1. Indian Philosophy

2. Why we want children?
• Different culture, societies and religions answers
this question differently based on their belief and
practises.
• Ancient Indians had explained the instinct of
motherhood very well long before the down of the
western civilization.
• According to ancient Indian philosophy the
biological purpose of life is to propagate once own
traits (genes) and all living creatures are here on a
transition phase to pass their own traits (genes) to
the next generation.

3. Nature has given a provision to all creatures to ensure
the immortality of its species through a process called
“reproduction”
Sex
ImportantReproductive
Tactic
Continuity of
Life
Indian Vedic Literature
Artha (Money)Dharma (Duty) Moksa (Salvation)Kama (Sex)
For a good happy life

5. Reproductive Health and Infertility

6. Estimated Magnitude of Infertility in India
India‟s projected
population (2009)
1166 Million
Male
604 Million
Female
562 Million
Married Female
(15-49 yrs)
216 Million (38.5%)
Age Group Rural Urban Total
15-49 3.38
Million
4.82
Million
8.2
Million
Prevalence of Infertility (3.8%)
Source – Registrar General of India, 2005
Sample Registration System, 2009
ICMR Study, 2011

7. 1 Austria 8.4
2 United Arab Emirates 7.9
3 Switzerland 7.8
4 Israel 7.8
5 Hong Kong, SAR 7.1
6 Libya 6.4
7 Denmark 5.6
8 Finland 5.4
9 Singapore 5.2
10 Norway 4.9
11 New Zealand 4.4
Source – Population Reference Bureau, 2011
Countries with around 8.2 Million Population
Figure in Millions

8. Assisted Reproductive
Technologies (ART)
New hopes to infertile couples

9. New Scientific Development
Raises several issues
• Ethical issues
• Technical issues
• Moral issues
• Social issues

10. National Guidelines for Accreditation,
Supervision and Regulation of ART Clinics in India
2005
Edited by
Dr R S Sharma
Dr P M Bhargava
Dr Nomita Chandiok
Shri N C Saxena
http://www.icmr.nic.in/art/art_clinics.htm

11. Drafting Committee
Dr. Pushpa M Bhargava, Hyderabad - Chairman
Dr. Rajeev Dhavan , Sr. Advocate Supreme Court of India,
New Delhi
Dr. Kamini Rao, Bangalore
Dr. Jayant G. Mehta, Chennai/Bangalore
Dr. Manish Banker, Ahmedabad
Dr. Gautam Allahabadia, Mumabi
Sh. Bhairav Acharya,
Ms. Aparna Ray
Advocate Supreme Court of India, New Delhi
Dr. M. S. Jayalakshmi, MOHFW, Govt of India, New Delhi
Dr. Keerti Malaviya, MOHFW, Govt. of India, New Delhi
Mr. J.K. Trikha, MOHFW, Govt of India, New Delhi
Dr. R. S. Sharma, ICMR, New Delhi – Member Secretary
National Advisory Committee on Assisted Reproduction

12. I ART (Regulation) Bill – 2013

13. The Assisted Reproductive
Technology (Regulation) Bill - 2013
Describes procedures for:
• Accreditation and supervision of Assisted Reproductive
Technology Clinics & Banks,
• ensuring that services provided by the Assisted
Reproductive Technology Clinics and Banks are ethical
and
• that the medical, social and legal rights of all those
concerned are protected with maximum benefit to the
infertile couples or individuals within a recognized
framework of ethics and good medical practice.

14. Authorities to Regulate ART Clinics
and Banks
Registration
Authority
State Board
(within 6 months)
National Board
DHR, MOHFW (within 3 months)
Advisory
Committee
National Registry of ART Clinics and
Banks in India (ICMR)
Established
(within 3 months)

15. All ART Clinics
a. Involve in infertility treatment – including IUI, AIH, AID
b. Infertility treatment involving the use and creation of
embryos outside the human body
c. Processing or storage of gametes and embryos
d. Research on embryos.
CHAPTER – III
PROCEDURES FOR REGISTRATION AND COMPLAINTS

16. Steps for Registration
under
National Registry of Assisted Reproductive
Technology (ART) Clinics and Banks in India
• Confirmation of contact No. and details of ART Clinics/Banks.
• Obtaining the information regarding available infrastructure
facilities, trained manpower and different ART procedure being
followed at your ART Clinic/Bank through prescribed Performa.
• Verification of the information provided by the respective ART
Clinic/Bank through a sight visit to be conducted by the
competent experts in the field at the respective ART Clinic/Bank.
• On receipt of satisfactory report of the Site Visit Committee, the
Unique Registration Number will be issued.

