This document discusses key aspects of the proposed Assisted Reproductive Technology (ART) Bill in India, including: - It establishes various regulatory authorities like the National Board for ART, State Boards, and a National Registry of ART clinics and banks. - It outlines registration requirements and minimum standards that ART clinics and banks must comply with. Harsh penalties including imprisonment are proposed for non-compliance. - It discusses various duties and procedures ART clinics and banks must follow regarding sourcing and handling of gametes and embryos, counseling patients, and reporting treatment outcomes. - Concerns are raised that some provisions may be too restrictive or ambiguous and could hamper the effective functioning of ART services in India.

1. Dr. Shivani Sachdev Gour
M.D. DNB, M.R.C.O.G. (UK)
SCI HEALTHCARE
New Delhi

2. ARE YOU READY??
After a brilliant session of talk by experts ,
lets find out what is the new ART Bill and how
will it affect gynaecologists especially those
who DO NOT have an IVF centre.

3. ESTIMATED MAGNITUDE OFESTIMATED MAGNITUDE OF
INFERTILITY IN INDIAINFERTILITY IN INDIA
Age Group Rural Urban Total
15-49 3.38
Million
4.82
Million
8.2
Million
Prevalence of Infertility

5. CURRENT STATUS:
Mushrooming or Unmet Need?
Cycles per million
population
3,000 per million
1,500 per million
500 per million
220 per million
120 per million
Israel/ Aus/ US/ Egypt/
India!

8. The Commercialization
of Medical profession is
cited as a common
reason for the dilution
of quality, doubts have
been raised regarding
the quality of training.
COMMERCIALIZATION OFCOMMERCIALIZATION OF
MEDICAL PROFESSIONMEDICAL PROFESSION

9. TITLETITLE

10. Differences in 2010/ 2014
 3.1 Clinics which should be
Registered
 Clinics involved in any one of the
following activities should be
regulated, registered and
supervised by the State
Accreditation Authority/State
Appropriate Authorities (Section
3.15).
 1. Any treatment involving the
use of gametes which have been
donated or collected or
processed in vitro, except for
AIH, and for IUI by level 1A
clinics who will not process the
gametes themselves.
 (previous guidelines)
2) Without prejudice to the generality
of the foregoing provisions, the
measures referred to in sub-section (1)
may provide for all or any of the
following matters, namely: ––
(e) (i) the regulation in respect of
counselling and providing patients
with all necessary information and
advice on various aspects of assisted
reproductive technology procedures;
(f) the regulation in respect of the
ways and means of disseminating
information related to infertility ….
……IUI CLINICS even if not
processing gametes included!!!
(Current proposed BILL)

11. Do you do consultation
for a patient who has
infertility?
Advise for : timed
intercourse; fertile
period etc?
Advise for medication
like clomiphene citrate
etc to help with
conception?
Induction of ovulation
in non-ovulatory
women without
Gonadotropins?
Trigger ovulation?
 Treatment of
oligozoospermia
without
asthenozoospermia.

12. NOW UNDER NEW LAW!!

13. WHY SHOULD YOU KNOW
ABOUT THE NEW LAW?
5) Notwithstanding anything
contained in sub-sections (1),
(2), (3) (4), if the Registration
Authority is of the opinion that
it is necessary or expedient so to
do in the public interest, it may,
for reasons to be recorded in
writing, suspend the
registration of any … clinic
without issuing any such
notice referred to in sub-
section (2).
 whether on an
honorarybasisorotherwise, and
who contravenes any of the
provisions of this Act or rules
made there under shall be
punishable with imprisonment
for a term which may extend to 5
years or with fine which may
extend to rupees ten lakhs or
with both and on any subsequent
contravention, with
imprisonment for a term which
may extend to seven years or
with fine which may extend to
rupees fifteen lakhs or with both.

