Radical Journal of Health 1988 Vol. 2, No. 4, March: Medicine and Law

Item

Title
Radical Journal of Health 1988 Vol. 2, No. 4, March: Medicine and Law
Date
March 1988
Description
Medical malpractices and law
Good manufacturing practices: Is government serious?
Norplant: ‘The Five-year Needle’ – the Bangladesh Trial
Understanding medical ethics
Banning pre-natal sex determination
Issues and debates
Scope and limits of Maharashtra legislation
extracted text
j

Medical Malpractices and Law

\Good Manufacturing Practices: Is Government Serious?

Norplant: 'The Five-Year Needle—The Bangladesh Trial

’

Understanding Medical Ethics

*

I

Banning Pre-natal Sex Determination
Issues and Debates

I
Scope and Limits of Maharashtra Legislation
k

Working Editors:
Amar Jesani, Padma Prakash, Ravi Duggal

Volume II

Editorial Collective:

MEDICINE AND LAW

Ramana Dhara, Vimal Balsubramanyan (A P), Imrana Quadeer, Sathyamala C (Delhi), Dhruv
Mankad (Karnataka), Binayak Sen, Mira Sadgopal
(M P), Anant Phadke, Anjum Rajabali, Bharat
Patankar, Manisha Gupte, Srilatha Batliwala
(Maharashtra), Amar Singh Azad (Punjab), Smarajit
Jana and Sujit Das (West Bengal)

EditoridI Perspective
LAW, MEDICINE AND THE PEOPLE
Anil Pilgaokar

All Correspondence:
Radical Journal of Health
C/o 19 June Blossom Society,
60 A, Pali Road, Bandra (West)
Bombay-400 050 India.
Printed and Published by
Amar Jesani for
Socialist Health Review Trust.
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March 1988

No 4

77

79
MEDICAL MALPRACTICES AND LAW
Mihir Desai

86
Banning Pre-Natal Sex Determination-/
ISSUES AND DEBATES
Teesta Setalvad

88
Banning Pre-Natal Sex Determination-//
SCOPE AND LIMITS OF MAHARASHTRA LEGISLATIONAmar Jesani

91
GOOD MANUFACTURING PRACTICES-HOW SERIOUS
IS THE GOVERNMENT?
Amitava Guha

95
MEDICAL ETHICS-AN INTRODUCTORY ESSAY
Gayatri Singh

99
UPDATE—News and Notes

101

SINGLE COPY: Rs. 8/-

NORPLANT 'THE FIVE-YEAR NEEDLE'
An Investigation of the Bangladesh Trial
UBINIG

(All remittance to be made out in favour of Radical
Journal of Health. Add Rs 5/- on outstation cheques)

The views expressed in the signed articles do not
necessarily reflect the views of the editors.

Editorial Perspective

Law, Medicine and the People
THE purpose of law, it is said, is to ‘regulate’ human
activities in a society and the medical world concerns
itself with “improvement in physical and mental health
of the people and the prevention, diagnosis and treat­
ment of illness”. It is, therefore, quite natural that laws
relating to the medical world need to be examined and
modified/rectified from lime to lime in relation to their
impact on the society and people they aim to regulate.
The Indian legal system and laws, in particular those
related to medical practices eta, are borrowed to a great
extent from the British system. It is pertinent to com­
pare their impact on the people(s) in terms of their
meaningfulness to them. It would be both cumbersome
and meaningless to make a comparison of each Jaw
(related to medicine) and examine its ‘regulatory im­
pact’ on the society. Besides, there are laws relating to
medical practice that are only remotely concerned with
the general public and are, therefore, not of conse­
quence here. In fact it might serve to consider here the
different entities and their functions and the laws per­
taining to them.
Doctors and Laws

Medical practioners must ‘register’ before they can
practice and collect fees for their advice and registra­
tion is subject to minimum standards of qualification.
Under the Medical Act these responsibilities are given
to respective Medical Councils. These Medical Coun­
cils are also empowered by the act to cancel the registra­
tion of a medical practitioner from the Medical
Register if there is “serious professional misconduct”
and there is a Medical Disciplinary Committee set up
for this purpose. In UK several registrations have been
erased either because it is “necessary for the protec­
tion of members of the public or in the best interest
of the person suspended.” And there is usually a very
meaningful debate on tjie issue in medical journals,
w'hich itself acts as a deterrent for others. Such erasure
of registration of medical practioner is almost absent
so far as the Medical Council of India is concerned.
However, the absence of erasure need not be construed
to mean that things are above board in India. Adultery,
improper association, negligence, and advertising are
some of the issues on which registrations can be eras­
ed and many of our practitioners violate at least some
of these and yet the MCI does not seem to be stirred
enough to take action.
To take another example, according to the Act:
“Nothing in the act shall extend or be construed to ex­
tend to prejudice or in any way affect the lawful oc­
cupation, trade or business of chemists and druggist
and dentist or the rights, privileges or employment of
duly licensed apothecaries so far as they extend to sell­
ing, compounding or dispensing medicines”. Yet it is
almost a universal practice for general practitioners in
India to dispense drugs and charge for the same*.
March 1988

Neither the MCI not the state have taken any action
on this.
Further, “It is the duty of every registered practioner
to bring to bear upon all his professional activities that
standard of skill and knowledge which is to be expected
of a practitioner of his experience and status and of
comparable standing to him. It is also his duty to ex­
ercise reasonable care in his treatment of a patient. If
the failure to exercise the necessary degree of skill or
care results in injury to the patient, he will have a right
of action for damages. Whether reasonable skill or care
has been exercised in a particular case is a matter which
has to be considered in relation to the facts of each
case” No branch of the law affects the practice of
medicine more strongly than the law of tort (civil
wrong) under which negligence is perhaps the most
talked about.
The glycerol tragedy in the J J Group of Hospitals
has highlighted the issue of negligence. There can be
no doubt about the fact that there was negligence on
the part of everyone including the doctors of the
hospital and yet is it not strange that the MCI has
chosen to remain silent on the issue? It is in cir­
cumstances such as these where the ethics and rules
enforcing bodies such as the MCI refrain from acting
that the absence of people’s participation in such mat­
ters become evident. What does one do when profes­
sional bodies fail to act?
Yet another example is that of the Bhopal disaster
where the gas-affected people were ‘denied’ the anti­
dote sodium thiosulfate for reasons that are still
unclear today. Doctors’ obligation, the Council’s
obligation and the state’s obligation are evident by their
absence.
Another issue that needs to be discussed here is the
one related to informed consent. “A doctor has no right
to do anything to a patient without his consent except
in the case of emergency when he must exercise his
discretion. The securing of a signature to a consent
should not be allowed to become an end in itself. The
most important aspect of any procedure must always
be the duty to explain to the patient or relative the
nature and the purpose of the proposed operation and
thus to obtain a fully informed consent. In our coun­
try this should be even more important (though ad­
mittedly also more difficult).since there is so much
illiteracy and lack of information. But it is common
knowledge (though difficult to prove) that informed
consent is reduced to a mere signature-obtaining exer­
cise. The matter becomes even more serious when, to
meet the family planning targets, healthy women and
men are subjected to sterilisation operations.
Drugs are another entity subject to standards. Our
drug laws are very similar to the British ones. An ad­
ditional regulation in India is the Drug Price Control
Order, which sets norms for prices of drugs. Despite
77 *

this, unlike in UK, the bulk of 40,000 to 60,000 for­
mulations put into the market by over 9,000 manufac­
turers, are irrational, useless or even hazardous in some
cases. A significant number of them are sub-standard.
Doctors’ prescriptions are often found to contain
superfluous and unnecessary drug formulations,
evidently to favour the drug companies’ represen­
tatives. One report indicates that in Tanzania, there is
one drug company representative for every four doc­
tors (see Mukarram Bhagat’s Aspects of Drug Industry
in India’). In India, with 9,000 drug companies, the
situation is very much the same. (In UK, the ratio is
1:20). Clearly the Indian patient pays a great deal more
for medicine and gets much less value for it. Laws and
the legal system need to lake cognisance of this and
ensure regulatory mechanisms to remedy this situation.
What is more, the Bangladesh drug policy has already
unequivocally demonstrated that the expenditure on
medicine can be reduced and more ‘value’ made
available to the patients and has also proved to be
sustainable.
Health Services and Law

If there is similarity in the British and Indian laws
in respect of drugs and registrations of doctors, the
hospital services policy is different. In UK, under the
National Health Services Act 1946, comprehensive
health services are made available to the people. This
includes a scheme of social insurance, and covers an
overwhelming populace of the country. In India there
is no comparable legislation and the state health sec­
tor incorporates the medical services including CGSS
and ESIS. Indeed there are public hospitals and dispen­
saries which are supposed to deliver medical services
free or at very nominal fees but in effect are found wan­
ting. There are no minimal standards clearly specified
for commissioning of hospitals or dispensaries and it
is not unusual to find Primary Health Centres being
reduced to the structure of bricks and mortar. Hence
even the Health Policy promises to have at least one
PHC for every 30,000 population, this goal is not at­
tained and al times even when there is a PHC existing,
it could hardly be functioning. Comically hotels and
restaurants of some cities in India are graded accor­
ding to the services they make available but not the
hospitals.
The quality and quantity of health/medical care
made available to the people is hopelessly inadequate
and with the paucity of resources it is clearly evident
that radical and pragmatic legislative and policy ap­
proaches are necessary. Strangely it is the countries
where health/medical care is of a high standard, which
are clamouring for ‘radical’ changes in their system to
be even-more effective e g, in March 1987, the British
Medical Association recommended that the govern­
ment introduce a ‘no-fault’ compensation scheme bas­
ed on the Swedish model. Diana Brahams (Lancet,
January 2/9, 1986, p 43) explains “In my view the term
‘no fault’ is inaccurate; in truth the scheme provides
compensation without apportioning blame for unex­
pected adverse results arising from medical treatment
in which error was an important factor. A failure to
78

act, or to act in time, may also be compensable.’’
Il is interesting to compare medical malpractice
perspective in US and UK (where consumer awareness
is high) before one lakes stock of the situation in India.
In the United States (as everyone knows) the suits per­
taining to medical malpractice are far more frequent
than those in United Kingdom. Lois Quam et al of the
Centre for Socio-Legal Studies, Oxford, have reported
in an excellent study in this respect (BM7,vol 294, 1987,
pp 1529-1532 and vol 294, 1987 pp 1597-1600)
that “the reasons for this are related to American
health care and social security systems. “Relative to
United Kingdom, there are fewer barriers of access to
the courts? “The differences between the National
Health Service and American health services are gross
and well recognised. The close relation between the
cash nexus of private practice and high rates of litiga­
tion in the USA is less understood’’ Patients who are
paid directly for their health care, through a mixture
of insurance premiums and contributions out of
pocket, seem more likely to feel aggrieved when treat­
ment fails. Moreover, litigation is fuelled by the sheer
cost of extra care after an'iatrogenic injury or treat­
ment.
In principle the National Health Service (UK) seems
likely to reduce claims in at least four ways: There is
no direct cost to the patient for extra medical care to
remedy injury; access to care is guaranteed throughout
life; there is no direct financial relation between doc­
tors and patients; and the system of referrals restrains
specialists while encouraging loyality between patients
and their general practioners?
It is important to note that in both the countries,
there is adequate provision (monetary or by services)
for medical and nursing care for the remainder of life.
In our country medical and health care is grossly in­
adequate and despite a number of medical malprac­
tices there is hardly any litigation or effort to redress
injustice caused. Even when there is litigation, the odds
are heavily pined against the patient in more ways than
one: (i) there is a strong nexus amongst doctors to ‘pro­
tect’ one another in the event of a case in the court;
(ii) patient record is not available to the patient (unlike
in Sweden) for proper presentation of the case; (iii) and
lastly the cases drag on (very often) for such an extra­
ordinary length of time that most people find it beyond
their means’to ‘sustain’ litigation. Although the Legal
Services Authority Bill has been passed under which
free legal services are made a statutory right the bill
has grave limitations and is self-defeating. That it does
not provide for mass participation and nor does it at­
tempt to provide relief beyond the monetary (see
Krishna Iyer’s Comment in From the Lawyer’s Col­
lective, November 1987). Thus, legal provisions can­
not be an end in themselves. While legislation provides
for the possibility of ensuring justice without prejudice
both its content and form are limited to the socio­
political context of particular societies. Its extension
and implementation is a consequence of people’s
movements.
Anil Pilgaokar
Radical Journal of Heald

Medical Malpractices and Law
mihir desai
Although medical negligence claims are an off-shoot of industrial capitalism, given the circumstances,
the existing negligence law can serve a useful purpose in imposing a certain accountability on the part
of the doctors and providing redressall for injuries. The legislation should thus be seen not just as
a reflection of bourgeois ideology but also as a bourgeois democratic right which requires to be extended
and expanded.
MEDICAL negligence litigation has in the past too decades
risen sharply in England and the US. Especially in the US
it has reached such a stage that a strong and active lobby
has come up against this. It has also led to the increasing
practice of ‘defensive medicine’ and a rise in doctors’
insurance rates. In India, of course, there is no correspon­
ding trend. The Indian law on this aspect, however, slavishly
follows the British and the American law. These trends
therefore become very relevant in India not only for gaug­
ing the potentialities of this type of litigation in India but
also to highlight the positive and negative aspects of this
system. Though the medical systems in the US and in UK
are very different—complete privatisation in the one while
state health services in the another—the law is virtually iden­
tical. These trends cannot be viewed in a vacuum but only
in the context of the socio-economic aspects of medical­
malpractice liability and the reasons why its development has
been stagnant in India.
Medical negligence litigation is a response to the follow­
ing types of questions.
What are the rights of patients vis-a-vis the doctors and
hospital?
What if the doctor wrongly diagnoses a disease?
What is the level of competence expected of a doctpr?
Does a doctor have to take the consent of the patient before
an operation?
If many doctors have handled a patient which of them is
ultimately liable?
The common issue in all this is the patient’s allegation that
the doctor has been negligent.
Negligence and Torts

Medical negligence is a branch of the law of negligence
which in turn is a branch of the law of Torts. The Tort law
is not based on any act of Parliament. It is mainly a judgemade law developing over the years through changing judicial
decisions. It is not possible to define Torts but broadly speak­
ing tort is a wrong done by one person to another for which
the law provides a remedy. The idea is to monetarily com­
pensate the victim rather than punish the offender—as would
be the case in criminal law. It includes disparate events such
as a car accident, injuries due to emission of poisonous gas,
doctor’s negligence causing death of a patient, defamation
of a person, compensation for injuries suffered by a wife
at the hands of her husband, etc. The motives of the offender
are not very relevant. The focus is on the victim.
A person is said to be negligent when s/he acts without
due care in regard to the harmful consequences of his/her
action. When we say that a person has been negligent we
are saying that s/he acted in a way that s/he ought not to
have acted. This assumes that we know how s/he ought to
March 1988

have acted. The way in which we consider that s/he ought
to have acted is the norm or standard which entitles us to
condemn the person for being negligent when s/he fails to
comply with the standard.
The tort of negligence is made up of three components:
(1) A duty or obligation recognised by the law requiring
the person to comply with certain standards of conduct for
the protection of ethers against unreasonable risks. Initially
charitable hospitals used to claim that they could not be held
negligent as they had no duty to take care of patients since
they were not charging them. Now of course the courts always
disregard such defences.
(2) A failure on the part of the person to conform to the
standard required—what is known as a ‘breach of duty’.
(3) A reasonably close causal connection between the con­
duct and the resulting injuries’.
(4) Actual loss or damage resulting to the other.
So, negligence ultimately is a matter of risk—that is to say,
of recognisable danger or injury. Persons are supposed to
meet with certain standards of conduct. This standard is sup­
posedly based on what society demands of its members,
rather than upon the actor’s personal morality. A failure to
conform to the standard is negligence even if it is due to clum­
siness, forgetful nature, an excitable temperment or even sheer
ignorance. In other words, the state requires of a person not
to be awkward or a fool.
In negligence, the actor does not desire to bring about the
consequences which follow nor does s/he know that they are
certain to occur, or believe that they will. There is merely
a risk of such consequences sufficiently great for a
‘reasonable person’ in his/her position to anticipate them
and to guard against them. Risk can be defined as a danger,
which is apparent or should be apparent, to one in the
position of the actor.
Nearly all human acts, of course, carry some recognisable
or remote possibility of harm to another. No person so much
rides a horse without some chance of a runaway nor does
any surgeon perform an operation without some chance of
himself suffering a heart attack and messing up the opera­
tion. These are of course, ‘unavoidable accidents’ for which
there is no liability. As the gravity of the possible harm in­
creases, the apparent likelihood of its occurrence needs be
correspondingly less to generate a duty of precaution. Thus
the standard of conduct which is the basis of the law of
negligence is normally determined upon a risk-benefit form
of analysis by balancing the risk in the light of the ‘social
value’ of the interest threatened, and the probability and the
extent of the harm, against the value of the interest which
the actor is seeking to protect and the expedience of the
course pursued.
79

this, unlike in UK, the bulk of 40,000 to 60,000 for­
mulations put into the market by over 9,000 manufac­
turers, are irrational, useless or even hazardous in some
cases. A significant number of them are sub-standard.
Doctors* prescriptions are often found to contain
superfluous and unnecessary drug formulations,
evidently to favour the drug companies’ represen­
tatives. One report indicates that in Tanzania, there is
one drug company representative for every four doc­
tors (see Mukarram Bhagat’s Aspects of Drug Industry
in India*). In India, with 9,000 drug companies, the
situation is very much the same. (In UK, the ratio is
1:20). Clearly the Indian patient pays a great deal more
for medicine and gets much less value for it. Laws and
the legal system need to take cognisance of this and
ensure regulatory mechanisms to remedy this situation.
What is more, the Bangladesh drug policy has already
unequivocally demonstrated that the expenditure on
medicine can be reduced and more ‘value’ made
available to the patients and has also proved to be
sustainable.
Health Services and Law

If there is similarity in the British and Indian laws
in respect of drugs and registrations of doctors, the
hospital services policy is different. In UK, under the
National Health Services Act 1946, comprehensive
health services are made available to the people. This
includes a scheme of social insurance, and covers an
overwhelming populace of the country. In India there
is no comparable legislation and the state health sec­
tor incorporates the medical services including CGSS
and ESIS. Indeed there are public hospitals and dispen­
saries which are supposed to deliver medical services
free or at very nominal fees but in effect are found wan­
ting. There are no minimal standards clearly specified
for commissioning of hospitals or dispensaries and it
is not unusual to find Primary Health Centres being
reduced to the structure of bricks and mortar. Hence
even the Health Policy promises to have at least one
PHC for every 30,000 population, this goal is not at­
tained and at times even when there is a PHC existing,
it could hardly be functioning. Comically hotels and
restaurants of some cities in India are graded accor­
ding to the services they make available but not the
hospitals.
The quality and quantity of heahh/medical care
made available to the people is hopelessly inadequate
and with the paucity of resources it is clearly evident
that radical and pragmatic legislative and policy ap­
proaches are necessary. Strangely it is the countries
where health/medical care is of a high standard, which
are clamouring for ‘radical’ changes in their system to
be even more effective e g, in March 1987, the British
Medical Association recommended that the govern­
ment introduce a ‘no-fault’ compensation scheme bas­
ed on the Swedish model. Diana Brahams (Lancet,
January 2/9, 1986, p 43) explains “In my view the term
‘no fault’ is inaccurate; in truth the scheme provides
compensation without apportioning blame for unex­
pected adverse results arising from medical treatment
in which error was an important factor. A failure to
78

act, or to act in time, may also be compensable’’
It is interesting to compare medical malpractice
perspective in US and UK (where consumer awareness
is high) before one takes stock of the situation in India.
In the United States (as everyone knows) the suits per­
taining to medical malpractice are tar more frequent
than those in United Kingdom. Lois Quam et al of the
Centre for Socio-Legal Studies, Oxford, have reported
in an excellent study in this respect (BMJ,vo\ 294, 1987,
pp 1529-1532 and vol 294, 1987 pp 1597-1600)
that “the reasons for this are related to American
health care and social security systems. “Relative to
United Kingdom, there are fewer barriers of access to
the courts’’ “The differences between the National
Health Service and American health services are gross
and well recognised. The close relation between the
cash nexus of private practice and high rates of litiga­
tion in the USA is less understood’’ Patients who are
paid directly for their health care, through a mixture
of insurance premiums and contributions out of
pocket, seem more likely to feel aggrieved when treat­
ment fails. Moreover, litigation is fuelled by the sheer
cost of extra care after an'iatrogenic injury or treat­
ment.
In principle the National Health Service (UK) seems
likely to reduce claims in at least four ways: There is
no direct cost to the patient for extra medical care to
remedy injury; access to care is guaranteed throughout
life; there is no direct financial relation between doc­
tors and patients; and the system of referrals restrains
specialists while encouraging loyality between patients
and their general practioners.”
It is important to note that in both the countries,
there is adequate provision (monetary or by services)
for medical and nursing care for the remainder of life.
In our country medical and health care is grossly in­
adequate and despite a number of medical malprac­
tices there is hardly any litigation or effort to redress
injustice caused. Even when there is litigation,, the odds
are heavily pitted against the patient in more ways than
one: (i) there is a strong nexus amongst doctors to ‘pro­
tect’ one another in the event of a case in the court;
(ii) patient record is not available to the patient (unlike
in Sweden) for proper presentation of the case; (iii) and
lastly the cases drag on (very often) for such an extra­
ordinary length of time that most people find it beyond
their means to ‘sustain’ litigation. Although the Legal
Services Authority Bill has been passed under which
free legal services are made a statutory right the bill
has grave limitations and is self-defeating. That it does
not provide for mass participation and nor does it at­
tempt to provide relief beyond the monetary (see
Krishna Iyer’s Comment in From the Lawyer’s Col­
lective, November 1987). Thus, legal provisions can­
not be an end in themselves. While legislation provides
for the possibility of ensuring justice without prejudice
both its content and form are limited to the socio­
political context of particular societies. Its extension
and implementation is a consequence of people’s
movements.
Anil Pilgaokar
Radical Journal of Health

