disease in America and Britain; in India it is indicated for cerebrovascular disease as well) Relaxyl (diclofenac): The claim gentle on the gastrointestinal tract is not in accord with the reported high incidence of gastrointestinal side effects (up to 30% in Australian approved product information). 4. Promotion of Hazardous, Banned and Bannable Drugs Internationally, a whole group of "block buster" drugs have been in serious trouble. These include rofecoxib ("Vioxx"), valdecoxib ("Bextra"), celecoxib ("Celebrex"), atoravastin ("Lipitor"), etc. as of writing there is enough evidence to doubt the safety of a host of cyclooxygenase (COX) -2 inhibitors. (i) The case of Rofecoxib shows how a leading MNC drug company with a block buster does anything to ensure its continued presence in the market, how research studies are reported and interpreted selectively and how meta-analyses

15

can be used to support contrary positions, and how the US FDA acts ever so haltingly and indecisively. Rofecoxib was first marketed by Merck in 1999. The following year, a randomized trial revealed increased rates of adverse cardiovascular events. Merck aggressively defended rofecoxib's safety with a series of meta-analyses and retrospective studies, and spent hundreds of millions of dollars marketing rofecoxib to physicians and consumers. Merck's eventual decision to withdraw -effective September 30, 2004 from the market was based on an increased risk for heart attacks and strokes. US FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 per cent of which were probably fatal, in the five years the drug was on the market.
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(ii) Valdecoxib was eventually withdrawn on April 7, 2005 after a US FDA request asking Pfizer to voluntarily remove Bextra (valdecoxib) from the market, a decision based on an incidence of severe skin reactions and evidence of increased risk of cardiovascular malfunction. (iii) Celecoxib is the only COX-2 inhibitor still available. It now carries a boxed warning regarding cardiovascular and gastrointestinal risks. The Drug Controller General Of India (DCGI) has asked drug companies to carry a warning on the label of selected Cox-2 inhibitors. "This drug should be used with caution in patients from Coronary Heart Disease (CHD) / Cardiovascular Disease.

(iv) Atorvastatin. Pfizer misled consumers into using its anti-cholesterol drug brand Lipitor despite the absence of evidence from clinical trials that the drug or others in its class are of any benefit to large segments of the population, according to a consumer class action lawsuit filed against the worlds largest maker. Lipitor is in the class of cholesterol lowering drugs and it is the best selling drug in the world, with sales in 2004 of more than $10 billion. The idea that lowering cholesterol always reduces the risk of heart disease had become the conventional wisdom, which drug companies like Pfizer have taken great pains to promote. But for women under 65 and people over 65 with no history of heart disease or diabetes, the evidence isnt just there. Millions of women and seniors are spending huge sums to take Atorvastatin every day despite a lack of proof that its doing anything beneficial for them, and may actually be harming the elderly with its side effects. (v) Thalidomide: most women experience nausea during pregnancy which is a physiological condition, but interestingly a drug was invented to cure it and blindly propagated with the sole purpose of making money. It is another example where a drug was pushed into the market without adequate evaluation of its safety.

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Unfortunately above 8,000 mothers who unsuspectingly took the drug bore children without arms and legs, the condition which is known among doctors as phocomelia (seal like limbs). (vi) Clioquinol a widely used over the counter drug to treat diarrhoea and marketed as Entero-Vioform, Mexaform, etc. It damages the central nervous system resulting in paralysis, blindness (Subacute myelo-optic neuropathy, SMON). About 11,000 people in Japan were victims of these side effects caused by the drug. The Swiss drug company, Ciba-Geigy, was found guilty of marketing this drug without revealing its hazards.
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(vii) Nimeuslide was discovered by an American Company, 3M Pharmaceuticals, but never got approval for use in the US, Canada, Britain, Australia, New Zealand and 140 other countries around the world. It was banned in Spain and England in 2001 on reports of its hepatotoxicity. Even in Sri Lanka and Bangladesh, it is not allowed to be marketed. In August 2003, the European Medicine Evaluation Agency (EMEA) had banned the use of nimesulide in all the 25-member countries. Its use for fever is not permitted. Numerous studies have established the life-threatening adverse events with nimesulide such as hepatotoxicity, renal toxicity, severe skin reactions including fixed eruptions, gastrointestinal toxicity, potentiation of seizures, potentiation of colitis in passive cigarette smoking. There is no reason for selecting nimesulide as the first drug of choice for fever or pain. In India, marketing approval for the drug was granted in 1994 for painful inflammatory febrile disorders but unfortunately due to huge profit potential it is being promoted as first line antipyretic therapy. Despite of serious side effects and its indication for specific clinical conditions, there is abundance of Nimesulide Formulations in our country. Pharmabiz.com reports that, ...200 nimesulide formulations are marketed without the approval of Drug Controller General of India. Out of these 200 products, 70 are nimesulide suspensions and the remaining 130 are fixed dose combinations of nimesulide with a number of other drugs. Combinations of nimesulide and paracetamol, numbering 50, are the largest segment in this group. Top selling brands in all the three categories are being marketed by major pharmaceutical companies in the country Studies have shown that nimesulide should not be used as the primary mode of treatment as an antipyretic or analgesic, especially in children, for whom much better and safer choices are available. But there are over 70 brands of pediatric suspensions, including Nise of Dr. Reddys Labs and Nimulid of Panacea Biotec. Two account for more than 50 per cent of the market. And the nimesulide market is around Rs. 700 crores with profit percentage over 1500%. When a PIL was filed in Delhi High Court seeking a ban on nimesulide, it was informed by DCGI that on the basis of an opinion poll among just 50 doctors of the over 4,00,000 doctors, the Indian Medical Association (IMA), Delhi branch, has

