pharmaceutical jurisprudence

1. THE MEDICAL TERMINATION OF
PREGNANCY ACT
Throughout the world there are
liberalized laws on abortion.
There are about 8 percent of
world's population lives in
countries where law prevents
abortion. Mortality and morbidity
rates following illegal abortion are
very high and often make the life
of many women miserable. To
reduce the colossal morbidity and
mortality associated with
abortion, Shantilal Shah
Committee (1964) recommended
liberalization of abortion laws in
India in 1966. In 1969, Medical
Termination of Pregnancy (MTP)
Bill was introduced in Rajya
Sabha and Lok Sabha which was
later passed by the parliament in
from 1.4.1972 and extended to
the whole of the country except
the state of Jammu and Kashmir.
introduced in Rajya Sabha and
Lok Sabha which was later
passed by the parliament in
August 1971. It came into force
from 1.4.1972 and extended to
the whole of the country except
the state of Jammu and Kashmir.
There is no fix trend on MTP. In
2008, there were 6.41 lakh
abortions across 12,510
institutions approved to carryout
MTP. India recorded 7.25 lakh
MTPs in 2005, 7.21 lakh in 2006
and 6.82 lakh in 2007 and 7.01 lak
country except the state of
Jammu and Kashmir.
There is no fix trend on MTP. In
2008, there were 6.41 lakh
abortions across 12,510
institutions approved to carryout
MTP. India recorded 7.25 lakh
MTPs in 2005, 7.21 lakh in 2006
and 6.82 lakh in 2007 and 7.01
lakh
and 6.82 lakh in 2007 and 7.01
lakh in 2014.
Prior to enactment of the
legislation, the Indian Penal Code
(Act No. 45 of 1860) permitted
abortion only when it was justified
for the good faith purpose of
saving the life of the woman. The
present act was intended to grant
women freedom from unwanted
Abortion Laws Around the World
US: The abortion can be done at any stage
by a woman even without the consent of
spouse.
UK: Legally the abortion is permitted till
24 weeks of pregnancy under Abortion
Act 1967. However, it can be done at any
stage if doctors detect risk to mother's life
or severe abnormalities in foetus.
Australia: Abortion is permitted at any
stage of pregnancy in the capital territory.
However, in other states, the rules allow
termination between 14 and 28 weeks.
Canada: The termination of pregnancy is
not permitted that has crossed 24-week
period unless the experts are of opinion
that continuation of pregnancy is a threat
to life or foetus has severe abnormalities.
Japan: Abortion is permissible only if the
pregnancy threatens woman's life or
pregnancy caused by rape.
Brazil: Abortion is permissible only if
woman's life is endangered by
continuation of pregnancy. However, in
2012 Supreme Court allowed abortion if
the foetus severely abnormal.
(Source: The Times of India, New Delhi,
August 2, 2008, page 16.).

2. pregnancies, especially when there
was social censure or medical risk
involved. Apart from these
benefits, it also ensured the easy
accessibility of abortion services.
This can be viewed as path-
breaking legislation which would
eliminate unwanted or forced
pregnancies, or going to quacks
that resulted in postnatal trauma. It
was for the first time that
contraception failure was legally
accepted as a valid reason for
terminating pregnancy. MTP is one
of the maternal healthcare
measures to reduce maternal
morbidity resulting from illegal
abortion.
In a significant order while
dismissing the plea of 10-year-old
rape victim to abort her 32 weeks
foetus as the medical report was
against, the Supreme Court (SC)
urged for setting up of permanent
boards across the states so that
the women especially child rape
victims can receive expedient
medical care. At present, women
are forced to undertake the
cumbersome process of
approaching different courts, from
district courts to high courts and
finally the Supreme Court, for
permission to medically terminate
their pregnancies which are over
20 weeks.
In another judgement, SC
Allowed 13-yearold rape survivor, a
Mumbai-based seventh class
student, to abort her 32-week-old
foetus (6 September 2017). Based
on medical board's report, SC
directed to complete MTP
immediately. However, as the
doctors found the foetus to be
completely developed, they
performed a cesarean operation
and the girl delivered a boy
World Health Organization
Recommendations on
Regulation, Policy and
Human Rights Related to
Abortion
• Laws and policies on abortion
should protect women's health and
their human rights.
• Regulatory, policy and
programmatic barriers that hinder
access to and timely provision of
safe abortion care should be
removed.
• An enabling regulatory and policy
environment is needed to ensure
that every woman who is legally
eligible has ready access to safe
abortion care.
Policies should be geared for
respecting, protecting and fulfilling
the human rights of woman, to
achieving positive health
outcomes for women, to providing
good quality contraceptive
information and services, and to
meeting the particular needs of
poor women, adolescents, rape