Medical Malpractices and Law
mihir desai
Although medical negligence claims are an off-shoot of industrial capitalism, given the circumstances,
the existing negligence law can serve a useful purpose in imposing a certain accountability on the part
of the doctors and providing redressall for injuries. The legislation should thus be seen not just as
a reflection of bourgeois ideology but also as a bourgeois democratic right which requires to be extended
and expanded.
MEDICAL negligence litigation has in the past too decades
risen sharply in England and the US. Especially in the US
it has reached such a stage that a strong and active lobby
has come up against this. It has also led to the increasing
practice of ‘defensive medicine’ and a rise in doctors’
insurance rates. In India, of course, there is no correspon­
ding trend. The Indian law on this aspect, however, slavishly
follows the British and the American law. These trends
therefore become very relevant in India not only for gaug­
ing the potentialities of this type of litigation in India but
also to highlight the positive and negative aspects of this
system. Though the medical systems in the US and in UK
are very different—complete privatisation in the one while
state health services in the another—the law is virtually iden­
tical. These trends cannot be viewed in a vacuum but only
in the context of the socio-economic aspects of medical­
malpractice liability and the reasons why its development has
been stagnant in India.
Medical negligence litigation is a response to the follow­
ing types of questions.
What are the rights of patients vis-a-vis the doctors and
hospital?
What if the doctor wrongly diagnoses a disease?
What is the level of competence expected of a doctpr?
Does a doctor have to take the consent of the patient before
an operation?
If many doctors have handled a patient which of them is
ultimately liable?
The common issue in all this is the patient’s allegation that
the doctor has been negligent.
Negligence and Torts

Medical negligence is a branch of the law of negligence
which in turn is a branch of the law of Torts. The Tort law
is not based on any act of Parliament. It is mainly a judgemade law developing over the years through changing judicial
decisions. It is not possible to define Torts but broadly speak­
ing tort is a wrong done by one person to another for which
the law provides a remedy. The idea is to monetarily com­
pensate the victim rather than punish the offender—as would
be the case in criminal law. It includes disparate events such
as a car accident, injuries due to emission of poisonous gas,
doctor’s negligence causing death of a patient, defamation
»of a person, compensation for injuries suffered by a wife
;at the hands of her husband, etc. The motives of the offender
•are not very relevant. The focus is on the victim.
A person is said to be negligent when s/he acts without
odue care in regard to the harmful consequences of his/her
action. When we say that a person has been negligent we
are saying that s/he acted in a way that s/he ought not to
Fhave acted. This assumes that we know how s/he ought to
March 1988

have acted. The way in which we consider that s/he ought
to have acted is the norm or standard which entitles us to
condemn the person for being negligent when s/he fails to
comply with the standard.
The tort of negligence is made up of three components:
(1) A duty or obligation recognised by the law requiring
the person to comply with certain standards of conduct for
the protection of ethers against unreasonable risks. Initially
charitable hospitals used to claim that they could not be held
negligent as they had no duty to take care of patients since
they were not charging them. Now of course the courts always
disregard such defences.
(2) A failure on the part of the person to conform to the
standard required—what is known as a ‘breach of duty’.
(3) A reasonably close causal connection between the con­
duct and the resulting injuries’.
(4) Actual loss or damage resulting to the other.
So, negligence ultimately is a matter of risk—that is to say,
of recognisable danger or injury. Persons are supposed to
meet with certain standards of conduct. This standard is sup­
posedly based on what society demands of its members,
rather than upon the actor’s personal morality. A failure to
conform to the standard is negligence even if it is due to clum­
siness, forgetful nature, an excitable temperment or even sheer
ignorance. In other words, the state requires of a person not
to be awkward or a fool.
In negligence, the actor does not desire to bring about the
consequences which follow nor does s/he know that they are
certain to occur, or believe that they will. There is merely
a risk of such consequences sufficiently great for a
‘reasonable person’ in his/her position to anticipate them
and to guard against them. Risk can be defined as a danger,
which is apparent or should be apparent, to one in the
position of the actor.
Nearly all human acts, of course, carry some recognisable
or remote possibility of harm to another. No person so much
rides a horse without some chance of a runaway nor does
any surgeon perform an operation without some chance of
himself suffering a heart attack and messing up the opera­
tion. These are of course, ‘unavoidable accidents’ for which
there is no liability. As the gravity of the possible harrrt in­
creases, the apparent likelihood of its occurrence needs be
correspondingly less to generate a duty of precaution. Thus
the standard of conduct which is the basis of the law of
negligence is normally determined upon a risk-benefit form
of analysis by balancing the risk in the light of the ‘social
value’ of the interest threatened, and the probability and the
extent of the harm, against the value of the interest which
the actor is seeking to protect and the expedience of the
course pursued.
79

Professional Negligence

Uptil now what we have talked about is the minimum stan­
dard below which the individual is not permitted to fall. But
if a person in fact has knowledge, skill or even intelligence
superior to that of the ordinary person, the law will demand
of that person’s conduct be consistent with it. Professional
persons are not only required to exercise reasonable care in
what they d^ but also a standard minimum of special
knowledge and ability.
Let us look at how in practical situations the law applies
to doctors. A doctor may, of course, contract to cure a pa­
tient, or to accomplish a particular result, in which case he
may be liable for breach of contract. This is not, however,
what generally happens. In the absence of such an express
agreement, the doctor does not warrant or insure a correct
diagnosis or a successful course of treatment and a doctor
will not be liable for an honest mistake of judgment where
the proper course is open to reasonable doubt. But by under­
taking to render medical services, even though gratuitously,
a doctor will evidently be understood to hold himself out
as having standard professional skill and knowledge. The for­
mula which is used is that the doctor must have and use the
knowledge, skill and care ordinarily possessed and employed
by members of the profession in good standing, and a doc­
tor will be liable if harm results because he does not have
them. Sometimes this is called the skill of the ‘average’
member of the profession, but this is clearly misleading.
Since only those in good professional standing are to be con­
sidered; and of this it is not the middle but the minimum
common skill which is to be looked to. If the doctor claims
to have greater skill than this, as when the doctor holds
himself out as a specialist, the standard has to be modified
accordingly.
Of course, there are areas in which even experts differ.
Where there are different schools of medical thought and
alternative methods of acceptable treatment, it is held that
the dispute cannot be settled by the law and the doctor is
entitled to be judged according to the facts of the school the
doctor prefers to follow. This does not mean that any quack
or a crackpot can let himself be known as a ‘school’ and
so apply his individual ideas without liability. A ‘school’ must
be a recognised one within definite principles and it must
be the line of thought of a respectable minority of the pro­
fession. In addition there are minimum requirements of skill
and knowledge, which any one who holds himself out as
competent to treat human ailments is required to have,
regardless of his personal views on medical subjects.
Since judges/juries are essentially lay people, they are held
to be normally incompetent to pass judgment on questions
of medical science or technique and so only in certain types
of cases findings of negligence are given in the absence of
expert medical evidence. Normal reluctance of doctors to
testify against co-professionals came in the way in US and
UK and,is likely to be a big hurdle even in India. Now of
course, in US and UK more and more doctors came forward
to give evidence on behalf of patients. Also, where the matter
is regarded as within common knowledge of the lay people,
as when the surgeon saws off the wrong leg or where injury
is caused to a part of the body not within the operative field,
the judges often infer negligence without expert evidence.
The cumulative effect of all this is that the standard of
80

conduct becomes one of ‘good medical practice* i e, what
is customary and usual in the profession.
This, of course, gives medical profession a privilege denied
to others, ot setting their own legal standards of conduct,
merely by adopting their own practices, except in certain cases
like in the cases of sponges left in the patient’s abdomen after
an operation where the task of keeping track of them has
been delegated by the surgeon to a nurse. Though this was
and is still a routine practice, the doctor was found to be
negligent.
Some Specific Trends

In one of the earliest decided cases, in 1767, an English
...court felt that'the surgeon was liable as he had acted con­
trary to the known rule and usage of surgeons. What hap­
pens if the patient is injured because of the omission to carry
out an available test, which is not generally conducted by
doctors for such patients? In 1974 an American Appeal
Court was faced with this issue. Barbara Helling suffered
from primary open angle glaucoma. This is a condition of
eye where there is an interference in which nourishing fluids
flow out of the eye. There can be a resultant loss of vision.
The disease has few symptoms and in the absence of ‘pressure
test’, is often undetected till irreversible damage is done.
Helling contacted two opthamologists—Carey and j
Laughlin—at that time believing that she was suffering from
myopia (shortsightedness). From 1959 to 1968 she consulted
these doctors, who fitted contact lenses and believed that ir­
ritation caused in her eyes was because of complications
associated with the lenses. For the first time in 1968 they
tested the patient’s eye pressure and field of vision. This in­
dicated that she had glaucoma. By that .time the patient, who
was 32, had essentially lost her peripheral vision and her cen- j
tral vision was reduced. She filed a case for damages.
The doctors argued and proved that the standard of the
profession did not require the giving of routine pressure test
to persons under the age of 40 as the incidence of glaucoma
is 1 out 25,000 persons under the age of 40. They argued
that since they had acted in accordance with the standard
practice of the profession they had acted with reasonable
prudence. The court, however disregarded this defence. The
judges held: “In most cases reasonable prudence is in fact
common prudence, but strictly it is never its-measure. A
whole calling may have unduly lagged in the adoption of
new and available devices. Courts must in the end say what
is required: there are precautions so imperative that even their
universal disregard will not excuse their omission.’’
The court felt that despite the fact that a pressure test was
not used generally by opthalmologists, the doctors ought to
have used it. Barbara received compensation.
The importance of the case lies in the fact that the standard of care required of the doctors is widened. Normally,
of course the standard adopted in the profession would be
acceptable as the standard required of each doctor. But this
case for the first time obliged doctors to conduct certain
known tests even if they were not being conducted n the profession generally.
This case created a storm in the USA. Attempts were made
through courts and legislature to change the law laid down
by the case, but ultimately they have proved to be futile.
However, the application of this case is only confined to a
Radical Journal of Health

I
'
•
:
|
■

:
j

Professional Negligence

conduct becomes one ot ‘good medical practice’ i e, what
is customary and usual in the profession.
This, of course, gives medical profession a privilege denied
to others, of setting their own legal standards of conduct,
merely by adopting their own practices, except in certain cases
like in the cases of sponges left in the patient’s abdomen after
an operation where the task of keeping track of them has
been delegated by the surgeon to a nurse. Though this was
and is still a routine practice, the doctor was found to be
negligent.

Uptil now what we have talked about is the minimum stan­
dard below which the individual is not permitted to fall. But
if a person in fact has knowledge, skill or even intelligence
superior to that of the ordinary person, the law will demand
of that person’s conduct be consistent with it. Professional
persons are not only required to exercise reasonable care in
what they dOj but also a standard minimum of special
knowledge and ability.
Let us look at how in practical situations the law applies
to doctors. A doctor may, of course, contract to cure a pa­ Some Specific Trends
tient, or to accomplish a particular result, in which case he
In one of the earliest decided cases, in 1767, an English
may be liable for breach of contract. This is not, however,
.
court
felt that the surgeon was liable as he had acted con­
what generally happens. In the absence of such an express
trary to the known rule and usage of surgeons. What hap­
agreement, the doctor does not warrant or insure a correct
pens if the patient is injured because of the omission to carry
diagnosis or a successful course of treatment and a doctor
out an available test, which is not generally conducted by
will not be liable for an honest mistake of judgment where
doctors for such patients? In 1974 an American Appeal
the proper course is open to reasonable doubt. But by under­
Court was faced with this issue. Barbara Helling suffered
taking to render medical services, even though gratuitously,
from primary open angle glaucoma. This is a condition of
a doctor will evidently be understood to hold himself out
eye where there is an interference in which nourishing fluids
as having standard professional skill and knowledge. The for­
flow out of the eye. There can be a resultant loss of vision.
mula which is used is that the doctor must have and use the
The
disease has few symptoms and in the absence of ‘pressure
knowledge, skill and care ordinarily possessed and employed
lest’, is often undetected till irreversible damage is done.
by members of the profession in good standing, and a doc­
Helling contacted two opthamologists—Carey and
tor will be liable if harm results because he does not have
Laughlin
—at that time believing that she was suffering from
them. Sometimes this is called the skill of the ‘average’
myopia (shortsightedness). From 1959 to 1968 she consulted
member of the profession, but this is clearly misleading.
these doctors, who fitted contact lenses and believed that ir­
Since only those in good professional standing are to be con­
ritation caused in her eyes was because of complications
sidered; and of this it is not the middle but the minimum
associated with the lenses. For the first time in 1968 they
common skill which is to be looked to. If the doctor claims
to have greater skill than this, as when the doctor holds tested the patient’s eye pressure and field of vision. This in­
himself out as a specialist, the standard has to be modified dicated that she had glaucoma. By that .time the patient, who
was 32, had essentially lost her peripheral vision and her cen­
accordingly.
tral vision was reduced. She filed a case for damages.
Of course, there are areas in which even experts differ.
The doctors argued and proved that the standard of the
Where there are different schools of medical thought and
profession did not require the giving of routine pressure test
alternative methods of acceptable treatment, it is held that
to persons under the age of 40 as the incidence of glaucoma
the dispute cannot be settled by the law and the doctor is
is
1 out 25,000 persons under the age of 40. They argued
entitled to be judged according to the facts of the school the
that since they had acted in accordance with the standard
doctor prefers to follow. This does not mean that any quack
practice of the profession they had acted with reasonable
or a crackpot can let himself be known as a ‘school’ and
prudence. The court, however disregarded this defence. The
so apply his individual ideas without liability. A ‘school’ must
judges held: “In most cases reasonable prudence is in fact
be a recognised one within definite principles and it must
common prudence, but strictly it is never its measure. A
be the line of thought of a respectable minority of the pro­
fession. In addition there are minimum requirements of skill whole calling may have unduly lagged in the adoption of
and knowledge, which any one who holds himself out as new- and available devices. Courts must in the end say what
is required: there are precautions so imperative that even their
competent to treat human ailments is required to have,
universal disregard will not excuse their omission.”
regardless of his personal views on medical subjects.
The court felt that despite the fact that a pressure test was
Since judges/juries are essentially lay people, they are held
not used generally by opthalmologists, the doctors ought to
to be normally incompetent to pass judgment on questions
of medical science or technique and so only in certain types have used it. Barbara received compensation.
The importance of the case lies in the fact that the stan­
of cases findings of negligence are given in the absence of
expert medical evidence. Normal reluctance of doctors to dard of care required of the doctors is widened. Normally,
testify against co-professionals came in the way in US and of course the standard adopted in the profession would be
UK and,is likely to be a big hurdle even in India. Now of acceptable as the standard required of each doctor. But this
course, in US and UK more and more doctors came forward case for the first time obliged doctors to conduct certain
to give evidence on behalf of patients. Also, where the matter known tests even if they were not being conducted n the pro­
fession generally.
is regarded as within common knowledge of the lay people,
This case created a storm in the USA. Attempts were made
as when the surgeon saws off the wrong leg or where injury
through courts and legislature io change the law laid down
is caused to a part of the body not within the operative field,
by the case, but ultimately they have proved to be futile.
the judges often infer negligence without expert evidence.
The cumulative effect of all this is that the standard of However, the application of this case is only confined to a
80

Radical Journal of Health

marrow field of possibilities and that of ‘general practice’
vwithin profession is still widely applied.
[Hospital Liability

A question of immense significance is whether a hospital
ocan be made to pay for negligence of doctors, nurses and
oother staff. This is an issue of great importance in India.
IMany times it is not possible to point out the person whose
megligence led to injury. Take the example of a patient who
iis given saline by a number of doctors and nurses from time
no time. A particular needle may not be sterilised causing
^gangrene. It is not possible to know who exactly was
inegligent. Can one then sue the hospital? Or many times it
imay so happen that the negligent staff member does not have
] means to pay. Can one sue the hospital and recover?
The most important American case on this point was
Darling vs Charleston Community Memorial Hospital
• decided in 1966. In November 1-960, Darling, 18 years old,
broke his leg while playing college football. He was taken
to emergency ward of Charleston Hospital and treated by
Dr. Meroander, who applied traction and placed the leg in
a plaster cast. Soon after, Darling was in great pain and his
toes which protruded from the cast, became swollen and dark
in colour. His condition kept on worsening and ultimately
the leg had to be amputated. '
As to the question whether there was negligence or not,
the court held that the nurses had not checked sufficiently,
and as frequently as necessary, the blood circulation in the
leg. Skilled nurses would have promptly recognised the con­
dition, and would have known that they would have become
irreversible in a matter of hours.
The question was whether the hospital was liable. The
judges held: “The conception that the hospital does not
undertake to treat the patient, does not undertake to act
through its doctors and patients, but undertakes instead
simply to procure them upon their own responsibility, no
longer reflects the fact. The present day hospitals, as their
manner of operation plainly demonstrates, do far more than
furnish facilities for treatment. They regularly employ on a
salary basis a large staff of physicians, nurses and interns,
as well as administrative and manual workers, and they
charge patients for medical care and treatment, collecting
for such services, if necessary, by legal action. Certainly the
person who avails himself of hospital facilities expects that
the hospital will attempt to cure him not that the nurses and
other employees will act on their own responsibility”. The
hospital was made to pay damages.
The Darling case became a landmark decision in medical
malpractice claims as it places a direct responsibility on the
hospital for the maintenance of an acceptable standard of
care for patients. Subseqently, the scope of even this deci­
sion has been widened and charitable hospitals have also been
held to be responsible.
Is the hospital liable if the patient’s infection is traced to
blood products supplied during his operation?-In a 1970
Illinois state case, the hospital was held to be strictly liable
for supplying contaminated blood. A hospital will also be
liable for negligence of any honorary doctors or specialists
it calls but not for private doctors called by the patients
themselves. Hospitals, in same case have been held guilty even
when its employees have acted in direct contradiction of the
hospitals’ instructions or prohibitions causing injury.
March 1988

Strict Locality Rule

The standard of care expected of doctors' is generally
speaking that prevalent in the profession. They are not only
required to perform tests generally performed, but also.to
be informed sufficiently about the new developments in the
field.
One of the most debated issues in the US and UK arose
out of a presumption that the rural and small time practi­
tioners would be less adequately informed and equipped than
their big city colleagues. To adjust to this the courts'came
out with a theory that there could not be any national stan­
dard of care but the standard varies from locality to locality.
They applied the strict locality rule which meant that the
standard of care expected of doctors depended on the general
standard of Jhat particular locality. However, in recent times
this rule has been given up and national standard applied
on the basis that “new techniques and discoveries are
available to all doctors within a short period of time through
medical journals, closed circuit television, special radio net­
works for doctors, tape recorded digests of medical literature
and current correspondence course”.
This situation is prevalent only in developed capitalist
countries. In backward countries like India with uneven
development, it is very likely that when cases come up, the
strict locality rule will be applied
Res Ipsa-Loquitor

Ultimately it is for the patient to prove that, it was
negligence which caused her/his injuries." It many times
becomes difficult to do so for varied reasons like informa­
tion hiding by the doctors, etc. What happens in some cases,
however, is that after presenting all evidence, though directly
negligence is not proved, it is still pretty obvious that the pa­
tient could not have suffered injuries except through
negligence. In such cases the legal doctrine of Res Ipsa
Loquitor' or ‘the thing speaks for itself is applied.
Negligence is presumed to have been proved and the doc­
tors held liable.
In a case decided in an American court in 1975, a patient
Anderson was admitted to hospital for a back operation.
During the operation, the tip or cup of a forcep like instru­
ment (angulated rongekur) Broke off while it was being
manipulated in the patient’s spinal chord. It could not be
recovered and the patient suffered permanent injury. Anderson
sued the doctor, the hospital, the manufacturer and the
distributor. Each tried to push the blame on the other and
it could not be proved as to whose negligence had led to this
complication. It was not established whether the rongekur
broke because of manufacturing .defect, certain problems
during transit or due to the doctor’s negligence. If it was
merely a case of determining negligence from amongst the
hospital staff and doctors then even without establishing who
exactly was negligent, the hospital could have been saddled
with damages. Here of course, the hospital was saying that
•it was not the neglect of staff or doctors which caused the
rongekur to break but that of the manufacturer or dealer.
It was just not possible to establish what caused the
breakage. The court, however, came to the rescue of the pa­
tient and observed, “In the type of case we consider here,
where an unconscious or helpless patient suffers an admit­
ted mishap not reasonably foreseeable and unrelated to the
81

scope of surgery (such as cases in wmcn foreign objects are
left in the body of the patient), those who had custody of
the patient, and who ow’e him a duty of care as to medical
treatment, or not to furnish a defective instrument for use
in such treatment can be called to account Jpr their default.
They must prove their unculpability or else risk liabilities for
injuries suffered”. All of them were held jointly liable.
The doctrine of Res Ipsa Loquitor has been extensively
used in ‘swab cases’ where after the operation, an instrument
is left inside the patient’s body. It has also been used for other
types of cases—for instance in the Canadian case of
MacDonald vs York County Hospital Corporation, the pa­
tient was admitted for treatment of fractured ankle and left
with an amputated leg. Heavy damages were awarded to
MacDonald despite there being no direct proof of negligence.
Misdiagnosis

A liability will be imposed when the doctor fails to con­
duct tests which a competent practitioner would have con­
sidered appropriate or when the doctor fails to diagnose a
condition which would have been spotted by a competent
practitioner. In Langley’s case the patient had Yeturned from
East Africa shortly before the development of symptoms.
The general practitioner failed to diagnose malaria and this
was considered as negligence. Similarly in 'Ihffil’s case the
patient had spent many years in a tropical climate, the doctor
failed to diagnose ameobic dysentry which proved fatal. This
failure to diagnose was held to be negligence.
A question which arises is whether a new doctor would have
the same responsibility as a seasoned doctor? The law makes
no distinction in this regard. In Wilsher vs Essex Area Health
Authority, the patient had been born prematurely and had
been admitted to a special unit where extra oxygen was admini­
stered to him over a long period. His sight was badly affected
as a result of a junior doctor’s failure to monitor properly
the supply of oxygen. The hospital was held to be liable.
In many cases it is a part of the duty of the doctors and
nurses to predict that the patients may damage themselves as
a result of their medical condition. For instance in one case
the patient had been admitted to hospital after a drug over­
dose. Although he had known suicidal tendencies he was not
kept under constant observation and he climbed on the
hospital roof and fell incurring injuries, while the two nurses
on duty were out of the ward. He was awarded damages of
£ 19,000.
Informed Consent

One of the most rapidly growing medical malpractice
litigation is in the areas of ‘informed consent.’ This concerns
the duty of physician or surgeon to inform the patients of
the risk involved in treatment or surgery.
The principle behind this is the classical bourgeois
democratic ideal of individual autonomy, i e, that every per­
son has a right to determine what will be done to her own
body and the.right to have bodily integrity protected against
invasion by others. Only in certain narrowly defined cir­
cumstances can this integrity be compromised without the
individual’s consent.