17

come to the conclusion that nimesulide was safe and effective for all age groups starting with day one to over 60 years. In the wake of media reports the Indian Academy of Pediatrics (IAP) also advocated use of nimesulide by Indian children. It is indeed disturbing that while the leading countries of the world have not allowed / banned or withdrawn the drug, the opinion of a mere 50 private doctors has tilted the scale towards allowing the drug to continue to be marketed in India, because of the vested interests of the powerful pharma industry lobby.
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(viii) Depo Provera is an injectable contraceptive for use by women manufactured by the American multinational, Upjohn. This drug is not allowed for use as contraceptive in USA. Yet the drug is sold in the Third World for contraceptive use. The drug is associated with breast and endometrial cancers and lowered resistance to infection. The drug causes severe birth defects if a woman who is unaware of her pregnancy, take the drug. (ix) Dexorange: An outstanding example of a patently irrational drug is that of Dexorange. This formulation is used for treatment of one of the most common and serious health problems of people, anemia. It is one of the top selling preparations in India with a Moving Annual total in retail sales of Rs. 57 crores. Till 2000 this company, for over a decade and a half, was adding minute amounts of hemoglobin obtained from slaughterhouses under unhygienic conditions to its otherwise irrational formulation of iron. The amount of hemoglobin added to the preparation was such as to provide a meager additional 2-3 mg of iron per 15 ml. Finally, the Government banned hemoglobin. But, the addition of hemoglobin of animal origin to an iron preparation is without parallel in the pharmaceutical sector worldwide. No other formulary mentions it, and no other country ever allowed it. This particular preparation still contains an iron salt, which is less efficiently absorbed, in a concentration that is low, and is still marketed at a price that is extravagant. The cost of treating iron deficiency anemia with this preparation can be up to Rs. 600 per month, against the cost of a simple iron-folic acid preparation that should cost Rs. 9 per month. The case of the consistent marketing success of Dexorange is not a mere example but stands as a damning indictment of the state of affairs in the pharmaceutical sector, the government and the prescribers. It has put the interests of the voiceless patient / consumer in the background. (x) Cisapride: Causes acidity, constipation, etc. Reason for ban: Irregular heartbeat. But continues to be marketed by brand name: Ciza, Syspride, etc. even as suspensions for our children. 5. Doctors as Key Opinion Leaders: Key Opinion Leaders (KOLs) are influential specialists in their fields such as doctors at teaching hospitals, senior consultants, authors etc. An endorsement by a KOL in favor of new products or new uses of old products is a top priority for pharma companies. Aggressive, often highly unethical, tools are employed to capture KOLs. Consider the following actions of drug companies and their KOLs. 1. Sun Pharmaceuticals sponsored over a dozen educational seminars all over India to advocate Letrozoles use in infertile young women. KOLs were paid up to Rs. 30,000 per lecture to endorse the new indication. It is illegal to promote any drug for unapproved indications.

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2. According to one KOL of Jammu, he has already prescribed cisapride to

40,000 patients. Another KOL from Jammu says the same thing in the same language and he too has prescribed for 40,000 patients and from 1990 at that when the drug was not even marketed! Another KOL says it is okay to give it to infants for pain in abdomen when it is prohibited for use in children and yet another has determines that the side effects of cisapride are to be found in 0.0001% of the patients whereas the US FDA says it is about 5 percent! TOP

3. Professional associations endorse products: Delhi branch of the Indian Medical Association endorsed nimesulide and in its so-called survey for the purpose, the sample of adults to children taken if extrapolated results in the number of children of India being more than the population of India!

4. The Journal of Indian Medical Association has a Research Analysis

Section that in effect provides a platform to Pharma companies to market their products. Example: JIMA (Volume 99, No 3, July-Sep 2001) published two articles in a span of a few months. Both promoting iron polymaltose (IP) preparations claiming superiority of IP over ferrous fumerate and then quotes the publication of these papers in marketing Mumfer, its brands of IP!

A further and more blatantly unethical form of manufacturing consent is by ghostwriting research papers. Estimates suggest that almost half of all articles published in journals are by ghostwriters. While doctors who have put their names to the papers can be paid handsomely for lending their reputations, the ghostwriters remain hidden. They, and the involvement of the pharmaceutical firms, are rarely revealed. 6. Biased Clinical Trials The medical fraternity believes in evidence based medicines but many times: trials are sponsored, evidence is created and favorable results are arrived at. Research that is sponsored by a drug manufacturer is more likely to yield a positive result for the companys product. Examples of Methods for Pharmaceutical Companies to get the Results they want from Clinical Trials: 1. Conduct a trial of your drug against a treatment known to be inferior. 2. Trial your drugs against too low a dose of a competitor drug 3. Conduct a trial of your drug against too high a dose of a competitor drug (making your drug seem less toxic) 4. Conduct trials that are too small to show differences from competitor drug 5. Do multi centre trials and select for publication results from centers that are favorable. 6. Conduct subgroup analyses and select for publication those that are favorable. 7. Present results that are most likely to impress. When we talk of scams involving drug trials in India, none can forget unethical trials of G4N which was discovered in USA but was unlawfully tested on oral cancer patients at Regional Cancer Center in Kerala.