3. survivors and women living with
HIV. [Source: Bulletin of World
Health Organization, 2017; 95, 542-
544.] Though the Act was intended
to permit abortion on certain
specified conditions, the general
perception was that abortion is
legalized. Unfortunately, the act is
often viewed as method of family
planning or a method of reducing
birth rate. The strong preference
for sons under patriarchal
traditions and the availability of
inexpensive prenatal diagnostic
techniques have resulted in an
increased use of prenatal gender
tests in India and selective
abortion of girl child. In the name of
contraceptive failure, MTP is
continued resulting in sex selective
abortion. This has caused the child
sex ratio (0-6 years) plummeting
from 874 girls for every 1,000 boys
in 1991 to an abysmal 754 in 2001.
The population census of 2011
reported the gender ratio at 940
females per 1000 males.
The MTP Act, 1971 was amended
by the MTP (Amendment) Act,
2002. The main objective of the
recent amendment to the MTP Act
aimed at reducing the rate of
unsafe abortions by making legal
abortion more widely accessible.
Lack of access to MTP services at
the primary healthcare level is an
important reason for the high rate
of unsafe and illegal abortions. The
amendment is aiming at
decentralization of authority for
approval and registration of MTP
centres from the state to the
district level.
Milestone in Abortion Legislation
in India
• Indian Penal Code (Act No. 45 of
1860).
• Shah Committee Report, 1966. •
MTP Act, 1971.
• MTP Rules, 1975.
• MTP (Amendment) Act, 2002.
• MTP Rules, 2003.
The Act allows termination of
certain pregnancies by the
registered medical practitioners.
MTP Permissible
• Where the length of the
pregnancy does not exceed twelve
weeks; and if such medical
practitioner is:
• Where the length of the
pregnancy exceeds twelve weeks
but does not exceed twenty weeks;
if not less than two registered
medical practitioners are: of the
opinion, formed in good faith, that,
i.The continuance of the pregnancy
would involve a risk to the life of
the pregnant woman or of grave
injury physical or mental health; or
ii. There is a substantial risk that if
the child were born, it would suffer
from such physical or mental

4. abnormalities as to be seriously
handicapped.
Pregnancy caused by rape and the
anguish caused by such pregnancy
is presumed to constitute a grave
injury to the mental health of the
pregnant woman. Similarly, the
anguish caused by unwanted
pregnancies as a result of
contraceptive failure used for
limiting number of children is
presumed to cons a grave injury to
the mental health of pregnant
woman.
When length of pregnancy exceeds
20 weeks, if two registered medic
practitioners are of the opinion that
the continued pregnancy would
danger the women's life. It does
not consider on of child to be born.
It is legally not permissible.
The Nikita Mehta case (see box)
has forced the authorities to review
the act. It says "The Act has
become old and a lot of new
scientific and technological
development have taken place
since 1971. The Act needs to be
concurrent with the present-day
ethics and social structure. It
needs a review".
As long as the above conditions
are fulfilled, the registered medical
practitioners can terminate a
pregnancy without the fear of
being prosecuted.
In the event of abortion to save
a woman's life the law makes
exceptions: the doctor need not
have stipulated experience or
training but still needs to be
allopathic doctor. A second
opinion is not necessary for
abortion beyond 12 weeks and the
facility need not have prior
certification.
The Government of India
proposed for an Amendment of the
Act, Draft Medical Termination of
Pregnancy (Amendment) Bill 2014.
This is yet to be passed by the
Parliament. In recent time there
have been many legal cases
seeking permission from High
Courts and Supreme Court for
termination of pregnancy beyond
20 weeks. A few cases are cited in
the box for readers' reference.
Women are Entitled to end
Pregnancy Irrespective of
Reason-Bombay High Court
(September 19, 2016)
The court observed that:
• MTP Act should extend to the
'mental health' of the women and
she should be allowed to opt out of
an unwanted pregnancy
irrespective of the reason. "Not
allowing a woman to terminate her
pregnancy amount to grave injury
to her mental health”. MTP should