17. Application for Registration
under
State Board
(i) Unique Registration Number Certificate from the National
Registry of Assisted Reproductive Technology (ART) Clinics
and Banks in India of the ICMR.
(ii) Bio-data of all the faculty members of the clinic or bank
including Director or in-charge of the clinic or bank.
(iii) Copies of the degrees and certificates of all the faculty
members of the clinic or bank including Director or in-chare of
the clinic or bank.
(iv) Such other information and documents as may be prescribed.

18. Dr. R. S. Sharma, FNAMS
Sr. Deputy Director General, Scientist-G &
Member Secretary,
Drafting Committee, ART (Regulation) Bill
Indian Council of Medical Research,
Ansari Nagar, New Delhi -110 029 (India)
Third Party Reproduction:
Do‟s and Don'ts

19. Surrogacy

20. Lord Balrama
Lord Krishna
Mrs. Deviki & Mr. Vasudeva
Mrs. Rohini
Embryo transfer to
Hindu Mythology
“Mahabharatha”

21. Indications for surrogacy
Surrogacy by ART should be
considered only for patients for whom it
would be physically or medically
impossible/undesirable to carry a baby
to term.

22. Notifications
from
Govt. of India
Ministry of Home Affairs (Foreigners Division)
The appropriate visa category will be a medical visa for foreign
nationals who are coming to India for commissioning surrogacy.
Such a visa may only be granted if the following conditions are fulfilled:
I. The foreign man and woman are duly married and the marriage
should have sustained at least for two years.
(I) No.25022/74/2011-F.I dated 9th July, 2012
(II) No.25022/74/2011-F.I dated 7th March, 2013
(III) No.25022/74/2011-F.I dated 16th July, 2013
(IV) No.25022/74/2011-F.I dated 14th October, 2013

23. II. A letter from the Embassy of the foreign country in India or the
Foreign Ministry of the Country should be enclosed with the Visa
application stating clearly that
a) the country recognizes surrogacy and
b) the child/children to be born to the commissioning couple
through the Indian surrogate mother will be permitted entry
into their country as a biological child/children of the couple
commissioning surrogacy.
iii. The couple will furnish an undertaking that they would take care of
the child/children born through surrogacy.
iv. The treatment should be done only at one of the registered ART
Clinics recognized by ICMR.
v. The couple should produce a duly notarized agreement between
the applicant couple and the prospective Indian surrogate mother.

24. Other Conditions
• Before the grant of visa, the foreign couple need to be told that
before leaving India for their return journey, „exit‟ permission from
FRRO/FRO would be required.
• Before granting „exit‟, the FRRO/FRO will see whether the foreign
couple is carrying a certificate from the ART Clinic concerned
regarding the fact that the child/children have been duly taken
custody by the foreigner and that the liabilities towards the Indian
surrogate mother have been fully discharged as per the
agreement.
• A copy of the birth certificate(s) of the surrogate child/children will
be retained by the FRRO/FRO along with photocopies of the
passport and visa of the foreign parents.
• The foreign couple can be permitted to visit Indian on a Tourist
Visa for signing agreement between the applicant couple and the
prospective Indian Surrogate mother.

25. Notification
from
Govt. of India
Ministry of Commerce and Industry, Deptt. of Commerce
No.52 (RE-2013)/2009-2014 dated 2nd Dec., 2013
Policy for import of human embryos
Human embryo is classified under ITC (HS) Code 0511 99 99 of Chapter
5 of ITC (HS) 2012, Schedule 1 (Import Policy).
Import of Human Embryo will be „free‟ subject to a „No Objection
Certificate‟ from Indian Council of Medical Research (ICMR).

26. No Objection Certificate (NOC)
from ICMR
1. Request for NOC should be submitted only by the Director/In-
Charge of the ART Clinic on the Letter Head whose name has been
registered with National Registry of ART Clinics and Banks in India
of ICMR as Director/In-Charge of the ART Clinic.
2. Also mention the Enrolment Number of the Clinic issued by
the National Registry of ART Clinics and Banks in India of ICMR, in
the application for NOC.
3. All the certificates / agreements should be in compliance with the
notification F.No. 25022/74/2011-F.I dated 9th July 2012 issued by
the Ministry of Home Affair in this matter.

