Corneal transplant plagued by Human Organs Act
Rita Dutta - Mumbai

While eye-donation in India needs that big push to bridge the yawning gulf between demand and supply of corneas, experts feel all efforts are futile with the existing Transplantation of Human Organs Act, 1994. Corneal transplant has been severely plagued by improper legislation.

It may be recalled that the first legislation with regard to eye-donation in India was enacted by the then Bombay state under the name ’the Bombay Corneal Grafting Act, 1957’, which was followed by several legislation in other states. To remove the lacunae in the various legislation, Eye Bank Association of India (EBAI), a registered body representative of all eye banks in the country, founded in 1988 prepared the Corneal Grafting Act, 1991.

Jashwant Mehta, former president, EBAI, recalls, “Overwhelmed by the success of Maryland state, US in eye-banking, EBAI modeled the Corneal Grafting Act on the Maryland Act. Though eye-banking in India started in 1945, it went on a very sluggish pace till late 80’s as awareness level was poor and success of corneal transplant was not more than 20 per cent. We lobbied vigorously to convince the government to accept Corneal Grafting Act. However, the government felt it convenient to introduce Transplantation of Human Organs Act, dealing a big blow to eye-donation.”

Experts feel that it is improper to include eye-donation in the Organs Act as unlike organ donation which requires a live donor, the donee to have anti-rejection drug through out his life-time, involves ’tissue matching’, eye-donation is relatively easy requiring a deceased donor , no tissue-matching and no anti-rejection drug.

Experts deride the improper framing of “Presumed consent” under section six in the Organs Act, which focuses on the consent of the deceased than on the relatives. “Presumed consent”, as practiced in developed countries implies that for medico-legal cases unless there is a pre-recorded objection or an intimation of objection from the next of kin deceased prior to his death, corneas can be removed as needed. In the US, where the first eye-bank was established in 1945, the real momentum for growth of eye-banking and keratoplasty took place after the legislation included “Presumed consent” in 1975. As against the total of 20,000 corneas transplants performed in the US between 1961 and 1971, the number of transplants touched a figure of 36,900 in 1988 as against 6,000 eye-donations received in 1967, the figure jumped to 83,758 in 1987.

However, the Organs Actin India states that the person authorised to remove cornea can perform provided that he is satisfied that the deceased person had not expressed, before his death, any objection to any of his human organs being used, for therapeutic purposes.”

This improper legislation has been denounced as the wish of the deceased donor has no relevance under law. It is the consent of two relatives of the deceased which enables the person authorised to remove the cornea. “No eye-balls could be collected under this improper legislation. This has turned to be a huge loss as corneas received from medico-legal cases constitute the most concentrated source of excellent quality tissue from relatively young donors and it makes the chief pathologist the pivotal figure in determining whether the eye collection will succeed or not. As compared to this the quality of corneas procured from the dead body of a person dying due to old age is generally poor as the endothelium cell count, which is vital for a successful transplant especially in the case of a penetrating graft deteriorates as the age advances,” explains Mr Mehta.

While in the developed countries e-nucleation can be performed by a the dy chief or as asst medical examiner as the case may be (unless there is a pre-recoredtechnician trained in eye-banking, the Organs Act limits e-nucleation to only a registered medical practitioner. The Maryland Act which was the first to include presumed consent enables the chief medical examiner, the Dy chief or an Asst medical examiner as the case may be, in any case where a patient is in need for corneal tissue for a transplant, to remove corneas from a dead body where the autopsy is required in accordance with the law (unless there is a pre-recorded objection of an intimation of objection from the next of the kin of the deceased). Rekha Mehta, administrator, Eye Bank Co-ordination and Research Centre (EBCRC), Mumbai, says, “The limitation of e-nucleation to only RMPs is is an unwise decision as it is difficult for a doctor to spend a minimum of two to three hours for attending to a call for e-nucleation of corneas from a dead body, in cases where the cornea is to be e-nucleated at the residence of the deceased. Sometimes such calls may be received at odd hours when it is impossible for a medical practitioner to leave his practice and rush to the spot where the dead body is lying for the purpose of e-nucleation.”

Experts have also expressed dissatisfaction over the un-availability of corneas of unclaimed body. Sec 5 (I) of the act provides for removal of human organs including eyes from the dead body only after 48 hours from the time of death. Sec 5 (2) of the act further provides that the authority for the removal of human organs including eyes cannot be given even after the lapse of 48 hours after the occurrence of death if the person is competent to give such authority has reasons to believe that any relative of the deceased person is likely to claim the body even after the lapse of 48 hours in question. Experts feel this is a damaging provision as the cornea removed after 4 to 6 hours of death has no viability for the purpose of transplant.

The scenario may change if the amendment suggested by EBAI is passed by the parliment. Experts feeel that with the amended act India can be on par with the US where there is no dearth of corneas or even for that matter Sri Lanka which apart from meeting its own demand flows eye balls to nearly 135 cities. It is another story, however, that the success rate of transplants are not more than 20 to 30 per cent in states like Assam, West Bengal, Bihar and other eastern part of India in the absence of processing centres. “Ten years back the success rate of transplants in India was dismal as we did not have any processing centre. Disturbed by the poor success I met with Mr Federick N Griffith, CEO, International Federation of Eye Banks, US and what emerged from the discussion was that US has attained 80 to 90 per cent success in tranplant after opening processing centres,” says Mr Mehta. Though over the years around eight processing centres have sprung up in India, the east is still deprived of one. Experts say it is important to send the eyes for processing before transplant as 80 cent of the eyes are not fit for transplant.

Reportedly, while the eastern states do not perform the necessary blood test of the donor before e-nuleation, some hospital authorities do not send the corneas for processing even if a processing centre is not too far away. In the US where corneal transplant comes under health insurance and the eye-bank charges are as much as 1,500 $, all the corneas are processed. Perhaps, Indian has to wait that long for health insurance to take corneal transplant in its purview to usher in light in the world of the all the visually impaired.