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Drug companies, driven by economic pressure conduct often post-approval studies. Merck and Pharmacia did extensive post-approval studies to show that their arthritis pain medications, Vioxx and Celebrex, were easier on the stomach. Mercks study, involving 8000 adults, showed Vioxx causes fewer stomach complications but also found it increases the risk of heart attacks. Despite that only the advantages were selectively revealed, intentionally hiding the life threatening side effects. In fact, it is better to kill a new hazardous drug which is brought into the market without adequate clinical trials rather than to kill many unsuspecting patients. TOP 7. Disease Mongering: Corporate Construction of Disease One of the important ways drug companies make money is by telling people they are sick, even when they are passing through one of lifes many normal transitions. This Disease Mongering suits the medical profession too, as it helps medicalising problems.

1. In India, piractecam is being promoted for vague conditions like

intellectual decay, social maladjustment, lack of alertness, change of mood, deterioration in behavior and learning disabilities in children associated with the written word. The recommended duration of treatment for the last indication is entire school year in dose of 3g per day i.e. 7-8 capsules of 400mg daily. If the drug is administered for the entire school year as recommended, it will mean parents buying at least 2700 capsules at a cost of Rs. 12,775 year after year. The unending claims of the drugs efficacy include the treatment of sickle cell anaemia, stroke and vertigo. In Britain, piracetam (Nootropil) is permitted for use in just a single indication, a rare disorder called cortical myoclonus, that too only as an adjunctive therapy. While in India, the drug is being promoted for use in young children, in Britain its use is contraindicated for adolescents under the age of 16 years. If the Indian company marketing piracetam is to be believed, the drug is nothing short of nectar. It has no contraindications; no need to observe any precautions and no adverse drug reactions. In Britain, the drug is contraindicated in hepatic and renal impairment, during pregnancy and lactation. It is not marketed in USA.

2. Buclizine (brand Longifene in India) is being promoted as appetite

stimulant while the drug itself is not commercially available in the US and is restricted worldwide for treatment of migraine in combination with analgesics. Internationally reported adverse effects include: drowsiness, blurred vision, diarrhoea, difficulty in passing urine, dizziness, dryness, tachycardia, headache, nervousness, restlessness, hallucinations, skin rash and upset stomach. Bottles of Longifene, the only brand of buclizine being sold in Indian do not contain either the package insert or the patient information leaflet.

3. Warner Lambert invented a condition called halitosis which makes

ordinary bad smell in the breath sound serious. Sales of Listerine rose from US $ 100,000 to US $4 million in six years.

4. In the 1980s Glaxo needed to expand their market for ranitidine (brand
Zantac). They again created a condition called gastro-oesophageal reflux disease (GERD) which is a serious sounding name for heartburn, an ageold complaint. The companies also setup a platform called the Glaxo

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Institute for Digestive Health, which in due course led to a PR exercise called Heartburn Across America. Annual sales of Zantac peaked at US $2 billion.

5. Capturing impotence in an acronym: During the 1990s Pfizer had to

create a market for sildenafil citrate (Viagra) and it ended up calling the broader condition of impotence as erectile dysfunction (ED). Calling impotence ED caused probably less embarrassment to shy patients as they could now discuss a medical problem called ED with their doctors.
TOP

6. A legendary example of this condition (called) branding strategy was the

development of Xanax (alprazolam) for panic disorder. A conference then published diagnostic criteria for panic disorder and how best to treat it. Of course, Xanas was the first to receive an exclusive indication, thereby maintaining its leadership in anxiety disorders.

7. In Australia, baldness in men was medicalised by merck to sell its hairgrowth drug finasteride (Propecia).

8. Manufactures

of fluoxetine as a marketing strategy eulogized premenstrual syndrome which is a routine physiological hormonal transition. valuable treatment for social phobia. Its press release says more than one million Australians suffers from this soul-destroying condition.

9. Roche started promoting its antidepressant Aurorix (moclobemide) as a

Where most of the drug research is funded by the pharmaceutical industry, truthful reporting is unlikely to occur. 8. Direct to consumer advertising (DTCA) Some products which should be taken under medical guidance are marketed through advertisements using electronic & print media. Tall claims are made about the results they will bring about but they are silent on the side effects which will occur. Thus medicines are promoted like any other consumer item just to increase the sales. For example Oral emergency contraceptive pill: Unwanted 72 and I-Pill

Cough Syrups

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Cough Syrups and expectorants are mixtures of drugs which stimulate coughing (ammonium chloride, ipecac) as well as those which suppress coughing (codeine, noscapine) and antihistamines that dry the secretions (some common brand names are Benadryl Expectorant, Piriton Expectorant, Avil Expectorant). Prolonged use of cough syrup is habit-forming, it may cause stomach upsets, reduce food intake and cause drowsiness. Coughing is a protective activity of the body. It should not be suppressed except in certain conditions. Simple steam inhalation is advised. If it is necessary to use drugs, use only a single ingredient cough suppressants such as codeine, dextromethorphan. There is no scientific basis for using cough suppressants and cough stimulants together. The WHO List of Essential Drugs does not include cough syrups and lozenges. Bangladesh has banned them on the grounds they are "of little or no therapeutic value and amounts to great wastage of meager resources"
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9. Influencing Government Policies Multinational companies (MNCs) are complex, highly technical structures, with economic and political clout often exceeding that of the governments of the countries where they operate. In a bid to expand their markets internationally, MNCs resort to business practices which may be unethical. They are known to take advantage of the economic weaknesses of the host countries to conduct operations of a nature which have deep adverse effects on the host country's economy, human health and environment.