27. The following certificates and documents should be submitted to the
National Registry of ART Clinics and Banks in India (NRACBI) of
ICMR.
Certificates
I. A certificate from the authorized/registered Foreign ART Clinic.
II. Certificate from the infertile foreign couple.
III. A certificate from the enrolled ART Clinic in India.
Documents
I. Authorized identification proof of both husband and wife.
II. Marriage certificate of the infertile couple.
III. Copy of the registration certificate of the ART Clinic from foreign
Country where the treatment of the infertile couple is undergoing.
If the embryos have been generated at some other ART clinic,
then please provide the copy of registration certificate of that
clinic also.

28. 60. Rights and duties in relation to
surrogacy
60.(1) Both the couple or individual seeking surrogacy through the
use of assisted reproductive technology, and the surrogate, shall
enter into a surrogacy agreement which shall be binding on the
parties.
(2) All expenses, including those related to insurance if available, of
the surrogate related to a pregnancy achieved in furtherance of
assisted reproductive technology shall, during the period of
pregnancy and after delivery as per medical advice, and till the child
is ready to be delivered as per medical advice, to the biological
parent or parents, shall be borne by the couple or individual seeking
surrogacy.
(3) Notwithstanding anything contained in sub-section (2) and subject
to the surrogacy agreement, the surrogate may also receive
monetary compensation from the couple or individual, as the case
may be, for agreeing to act as surrogate.

29. (4) A surrogate mother shall relinquish all parental rights over
the child.
(5) No woman under twenty one years of age and over thirty five
years of age shall be eligible to act as a surrogate mother
under this Act.
Provided that no woman shall act as a surrogate for more
than three successful live births in her life including her own
children and with not less than two years interval between
two deliveries.
(6) Any woman seeking or agreeing to act as a surrogate shall
be medically tested for such diseases, sexually transmitted
or otherwise, as may be prescribed, and all other
communicable diseases which may endanger the health of
the child or children, and must declare in writing that she has
not received a blood transfusion or a blood product in the
last six months.

30. (7) The individuals or couples may obtain the service of a
surrogate through an assisted reproductive technology bank,
which may advertise to seek surrogacy.
Provided that no such advertisement shall contain any details
relating to the caste, ethnic identity or descent of any of the
parties involved in such surrogacy and no assisted
reproductive technology clinic shall advertise to seek:
surrogacy for its clients.
(8) A surrogate shall, in respect of all medical treatments or
procedures in relation to the concerned child or children,
register at the hospital or such medical facility in her own
name, clearly declare herself to be a surrogate and provide the
name or names and addresses of the person or persons, as the
case may be, for whom she is acting as a surrogate, along with
a copy of the agreement referred to in sub-section (1) and the
copy of the certificate referred to in sub-section (16).

31. (9) If the first embryo transfer has failed in a surrogate, she may,
if she wishes, decide to accept on mutually agreed financial
terms, at most two more successful embryo transfers for the
same couple that had engaged her services in the first
instance and no surrogate shall undergo embryo transfer
more than three times for the same couple.
(10) The birth certificate issued in respect of a baby born
through surrogacy shall bear the name of individual or
individuals who commissioned the surrogacy, as parents.
(11) The person or persons including foreigners who have
availed of the services of a surrogate shall be legally bound
to accept the custody of the child or children irrespective of
any abnormality that the child or children may have.

32. (12) Subject to the provisions of this Act, all information about
the surrogate shall be kept confidential and information about
the surrogacy shall not be disclosed to anyone other than the
National Registry of Assisted Reproductive Technology
Clinics and Banks in India of the Indian Council of Medical
Research except by an order of a court of competent
jurisdiction.
(13) A surrogate shall not act as an oocyte donor for the couple
or individual, as the case may be, seeking surrogacy.
(14) No assisted reproductive technology clinic and assisted
reproductive technology bank shall provide information
on or about surrogate or potential surrogate to any person.
(15) In the event that the woman intending to be a surrogate is
married, the consent of her spouse shall be required before
she may act as surrogate.

33. (16) A surrogate shall be given a certificate by the person or
persons who have availed of her services, stating
unambiguously that she has acted as a surrogate for them.
(17)(a) A foreigner or foreign couple not resident in India, or a
non-resident Indian individual or couple, seeking surrogacy in
India shall –
(i) appoint a local guardian who shall be legally responsible
for taking care of the surrogate during and after the
pregnancy, till the child or children are delivered to the
foreigner or foreign couple or the local guardian;
(ii) insure the child or children born through the surrogacy,
at the time of signing the agreement, till the age of twenty
one years or till the time of custody of the child or children
is taken, whichever is earlier, for wellbeing and
maintenance of the child or children;

