annexure i concept note_2

8/2/2019 Annexure I Concept Note_2

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INDEX

A. Problem Statement 3-4

B. Pharma Scenario in India - Poverty Amidst Plenty 5-13

& How doctors are used as an instrument

1. Prescription by brand name2. Prescription of non essential drugs

3. Irrational Prescriptions

C. Aggressive Drug Promotion14-23

1. Influencing Doctors

2. Lack of objective drug information

3. False evidence based medical practice

4. Promotion of hazardous, banned and bannable drugs5. Doctors as Key Opinion Leaders

6. Biased clinical trials

7. Disease Mongering

8. Direct to consumer advertising

9. Influencing Government Policies

D. Implications of unethical promotion 24-25

E. The Solution 26-281. Rational use of drugs Prescription by generic name

Adoption of Essential Drug List Use of standard treatment guidelines

2. Availability of low cost drugs at govt. run medical shops

F. Chittorgarh Model 29-31

G. Concept Note on generic drugs 32-33

H. Frequently Asked Questions 34-35

AnnexuresAlphabetical List of 570 low cost generic medicines

Comparative list of 300 low cost ethical drugs

List of 54 IV fluids

List of 142 surgical itemsDocumentation by

Dr. Samit SharmaCollector & District Magistrate

Chittorgarh (Rajasthan)

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

PROBLEM STATEMENTTOP

Huge gap in access to drugs

With a population of nearly 100 crores, India accounts for 16 per cent of the globalpopulation. Sizeable population lives below the poverty line and 48 per cent of thepeople are illiterate. India accounts for huge morbidity & mortality burden due tolarge number of deprived & extremely poor people. WHO says that 65% of thepopulation still lacks regular access to essential medicines. With the rise in healthcare cost, over 23 % of the sick dont seek treatment because they are not havingenough money to spend. A study by World Bank shows that as a result of singlehospitalization 30 % of people fall below poverty line. Over 40% of thosehospitalized, need to borrow money or sell their assets.

Healthcare costs are high and are increasing further. Expenditure on drugsconstitutes 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 forrural indebtedness in India)

Where does the money for health expenditure (in India) come from?

Private out of pocketexpenditure

79%

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 theglobal drug production of which only 0.7 per cent are essential drugs. Yet 1.3 percent are non essential, profit-oriented formulations which are highly priced,irrational or useless. Crores of our people, living in abject poverty, can barelyafford a square meal a day, can they afford to spend on costly medicines.

People are being pushed further into poverty, disability and death because ofthese costs. Completely irrational drugs, which do nothing but waste peoplesmoney, are widely sold. More and more drugs flood our markets every year. Thereare over 20,000 pharmaceutical units in the country producing over 1,00,000 (onelakh) formulations of drugs. It is paradoxical that while essential and life-saving

drugs are in short supply, more and more drugs which are not therapeuticallymore effective, irrational and may be even dangerous, are being produced andpushed in the market with absolute disregard to the country's health needs. Theproblem becomes more acute in developing countries where resources for thepurchase 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, bigcompanies and retailers pocket a large share of the money paid out by theconsumer. Retail prices of drugs show complete arbitrary variation betweenbrands. There are abnormally high trade margins with wasteful, unregulated andunethical drug promotion. There is a nexus between drug companies, stockists,

retailers, Medical Representatives (M.R.) & some medical practitioners whichdisproportionately inflates the cost of medicines & the overall treatment. Each

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gains down the line, the only loser being the poor patient for whom the drugsbecome unaffordable. TOPIssue of Research Cost Recovery

The life cycle of a drug has four phases:

1. Research2. Development3. Patentee commercialization4. Generic commercialization

When the product is in the research mode, a research institution invents a newdrug. Then a patent application is filed to preserve rights. When the institutionstarts pre-clinical and clinical testing of the drugs, the development phase begins.In the patentee commercialization phase, the innovator (patent holder) beginsselling in at least one country. In this process, doctors, patients, hospitals, publichealth agencies and insurers get involved. Generic commercialization commenceswhen 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 newdrugs.

Without patents, research and development would be reduced. Withoutgenerics, access to medicine would be impaired. Thus, we have to strike a balancebetween encouraging research and development of new drugs and the drugswhich are already discovered should be affordable and accessible to the entiremankind. All research should be carried out with the intention of improving thehealth of the crores of people of this world and not with the intention of gettingmore and more money out of their pocket. Studies suggest that the money spenton research is just 2 20% of the total turnover, but huge profits are reaped in thename of recovering research expenditure. During the patent period cost should besuch 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 addedto cost of manufacturing the drug.

Drugs which are similar to their predecessors are invented just by making someminor change in the original drug chemical and are then patented andaggressively promoted Me too drugs (higher priced alternatives of a parentdrug without a clear therapeutic advantage). In contrast to the breakthroughdrugs, they have no significant treatment benefit, but are just created to continueto enjoy the patent protection (ever greening of patents) and thereby reap hugeprofits after anyhow convincing the doctors to prescribe them.

The country where 3 out of 4 children & every other woman are anemic & irondefensive anemia is the most prevalent public health problem; the drug companiesare free to sell the iron preparation at any cost which comes to about five to tentimes 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 makinghuge profits rather than the intention of serving the sick and the needy. Theultimate aim of drug production should be, to make drugs affordable andaccessible to all so that people of the world can be cured of their diseases. Thepharma 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 weallow commercial interests to dominate us so completely?

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Pharma Scenario in India- Poverty AmidstPlenty

TOP

India has a vast pharma market, and is rightly celebrated in international circlesfor making medicines very affordable and low-priced. As of 2003, Indian industrywas supplying 20 percent of the worlds drugs and is currently one of the largestpharma industries in the world. At least 60 manufacturing plants in India have USFederal Drug Administration (FDA) approval, second only to the Unites States.Currently a dozen top Indian companies are major suppliers to the US andEuropean market as well as China. India has one of the best developedpharmaceutical industries among the developing countries with over 20,000 unitsproducing between 60,000 to one lakh formulations. The drug industry has a totalannual turnover of approximately Rs 52,000 crores. Nevertheless, the boomingIndian pharma market coming to the rescue of generic world over, especially bymaking low priced antiretroviral, is a good part of the story.