82

Surgeons and other doctors have to provide their patients
sufficient information to permit the patient to make an in­
formed and intelligent decision on whether to submit to a
proposed course of treatment or surgery. So, even if a pro­
cedure is skillfully performed, the doctor may nevertheless
be liable for an adverse consequence about which the patient
was not adequately informed. Of course, the patient has to
show a causal link between the non-disclosure and her injury
by proving that she would not have undergone the treatment
if she had known the risk of harm that in fact occurred. The
courts believe that all patients in retrospect would say this
and so even here they have evolved the criteria of ‘reasonable
patient’, i e, whether this hypothetical patient in the actual
patient’s place would have withheld consent to the treatment
had the material risks been disclosed. This, of course, is pro­
blematic because the individual patient’s characteristics are
totally ignored. Slowly, the courts in US are trying to incor­
porate even this subjective factor.
What risks have to be disclosed? All the material risks.
i e, the nature of pertinent ailment, the risks of proposed
treatment, including the risks of failing to undergo treatment,
have to be disclosed. Even if the risk is a remote possibility
it should be disclosed. However, unexpected risks may not
be communicated. For instance, in an American case a
patient suffered cardiac arrest during amniocentesis. There
were no prior documented cases like this. The doctor was
not held to be negligent.
Even otherwise there are cases where the risk disclosure
may be precluded by an emergency situation or the patient’s
incapacity. In fact in the US all states have passed what are
called ‘Good Saiparitan Laws’ aimed at protecting doctors
giving emergency roadside treatment.
The disputed issue is whether for the benefit of the pa­
tient, the doctor can withhold information from them. This
happens many times when doctors feel that the patient will
suffer mental shock or nervous breakdown if th^risk,is com­
municated. Such withholding is called ‘theraupeutic
privileges’. But there is another school which believes that
all information should be disclosed so that the patient can
make up her/his mind in the light of all the circumstances.
The courts are divided in this point. <
A problem which has not arisen in the western countries
but which can arise in India is if the patient is conscious and
does not consent to a treatment which is necessary to save
her/his life. Can forcible treatment be justified? In most of
the western countries suicide is no longer a crime and so doc­
tors cannot forcibly treat anyone. In India, of course, this
question is likely to cause some problems.
The case of minors also raises a perplexing problem. Since
minors are considered by law incapable of giving consent
the parents’ consent has to be obtained. But what happens
if a minor who is of understanding age gives instruction con­
trary to that of the parents? In one English case, a school
girl aged 15 wanted an abortion but the parents refused to
grant permission. The court held that the girl v/as entitled
to abortion as she was capable of undersianding its
implications.
Nowadays, at least before surgery, a patient is normally
required to sign a consent form. But the patient can still prove

Radical Journal of Health

that no consent or informed consent was taken and the
doctor will then be liable to pay damages.

Speaking about the duties of doctors the court repeated
the British and American law saying, “The duties which a
doctor owes to his patient are clear. A person who holds
Indian Cases
himself out ready to give medical advice and treatment im­
pliedly undertakes that he is possessed of skill and knowledge
In spite of making a detailed survey, the writer could find
for the purpose. Such a person when consulted by a patient
only three reported cases on medical negligence in India.
(1) The first case was decided by the Lahore High Court owes him certain duties, viz, a duty of care in deciding
whether to undertake the case, a duty of care in deciding what
in 1935. R N Rao, a lawyer, suffered from high fever and
treatment to give or a duty of care in the administration of
sores on his face. Dr Whitamore, the Civil Surgeon, treated
him. He diagnosed the disease as syphillis and gave injec­ that treatment. A breach of any of these duties gives a right
of action for negligence to the patient”.
tion of Sulphatab. Later Dr Rao suffered from gangrene and
(3) The third case was decided by the Bombay High Court
had to have his fingers amputated. His eyesight was affected
and he lost his strength. He never had any syphyllis and he in 1975. This case reads ’ike a doctor’s apology. Philips India
was informed that he had contacted peripheral nuerilis had appointed a doctor to give treatment to the employees.
One employee contacted smallpox and died. The doctor had
because of a mistaken injection of arsenic.
treated him for veneral disease. The court felt that there was
The court, however, did not find the doctor guilty. The
reason given was that though the diagnosis was wrong a genuine error of judgment and since the particular variety
specific carelessness was not proved. The court adopted a of smallpox was fatal, the doctor anyway could not have done
reasoning which would be totally unacceptable today. It did much. The problem with the case is not that it exonerated
not go into the question as to whether the doctor had the doctor, especially considering the peculiar facts of the
performed the required tests before concluding that there was case, but the extent to which it sought to protect doctors.
syphilis. Neither did it try to a answer the question as to what The court expressed the view that negligence for doctors
sttould be interpreted much more narrowly than negligence
caused the gangrene.
(2) The second case was one decided by the Supreme Court of others, i e, the doctor has to be placed on a high pedestal
in 1969. Anand met with an accident on the beach at Palshet and held to be negligent only if it is totally unavoidable.
Of course, this ejase is not likely to have any impact on
in Maharashtra which resulted in the fracture of the femur
of his left leg. The only treatment the local physician gave subsequent cases, but still it shows the attitude of the judges.
was to tie wooden planks on his legs for immobilisation. The The important point decided by this case, however, was in
follwing day he advised removing Anand to Poona for treat­ holding that if the doctor had been proved to be negligent,
ment. He also substituted splints for the planks. After that, the company which employed him would also automatically
in a taxi, Anand was shifted to Poona. Dr Joshi got him be negligent.
All the three cases relied only on English law books—by
screened and found that he needed pin traction. He was then
taken to Dr Joshi’s hospital. Dr Joshi asked his assistant to of course picking and choosing what suited the court’s
give Anand two injections of morphia and hyoscine HB at conveniance.
/i hour interval. Dr Irani gave only one injection. Anand
Politics of Torts
was then taken to the X-ray room, and after taking two X-rays
removed to the operation room. After about /i hour when
A proper understanding of the rise of ‘negligence law’ re­
the treatment was over, he was shifted to the room he was quires an analysis of the development and rise of the Tort
allotted. On an assurance given by Dr Joshi that Anand
Law. An extensive application of tort law is found only in
would be out of the effect of morphia in 1 /i hours, Anand’s developed capitalist countries. Developments at similar scale
father went back to his village. Anand’s mother remained cannot be expected in third world countries. Let us therefore
with him. After about an hour she found that Anand was look at the causes which gave rise to tort law in developed
having difficulty in breathing and was coughing. The doc­ capitalist countries.
tors were called, Dr Irani, Dr Joshi’s assistant gave emergency
In the earlier period, law’ was largely preoccupied with per­
treatment upto 9.00 pm when the boy died. Dr Joshi issued sonal status, control over resources (primarily land) and the
a certificate saying that Anand had died of fat embolism. development of contractual relations (mercantile capitalism).
Dr Joshi was sued. Anand’s father contended that Dr Joshi
Industrial capitalism transformed the entire social structure,
did not perform the essential preliminary examination of the engendering urbanisation which enormously increased the
boy before starting his treatment and injecting morphia. It frequency of interaction among strangers. Important,
was also alleged that while putting the leg in plaster manual because unlike aquaint^nces or intimates strangers would
traction was used, using excessive force with the help of three have less incentive to exercise care not to injure one another
men though such traction is never done under morphia alone, inadvertently and would find it more difficult to resolve the
but under proper general anaesthesia. Dr Joshi in his reply differences when injury occurred. At the same time inter­
denied the allegations by saying th ♦ no general ahaesthesia action between friends and intimates became progressively
was given considering the exhausted condition of patient. limited—ultimately confined to the nuclear family. Intimates
It was decided to immobilise the fractured femur jy plaster commit most intentional torts. But within the nuclear family
of Paris bandage, and no excessive force was used. However, they are rarely resolved by the legal system, (a) because they
on evidence the court felt that Dr Joshi was negligent. It came would destroy the relationship (b) the persons committing
to the conclusion that it was due to shock resulting from torts are sufficiently powerful.
reduction of fracture attempted without taking the elemen­
Industrialisation gave capitalists the power to effect ex­
tary precaution of giving anaesthetic to the patient.
tensive damages first through domination of unprecedented
March 1988

83

amount of physical force (factories, railways, etc) and now
through toxic chemicals. Concentration of capital and mass
production increased the number of workers, consumers and
others who might be harmed by capitalists’ indifference or
miscalculation.
Capitalism also shapes the experience of injury. It must
create a proletariat which must sell its labour for wages to
live. It simultaneously destroys the obligation of mutual sup­
port outside the nuclear family and pays those within it who
arj gainfully employed at a level of wages too low to sup­
port non-production members. As inability to work becomes
tantamount to destitution or dependence upon charity, the
core of damages is compensation for loss of earning capacity.
Second, capitalists, middle classes and even industrial
workers acquire consumer goods which require protection
against inadevertent destruction.
Third, family is no longer able to care for injury or illness,
partly as members must seek employment outside and partly
because care itself is commodified and monopolised by the
emergent medical profession. As the monopoly allows pro­
fessionals to command high fees, injuries ‘cost’ a great deal
more.
Finally, commodity form is progressively extended to non­
productive experience.
Capitalist tort law exploits and alienates the victims in ways
parallel to exploitation and alienation of labour. In pre­
capitalist society, injury like work creates use value, it elicits
cure from intimates who are motivated by concern and pro­
motes demand for apology backed by threat of retribution.
The capitalist state which asserts its monopoly of force to
obstruct the latter response also creates a market for injuries
in torts and legal system. It separates through the legal pro­
ffession tort victims from means of redressing their wrongs
and medical profession disabled victims and intimates from
caring for the ill. In each instance, a faction of the ruling
class mobilises the power of the state in its own interests to
protect the monopoly of expertise of lawyers and physicians.
The lawyer then combines legal expertise with the victim’s
injury (as the capitalist combines capital with the workers’
labour) to produce a tort (a commodity) that has exchange
value both in the state-created market (the court) and in the
dependent markets (negotiated settlements).
As capitalists have to maximise profit in a competitive
market, they must sacrifice health and safety of others.
Another reason why capitalism fosters injury is that it must
expand its market and increase consumption; torts contribute
to it just like planned obsolescence and warfare.
Tort law, following legal liberalism, eliminated formal legal
discrimination. So, with its development discrimination bet­
ween patients who are victims of charitable hospitals and
those of non-charitable hospitals, etc, were eliminated. But
it could not and cannot remove certain deeper inequalities.
First, of course, the inequality in the incidence of injury
and illness: capitalists and professionals are subjected to totally
different hazards than those suffered by workers at the work
place or women at home. The rich can avail of the best
medical facilities, equipment and medicines, not so the poor.
Secondly, the class and gender will affect the extent to
which and the way in which the experience of injury is
transformed into a claim for legal redress, the sense of en­
titlement to physical, mental and emotional well-being
84

(women only recently began to legally resist abuse by their
husbands, workers are only now coming to view hazards at
work place as a negotiable demand), the feeling of com­
petence to assess a claim, the capacity to mobilise legal pro­
cess, ability to overcome delay, etc.
Third, the law also discriminates in the availability and
generosity of the remedies it offers, the biggest difference
being between tort damages and other compensation systems.
An industrial worker is far more likely to be injured at work
than a person from another occupational category, such
injuries are relegated to workmen’s compensation, which pays
only a fraction of tort damages and rejects altogether cer­
tain tort categories. Other oppressed categories—women,
children, dalits, religious minorities—are also excluded from
tort recovery. They are most frequently the victims'of violent
crimes and other social crimes whose assailants are either
unidentifiable, unavailable, financially irresponsible or
simply too powerful. Women and children injured by relatives
are left without any remedy.
Another type of discrimination is internal to the tort
system. Pecuniary damages are paid on the basis of income
of the person. Even the damages for pain and suffering are
often expressed as multiples of pecuniary damages. So a poor
person will get much less damages than a rich person.
Women will get much less than men.
Production of Illness

Capitalist tort law systematically encourages unsafety. The
dynamic of capitalism—the pursuit of profit impels the
enterprise to endanger the workers, its employees and those
who inhabit the environment it pollutes. As the cost of safely
reduces profits a capitalist must be as unsafe as he can get
away with being.
Apparently the Tort law curbs these destructive tenden­
cies through the threats of damages. But this is not what
actually happens.
First, compensation is paid on the basis of the status of
the victim not of the offender—the doctor for instance.
Second, the insurance mechanism goes a long way in
virtually nullifying the burden on the offender.
Third, as seen above, due to the discriminatory aspect of
Tort law many injuries and victims are excluded from its
purview.
In fact Tort law motivates the entreprenuers and the pro­
fessionals to seek to evade the consequences of carelessness
not to enhance safety. Their response to the threat to tort
liability is to strive to externalise accident costs by concealing
information. For instance, the market deterrence, by manda­
ting the payment of money damages, subverts collective ef­
forts to exert control over safety—damages are paid only for
an injury caused by the offender’s act. This means that
unsafe conduct causing no injury is not deterred and that
the legal attention is focussed on the temporarily delineated
act of an individual rather than on the ongoing activity of
a collectivity. Capitalist Tort law; like capitalist medicine, is
obsessed with individual care at the expense of collective pre­
vention because capitalism creates a market only for the
former.
In fact the medical profession is not even interested in cur­
ing patients, only in ‘treating’ as many as possible. Also the
costs of damages are externalised by increased professional
Radical Journal of Health

fees and insurance. In England, various Medical Defence
Societies have been established. It there is a successful claim
involving negligence of a hospital employee, the amount will
be shared by the authority and society. As regards nurses,
the Royal College of Nursing holds an insurance policy,
idemnifying every member. So, ultimately the costs are passed
on to citizens.
The Tort law is significant for the reproduction of
bourgeois ideology. The fault concept upon which the law
was built reinforces a central element of bourgeois ideology,
individualism. Predicating liability upon the offender’s fault
and denying recovery because of the victim’s fault perfectly
express the bourgeois belief that each person controls his or
her own fate.
Tort law offers symbolic support for inequality—by com­
pensating owners for property damage it upholds the no­
tion of private property and its concomitant, i e, the per­
son’s worth as a tort plaintiff is. proportional to the value
of the property he owns.
Also, by relegating injured employees to worker’s compen­
sation, which is limited to a fraction of the lost wages, the
law treats workers like pure labour value, implicitly denying
that they undergo the pain and suffering for which tort vic­
tims are given compensation.

Finally, Tort law assumes that for every pain suffered there
is some equivalent pain which will erase it, a pleasure that
can be bought with money and, therefore, the judges must
simulate a market in sadomasochism by asking themselves
what they would'charge to undergo the victim’s misfortune.
Also the Tort law treats all relationships as forms of
prostitution—the semblance of love exchanged for money:
Tort law thus generalises the feminist critique of marriage.
Just as society pays ‘pain and suffering’ damages to the in­
jured victim who is shunned (so s/he can purchase the com­
modified care and companionship that will no longer be
volunteered out of love and obligation), so it pays damages
to those who loved him, compensating them for their lost
‘investment’ in the relationship (so that they can invest in
other human capital).
The Socialist Approach

The primary concern of a socialist alternative should be
to ensure that those at risk regain control over the threat of
injury and illness: compensation must be subordinated to
safety, although the former goal remains important.
Even if all defects in the capitalist compensation system,
are removed—100 per cent damages, etc—two defects are
irremediable.
First, it would mean spreading the costs across society
through a social welfare scheme but does not mean spreading
the risk of accidents more equally.
Secondly, valuation of injury and illness is still done by
the state and not by people who suffer it. These are the pro­
blems in New. Zealand where since 1974, in place of
negligence they have what is called a ‘no fault’ compensa­
tion system.
A just system should be based on substantive equality. It
should respond to alt victims. Equality amongst victims
would mean response to their needs whether or not their
March 1988

misfortunes were caused by fault or by human actions. The
second is that the qualities of wealth and income should not
be reproduced in the level of compensation.
It is obvious that tort law can develop extensively only in
developed capitalist societies—only where there is a strong
dominant ideology of bourgeois individualism, extensive and
all-pervading commodity production (where everything is
measured in term of money) and certain minimum standard
of living where victims have the ‘staying power’ in courts,
and offenders have sufficient means of payment. This, of
course, is not the case with India, where we have a backward
capitalist economy. Even then with the growth, of capitalism
more and more actions in torts ar^Y^rely to arise.
Conclusion

Medical malpractice is already a well entrenched litigation
sphere in western countries. Though in India uptil now there
has been precious little happening on this front, it seems that
more and more medical malpractice claims are being filed
since the past five years, and over the next decade or so this
branch will acquire at least some significance.
One cannot deny the fact that medical negligence claims
are an offshoot of industrial capitalism and premises on the
bourgeois ideology. Accountability of doctors coupled with
redress for the victim can b.e much better tackled through
and for a greater extent solved in societies not based on com­
petition, treating injuries as commodities. The existing
negligence law is not a panacea. But given the circumstances,
it serves a useful purpose at least to an extent to mitigate
the victims and bring accountability to doctors. In fact it
should be seen not just as a reflection of bourgeois ideology
but also as a bourgeois democratic right which requires to
be extended and expanded. Also, in a country like India,
where especially the poor receive extremely negligent medical
treatment, extensive application of medical negligence law
by people and by progressive groups can be very helpful to
people and at least some way of improving health services.
Also, surveys in US indicate that medical practice litigation
provokes greater care at least in diagnosis.
One can only end by saying that despite its limitations,
the law of medical negligence should be as widely used in
India as possible.
Notes
[For many of the ideas expressed in this article I am deeply obliged to
the following works.]
1
2
3
4
5
6
7
8
9
10
11
12
13

Article by Richard Able in Politics of Law—A Progressive Critique.
Hugh Collins: Marxism and Law.
Fire: Democracy and the Rule of Law.
Ronald Dwarking: Taking Rights Seriously.
Paul Philips: Marx and Engels on Law and Laws.
Pashukanis: Marxism and Law.
Curran Shopiro: Law, Medicine and Forensic Science
Mason and McCall Smith: Law and Medical Ethics
Keetortn: Torts.
Christie: Cases and Materials on Law oi Torts.
Charlesworth: Negligence.
James: General Principles as the Law of Torts.
K. Bingham: Modern Cases on the Law of Negligence.

85

Banning Pre-Natal Sex Detennination-1

Issues and Debates
by teesta setalvad
Five years of extensive campaigning by women and health activists has resulted in a legislation banning
the selective abortion offemale fetuses through the misuse of amniocentesis and other technologies.
What have been the major issues which have emerged in the course of the nation-wide debate?

