Ecks & Basu 2009 in Transcultural Psychiatry : The Unlicensed Lives of Antidepressants in India:...
Transcript of Ecks & Basu 2009 in Transcultural Psychiatry : The Unlicensed Lives of Antidepressants in India:...
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Forthcoming in Transcultural Psychiatry as:
The Unlicensed Lives of Antidepressants in India:
Generic Drugs, Unqualified Practitioners, and Floating Prescriptions
Stefan Ecks
Soumita Basu
Author’s Mailing Address:
Dr. Stefan Ecks
School of Social & Political Studies
University of Edinburgh
George Square
Edinburgh EH8 9LD, United Kingdom
Tel: +44-(0)131-650-6969
Fax: 44-(0)131-650-3945
Email: [email protected]
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Abstract Antidepressant uses have been rising rapidly over the past decades. Two main theories
have been advanced to explain this. One claims that socio-economic change causes a global rise
of depressive illness. The other holds that European and North American corporations are
aggressively marketing antidepressants to expand their global reach. Both theories assume that
multinational capitalism drives rising depression rates. Based on ethnographic data from India,
this paper shows that antidepressants are increasingly used there as well, but for reasons than
have been little explored yet. Taking fluoxetine (Prozac) as the main example, it is argued that
the spread of antidepressants in India is “unlicensed” by Euro-American corporations in at least
three ways: (i) drug marketing is driven by Indian generic producers; (ii) fluoxetine is given by
practitioners who have no license to do so; and (iii) knowledge of fluoxetine is spread through
unlicensed “floating” prescriptions that patients take from one prescriber to another.
Running Title: Unlicensed Lives of Antidepressants
Keywords: depression, globalization, psychopharmaceuticals, fluoxetine, prescription practices,
India
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How Depressing is Globalization?
It is certain that prescriptions for antidepressants have been greatly increasing since the late
1980s. Prozac (fluoxetine) alone has been used by more than 54 million people since its launch
in 1987, making it the most often prescribed antidepressant brand in history (Eli Lilly, 2007). It
is also certain that this increase is not limited to Europe and North America, but is also occurring
in developing countries. What is not certain, however, is what or who is driving this process.
“Globalization” plays a dual role in the career of antidepressants. On the one hand,
economic globalization appears to be associated with an increase of depression around the world,
and with it an increase of prescriptions. For example, Bhugra and Mastrogianni (2004) argue that
globalization is linked to urbanization, migration, and deeper divisions between the rich and the
poor, all of which cause a rise in the use of antidepressants. Economic change is disrupting
traditional forms of social cohesion and is stripping cultures of their psychologically protective
powers (Bhugra & Mastrogianni, 2004, p. 12). Similarly, the World Health Organization (2001,
p. 27) has argued that individual poverty, mental illness, and macroeconomic impacts form a
vicious circle. According to WHO, social inequality leads to a higher prevalence of mental
disorders which, along with a lack of appropriate care, decreases economic growth, as people
become less productive or become unable to work. If it is indeed the case that economic
globalization causes more social inequality, then it should be no surprise that antidepressant sales
are rising.
On the other hand, globalization is often seen as the very process that disseminates
western notions of “depression” along with its pharmaceutical therapies. For example, Kirmayer
and Minas (2000) hold that the global spread of psychiatric disease classifications and diagnostic
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routines account for the increase in antidepressant uses. This argument is sharpened by the
suspicion that the globalization of antidepressants is, by and large, the work of pharmaceutical
marketing. As Healy (2004, p. 2) points out, it is strange that psychiatrists did not recognize
depression as a widespread affliction before the commercial availability of antidepressants. From
today’s perspective, it seems odd indeed that rates of depression should have multiplied by a
factor of 1,000 since antidepressants were marketed. Diffuse states of sadness, which earlier
went without therapeutic intervention, are becoming increasingly medicalized and treated with
drugs (Clarke, Shim, Mamo, Fosket, & Fishman, 2003; Rose 2006).
These two theories of globalization give different answers to the question posed by rising
rates of antidepressant uses. The first proposes that economic globalization causes real anguish
and therefore increases the need for psychopharmaceuticals. First comes the need, then comes
the drug therapy. The second theory proposes that the global demand for drugs is created by
multinational corporations in tandem with professional medical interests. In this version, the
drugs come first, and then comes the manufactured need for them. Each theory conceptualizes
supply and demand differently. The first holds that European and North American drug
companies only supply an existing demand. The second theory holds that these companies
actively create demand for their products by changing people’s ideas about health and illness.
Healy expresses this as follows:
The marketplace, far from being shaped by the laws of supply and demand, is
constructed by large corporations ... Companies act to control not only the supply
of products to a market but also the flow of ideas to the ideas market and to
regulate the demands that come from the market (1998, p. 212).
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It is much easier to collect convincing evidence for the second theory than for the first. In
fact, it is not difficult to find people working in the pharmaceutical industry who believe that
marketing comes before demand. Any drug that works better than a placebo promises a decent
profit. Once a drug is approved as (relatively) safe and (relatively) effective, any company must
strive to create as much demand for it as it can. This applies to all products, but particularly to
newer antidepressants, such as the selective serotonin reuptake inhibitors (SSRIs). According to
Kalman Applbaum, the pharmacological effects of SSRIs are so muddled that “the latitude for
the reinterpretation of their value back to the consumer through brand positioning is somewhat
flexible” (2006, p. 107). To create a demand for antidepressants and to continually grow the
market for them can only be a scandal for those who believe in the fiction of a “real” demand for
such drugs.