The not so good part is that the Indian pharma scenario, as far as theordinary poor consumer is concerned, is a failure of the market. As a result of thisextreme market failure of regulation in the absence of well-functioning markets,the drug (medicines) availability situation in India is one of the poverty amidstadequacy there is inadequate access and supply of even essential drugs to thepoor despite adequate drug production. Adding to this misery is the poorlyfunctioning public health system. While the sales of Indian pharma companies areincreasing 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 dependingon rural / urban locations and inpatient / out patient treatment. All-India figures forper 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 lacformulations are sold in the drug market, medicines are out of reach of millions ofpeople, because they are unaffordable. The large scale production has not had anysignificant 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, mostof the formulations produced are unnecessary, unaffordable, irrational and verycostly.

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 ofthe patients. It has been estimated that barely 20 per cent of the medicinesavailable 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 ofsimple household remedies like cough syrups and vitamin preparations. But life-saving drugs account for only 20-30 per cent of the total value of the formulationssold 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 utterdisregard to country's health requirements.

In 1975, the Hathi Committee which was appointed by the Government of India toanalyze the Indian drug industry, recommended a restricted list of essential drugs

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and that measures be implemented to ensure their production, that a gradual shiftbe made from brand names to generic names, that price control measures beeffected 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 bereserved to encourage the growth of Indian drug companies. The Committee alsorecommended 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 parentcompany in the case of MNCs. Despite knowledge of the ban, manypharmaceutical companies continue to market the banned drug, making falseclaims regarding their safety and efficacy. For example, the ban order onestrogen-progesterone drugs was challenged by certain drug companies and astay was obtained in 1982 on technical grounds. Anabolic steroids were marketedas appetite stimulants for growing children in the developing countries. Drugswhich have a sizeable stake in our country are not marketed by MNCs in their

countries, e.g. cough expectorant, pain killers, growth tonics, appetite stimulantsand anti-inflammatory containing phenyl- and oxyphenbutazone. Another suchdrug that has now acquired some notoriety is analgin and analgin-based drugs likeNovalgin, Baralgan, etc. It is banned in Germany, parent country of Hoecsht, andin several countries of the West but marketed in India (Baralgan has since beenbanned in India by an order of the Supreme Court).TOP

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 forinformation about drugs. MRs knows that for most of the doctors the cure of thepatient is of utmost importance. Thus, doctors are made to believe that although aparticular brand is a bit costly but it is of the best quality and is the most effectiveone in the market, which will definitely cure the patient. They are also introducedto so called latest discoveries which will lead to a magical cure, but which are infact minor chemical alterations in the parent drug & are just introduced with thesole purpose of ever greening of patent and to enjoy monopoly pricing & are nonessential drugs. Similarly with utter disregard to patients health needs drugs whichare 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 forupdation of their medical knowledge and their prescription pattern is largely

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influenced by them. Unsuspecting doctors fail to understand that the personcoming to them has been hired by a drug company to promote its sale and makeprofits. TOP

Thus, unknowingly doctors help the drug companies and adversely harm thepatients in three different ways.

1. Prescription by brand name2. Prescription of non essential drugs3. Irrational Prescriptions

1. Prescription by brand name

In India there are 72 salts which come under drug price control order (DPCO). Itmeans that the selling price of these drugs is under control & decided by the NPPA(National Pharmaceutical Pricing Authority). This also means that for all theremaining 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 priceto the consumer but in case of drugs it is not so. The reality is that the same salt isbeing marketed by different companies under different brand names but theselling 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 employingMedical Representatives, who using various means persuade the doctors toprescribe medicines by brand name of the company & the unsuspecting patienthas no choice except to buy that particular brand even when less costlyalternatives are available in the market. So, due to brand names artificialmonopolies are created in the pharmaceutical market which prevents pricecompetition amongst the same product and consequently all the brands are sold

at high prices.

For example:Amikacin

Drugmanufacturing

company

Name givenby

company(BrandName)

Salt name ofmedicine(GenericName)

Rate at which drugis purchased by thechemist (Stockiest

price)One Injection

Rate at whichdrug is sold tothe customer(Printed MRP)

Cadila Amistar500

Amikacin 500mg

8.00/- 70/-

GermanRemedies

Amee 500 Amikacin 500mg

8.00/- 70/-

Wockhardt Zekacin500

Amikacin 500mg

9.90/- 70/-

Alembic Amikanex500

Amikacin 500mg

8.22/- 64.25/-

Intas Kami 500 Amikacin 500mg

8.13/- 60/-

Unichem Unimika500

Amikacin 500mg

7.80/- 72/-

Ranbaxy Alfakim 500Amikacin 500mg

8.50/- 70/-

Cipla Amicip 500 Amikacin 500mg

7.42/- 72/-

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

See an example where the same company markets the same salt by differentbrand names and use differential pricing policy.

Drugmanufacturing company

Namegiven bycompany

(BrandName)

Salt name ofmedicine

(Generic Name)

Rate at whichdrug is

purchased by

the chemistfor 10 Tablets(Stockiest price)

Rate atwhich drug is

sold to the

customer(PrintedMRP)

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/-

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If you dont believe this then see the list below. TOP

8

MRP Printed on the pack

Stockist Price


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pharmaceutical sector. This monopolisation of the market by the drugs industry isone 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 asthe 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 ofbrand 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, theconsumers/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 drugsTOP

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 thepopulation. But when we analyze the sales of top 300 brands only 38% of brandsare of the drugs mentioned in the NLEM. The other 62% brands comprise drugsthat are higher priced alternatives without a clear therapeutic advantage andmany are unnecessary, irrational and even hazardous.