The companies repeatedly and illegally influence policy makers, to keep the essential drugs out of price control and to keep on utilizing pharmaceuticals that have been banned in developed countries and dumped on the Third World. All in all, the abuses and false promotion of needless, costly, and irrationally combined medications have reached alarming and health-threatening proportions, particularly in India.
HISTORY OF DRUG PRICE CONTROL IN INDIA India being a socialistic country, decided to control the prices of medicines. Two important policy interventions had helped keep drug prices from spiralling. One, the 1970 Patents Act and the other, the Drug Prices Control Order (DPCO). The former did so by making process patents valid in India for pharmaceuticals. This dramatically brought down the prices, facilitating local bulk drug manufacture at costs one-tenths of international drug companies. The latter is issued under Essential Commodities Act,1955 which empowers the central govt. to keep a check (ceiling) on drug prices by issuing Drug Price Control Order (DPCO). In 1979, 347 essential drugs were under control. Subsequently drug companies, national and multinational, had their way, and have succeeded in persuading the government to reduce the basket of price controlled drugs from 347 in 1979 to 142 drugs in 1987. In 1995 this came down to 76 and at present only 74 out of over 500 commonly used drugs are under statutory price control. It means for all the remaining drugs the companies are free to charge any price from the patient, as there is no ceiling on M.R.P. This is an irony that most of the essential drugs and their formulations are outside the PRICE CONTROLLED DRUGS LIST. This means that for all other drugs, the companies are free to fix MRP of their choice ,

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which could be 5 to 10 times the actual production cost (even at the cost of many lives).

Implications Irrational
TOP

of

Unethical Use
THE SUFFERING

Promotion and of Drugs

The consequences of this widespread uncontrolled misuse are devastating: 1. MEDICINES BECOME UNAFFORDABLE.- Suffering and deaths Profiteering and huge expenditure incurred on marketing & commissions by drug companies inflates the cost of medicines many times. By selling drugs at inflated prices, big companies and retailers pocket a large share of the money paid out by the consumer. In low and middle-income countries including India, public medicine expenditure does not cover the basic medicine needs of the majority of the population. In these countries, patients pay for 50-90 per cent of the medicines from their own pockets. Consequently, many families are driven into debt. Many Indian families shift below poverty line, annually due to health expenditures. Many patients spend their lifetime savings to procure them. Many who have no savings have no option, but to die without treatment. WHO estimated in 1999 that the percentage of Indian population had sustainable access to essential drugs was in 0-49 range, categorized as very low access country. This is the most unfortunate part of the story. It is important to remember that consumers of pharmaceutical products are extremely vulnerable. They are in no position to reject or postpone buying medicines, even if the medicines are expensive. If a doctor prescribes a particular drug, the patient has to buy it. Drug companies exploit this vulnerability, especially in India where drug consumers are fragmented and unrepresented, unlike in the West. In the West, people either get themselves insured or are insured by their employers. The insurance company buys the patient's medicines. Expenditure on health is also responsible for APL to BPL shift, rural indebtness & failure to rise above poverty line.

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Lets take an example. A doctor has prescribed an injection (Amikacin 500) for pneumonia which bears MRP of Rs. 70. In India there are many patients who have just Rs. 10 in their pocket and hence are not able to purchase injection Amikacin as it is sold in the market at Rs.70 (MRP). Therefore, many poor patients are forced to die for want of medicines. Although, the actual cost is less than Rs. 10. In our country where millions live below poverty line, many poor people die like this, every day, in this criminally exploitative and brutally unjust system. If, the injection which actually costs Rs. 8 could be supplied at Rs. 10 instead of Rs.70 (printed MRP), many more patients could afford treatment and many more lives could be saved. 2. INAPPROPRIATE MEDICATION Approximately 4 million children die each year from diarrhea-related causes, primarily dehydration, according to the WHO. Many of these deaths can be prevented through oral rehydration therapy, which is simply the replacement of fluid and mineral losses caused by the diarrhea with a mixture of clean water, salt and sugar. Yet, according to WHO appropriate treatment "often remains the exception rather than the rule. A large number of pharmaceutical agents of dubious efficacy and potential toxicity are widely used. Tragically, many spend their scant savings on medicines that are ineffective, worthless and sometimes even harmful. The inappropriate use of drugs often delays or replaces appropriate treatment. TOP Many drugs eg. protein powders, vitamins, health tonics, etc which are not required for the patient are prescribed, virtually regardless of the condition being treated, just to increase the sale of a particular brand and draw commissions from this sale. Side effects are inevitable in such cases. Also, indiscriminate use of antibiotics could lead to resistance. 3. CIRCULATION OF BANNED DRUGS. Drugs banned or withdrawn in Europe are widely available in the Third World. Right now, 85 types of drugs, considered hazardous and therefore banned in the West, are being sold in India . The majority of the drugs on the list are analgesics and antibacterials, for which there are several safer alternatives that appear on the World Health Organization essential drugs list. Many such drugs are available in India, for eg. Analgin, Cisapride, Droperidol, Furazolidone, Nemisulide, Nitrofurazone, Phenopthlein, Phenylpropanalamine, Oxyphenbutazone, Piperazine, Quinodochlor.(source: MIMS) 4. EXTRA BURDEN ON GOVT. EXCHEQUER. The govt. hospitals indent and receive medicines by generic name. Thus, medicines written by brand name are usually not available in hospital supply. Therefore, pensioners and other govt. servants buy these overpriced branded medicines from private chemists, and claim medical reimbursement from the govt. This leads to a heavy burden on the govt. exchequer. This money can be saved very easily by generic prescribing and making low cost drugs available to the patients and this money, can be used to treat more patients. 5. DRAIN ON FOREIGN EXCHANGE. Importation of pharmaceuticals is one of the fastest growing drains on hard foreign currency for developing countries, explains WHO. The Third World pays the rich world an estimated nine billion dollars a year for drugs. And prices are rising: four times as fast as GNP in many poor countries. In fact, some health ministries are spending over 50 per cent of their budgets on drugs alone. Poorer countries waste limited currency on unnecessary drugs.