There are irreconcilable differences between these two theories, but they also share some
common ground: both locate the origin of this demand in economic globalization. One holds that
globalization increases socio-economic tensions and, therefore, a need for relief from them; the
other claims that North American and European corporations create a global demand for their
products. According to either theory, capitalist corporations—and the culture that comes with
them—would ultimately appear to be the source of a rising global demand for antidepressants.
What medical anthropologists can offer to this debate are ethnographic explorations of
how demand for antidepressants is emerging in specific locations. It might be true that North
American and European corporations are driving the global spread of antidepressants, but is this
the only reason why these drugs are spreading in a country like India? In this article, we examine
the dynamics of the antidepressant market in the Indian state of West Bengal. The data presented
here have been collected between December 2006 and July 2008 as part of the ESRC/DFID-
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funded project “Tracing Pharmaceuticals in South Asia: Production, Distribution, and
Consumption.” The key idea of this research is that the social lives of pharmaceuticals can only
be understood if they are traced through production, marketing, distribution, prescription, retail,
consumption, and regulation. The goal of this research is to obtain an ethnographic view of all
the players involved in a drug’s trajectory. We focused on three specific substances: the hormone
oxytocin, the antibiotic rifampicin, and the antidepressant fluoxetine—the subject of the present
paper. We decided to explore the uses of each of these drugs in three South Asian cities
(Kolkata, Delhi, and Kathmandu) and to trace them upward and downward from there.
We chose to focus on fluoxetine to assess the claim by the World Health Organization
and other large agencies that there is a wide “treatment gap” for depression between richer and
poorer countries. It is frequently argued that people in countries like India have almost no access
to mental health treatments, for a number of reasons: people do not recognize depression as a
medical problem; depression is somatised and its symptoms are mistaken for physical ailments;
stigmatization of psychiatric services prevents people from seeking help; suffering goes
undiagnosed by ill-trained doctors; patients end up with quacks and faith healers instead of
competent doctors. Indian media reporting on mental health echoes all these arguments. For
example, a lead article in the Kolkata newspaper The Telegraph (Jayan 2008) calls depression a
“secret disease” that is becoming a “significant public health problem.” It cites the WHO data on
the rise of depression and quotes a professor from the All India Institute of Medical Sciences:
“Depression is grossly underdiagnosed and undertreated in India.” There were many reasons for
the rise of depression, but any effective treatment had to target the brain with drugs: “Certain
changes occur in their brains and … they require medication to help rewire the brain.” Such
claims about the gross lack of depression treatments in India rely on only a handful of studies
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conducted in psychiatric outpatient clinics and on general observations about how few
psychiatric patients are treated in government institutions.
To move beyond such generalizations, we began our research by examining the actual
availability of antidepressants in India. For example, there are at least 60 different brands of
fluoxetine on sale in Indian medicine shops. Other antidepressants, such as amitriptyline,
sertraline, escitalopram, or venlafaxine, are also cheaply available from dozens of generic
producers. We reasoned that, if there are hundreds of antidepressant brands, there must surely be
a large number of people in India who are taking them. In this article, we attempt to understand
why there is such a discrepancy between public pronouncements about the “treatment gap” and
the evidence of actual sales and uses of antidepressants.
Prozac Proletariat
In February 2007, we attended the All-Bengal meeting of the Rural Medical Practitioners’
Association (RMPA) in Kolkata. The event was held in an unassuming meeting hall near the
center of the city. For two days, the venue was packed with around 300 delegates from across
West Bengal, most of them men aged 30 to 50. As is the custom in India, the meeting opened
with a ritual. But unlike most other conferences, this ritual did not involve the lighting of lamps
and a poetic song, but consisted of the hoisting of the RMPA flag and the laying of garlands
around the picture of the Association’s idol, the Canadian Dr. Norman Bethune.
Born in Ontario in 1890, Bethune studied medicine at Toronto and had a long-standing
association with McGill University, where he taught thoracic surgery. During the Spanish Civil
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War, he worked as a field surgeon on the side of the Republicans (1936-1937), went on to China
to support Mao’s troops against Japan, and died of blood poisoning in one of his mobile
surgeries in 1939. One of the posters outside the meeting hall (Fig. 1) features a heroic Bethune
and a quote from him, which says that the world does not need celebrity doctors and surgeons,
but doctors who have foresight, who work for the country, and who have a social conscience. In
an obituary in honour of Bethune, Mao Tse-tung (1979 [1939]) supported Lenin’s realization
“that the world revolution can only succeed if the proletariat of the capitalist countries supports
the struggle for liberation of the colonial and semi-colonial peoples,” and stated that Bethune
vigorously put this theory into practice. According to Mao, Bethune’s work supported the ideal
of “internationalism” and helped to fight “narrow nationalism and narrow patriotism.”