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Doctor should

act as FILTER

ESSENTIAL

DRUGS

NON ESSENTIAL

DRUGS

For the Patient

For the


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This indicates that contrary to what is advocated by WHO & as adopted in ournational health policy, the drugs which are most useful & cost effective for thetreatment are not being prescribed & the non costlier & irrational drugs are soldmore often (The government of Rajasthan has directed that at least 85% of thedrugs prescribed should be from EDL) TOP

Top 300 Brands and their Relation to the National Essential MedicinesList

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

Brandname

Uses and Remarks Moving AnnualTotal in rupeescrore (Oct 2003)

Corex Cough suppressant. Abused as drug of

addicition because of presence of codeine

88.18

Becosules Multivitamin, unnecessary preparation 79.74Liv-52 Ayurvedic liver preparation 62.67Neurobion Irrational Multivitamin preparation 60.27Nise Hazardous drug for pain relief 58.31Dexorange 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 alower cost essential drug

Example: Cifran brand of ciprofloxacin is the largest selling antibiotic, whereas it isthe 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 therapeuticvalue, are touted as effective remedies and promoted aggressively. In our countryabout 75 % of the children & 50 % of the women suffers from Anemia and irondeficiency anemia is responsible for 1/3 of all maternal deaths. But the mostpopular prescription is of fancy multivitamin formulations instead of iron and folicacid preparations.

The sales figures reflect the fact that in India, drugs which are not consideredessential sell more than rational & essential drugs, that costlier drugs most often

sell more than cheaper alternatives(even those made by well knownmanufacturers), and downright irrationaland hazardous drugs are among the top-sellers. The majority of sales are comingfrom the sales of drugs not consideredrelevant by experts for inclusion into anessential medicines list, and notconsidered important by the governmentfor regulation of their price.

Brief analysis of the top 300 brandssuggests that the Indian doctors areprescribing drugs without adequate

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concern for evidence of their efficacy, safety and cost. This is because of pooraccess to unbiased information on drugs, aggressive and often misleading drugpromotion by the drug industry. The result is increased health care costs, irrationaluse 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 vitaminsin solutions of sugar and alcohol. Among the top-selling 25 medicines in India areBecosules, Neurobion and Dexorange; the first two are irrational and / orunnecessary 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 withvitamins. Regular intake of Vitamin A and D can be excessive and hencehazardous. Bangladesh had banned tonics, enzyme mixture / preparations and

restorative product because such products flourish on consumer ignoranceandof no therapeutic value. The United Kingdom does not recognize tonics as drugs.

The production of the high-potency or Forte preparations of multivitamins is asheer economic waste. It is a drain on the consumers and governmentdispensaries. High-potency preparations are also a drain on the countrys foreignexchange 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 ofcrore rupees. TOP

S.N.

Brand Name Moving Annual Total (rupeescrores)

1 Becosules 79.742 Revital 47.643 Polybion 40.854 Zincovit 32.265 Cobadex

Forte26.10

6 Methycobal 21.877 Zincovit 21.658 Neogadine 21.529 Riconia 20.7810 R.B. Tone 20.21

11 A to Z 19.0712 M2tone 18.2213 Supradyn 15.2514 Becadexamin 14.6315 Raricap 13.8916 Becosules-Z 12.0317 Optineuron 11.97

Total 437.68

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

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3. Irrational Prescriptions TOP

Ideally use of drugs should be only when there is an appropriate indication, butthis is not in the interest of the drug industry which is more interested in salespromotion. Higher the sales, higher the profit. Therefore doctors under constantpersuasion of MRs sometimes follow what is being promoted by the brochures ofdrug companies instead of prescribing what they have read in their standardmedical text books. For example:

-> A one year old with low body weight for age is seen in the OPD, because theparents noticed a pot belly. This is due to under nutrition. The family is poor butthe child has not been weaned and given solid foods. Should the child receiveadvice 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 pain-killers like indomethacin, valdecoxib, tramadol, etc (all of which have well knownserious side effects) or advice on posture, exercise and a proper chair whichsupports lower back?

-> A chronic smoker comes with cough off and on, especially in the morning. Thereis no shortness of breath. The clinical examination is normal. Should he receive acough suppressant, an antibiotic or advice and support for stopping smoking?

Reasons for Irrational Prescribing:

1. The MR said so.

2. The latest is the best (latest antimalarials, antibiotics, analgesics, etc.)3. Costlier the drug, the better it is.4. The more I write the more I earn.5. Availability of Irrational Drugs in the Market6. 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 theestimated 20,000 manufacturing units India) in the Indian market, many of whichare similar except for different brand names or for a few unnecessary additionalingredients.Pharmaceutical companies therefore indulge in aggressive marketing

to promote the sale of their brands. Sometimes, it results in unethical marketingpractices.

As pharmaceutical business is very profitable, it is hardly any wonder thatpharmaceutical companies spend at least 20 percent of their sales revenue onpromoting their products. Drug promotion is carried out by means of heavyadvertising, frequent visits to private medical practitioners by the medicalrepresentatives of pharmaceutical companies with literature on their drugs, freesample of drugs, and even gifts like diaries, posters, calendars, pens andsometimes also invitations to medical conferences held in five-star hotels. Thecompanies also encourage articles in newspapers and magazines, television and

radio programs, release promotional materials as news stories about latestdevelopments in medical field and sponsoring television programs. Thus, drug

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promotion is a comprehensive attempt to influence the doctors to suspend theircritical judgment and prescribe what is profitable for the manufacturer.1. Influencing Doctors to prescribeirrational, non essential drugs by brandnameCompanies prefer to spend more on drugpromotion because they recover theirexpenses by pricing the drug highly. Doctorsare influenced into prescribing a particularbrand which is often more expensive. TheHathi Committee in its report, made thisobservation about the multinational drugindustry: "High pressure sales techniquescoupled with distribution of medical samples on a liberal scale to the medicalprofession was their (MNC's) forte". According to David Jones, former vicepresident of Public Affairs for Abbott Laboratories, and former Executive Director ofPublic 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 isinflated beyond the medical need. Uses are promoted that are neither healthy norwise"

World over, and in India specially, medicines are promoted by all means fair andfoul. Drug industry treats doctors as prescribers and not cares givers.

2. Lack of Objective Drug InformationTOP

It is doubtful whether the majority of doctors in India are in the habit of regularlyreferring to standard textbooks or standard medical journals. In Britain, all

practicing doctors are supplied every six months with a copy of the BritishNational Formulary (BNF) which contains reliable, updated information includingcosts on the preparations on sale in the UK.In the absence of objective information on new drugs, doctors in many Third WorldCountries, are fully dependent on drug information supplied by the pharmaceuticalcompanies. And owing to the profit-oriented nature of the drug companies, theinformation provided in its literature is bound to be in favor of the drug.