5. be allowed even if there is no risk
to her physical health.
• The Act must be extended not just
to married women, but also to
those women who 'stay with their
partners as married couples in live-
in relationships'.
Pregnancy beyond 20 weeks
Bombay High Court denies
abortion of 25 weeks foetus
A couple and a gynaecologist
petitioned the Bombay high court
(known as Nikita Mehta Case) with
a request to permit an abortion
beyond the legal 20 weeks on the
grounds that the new-born’s health
may be at risk. The couple have
asked to amend the provision to
allow for an abortion "if the
physical or mental health of the
foetus is at risk. The court
observed that the committee of
medical experts should give a
positive opinion on whether there
is substantial risk that if the child is
born, it will have serious mental or
physical deformity for making a
decision. The final report
submitted by JJ Hospital
Committee said "The committee is
of the opinion that there are very
least chances that the child will be
born incapacitated and
handicapped to survive". The High
Court dismissed the plea to permit
an abortion of 25 weeks foetus
with a complete congenital heart
blockage and malpositioned
arteries that could, doctors say,
require a pacemaker implantation
soon after birth.
The justices observed "We can
interpret the law and not make the
law. The JJ report is clear that the
child is not deformed. Once there is
life, can you ask for it to be killed
now? Is it any different from mercy
killing?"
Rape Survivor can Terminate
Pregnancy: Kerala High Court
(November 15, 2016)
A woman from Kasaragod (Kerala)
filed a petition seeking permission
to terminate her pregnancy that
had resulted from rape. Earlier her
requests for termination were
turned down by Kasaragod
Government Hospital and
Kozhikode Medical College
Hospital. She was in sexual
relationship with a man who
promised to marry her. She filed a
police complaint of rape when the
man did not keep his promise and
married to another woman. On her
petition, the High Court observed
that a rape survivor is eligible for
termination of pregnancy as
unwanted pregnancy is a threat to
her life.
The High Court ordered the
Medical Superintendent of the
Kozhikode Medical College

6. Hospital to take necessary step for
MTP.
Supreme court of India rejected the
plea of HIV + Rape survivor to abort
(9 May, 2017)
A 35-year-old destitute HIV+
woman facing complications in her
26 weeks pregnancy resulted from
rape approached the Supreme
Court seeking permission to abort
her pregnancy. The apex court
rejected her plea as the medical
report prepared by AIIMS doctors
said that her life might be in danger
if MTP of foetus was done at such
an advanced stage.
The court observed that this
delay was due to fault of State
Government and Patna Medical
College Hospital. Earlier the State
Government opposed her plea in
High Court. The High Court refused
to allow her abortion. By the time
she approached the Supreme
Court it was too late. However, the
apex court ordered the State
Government of Bihar to provide
medical care at Patna and pay
compensation of three lakh rupees
under rape survivor scheme.
The Supreme Court during a
hearing of a petition from Kolkata
woman observed that law should
be more meaningful and favours
the amendment of the MTP Act to
allow the MTP in case of terminally
ill foetus beyond the current limits
of 20 weeks.
Consent Required
• The pregnant woman's (attained
18 years of age) informed consent
is required for MTP. No other
person's consent is necessary.
• In case of pregnant minor: Written
consent of guardian is necessary.
• In case of pregnant women (18
years and above) but of unsound
mind, written consent of guardian
is necessary.
It is important to note, in this
section, that the consent of the
woman is the essential factor for
termination of her pregnancy. The
husband's consent is irrelevant.
Therefore, if the woman wants an
abortion but her husband's objects
to it, the abortion can still be done.
However, if the woman does not
want an abortion but her husband
wants, it cannot be done.
No MTP without Consent
even if Woman is Retarded
A rape victim, staying in a home
for mentally challenged in
Chandigarh, wanted to continue
pregnancy till its full term and bear
a child. As the said woman is
assumed to be mentally incapable
to making an informed decision,
the Chandigarh High Court
permitted MTP. On reversing the

7. order of High Court, the Supreme
Court in its final order observed
"the MTP on a person found in a
condition of borderline, mild or
moderate mental retardation, is
antidemocratic and violative of the
guarantee of 'equal protection
before the law' as laid down in
Article 14 of our constitution.". The
court also observed “There is no
doubt that a woman's right to make
reproductive choices is also a
dimension of 'personal liberty'
under Article 21.
"MTP cannot be done without
the consent of the woman even if
she is mentally retarded and not in
a position to understand the
consequences", the Supreme Court
observed.
(Source: The Hindu, Tiruchirappalli,
August 30, 2009.)
In case of pregnant minor, she
may be advised to consult her
parents, guardian, family members
or friends before termination of
pregnancy. However, if the minor
decides not to consult them, she
should still be allowed to go ahead
with her decision to terminate
pregnancy. The act also makes
provisions for pregnant women
who are unable to make a decision
on account of illness: Severe
mentally disabled, in a state of
continue unconsciousness.
Places for MTP
• A hospital established or
maintained by government, or
• A place for the time being
approved for the purpose of this
Act by government or a district
level committee constituted by the
government with the chief medical
officer or district health officer as
chairperson of the committee.
However, exceptions are made
for emergencies. A doctor may
terminate a pregnancy if it is
"immediately necessary to save
the life of the pregnant woman". In
such situations, the requisites
relating to the length of pregnancy,
the need for two medical opinions
and the venue for operation do not
apply.
Approval of Place for MTP
The approval process has been
decentralized from the state level
to district committee. The
centralization of power for
approval of places as MTP centres,
from state to district level aims at
enlarging the network of safe MTP
centres. The non-government
institutions may also take up
abortions provided they obtain a
license from Chief Medical Officer
of the District. The Act provides
punitive measures of 2-7 years
imprisonment for individual
provider or owner of facilities not
approved or maintained by the
government. To reduce the