Insert Figure 1 about here
After Bethune’s picture had been garlanded and a number of honorary speakers had been
heard (the authors were also invited to say a few words), the conference proceeded with a long
sequence of impassioned speeches on the prickly situation that the RMPA and its members find
themselves in. One of the major concerns, voiced by a dozen delegates, was that it is still illegal
to practice as a rural medical practitioner. What was needed, with immediate effect, was the
legalization of RMPs and their inclusion into the state health system. It was high time that their
grassroots work for people’s health was acknowledged by the government and that it stopped
treating them as unlicensed charlatans without medical expertise.
During the meeting and in the months afterward, we had the chance to interview fifteen
RMPs individually. While they had various reasons for having become RMPs, the most common
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were the inability to find other suitable work and a strong yet unmet demand for medical care in
Bengal’s rural areas. All of them said that there were too few government hospitals available and
they were often too far from where people live. Government hospitals and health posts were
usually badly run, staff was absent, equipment was not working, and drugs were out of stock.
One of the RMPs we interviewed had seen his father die because the Primary Healthcare Centre
(PHC) in his local area did not offer any treatment when his family brought him there. Despite
these problems, the RMPs said that they had cordial relations with both the staff in the state
health facilities and with general practitioners in private practice. Indeed, many had worked as
assistants to college-trained GPs (“MBBS doctors,” that is, the Bachelor of Medicine & Surgery)
before starting their own practice.
When we asked the RMPs about “mental” problems among patients who came to see
them, the consensus was that such illnesses were rising. Asked about how they knew that mental
illnesses were increasing, they cited chronic economic insecurity: “Anxiety, depression is
increasing. It is mostly because of the economic situation. This is our analysis and we are sure of
this conclusion” (RMP-1). A further source of evidence for this rise was the RMPs’ memory of
how patient profiles had been changing over the years. One of the RMPs said that, during his
fifteen years of practice, he had seen mental problems increase, and that his patient records could
easily prove this. Another RMP whom we interviewed shifted the perspective away from his
own expertise in diagnosing psychiatric disorders to how MBBS doctors had been changing their
prescription habits over the years:
We get two kinds of patients. One, the psychiatric patients come to us who are
already on psychiatric drugs that have been prescribed by some specialist. They
start the medicine and then come to us to know what it is all about. Or they may
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have stopped the medicine and then come to us for the problems that arise after
stopping the medicine. Two, they may come for other health problems and in the
process show us the prescriptions from where we can learn what they are taking.
(RMP-2)
The perceived rise of depression, anxiety, and other mental problems does not come from
learning to diagnose symptoms, but from learning patients’ medication histories. RMPs get
access to prescriptions when patients are unsure about treatments advised by licensed doctors.
Patients come with prescriptions that they do not fully understand to ask the RMPs, to whom
they have a less distanced relation, “what it is all about.” They come with prescriptions that they
discontinued without the supervision of an MBBS doctor. And they come with prescriptions that
the licensed doctor did not want to be shown to other practitioners. In this way, the RMPs learn
about psychiatric treatments through doctor-shopping patients, and they deduce from a
noticeable increase in psychotropic prescriptions by licensed doctors that mental illnesses are
rising.
The RMPs associated a range of physical symptoms with depression, including sleep
disturbance, lack of concentration, lack of libido, sexual weakness, irritability, irregular thoughts,
and burning sensations in the head. Digestive problems such as “gas” were also mentioned as
important symptoms for mental disturbance.
Several RMPs said that they were against using psychopharmaceuticals. One reason
mentioned was the price of pills. Some RMPs stated that patients in rural areas had difficulties
paying for medications, especially if the treatment lasted for a prolonged period. The RMPs also
felt that they did not know much about the effects of these drugs. A further problem with
psychotropic medications was their addictive potential. When we mentioned fluoxetine, one of
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the RMPs asked us if we meant “the sleeping pill?” He went on to narrate how he had once
suffered from stomach pains and went to see a city doctor about it:
I have never touched alcohol, cigarettes, betel leafs, or tea. I used to suffer from
gastritis pains. I went to a doctor in the city and he gave me some medicines. I did
not check with CIMS [a drug reckoner] to know what kind of medicine it is. After
having it for a month, when I checked I found it was a sleeping pill. It was called
Ativan [lorazepam, a benzodiazepine]. When I came to know it is a sleeping pill,
I thought: ‘Let me discontinue and see how I do.’ I have never been addicted to
anything. So I wanted to discontinue the sleeping pill. Then I started praying and
used to fall asleep while praying. I use the same treatment for my patients. (RMP-
4)
In this case, the RMP had learned through his own experiences as a patient and through
his readings in a drug manual that MBBS doctors prescribe psychopharmaceuticals for such
symptoms. It did not bother him that the licensed doctor had diagnosed a mental problem, nor
that he had not been told about diagnosis and treatment. What worried him was the risk of
becoming addicted to these drugs, and this is what stopped him from giving
psychopharmaceuticals to his patients.
Above all, the RMPs saw the root of depression as economic and social and, therefore,
not solvable through drug treatments. Nevertheless, all the RMPs who used antidepressants said
that these drugs could alleviate mental problems over a short period: “I don’t think this problem
[depression] can be solved with medicines. The cause is socio-economic. But we use medicines
to take care of the symptoms” (RMP-1).
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We also interviewed the honorary speakers from the RMPA conference. One of them, Dr.