The prescribing information in most publications cannot be relied upon. Some ofthese journals bring out "Review of New Drugs", which are actually based onunreliable information. These publications even bring out pseudo-scientific reviews

of irrational drugs!

Doctors in India usually rely on information supplied by medical representativesand drug companies which can be very biased and selective. Also, doctors are ledto believe a lot of new products are being marketed every day. Many of these arenot new discoveries, which radically alter the course of treatment.

3. False Evidence-based medical practice:The practice of medicine basedon scientific evidence is more talked about and less practiced. Some timesevidence is selectively quoted or false evidence is produced to promote a drug. ForExample:

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Glaxo Laboratories cited the authority of a British medical journal, theLancet to promote its sales of Ostocalcium B-12 even though there was nosuch 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 promotetheir tonic, whereas Vitamin B-12 has no role in ordinary anaemia.

S.G. Chemicals (Indian subsidiary of Ciba-Geigy) misquoted Goodman andGilman and Martindale to promote a combination of two dangerous drugsanalgin and oxyphenbutazone, whereas in fact the texts warn against thisdangerous combination.

There also exist double standards in the information given on drugs by

MNCs in the developed and developing countries. In the developingcountries, warnings about the side-effects or contraindications are notgiven; drugs are recommended when their efficacy is not proven and evenwhen its safety is not established fully. For instance, oral contraceptivedrugs are not recommended in U.S.A. and Britain for premenstrual tension,menstrual cramps, and menopausal problems and in dysfunction of thefemale reproductive system.TOP

Opinions of International Panel on Drugs Advertised in Indian Editionof BMJ

Trental 400 (pentoxifylline): The advertisement makes unsubstantiatedclaims of improvement in mental function. (This drug is marketed only forperipheral vascular disease in America and Britain; in India it is indicated forcerebrovascular disease as well)

Relaxyl (diclofenac): The claim gentle on the gastrointestinal tract is not inaccord with the reported high incidence of gastrointestinal side effects (up to30% in Australian approved product information).

4. Promotion of Hazardous, Banned

and Bannable Drugs

Internationally, a whole group of "blockbuster" drugs have been in serioustrouble. These include rofecoxib ("Vioxx"),valdecoxib ("Bextra"), celecoxib("Celebrex"), atoravastin ("Lipitor"), etc. asof writing there is enough evidence todoubt the safety of a host of cyclo-oxygenase (COX) -2 inhibitors.

(i)The case ofRofecoxib shows how a leading MNC drug company with a blockbuster does anything to ensure its continued presence in the market, howresearch studies are reported and interpreted selectively and how meta-analyses

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can be used to support contrary positions, and how the US FDA acts ever sohaltingly and indecisively.

Rofecoxib was first marketed by Merck in 1999. The following year, arandomized trial revealed increased rates of adverse cardiovascular events. Merckaggressively defended rofecoxib's safety with a series of meta-analyses andretrospective studies, and spent hundreds of millions of dollars marketingrofecoxib to physicians and consumers. Merck's eventual decision to withdraw-effective September 30, 2004 from the market was based on an increased risk forheart attacks and strokes. US FDA analysts estimated that Vioxx caused between88,000 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.TOP

(ii) Valdecoxib was eventually withdrawn on April 7, 2005 after a US FDA requestasking Pfizer to voluntarily remove Bextra (valdecoxib) from the market, a decisionbased 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 boxedwarning regarding cardiovascular and gastrointestinal risks. The Drug ControllerGeneral Of India (DCGI) has asked drug companies to carry a warning on the labelof selected Cox-2 inhibitors. "This drug should be used with caution in patientsfrom Coronary Heart Disease (CHD) / Cardiovascular Disease.

(iv) Atorvastatin. Pfizer misled consumers into using its anti-cholesterol drugbrand Lipitor despite the absence of evidence from clinical trials that the drug orothers 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 thatlowering cholesterol always reduces the risk of heart disease had become theconventional wisdom, which drug companies like Pfizer have taken great pains topromote. But for women under 65 and people over 65 with no history of heartdisease or diabetes, the evidence isnt just there. Millions of women and seniorsare spending huge sums to take Atorvastatin every day despite a lack of proof thatits doing anything beneficial for them, and may actually be harming the elderlywith its side effects.(v) Thalidomide: most women experience nausea during pregnancy which is aphysiological 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 adrug was pushed into the market without adequate evaluation of its safety.

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come to the conclusion that nimesulide was safe and effective for all age groupsstarting with day one to over 60 years. In the wake of media reports the IndianAcademy of Pediatrics (IAP) also advocated use of nimesulide by Indian children. Itis indeed disturbing that while the leading countries of the world have notallowed / banned or withdrawn the drug, the opinion of a mere 50 private doctorshas 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.TOP

(viii) Depo Provera is an injectable contraceptive for use by womenmanufactured by the American multinational, Upjohn. This drug is not allowed foruse as contraceptive in USA. Yet the drug is sold in the Third World forcontraceptive use. The drug is associated with breast and endometrial cancers andlowered resistance to infection. The drug causes severe birth defects if a womanwho 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 andserious health problems of people, anemia. It is one of the top selling preparationsin India with a Moving Annual total in retail sales of Rs. 57 crores. Till 2000 thiscompany, for over a decade and a half, was adding minute amounts of hemoglobinobtained from slaughterhouses under unhygienic conditions to its otherwiseirrational formulation of iron. The amount of hemoglobin added to the preparationwas such as to provide a meager additional 2-3 mg of iron per 15 ml.

Finally, the Government banned hemoglobin. But, the addition ofhemoglobin of animal origin to an iron preparation is without parallel in thepharmaceutical sector worldwide. No other formulary mentions it, and no othercountry ever allowed it. This particular preparation still contains an iron salt, whichis 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 thispreparation can be up to Rs. 600 per month, against the cost of a simple iron-folicacid preparation that should cost Rs. 9 per month. The case of the consistentmarketing success of Dexorange is not a mere example but stands as a damningindictment of the state of affairs in the pharmaceutical sector, the government andthe prescribers. It has put the interests of the voiceless patient / consumer in thebackground.