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6. RISK OF ADVERSE EFFECTS: All drugs carry the risk of side - effects, e.g. majority of the pain killers carries the risk of side - effects on the stomach. The unnecessary use of drugs exposes patients to the risk of side effects. About 4% to 10% of hospital in-patients suffer an adverse drug reaction in developed countries. This is the fourth to sixth leading cause of death in the US. 7. RISK OF TRANSMISSION OF DISEASES THROUGH UNSAFE INJECTIONS: An average Indian receives 2.9-5.8 injections per year. The safety of such injections was abysmal with 62.9 per cent of injections being adjudged as unsafe and nearly 32 percent were considered to be capable of transmitting serious blood borne viral infections. A proof of the hazard of unsafe injections has been in outbreaks of hepatitis B with high fatality. Unsafe injections contributes to 80,0001,60,000 HIV infections, 2.7-4.7 million Hepatitis C virus infections, and 8-16 million Hepatitis B virus infections globally every year. 8. RISK OF ANTIMICROBIAL RESISTANCE: Globally there is a rise in the resistance to antibiotics and a major cause is the wrong use of these medicines.

E. The Solution
1.
TOP

Rational

use

of

Drugs

(i). Generic Prescribing: Generic drugs play an important role in health care and the prescription and availability of generic drugs eliminates the monopoly of the drug companies. WHO calculates that generic prescribing of essential drugs could save 70 per cent of the drugs bill in rich countries alone. In poor countries benefit to the patients will be much more. A generic medicine provides the same quality, safety and efficacy as the original brand name product and undergoes strict scrutiny before it is licensed and given market approval by the authorities. A generic medicine is typically 20% to 80% less expensive than the brand-name original. In addition, the availability of lowerpriced generic medicines brings down the price of originator drugs through market competition. Advantages of having a generics-only policy Ensure production, sale and dispensing of more rational single ingredient drugs. Quality drugs are much cheaper when purchased under their generic names rather than their brand names. Ensure clarity and avoids confusion arising out of many dissimilar brand names of the same drug. Curtail the heavy promotion of brands and their high cost.

(ii) Adoption of essential drugs list WHO points out that a selection of just few drugs are needed to treat the majority of diseases i.e. Essential Drugs. But there are over 1,00,000 available in India. The govt. of Rajasthan acknowledges that high profits in pharmaceutical industry has led to a large number of drugs and medicinal products under various brand names and number of them have been reported to be irrational combinations as per WHO criteria. Thus to

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promote rational use of drugs on basis of suitability and cost effectiveness, the state govt. has adopted an essential drug list (EDL) which includes about 350 medicines. The govt. hospitals have been directed to spend 85 percent of their budget to procure medicines from EDL and the govt. doctors shall prescribe medicines out of EDL as far as possible. The need of the hour is to give effect to these govt. orders. (iii) Adoption of Standard Treatment Guidelines to discourage Luxury drugs WHO believes that expenditure on preparations which are not in EDL is a criminal waste of resources. Many health tonics, vitamins, antioxidants, etc. are promoted by companies just to increase sales and reap profits. Any new product, including a new analgesic or antibiotic, generates enthusiasm in physicians, which is multiplied many times through the persuasive influence of M.R.s who claims this costly new drug is more effective. Tragically, millions of poor spend their scant savings in medicines that are worthless and sometimes even harmful. Though they can be easily treated with help of essential drugs. Thus, curbing the marketing of useless or harmful drugs is equally important. This can be done by putting Standard Treatment Guidelines (STG) into practice. This will prevent the doctor from prescribing useless drugs unnecessarily.