FIVE YEARS of extensive compaigning by women ano
health activists have earned us the assurance of proposed
legislation bannii^T^e selective abortion of female foetuses
through the misuse of amniocentesis and other technologies.
The legislation will be restricted to Maharashtra despite
the centre’s assurances of a countrywide law. This limitation
tould prove fatal to the effective implementation of the aims.
The lack of a ban in neighbouring states, where the practice
of selective abortion of female foetuses has grown in alar­
ming proportions sijice 1983, could prompt a largescale
burgeoning of clinics offering this facility indiscriminately,
just across the Maharashtra border.
Though the central government has given all possible
indications of passing an all India law banning the selective
use of amniocentesis and other technologies, and a special
committee to recommend the terms of this legislation had
been appointed in March 1987 which has submitted these
to the government around September last year, New Delhi
seems to have chickened out of the issue. Laudable though
the decision of the Maharashtra government must seem, it
must be remembered that in Gujarat, Punjab, Haryana, and
even New Delhi, the country’s capital with these clinics
blatantly offer these facilities.
Debate among activists demanding such legislation cen­
tred around two points, whether such a ban should be total
or selective and if the latter, which clinics should be exemp­
ted: in the interests of the benefits of some of these tests that
are vital in detecting the genetic abnormalities of a foetus.
Many activists, though genuinely fearing the growing trend
of such selective abortions, expressed grave reservations that
such legislation would only push these tests underground.
Legislation cannot and should not be the aim of such a cam­
paign. Such legislation that precedes the change in social
mores and attitudes so drastically must be backed up by cer­
tain schemes that create conditions for the aims of the law
to be implemented. The debate among activists on the ques­
tion of a ban, selective or complete, focussed around two
main issues: the overall status-of women in the country that
can lead to such largescale abortion of female foetuses and
the grave question of the misuse of advanced technologies,
ignoring its impact on the health of women. Several demo­
cratic and liberal forces ranged against the discussion and
strove through their stand to defend that ultimate test of
freedom—choice.
Are choices exercised in a vacuum? The scores of women
interviewed and questioned by journalists and activists clearly
enunciated the rationale behind their exertion of the supreme
choice—to abort after the result of a sex determination test
showed the foetus to be female—to save their skin from
torture or battering, to maintain their status within the
marital home, to save a marriage on the rocks. A'll this
86

because of the woman’s supposed inability to bear a son.
Even more infructuos arguments were used. These includ­
ed the defence of amniocentesis and other tests as a tool to
reach family planning targets. Another devious counter to
the increasingly vociferous protests from women’s groups was
the postulate that the status of women would naturally im­
prove in societies where the sex ratio has declined. Both
arguments, it needs to be stressed, have been effectively
countered.
Sex determination tests do not guarantee a male child.
They merely ensure multiple abortions (that is an abortion
for every second foetus tested for its sex) which can do im­
mense, if not irreparable harm to a woman’s health. Women
are being increasingly used and singled out as target groups
(and as a result, victims) for family planning and am­
niocentesis is part of this trend. Lack of food, clean drink­
ing water and a total denial of economic securities and safe
clinical facilities have led to a situation where one woman
has to have 6.2 children to ensure one surviving male child.
The argument therefore, that successive abortions followed
by amniocentesis act as family planning tools is untenable.
Research studies on societies having adverse female sex
ratios, reveals that customs like polyandry, sharing a wife
(outside wedlock) abduction and purchase of women are
widely prevalent in such societies. Besides, it is strongly felt
that adverse sex ratios may in fact lead to an increase in in­
cidence of rape, prostitution and grave controls over women.
Female mortality was 60 per cent higher than.that of males
in the age group upto five years. Today, in a situation where
the sex ratio is declining, this 60 per cent higher mortality
exists upto 8-9 years among girl children.
Faced with these social circumstances, and now assured
of legislation completely banning the use of these tests for
sex determination of the foetus, activists belonging to the
Forum Against Sex Determination and Sex-Preselection
(FASDSP), the umbrella organisation of several groups, have
forwarded their demands to the government that would give
more teeth to the proposed law. Greater powers, like the one
to seize and examine documents must be given to voluntary
organisations that make up the Vigilance Committees to
ensure that the proposed law is effectively implemented.
Moreover, the FASDSP is also demanding that these
Vigilance Committees consist of adequate representation
from voluntary organisations, doctors and government
officials who have powers under the Criminal Procedure
Code to ensure concrete results.
The Forum is also asking for the inclusion of all inter­
nationally accepted indications and ‘exposure to potentially
teratogenic chemicals and/or radiations’ in the eligibility
criteria for prenatal diagnosis. The creation of an all-India
supervisory body, like a Technical Expert Committee to issue.
Radical Journal of Health

renew and cancel licenses and ensure uniform standards at
the places approved for prenatal diagnosis, has also been
demanded. Periodic inspection visits by this committee to
those centres granted licenses to carry out these tests could
act as a monitor.
Since the entire campaign, spanning over five years had
exposed the blatant ambivalence of the medical profession
on an essential question of medical ethics, the FASDSP is
also asking tor suitable amendments to the Indian Medical
Council Act to enable cancellation of the registration of those
doctors found violating this proposed legislation. The Forum
argues that the two processes of collection of samples and
the testing should be de-linked. The former, that involves a
collection of the amniotic fluid in safe and hygenic condi­
tions could be carried oui at the medical college level after
careful screening of applications. Thereafter the testing-must
be carried out at genetic counselling laboratories where the
testing, with sophisticated machinery need be don?- Misuse
of ultrasonography for sex determination should also tre an
offence though ultrasonography itself must be excluded from
the purview of the ban due to its varied application. The
government is considering imprisonment and fine to the
offenders and the Forum is stressing that women who
undergo these tests must not be punished.
It can be clearly seen that the emphasis, at every Stage,
in the recommendations put by the FASDSP, for the legisla­
tion to have any use, is on vigilance. Vigilance that involves
a high level of commitment from both volunteers and
officials who participate in the process. The limitations of
just resting with this legislation cannot be underemphasised.’
The greatest problem being the blind preference for a male
child, in a patriarchial society where male attitudes and
values dominate.
Maharashtra and Gujarat, have over the last few years im­
plemented schemes aimed directly at promoting the girl
child/children family norm. Felicitation from the state to a
family with only girl children, a special green card that pro­
cures extra rations, concessions in education apart from an
all out publicity campaign have already begun. Moreover,
one of the promotion schemes started in Maharashtra depcit not merely the single girl child family but portray the
womah at the helm, making all relevant decisions concern­
ing health and family. Apart from enthusisastic vigilance
•from-voluntary agencies, commitments of this kind in the
state’s health policy could make the social impact of this
legislation more effective. The aim is to give the woman, from
girlhood her rightful place and share in society.
Pathetic Attitude of Doctors

More than anything else, the public debate that preceded
the legislation reflected as never before the pathetic ‘neutrality’
of the medical profession on the ethics of the issue. Whereas
more ‘glamorous’ questions like euthanasia draw the most
eminent into the pros and cons of the debate, the selective
abortion of female foetuses left the top medicos unmoved.
On the contrary, until pushed into a corner on the blatantly
embarassing statistics provided through studies conducted
by several organisations, medical practioners openly said that
‘amniocentesis and.appendicitis were their bread and butted
At as much as Rs. 500 per sample taken, even in remote rural
areas, amniocentesis for sex determination has become a
March 1988

lucrative commercial proposition. The number of such cen­
tres, with not even minimum standards has proliferated. In
Bombay, the capital of Maharashtra the number has gone
up from three to at least 20 in the period between 1983 aqd
1986. The larger of these sex determination clinics perform
a minimum of 1,500 amniocentesis tests a year.
The Voluntary Health Association of India (VHA1) has
pointed out through a study that the chances of a premature
delivery in a woman having undergone amniocentesis are as
high as four per cent, and the risk of abortion as high as
1.5 per cent. With these tests normally being conducted in
the fourteenth and fifteenth weeks of pregnancy, abortions
that follow in the second trimester are inherently dangerous.
It need not be mentioned that these risks were either not
revealed at all by the doctors performing these tests or, were
grossly underplayed. Unless the culpability of the medical
profession is assured through the proposed legislation,
loopholes that already exist through provisions of the
Medical Termination of Pregnancy (MTP) Act that enable
a woman to ua'T an abortion, could be exploited while this
abhorrent practice continues unabated.
If effective vigilance is not maintained and these tests con­
tinue to be available at different centres for sex determina­
tion underground, there is no way in which the offence could
be detected at the stage at which a woman comes for the
medical tefthiriation of her pregnancy, that is, abortion.
Under the MTP Act, a section provides that a woman can
undergo an abortion for ‘failure of contraception’. It is being
argued that this section could bd misused by unscrupulous
medical practitioners in league with family members of the
woman who have managed a test that reveals the sex of the
foetus.
Apart from this, another lacunae exists that can be bla­
tantly used by practitioners to escape the law. This was
brought out through a case filed by the Mahila Dakhsata
Samiti in the Bombay High Court after 21-year old Sunita
Chaturvedi, mother of two girls, died as a result of an abor­
tion that followed a sex determination test. The case which
came up before the High Court in October 1986 but has lain
in cold storage since, cited the victim’s husband, Girdhari
Chaturvedi and two doctors Dr. Meenaxi Merchant and
Dr. Rajani Arya as respondents. Apart from making out a
strong case against the misuse of amniocentesis, this pattern
that has failed to move legal brains, reveals how section 8
of the MTP Act can be misused by unscrupulous doctors
to shield themselves from the consequences of heinous acts.
This section, provides that no suit or other legal pro­
ceedings can lie against registered medical practitoners for
any damage caused by apy action committed ‘in good faith!
Abortion followed by amniocentesis, dangerous and fatal
though it might be in the Second trimester of pregnancy for
the woman, can leave a doctor untouched if this section
remains. Such lacunae in the law can be misused against
whatever limited benefits that the proposed legislation sele
tively banning these tests might achieve. Social attitude ar
it must be remembered, medical practitioners though
somewhat hedged in with the threat of legislation, a
to be the main contenders of the law.
Unless an internal code of medical ethics or s
vision in general criminal law hold them acc

(Co

Banning Pre-Natal Sex Determination-II

Scope and Limits of Maharashtra Legislation
amar jesani
The Maharashtra government’s bill regulating the use ofprenatal diagnostic techniques is a concession
to the demands of the five-year long campaign. It is also an indictment of the Medicai Council for
its open disregard of its own code ofprofessional ethics. On the other hand, it carefully avoids touching
the private sector, makes a mockery of people’s participation and offers many concessions to the medical
lobby.
FHE Government of Maharashtra has recently introduced
a much awaited and talked about bill in the state assembly,
“Maharashtra Regulation of Use of Prenatal Diagnostic
Techniques Act, 1988”. The bill has come in response to a
concerted campaign mounted mainly by the Bombay based
Forum Against Sex-determination and Sex-preselection and
supported by organisations of women, doctors, health ac­
tivists, democratic rights activists and even a research institu­
tion. These groups organised demonstrations, marches,
dharanas, exhibitions, seminars and workshops. They also
used all available media to draw people’s attention to the ram­
pant misuse of medical techniques like amniocentesis,
chorion villi biopsy, sonography leading to female foeticide.
Many sensitive journalists and other media people helped
focus the campaign not only on the issue of misuse of
medical techniques but also on the status of women in our
society. Several members of these organisations also accepted
the government’s invitation to participate in a committee
which did some necessary groundwork to identify the
technical and legal issues involved in stopping this misuse.
The bill presented in the Assembly was, however, drafted by
the government on its own.
Medical Council Indicted

Although the statement of ‘Objects and Reasons' given
by the minister of state in the bill, does not explicitly criticise
the Medical Council, states that “In breach of professional
ethics, unscrupulous medical practitioners do not hesitate
to perform abortions even when the sole or one of the reasons
for doing so is female foeticide”. It also laments that “there
seems to be a misconception about the objectives of the
existing laws in the minds of many medical practitioners”.
It seems naive to enact a full-fledged legislation if the issue
involved was only a simple misconcept about the existing
laws. But to expect the government to be forthright in its
assessment of the medical profession is asking for the moon.
Nevertheless, this statement brings out that sex­
determination practices involved in breach ot medical ethics.
Therefore, it squarely indicts the Medical Council. The MC
in our country has scarely made any attempt to regulate the
medical profession according to the code of medical ethics
formulated by it. It has not only allowed the violation of
ethics to go unpunished but also at times attempted to pro­
vide justificaion and legal cover to such violation. This at­
titude was very glaring in the specific case of sex determina­
tion where it refused to shed its lethargy despite a very hot
debate in the media far last seven years. Not only that, in
a private conversation, the president of Maharashtra MC

88

defended sex-determination practices of the doctors saying
that the medical profession must grant full autonomy to the
patients. It was also argued that it is difficult to prove in in­
dividual cases that sex-determination was done to get female
foetuses aborted.
There are enough provisions in the code of medical ethics
of the MC to take stringent action against the profession on
this issue. Some individual cases also came to notice but the
MC did not move. For instance, Dr. Datta Pai, who runs an
abortion clinic (Pearl Centre)-in Dadar, Bombay and who
was a member of the government’s committee on this issue,
has publicly admitted that his abortion centre had provided
facilities for amniocentesis till he was invited to join the
government' committee, though he never admitted that
amniocentesis was used for female foeticide in his centre. Yet
this was a fit case for the MC to seize his records of am­
niocentesis and the MTPs in this period and scrutinise
whether in the same centre women who underwent amnio­
centesis were offered MTP when the foetus was found to be
female. And if it were found to be so, the MC could have
used two clauses of its code, namely, first, no discrimina­
tion in medical practice and second, the social responsibility
of doctors, in addition to the violation of the MTP act, to
punish the guilty persons.
Thus, though this bill is a concession to the Forum’s
demand, it is also an indictment of the Medical Council for
its open disregaid of its own code of professional ethics.
In our country only drugs and pharmaceuticals are
regulated under a full-fledged law (albeit, a very ineffective
law). The rest of what constitutes medical technology and
techniques are not regulated under any comprehensive law.
This bill restricts itself to the regulation of pre-natal
technologies and techniques. Again, it does not regulate the
introduction of new technologies and techniques even in pre­
natal diagnosis. In fact it regulates only their use. Never­
theless, it is an admission of the fact that medical
technologies are being misused in pre-natal diagnosis to such
an extent that an independent law is needed to deal with
them. By logical extension, it could be said that it gives room
for health activists to push the idea that all medicdl
technologies ana techniques could be widely misused, ana
they are being misused, therefore stringent regulation on all
medical technologies in general and new technologies in par­
ticular is urgently needed.
Secondly, it explicitly bans the use of medical techniques
and technologies for the purpose of pre-natal sex determina­
tion leading to female foeticide. Thirdly, it declares illegal
the giving of any advertisement in any manner regarding

Radical Journal of Health

facilities available for the pre-natal prediction of sex at the ture which includes over 1500 primary health centres and
centre, laboratory or clinic. Thirdly, it makes illegal the seek­ about 200 rural hospitals. In addition they also manage cot­
ing of such facility by the woman or by any other person tage hospitals, district hospitals etc. They are hardly able to
for her for the pre-natal determination of sex. Fourthly, it efficiently regulate these establishments. One can only
prohibits the indication of “the sex of a foetus with or imagine with what efficiency they will be able to regulate
without the possible object of female foeticide”. And lastly, private medical profession and its ever increasing number
it prescribes rigorous punishment to those who indulge in of laboratories.
The composition of the Appropriate Authority (AA) is:
pre-natal sex determination activities.
Thus, the pressure generated by the Forum’s and other Two ex-officio government bureaucrats from the public
individuals and organisations’ efforts has helped make some health department, one bureaucrat from the medical educa­
breakthroughs in the present situation. But the gains are quite tion department, one bureaucrat from the Indian Council
inadequate in many respect and this bill is a big compromise of Medical Research, two doctors: one gynaecologist and one
solution worked out by the government and the medical geneticist (no other qualification mentioned) and two
authorities—both private and public. These inadequacies representatives of voluntary organisations (in the field of
make the bill, if not weaker, than at least as weak as the pre­ health, women and human rights). Except ex-officio
sent Drugs and Cosmetics Act. In many ways it is a defeat members, the rest in the eight member team will be
nominated by the government. Thus, the participation of
in the victory for the Forum.
voluntary organisation will be as per the needs of the govern­
Sacrosanct Private Sector
ments and since the AA will take decisions on simple
The Forum has, from the very beginning, demanded the majority, the voluntary organisations will not have much
abolition of pre-natal sex determination techniques in the decisive say in most matters.
private medical sector. For it is the private medical sector
which is primarily guilty of their misuse and not the public Mockery of People's Participation
sector. In government institutions the government has issued
This bill is a classical example of what the government
a directive almost a decade back to stop their usage for sex means by people’s participation. As stated above, the selec­
determination.
tion of the voluntary agency to be represented in the AA will
However, the government with talks of inefficiency and be made by the government and not the people. Further, there
corruption in the public sector is building a case for privatisa­ will be another agency called the state Vigilance Committee
tion (which is already underway). It has failed to even pay (SVC) to oversee the implementation of the act. Here also,
lip-service to the nationalisation of the private medical sector in the seven member committee, two representatives of volun­
despite such revelation of gross malpractices. It even fails tary organisations will be appointed by the government. In
to acknowledge that the ‘liberalisation’ that is prevailing in its supervisory functions, the SVC will pay periodic visits to
the private medical sector, has brought only ills for the people the recognised centres, but it will not have authority to take
and for the women in particular.
action against those violating the act. For this the SVC will
Instead of abolishing all genetic laboratories and genetic have to approach the AA.
clinics in the private sector the bill only wants to regulate
Further, on the one hand representation to the voluntary
them. As we know that such a regulation of the phar­ agencies in the implementing bodies is given under the.guise
maceutical industry under the Drugs and Cosmetics Act has of people’s participation on the other common citizens are
not radically changed the drug scene and its misuse continues forbidden to directly prosecute erring doctors, centres and
in legal as well as illegal manner. The regulation of genetic laboratories. Such citizens will have to first approach the SVC
laboratories, genetic centres, genetic clinics, gynaecologists, and the A A with their complaints. There is, however, a pro­
medical geneticists and so on will ultimately entail the crea­ vision for such citizens to go to court after giving two
tion of an administrative set-up which will look like a mini­ months’ notice to the AA about their complaint. But to
FDA. The expenditure that government will incur and what counterweigh such action, the AA and SVC, which will be
people will pay for these services in these centres, in the name in possession of all information needed to prosecute doctors,
of registration fees will far off-set in a few years the total centres and laboratories, are given the power to refuse to
expenditure the government would have made as a compen­ make information available to such citizens if the same is,
sation in taking over all genetic laboratories in the state. As in its opinion, against the public interest. Thus, in the last
a bonus, this would have made the implementation of the analysis, while talking aloud about people’s participation and
ban easier and effective without depriving those women who extending an olive branch to the voluntary organisations, the
medically need pre-natal diagnosis.
government has made clever provisions in the bill to see that
The story of regulation does not end here. The body (called even those people who want to participate to stop the misuse
Appropriate Authority (AA) in the bill) which will grant of pre-natal diagnostic techniques cannot do so or are
licenses and enforce the law is full of those health bureaucrats effectively frustrated in their efforts.
who are already overloaded and proven to be inefficient in
regulating their own departments. The Director and the Joint Concessions to Medical Lobby
Director of Health Services, who will become ex-office chair­
The pressure exerted by the medicaFlobby while the bill
man and secretary of the Appropriate Authority respectively, was being drafted is clearly visible at several places. This is
have never made any serious attempt to curb private prac­ not surprising. The medical bureaucracy has time and again,
tice by the doctors in pur rural health services. Further they on various issues (recently on the issue of charging for ser­
are in charge of an ever-expanding rural health infrastruc­ vices) expressed its sympathy for the values of the private
March 1988

89

sector. Further, people like the president of Maharashtra Ml
and Dr. Datta Pai are close advisers of the government health
department.
In the defining indications and conditions for which pre­
natal diagnostic techniques should be used, they have seen
to it that the Forum’s proposal of getting written opinion
of three concerned specialists has been completely excluded
in the bill. In the absence of such a provision, the private
gynaecologist will be the sole decision-maker whether to offer
pre-natal diagnostic facility to the woman or not. However,
vague indication like the history of two or more abortions
or foetal loss could be misused in the same way as the failure
of contraception as an indication is used for the MTP. Just
as the failure of contraception as indication for the MTP
has rightly made abortion facilities legally available to
women, the indications like foetal loss will wrongly make
available sex-test to women who want to go for female
foeticide.
The medical lobby has scored the most in the chapter on
‘Offences and Penalties’. This chapter identifies three types
of offenders. Type one: Doctors, centres and laboratories.
Type two: The woman who seeks the test, her husband and
in-laws. Type three: All those who contravene any of the pro­
visions of the act.
The penalty prescribed for type one offenders is rigorous
punishment upto three years and fine upto Rs 5000. To
demonstrate that the government is going to be very strict
with offending doctors, centres and laboratories, the bill has
a clause here saying that the minimum penalty to these peo­
ple should be at least one year imprisonment and fine of
Rs. 1000. But the hollowness of this provision becomes evi­
dent as we read the last clause of this chapter. This clause
empowers the court, if it so desires and after giving reasons,
to award less punishment than the minimum stipulated under
the act. That is, a rich doctor who has misused the techni­
ques leading to female foeticide, can, with the help of power­
ful Lawyers, persuade the court to award minor punishment.
The second type of offenders include the woman, her hus­
band and her in-laws. The bill says that the woman should
be assumed to be innocent and thus charged only Rs 50 as
a token fine and no imprisonment. The bill also says that
it should be assumed that she was compelled by the husband
or in-laws to undergo the sex-test. The husband or her in­
laws will be punished for abettment of the offence, with
rigorous imprisonment upto three years and with fine upto
Rs.3000. The bill says, “The court shall always assume, unless
otherwise proved, that a woman who seeks such aid of pre­
natal diagnostic procedures on herself has been compelled
to do so by her husband or members of his family’’. Here
the catch is provided with the addition of words “unless
otherwise proved”. It is easy to prove that the victim woman
will be caught and not the husband or in-laws. Who will pro­
ve it otherwise? If the husband is arrested, he will simply
say that he did not force his wife to undergo the test. Now,
in our society, what is the wife going to say? Of course, she
herself will come forward to prove that she was not under
compulsion. Feminists and their supporters were fighting
against the government to save the woman who is a victim
of the patriarchal system. This bill makes the victim a
criminal who will have to serve upto three years in prison.
This is an outright anti-woman provision. The earlier
90

everybody starts raising their voice against it the belter.
We all know that there is inequality in our society. But
our constitution says that everybody is equal before the law.
We all call it formal equality. But not so in this bill. There
is no equality between the doctors, centres and laboratories
on one hand, and the victim woman and her husband or in­
law on the other hand. The bill says that the offence com­
mitted by type two- and type three offenders “shall be
cognisable, non-bailable and non-compoundable”. This
means, when a complaint is made to the police against the
victim woman, her husband or her in-laws, the police has
to act to arrest them. Once arrested, only the court can give
bail. The non-compoundablity makes it difficult to get any
compromise settlement.
But the type one offenders (doctors, centres and
laboratories) are excluded from the above provisions by mak­
ing their offences, non-cognisable (the police is not required
to act when the complaint is filed), bailable (if arrested at
all, can get out immediately on personal bond, i.e., the police
itself can grant bail) and compoundable (can hammer out
an out-of-court settlement).
This shows that our government considers the offences
committed by the doctors less criminal than those commit­
ted by the victims (who paid that doctor exhorbitant
amounts). In our society the person who actually commits
female foeticide by doing a sex-test and selective abortion
is less of a criminal than victims of patriarchal ideology and
physical and socio-economic compulsions.
Some Lessons and Future Plan

This bill has once again emphasised that only good
intentions of some individuals, groups and the ‘goodness’
of some bureaucrats do not add upto desired change. This
is not to question intentions, but the methodology of affec­
ting change and the ultimate gains. The system does not like
to have gross irregularities in its functioning. The current
system permits irregularities outside its rules only upto the
time it needs them. Thus, the government will also be found
responding to certain demands for establishing the rules of
game in the fields where such irregularities are rampant. Only
such an approach can keep up the credible face of the system
before the masses.
But these rules of game, under the pressure of small groups
and media, are not framed while punishing the guilty. The
Environment Act came without punishing Union Carbide.
The industry was not punished before bringing the Consumer
Protection Act. In the same way the builders are not going
to be disciplined before the housing act is brought in. And
no doctor isjspjar penalised for committing female foeticide.
This-shows the light-mindedness of the government and the
feebleness of the efforts made by the groups concerned. As
a result, all laws are passed but they are toothless laws.
Therefore, the groups who campaigned against female
foeticide cannot remain complacent. They must continue
their campaign raising their original demands like abolishing
pre-natal diagnosis in the private sector, absolute , rotection
to the victim woman and so on. They must, while going to
the masses with those demands, also demand amendments
in the bill. If the bill is made a law without demanded
changes, the campaign must be continued. At the same time,
(Contd on page 98)
Radical Journal of Health

Good Manufacturing Practices
How Serious is the Government
amitava guha
Through a notification the government has introduced a draft amendment to the Drugs and Cosmetics
Rules, 1945 which are aimed at introducing Good Manufacturing Practices (GMP) in the pharmaceutical
industry. But clearly, the government is not at all serious about implementing these measures as becomes
obvious if the draft GMP is scrutinised.