8. administrative delays, a timeframe
has been defined for registration
and mandates the district
committee to inspect a facility
within two months of receiving an
application for registration and
process the approval within next
two months if no deficiency found,
or within two months after
rectification of any noted
deficiency.
Requirements for Approval
• Safe and hygienic condition;
• Up to 12 weeks of pregnancy (first
trimester): A gynecology/labor
table, resuscitation and
sterilization equipment, drugs and
parenteral fluid, back-up facilities
for treatment of shock and
facilities for transportation; and
• In case of second trimester (up to
20 weeks of pregnancy): An
operation table and instruments
for performing abdominal or
gynecological surgery; anaesthetic
equipment, resuscitation
equipment and sterilization
equipment, drugs and parenteral
fluids and other requirements as
notified by the government
Composition and Terms of
district committee:
•Gynecologist/surgeon/anaestheti
st;
•Other members from local
medical profession, non-
government organization, and
Panchayati Raj Institution of the
district.
•One of the members of the
committee must be a woman.
• Tenure of the committee is for
two calendar years. Tenure of non-
government members is for not
more than two terms.
Approval Process
• Application for approval is to
be addressed in prescribed
form to the Chief Medical
Officer of the District
• Chief Medical Officer on
verification of application
inspects the place to satisfy
himself that MTP can be
performed under safe and
hygienic condition.
• Chief Medical Officer would
recommend the approval to
the committee.
• The committee on
consideration of application
and recommendation of the
Chief Medical Officer may
issue a certificate of
approval in prescribed form.
The certificate of approval
should be conspicuously
displayed at a place easily
visible to the person visiting the
place.
Inspection, Cancellation or
Suspension of approval:

9. Chief Medical Officer may
inspect the approved place as
often as necessary to verify
whether MTP is being
performed under safe and
hygienic condition. After
inspection, if Chief Medical
Officer satisfied that the facility
is not maintained properly and
MTP cannot be performed
under safe and hygienic
condition, may report the same
to the committee giving details
of the defects and deficiency.
On satisfaction the committee
may suspend or cancel the
approval after the owner is
given an opportunity to make
presentation. Once the approval
is cancelled or suspended, the
owner may make addition or
improvements in the place and
may make application to the
committee for approval. The
aggrieved owner of the place
may make an application to the
government for review within a
period of sixty days of such
order. The government may
condone the time delay, if
required. After hearing the
owner's view, the government
may confirm, modify or reverse
the order.
Experience and Training
of registered Medical
Practitioner for
performing MTP:
The registered medical
practitioner should have one or
more of the following
experience or training in
gynecology and obstetrics:
• Registered medical
practitioner (registered before
the commencement of the Act)
minimum of three years of
experience in the practice of
gynecology and obstetrics;
• Registered Medical
Practitioner completed six
months of house surgency in
gynecology and obstetrics; or
experience at any hospital for a
minimum period of one year in
the practice of gynecology and
obstetrics;
• Registered medical
practitioner assisted in
performing 25 MTP out of which
at least five must have been
performed independently. This
training enables the medical
practitioner to perform MTP for
cases below 12 weeks.
• Registered Medical
Practitioner holding a
postgraduate degree or diploma
in gynecology and obstetrics.
Maintenance of Records
and Procedure followed:
The opinion of registered
medical practitioners should be
recorded in the prescribe form