Das (a pseudonym), a lecturer in pharmacology at one of Kolkata’s medical colleges, is one of
the organization’s long-time mentors. Dr. Das had been organizing teaching workshops for, as he
put it, “illiterate peasants” in rural Bengal for many years. These workshops were attended both
by villagers wanting to know about basic treatments and by those aiming to become RMPs. By
building up a large network of people in the countryside, Dr. Das could collect thousands of
doctors’ prescriptions from across the state. He used this material to track changes in prescription
habits and to alert the public to what he saw as grossly irrational uses of drugs. In his view, up to
80% of all drugs used in India were either irrational, fake, spurious, or of substandard quality.
The fact that India’s best-selling medicines are cough syrups was, to him, symptomatic of how
badly patients were duped by doctors.
Dr. Das positioned his support for the RMPs and his grassroots work in drug education
within the politics of “Social Pharmacology.” While explaining this approach to us, Dr. Das
drew a diagram (Fig.2).
Figure 2 about here
Social Pharmacology applies Marxist philosophy to pharmacology. Materialism can
explain everything: “What is life? It is a chemical interaction of matter.” Atoms are the basis of
all matter. Kicked into action by the sun, atoms create chemical elements. The elements are the
building blocks of proteins, fats, and all other biochemical substances that constitute living cells.
The cells make organs, and organs build up bodies. Cells divide, multiply, and produce not just
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one organism, but a whole society of thinking and feeling people: “Everything has a material
basis. Your consciousness, your imagination, your thinking, your love, your depression. For
everything there is a chemical reaction in the brain.” If looked closely, the material, the social,
and the mental were all based on the same dialectics: “Everywhere in matter, there are two
opposites … This is also the principle in physics and chemistry. In biochemistry it is life and
death. And in society, it is the class struggle, between the haves and the have-nots.” The source
of this philosophy was Josef Stalin, who, as Dr. Das held, had been the first to fully realize that
the brain is matter in its highest form.1
Asked about the role of psychotropic medications such as fluoxetine in society, Dr Das
also took a materialist position. Fluoxetine was a useful antidepressant drug. Yet, as he pointed
out, it might not be of use in the future, because everything was dialectically changing.
Fluoxetine interacted with the brain, and changed it in the process. At the same time, society was
also changing, and with it the conditions of mental well-being. The political goal of Social
Pharmacology was to create a synergy between social change and pharmaceuticals, toward a
revolution:
Without fluoxetine, you cannot change. But without changing society, you cannot
depend only on fluoxetine. You have to see both sides, social change and
fluoxetine … At the current moment, the question of society is primary. That is
our target of activity. Simultaneously we are administering fluoxetine and ask the
people who are suffering from depression to act with the society.
According to Dr. Das’s Social Pharmacology, one could not heal the depressed mind without
revolutionizing society, but it was also impossible to heal the mind without
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psychopharmaceuticals. Both the endogenous and exogenous sources of depression had to be
tackled simultaneously.
How are these ideas about psychopharmaceuticals related to the two theories of
globalization? The RMPs and Dr. Das seem to agree mostly with the theory that economic
change triggers a rise in mental illness. Surprisingly, the theory that multinational corporations
artificially create a demand for drugs was not mentioned. Furthering the cause of corporate
capitalism is clearly not on the RMP agenda. They see their work as part of a struggle for social
equality and praise socialist internationalism over capitalist globalization. Given the RMPA’s
references to Marx, Mao, and Bethune, one might have expected to hear a sharp critique of
corporate “disease mongering,” but nothing of the kind was talked about, not even by someone
as sceptical as Dr. Das.
The lack of this particular type of corporate critique might partly be explained by the
RMPs’ marginal position in relation to pharmaceutical companies. No medical representatives
were seen anywhere near the RMPA meeting: while the conferences of licensed doctors are
heavily sponsored by drug producers, the RMPs met at a modest location, without industry
funding. (To be sure, any drug manufacturer would be foolish to endorse an RMPA meeting
officially, as their practice is illegal.) RMPs do not make much money out of prescribing drugs,
and they surely come nowhere near the fortunes made by licensed doctors.
But despite their ideology, the RMPs who are promoting antidepressants are also
promoting private corporate interests. This is clear enough in regard to Indian manufacturers,
since the RMPs are increasing their sales in rural areas. For multinational producers, the RMPs
are a mixed blessing—but a blessing still. On the one hand, the global market share of the
original patent holders is being further eroded by the spread of cheap generics. On the other
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hand, the unlicensed uses of antidepressant are growing the Indian market for
psychopharmaceuticals to an extent that could never be achieved by corporations trying to sell
expensive patent-protected drugs. Arguably, a larger market for such drugs will, in the future, be
beneficial for the multinationals. To make this argument more clearly, we need to take a step
back and look at the origins of the current scenario. What happened to Prozac before Bengali
rural medical practitioners started to prescribe generic fluoxetine?
Globalized Supply and Demand
The psychopharmaceuticals that are currently available in the Indian market were first developed
and patented by pharmaceutical corporations headquartered in North America and Europe. From
among the SSRI-type antidepressants, citalopram was developed by the Danish company
Lundbeck, fluvoxamine by Switzerland’s Solvay, and paroxetine by the UK-based
GlaxoSmithKline. Pfizer’s sertraline and Eli Lilly’s fluoxetine were both developed in the
United States. However, not one of these companies could exploit its original patent monopoly in
India.