2. Availability of Low cost drugs.

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Drug procurement by generic name through open tender system: The prerequisite for such a system is identification of required drugs by generic name. Drugs are then procured by a two stage transparent tender system. This ensures that only those companies that are capable of supplying products of adequate quality receive orders. The tender process is limited to companies that fulfill the "quality" criteria. Through a two stage tender system (technical bid and price bid), it is ensured that the purchases are made from companies complying with the good manufacturing practices. The prices offered by pharmaceutical companies to the Government during quality conscious bulk procurement are only to the tune of 2 20 % of the retail price (MRP). The Tamil Nadu model and Delhi Model of centralized procurement are being followed by many other states in the country. This has enhanced the supply of prescription drugs in the hospitals, besides causing a substantial reduction in drugs procurement cost. II. Distribution of Low cost drugs through govt. drug counters. The drugs procured through centralized procurement system or manufactured by PSUs costs very low. It is not enough to supply these in govt. hospitals, but they should be made available to all the patients at govt. run drug counters at low cost. For example tab. Diazepam is being supplied to govt. hospitals at 90 paise per 10 tabs. However, the same drug is available to the patients by the brand name of Valium, for Rs. 19.50. A mechanism needs to be devised to provide all the commonly used medicines at their actual costs to all citizens.

I.

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The possible drug counters could be: 1. 2. 3. 4. 5. Life-line drug stores (run by RMRS) Co-operative Medical Stores Kray Vikray Sahakari Samiti (KVSS) Medical shop runs by Red Cross societies Jan Aushadhi Kendra

TOP

In Rajasthan the life-line fluid stores run by RMRS in govt. hospitals are already providing cheap injections and IV fluids. In 2004, the govt. instructed to upgrade these fluid stores to life-line drug stores i.e. apart from fluids they will also sell other drugs as well but these drug stores have come up only in few cities. Moreover, these are procuring and supplying medicines by brand names which are costly. If such stores are opened in all govt. hospitals and they procure and provide all essential drugs by generic name, then it will improve the supply of low cost medicines to the patients. Rates must be displayed prominently outside the stores. If these low cost generic medicines are made available at govt. stores counters the cost of medicines can be reduced to more than half in most cases and this price fall will come down to the extent of one tenth of the prevailing market rate in certain cases, like cetrizine and nimesulide. Once choice of low cost drugs is available to the consumer, market competition will ensure that private medical shops also reduce their prices.

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LOW COST MEDICINES INITIATIVE CHITTORGARH

TOP

DISTRICT LEVEL INTERVENTIONS THE MODEL We knew that the actual cost of most of the drugs is very low. But, these were not available to patients at low rates because of three obstacles: 1. The doctors prescribe medicines by brand name of a particular drug company. This prevents competition and creates monopoly in the drug market and enables the drug company to put a very high MRP. 2. As very high MRP is printed on the drugs, the chemists charge the same amount from the patient. 3. Consumers are not aware that the actual cost of production of most of the drugs is very low. Moreover, once doctor has prescribed a particular brand, the patient has got no option, but to buy it, even when other low cost brands are available in the market. For example if doctor has prescribed a brand Glivec to a patient of blood cancer, a months course will cost Rs.1,14,400/- to the patient. Whereas, the same anti cancer drug, but with a different brand name Veenet costs just Rs.11,400/-. And Cipla supplies the generic equivalent of this drug (imitib) at Rs. 8,000/- & Gelnmark supplies it for Rs. 5,720/-!!!!!

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So, the district administration adopted the following strategy to provide low cost medicines to the patients. Generic medicines are on an average 5 times less the cost of branded medicines. We broke the monopoly of drug manufacturers by pursuing doctors to prescribe by the salt name and we made arrangements to sell medicines below the MRP at govt. drug counters and made consumer aware. This was done in three steps: 1. Ensuring that doctors prescribe drugs by generic (salt) name, as directed by the state govt. The state govt. has issued various circulars/ orders, which directs all govt. doctors to use generic names, instead of brand names. 1. Circular No. P13 (108) M.E/gh1/98 dated 03.09.05 2. Circular No. P4/PMF/2005/20VBOT/5892-0037 dated 26.09.05 3. Circular No. P31(108) M.E./gh1/98 dated 18.08.05 4. Circular No. F.22(1) M.R./96 dated 24.05.96 5. Circular dated 24.04.02 6. Circular dated 04.12.04 7. Circular No HA/MR/ Circular05/10 dated 19.07.05 8. Circular No chi/pra/05/MR/1802-1887 dated 01.09.05 9. Circular No P(193)(a) RPMF/2005/6041-6107 dated 13.10.06 10.Rule 32 of Raj.C.S.Medical (Attendance) Rules, 1970. The following issues were addressed before the project could take off. A. Quality? A team of doctors was constituted to suggest the companies, which they believe, produce good quality drugs. Only these were procured and supplied at co-op. stores. B. Combination preparations? Commonly used combination generic drugs were made available at co-op. stores. C. Chemists will give brand of his choice and will charge the printed MRP? If the patient gets medicine from hospital supply or is educated to buy low cost drugs from co-op. store, the problem is no more. Once, patients understand that the same drugs are available at co-op. store at much cheaper rate, market competition ensures that the chemists also sell at lower rates. Eventually the patient benefits. TOP D. Govt. can put a ceiling on MRP? This cannot be done at the state govt. level. Central govt. can do it using the provisions of Essential Commodities Act and Drug Price Control Order. Doctors were convinced that by the time a ceiling on MRP is put by the central government they should not wait and start helping their patients, specially the poor.

2. Govt. Cooperative Medical Stores and Life-line drug stores (run by

RMRS) provide low cost medicines of well reputed companies.