10. (Form I) and the registered
medical practitioner who
performs MTP should record
such details within 3 hours of
such MTP in Form I.
The consent recorded together
with certified opinion of the
registered medical
practitioner(s) should be kept in
envelope, sealed and kept in
his/her custody until sent to the
head of the hospital, owner of
the approved place or chief
medical officer. The serial
number of the women in the
admission register should be
recorded in the envelope and
such envelope should be
marked as SECRET. Every
envelope should have the name
and address of the concerned
registered medical practitioner.
On receipt of the envelope,
the head of the hospital or
owner of the approved place will
keep them in safe custody. The
owner of the approved place or
head of the hospital is required
to send the monthly statement
on MTP to the Chief Medical
Officer in Form II.
However, when MTP is
performed in an unapproved
place, every envelope should be
sent by registered post to the
chief medical officer of the
state on the same day or in the
following working day.
The head of the hospital or
the owner of the approved place
is required to maintain a register
as prescribed in Form III
recording the details of women
admitted for MTP and the
register is to be preserved for
five years from the end of the
calendar year. The entries in the
admission register shall be
made serially and a fresh serial
shall be started at the
commencement of each
calendar year and the serial
number of the particular year
shall be distinguished from the
serial number of other years by
mentioning the year against the
serial number, for example,
serial number 5 of 1972 and
serial number 5 of 1973 shall be
mentioned as 5/1972 and
5/1973. Admission register is a
secret document and the
names and other particulars of
the pregnant women will not be
disclosed to any person. The
admission register is to be kept
in the safe custody by the head
of the hospital or the owner of
the approved place or by
authorized person and will not
be open for inspection except
under the authority of law.
The registered medical
practitioner may issue a
certificate on the application of
employed woman whose
pregnancy is terminated in

11. order to enable her to avail
leave. Such employer should
not disclose such information.
Various Forms
Form I: Opinion and Record by
Registered Medical
Practitioner.
Form II: Monthly Statement
Form III: Admission Register.
Form A: Application for
approval of place.
Form B: Certificate of approval
of place.
Form C: Consent form.
Making Rules
The Central Government may,
by notification in the official
gazette, make rules to carry out
the provisions of this Act with
respect to the experience or
training, or both, which a
registered medical practitioner
shall have if he intends to
terminate any pregnancy under
this Act or any other matter.
Every rule made by the Central
Government under this Act is to
be laid, as soon as may be after
it is made, before each House of
Parliament. If both Houses
agree in making any
modification in the rule or both
Houses agree that the rule
should not be made, the rule
shall thereafter have effect only
in such modified form or be of
no effect.
Power to Make Regulations
The state government may
make regulations for making
provisions for taking opinion of
registered medical
practitioner(s), certification by
registered medical practitioner,
preservation or disposal of
certificates; requiring registered
medical practitioners to give
intimation of termination,
prohibiting the disclosure of
such information in pursuance
of regulations to unauthorized
person.
Willful contravention or
failure to comply with
requirements of any regulation
is punishable with fine which is
extendable to one thousand
rupees.
In a case of 10-year-old child
rape victim, Chandigarh District
Court has der permission to
abortion on the ground that the
pregnancy is beyond 26 weeks
(2017 case). The judgment
raised several issues including
call for revisiting the MTP Act. In
this particular case, the victim's
life is at risk either way: Whether
in termination of pregnancy or
in a delivery process that
underage girl's body is not
equipped to withstand. Besides,

12. the legal process is often
viewed as perversely long
drawn leading to the pregnancy
getting into advanced stage.
In the light of several cases
of MTP reaching Supreme Court
seeking permission beyond 20-
week deadline because either
their foetus was malformed or
they were rape survivors, the
demand 24-week abortion
rising. This has another angle
too. The underprivileged
women are more impacted by
this 20week limit. There are
overcrowding of government
hospitals, the women find
difficult to get appointment for
ultrasound in the 18-20-week
window when an anomaly scan
requires to be performed. Even
if a problem is detected, it takes
another one or two weeks to get
a confirmation and by this time,
it crosses the legal limit of 20
weeks. Many cardiac anomalies
can only be detected at 22-23
weeks only. Hence, the demand
for 24week abortion rising.
Draft Medical Termination of
Pregnancy (Amendment) Bill,
2014
Realising the need of changing
MTP conditions, the Ministry of
Health and Welfare, proposed
the amendment of the existing
Act. Some notable features of
the proposed Amendment are:
• In addition to registered
medical practitioners the
following categories of
healthcare providers are also
proposed for MTP: - Persons
qualified with Ayurveda, Siddha,
Unani, and Homeopathy and
registered are also included; -
Nurse or Auxiliary nurse. • MTP
is permissible beyond 20
weeks: - Pregnancy exceeds 20
weeks but not exceeding 24
weeks. - Length of pregnancy is
insignificant (at any time MTP)
if the diagnosis con firms
substantial foetal
abnormalities. There has been
news that this would not be
pursued.
REFERENCE
TEXTBOOK OF FORENSIC PHARMACY, Guru
Prasad Mohanta

13. THANK YOU