THE DRUGS and Cosmetics Act, 1942 and Drugs and
Cosmetics Rules, 1945 are both ancient laws. They have to
render minimum check and control on production, distribu­
tion and marketing of modern pharmaceuticals. It is also
proved that this Act and its rules although amended in 1979,
1980 and 1982, cannot provide the government adequate
power even to ban a harmful drug. The Government of India,
through a notification of June 22, 1987 had introduced a
draft amendment to Drugs and Cosmetics Rules, 1945. The
amendments are aimed at introducing Good Manufactur­
ing Practices (GMP) and it is stated in the notification that:
Any objection or suggestions which may be received from any per­
son with respect to the said draft rules before the expiry of the period
(thirty days from the date on which the copies of the official gazette
in which this notification is published are made available to the public)
so specified will be taken into consideration by the Central government.

What is GMP

Without a high standard of ethics it is impossible to main­
tain GMP. In developed countries drug manufacturers had,
on several occasions, faced strong criticisms, litigations
resulting in heavy compensation and stringent government
regulations. The GMP is self-regulatory and not a compul­
sion under law in the developed countries. It was found that
the same international company which maintains GMP at
their establishments in parent countries, does not care to do
so at their establishments in the underdeveloped third world
countries. In some countries statutory actions have to some
extent forced the multinationals to follow some kind of
ethics. The Indian experience is different. The Committee
on Drugs and Pharmaceuticals (Hathi) expressed its concern
on the rampant violation of laws by the drug multinationals
in India. Despite this, the Government of India had decided
to enforce GMP only by changing the statute. It is, therefore,
necessary to analyse the nature of the amendment the govern­
ment intends to introduce and the consequences of the statute
if it is truly implemented.

In USA in the early 70s a large pharmaceutical company
was convicted when due to faulty manufacturing practices,
a drug manufactured by them caused a large number of Some Problems Relating to GMP
deaths. The same company, aiming to refurbish its image
WHO had suggested Good Manufacturing Practice for the
and goodwill proposed to other manufacturers a self
manufacture of formulations only. There is as yet no
regulatory code for manufacturing of pharmaceuticals. Later,
code/guideline for manufacturing basic bulk drugs. This is
the World Health Organisation took the initiative to prepare
particularly disturbing when now-a-days multipurpose
a norm of Good Manufacturing Practice. At the 28th World pharma plants are capable of producing more than one drug
Health Assembly in 1975 the revised text of ‘Good Practices
in the same process plants.
in the Manufacture and Quality Control of Drugs’ was
A company may produce a combination of two or more
adopted. It was recommended that all member states (which
drugs
of high technical quality and bioavailability but the
includes India) should apply the requirements of good
combination itself may be irrational and not needed by the
manufacturing practice.
population of the country where it is marketed. GMP should
The practices laid down in GMP are designed to ensure also cover these drugs. WHO had defined GMP as ‘pre­
that the drugs received by the consumers have been subject marketing quality assessment* the essential factors of which
to stringent control from the beginning to the end of the are:
manufacturing cycle to ensure that they are of high quality.
“A notification procedure: is the the least resource­
The expression ‘manufacturing’ for this purpose refers to all
intensive
ways of obtaining information on drugs offered sale
operations involved in the production of a drug including
processing, compounding, formulating, filling, packaging in a country. The amount of information required for
notification may vary. It<nay be initially restricted to the
and labelling.
name of the drug and manufacturer, and may then be
WHO has grouped GMP in mainly the following expanded to include the nonproprietarv names for active
sections—personnel, premises, equipment, sanitation, star­
ting materials, manufacturing operations, labelling and substances, the composition, including inactive ingredients,
packaging, quality control system, self inspection, distribu­ and pharmacological classification”. This will eliminate all
tion records, complaints and report of adverse reaction. It irrational formulations which have no place in any standard
has provided very broad guidelines of GMP for its adop­ books of pharmacology.
tion in a suitable form by the member countries. It took India
“An authorisation procedure: can be developed in which
about a decade to think of implementing the decision of the either all drugs or specified ones only require an authorisa­
World Health Assembly on GMP.
tion before they are marketed in the country. This may vary

March 1988

91

in its stringency but it almost always incorporates the ele­
ment of inspection of the manufacturer and the verification
of product quality by analysis.
“A registration procedure: comprises the evaluation of data
intended to prove the safety and efficacy of the drug and
to determine the indication for its use. The registration may
include an assessment both of the drug and of the manufac­
turing procedures”.
Pre-marketing quality assessment therefore should form
an integral part of GMP. This is missing from GMPs adopted
in most of the countries.
The other thing which is missing in these GMPs adopted
in the other countries is a complete set of guidelines for post
manufacturing surveillance which should include the
marketing code also. This we need to discuss more in the
context to our country.
It took a decade for the Government of India to formulate
GMP after they participated in 28th World Health Assembly
where the resolution on GMP adopted. It is clear why the
government suddenly became so conscious of the need to
introduce an amendment and pass it in a short 30 days’ time.
This of course, follow the recent pattern of the government
taking snap executive decisions bypassing even the Parlia­
ment. Causal, non specific and absurd rules have been sug­
gested that too without determining any logistics for their
implementation.
We have three major laws and regulations which govern
production and sale of drugs: Drugs and Cosmetics Act 1942;
Drugs and Cosmetics Rules 1945; Magic Remedies Act.
In UK the main law is the Medicines Act, 1971. There were
34 regulations set out by British government (upto 1981) to
govern the production and sale of drugs many of which are
directly and indirectly connected to GMP.
There are major inadequacies in the government’s draft
GMP as far as the premises and equipment are concerned.
In the draft only eight points are mentioned while in British
GMP thei are twenty-two specific directives. The draft says:
‘‘They (the building) should conform to the conditions laid
down in the Factories Act, 1948 (63 of 1948)’. It is well known
that because the age-old Factories Act has been of no use
in regulating the conditions of the technologically developed
modern factories the government has brought forth a fur­
ther amendment to the Factories Act. What type of control
then can one except from this Act on the ‘high tech’ phar­
maceutical factories?
The draft also had not cared to look into the effect of fac­
tories on environment inside and outside the premises. There
are international standards on the limit of toxic materials
and suspended particles in the air. The draft GMP has totally
ignored it. Not only this, the draft has not dealt with the
disposal of containers of bulk drugs and other materials
which may not loose potency by simple washing with soap
water. Nor does it mentioned how and where to dispose toxic
effluents. The British GMP, in contrast to our draft, says:
Waste materials should not be allowed to accumulate. It should be
collected in suitable receptacles for removal to collection points out­
side the buildings, and disposed of at regular and frequent intervals.
Special care is necessary over the disposal of waste containing
dangerous, highly toxic or sensitising materials (eg hormones, cyto
toxic agents, sensitising antibiotics). Disposal of raw materials, printed
packing materials and rejected products should be carefully controlled
and documented.

92

The draft is extremely casual in this area. It is very vague
and non specific when they state that the manufacturing area
for sterile drugs ‘‘shall be provided with air locks^for entry
and shall be essentially dust free and ventilated with an air
supply through bacteria retaining filters (HEPA filters)”.
While British GMP has a separate chapter containing 126
sub clauses for ‘Manufacture and control of Sterile Medicinal
Products’, our legislators had to be satisfied with only two
tiny paragraphs.
Various HEPA filters are used to create sterile conditions
of air for different purposes. Therefore, a standard is needed
to be fixed for production area of sterile materials. Not only
this, there should be standardisation of specific final filter
efficacy with recommended minimum air changes per hours
and the equivalent classification of HEPA filters available
in India. Absence of such standardisation will lead to the
controversies in application of strictures and the manufac­
turers will take recourse to some other laws to evade this
vague stipulation.
Another classic example of casual approach can be found
in the draft under the peculiar heading ‘All Medical Services’
that “Medical inspection of workers at the time of employ­
ment and periodic check up thereafter once in a year, with
particular attention being devoted to freedom from infec­
tion conditions and records thereof shall be maintained”.
It is beyond the scope of anyone’s understanding as to how
check up once in a year will ensure that the workers had no
infection in the remaining days of the year. We are yet to
imagine a worker who is suffering from infective cold volun­
tarily informing the management of his ailment. When there
are a large number of contract labourers working in both
big and small companies reporting of such minor but contaminous disease may mean loss of wages for the entire week.
British GMP is somewhat more specific in this respect:
“There should be preemployment medical checks, and steps
should be taken to see that no person with a disease in a com­
municable form, or with open lesions on the exposed sur­
face of the body, is engaged in the manufacture of medicinal
products.”
The staff should be required to report infections and skin
lesions and a defined procedure followed when they are
reported. Supervisory staff should look for the signs and
symptoms of these conditions”.
In the industrial policy declaration of 1984-85, the govern­
ment announced broad banding in the pharmaceutical
industry. Astoundingly the government under the scheme
mentioned that equipment each as mass mixers, cone
blenders, drying ovens can be used under broad banding.
The British GMP has elaborately dealt with how to avoid
cross contamination and mix-up. The draft Indian GMP has
only mentioned the term mix-up in a subheading but nothing
has been specified as to how to prevent it. Nothing has also
been specified regarding the use of masks, gloves, etc, in dif­
ferent manufacturing area.
There should be certain codes for pharmaceutical
machinery manufacturers also. For example in most of the
hot air driers the lining used is asbestos. The inner walls of
such driers, particularly for drying pastes, are usually coated
with heat resistant paints. There is every possible chances
that such paints may be dislodged from the inner surface
and get mixed up with the paste or powders kept in the trays.
Radical Journal of Health

It is also necessary that the GMP defines clearly the
maximum permissible operations per punches of the tablet
compressors after which they should be discarded. Similarly
it specifics limits per use of filler bags of the fluidised bed
driers, etc.
Experts who had drafted the GMP are so confident of
their work that they feel that their work will remain unaltered
for eternity. The draft has not suggested a periodical review
of the conditions recommended. The first edition of ‘Guide
to Good Pharmaceutical Manufacturing Practices’ was
published in UK in 1971. Thereafter it was amended in 1977,
and in 1985. It clearly stales—‘Time has shown that it would
be helpful to rearrange and in places, clarify and enlarge the
text and to give on further topics? Due to advancement in
technology and scientific concepts GMP cannot remain
static. In future GMP will need to include norms for elec­
tronic data processing and retrival systems.
Quality Control Laboratory

The section on laboratory practice is the most important
and sensitive part of GMP. In fact a separate set of
law/guideline is needed for this. In the 28th World Health
Assembly it was decided that a comprehensive review of ap­
proaches to quality assurance system would be made (WHA
28.66). A document accordingly was prepared by the Experts
Committee and its report was published in the twenty-seventh
report of the committee. Thereafter, the committee has pro­
duced three more reports elaborating the quality assurance
systems. The thirtieth report had reviewed and added more
recommendations to the earlier reports. The draft Indian
GMP has ignored these facts. In the 28th World Health
Assembly a small guideline was prepared on quality control
system giving some objectives. The draft GMP has simply
reproduced these guidelines but has not elaborated on either
the methodology or the stipulations which are needed for
good laboratory practice.
A major decision which is needed to be taken is whether
there should be any commercial establishments for certifying
quality assurance. After the facts revealed in Justice Lentin’s
Commission chart how political power and profit dictates
the reports of the private laboratories, it is high time we
decided whether any private commercial laboratories be
allowed to test drugs. On the other hand the government has
only five test laboratories in the country to cater to 9000 drug
firms registered under DGTD.
Further the government has not considered the prevailing
set up in India while preparing a new edition of the Indian
Pharmacopea which is a 90 per cent replica of the British
Pharmacopea. Any unit, big or small wanting to establish
its own quality control laboratory will definitely need
microbiology testing system spectrophotometry system for
both ultraviolet and visual range, etc. While the former needs
a large of space and special furniture the latter costs a large
amount of money. The minimum necessary equipment for
such a laboratory needs an investment of Rs 3 lakh. The
definiti9n of a small scale industry till date is a company
having turn over of Rs 50 lakh. How can such a company
invest Rs 3 lakh for a quality control laboratory?
Moreover, considering that all companies would have their
own quality control system where maintainence of a spec­
trophotometer would be a must would our government
March 1988

laboratories be in a position to supply International Chemical
Reference Substances of all drugs (both active and inactive
substances) for regular calibration of their instruments. Our
experience is that even the government laboratories do not
maintain all reference substances to calibrate their own spec­
trophotometers. The draft amendment only says: “Every
manufacturing establishments shall have a quality control
department supervised by approved expert staff...’’ It does
not say anywhere what should be the minimum equipment
to be maintained in this section.
It is also necessary to clearly describe the premises of the
quality control laboratory—how they should be arranged;
what are the hygenie conditions, temperature, humidity,
sterility conditions etc to be maintained inside. How the
instruments are to be calibrated and how often their
sensitivity be checked under what standard. Similarly, the
reagents need to confirm to a standard guideline. Guidelines
for maintaining concentration, standardisation factors, shelf
life and storage factors, should also be specified and how
often the prepared reagents should be checked to find out
their suitability, etc.
There should be clear guidelines as to the stage pf collec­
tion of samples for quality testing and for identifying, preser­
ving and recording the samples before and after testing.
Documentation of the analysis is also of great importance
as well as a good documentation system.
The draft GMP had not considered many other substances
which are used for curative purposes. No GMP had been
suggested for the manufacture of medical gases, or of radio
pharmaceuticals. A large number of verterinary medicines
are also used in ur country. The draft GMP says nothing
about these not even that the GMP for other pharmaceuticals
should be followed in producing veterinary medicines as well.
Interestingly the British GMP says: “Some veterinary pro­
ducts such as those used for mass external treatment of
animals (e g, sheep dips), have no direct equivalent among
products for human use and the recommendations on
manufacturing premises and equipment given elsewhere in
the guide may not be appropriate.’’
Post manufacturing GMP

Two most important points not given any consideration
at all by the draft GMP are post marketing surveillance and
distribution. The responsibility of a drug company does not
end with the manufacturing of a drug. The manufacturer
needs to take care th^t the drug is stored under prescribed
appropriate storing conditions in the factory warehouse and
the same has tp be followed by the middle men engaged in
wholesale and by the retailers in the chemist shop also. Clear
guidelines'are needed to be specified for transport conditions
particularly for a vast country like India. Where products
in transit may be subject to conditions such as unacceptable
degrees of heat, cold, light, moisture or other adverse
influence including attack by micro-organisms and pests.
There should be certain specified norms regarding
maintenance of stocks which are rejected due to damages
for spillage or breakage. These are to be kept separated from
the stocks of expired drugs. Proper recording, labelling and
disposal is also to be specified. Therefore GMP should in­
clude ‘Good pharmaceutical storage, distribution and/or
wholesale practice* also.
93

There i« virtually no system in our country to supply
package inserts along with each, sales pack of drugs giving
important side effects, precautions, adverse reactions, interac­
tion with other drugs, etc. Lack of proper norms of labell­
ing has led to situations where sometimes it is very difficult
to decipher the constituents-of the active ingredients of the
Hrugs from the labels. Brand names are printed in bold while
the generics are printed in or in very small type.
In 1968, the 21st World Health Assembly adopted a resolu­
tion (WHA 21.41) urging member countries to enforce con­
trol on advertisements. The resolution stated the ethical and
scientific criteria for pharmaceutical advertising and covered
advertising to the medical and related profession as well as
to the public. From the perspective of consumer protection,
it is important that the consumer should be. alerted to all
side effects, contraindications, warnings, hazards, and
precautions. It has been observed that a fair balance can be
considered to be lacking if:

cepting the fact that a manufacturer may report some in­
cidents of adverse drug reaction, what would the government
do? The draft GMP suggests nothing. In the event of such
incidents, the British GMP elaborates on how to recall the
product. The system of recall inflicts a red alert. It not only
stop the sale of the product but also directs stoppage of the
production operation till the reasons for adverse reaction arc
explored after investigation by the government authorities.
From the above, it can be concluded that while preparing
he draft GMP, the government had not been in the least
serious^ Incomplete measures, casualness and pro­
manufacturers bias to more or less maintain existing frivolous
attitude to'the safety of the consumers has been reflected
in the-clauses of this draft. Moreover it will be impossible
for the small scale industries to follow this GMP, if the
ammeridment is converted to law. It will be impossible for
them to establish full fledged in-house quality control
laboratories. It will also be impossible for the old industries
a) Information is included in'an advertisement that has not been ap­ particularly those which are situated in the densely populated
proved for inclusion in the profnotioriarmaterial at the time of
area or housed inside old industrial estates to expand the
registration.
»
.. .
. •
'
b) Advantages are claimed for the drug without simultaneous manufacturing area as required by the GMP. Therefore, the
incoming GMP will have to compromise with the industry
disclosure of disadvantage.
c) Obsolete information is used
irrespective of their size and capability in the areas of quality
d) Claims are exaggerated
of products and will in no way bring minimum safety and
e) Animal or laboratory data are cited as clinical experience
security to the consumers and. workers of the pharmaceutical
f) A statement by a recognised authority is quoted without also citing
industry.
any unfavourable opinions of that authority.
g) Statements are used out of context.
h) Statistics are used, in a misleading way
i) A headline or pictorial presentation is misleading (Guidelines forthe Development of a National Drug Control Programme’, Pan
American Health Organisation; pp 79-80)

The draft GMP shall include all these conditions for the
dissemination of correct and unbiased information.
Monitoring of a drug, new or old is continuous work. It
has international impact also. Since 1960, the World Health
Organisation had been insisting that all member countries
should develop centres'for monitoring adverse drug reactions.
In the 1963 World Health Assembly it was resolved that the
member countries would co-operate with each other in the
dissemination of adverse drug reaction so that the best possi­
ble protection can be offerred to consumers.
In our country, no system of monitoring adverse drug reac­
tions had been set up. Although a few such centres are in
existence but they are often found to defend the hazardous
drugs instead of monitoring their adverse reaction. A cen­
tre under the University-College of Medicine, Calcutta was
found, a few years ago, to be conducting a study financed
by an industry house on the need of a combination drug—
chloramphenicol and streptomycin. The head of the centre
lafer published their study in support of this irrational and
hazardous combination in the Journal of Indian Medical
Association.
The draft GMP, under the subhead ‘Records of Com­
plaints and Adverse Reaction’ only says that—“Reports of
serious adverse reactions resulting from the use of drug along
with comments shall be informed to the concerned licens­
ing authority”. This is the only thinking expressed in "the draft
regarding adverse drug reaction. The total responsibility has'
been left to the manufacturers who have no mechanism to
keep track of adverse drug reactions. Their tendency is to
suppress such information however rare it may be. Even ac­

A Note
THIS note is to inform the readers of RJH that from
June, 1988. I shall be moving from the category of Work­
ing Editors of RJH to that of the Editorial Collective. The
reason for this shift is that for the past one year I have
moved out of Bombay to a small village in Pune district
of Maharashtra for a period of five to six years. I have
thus hardly been a ‘working’ editor during this period.
It is only due to my persistent request that the other
Working Editors have finally, and reluctantly, agreed to
let me shift out. Moving out creates in me a feeling of
deep personal loss because all the three Working Editors,
as well as some of the comrades in the Editorial Collec­
tive of RJH are my closest friends. During the next five
years 1 shall greatly miss'the warmth and the intellectual
stimulation that the RJH collective has always offered to
me.
'
"
I shall certainly continue to stay within the Editorial
Collective of RJH because I fully believe in the ideological
perspective of the Journal and have no differences either
political or personal with the form and content of RJH.,
I am sorry that l am not able to undertake more respon­
sibility on behalf of RJH, much as I want to.. And, I am
aware that the loss is mine.
In solidarity
Manisha Gupte.