During the late 1980s and 1990s, when these drugs were first licensed, the Indian
government did not protect product patents. Between 1972 and 2005, India’s laws only protected
the process of drug manufacturing, but not the active ingredients. In practice, this meant that any
molecule, even if protected in other countries, could be reverse-engineered and generically
produced in India. Over the past decades, this patent regime allowed the Indian pharmaceutical
industry to become the world’s leading producer of generic medications (Chaudhuri, 2005).
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By protecting different production processes, the old patent regime fostered a market
where thousands of small, medium, and large companies compete with practically identical
products. The field is so diverse that estimates of the number of pharmaceutical companies active
in India today vary widely, ranging from 3,000 to 20,000 companies. If a report commissioned
by the Indian government is to be believed, there were 5,877 licensed drug producers in 2003. Of
these, 4,534 produced formulations and 1,333 manufactured bulk drugs (Government of India,
2003, p.3). Only about 250 of these firms generated sales of more than US$ 2 million (Ernst &
Young, 2005).
Great changes have been underway in the Indian market since several World Trade
Organization (WTO) agreements came into force, in particular the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) which the Indian government fully joined in
2005. Multinational pharmaceutical companies wanted worldwide protection of their patents and
lobbied hard for an inclusion of India in TRIPS (Braithwaite & Drahos, 2000). However, before
signing the agreement, the Indian government negotiated a 10-year transition period during
which Indian pharmaceutical companies could continue to produce generics without paying
licensing fees to patent holders. Moreover, the new law only protects drugs patented in India
after 2005, to prevent multinational companies from patenting products that are already
generically available (see Ecks, 2008). Over the next decade, the new patent regime will force
many small and medium-sized companies out of the market, to the benefit of multinationals.
To date, however, while most of the large European and American MNCs have
established a presence in India, their combined share of the market is only around 25%. For
example, the world’s largest drug company, Pfizer, is the second-largest pharma MNC in India.
While Pfizer India is clearly doing well, with sales of around US$100 million in 2004, its
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revenues are modest compared to the Indian market leaders. Ranbaxy, India’s largest
pharmaceutical company, reported sales of over US$ 823 million in 2004 (Ernst & Young, 2005,
pp. 6 & 9). Furthermore, nearly all drugs sold in India today are off-patent. It will possibly take
at least ten years for patent-protected products to have a wider impact on drug affordability and
availability. (Indeed, Indian drug manufacturers are more anxious about other changes, such as
the tightening of WHO/WTO-backed Good Manufacturing Practices, than about the
strengthened position of patent-holding multinationals; see Jeffery, Ecks & Brhlikova, 2007.)
Despite a large and growing middle class, profits from pharmaceuticals in India are small
compared to those derived in wealthier countries. Hardly anyone in India is covered by private
health insurance, and most drugs must be paid for out-of-pocket. In 2003, spending on health
care was only about US$ 28 per person, out of which only US$ 3 were spent on pharmaceuticals.
By comparison, per capita health spending was US$ 2,307 in the 30 member states of the OECD
and an enormous US$ 5,635 in the United States. Nevertheless, health expenditures in India are
expected to rise considerably in the future (Ernst & Young, 2005, p. 4), and it is believed that
drugs that treat chronic “lifestyle” diseases such as depression will benefit the most.
Since the 1980s, branded antidepressants have been highly profitable in North America
and Europe because more people have been diagnosed and prescribed drugs than before. While
Prozac became an icon of American popular culture, Eli Lilly never even introduced the drug in
India: profit expectations were simply too low, and continue to be low. In the US in 2008, Eli
Lilly’s Prozac 20mg sells for around US$ 40 per 10 capsules. In India, where the market is
completely dominated by generics, the typical price charged for 10 capsules of fluoxetine 20mg
is less than US$ 1. Other multinationals that took their products to the Indian market had to do so
at a heavily reduced price. For example, Pfizer India sells sertraline under the brand name Daxid
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at a vastly lower price than its Zoloft brand in the US. In 2008, at least 30 rival versions of
sertraline were available. Faced with such competition, Pfizer sells Daxid at a price that is even
lower than some of its generic competitors (for example, Torrent’s Serenata and Ranbaxy’s
Serlift). While there has never been a lucrative Indian market for high-priced brands, the
presence of cheap generics makes it unlikely that expensive medicines launched post-2005 will
grab big pieces of the antidepressant market anytime soon.
Even if the original antidepressants came to India from the US and from Europe, it is now
Indian companies that are exporting them to Euro-American markets. The most famous case of
this reverse flow of drugs is Dr. Reddy’s Laboratories’ (DRL) success with exporting fluoxetine.
DRL was founded in 1984 and is now one of India’s largest pharmaceutical companies (Dr
Reddy’s Limited, 2006). From 2001 onward, a large part of DRL’s profits came from its
fluoxetine exports to North America. In 2001, DRL challenged Eli Lilly’s patent on Prozac in a
US court and won 180 days of exclusive marketing rights for fluoxetine 40mg. This was a
historical event for the Indian industry, as no other company had ever achieved such a legal
victory. DRL earned almost US$ 70 million over this 180-day exclusivity period, while Eli Lilly
lost 80% of its US market share. In 2004, fluoxetine was by far DRL’s best-selling product,
contributing more than 40% to its annual revenues (ca. US$ 45 million out of US$ 107 million).