14. HARSH PENALTIES
If the practitioner has
been convicted by the
court, his name shall be
removed from the
Register of the
concerned Medical
Council by the State
Board for a period of 5
years for the first
offence and permanently
for the subsequent
offence. All the offences
under this Act shall be
cognizable offence

16. SALIENT FEATURES OF THESALIENT FEATURES OF THE
BILLBILL
1. Constitution of
National Advisory
Board,
2. National Registry of
ART Clinics and
Banks,
1. State Boards
2. State Registration
Authorities:
Procedure for
Registration of
Assisted Reproductive
Technology Clinics &
Banks

17. CHAPTER II
AUTHORITIES TO REGULATE
ASSISTED REPRODUCTIVE
TECHNOLOGY
3. (1) With effect from such date as the Central
Government may, by notification, appoint, there shall
be established, for the purposes of this Act, a National
Board to be called the National Board for Assisted
Reproductive Technology.
(2) The National Board shall be a body corporate by
the name aforesaid, having perpetualsuccession
andacommon seal, with power, subject to the
provisions of this Act, to acquire, hold and dispose of
property, both movable and immovable with prior
approval of the Central Government, and to contract,
and shall, by the said name, sue or be sued.
18. With effect from such date as the Central Government
may, by notification, establish for the purposes of this
Act, a National Registry to be called the National Registry
of Assisted Reproductive Technology Clinics and Banks in
India at Indian Council of Medical Research, New Delhi
19. The National Registry referred to in section 18 shall
consist of a Director, Scientists at various levels, not less
than eighteen, technical, administrative and supporting
staff, not less than twenty, who shall be appointed by the
Indian Council of Medical Research on the
recommendations of the Selection Committee which shall
consist of such number of members as may be
determined by the Central Government.

18. (3) The State Board shall consist of the following members, namely :––
(a) a Chairperson to be appointed by the State Government who shall be a person of eminence and
standing in the field of assisted reproductive technology or Bio-medical Sciences and who shall be
equivalent to the rank of Secretary to the State Government; Chairperson, ex officio;
(b) one nominee shall be from the National Registry of Assisted Reproductive Technology Clinics and Banks in
India of the Indian Council of Medical Research; and
(c) a nominee of an Indian professional society concerned primarily with assisted reproduction – Member;
(d) a nominee of an National Commission for Woman – Member;
(e) a nominee of National Commission for Protection of Child Rights – Member;
(f) other expert members not exceeding ten who shall be experts in the fields of assisted reproduction, gynaecology,
embryology, andrology, bioethics, mammalian reproduction, medical genetics, social science, law or human
rights, public health to be nominated by the State Government – Members:

19. POWERS OF THE BOARD
16. (1) The National Board shall have, for the purposes of
discharging its functions under this Act, the same
powers as are vested in a civil court under the Code of
Civil Procedure, 1908, while trying a suit, in respect of
the following matters, namely:––
(2) Every proceeding before the Board shall be deemed to be
a judicial proceeding within the meaning of sections 193
and 228, and for the purposes of section 196, of the Indian
Penal Code and the Board shall be deemed to be a civil
court for the purposes of section 195 and Chapter XXVI of
the Code of Criminal Procedure, 1973.

20. 42 .The Registration Authority and National Registry shall
have the power to inspect, with or without prior notice on a
working day during working hours, any premises relating to
assisted reproductive technology or call for any document or
material in the discharge of its powers and functions

21. Other Salient Features of Bill
3. Duties of Clinics & Banks
4. Sourcing, handling, record keeping for gametes,
embryos and surrogate mother
5. Research on Human Reproductive Material
6. Rights and duties of Patients, Donors, Surrogates &
Children
7. Procedure for Registration of Complaints
8. Offences and Penalties
9. Finance, Accounts, Audits & Reports
10. Miscellaneous Provision

22. SALIENT FEATURES:
regulation in respect of the minimum requirements
related to staff and physical infrastructure for the
various categories of assisted reproductive technology
clinics and assisted reproductive technology banks;
(z) “Record” means documents pertaining to infertile couple,
gamete donor and surrogate mother’s medical history,
diagnosis/screening, types and steps of treatments/
procedures and their complications, if any and final
outcome, written consent’s, agreement’s, other related
documents etc.

