4th September, 2002
Ministry of Health & Family Welfare  


GUIDELINES ON ASSISTED REPRODUCTIVE TECHNOLOGY CLINICS IN INDIA


Secretary, Family Welfare, Shri J.V.R. Prasad Rao said that infertility is a problem which has a direct bearing on the emotional and the social aspect of the people. In India where of 23-25 per cent of the pregnancies are unwanted, the other spectrum of the problem is that 10-15 per cent of the couples in the country are infertile. The Guidelines on Assisted Reproductive Technology (ART) Clinics is an important step and addresses, the important issues of infertility, surrogacy, rights of the child born through various ART technologies etc. The Secretary released these guidelines on ART Clinics in India for public debate, here today.

Speaking on the occasion the DG,ICMR Prof N.K.Ganguly said that the document deals with the social and cultural ethos of the country. The affordability and feasibility of ART Services is a matter of concern and this aspect has to be looked into. He also called for need to formulate a proper IEC document that would be helpful for behavioural change.

The Indian Council of Medical Research, New Delhi in collaboration with National Academy of Medical Sciences, New Delhi had constituted a Committee of Experts from different disciplines i.e. gynaecologists, biologists representatives from legal/social/professional bodies, representatives from various ART clinics from different parts of the country, to formulate the "National Guidelines for accreditation, supervision and regulation of ART clinics in India".

The Code of Practice described in the draft guidelines deals with all those areas, which affect the doctors, scientists and patients. Salient feature of the draft are as follows:

Ø The ART Clinic must not be a party to any commercial element in donor programmes or in gestational surrogacy.

Ø No ART procedure shall be done without the spouse’s consent.

Ø Sex selection at any stage i.e. both before and after fertilization or abortion of embryos of any particular sex should not be permitted except to avoid the risk of transmission of a genetic abnormality assessed through genetic testing of biological parents or through pre-implantation genetic diagnosis (PGD).

Ø Use of sperm donated by a relative or a known friend of either the wife or the husband should not be permitted. It will be the responsibility of the ART clinic to obtain sperm from appropriate banks.

Ø The committee has recommended accepting semen only from Semen Bank and not from the individual. Hence it has also been recommended that Semen Bank should be an independent organization, if set up by an ART clinic it must operate as a separate identity.

Ø No relative or a person known to the couple may act as surrogate.

Ø Surrogacy by assisted conception should normally be considered only for patients for whom it would be physically or medically impossible/undesirable to carry a baby to term.

Ø The genetic (Biological) parents must adopt a child born through surrogacy.

Ø After a specific consent, the embryos may be stored for five years and stored embryos may be used either for other couple or for research after taking the consent of the couple to whom the embryos belongs.

Ø The sale or transfer of human embryos or any part thereof, or of gametes in any form and in way that is directly or indirectly to any party outside the country must be prohibited.

Ø Human cloning for delivering replicas must be banned.

Ø Stem cell cloning and research on embryos (less than 15 days old) needs to be encouraged.

Ø A child born through ART should be presumed to be the legitimate child to the couple, born within wedlock and all the attendant rights of parentage, support and inheritance.

Ø Though there is no legal bar on an unmarried or single woman going for AID (Artificial insemination with donor), however it is universally recommended that AID should be performed only on married woman and that, too, with the written consent of her husband.

Ø There is an urgent need to have infertility treated like any other disease the expense of dealing which by authorised ART clinics should be reimbursable e.g. by the Government or other employer or by the health insurance company, but for one child only.

The members of the expert committee are Dr. B.N. Chakravarty (Chairman), Dr. T.C. Anand Kumar, Dr. P.M. Bhargava, Dr. Sulochana Gunasheela, Dr. Sudarsan Ghosh Dastidar, Dr. M. Kochhar, Dr. Kamini Rao, Dr. Mehroo D. Hansotia, Dr. Sadhana K. Desai, Dr. C.P. Puri, Dr. Firuza R. Parikh, Shri Rajeev Dhavan, Dr. Mira Shiva, Dr. Lalrintluangi, Dr. V.K. Behal, Dr. Vasantha Muthuswamy, Shri N.C. Saxena, Dr. R.S. Sharma and Dr. Nomita Bedi.