Since then, however, DRL’s fluoxetine sales sharply decreased, to US$ 21 million in 2005 and
US$ 9 million in 2006. Far from fluoxetine being less often prescribed, it was the increased
generic competition from other Indian companies that ate up DRL’s profits. This competition
affects the Indian domestic market even more than the export market.
Among the more than 60 different generic versions of fluoxetine available in India in
2008, a few brands dominate the market, for example, Fludac (Cadila) (Fig.3), Prodep (Sun), and
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Flunil (Intas). But smaller products, such as Floxin from D.D. Pharmaceuticals, are holding their
ground. A standard strategy of Indian manufacturers is to bring out combinations, for example,
fluoxetine 20mg combined with alprazolam 0.25mg. More than twenty of these combination
drugs were marketed in 2008.
Figure 3 about here
Before the first Indian RMP started to prescribe fluoxetine, it became available and
affordable in generic form. The low threshold for entering the pharmaceutical manufacturing
business, owing to the absence of product patents, created fierce competition and drove down
prices. A WHO-sponsored study on the availability and affordability of drugs in West Bengal
found that fluoxetine is affordable even to poorer rural people (Tripathi, Dey, & Hazra, 2005).
Availability of the drug is also very high: the highest-selling generic of fluoxetine (Cadila’s
Fludac) is on sale in 74% of medicine shops, and some form of fluoxetine is sold in 77% of all
shops. Fluoxetine is more widely available than even vital drugs such as ibuprofen or
ciprofloxacin. It is also easier to buy fluoxetine from a private shop than amitriptyline, which
was previously the most commonly used type of antidepressant in South Asia.
You Only Live Thrice
Like many other psychopharmaceuticals, fluoxetine spread from a limited market of psychiatrists
to a much wider group of prescribers. As we argue in this section, the market presence of the
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drug went through three phases: from psychiatrists to licensed generalists, and subsequently to
unlicensed practitioners.
Since the mid-1990s, when Indian companies began producing fluoxetine for the
domestic market, they have promoted the drug to the obvious specialists in this area:
psychiatrists in private practice. (Fluoxetine has been dispensed by government pharmacies only
since 2007). In a situation where scores of producers are competing with identical products for
the patronage of a small group of specialists, corruption is part of the promotional routine.
Depending on how “famous” a doctor is and how many prescriptions he can generate, different
investments can be made in him. Regular visits by medical sales representatives to doctors are
only the basic pitch. If a doctor looks promising, he can be treated to expensive meals at
restaurants, conference travels, and expensive goods (refrigerators, TV sets, even cars). It is also
an open secret that doctors can ask to be paid in cash for switching to prescribe a particular
product. The scale of such rewards is said to have risen enormously over the past years. Earlier,
doctors used to ask for conference trips within India; now they ask for trips abroad (Vienna being
one of their favorites). Marketing people see psychiatrists as more “corrupt” than doctors in other
specialties, because psychiatrists rely almost entirely on drugs and, by extension, on kickbacks
from pharmaceutical companies for extra income. Other specialties, such as gastroenterologists,
can make more money from diagnostic tests than from drugs.
In India, the legal situation for such practices is murky. In December 2006, the
Organisation of Pharmaceutical Producers of India (OPPI), the chief lobby group for
multinational companies in India, started promoting a new code of ethical marketing (Pharmabiz
2006). The goal of this revised code was to make Indian manufacturers conform to standards laid
down by the International Federation of Pharmaceutical Manufacturers (IFPMA). The rules try
21
to prevent corruption in any form and to establish “Good Marketing Practice” in the same
fashion as codes for Good Manufacturing Practice or Good Clinical Practice. However, the de
facto situation remains that any form of “convincing” doctors is tolerated; the new code has done
nothing to change this.
The second phase of fluoxetine’s life cycle has been promotion to non-specialists,
especially general practitioners and non-psychiatric consultants who deal with chronic illness,
such as cardiologists and gastroenterologists. Targeting non-specialists is the logical next step to
increase sales in developed and developing countries alike. In India as elsewhere, the number of
psychiatrists is small compared to that of other prescribers. A handful of psychiatrists are
available in metropolitan cities such as Kolkata, but they are practically nonexistent in rural
areas. The West Bengal branch of the Indian Psychiatric Society has only around 340 members,
most of whom are based in Kolkata. Placed in the context of West Bengal’s total population of
more than 80 million people, psychiatrists clearly are a rare species.
The incentives used to convince non-specialist doctors to prescribe a particular version of
fluoxetine are more or less the same as those used with psychiatrists, except that the rewards are
lower. The drug is also pitched differently depending on therapeutic specialties. A marketing
manager for fluoxetine explained how he changes focus with different doctors. For example, “to
a diabetologist, I position [our product] as a drug that reduces carbohydrate cravings, and not as
an antidepressant.” Different dosages and different packaging aim to make the drug attractive to
different prescribers. For example, liquid fluoxetine is promoted for use with obstinate patients:
“Some patients don’t like to take antidepressants. They think they are going mad and don’t want
to take medication. In such cases, we promote fluoxetine in the liquid form. Every 5ml has 20mg
22
of fluoxetine.” The liquid form works best if relatives put the drug into food or drink, without
knowledge of the patient.