34. (iii) use at least one gamete of their own in creation of the
embryos;
(b) The party seeking the surrogacy must ensure and establish to the
assisted reproductive technology clinic through proper
documentation (a letter from either the embassy of the Country in
India or from the foreign ministry of the Country), stating that the
child or children born through surrogacy in India, shall be
permitted entry in the Country as a biological child or children of
the commissioning couple or individual that the party shall be
able to take the child or children born through surrogacy,
including where the embryo was a consequence of donation of an
oocyte or sperm, outside of India to the country of the party's
origin or residence, as the case may be;
(c) (i) If the foreign party seeking surrogacy fails to take delivery of
the child or children born to the surrogate commissioned by the
foreign party, the local guardian shall be legally obliged to take
delivery of the child or children and be free to hand the child or
children over to an adoption agency, if the commissioned party or
their legal representative fails to claim the child within one month
of the birth of the child or children:

35. Provided that during the transition period, the local guardian
shall be responsible for the well-being of the child or children.
(ii) If the child or children are being given adoption to an
adoption agency, the child or children shall be allowed to
claim the provisions of Indian Citizenship Act, 1955 in
respect of matters relating to Indian citizenship.
(18) couple or an individual shall not have the service of more
than one surrogate at any given time.
(19) A couple shall not have simultaneous transfer of embryos
in the woman and in a surrogate.
(20) Only Indian citizens shall have a right to act as a surrogate,
and no assisted reproductive technology bank or assisted
reproductive technology clinic shall receive or send an
Indian woman for surrogacy abroad.

36. (21) Any woman agreeing to act as a surrogate shall be duty-
bound not to engage in any act that may harm the foetus
during pregnancy and the child after birth, until the time
the child or children is handed over to the designated
person(s).
(22) The commissioning parent(s) shall ensure that the
surrogate and the child or children she deliver are
appropriately insured until the time the child or children is
handed over to the commissioning parent(s) or any other
person as per the agreement and till the surrogate is free of
ail health complications arising out of surrogacy.

37. ART Clinic should “DO” & “DON‟TS”
1. Surrogacy by ART should be considered only for patients for
whom it would be physically or medically impossible/undesirable
to carry a baby to term.
2. Surrogacy shall be available to all Indian persons including single
persons and married couples.
3. All provisions of the Surrogacy listed under the ART (Regulation)
Bill should be followed.
4. No woman under twenty one years of age and over thirty five
years of age shall be eligible to act as a surrogate mother under
this Act.
5. Provided that no woman shall act as a surrogate for more than
three successful live births in her life including her own children
and with not less than two years interval between two deliveries.

38. For Foreign Nationals
1. Surrogacy shall be available to only married foreign nationals
whose marriage should have sustained at least for two years.
2. Only those ART Clinics who are enrolled/registered under the
National Registry of ART Clinics and Banks in India (NRACBI) of
ICMR shall be permitted to provide surrogacy services for foreign
married couple.
3. All the provisions of the notification issued by Ministry of Home
Affairs should be strictly followed.
4. The foreign married couple shall have to physically come to India
for signing Agreement between the surrogate mother and married
couple, on Tourist visa, but no samples may be given to any
Clinic during such preliminary visit.
5. However, the foreign married couple has to come to India on
Medical Visa to take the custody of the child/children born
through surrogacy.

39. 6. OCI/PIO Card holders coming to India for commissioning
surrogacy will not require a separate medical visa. However, on
arrival to India and before commissioning surrogacy they will have
to obtain a special permission from the FRRO/FRO concern.
7. The FRRO/FRO concern may grant the permission subject to all
the conditions mentioned in the MHA notification dated 9th July,
2012.
8. The ART clinic should send a copy of the agreement to the
concerned FRRO/FRO and to the National Registry of ICMR along
with photocopies of the passport and the visa of the foreign
couple.
9. For import of embryos, the Director/In-Charge of the Enrolled ART
Clinic shall apply to the NRACBI of ICMR for NOC along with all
mandatory certificates and documents.
10. In such case also, the married foreign couple shall have to come to
India signing the Agreement if the embryos are to be transferred
into the surrogate womb.

40. Conclusion
Indian society considered surrogate mother as an
amalgam of religion, culture and science and is a social
act of highest level of services which is scientific and
brims with goodwill.
The proposed draft Assisted Reproductive Technology
(Regulation) Bill proposes to ensuring that services
provided by them are ethical and that the medical, social
and legal rights of all those concerned are protected with
maximum benefit to the infertile couples or individuals
within a recognized framework of ethics and good
medical practice.

41. Thanks