Medicines which are commonly used by the patients and prescribed by Doctors were listed after discussions with various medical specialists.

29

A committee of doctors was consulted which recommended that drugs of reputed companies like Cipla, Cadila, Ranbaxy, German Remedies, Alembic, etc. can be purchased . (Initially 22 and now 57 companies are approved) Finally, the tender was floated for these medicines. The tender included 564 generic medicines and more than 100 surgical and I.V. fluids. Cooperative store invited bids to purchase the drugs of these companies from the local stockists at competitive prices, after preparing comparative statement and finding out the most economical company (L1). The medicines are then sold at 20% profit margin to the patients. This money goes to the coop. deptt. and will make the project self sustainable. Thus, medicines of reputed drug manufacturers (which are unthinkably cheap) were made available at government co-op. medical stores for sale. Pricelists are displayed outside the coop. stores to advertise the rates and educate the patients. Once choice of low cost drugs is available to the consumer, market competition will ensure that private medical shops also reduce their prices.

3. Awareness generation. Doctors were sensitized by organizing discussions.

Training of co-op. pharmacists was carried out. The consumers were made aware by displaying boards showing comparative price lists and positive use of local electronic and print media. Quality control and Audit:The quality control Officer is Dr. Dinesh Vaishnav who is assisted by drug Inspector Sh. Jain. This team ensures that the drugs of the companies approved by the committee of doctors only are available. So far 33 samples of generic drugs from various shops have been tested and all of them have been found to be of standard quality.

THE

IMPACT: many human lives saved

TOP

1. Medicines are available at unbelievably low prices, at govt. co-op. store, much below the printed market rate i.e. MRP. See the (illustrative) list. Generic Name of Drug Albendazole Tab IP 400 mg Alprazolam Tab IP 0.5 mg Arteether 2 ml Inj Amlodipine Tab 5 mg Cetrizine 10 mg Ceftazidime 1000 mg Atorvastatin Tab 20 mg Diclofenac Tab IP 100mg Chittorgarh Unit Bhandar Rate* (Rs.) 1.37 1 tablet 1.75 10 tablets 11.72 1 Injection 3.12 1.50 64.90 22.59 2.75 10 tablets 10 tablets 1 Injection 10 tablets 10 tablets MRP Printed on pack / strip (Rs.) 25.00 14.00 99.00 22.00 35.00 370.00 170.00 25.00

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Diazepam Tab IP 5 mg Amikacin 500 mg

1.90 8.67

10 tablets 1 Injection

29.40 70.00

2. Treatment cost of most illnesses falls sharply. 3. Increase in number of patients getting free drugs from hospital supply. 4. Decrease in expenditure from Rajasthan Pensioners Medical Fund (RPMF), so more patients can now be benefited. This can be made possible if two things happen simultaneously:

Rational Prescription (by Doctor )

1. Prescription of drugs by generic (salt) name. 2. Prescription out of essential drugs list. 3. As per Standard Treatment Guidelines.

Low cost drugs made available (at govt. medical shops)

1. Transparent procurement through open tender system. 2. Distribution of Low cost drugs through Life Line/ Coop. Store. 3. Display of Rates

THE ULTIMATE SOLUTION: Statutory price control for all essential drugs
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It is the government, which can provide medicines at an affordable cost and improve medicine accessibility. In India, an effective price control mechanism is a must, failing which the medicine accessibility will become less and lesser as most of the countrymen pay for medicines from their own pocket. The need is that Central Government should introduce a more effective drug pricing policy that would bring down the high profit margins for the pharmaceutical trade and make medicines more affordable for the common man. Liberalisation has nothing to do with a price protective mechanism in a sector as vital as healthcare. The medicines under national list of essential drugs must be kept under price control domain and the provision to control of newer necessary medicines useful in public health should be made. Supreme Court in its interim order dated, March 10, 2003 in Gopi Nath case has directed the central government to ensure that essential and life saving drugs are kept under price control. The fact that Karnataka High Court and subsequently Supreme Court stayed the implementation of pharmaceutical policy 2002

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questioning the stand of Government over the exclusion of many essential drugs under the ambit of price control speaks the importance of price controlled essential drugs in India. This is yet to be complied with. At present only 74 drugs have ceiling prices. If SC orders of 10 Mar.03 are complied with, it would result in control on ceiling prices (ie control on MRP) of about 350 Essential Drugs and many other life saving drugs as well. Even if these drugs could be provided at affordable prices many more human lives could be saved.