23. Clause 46(14) AGE Criterion : No ART procedure shall be
performed on a women below the age of 23 years and
above the age of 50. The concerned gynaecologists shall
furnish certificate indicating that the woman is medically
fit to opt for the ART services.
Ghaziabad, 2015
The age restriction has no reasonable basis. The marriageable age of
a woman is 18 years . there is no appropriate reason for a lady to
wait for five years to become a parent ..

24. Further, it would be unreasonable to ask the
Gynaecologist to give certificate that the
woman is medically fit to opt for the ART
services. There could be certification that the
parents are not able to conceive naturally/ have
medical complcations and can look for / if
desirable to them / opt for ART services as may
be suggested by the ART specialist.

25. The highest possible standards should be followed in the
storage and handling of gametes and human embryos in
respect of their security, and with regard to their recording
and identification.
highest possible technology may not be available locally
and also the companies designing this could make it cost
prohibitive. Also Hon Supreme Court says reasonable
care as per the norms is required so it is contravention of
guidelines.

26. 46. (1) The assisted reproductive technology clinics and banks shall
ensure that patients, donors of gametes and surrogates are eligible
to avail of assisted reproductive technology procedures ….. that they
have been medically tested for such diseases, sexually transmitted or
otherwise, including HIV/AIDS as may be specified and all other
communicable diseases which may endanger the health of the
commissioning couple, or any one of them, surrogate or child.
how can a doctor screen for ALL diseases possible -- as
many diseases are very rare and it may be identified only
on a rare specific testing. As Hon Supreme Court has said
a reasonable tests as per standard norms should be
prescribed. Even Internationally no doctor can give a
hundred percent guarantee

27. 18) Except the Assisted Reproductive Technology Clinic and Assisted
Reproductive Technology Bank registered under the Assisted
Reproductive Technology Bill, or any person authorized to deal with
Assisted Reproductive Technology under the Assisted Reproductive
Technology Bill, or with prior permission of Central Government, no
person (the term “person” as defined under Income Tax Act),
whether resident or foreigner provides any service or advice
direct or indirect relating to Assisted Reproductive
Technology and Surrogacy for commercial purpose or for any
profit or gain.

28. MEDICAL ISSUES:MEDICAL ISSUES:
Chapter IV: Duties ofChapter IV: Duties of
an ART Clinic andan ART Clinic and
ART BankART Bank

29. Clause 46 (5) indicates that ART clinic shall obtain donor
gametes from ART Bank.
If the above clause is enforced then ART Clinic shall have no option but to do IVF with frozen
oocytes. The use of Frozen embryos is relatively new development and Frozen oocytes success
of live birth at present is very poor. In India so far we do not have any existing data to show
the proven result , so the relevant Data from UK government website is reproduced herein
below to indicate what has been suggested
The use of frozen eggs in treatment is a relatively new development. Up to December 2012,
only 20 babies have been born in the UK after treatment using patients’ own frozen eggs
(although more have been born from donor eggs).

30. Eggs do not respond as well as embryos to freezing, and generally the
resulting success rate is not as high, although this will vary from clinic to
clinic. However, vitrification (a new method for egg storage) has recently
been shown to improve the chance of eggs surviving the freeze-thaw
process and therefore increase the success rate
Records show that up to December 2012 around 18,000 eggs have been
stored in the UK for patients' own use. Around 580 embryos from stored
eggs have been created. These embryos were transferred to women in
around 160 cycles, which resulted in around 20 live births. These figures
are for patients using their own eggs, both eggs which have been stored
using slow freezing and vitrification methods.

31. Associated risks related to egg freezing: The usual risks of
using fertility drugs apply to the fertility treatment involved. Egg freezing
is still a relatively new technique and not all eggs will survive the freezing
and thawing process or become fertilised.
It is important that you take into consideration the risks of this procedure
and the likelihood of your eggs surviving the process when deciding
whether to store your eggs for future use. Your clinic should give you
information on the risks involved.
Consequence of Ova freezing leaves Malta with an 8% success rate
http://www.maltatoday.com.mt/news/national/58096/embryo_vitrification_necess
REF : http://www.hfea.gov.uk/46.html.