Radical Journal of Health

Medical Ethics
An Introductory Essay
gayatri singh
With the rapid advan ce in medicine and its increasing privatisation, the highest standards of ethical
conduct are .called for from doctors. It is for this reason that the medical profession is governed by
certain fundamental ethical, principles'. By setting certain ethical principles a doctor's expertise is
attempted to be harnessed for the needs of society.' What are the issues which confront doctors when
interacting with patients?
WITH the medical profession becoming increasingly his/her patients in the manner which he/she thinks is most
specialised, (he acquisition of higher medical education and; appropriate. If a doctor uses the medical profession to max­
knowledge has become the prerogative of the upper middle imise his/her profits that is the personal choice of the doc­
class, resulting in fundamentally altering the age-long close-: tor'which ought not to be interfered with.
knit ‘family relationship’ that existed between a doctor and^
Yet, though doctors may relate to their patients at a private
a patient. Not only has the doctor become-increasingly-; level, the fact is that* docrors play a vital role in preserving
isolated from the neefc of the patient, but the medical,pro­ and maintaining the health of a society and the medical pro­
fession as-a whole has miserably failed to extend its fession cannot be left to regulate itself for important life and
knowledge and facilities Tor the benefit of the public.
J death issues .are-involved. Since doctors do not operate in
Overawed by the doctor’s grasp of medical ‘knowledge’,.. . a vaccurh the decisions that they take vis-a-vis their patients
and unable to comprehend the complexities of the medical ’ have a bearing upon how they see their role within the
world, the patient is placed in a hopelessly unequal bargain­ medical profession. A doctor does not relate only with the
ing position. The surrendering of-the.patient to the doctor patient but.assumes various roles.which require him/her to
has become complete to such an extent that treatment, even-*.* take important decisions which may adversely affect others.
if unsafe, is not questioned. Being thus placed in a position- Thus, when a doctor decides to perform an abortion, despite
where the doctor has virtual control oV'er the well being of; • laws to the contrary,.s/he is not only expressing his/her per­
the patient it is not surprising that the doctor can, wittingly.- -: sonal yiewsion abortion but is in fact making a public state­
or unwittingly, abuse his/her superiority. As a consequence} ment as to whether persons have a basic right to choose
of this strained relationship the nagging question that’a doc-; whether to bear a child or not; conversely, by refusing to per­
tor is constantly faced ".with and which.he has to ultimately
form an abortion because of one’s religious or personal views,
is: whether the health and well-being of a patient’should be one is clearly taking a public stand by refusing to extend one’s
given priority or whether private profit and fame should be services for performing abortions.
the driving motive which ought to define the doctor’s rela­
Considering the complex social issues that one is contionship with his/her patients. Doctors must perforce decide. 5 fronted with, it may be extremely difficult to distinguish bet­
which interests out of the two should prevail and the taking- ween, what constitutes medical morals and medical ethics.
of such a decision depends to a large extent on the personal’ For instance, when does one’s personal views become the con­
inclinations of a doctor. Since a patient is not divorced from- cern of the public so that public intervention becomes
the rest of society, the doctor’s personal views with regard'- • necessary for setting standards with regard to a doctor’s prac­
to the jnode of treatment of patients has raised important? tice? With the rapid advance in medicine and its increasing
ethical questions like: Should drugs,'known-to be positively privatisation,* the highest standards of ethical conduct are
harmful be prescribed to patients without explaining to them! < called for from doctors. It is for this reason that the medical
their harmful effects? Should technology and research be profession is governed by certain fundamental ethical prinpromoted for purpose other than For remedying rhe health ■ ciples however outmoded they may be today. By setting cer­
of patients? Should doctors aid police officials in issuing' tain ethical principles a doctor’s expertise is attempted to be
false certificate certifying the death of a person to be ‘natural’
harnessed for the heeds of society. It attempts to lay down
when in fact the death is known to be the direct consequence certain guidelines though vague, with regard to what ought
of tortue inflicted by the police? Should doctors refuse to to be ‘acceptable social conduct’ of a doctor.
give emergency treatment to a person solely because it is a
Evolution of Medical Ethics
medico-legal case?
These are just a few of the many troubling issues, which ?
If we look at the history of the growth and evolution of
doctors are invariably confronted with in their day to day
medical ethics we find that it was the doctors who initially
practice while interrelating with patients. A doctor may played a vital role in establishing and setting standards for
choose not to answer these questions and wriggle out of a their profession. It is for this reason that the personal views
delicate ethical dilemma by arguing that the manner in which of the doctors got reflected in the constitution of medical
a doctor relates to his/her patient is basically a private mat­ ethics. As the public became increasingly aware of its rights
ter. It has been argued that the setting of standards for within the health care system, higher standards of practice
medical practice, directly impinge upon a doctor’s right to were sought to be imposed upon doctors, though the code
practice and hence no such standards should be artificially of ethics followed by the medical community has remained
imposed. A doctor should be allowed to freely relate with virtually stagment and the changes have been far from
March 1988

95

satisfactory.
The earliest and the first known medical code was the
Code of Hammurabi (a 1900 B.C.), which set out, amongst
other guidelines for doctors, the mode of receiving payments
from their patients. According to this code, payments should
inter alia, take into consideration: (a) the results of the treat­
ment; (b) the patient’s ability to pay, and (clothe status of
the patient. Though the concept of payment for professional
services has undergone certain changes, the basic concept
of “no cure, no payment” has been deprecated, in modern
day medical ethics.
As medicine developed and became more complex, n
became apparent that certain standards for the practice of
doctors would have to-be specifically outlined with a view
to prevent malpractices. Thus, a code of ethics evolved, which
is today commonly known as the Hippocratic Oath This
oath forms the basis, upon which all subsequent international
and national medical ethics have evolved. It is interesting to
note that this oath was not a product of any public outcry
against malpractices, but received inspiration and support
from within the medical community. The oath lays down the
following ethics to be followed by doctors:
1. The medical profession is to be harnessed for the benefit
of the public and the doctor must, to the best of his
ability, do good to the patient.
2. Abortion and euthanasia are to be condemned.
3. The nature of doctor/patient relationship is outlined and
to take advantage of the superior position of a doctor
is disapproved.
4. Strict medical confidentiality is to be maintained.
A modernised version of the oath.was introduced by the
World Medical Association as the Declaration of Geneva,
which was amended at Sydney in 1968. Certain general
guidelines for doctors were outlined (which stressed the
importance of the health of the patient and the belief that
the doctor should not only practice his profession with con­
science and dignity, bur should devote his life to the service
of humanity. Great stress was laid on confidentiality which
should be maintained even after the death of the patient.
Competition within the medical community was also strongly
condemned. “Utmost respect for human life from the time
- of conception” was the advise given to doctors. The strong
views of the medical community against abortion is clearly
reflected in this declaration even as late as 1968.
This declaration provided the basis for a more comprehen­
sive International Code of Medical Ethics which lays down
the duties of doctors in general, namely that a doctor must
maintain the highest standards of professionai conduct and
must practice his profession uninfluenced by the profit
motives. The doctor must not do anything unethical like self
advertising, collaborating in any form of medical service in
which the doctor loses his professional independence or
receive any money in connection with services rendered to
a patient other than a proper professional fee. As far as the
duties of doctors to the sick are concerned the International
Code states, inter alia, that a doctor must preserve absolute
secrecy and must give emergency care as a humanitarian duty
unless he is assured that others are willing and able to give
such care. As far as duties of doctors to each other are con­
cerned doctors are prohibited from enticing patients from
their colleagues and a doctor in advised to treat his colleagues
96

as “he would have them behave to him”. Though al! the three
codes, the Hippocratic oath, the Declaration of Geneva and
the International Code of Medical Ethics are vague and
general in nature, the basic principle underlying all these three
codes is the subservience of profit to the motives of the health
and well-being of the patient.
An international attempt at setting medical ethics with
regard to torture and other cruel, degrading and inhuman
treatment, has also been made. This statement is embodied
in the Declaration of Tokyo, 1975. Since a medical doctor
practices medicine in the “service of humanity” having the
utmost respect for human life, he is expected not to
“countenance, condone or participate in the practice of tor­
ture or other forms of cruel, inhuman or degrading pro­
cedures, whatever the offence of which the victim of such
procedures is suspected, accused or guilty”. Nor shall the
doctor provide any premises, instruments, instances or
knoweldge to “facilitate the practice of torture or other forms
of cruel, inhuman or degrading treatment or to diminish the
ability of the victim to resist such treatment.” The doctor
must also have complete “clinical independence in deciding
upon the care of a person for whom he or she is medically
responsible. This code for the first time lays international
standards and calls upon doctors to take an unabiguous stand
against torture, and inhuman treatment of persons. It is ob­
vious, that this declaration is applicable not only to coun­
tries under dictatorial rule but equally to countries which
operate under the facade of ‘democracy’. For it is here that
the services of doctors have a greater chance of being
misused. Fear of losing their jobs in government hospitals
or fear of being deprived of certain benefits and privileges
may force doctors to give false evidence or wrongly diagnose
the injury of a patient or issue false certificates upon instruc­
tions from government officials. To fall a prey to such prac­
tices is clearly unethical and the concerned doctor can be
hauled up by the national medical bodies for ‘misconduct’.
With the increasing growth of medical technology, new
inroads are being made in bio-medical research which involve
human beings as research subjects, and hence the need was
felt by international medical bodies to set guidelines in this
regard. The Helsinki Decleration sets guidelines for conduc­
ting medical research which are essentially diagnostic and
therapeutic in nature as well as for those whose essential
object is purely scientific. It declares that concern for the
interests of the subject must always prevail over the interest
of science and society, and “in any research on human beings
each potential subject must be adquately informed of the
aims, methods, anticipated benefits and potential hazards
of the study and the doctor should obtain the subject’s freely
given informed consent, preferably in writing”. Unfortunately,
the Helsinki Declaration bases its recommendations on the
premise that if medical progress is to take place at all it must
rest, in part, on experimentation which basically involve
human subjects. At any rate, the positive aspects of this
declaration are being implemented more by their breach.
The Indian code of medical ethics is based upon principles
and standards set out under various international codes men­
tioned above. It incorporate the basic principles with regard
to: (a) Service to humanity, (b) Misuse of medical knowledge
contrary to the laws of humanity, (c) utmost respect for life
from the time of conception; (d) respect for the secrets which
Radical Journal of Health

are confided in the doctor; (e) upholding the noble tradi­
tions of medicine; (f) treating colleagues as ‘brothers’.
The general principles under the code outline the character
of the physician and his/her relationship to society. Adver­
tising or solicitation of patients is specifically prohibited.
Income from professional activities is to be limited to ser­
vices rendered to the patient and remuneration to be received
for such services should be specifically announced to the
patient. A physican is prohibited from prescribing or dispen­
sing secret medicine or other secret remedial agents of which
he/she does not know the composition. Duties of doctors
to their patients deal with emergency treatment, maintenance
of strict confidentiality and provision of proper medical care.
The code also deals with duties of the physician to the pro­
fession at large, to each other, in consultation and to the
public.
The national as well as state codes provide for initiating
disciplinary action against a doctor for breach of any of the
specified medical ethics. The action may be brought before
the appropriate medical council (national or state). The
medical council may consider and deal with any form of
unethical practice which may be brought before it although
it may not appear to come within the scope of the precise
wording of any of the categories mentioned in either the
national or state codes. It is obvious that if an unethical prac­
tice is specifically prohibited by any of the international codes
of which India is a signatory, the national or state medical
council can take as action against the erring doctor. The ap­
propriate medical council may award such punishment as
may be deemed necessary or may direct removal permanently
or for a specified period from the register.
At the national level there are various laws which govern
medical ethics of the medical profession.
The Indian Medical Degrees Act, 1916 prohibits all per­
sons, save certain specified authorities, from issuing or alleg­
ing that they are entitled to issue any degree or diploma in
western medicine or surgery. The act is restricted to the
western methods of allopathic medicine and surgeons,
homeopathic, ayurvedic and unani practitioners being
excluded.
The Pharmacy Act, 1948 allows for only those who have
attained a minimum standard of professional education to
practice the profession of oharmacv. The Central Council
of Pharmacy set up under the act is empowered to prescribe
minimum standards of education and approved courses of
study of examination of pharmacists. Section 36 of the Act
lays down conditions under which the name of a registered
pharmacist can be removed from the register for e.g. if the
name has been entered by error or on account of misrepresen­
tation or if the pharmacist has been guilty of any ‘infamous
conduct’ which includes breach of professional ethics.
The Dentist Act, 1948, contains provisions for the con­
stitution of an Indian Dental Council which is empoowered
to lay down minimum standards of training and Provincial
Councils which are empowered to maintain registers of per­
sons entitled to practice dentistry. Section 17A of the act em­
powers the Dental Council of India as well as the State Dental
Councils to prescribe standards of professional conduct and
etiquette or a code of ethics for dentists. Such regulations
may specify which violations thereof shall constitute
‘infamous conduct’ or in other words professional miscon­
March 1988

duct. Since the State Dental Councils have powers to adopt
rules of professional ethics, they vary from state to state.
The Indian Medical Council Act, 1956, gives representa­
tion to licentiate members of the medical profession and pro­
vides for the maintenance of an all-India register by the
Medical Council of India which will contain the names of
all the medical practitioners possessing recognised medical
qualifications. Section 20A empowers the medical council
(state or central) to prescribe standards of professional con­
duct and etiquette, and the regulations so framed may specify
which violations thereof shall constitute ‘infamous conduct*
or professional misconduct. Under the act, the name of the
medical practitioner can be removed from the register either
on his/her own volition or if a misconduct has been indulged
in. ‘Misconduct’ is defined as:
(a) Conviction of a registered practitioner by a criminal
court for an offence which involves moral turpitude.
(b) Conviction under the Army Act, 1950
(c) Any conduct which in the opinion of the council, is
infamous, in relation to the medical profession particularly
under any code of ethics, prescribed by the council or by the
Medical Council of India constiuted under the Medical
Council Act.
For any of the misconducts an inquiry has to be conducted
by the appropriate medical council, before any action against
the doctor can be initiated.
Role of the Medical Council

Since the Medical Council is the governing body of the
medical profession, its main function has been the protec­
tion of a doctor’s interest, and moves into action only if the
conduct of a doctor brings disrepute to the medical profes­
sion. Take for example the highy unethical practices indulged
in by the Federation of Obstetric and Gynaecological
Societies of India (FOGSI) which took upon itself the task
of representing and promoting' a particular contraceptive.
The Federation had circulated letters to the medical com­
munity urging them to promote the use of Today, a con­
traceptive manufactured by Bliss Chemicals. (Report by Rupa
Chinai, Indian Express, 5.4.1988). The Maharashtra Medical
Council because of the publicity, was forced to act against
Dr. Daftary chairman of the Medical Termination of
Pregnancy Committee. Clause 30 of the Maharashtra Code
of Medical Ethics clearly states that medical practitioners
would be guilty of ‘misconduct’ if they associate with
“medical agents or manufacturers in the advertisement of
products of particular.manufacturers.” This is not the first
time that a medical body like the FOGSI has been closely
associated with drug manufacturers.- In the public hearing
on high dose EP drugs held at Bombay, FOGSI filed af­
fidavits supporting the u«e of this drug despite the existence
of voluminous evidence to show that the drug was harmful.
High dose EP drugs are being promoted by various phar­
maceutical companies and it is evident, by going through the
affidavits alone, that the FOGSI in collaboration with certain
drug manufacturers was promoting the drug realising fully
well that the drug had been banned in certain western coun­
tries because of its proven harmful side effects. The medical
council has not taken any action against the FOGSI.
With the growth and poliferation of pharmaceutical com­
panies, the bond between doctors and drug companies has
97

become stronger. In order to promote a particular brand of
a drug company, doctors prescribe medicines to their
patients, which are either of no use or are patently harmful.
The tremendous hold of the drug industry over the health
care system in our country, was recently brought to light by
the Lentin Commission. Another example of the prolifera­
tion of useless and spurious drugs in the fact that more than
20,000 kinds of non-prescription drugs are on sale in the
Indian market, most of which are non-essential and about 25
per cent of them spurious. As against this, the WHO has
prepared a check list of only 200 essential drugs. Though
the medical council is fully aware of the unethical practices
of doctors prescribing drugs known to be harmful and
useless, why has the council not prosecuted the doctors and
more importantly should not the medical council have powers
to initiate proceedings against drug companies?
The research establishment, both private and government,
also collaborate with drug multinationals in conducting
human trials. Human experimentation by the medical com­
munity is justified on the ground that such trials are for the
benefit of humanity. For example, experimentation by ad­
ministering injectable contraceptive Net-pen, which has not
been proved as a safe drug is being conducted on several
thousands of Indian women, who are being used as guinea
pigs without their informed consent. These trials are being
initiated by the government’s family planning programme.
The Helsinki Declaration clearly states that no tests should
be conducted on human beings unless they are proven to be
safe and without obtaining the informed consent of the
person on whom the experimentation is to be done. The Netten tests are in clear violation of this declaration. The govern­
(Contd from page 87)
selective abortion of female foetuses could continue
unabated. The callous and blatant attitude of the medical
profession towards this question can be illustrated through
a front-page advertisement appearing in one of the city’s
eveningers barely five days after the Maharashtra govern­
ment’s triumphant declaration of intent on January 1. This
advertisement read in bold type, “Boy or Girl? Contact. . .
clinic!’ A proposed legislation that will, in all likelihood ban
such blatant advertising did not deter the doctor couple of­
fering sex determining facilities. It must not be forgotten that,
though pushed into a corner on several occasions, the medical
profession refused to take an ethical stand before the govern­
ment’s declaration of bringing in such legislation. Apart from
the high level of vigilance, a commitment from an ambivalent
medical profession, faced with the loss of quick commer­
cial gains, is a must.
(Contd from page 90)
the groups should utilise the avenues available to participate
in the implementation process, in order to expose the
hollowness of the bill.
The medical establishment had earlier argued that a law
would force female foeticide underground. Now they have,
in collaboration with the government, brought a law which
can partially keep female foeticide above ground, within th'e
purview of law. There is no alternative but to continue strug­
gle against the medical practice of female foeticide.

mental institutions are the most consistent violators ot
medical ethics and yet the medical council and courts nave
been hesitant and unwilling to take any action.
In the Bhopal case,- the government arid its research
institutions have effectively suppressed all medical informa­
tion pertaining to the after-effects of MIC. and the treat­
ment to be given to the victims. For example, though the
Indian Council of Medical Research (ICMR) prescribed mass
detoxification to the victims, by injecting sodium
thiosulphate, the medical community in Bhopal ignored this
recommendation.
The recent scientific advances in the field of reproduction
like amniocentesis, chorion villi biopsy (CVB) are calling into
question the philosophy and values of medical ethics. Those
techniques which were meant to detect genetic deformities
are now being widely-used for sex-deter mi nation. Not a single
doctor has been prosecuted by the medical council.
These are just few of the examples where not only doctors
but government institutions have flagrantly violated the
various international and national c.odes. And yet nothing
has been done and the medical system continues to devour
and.maim a large number^of people.
The extent to which the medical profession will conform
to proper standards of-medical care will depend to a large
degree-on the-development of the public’s awareness of the
issue. The basic rules of social conduct can be ensured only
if the public maintains a constant and vigilant eye on the
doctors in particular and the functioning of the health care
system in general. It is only then that the doctors will be forc­
ed to abide by the highest standards of medical practice.

SCIENCE AS CULTURE
Edited by Les Levldow
Political forces shape science and
technology: the practitioners, the
research questions, the conceptual
frameworks, the funding institutions
that promote certain directions, and
the official history of their progress.

The contributors to this collection
take up several examples: ’Social
Darwinism’, the Copernican
Revolution, dialectical biology, the.
export of hazards, nuclear politics in
Yugoslavia, the tunnel vision of the
sociology of science, and the lives of
famous scientists.
Radical Science Series no. 20

£5.95/57.50 from
m n Free Association Books

26 Freegrove Rn~ '

________ L°ndOn

9R(f

This Bill has been passed in the Maharashtra Assembly without any
significant amendment in April I988|.

