INDIA: HIV Case Shows Need to Fix Rules on Assisted Reproduction

By Sujoy Dhar Reprint | | Print |

Sujoy Dhar

KOLKATA, India, Jun 5 2003 (IPS) - Already under emotional stress from being infertile, Indian couples are finding that the artificial route to conceiving children is fraught with danger, and that sometimes it can be deadly.

The discovery in May that a 35-year-old woman in the eastern Indian metropolis of Kolkata contracted the human immuno-deficiency virus (HIV) from artificial insemination has shocked health officials here and elsewhere in the country.

At issue is the regulation of the burgeoning number of clinics that offer diagnostic and therapeutic interventions for infertile couples. It is big business in a country which, according to estimates by the World Health Organisation (WHO), accounts for up to 15 percent of the world’s infertile couples, a number that can be anywhere from 60 million to 80 million.

"This is a shocking case. She is the 15th such case in the world, but this is the first of its kind in Asia," said Dr Dhrubo Neogi, head of the Calcutta School of Tropical Medicine’s virology department.

Health officials in Kolkata, capital of the state of West Bengal, say they are working to identify the chain of transmission – she had six sessions of artificial insemination at three infertility clinics which she visited between 1997 and 2002.

But tough questions need to be answered before assisted reproductive technologies (ART) can be deemed to be safely regulated in India.

Indeed, the state director of medical education C R Maity explained, "Artificial reproductive clinics in the city were registered as ordinary clinics till recently, which is why the government knows so little about them. We admit to glaring lapses in the system."

A frank admission, but it will do little to reassure the many couples who have pinned their hopes on ART as a means to have children. Because the demand has driven supply, the state government estimates that there are 2,500 fertility clinics in West Bengal alone, but Maity calls this a conservative estimate.

The clinics, the minister said, will now have to be re-registered as ‘artificial reproductive clinics’. "If required, we will amend the rules to ensure that they do. Now these clinics will have to obtain licences from us based on ART guidelines, which have yet to become an act."

There lies the problem. Fertility expert Dr Baidyanath Chakraborty said: "We have been pressing for swift implementation of the national guidelines for the accreditation, supervision and regulation of artificial reproductive clinics. But the bill is still pending and it will be some time before a national policy evolves."

The sad irony is that the guidelines were drawn up in 2002 by the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research.

Explaining the need for draft guidelines that should lead to legislation, an ICMR statement said: "The mushrooming of infertility clinics in India has been a matter of great concern. Unlike most other medical techniques, the success rate using ART is poor."

"However," the statement went on, "the desire – of those whose marriages have remained barren – to have children is so great that 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."

In grim confirmation of the ICMR warning, Dr Neogi’s suspicion is that one of the three infertility clinics whom the woman visited very likely did not properly screen the male donor for HIV.

"The chances of the woman having contracted HIV other than from artificial insemination is being ruled out because neither had she undergone a blood transfusion, or belong to the high-risk group," Neogi said.

He said that a sperm bank is required to test the blood of a donor and cryogenically preserve the sperm for six months, after which it had to be tested again, and only then could it be used for artificial insemination. "Here it seems the procedure was not followed," he said.

Chakraborty explained, "Transmission of HIV from a donor’s sperm happens when he is not screened properly. The incubation period of HIV also played an important role. If a donor is tested today, the result might not be positive. But six months later, it might. So insemination should not be done within six months of donation."

Experts say that tests including the Elisa, polymerase chain reaction (PCR) and P-24 antigen tests should be done to eliminate the possibility of HIV infection before artificial insemination is opted for.

Furthermore, Chakraborty pointed out that "in Kolkata, only two or three infertility clinics can cryopreserve semen".

Whether the right safeguards were followed are the terms of reference for the investigation that the state health department is currently conducting.

But the scale of the demand indicates just how widespread the problem may be – intra-cytoplasmic sperm injection, commonly referred to as the test-tube baby, costs anywhere between 80,000 and 90,000 rupees (1,700 and 1,900 U.S. dollars). Given the estimated numbers of infertile couples, this medical service has proved to be hugely lucrative.

Yet with a success rate of less than 30 percent for ART procedures, as the ICMR states, "the whole exercise can be both expensive and emotionally draining, given the societal pressures".

A WHO study on infertility conducted in 2001 says that the best clinics in India claim a 30 to 40 percent success rate, "but it seems to be much lower in reality".

Moreover, the WHO study cautions, this is the pregnancy rate and not the birth rate. Most clinics claim to have a success rate higher than the 5¡10 percent usually reported by clinics in developed countries.