(x) Cisapride: Causes acidity, constipation, etc. Reason for ban: Irregularheartbeat. But continues to be marketed by brand name: Ciza, Syspride, etc. evenas suspensions for our children.

5. Doctors asKey Opinion Leaders:

Key Opinion Leaders (KOLs) are influential specialists in their fields such as doctorsat teaching hospitals, senior consultants, authors etc. An endorsement by a KOL infavor of new products or new uses of old products is a top priority for pharmacompanies. Aggressive, often highly unethical, tools are employed to captureKOLs.Consider the following actions of drug companies and their KOLs.

1. Sun Pharmaceuticals sponsored over a dozen educational seminars allover 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 illegalto promote any drug for unapproved indications.

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2. According to one KOL of Jammu, he has already prescribed cisapride to40,000 patients. Another KOL from Jammu says the same thing in the samelanguage and he too has prescribed for 40,000 patients and from 1990 atthat 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 childrenand yet another has determines that the side effects of cisapride are to befound in 0.0001% of the patients whereas the US FDA says it is about 5percent! TOP

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

4. The Journal of Indian Medical Association has a Research AnalysisSection 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 aspan of a few months. Both promoting iron polymaltose (IP) preparationsclaiming superiority of IP over ferrous fumerate and then quotes thepublication of these papers in marketing Mumfer, its brands of IP!

A further and more blatantly unethical form of manufacturing consent isby ghostwriting research papers. Estimates suggest that almost half of all articlespublished in journals are by ghostwriters. While doctors who have put theirnames to the papers can be paid handsomely for lending their reputations, theghostwriters remain hidden. They, and the involvement of the pharmaceuticalfirms, are rarely revealed.

6. Biased Clinical Trials

The medical fraternity believes in evidence based medicines but many times: trialsare sponsored, evidence is created and favorable results are arrived at. Researchthat is sponsored by a drug manufacturer is more likely to yield a positive resultfor the companys product.Examples of Methods for Pharmaceutical Companies to get the Results they wantfrom 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 drug3. 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 drug5. 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 unethicaltrials of G4N which was discovered in USA but was unlawfully tested on oral cancerpatients at Regional Cancer Center in Kerala.

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Drug companies, driven by economic pressure conduct often post-approvalstudies. Merck and Pharmacia did extensive post-approval studies to show thattheir arthritis pain medications, Vioxx and Celebrex, were easier on the stomach.Mercks study, involving 8000 adults, showed Vioxx causes fewer stomachcomplications but also found it increases the risk of heart attacks. Despite thatonly the advantages were selectively revealed, intentionally hiding the lifethreatening side effects. In fact, it is better to kill a new hazardous drug which isbrought into the market without adequate clinical trials rather than to kill manyunsuspecting patients. TOP

7. Disease Mongering: Corporate Construction of Disease

One of the important ways drug companies make money is by telling people theyare sick, even when they are passing through one of lifes many normaltransitions. This Disease Mongering suits the medical profession too, as it helpsmedicalising problems.

1. In India, piractecam is being promoted for vague conditions likeintellectual decay, social maladjustment, lack of alertness, changeof mood, deterioration in behavior and learning disabilities inchildren associated with the written word. The recommended duration oftreatment for the last indication is entire school year in dose of 3g perday i.e. 7-8 capsules of 400mg daily. If the drug is administered for theentire school year as recommended, it will mean parents buying at least2700 capsules at a cost of Rs. 12,775 year after year. The unending claimsof the drugs efficacy include the treatment of sickle cell anaemia, strokeand vertigo. In Britain, piracetam (Nootropil) is permitted for use in just asingle indication, a rare disorder called cortical myoclonus, that too only asan adjunctive therapy. While in India, the drug is being promoted for use inyoung children, in Britain its use is contraindicated for adolescents underthe age of 16 years. If the Indian company marketing piracetam is to bebelieved, the drug is nothing short of nectar. It has no contraindications; noneed to observe any precautions and no adverse drug reactions. In Britain,the drug is contraindicated in hepatic and renal impairment, duringpregnancy and lactation. It is not marketed in USA.

2. Buclizine (brand Longifene in India) is being promoted as appetitestimulant while the drug itself is not commercially available in the US andis restricted worldwide for treatment of migraine in combination withanalgesics. Internationally reported adverse effects include: drowsiness,

blurred vision, diarrhoea, difficulty in passing urine, dizziness, dryness,tachycardia, headache, nervousness, restlessness, hallucinations, skin rashand upset stomach. Bottles of Longifene, the only brand of buclizine beingsold in Indian do not contain either the package insert or the patientinformation leaflet.

3. Warner Lambert invented a condition called halitosis which makesordinary bad smell in the breath sound serious. Sales ofListerine rose fromUS $ 100,000 to US $4 million in six years.

4. In the 1980s Glaxo needed to expand their market for ranitidine (brandZantac). They again created a condition called gastro-oesophageal refluxdisease (GERD) which is a serious sounding name for heartburn, an age-old 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 exercisecalled Heartburn Across America. Annual sales of Zantac peaked at US $2billion.

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

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

6. A legendary example of this condition (called) branding strategy was thedevelopment of Xanax (alprazolam) for panic disorder. A conference thenpublished diagnostic criteria for panic disorder and how best to treat it. Ofcourse, Xanas was the first to receive an exclusive indication, therebymaintaining its leadership in anxiety disorders.

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

8. Manufactures of fluoxetine as a marketing strategy eulogizedpremenstrual syndrome which is a routine physiological hormonaltransition.

9. Roche started promoting its antidepressant Aurorix (moclobemide) as avaluable treatment for social phobia. Its press release says more thanone million Australians suffers from this soul-destroying condition.