98

Radical Journal of Health

UPDATE
News and Notes

Fee for Service in Maharashtra Hospitals
ii is qot surprising that the Government of
Maharashtra has been the first to introduce feefor-service medical care in all district and
, Government medical College hospitals from
February 9 this year. The trend had started long
back: the Municipal Corporation dispensaries
and hospitals hiked the OPD case paper charges
over a year ago with no significant resistance
from any corner. But now the fee-for-service will
be and is being charged at a higher rate not only
for the OPD and indoor case papers, also for
each component of the service availed of by the
patient. The outdoor case paper now costs Rs.2
instead of 10 paise for seven days’ treatment, and
for indoor patients the charge is Rs.5 per day (in
addition Rs. 3 per day are charged for diet). For
laboratory investigations the charges are: Rs.5 for
routine blood, Rs.10 for urine, stool, sputum,
ESR, malaria and filaria, Rs.5 for MMR and
screening, Rs.20 for standard X-ray. For opera­
tions, the charges are: Rs.120 for major opera­
tions, Rs.50 for minor operations done in minor
OT., Rs.10 for minor operations done in the OPD
without anaesihesia. For deliveries in these
hospitals, family planning disincentives are ap­
plied: Rs.20 for third and subsequent deliveries.
The virtues of fee-for-service. have been
rigorously propagated in Maharashtra for the
last one and a half decades. The political and
economic crisis of the Indian rulers, which began
to manifest itself from the late 1960s, was
reflected acutely in the health-care sector. The
experimentation primarily with the support of
foreign funding agencies which led later to the
formulation of international and national
strategies for the primary health-c&re and the
health for all had begun as early as the late 1960s
and the early 1970s. All these experiments were
meant to develop a strategy without radically
changing the health-care structure and so also
the social structure and without demanding any
extra resources'from the state to provide some
basic health care to the people.
r f As these experiments grew under the ‘care’ of
NGQs and.voluntary agencies all over India, par­
ticularly in Maharashtra, they exerted a strong
influence on government policy-making. Many
of them’ attributed their success in people’s participation to their policy of charging for services,
albeit charging al low price. While attacking
government policy of providing free services, it

,

»

j

»

i

, March 1988

•.n'.szA',

lu'.nuoV

was argued that people do not appreciate services
when provided free and there is a wastage of
resources, as people misuse and overuse govern­
ment services. They did not stop here. They even
carried out some studies showing that the com­
munity is ready to pay for the services fropi the
village health worker level to the hospital level.
Thus evolved a strong case for the ‘community
financing’ of health-care.
In this context, two points should be noted.
Firstly, the majority of the NGO experiments
were and are being carried out noy in the
developed districts but in the underdeveloped
areas (Jesani, Duggal, Gupte, 19). Therefore, in
these areas the penetration of commodity rela­
tions is very pronounced. The NGOs’ policy only
took it further. Secondly, corruption and
malpractices in the government sector are so
rampant that they have already become institu­
tionalised. The PHCs are no longer exclusive free
service institutions nor were the district and the
medical college hospitals before the February
1988 order. In a very significant number of them
private practice by doctors both inside as well
as outside the institution is the norm rather than
the exception. In fact, about 25 per cent of PHCs
and all rural hospitals and district hospitals
officially allow doctors to dp private practice,
although not within the institution. Therefore,
a fee-for-service atmosphere and value system
has existed for long in the government sector.
The health bureaucracy too believes in and en­
courages this state of affairs.
However, despite corruption and malpractice,
poor were able to avail of some services, though
it was second grade as doctors used to be more
concerned about those patients who were either
VIPs or used to fill their pockets. Now with the
government becoming a ‘private practitioner’,
even this second grade service is no longer
•available to the poor. The provision of providing
free treatment to 40 per cent of patients is an
eyewash, as it is at the discretion of the civil
surgeon and the superintendent, who neither
have inclination nor time to indentify such needy
patients. Undoubtedly the government has in one
stroke thrown overboard the fundamental recom­
mendation of the Bhore Committee(1946) that
health care should be available to people irres­
pective of their ability to pay.
Ironically enough privatisation of health

99
;

financing has take place in the context of me
much lauded primary health-care and health for
all. Certainly, privatisation does not necessarily
and logically flow from the basic principles of
primary health care. But when the PHC ap­
proach is articulated within backward capitalism
which has historically, in our country, encourag­
ed private sector through public sector resources,
and at a time when the private health sector is
attempting to expand its sphere of operation, it
could generate a dynamic towards privatisation
unless the PHC approach is combined with a
vociferous demand for complete nationalisation
of health-care services and allied drug and in­
struments industry.
Moreover the demand for low cost health-care
must be made secondary to the demand for a
National Health Service. In a climate where the
private sector is allowed and given concessions
to establish hi-tech medical care and the govern­

ment hospitals in the urban areas—especially
those also catering to the VVIPs—following the
same line, people’s expectation and aspiration to
be treated with the best of medical tools will
naturally increase This is irrespective of whether
the so-called best is really the best or not, ra­
tional or not and even appropriate or not. This
climate decisively undermines the basis ’of
primary health-care approach and it will be
regarded as a second grade service by the peo­
ple. Thus while one must continue to work for
rational medical practice—even show to the
government how resources could be saved by
having rational medical practices in our hospitals
(as against charging for services to meet
demands)—unless low-cost medical care is pro­
pagated with a demand for an NHS, the PHS
approach may well turn out to be self-defeating.
—ACJ

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Radical Journal of Health

Norplant: ‘The Five-Year Needle’
An Investigation of the Bangladesh Trial
ubinig
Norplant, a contraceptive subermal implant was introduced for clinical trials in Bangladesh as early
as 1981. However, partly because of resistance from conscious groups the trial was abandoned. Four
years later, the Bangladesh Fertility Research Programme with other international organisations and
a pharmaceutical company once again initiated the trial. This is a report of investigations con­
ducted by a concerned group in Bangladesh.
“*
. ..
NORPLANT is the registered trade mar* of the Population
Council for contracepive subdermal implants. It consists of
flexible, nonbiodegradable tubes filled with levonorgestrel,
a synthetic hormone of the progestin family. The implants
are placed under the skin on the inside of a woman’s upper
or lower arm. The hormone is slowly released at an almost
constant rate for several years.
Norplant implants come in two form. The first, called
simply Norplant consists of six hollow silastic (silicone rub­
ber) capsules, each capsule is 34 mm long, with a diameter
of 2.4 mm, and contains 36 mg levonorgestrel. The ends of
the capsules are sealed shut with silastic adhesive. This is the
most widely used of the two systems. .In Bangladesh, this
system is being used.
The other system called Norplant-2, consists of two solid
silastic rods, each 44 mm long. A total of 70 mg
levonorgestrel is dispersed in the matrix of each rod. (PRS,
1987).
The promoters of the system are a coalition of
hetrogeneous partners, (1) Population Council, New York,
USA working through its International Committee for Con­
traceptive Research (ICCR) and (2) Leires Pharmaceuticals
Company, Finland. In Bangladesh the preintroductory trial
is being carried out by Population Council and Family
Health International (FHI) through the Bangladesh Fertility
Research Programme (BFRP).
Norplant Trial in Bangladesh

In this section we shall provide some information regar­
ding the history of Norplant trial in Bangladesh which began
as early as 1981.
The 16th meeting of the National Council for Population
Control and Family Planning was held on February 7, 1981
at Bangabhavan and was presided over by the late president
Ziaur Rahman. In this meeting, among other matters, it was
discussed that, Norplant, a sub-dermal contraceptive which
is easier and more effective than sterilisation should be in­
troduced on a trial basis (National Council, 1981). Accor­
dingly, a steering committee was formed on Norplant for in­
troduction and examination of suitability and acceptability
in Bangladesh. In August 22, 1981 a meeting of the subven­
tion committee, Population Control and Family Planning
Division, was held. The meeting considered the project pro­
posal of BFRP on ‘Clinical Study of Norplant Reversible
Hormone Implant Contraception’. It was approved in prin­
ciple and a sum of Tk. 7,43,000 including US 20,000 in
foreign exchange was recommended for the project to be paid
in phases. On October 4, 1981, BRFP put an advertisement
March 1988

in the Bangladesh Observer and Holiday, a daily and week­
ly newspaper respectively:
A new birth control method
NORPLANT

A wonderful innovation of modern science
• This method is for women
• This can be implanted under the skin of arm
• This will ensure sterility for 5 years
• When removed, can have child again.

Get more information:
Bangladesh Fertility Research Programme

3/7, Asad Avenue, (1st Floor), Mohammadpur, Dhaka.

Immediately, there was resistance from conscious groups
who pointed out the unethical aspect of the advertisement.
An article was published on October 25, 1981, where several
issues were raised. A brief text of the article is presented
below:
So far as we know through reliable sources that the Technical
Advisory Committee in Bangladesh did not approve its use in
Bangladesh. However, the BFRP has successfully bypassed the
Technical Advisory Committee and announced and advertised its use.
It should be noted here that the BFRP was also the pioneer in us­
ing Depo-provera and Norigest in Bangladesh.
Finally, some comments on the BFRP advertisement for Norplant.
First, the advertisement syas "Norplant-a wonderful innovation of
modern science” Hard to believe because we do not have any scien­
tific evidence.
Secondly, the method isfor use by women. As women are politically
less dangerous.
Thirdly, it will be implemented under the skin of the arm. Will en­
sure identification for coercion.
Fourthly, this method will ensure infertility for five years: A safe
method for the population controllers and not the users.
Fifthly, when removed will ensure fertility again: Nobody knows
(Norplant, 1981).

The trial was then postponed, as it was known through
sources in government that the Population Council was not
interested in being involved with controversial issues. A group
of 151 doctors and pharmacists made a petition to the
minister for health and population control to stop such an
unethical trial. This part of the information seems to be lost
in the present document of BFRP. There is no mention of
the attempt of the trial in 1981. The BFRP documents now
shows that they have initiated the clinical trial on Norplant
in February 1985 under the financial and technical assistance
101

from Population Council and Family Health International
(FHI) (FERP, 1986).
In an article by Dr. Halida Hanum Akhter, the present
director of BFRP, it was mentioned that the BFRP has in­
itiated the study after obtaining clearance from the Direc­
torate of Drug Administration “to assess the acceptability
and effectiveness of the new method among Bangladeshi
women through government controlled hospitals and clinics
such as the Institute of Post Graduate Medicine and Research
(IPGMR), Dhaka Medical College Hospital (DMCH) and
Mohammad pur Fertility services and Training Centre •
(MFSTC)” (New Nation, 1987).
Earlier BFRP had obtained clearance from its 19 member executive
council headed by the secretary ministry of health and family plann­
ing and consisting of members from various government and non­
government research organisations. University departments and ob
gyn departments of medical colleges.
The advisory committee was constituted by the Bangladesh govern­
ment in February, 1985 to make major policy decision relating to the
clinical trials and use of Norplant as a contraceptive, to decide the
mode of Norplant study and monitor the acceptability of the new
method of female contraception and to decide on the use of Norplant
in large scale in the family planning programme cleared the use of
Norplant in Bangladesh. . . The BFRP initiated the pre-introduction
clinical trials only after the World Health Organisation decided at
its Special Technical Review in November. 1984 that the Norplant was
an effective and reversible, long-term birth control method which has
proved to be superior to all other reversible methods.
It has been found by researchers that contraceptive pills contain­
ing progestin and more commonly used other reversible methods
necessitate continuous motivational involvement oy me user. In a coun­
try like Bangladesh this fact is more true than in the developed world.
It is, therefore, necessary to introduce methods in Bangladesh which
can continue to be effective for long.periods without continuous •
motivation by Family Planning Workers. Norplant is perhaps the most
effective method which is likely to prove successful here.

The articles does not say ariything about the study on the
safety aspects of the research. Again, when BFRP is quoting
the WHO special Technical Review decision (which also says
nothing about safety) it only emphasises the effectivity and
the superiority over other methods.
The BFRP protocol of research does not have the objec­
tive of looking into the safety aspects of the method. An
effective method means that the method can ensure birth
control; but it does not necessarily mean that by being ef­
fective it is safe for user’s health. The safety aspects are direct­
ly relavant for women’s health, while the effectivity only deals
with population control programme aspects.
It is interesting to note that even before BFRP undertook
the trial in February 1985, the Third Five Yeai Plan had in­
corporated the use of Norplant. It says:
This long lasting method has the potential advantage of not requir­
ing day-to-day use and therefore may be particularly suitable for our
semi-literate population. It is proposed to introduce this method in­
itially on trial basis, and the programme for its wider use can be decid­
ed according to the experience of the trial (TFUR, 1985). Here again,
the effectivity question is mentioned and is specially targetted towards
the semi-literature population, in other words, the poorer section of
the population, so that population control can be ensured.

The BFRP had started promoting Norplant even before
the trial was completed. While the trial began in 1985, the
BFRP started making the following claims:
The Norplant contraceptive system is suitable for most women of
reproductive age. (BFRP, 1986).

Norplant is a contraceptive system which is still under scien­
tific investigation or trial. Because of the known and
102

unknown health hazards of administering long acting hor­
monal implants scientists and women’s groups all over the
world as well as concerned individuals are resisting even the
trial of this system. The trial was attempted secretly in Brazil.
Later when it became a public scandal and had started fac­
ing resistance the experimentation was stopped.
It is important to briefly state the scientific status of
Norplank Here’s a critique of the ‘Facts About an Implan­
table Contraceptive’ published in the Bulletin of the World
Health Organisation 63(3): 485-494 (1985).
A. Insufficient Animal Experiment'.
1. Levonorgestrel and the half as actived, I norgestrol
isomer are used interchangeably. Only the investigations
referring to levonorgestrel are relevant. The interchangeable
use of the two substances is confusing’, and it is not known
how far results for one substance are valid-for the other
substance.
2. The comparison of the doses feiven to animals and
humans is misleading because, there, are big differences in the
bioavailability and terminal half lives of the drugs between
different species.
fable 1. Bioavailability and Terminal-Hall 1 tie of Drug between Species

Species
Rat
Dog (Beagle)
Rhesus Monkey
Women

Bioavailability

9
22-6.
94
100 *

Terminal Half l ife
0.5
12-0.3
4.4-0 5
26.4-72

3. Although it is accepted that the beagle bitch is an un­
suitable model for studying progestagins, experiments with
this animal are included and no replacement experiments
were carried out.
4. In the majority of experiments d, 1/levonorgestrol was
given by the oral route. The comparison with implanted
doeses is misleading because there is a difference in
bioavailability.
.5. Experiments are included which were carried out for
approval as an oral contraceptive.
6. Although the rat appears to be a poor model for the
testing of implants (local sarcomas) it is nevertheless used
in animal experiments.
B. Insufficient Clinical Research’.
1. The effect of Norplant on lipid metabolism—the ex­
periments carried out to date are contradictory. Fat
metabolism' is associated with the development of cardiac
problems.
2. The relationship between Norplant use and an abnor­
mal glucose tolerance test. (This was only examined in six
women according to WHO report.)
3. The safety of long term use of Norplant.
4. The effect of Norplant on blood coagulation.
5. The use of Norplant during lactation. Its effect on tne
growth and development of the child.
6. The use of Norplant during pregnancy.
7. The effect of Norplant on the levels of testosterone and
rostenedione. The experiments carried out to date are
contradictory.
8. The effect of Norplant on systolic and diastolic blood
pressure in the fourth and fifth year of use.
Radical Journal of Health

the problem sucn as infection, bleeding and peforation of uterus and
Inadequacy of Relevant Area of Investigation:
yet I have requested for the MR.
1. In general, investigations were carried out with young,
Jahanara put her fingerprint on the paper without knowing what
healthy, non-smokers. By ‘healthy’ is understood: without
was written on it.
ri
Then wc came downstairs. I saw that several clients were sitting,
cardiovascular disease, without diabetes (also preferably not
while two motivators were trying to motivate the clients. A doctor
in the family), not overweight, without liver disease. Com­
came out of the room and asked. “Did you find a client? The
mon causes of this are alcohol and poor nutrition. Women
motivators said, “No”. The doctor said, “Try to motivate them”.
who had used injectable contraceptives were eliminated from
I asked the motivators about the 5-year injectables. They said that
it was called Norplant. They also informed me that it is given in the
some experimental series. Thus, not a good cross section of
PG hospital, the medical college and Mohammadpur Fertility Clinic
the population.
arid through Dr. Firoza Begum. They also mentioned that Norplant
2. Frequently results are compared with those of women
was being given through some private clinics. I became very worried
who use oral contraceptives, instead of comparison with
• and went to the room where Jahanara had her MR. I told her not
women who use no hormonal contraception.
to take Norplant. The I went to the doctor and requested her to let
3. Some side effects (although not frequent ones) were not us go on that day. We would come back later. In this way Jahanara
was’saved from Norplant.
included in the WHO report. More implants were removedAfter this, we tried to find out more about Norplant.
as a result of ‘other medical reasons’ than because of
menstrual problems (6.5 per cent of- 5.6 per cent), while ’ UBINIG research team found that most of the clients in the
menstrual problems-occur more frequently.'Some of these ,PG hospital were being motivated for accepting Norplant.
side effects are depression (1 per cent), more then 10 kg However, they were found to have been asked questions such
weight loss (2 per cent in Thailand); arid epilepsy, (study in • as* whether the woman was a lactating mother or not. One
Aya thought that the research team was there as client. She
family planning).
Therefore, the claim of suitability for most women of suggested that if they take Norplant, then they could be given
Tk 30.00 [app. Rs 60] and some medicine during the first
reproductive age is not based on facts and is misleading.
visit. The client could come back in case of any problem and
would receive Tk. 30 and medicine. In the PG hospital, we
UBINIG’s Involvement in Study
—
collected a leaflet which was distributed to the clients. The
Since 1981 UBINIG has raised the question of ethics of leaflet said:
the research which is conducted on human beings. There are
Facts About Norplant
specified guidelines for bio-medical research, which must be
followed. But it has been observed that the research ethics . ’ 1. Norplant is a new temporary family family planning method. It is
effective for 5 years.
was violated’ in several ways'. UBINIG’s main concern js the I
2. Its use is relatively easier.
health of women and that women, specially the poorer I 3. It is given under the skin of the arm with an injection needle.
women, because of jheir vulnerable condition, should not
4. Generally the side-effects of this method are less than that of the pill.
become the victims ofsuch research. From this commitment.
5. It is 100 per cent effective as sterilisation.
6. The user can take out the norplant whenever she wants.
UBINIG has always pointed out the lapses found in the
7. The return of fertility after taking out Norplant is after one year.
research in order to improve, the situation.
8. It is possible to carry out normal movement and works when it is
In 1985, UBINIG was informed of the trial on Norplant
in the body.
by a development worker working with women in the slum
9. There is no need of taking any other method when the method is
in use.
areas of Dhaka city. She;wrote a brief account of her ex­
10. The doctor will examine the client before the method is given.
perience,with the trial:

C.

To know more about Norplant, contact the doctor
One of our group members (Jahanara) had four- children. She
(Collected From IPGMR on December 24, 1985.)
became pregnant again and was worried. She went to several family
If we evaluate the points mentioned in the leaflet, we find
planning centres for abortion (MR), bbl- failed: Finally she told me
that it actually violates the ethics by providing false infor­
everything and sought.my help.
On 15th December,985 I took her to Mohammadpur Fertility
mation to the clients. A few examples of the falsity of the
Clinic for MR services. We were told that .abortion cannot be done
information are given below:
because it is already 11 weeks of pregnancy. But soon they said that
Point 1: The claim of effectiveness is not completely true,
MR can only be done if she takes ligation operation simultaneously.
because according to BFRP newsletter the rate of acciden­
Jahanara did not want to take ligation. So she. was refused by the
tal pregnancies during the first year was 0.4 pregnancies per
centre.
I, then, took her to the medical college and met with the counsellor. 1000 users. The WHO records indicate a gross cumulative
Jahanara told the counsellor that she would prefer to take an IUD • pregnancy rate at 5 years of 2.6 per 100 women years. The
(plastic coil) after the MR. She said that she would not be able to
take fest at least for three days after the ligation operation. She has . annual pregnancy rate during the first 5 years ranged from
0.2 to 1.3. (‘Facts about an Implantable Contraceptive’, WHO
to work.. Sb it is better not to do it now. Then the counsellor told
her about an injection. I remembered the side-effects about injectables
Bulletin. 63(3) p. 485-494 (1985).).
so I said injections have possible side-effects. The counsellor said:
Point 2: Its use is not easier because it needs surgical ap­
“You are talking about injectables with 2/3 months duration. But here
proach
toput the capsules under the skin. The .WHO recom­
is another injectable which is of 5 years duration. It does not have <mends that to minimise the risk of infection, both inser­
any side-effects.
I was confused, because earlier 1 heard of Norplant which is of tion and removal should be performed in a clinical setting.
5 years duration, but the counsellor did not say that it was Norplant.
It is of utmost importance that sterile techniques be main­
During our conversation, the counsellor opened up a form and ask­
tained throughout both procedures.
ed Jahanara to put her fingerprint on the paper. 1 could read what
The above two examples also indicate the violation of ethics
was written in it, although the counsellor did not make any effort
by trying to motivate women with false information.
to rea1d the text to Jahanara which was meant for her. It said: I am
completely aware of the method of menstrual regulation. 1 know about’
We have tried to collect more information but were not

March 1988

103

successful because of the non-cooperation from the research
organisations. In November 1986, a conference was organised
by BFRP on “Contraceptive Technology Update”, among
other issues. Norplant research was discussed. A preliminary
report was presented by S. Firoza Begum. According to her
report 600 clients were admitted under the study within the
period February 1985 to April 1986, but the total number
that remained in the period Jan-April 1986 was 187 i.e. 31
per cent of all those admitted. She listed a number of reasons
for removal. (Table 2).
From the users’ satisfaction point of view Firoza Begum
had pointed out that 40 per cent have liked the method
because it lasts for 5 years, while 30.7 per cent liked it for
easiness. About 56 per cent disliked it because of its effects
on the change in menstrual pattern. 82 per cent have said
that they have received ‘enough’ information about the
method, while 17.8 per cent have not. One wonders what
‘enough’ means. If the above leaflet is the only source of in­
formation it cannot reach all the users because many of them
are illiterate.