In 2008 fluoxetine no longer requires a significant marketing effort. A marketing
manager for a top-selling brand told us that he was not focusing on the drug any longer, not
because fluoxetine was going out of the market, but because sales were so stable. Fluoxetine was
one of the company’s “cash cows” that provided the resources to launch new products. His brand
was so firmly established among both psychiatrists and non-specialists that a brief reminder over
regular intervals was sufficient to maintain strong sales. However, an occasional focused
marketing effort could also result in high returns. When asked about the sales trends of
fluoxetine in his zone, this manager said that he almost doubled sales between 2006 and 2007
through focused marketing to GPs and other non-specialists: “We had our focus to promote [our
product] to all the physicians and the result came instantly. These tremendous sales we got not
from psychiatry, but from physicians, from diabeto, cardio and all.” That a strategy of temporary
investment in non-specialist prescribers is enough to double sales reflects a later stage in the
product’s life cycle.
Apart from direct contact with doctors, marketers told us about another key source from
which demand is generated: the “floating” prescription. Psychiatrists are said to be the
trendsetters in prescription patterns, whereas non-specialists wanted tried and tested drugs. The
route through which the non-specialists learned about the most common treatments was not
through medical representatives, but through prescriptions that patients brought to them. One of
the marketing directors for psychopharmaceuticals described this as follows: “Once the
consultant prescription is done, it floats in the market and immediately it reaches the GP …
When a consultant shows faith in a particular product, it is immediately picked up by the GP.”2
23
There are different situations in which a psychiatrist’s prescription might travel with the
patient to a non-specialist. A patient could regularly see a psychiatrist but also seek treatment
from a GP for illnesses that do not require specialist attention. In another common scenario, a
patient may pay several visits to a psychiatrist and then stop consulting him, perhaps because
access is too cumbersome, or because his fees are too high: “They continue with the drug by the
consultant and then, if they face any problems, they go to the GP. The GP learns about the
prescriptions and he will immediately ask what the actual problem was,” said one of the
marketing managers we interviewed. One important reason why GPs and other non-specialists
try to imitate the prescription style of psychiatrists could be their fear that the patient might go
back to the psychiatrist and reveal the GP’s ignorance about diagnosis and treatment. Copying
prescriptions and forming a consensus about a “good drug” from a “good company” avoids loss
of face among doctors.
What is striking about floating prescriptions is how long they can linger: some seem to
drift through a series of doctor-patient encounters for up to 10 years. Marketing managers told us
that they often can only guess at where demand for a product is generated, since floating
prescriptions widened the gap between active promotion to doctors and actual sales in shops. The
unlicensed staying power of floating prescriptions is made possible by their easy over-the-
counter availability. According to its legal classification as a “Schedule H” drug, fluoxetine
cannot be sold over the counter and its packaging is stamped with the following message:
“SCHEDULE H DRUG: Warning: To be sold by retail on prescription of a Registered Medical
Practitioner only.” While one can hear the occasional story about a shop losing its license
because it sold Schedule H medicines without prescription, in general such drugs are easily
available over the counter. It does not matter if a prescription is old or if it was written for
24
another person. The retailers whom we interviewed justified this illegal practice with reference to
poverty: why should anyone be forced to waste money on doctors’ fees if the required medicine
can be obtained directly from the shop? Indeed, retailers themselves commonly act as unlicensed
prescribers. Learning about the most regularly prescribed drugs through their daily work, they
feel free to give prescription medicines directly to any customer who asks them for advice. For
retailers, this practice is not only a way of making money, but also a means of maintaining good
relations with their customers. Making a fuss about prescriptions or even turning down a
customer’s request to buy a drug is bad business.
Floating prescriptions not only bring fluoxetine from psychiatrists to the GPs; they also
carry the drug from licensed to unlicensed prescribers. This is the third phase of the drug’s
market presence. Similar to the transition from psychiatrists to GPs, the floating prescription
establishes a product as frequently used and, therefore, trustworthy. As discussed earlier, drug
companies never officially endorse unlicensed prescribers such as the RMPs. However, in
practice they have begun targeting them individually, almost as if they were licensed GPs. While
no company has yet sponsored RMP gatherings or organized CME (Continuing Medical
Education) events for them, all of the RMPs we interviewed confirmed that they were regularly
visited by company medical sales representatives in their private chambers, simply because they
promised to generate good sales.
One RMP said that the samples provided by the MRs free of cost were the only way that
they could give drugs to the poorest patients: “Often we have to give [poor patients] the
physician’s sample that we get. The company representatives come and give us these samples
just the way they give to the qualified doctors” (RMP-5). According to this RMP’s estimate, the
ratio between MBBS doctors and RMPs can be as skewed as 1 MBBS to 42 RMPs:
25
In our block, there are not more than four qualified doctors, whereas there are 170
RMPs. Naturally, we see most of the patients. So the companies try to capture this
market. They did not visit the RMPs earlier because of their status, but now they
know that their volumes will grow if they come to us. (RMP-5)
When asked how many medical representatives come to visit, the same RMP estimated
that, in a regular month, up to 35 MRs came. It could happen that, in a single day, up to twelve
representatives paid a visit. It seems that the companies understand that if they want to reach into
rural pharmaceutical markets, they must reckon with the prescribers that matter, even if they are
unlicensed.
