A proposed legislation seeking to curb and monitor the functioning of fertility clinics which have mushroomed across India has caused acute consternation among the country's gynecologists and obstetricians. India is home to 14 per cent of an estimated 80 million infertile couples in the world.

In what its detractors declare will be a blow to infertile couples, the Indian Council of Medical Research (ICMR) has framed guidelines for licensing and supervision of all clinics treating infertility by using gametes donated or dealing in storage of gametes or embryos for research.

The national guidelines for 'Accreditation, Supervision and Regulation of Assisted Reproductive Technology (ART) clinics', were drafted by a 19-member ICMR team in collaboration with the National Academy of Medical Sciences. These forbid any ART clinic to be a party to any commercial element in egg/sperm donor programs or in gestation surrogacy. Tests to 
ascertain the sex of the fetus and human cloning are also banned.

The highlights of the proposed legislation are to ban egg/sperm donation of a relative or friend, as well as surrogate motherhood by a relation or friend. Most importantly, it declares the right of the offspring after attaining 18 years of age to know the donor of the egg/sperm. With hundreds of largely unregulated fertility clinics offering in-vitro fertilization, and the availability of sex determination techniques to a society that prefers male children, policymakers warn that India is in danger of becoming an embryo surplus nation and encouraging illegal trade in human embryos.

The objectives of the ICMR guidelines are to prevent violation of human ethics, streamline foreign collaborations in this field and introduce safeguards against commercial exploitation of embryo research, says J V R Prasada Rao, Secretary, Ministry of Health and Family Welfare. "We are 
confident that these guidelines will be legislated in the form of an Act within a year. And people will welcome it because desperate, infertile couples are being emotionally and financially exploited through unethical practices."

In a prefatory note to the guidelines, ICMR Director General Dr N K Ganguly states: "New scientific developments like ART, that have wide application and that impinge on human life, raise great public concern about their possible misuse. ART technologies have also raised questions from society on their ethics and safety and in some instances, moral issues too are involved."

Gynecologists on the other hand, are against prohibition on related donation because they feel it could be detrimental to infertile couples who suffer the "stigma" of infertility, besides triggering a vicious cycle of commercial donation.

Says Dr Chandra Mansukhani, Consultant Gynecologist at Sir Gangaram Hospital, "Every couple has a right to reproduce by whatever means and the government should provide all options to them." Personally, she advocates adoption instead of fertility treatment that is costly, traumatic and not 
always successful. In the present context, however, Dr Mansukhani feels fertility clinics must be allowed to function without restrictions because these would have 'devastating' implications on infertile couples.

Like many other experts, she feels the prohibition of related donation will encourage ART clinics and commercial donors to make a lot of money at the expense of the donee. According to reports, a paid sperm donor pockets between Rs 200 to 5,000 (1US$=Rs49) and an egg donor gets Rs 10,000 to 
20,000; doctors pay out such amounts in the garb of 'traveling expenses'. Donees are known to pay a staggering amount - Rs 70,000 to Rs 100,000 for one cycle of pregnancy, the success of which is only 25 per cent.

Doctors think a related donor is more dependable than a paid donor, and that the ban on pre-natal diagnostic tests and professional blood donation has not stopped clinics from continuing the practice.

"Whom are we trying to encourage as potential donors?" Dr Harish Grover of the Delhi Medical Council (DMC) asks rhetorically. "Sperm banks are already flourishing in a big way and the proposed legislation will only encourage the practice of commercial donors thus raising more medical problems."

Dr Grover is Chairman of the Council's Disciplinary Committee that looks into public complaints against the city's practicing allopathic doctors. So far, he says, the Committee has not received a single complaint against the functioning of fertility clinics. "Ultrasound, if not misused for sex 
determination, is a very useful machine for monitoring the development of the unborn child and checking for possible deformities. But with a blanket ban on this method, women have been denied a valuable medical tool," he regrets.

The draft bill directs that all ART clinics will have to secure a license from ICMR and "no ART clinic may start operating unless it has obtained a temporary license to do so. This license would be confirmed only if the clinic obtains accreditation from ICMR or the state's appropriate accreditation committee within two years of obtaining temporary license. The license must be renewed every three years." The draft document also proposes the setting up of a national accreditation agency and a national database on donors of eggs and sperms.

Mr Prasada Rao defends what he calls the 'ethical regulations' inherent in the draft bill. "Unlike in many western countries, self-discipline is lacking in India. Female feticide is legitimized with the argument that a family has a right to choose the child." It is precisely because of this mindset that there has to be regulation, he says.

But professionals like Dr Grover caution against hasty decisions on what has unquestionably become a very sensitive social issue. "There should be a public debate on this matter and views should be ascertained from all sections of society before making it a law."