The information obtained from (1) Dr. Hosna Ara Ali,
deputy director and Ms. Pervin (a family planning worker)
in the Mohammadpur Model Clinic, (2) Dr. Kohinoor,
gynaec specialist and directly working with the Norplant
study in Dhaka Medical College Hospital and Ms. Nadira
Begum, a family planning counseller in IPGMR.
It was known that about 616 women were given Norplant
in three centres. Except in IPGMR the other two c.entrcs had
200 clients each, while in IPGMR it was 216. The counsellor
reported that another 14 clients will be given Norplant within
one month of the interview (i.e. January 1988).
Information received from Mohammadpur Model Clinic
shows that the age range of the clients is between 18 and 40
years. The Norplant is given within 1-7 days of menstrua­
tion. Women who are not breast feeding their babies arc given
the method. All medical check-up is done for the clients so
that no disease such as jaundice, hypertension, diabetes ip
found in her. If the clients fall sick after the use of the method
then it is taken out and she is admitted to the hospital.
The follow-up is done within 1.3 and 6 months of inser­
UB1NIG Study on Norplant Clients
tion. Those who have taken Norplant have come from Dhaka
mostly, although a few have gone to Chittagong and ComWe found out the clients of Norplant during our study
ilia after the insertion. However, they have stopped inserting
on the injectables in urban slum areas. In the area of Mohamany further Norplant since last one year.
madpur, Tikkapara slum we identified women who have
In the Dhaka Medical College, the criteria of the Norplant
taken injectables. We also went to Basila village which is a
semi-urban village and found a number of injectable clients. receipients in terms of age was same as the other two cen­
During the interview we discovered one injectable client with tres i.e. between 18 and 40 years. In addition to that, the
Norplant. The client told us that she has taken a ‘five-year gynaec specialist said that one should use Norplant after one
needle’. Then she showed her arm having the capsules. child is born. The breastfeeding mothers should not use it,
Gradually we found more women in the same village who because according to Dr. Kohinoor, “the hormone which is
have taken the ‘Five-Year Needle’. We have interviewed 10 in Norplant may pass from mother to the child through
breastmilk and can cause harmful affects on the bab/’ In
women who have taken Norplant.
Three centres were visted by the UBINIG research team response to the question, how do they get the clients Dr.
in order to get information about the trial. These centres are: Kohinoor said, “When women come here for taking a con­
(1) Mohammadpur Fertility Services and Training Centre, traceptive method we give them a leaflet where the good and
commonly known as Mohammadpur Model Clinic or the bad effects of Norplant use are written. But the women must
Mohammadpur Fertility Centre; (2) Dhaka Medical College get the consent of their husband”. About follow-up she said
Hospital, DMCH; (3) Institute of Post Graduate Medicine that each and every client has a card. If the women do not
turn up for follow-up care then workers go and visit them
and Research, IPGMR.
at their homes.
Table 2: Reasons for Removal
No insertion is made without complete medical checkups.
Those who have hypertension should not be given, nor those
Reasons
(N = 32)
having jaundice and diabetes.
No
Per Cent
As frr side-effects, the most common side-effect is
1. Pregnancy Related:
amenorrhoea.
“However, this is not a serious side-effect”,
2
Luteals Phase*
6.2
she said. “It is better for the health to have amenorrhoea.
Planned Pregnancy
1
3.1
Because it saves the blood which would have gone through
2. Change in Menstrual Pattern:
Amenorrhoea
4
12.5
menstruation eveny month. Therefore there is no chance of
Polymenorrhoea
6
18.8
having anaemia. You know these women are already
Menorrhagia
2
6.2
malnutritioned Norplant is better for their health.” she add­
Irregular Bleeding/Spotting
5
15.6
ed. According to her 95 per cent of the clients belong to very
3. Medical Reasons:
Body Pain
poor class. “They are responsible for giving 4 to 5 births each.
3.1
1
9.4
Headache/Nausea/Burning Sensation 3
Since they cannot remember to take birth control method,
Loss of Libido
6.2
2
like pills, every day, long acting methods are better for them.
Weight Gain
3.1
1
On the other hand, women in the upper class are intelligent
Serum Hepatitis
3.1
I
and can take any other method”.
Infection at Insertion Site
3.1
1
Jaundice
Finally she said, “In order to gel a good thing there is a
3.1
1
4. Personal Reasons:
trade off. If 2/3 women die what’s the problem? The popula­
6.2
Husband Eent Abroad
2
tion will reduce and 70 per cent of our research has been
successful. In every birth control method there are good and
* In these two cases women were pregnant at the time of admission.
Source: Report of Firoza Begaum (1986).
bad sides. This has, too.”
104

Radical Journal of Health

The doctor in the PG hospital has oqly joined recently,
so she could not give much information.
Every centre we visited referred us to BFRP. But BFRP
refused to give information on the ground that we will
‘misinterpret them’. We have requested the director in writing.

Profile of Norplant Users
Below we shall provide a brief picture of the users of
Norplant in the village Basila, in Dhaka city. There were 10
women, who were found to take Norplant from Mohammadpur Fertility Centre.

(i) Economic Condition’. According to the information
available about occupation of the husbands of users, and
by direct observation of their household conditions, the
economic status of the users is poor (6) and lower middle
(4). Those who are poor are working as boatmen, fish sellers,
day labour and small business. The average daily income is
Tk. 40.00 to Tk. 50.00. They have no land and have to de­
pend on selling labour for earing their livelihood. The lower
middle families are mainly engaged in small business such
as rice and groceries. The families are also found to be in­
volved in briek business.

number of child births is 4.7 (the maximum is 9).
c) Age at first child birth: Three women have got children
before they reached 15 years, while 7 had children between
16 and 20 years of age.
(d) Time gap of first child birth and marriage: Five women
got children only after a year of marriaee. 4 had between
2 and 3 years and one had 5 years of time gap after mar­
riage before the first child birth.
(e) Average gaps between child birth: The average gap bet­
ween child births were found to be 2.1 years, with 4 years
as the maximum gap.

(v) Information on Contraceptive Acceptance; Except-3,
seven users have accepted other methods before taking
Norplant. These other methods are pill and injection.
Norplant has been used as a method of switch from other
methods or other methods were taken after Norplant use.
This is shown in Table X
Table 3: Use-of Norplant and Other Methods
No of Users

Category 1 •

i Norplant as the first method and no switch
II Norplant as the first method but switched
to other methods
Education'. Eight out of 10 users are illiterate; one has III Norplant alter using other methods

(ii)
read upto primary level, and another has got secondary
education.

3
I

6

That is most of the users have switched to Norplant as
a
change
of contraceptive method from other methods. One
(iii) Age: Two users are in the age range of 15-20 years, three
woman
in
the category II has already changed from Norplant
are in 26-30 years, one is in 31-34 years and four users over
35 years of age. The highest age was found to be 45 years, to other method such as pill. In category I, one woman has
taken off Norplant and has not taken any other method. In
while the lowest age is 18 years.
category
III, one women has taken off Norplant. Out of 10,
The age was determined by our investigators by asking the
user about hei age; about the age at marriage; about her the drop out of Norplant is 3.
Those who used other methods have started using the
menstrual situation at the time of marriage and about the
methods
since 1976. The Norplant was given in 1985. Only
age of her first child.
one
woman
has taken Norplant in 1986.
All this information together helped the investigators to
come to a figure for age of the user. This age information (vi) Present Health Condition of User. We have taken weight,
is more or less accurate. In the centres where Norplant is height, blood pressure, pulse, anaemia etc. as minimum in­
given, the age limit is said to be 18 to 40 years and is noted dications of health condition of the user. We shall provide
only by asking the user about her age.- In our sample, we the information in terms of average and maximum and
find that a woman over 40 years has been given the method. minimum figures.
It is interesting to note that the draft protocol of the
Height:
Average
4.11
Norplant study does not say anything about age of the users.
Maximum
5.1
N = 10
Moreover, the preliminary report submitted by Firoza Begum
Minimum
4.9
does not mention anything about the age level of the 600 Weight:
Average
42.3 kg
users of Norplant. The question is whether the researchers
Maximum 48.0 kgN = 10
Minimum
38.0 kg
are not taking the issue of “age of the user” as an impor­
90/60
Blood pressure:
N = 10
tant criterion of the research, whereas Norplant as a “longMinimum Normal Level
acting contraceptive” method must have a limit for age for Pius rate:
65-80 per minute 5N = 10
the method to be effective.
More than 80 per
(iv) Marriage and Child Birth Information: (a) Duration of
married life: Six women had a long married life of 20 to 30
years, while others had between 10 and 20 years. Only 2
young women were married in 1981. It is somewhat related
to the age of the user. Most of the users (8) were married
at an age of 13 to 16 years, and only 2 were married at the
age of 18 years.
(b) Number of living children and children ever born: The
average number of children for all the users (N = 10) is 43,
while maximum number is 8 and minimum is one child. As
is known from national statistics, the number of child births
is higher than the number of living children. The average
March 1988

Anaemics:

minute
5
Normal
2
Mild anaemic
2
Moderate anaemic 4
Severe anaemic
2

N = 10

(y\\)Health Condition before Use of Norplant: We have asked
questions whether they had any specific health problems
before the use of Norplant, we got the following response.
There was no problem
8
Irregular Menstruation
2
N = 10
That is,' women having amenorrhoea arid irregular menstrua­
tion were given Norplant, which aggravated their problem
105

even further. We could not however get information on health to take the 5 year needle instead of the 3 month one. From
conditions for which Norplant is contraindicated such as their village, it is difficult to go to the centre frequently, so
jaundice, diabetes etc. So we abstain from making any it was better if they could have a method of 5-year duration.
analysis of it.
One woman said that every woman goes to take Norplant is
(viii) Health Conditions after Use of Norplant. All the 10 asked to talk about the benefits of Norplant to their neigh­
Norplant users were facing problems since they have taken bour, and that they should send their neighbours to take the
method. None of the user has mentioned that they were using
Norplant. These were as they have expressed.
the method as a trial. The only information which was given
“No menstruation since 1 to 1!4 years!’
“Once menstruation is started continues for 15 to 20 days!’ to the clients was that Norplant was a ‘needle for 5 years’.
“Irregular bleeding, spotting’’ etc.
(x) State of Lactation, Pregnancy and Affects by other Con­
In addition to this the other problems are loss of apetite, traceptives'. We have received information which is vital
vertigo, burning feeling in hand and feet, body ache, before a contraceptive like Norplant is taken by women. Thble
weakness, leucorrhoea, etc. If we order the health complaints 4 is the representaton of the situation.
Table 4: Status of Women before Taking Norplant
in terms of the frequency of reporting, then the following
pattern emerges:
State of Client’s Condition at the Time of
Number of
N = IO
1. Amenorrhoea10
2. Irregular menstruation
4
3. Burning sensation
3
4. Excessive Bleeding, White Discharge, Body ache 2
5. Tiredness
1
* Almost all the clients suffered from amenorrhoea for different periods
of time and most of them developed irregular or excessive bleeding in
between.

Clients

Norplant Acceptance

Breastfeeding
Pregnant
Already had problems due to use of other
contraceptive methods
Both breastfeeding and affected by other methods
None

3
0

I
3
3

Here by amenorrhoea is meant long period without Six out of 10 women were breastfeeding out of which two
menstruation, even more than 45 days. According to some women had a child below one year of age. One of these
clients they had no menstruation for one year or more
clients had her last baby with the age of 1 Vi months only.
A few examples of the users’ complaints:
Four women were still breastfeeding their child even though
(a) “After I have taken the “Six” (the needle), I felt aches the child was over 1 year of age. In Bangladesh, the average
in my body after six months. I cannot look up, I do not have length of breastfeeding is about 18 months.
any apetite, I am going to die. The menstruation is very ir­
Table 5 shows that there is no sign of using Norplant as
regular, and during last Shabe-Barat (a religious occasion) a trial, it is used as a contraceptive method, like the injecI had menstruation for 2 months at a stretch’’, Anwara tabl’es, IUD etc. The clients are not included under the trial
Khatun (30 years).
with their informed consent nor any proper care is being
b. “I did not get menstruation for 2 year since I have taken taken for the health problems of the clients. However, the
this 5 year needle. Now I have aches in my hands, legs; I feel centres are selectively doing urine tests for some clients and
weak, I cannot explain; it is a terrible feeling’’, Fulbanu (35 not all of them. It is assumed that they want to eliminate
years).
the cases where the women are not coming within 1-7 days
c. “Since I have taken the needhe, I get menstruation which of menstruation. By urine tests they want to be sure about
continues for 12 + 13 days together. When I took the 3 pregnancy.
month needle, I had regular menstruation but now I had
Here again, the evidence suggest that the rules for trial
bleeding; clots of bloods going at the time of menstruation. were not followed although the workers are found to be aware
I feel pain in the body. I put kerosene oil on my body; when of certain rules. Violations are particularly made in taking
I go near the stove to cook, I see things double. I cannot informed consent, in the selection of clients for the method
go near the fire”. Nawab Banu (38 years).
and in the follow-up care. Information on the monetary in­
Three women who could not tolerate the problems insisted centives for follow-up monitoring was received from IPGMR
on taking the Norplant off, and finally could succeed in con­ Hospital. The doctor told us that they give Tk. 20.00 to each
vincing the centre to take it off.
client for motivating the clients for visiting the centre for
For health problems, the users have gone to the centre to follow-up monitoring. They also reported that the clients are
express the problems, but they were given only 30 vitamin given Tk. 50.00 at the time of first insertion of the method.
tablets and in some cases a prescription to buy medicine from While the centres try to motivate the clients to come for
outside. No other treatment was done from the centre. But follow-up visits the clients reported the contrary. According
they had to go to some doctor. For example 2 have gone to to the clients, there was rather discouragement for reporting
a qualified allopath doctor, 3 have gone to traditional healers, health problems. The centre workers are friendly in their at­
called the kabiraj, and one to a quack allopath doctor. Five titude before insertion of the method, but afterwards ‘they
women did not go to any doctor because they did not have do not’even want to talk’. The family planning workers at
the money to spend.
the centre do not appreciate the clients’ health problems at
(ix) Hovj was Norplant Taken by Users?: The users first all and they also do not want to take it off. Since the method
heard of injectables, the 3 month dose, from the family plan­ is clinical, and the clients cannot take, it off by themselves,
ning workers but later they heard from the neighbours that they feel helpless and therefore have to go to the centre and
there is a needle for 5 years. They heard that it was better plead for taking off the method. It is upto the decision of
than the 3 month injection so it would be better for them the workers whether it would be taken off or not. This is
106

Radical Journal of Health

a helpless situation for the clients.
The clients also become discouraged to go to the centre
for follow-up care because they are not given any treatment.
They are given ‘slip’ only i e, prescription. The centre workers
says that there is no medicine for treatment of the clients.

Table 6: Discrepancy and Similarities Found in Information Given
by Centre and Information Received from Clients

Centre

Clients

Norplant is given within All the clients reported of same time
period after menstruation.
1-7 days of
menstruation
Discussion
b. Women who are breast­ Six out of 10 users were breastfeeding
at the time of taking Norplant.
feeding arc not given
If the trial is for acceptability and effectivity, the
the method
methodology is inadequate to prove either. The research c. Norplant is taken out as Three clients have taken out Norplant.
methodology is directed more towards getting women so that
But their experience is that the centre
soon as any side-effect
is noticed.
did not want to take it off for first 2-3
the method can be inserted. Women are not considered as
times. Then when they insisted further.
a human and social being. Therefore, no information is be­
then it was taken off.
ing shared with her except the information which will only
in the words of a client, “when I had
lead to the insertion.
problems, and could not bear it
anymore, then 1‘went to the centre.
Women who are motivated to take Norplant are supposed
but they refused to take if off. They
to be motivated with full knowledge of the method as a trial.
said why did you take it?"' Next time I
This is not happening. This can be proved not only by the
went and made a lie by.saying that my
two children are drowned in the river
Table 5: An Examination of Rules to be Followed for Trials
and my husband wants another‘child.
This time they took it off.
Rules
Whether It Was Followed by the Trial ;
The rest seven clients are having side
effects but the method is not taken
a. Informing the clients
None of the sample clients know that
off.
about the method and
the method was on trial. The
d. All pre-medicaljests arc The clients have reported only urine
that it is on trial
information which was given to the
done. These include
test, blood pressure checking, irregular
clients was that: ‘It is one of the con­
checking of disease like p/v exam and weight as the premedieal
traceptive methods and it is of 5 years’
hypertension, jaundice,
test done for them. But these were
- duration’.
asthma, etc.
also not done for all rhe .client*
b. Informing the clients
Two clients were told that .“there will
e. Norplant is given to
One client was 16 years and one client
about the side-effects
be some disturbances in the menstrua­
women between 18 and was 45 years. The rest were within 18
tion cycle, either it will stop or may be
40 years of age.
to 40 years of age.
there will be more bleeding. There will
f. The follow-up procedure The clients.reported that they arc
be no other problem”.
is the following:
asked to go to the centre after every
Two clients were asked to come “if
1st follow-up after one
2-3 months. They know that the date
there is any problem”. One client was
month of insertion, 2nd is written on the card, but they have
told that “if you take this needle, there
and 3rd follow-up after not seen any worker coming to their
will be no problem, but if you get
three months of
houses for follow-up care.
sick, we will check”. One client was
insertion; Fourth on­
asked to .take milk, banana and other
wards follow-up in after
good food. Four clients were not given
six months of .insertion.
any information.
Dates of follow-up visits
c. Taking consent of the
No information was found which will
are written on the card.
clients after providing
reveal that an informed consent was
If they do not come
all the information
taken. The clients were not even told
then the centre workers
of the name of the method. Only one
go to the clients’ houses
client knew that the method was called
to. see how they are.
“Norplant” and the rest knew that it
g. A leaflet is made with No client has reported of such
was a 5 year injection..
the information of good information
d. Pre-medical examination Urine test and blood pressure checking
and bad effects of
of the client
was done for 2 clients, weight and
Norplant. This is read
blood pressure was taken for 8 clients.
out to the clients; and •
e. Medical support to
Six clients reported that when they
then if they decide to
clients having side- .
went to the centre to report about
take it then the method
effects after taking
their health problem, the centre gave
is given.
the method
them pre:.cription on plain white paper
h. Women having post­
All the 10 women wno have received
.and asked them to buy medicine from
partum amenohrroea,
Norplant during normal menstruation
outside. According to a client, “I have
are not given Norplant. cycle.
gone to the centre 2-3 times, they gave
i. The clients must have at The clients reported that'they were
us slips only and asked me to buy
least one child at the
asked about the number of children
from outside. I asked them, why
time of taking Norplant. they have.
should I buy medicine from outside
j. Those women who have Tvo clients were taking pill before
when I have taken the needle from
taken pills, must wait
taking Norplant. One of them has
here. I want my treatment to be done
six months before they
taken Norplant only after 2 months of
here. The big doctor told me that the
take Norplant
.. . stopping piHs.
govt, did not give medicine for us. If I*,
k. Clients must get consent Only six clients have taken consent
talk about my health problems more,
of their husbands before and four did not. •
they suggest I go for ligation opera­
taking Norplant.
tion”. One client was given 30 vitamin
tablets, another-client got pain killer
tablets once.
(Contd on page 108)

March 1988

a.

107

Dialogue

Obsession with Socialism
rohit j oza

I AM attempting underneath to answer some of Anant R.S!s
criticism (RJH II: 1-2, June-September, 1987) by quoting an
article from the December 1987 issue of the Russian
magazine Sputnik. The journal comments: “Problems posed
by health service [in Soviet Union] of late have come in for
criticism. The truth is that the health service has been obses­
sed by the quantity of services [the widely available and
almost free medical care referred to by Anant] rather than
quality of these services!’ Anant’s reference to “these stupid
civilisations [of capitalist countries] spending more on health­
care” can be well answered by the Sputnik article and I quote
“Health service has been dominated by conservatism in
economic management, thus creating serious propblems”.
Further, the article says, “the success stories of principles
of medical aid as practised in USSR should not be ignored.
But what was good yesterday will not necessarily be found
satisfactory tomorrow-”. As for Anant’s attempt to locate “the
indicator to find out what percentage of medical needs are
being met and in what manner”, the Sputnik article has
quoted the USSR Minister of Public Health as saying, “we
will dismiss specialists for whom medicine has been a random
choice of career and who refuse to treat the job seriously”.
(And this, Anant, in spite of the Soviet Union’s population
of 1.2 million doctors—the largest number as compared to
any country in the world.)
In the words of Anant: “A rough opinion in a proper direc­
tion is better than a precise obsessed opinion in a wrong
direction.” The “information'’ needed to “draw valid con­
clusions” is well provided in the Sputnik article: “By 1990
almost a million people will have died of lung cancer in the
USSR and most of these smokers”. (So much for the healthy

(Contd from page 107)
10 samples but also from the discussion with the centre
workers about their methodology. Therefore, it cannot be
proved with the number of drop outs that once they realise
the problems they are no more interested in it.
The follow-up monitoring is done to note down the pro­
blems but with little care of the clients. The problems such
as amenorrhoea are found to be frequent, but the tendency
of the centre is to justify the problem rather than giving
remedies for it.
References
B F R P, 1986: BFRP Bulletin News & Views. No 3, Vol 2, October 1986.
National Council, Proceedings of the 16th Meeting.of the National
Council for Population Control and Family Planning. March 17,
1981, No PP/s-6/l/78(Pl)/62).
New Nation, 1987: Clearance for a Contraceptive, Dr. Halida Hanum
Akhter, The New Nation, January 25, 1987.
Norplant, 1981: Norplant: Another Pop Con Trial; Farida Akhter Holi­
day, October 25, 1981.
Subvention Committee: Proceeding of the subvention Committee meeting
held on August 22, 1981. No PP/S-SOlI(C)/51/79(part-l) dt.
September 9. 1981.
TFYP, 1985: Third Five.Year Plan, GOB, 1985-90, p-384.

108

Soviet way of life as compared to the unhealthy .American
way of life.)
With reference to the “wrong work environment and
wrong social environment”, Anant should note the follow­
ing sentences in the Sputnik article: “A quarter of water supp­
ly is without adequate cleansing”; “from 1965 to 1985 the
incidence of lung cancer doubled in Soviet Union”; “forty
per cent of sixteen-year olds smoke”; and “medical specialists
pay little attention to the propagation of a healthy way of
life as a whole”.

In the end, 1 would like to quote five more sentences from
the Sputnik article to start, if possible, another ‘Dialogue’:

(1) “In Soviet Union, it is intended, by 1995, to double
the volume of Pay Services available.”
(2) “It is worth considering the question of large enter­
prises or big organisations paying at least partly for
the treatment of their employees (workers)”.
(3) “It would be just to levy a specific tax on smoking.
Such additional charge (income) could be used for
the treatment of smoking related diseases!’
(4) “The present situation [in the Soviet Union] can no
longer be tolerated by the party, the government and
the people. Nor indeed by us in the medical profes­
sion!*
(5) “The patient should also have a right to choose a
doctor whom he trusts!’

The Soviet Union is restructuring all spheres of its
economy, culture and life. It is high time Anant also ‘restruc­
tured’ his obsessions. Remember, all that glitters is not gold.

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