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 marketedthrough advertisements using electronic & print media. Tall claims are made aboutthe results they will bring about but they are silent on the side effects which willoccur. Thus medicines are promoted like any other consumer item just to increasethe 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 brandnames 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 thebody. It should not be suppressed except in certain conditions. Simple steaminhalation is advised. If it is necessary to use drugs, use only a single ingredientcough suppressants such as codeine, dextromethorphan. There is no scientificbasis for using cough suppressants and cough stimulants together. The WHO Listof Essential Drugs does not include cough syrups and lozenges. Bangladesh hasbanned them on the grounds they are "of little or no therapeutic value andamounts to great wastage of meager resources"TOP

9. Influencing Government Policies

Multinational companies (MNCs) are complex, highly technical structures, witheconomic and political clout often exceeding that of the governments of thecountries where they operate. In a bid to expand their markets internationally,MNCs resort to business practices which may be unethical. They are known to takeadvantage of the economic weaknesses of the host countries to conductoperations of a nature which have deep adverse effects on the host country 'seconomy, 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. Twoimportant 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 manufactureat costs one-tenths of international drug companies. The latter is issued underEssential Commodities Act,1955 which empowers the central govt. to keep acheck (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 thegovernment to reduce the basket of price controlled drugs from 347 in 1979 to142 drugs in 1987. In 1995 this came down to 76 and at present only 74 out ofover 500 commonly used drugs are under statutory price control. It means for allthe 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. Thismeans 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 manylives).

Implications of Unethical Promotion andIrrational Use of DrugsTOP

THE SUFFERING

The consequences of this widespread uncontrolled misuse are devastating:

1. MEDICINES BECOME UNAFFORDABLE.- Suffering and deaths Profiteeringand huge expenditure incurred on marketing & commissions by drug companiesinflates the cost of medicines many times. By selling drugs at inflated prices, bigcompanies and retailers pocket a large share of the money paid out by theconsumer. In low and middle-income countries including India, public medicineexpenditure does not cover the basic medicine needs of the majority of thepopulation. In these countries, patients pay for 50-90 per cent of the medicinesfrom their own pockets. Consequently, many families are driven into debt. ManyIndian families shift below poverty line, annually due to health expenditures.

Many patients spend their lifetime savings to procure them. Many who have nosavings have no option, but to die without treatment. WHO estimated in 1999that the percentage of Indian population had sustainable access to essentialdrugs was in 0-49 range, categorized as very low access country. This is the mostunfortunate part of the story. It is important to remember that consumers ofpharmaceutical products are extremely vulnerable. They are in no position toreject or postpone buying medicines, even if the medicines are expensive. If adoctor prescribes a particular drug, the patient has to buy it. Drug companiesexploit this vulnerability, especially in India where drug consumers arefragmented and unrepresented, unlike in the West. In the West, people either getthemselves insured or are insured by their employers. The insurance company

buys the patient's medicines. Expenditure on health is also responsible for APL toBPL 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) forpneumonia 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 Amikacinas it is sold in the market at Rs.70 (MRP). Therefore, many poor patients are forcedto die for want of medicines. Although, the actual cost is less than Rs. 10. In ourcountry where millions live below poverty line, many poor people die like this,every day, in this criminally exploitative and brutally unjust system. If, theinjection 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 livescould be saved.

2. INAPPROPRIATE MEDICATION Approximately 4 million children dieeach year from diarrhea-related causes, primarily dehydration, according to theWHO. Many of these deaths can be prevented through oral rehydration therapy,which is simply the replacement of fluid and mineral losses caused by the diarrheawith a mixture of clean water, salt and sugar. Yet, according to WHO appropriatetreatment "often remains the exception rather than the rule. A large number of

pharmaceutical agents of dubious efficacy and potential toxicity are widelyused. Tragically, many spend their scant savings on medicines that are ineffective,worthless and sometimes even harmful. The inappropriate use of drugs oftendelays or replaces appropriate treatment. TOP

Many drugs eg. protein powders, vitamins, health tonics, etc which are notrequired for the patient are prescribed, virtually regardless of the condition beingtreated, just to increase the sale of a particular brand and draw commissions fromthis sale. Side effects are inevitable in such cases. Also, indiscriminate use ofantibiotics could lead to resistance.

3. CIRCULATION OF BANNED DRUGS. Drugs banned or withdrawn in Europeare widely available in the Third World. Right now, 85 types of drugs, consideredhazardous and therefore banned in the West, are being sold in India . The majorityof the drugs on the list are analgesics and antibacterials, for which there areseveral safer alternatives that appear on the World Health Organization essentialdrugs 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 andreceive medicines by generic name. Thus, medicines written by brand name areusually not available in hospital supply. Therefore, pensioners and other govt.

servants buy these overpriced branded medicines from private chemists, andclaim medical reimbursement from the govt. This leads to a heavy burden on thegovt. exchequer. This money can be saved very easily by generic prescribing andmaking low cost drugs available to the patients and this money, can be used totreat more patients.

5. DRAIN ON FOREIGN EXCHANGE. Importation of pharmaceuticals is one ofthe fastest growing drains on hard foreign currency for developing countries,explains WHO. The Third World pays the rich world an estimated nine billiondollars a year for drugs. And prices are rising: four times as fast as GNP in manypoor countries. In fact, some health ministries are spending over 50 per cent oftheir 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. Theunnecessary use of drugs exposes patients to the risk of side effects. About 4% to10% 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 suchinjections was abysmal with 62.9 per cent of injections being adjudged as unsafeand nearly 32 percent were considered to be capable of transmitting serious bloodborne viral infections. A proof of the hazard of unsafe injections has been inoutbreaks of hepatitis B with high fatality. Unsafe injections contributes to 80,000-1,60,000 HIV infections, 2.7-4.7 million Hepatitis C virus infections, and 8-16million Hepatitis B virus infections globally every year.

8. RISK OF ANTIMICROBIAL RESISTANCE: Globally there is a rise in theresistance to antibiotics and a major cause is the wrong use of these medicines.

E. The Solution

1. Rational use of DrugsTOP

(i). Generic Prescribing: Generic drugs play an important role in health care andthe prescription and availability of generic drugs eliminates the monopoly of thedrug companies. WHO calculates that generic prescribing of essential drugs couldsave 70 per cent of the drugs bill in rich countries alone. In poor countries benefitto the patients will be much more.