32. Clause 49(2) : the number of oocytes or embryos to be
placed in woman during any one treatment cycle shall be
specified bt the National board or state board as the case
may be:
This is too ambiguous a clause. Thus, the ART clinics cannot
function till the boards are constituted. such a clause cannot be left
open ended.

33. Clause 52 (8) Donor to be married and have one live child
of her own and only one time donation and not more than
seven oocytes shall be retrieved from oocyte donor
Marriage is not a must to be donor. why it is put as a qualification. We can not force
individuals to marry first and then donate eggs. There seems to be lack of
understanding of medical aspect of ovalution: It is highly misunderstood that through
stimulation and egg retrieval process the egg depletion happens. In the stimulation
process , hormones are given to mature those eggs which would have withered or died
otherwise also:
Reference:
http://www.mcancer.org/fertility-preservation/for-female-patients/normal-ovarian-fu

34. Negligence of doctors: clause 52 (16) the doctors are
presumed guilty unless they prove otherwise.
Ghaziabad, 2015
This is so unreasonable and doctors cannot function with freedom .
The doctors are saviors of life and under this act they are treated as
criminals. It is contrary to the basic criminal law of the land which is
based on the fact that a person is innocent till proved guilty. The
purpose of informed consents shall get defeated. The very nature of
medical practice is such that risks to life is inevitable and no doctor
can guarantee for the same.

35. 36. No assisted reproductive technology clinic and assisted
reproductive technology bank shall practice any aspect of
assisted reproductive technology, or use any premises for
such purposes, withoutregistering as the assisted
reproductive technology clinic or assisted reproductive
technology bank with the Registration Authority
constituted under sub-section (1) of section 35and
National Registry of Assisted Reproductive Technology
Clinics and Banks in India of the Indian Council of Medical Research
Sir in a period of 90 days how will it be possible to submit all
applications including those of IUI clinics and IVF clinics all
over India which will be in thousands and also inspect them
and then give a registration number. Moreover the inspection
team if consists of practitioners how it is possible that they
may not have any bias against another colleague

36. DUTIES OF AN ASSISTED REPRODUCTIVE TECHNOLOGY
CLINIC AND ASSISTED REPRODUCTIVE TECHNOLOGY BANK
16) Only the assisted reproductive technology banks registered
under this Act shall be authorised to advertise for, procuring or
providing semen, oocyte donor or surrogate
Sir as there are no ART Banks in many cities or states how will
they work for oocyte donors or surrogate mothers. Also ART
bank registration will also take time so what will happen in
the interim. In many cities as the workload is not sufficient
ART banks may not want to get set up. Also many patients
want a relative to donate for altruistic reasons. That should be
permitted as it is a purely altruistic act.
CHAPTER IVCHAPTER IV

37. All assisted reproductive technology clinics shall, as and when
the National Registry of Assisted Reproductive Technology
Clinics and Banks in India of the Indian Council of Medical
Research is established, put on line all information available to
them in regard to progress of the patient, such as biochemical
and clinical pregnancy, within a period of seven days of the
information becoming available, withholding the identity of
the patient.
Sir what all information is included in such as --- this will
put tremendous pressure as 7 days is too short a period -
in the UK under HFEA this is done annually

38. Statistics on Medical Tourism inStatistics on Medical Tourism in
India – an InfographicIndia – an Infographic

39. SUGGESTION:
Permit Medical tourism!
Permit for IVF/
Surrogacy!!

41. Everything you do is under PNDTEverything you do is under PNDT
act now onwards!act now onwards!
All procedures/tests and techniques
done in ART/IVF centre or clinic
are recognised as either
 prenatal diagnostic procedure as per section 2(i)
or…
 prenatal diagnostic techniques as per section 2(j)
or…
 prenatal diagnostic test as per section 2(k)

42. PCPNDT LawPCPNDT Law
There are five types of Registration under PC-PNDT
Act.
 Genetic Counseling Centre
 Genetic Clinic
 Genetic Laboratory
 USG Centre
 Imaging Centre

43. NOTIFICATION ABOUTNOTIFICATION ABOUT
REGISTRATIONREGISTRATION

44. TITLETITLE

45. TITLETITLE

47. Ghaziabad, 2015