Infertility is a tragic and traumatic condition for the people who experience it. Though it does not claim an individual's life, it inflicts devastating emotional trauma on the individual for being unable to fulfill the biological role of parenthood. According to a WHO estimate, there are 60-80 million infertile couples worldwide. In India between 10-15 per cent of the couples are infertile.
The birth of the first test tube baby, Louise Brown, on July 28, 1978, by in vitro Fertilisation and Embryo Transfer (IVF-ET) technique by RG Edwards and P Steptoe laid the foundation for Assisted Reproductive Technologies (ART) and was a landmark in the treatment of infertility. A little later, an Indian team from Calcutta (now Kolkata) led by the late Dr Subhas Mukherjee, announced the birth of Durga following an IVF procedure on October 3, 1978. Unfortunately, Dr Mukherjee's work was not well-documented and the credit for producing India's first documented test tube baby, Harsha, went to Dr T C Anand Kumar, the noted reproductive biologist, and Dr Indira Hinduja, a well-known gynaecologist of Seth G S Medical College of K E M Hospital, Mumbai, on August 6, 1986.
Any medical technique that attempts to obtain a pregnancy by means other than by coitus is defined as ART. In other words, these techniques manipulate the sperm and oocytes (female eggs) outside the body, and the gametes (eggs and sperm are called gametes) are transferred into the uterus. ART includes artificial insemination (AI), in vitro fertilization-embryo transfer (IVF-ET) and gamete intra-fallopian transfer (GIFT).
The potential infertility treatment market in the country is estimated at over Rs 25,000 crore. The mushrooming of infertility clinics in India has been a matter of great concern. The desire of those, whose marriages have remained barren, to have children is so great many infertility clinics with little expertise or reliability have come up all over the country. The services offered by some of these clinics are questionable. There is no formal training in this discipline in the country. Further, guidelines have not been developed so far in regard to what procedures can be safely and ethically used and fully undertaken in these clinics. Even though the success rate in these clinics is hardly 20-30 per cent, they claim more than 70-75 per cent results.
In order to streamline the functioning of the infertility clinics, the Indian Council of Medical Research (ICMR) together with the National Academy of Medical Science (NAMS) has prepared a draft on " National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India." The document intends to remove this lacuna and has been prepared after extensive consultations held at both ICMR and other national institutions, with scientists, medical practitioners, lawyers, and social scientists and activists.
The draft guidelines were prepared by an Expert Committee with advice, assistance and cooperation of many individuals, institutions, government and non-governmental organisations, including the Medically Aware and Responsible Citizens of Hyderabad (MARCH), headed by Dr P M Bhargava. In fact, it was at the initiative of MARCH that ICMR had taken up the issue and formulated the document. Dr Bhargava, who is a member of the Expert Committee, has played a major role in drafting the document by providing editorial and professional inputs, and virtually doing everything.
The following are some of the guidelines:
*The practice of ART requires a well-orchestrated team of a gynaecologist, andrologist, and clinical embryologist, supported by a counselor and a programme coordinator/director. The gynaecologist must hold a post-graduate degree in gynaecology.
*Use of sperm donated by a relative or a known friend of either the wife or the husband shall not be permitted
*No surrogate motherhood by a relative or friend
*Any information about clients and donors must be kept confidential
*All relevant information must be given to the patient before treatment is given
*No treatment should be given without the written consent of the couple
*People seeking the treatment must be given proper counselling about the various implications of the treatment
*No woman should be treated with gametes or embryos derived from the gametes of more than one man or woman during any one treatment cycle. Mixing of sperm from two persons is also prohibited
*The accepted age for a sperm donor shall be between 21 and 45 years and for the donor woman between 21 and 35 years
*No ART procedure shall be used on a woman below 20 years
*There is no legal bar on an unmarried woman going for AID (artificial insemination through donor). The child thus born is deemed to be legitimate
*The ART clinic must not be a party to any commercial element in donor programmes or in gestational surrogancy
*A third party donor and a surrogate mother must relinquish in writing all parental rights concerning the offspring and vice versa
*No treatment shall be done without the spouse's consent
*Sex selection at any stage after fertilization, or abortion of embryos of any particular sex shall not be permitted
*Bans tests on human cloning
According to Dr Bhargava, MARCH had taken the initiative to organise public debates on the guidelines at Bangalore, Chennai, Kolkata, Jodhpur and lastly in Hyderabad. The public debates were attended by doctors, gynaecologists, social workers, lawyers and owners of infertility clinics and officials from the health ministry and ICMR.
The Hyderabad meeting witnessed a heated debate with several gynaecologists running infertility clinics, mainly women, questioning some of the provisions in the draft guidelines. The meeting, chaired by Dr Bhargava, was attended by Dr T C Anand Kumar, who has taken a leading part in pushing the legislation, and Dr Saxena, Deputy Director, ICMR.
During the debate several suggestions were incorporated in the document, while some were deleted. A modified document was now under preparation and a final draft would be submitted to both the Health Ministry and the Law Ministry to enact a law to prevent commercial exploitation and to streamline the functioning of the clinics offering ART.