A generic medicine provides the same quality, safety and efficacy as the originalbrand name product and undergoes strict scrutiny before it is licensed and givenmarket approval by the authorities. A generic medicine is typically 20% to 80%less expensive than the brand-name original. In addition, the availability of lower-priced generic medicines brings down the price of originator drugs through marketcompetition.Advantages of having a generics-only policy

Ensure production, sale and dispensing of more rational single ingredientdrugs.

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 pointsout that a selection of just few drugs are needed totreat the majority of diseases i.e. Essential Drugs. Butthere are over 1,00,000 available in India. The govt. ofRajasthan acknowledges that high profits inpharmaceutical industry has led to a large number ofdrugs and medicinal products under various brandnames and number of them have been reported to beirrational combinations as per WHO criteria. Thus to

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promote rational use of drugs on basis of suitability and cost effectiveness, thestate govt. has adopted an essential drug list (EDL) which includes about 350medicines. The govt. hospitals have been directed to spend 85 percent of theirbudget to procure medicines from EDL and the govt. doctors shall prescribemedicines out of EDL as far as possible. The need of the hour is to give effect tothese govt. orders.

(iii) Adoption of Standard Treatment Guidelines to discourage Luxurydrugs WHO believes that expenditure on preparations which are not in EDL is acriminal waste of resources. Many health tonics, vitamins, antioxidants, etc. arepromoted by companies just to increase sales and reap profits. Any new product,including a new analgesic or antibiotic, generates enthusiasm in physicians, whichis multiplied many times through the persuasive influence of M.R.s who claims thiscostly new drug is more effective. Tragically, millions of poor spend their scantsavings in medicines that are worthless and sometimes even harmful. Though theycan be easily treated with help of essential drugs. Thus, curbing the marketing ofuseless or harmful drugs is equally important. This can be done by putting

Standard Treatment Guidelines (STG) into practice. This will prevent the doctorfrom prescribing useless drugs unnecessarily.

2. Availability of Low cost drugs.TOP

I. Drug procurement by generic name through open tender system: The prerequisite for such a system is identification of required drugs bygeneric name. Drugs are then procured by a two stage transparent tendersystem. This ensures that only those companies that are capable of supplyingproducts of adequate quality receive orders. The tender process is limited to

companies that fulfill the "quality" criteria. Through a two stage tendersystem (technical bid and price bid), it is ensured that the purchases aremade from companies complying with the good manufacturing practices. Theprices offered by pharmaceutical companies to the Government duringquality conscious bulk procurement are only to the tune of 2 20 % of theretail price (MRP). The Tamil Nadu model and Delhi Model of centralizedprocurement are being followed by many other states in the country. This hasenhanced the supply of prescription drugs in the hospitals, besides causing asubstantial reduction in drugs procurement cost.

II. Distribution of Low cost drugs through govt. drug counters.

The drugs procured through centralized procurement system ormanufactured by PSUs costs very low. It is not enough to supply these ingovt. 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 togovt. hospitals at 90 paise per 10 tabs. However, the same drug is availableto the patients by the brand name of Valium, for Rs. 19.50. A mechanismneeds to be devised to provide all the commonly used medicines at theiractual costs to all citizens.

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LOW COST MEDICINES INITIATIVE CHITTORGARHTOP

DISTRICT LEVEL INTERVENTIONS THE MODELWe knew that the actual cost of most of the drugs is very low. But, these were notavailable 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 thedrug company to put a very high MRP.2. As very high MRP is printed on the drugs, the chemists charge the sameamount from the patient.

3. Consumers are not aware that the actual cost of production of most of thedrugs is very low. Moreover, once doctor has prescribed a particular brand, the patienthas got no option, but to buy it, even when other low cost brands are available in themarket. For example if doctor has prescribed a brand Glivec to a patient of bloodcancer, a months course will cost Rs.1,14,400/- to the patient. Whereas, the sameanti cancer drug, but with a different brand name Veenet costs just Rs.11,400/-. AndCipla supplies the generic equivalent of this drug (imitib) at Rs. 8,000/- & Gelnmarksupplies it for Rs. 5,720/-!!!!!

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A committee of doctors was consulted which recommended that drugs ofreputed companies like Cipla, Cadila, Ranbaxy, German Remedies,Alembic, etc. can be purchased . (Initially 22 and now 57 companies areapproved)

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 companiesfrom the local stockists at competitive prices, after preparing comparativestatement and finding out the most economical company (L1).

The medicines are then sold at 20% profit margin to the patients. Thismoney goes to the coop. deptt. and will make the project self sustainable.

Thus, medicines of reputed drug manufacturers (which are unthinkablycheap) were made available at government co-op. medical stores for sale.

Pricelists are displayed outside the coop. stores to advertise the ratesand 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 madeaware by displaying boards showing comparative price lists and positive useof local electronic and print media.

Quality control and Audit:-

The quality control Officer is Dr. Dinesh Vaishnav who is assisted by drug InspectorSh. Jain. This team ensures that the drugs of the companies approved by thecommittee 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 standardquality.

THE IMPACT: manyhuman lives saved TOP1. Medicines are available at unbelievably low prices, at govt. co-op. store, muchbelow the printed market rate i.e. MRP. See the (illustrative) list.

Generic Name of Drug ChittorgarhBhandar Rate*

(Rs.)

Unit MRP Printed onpack / strip (Rs.)

Albendazole Tab IP 400 mg 1.37 1 tablet 25.00

Alprazolam Tab IP 0.5 mg 1.75 10 tablets 14.00

Arteether 2 ml Inj 11.72 1 Injection 99.00

Amlodipine Tab 5 mg 3.12 10 tablets 22.00

Cetrizine 10 mg 1.50 10 tablets 35.00

Ceftazidime 1000 mg 64.90 1 Injection 370.00

Atorvastatin Tab 20 mg 22.59 10 tablets 170.00Diclofenac Tab IP 100mg 2.75 10 tablets 25.00

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Diazepam Tab IP 5 mg 1.90 10 tablets 29.40

Amikacin 500 mg 8.67 1 Injection 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), somore patients can now be benefited.