Conclusion
There is strong evidence for a growing use of antidepressants in all parts of India, with even
people in remote rural areas increasingly being medicated. The widened reach of
psychopharmaceuticals cannot be convincingly explained by the theory that Euro-American
pharmaceutical corporations are coaxing people in India into buying their branded products.
Indeed, the sphere of control exerted by European and American businesses in India is limited.
The lives of antidepressants in India are “unlicensed” in at least three ways. First, fluoxetine is
widely available in India, but only in generic versions. None one of the Indian companies that
manufacture generic Prozac has ever paid a penny in royalties, and Eli Lilly has never made any
profits from the Indian market.3 Significant resources have been invested in the marketing of
fluoxetine in India, but this has been done by Indian firms, not by Eli Lilly. Second, a large share
26
of antidepressant sales is not generated by licensed doctors, but by an amorphous group of
unlicensed prescribers who have never been formally trained in medicine. Third, the present
phase of fluoxetine prescriptions in rural areas cannot be solely attributed to the influence of
corporate marketing. Based on our interviews, it appears that RMPs have only recently become a
target group for medical representatives. Instead, patterns of psychopharmaceutical use “trickle
down” from specialist psychiatrists to general practitioners, and from there down to unlicensed
practitioners such as the RMPs. The main vector of this process is the “floating prescription,”
which patients carry from doctor to doctor.
That most uses of antidepressants in India are in various ways “unlicensed” does not
mean that they are ultimately against the commercial interests of Euro-American corporations.
Even if none of the original patent-owning companies could extract great profits from the Indian
market, the easy availability and affordability of generic antidepressants has grown the Indian
market for psychopharmaceuticals. Following the introduction of TRIPS, multinational
companies will soon bring out newer, patent-protected molecules and charge high prices for
them. These new drugs will be able to enter a market created and extended by the spread of
fluoxetine. Thus despite all their rhetoric of a proletarian struggle against capitalism, the RMPs
are becoming the unconscious avant-garde of a corporate psychopharmaceuticals revolution in
India.
Acknowledgements
27
This paper emerged from the collaborative research project “Tracing Pharmaceuticals in South
Asia” (2006-2009) that is jointly funded by the Economic and Social Research Council and the
Department for International Development (RES-167-25-0110). The project team comprises:
Soumita Basu, Gitanjali Priti Bhatia, Samita Bhattarai, Petra Brhlikova, Erin Court, Abhijit Das,
Stefan Ecks, Ian Harper, Patricia Jeffery, Roger Jeffery, Allyson Pollock, Santhosh M.R., Nabin
Rawal, and Madhusudhan Subedi. Martin Chautari (Kathmandu) and the Centre for Health and
Social Justice (New Delhi) provided resources drawn upon in writing this paper. Neither ESRC
nor DFID is responsible for views advanced here. An earlier draft of this paper was presented at
the McGill Summer School “Psychopharmacology in a Globalizing World” in 2007. Many
thanks to Laurence Kirmayer for organizing this wonderful event. The final draft of the paper
benefited greatly from comments by Kalman Applbaum and Transcultural Psychiatry’s
anonymous reviewers.
Notes
1. This is probably a reference to Stalin’s statement that writers are the “engineers of the
human soul.”
2. “Floating prescriptions” are not limited to West Bengal, but seem to occur throughout
India. Our joint research also found evidence of floating prescriptions in the state of Uttar
Pradesh (Roger Jeffery, personal communication).
28
3. Some retailers say that branded Prozac was smuggled into India until the mid-1990s,
before the first generic versions of fluoxetine came to the market. So it is possible that Eli
Lilly made a bit of a profit from Prozac in India. If at all, however, this profit must have
been smaller than the proverbial peanut.
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Biographical Notes:
Stefan Ecks, MA, DEA, PhD, is a Lecturer in Social Anthropology and Co-Director of the
Anthropology of Health & Illness program at the University of Edinburgh. He studied
anthropology, sociology, and philosophy at Göttingen, Berkeley, the School of Oriental &
African Studies, the École des Hautes Études en Sciences Sociales, and the London School of
Economics. He has carried out ethnographic fieldwork on health and medicine in India since
1999. His current work looks at emerging forms of pharmaceutical uses, evidence-based
medicine, and global corporate citizenship. Address: School of Social & Political Studies,
University of Edinburgh, George Square, Edinburgh EH8 9LD, United Kingdom; Email:
Soumita Basu, BA, MA, studied Sociology and Journalism at Calcutta University and at
Jawaharlal Nehru University, New Delhi. She did research on dowry deaths and notions of love
in a project run by the School of Oriental & African Studies, University of London. From 2006
to 2009, she is Research Associate in a project based at Edinburgh University that traces the
paths of three key drugs (fluoxetine, oxytocin, rifampicin) through regulation, production,
distribution, prescription, and consumption in India and Nepal.