CONCEPT NOTE ON GENERIC DRUGS: COST EFFECTIVE ALTERNATE TO BRANDED DRUGS

A Generic Drug is a copy that is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. Generic simply means that the drug is not sold as the brand name, but it has the identical strength, dosage and route of administration and the same active ingredients as the brand-name drug. The use of generic drugs is now widely accepted and they are commonly prescribed by physicians and dispensed at hospitals. While manufacturing generic drugs, the drug companies use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand name counterparts. Also, generic drugs have the same quality, strength, purity and stability as brand name drugs. It is seen that Generic Drugs work in the same way and in the same amount of time as branded drugs. The generic drugs are less expensive as compared to branded drugs as generic manufacturers do not have the investment costs of the developer of a new drug. New drugs are generally developed under patent protection. The patent protects the investment and the associated expense, viz. research, development, marketing and promotion. When patents are nearing expiration, manufacturers usually approach the Government/Drug Control Department to sell generic versions. In the process, the consumers get genetic drugs at substantially lower costs. Both branded and generic drugs are manufactured by conforming to International standards. Brand name drugs are usually given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator of such drugs to make good the initial costs incurred by him, viz., research development and marketing expenses, to develop the new drug. Many drug companies start manufacturing generic drugs once the patent license expires for a branded drug. The physician plays a vital role to determine whether his patient needs a branded drug or generic drug.
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Patients should become assertive and insist upon the doctors to prescribe generic drugs if available, so that the patient would get the product at the best possible price. Pharmacists also play a vital role in educating the doctors about the availability of generic drugs. Thus the right medication could be given to the patients at the best possible price. Generics are as good as branded drugs. Thus if generic drugs are bought by the patient, the patient may not lose money by going in for branded drugs, which are too costly. Health care costs continue to rise. Therefore, consumers, providers and policymakers need to assess the best way to keep health care affordable without adversely affecting access to quality care. With prescription drug (branded drug) costs serving as a major contributor to cost escalations, Generic drugs offer an important tool for reducing the rate of growth in overall health expenditure. Generic drugs play an important role in health care and the availability of generic drugs reduces the monopoly and oligopoly

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powers of the patent holder. The Government may also impose compulsory licensing so as to make available the much needed generic drugs. It is seen that many countries do not have the technological capability for manufacturing and supplying generic drugs even if the laws of those countries permit them to do so. It has also been found that prices fall substantially once the drugs are off the patent, if there are generic producers. When more generic producers enter the market, more is the fall in the prices. Differences between a Brand name Drug and a Generic Drug: The innovator of a branded drug does research to discover the new biochemical substances that eventually become new drugs. This research is essential for finding new and better treatments for various diseases. This process is expensive. The expense incurred by a pharmaceutical industry for coming out with a branded drug is passed on to the consumer, but most of the money is ploughed back into research and development of new products.

In America, FDA grants the innovator company a patent of exclusivity making it the only company able to produce and sell the drug. The patent expires 20 years from the commencement of drug development to drug marketing. When it does, generic companies are then allowed to manufacture and sell the drug.
Generic drugs offer significant savings to consumers. The cost of generic drugs averages 40 to 60 per cent below the cost of the innovator or brand name drug. It may be noted that the generic companys version of the drug has the same active ingredient with the same chemical purity as the brand name drug. Obviously this results in cost savings for the generic as it does not involve doing research as was done by the original inventor. Also, it would cost less for the generic company to market its drugs and thus the savings passed on to the patient. Generic drugs are regulated like band name drugs. Consequently, both are safe and effective when properly used. Generic drugs today are manufactured by branded drug manufacturers also employing the same technology and processes. The only differences are the labeling, tablet or capsule design and the price.
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A generic drug is pharmaceutically and therapeutically equivalent to brand name drug

Frequently Asked Questions about Generic Drugs

1. Are generic drugs as safe as brand-name drugs?
Yes, since generics use the same active ingredients and are shown to work the same way in the body, they have the same safety and benefits as their brand-name counterparts.

2. Are generic drugs as strong as brand-name drugs?

Yes, generic drugs to have the same quality, strength, purity and stability as brand-name drugs. The standards of quality, laid down in the pharmacopoeias are the same for branded and generic drugs.

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3. Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs. 4. Why are generic drugs less expensive? Generics cost less than brand-name drugs, mostly because manufacturers of generic drugs do not have the expense of research, development, advertisement and marketing related to a new drug. New drugs are developed under patent protection. The patent protects the investment by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, other manufacturers can apply to sell generic versions. Because those manufacturers don't have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, in U.S. almost half of all prescriptions are filled with generic drugs. Generic drugs save consumers an estimated $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

5. Are brand-name drugs made in more modern facilities than generic

drugs? No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. Drug authorities won't permit drugs to be made in substandard facilities. Inspections are conducted to ensure that prescribed standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

6. Does

every

brand-name

drug

have

generic

counterpart?

No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
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7. Is my generic drug made by the same company that makes the

brand-name drug? It is possible. Brand-name firms are responsible for manufacturing approximately 50 percent of generic drugs.

8. Why do medicines have more than one name?

Medicines will often have more than one name:

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a generic name, which is the active ingredient of the medicine a brand name, which is the trade name the manufacturer gives to the medicine.

The generic name is the official medical name for the active ingredient of the medicine. The brand name is chosen by the manufacturer, usually on the basis that it can be recognized, pronounced and remembered by health professionals and members of the public. An example would be Viagra - this is the well-known brand name given by Pfizer to the generic medicine sildenafil. (Brand names are capitalized; generic names are not.)

9. How does this affect me?

When a doctor is writing a prescription, or a consumer is buying an overthe-counter medicine, they may have a choice between a branded medicine and the generic version of that medicine. Generic medicines are mostly cheaper than brand-name medicines, but the active ingredient (the ingredient that produces the therapeutic effect of the medicine) is the same in both. If your doctor has prescribed a medicine by its brand name, your pharmacist must dispense that brand. However, if a medicine has been prescribed by its generic name, your pharmacist can dispense whatever version of the medicine they have available, because each version will have the same therapeutic effect.

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