This can be made possible if two things happen simultaneously:

THE ULTIMATE SOLUTION: Statutory price control for all essential drugsTOP

It is the government, which can provide medicines at an affordable cost andimprove medicine accessibility. In India, an effective price control mechanism is amust, 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 CentralGovernment should introduce a more effective drug pricing policy that would bringdown the high profit margins for the pharmaceutical trade and make medicinesmore affordable for the common man.

Liberalisation has nothing to do with a price protective mechanism in a sectoras vital as healthcare. The medicines under national list of essential drugs must bekept under price control domain and the provision to control of newer necessarymedicines useful in public health should be made.

Supreme Court in its interim order dated, March 10, 2003 in Gopi Nath casehas directed the central government to ensure that essential and life saving drugsare kept under price control. The fact that Karnataka High Court and subsequentlySupreme Court stayed the implementation of pharmaceutical policy 2002

31

Low cost drugs madeavailable

(at govt. medical shops)

1. Transparent procurementthrough open tender system.2. Distribution of Low costdrugs through Life Line/ Coop.Store.3. Display of Rates

Rational Prescription(by Doctor )

1. Prescription of drugs bygeneric (salt) name.2. Prescription out of essentialdrugs list.3. As per Standard TreatmentGuidelines.


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questioning the stand of Government over the exclusion of many essential drugsunder the ambit of price control speaks the importance of price controlled essentialdrugs in India. This is yet to be complied with.

At present only 74 drugs have ceiling prices. If SC orders of 10 Mar.03 arecomplied with, it would result in control on ceiling prices (ie control on MRP) of about350 Essential Drugs and many other life saving drugs as well. Even if these drugscould 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. Genericsimply means that the drug is not sold as the brand name, but it has the identicalstrength, dosage and route of administration and the same active ingredients asthe brand-name drug. The use of generic drugs is now widely accepted and theyare commonly prescribed by physicians and dispensed at hospitals. While

manufacturing generic drugs, the drug companies use the same active ingredientsand are shown to work the same way in the body, they have the same risks andbenefits as their brand name counterparts. Also, generic drugs have the samequality, strength, purity and stability as brand name drugs. It is seen that GenericDrugs 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 genericmanufacturers do not have the investment costs of the developer of a newdrug. New drugs are generally developed under patent protection. The patentprotects 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 tosell generic versions. In the process, the consumers get genetic drugs atsubstantially lower costs. Both branded and generic drugs are manufactured byconforming to International standards. Brand name drugs are usually givenpatent protection for 20 years from the date of submission of the patent. Thisprovides protection for the innovator of such drugs to make good the initialcosts incurred by him, viz., research development and marketing expenses, todevelop the new drug. Many drug companies start manufacturing generic drugsonce the patent license expires for a branded drug. The physician plays a vitalrole to determine whether his patient needs a branded drug or generic drug.TOP

Patients should become assertive and insist upon the doctors to prescribegeneric drugs if available, so that the patient would get the product at the bestpossible price. Pharmacists also play a vital role in educating the doctors aboutthe availability of generic drugs. Thus the right medication could be given tothe 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 losemoney by going in for branded drugs, which are too costly. Health care costscontinue to rise. Therefore, consumers, providers and policymakers need toassess the best way to keep health care affordable without adversely affectingaccess to quality care. With prescription drug (branded drug) costs serving as amajor contributor to cost escalations,

Generic drugs offer an important tool for reducing the rate of growth inoverall health expenditure. Generic drugs play an important role in health careand the availability of generic drugs reduces the monopoly and oligopoly

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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 asbrand-name drugs.

4. Why are generic drugs less expensive?

Generics cost less than brand-name drugs, mostly because manufacturersof generic drugs do not have the expense of research, development,advertisement and marketing related to a new drug. New drugs aredeveloped under patent protection. The patent protects the investment bygiving the company the sole right to sell the drug while it is in effect. Aspatents near expiration, other manufacturers can apply to sell genericversions. Because those manufacturers don't have the same developmentcosts, they can sell their product at substantial discounts. Also, once genericdrugs are approved, there is greater competition, which keeps the pricedown. Today, in U.S. almost half of all prescriptions are filled with generic

drugs. Generic drugs save consumers an estimated $10 billion a year atretail pharmacies. Even more billions are saved when hospitals usegenerics.

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

No. Both brand-name and generic drug facilities must meet the samestandards of good manufacturing practices. Drug authorities won't permitdrugs to be made in substandard facilities. Inspections are conducted toensure that prescribed standards are met. Generic firms have facilities

comparable to those of brand-name firms. In fact, brand-name firms arelinked to an estimated 50 percent of generic drug production. Theyfrequently make copies of their own or other brand-name drugs but sellthem without the brand name.

6. Does every brand-name drug have a generic counterpart?

No. Brand-name drugs are generally given patent protection for 20 yearsfrom the date of submission of the patent. This provides protection for theinnovator who laid out the initial costs (including research, development,and marketing expenses) to develop the new drug. However, when thepatent expires, other drug companies can introduce competitive generic

versions, but only after they have been thoroughly tested by themanufacturer and approved by the FDA.TOP

7. Is my generic drug made by the same company that makes thebrand-name drug?

It is possible. Brand-name firms are responsible for manufacturingapproximately 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 onthe basis that it can be recognized, pronounced and remembered by healthprofessionals and members of the public. An example would be Viagra - thisis the well-known brand name given by Pfizer to the generic medicinesildenafil. (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 over-the-counter medicine, they may have a choice between a branded medicineand the generic version of that medicine. Generic medicines are mostlycheaper than brand-name medicines, but the active ingredient (the

ingredient that produces the therapeutic effect of the medicine) is the samein both. If your doctor has prescribed a medicine by its brand name, yourpharmacist must dispense that brand. However, if a medicine has beenprescribed by its generic name, your pharmacist can dispense whateverversion of the medicine they have available, because each version will havethe same therapeutic effect.
http://www.netdoctor.co.uk/medicines/100002749.htmlhttp://www.netdoctor.co.uk/medicines/100002749.html

annexure i concept note_2

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