Health ministry explores change in law to introduce 'presumed consent' for cornea retrieval in hospital deaths

If you haven't specifically declared that you don't want to donate your eyes after you pass away, the government wants to presume that you have consented to your corneas being harvested.

A growing shortage of corneas and an ever-expanding waiting list of patients have prompted the health ministry to explore presumed consent for cornea donation. Under the proposed policy, hospitals would be allowed to retrieve corneas from deceased patients unless they had formally opted out during their lifetime.

Implementing this change will require amending the Transplantation of Human Organs and Tissues Act (THOTA), 1994, to incorporate the provision.

The proposal was discussed and agreed upon at a recent meeting of the Directorate General of Health Services (DGHS), according to minutes issued by the National Organ and Tissue Transplant Organisation (NOTTO), dated 15 October. Mint has reviewed a copy of the minutes.

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“One of the points which was deliberated in work is bringing a new policy, i.e., presumed consent for retrieval of cornea in all cases of hospital deaths of Indian citizens unless the person had opted out during his lifetime, should be implemented," said Dr Anil Kumar, director, NOTTO, who was present at the DGHS meeting.

Corneal conditions remain the leading cause of blindness among Indians under 49, accounting for 37.5% of cases, according to a survey conducted by AIIMS’s Rajendra Prasad Centre for Ophthalmic Sciences and the health ministry.

Yet, despite the urgent need for transplants, public hesitation—driven by cultural and religious beliefs—continues to impede organ donation across the country.

There is an international trend to move from explicit consent (opt-in) to presumed consent (opt-out) policies for deceased organ retrieval. Countries like Spain, Singapore and the UK have implemented opt-out policies. The US, however, still goes by opt-in.

Eye banks under pressure

India’s eye banks are struggling to keep pace with the growing demand for corneas. The health ministry has instructed states and Union territories to link all registered eye banks and transplant hospitals with a national registry managed by NOTTO to ensure better coordination.

Currently, of the 726 registered eye banks, only 200 are operational, with many suffering from staffing shortages, infrastructure gaps, and outdated equipment.

“None of the eye banks are following compliance requirements for prioritizing patients on the waiting list," said Dr. Kumar. “This mostly happens in the private eye bank centres."

He emphasized that all eye banks are mandated to collect at least 50 eyes or 100 corneas annually, and failure to meet these targets raises questions about their continued operation. “If these centres are not able to meet the compliance, then there is no point to let them being operational," Kumar added.

The health ministry has therefore requested data from states and Union territories to assess the performance of these centres to ensure only those functioning properly are granted licences, he said.

“Anywhere in the world, where corneal transplants are performed, we have to go by certain ethics, to collect and transplant corneas because these require human tissue," said Dr. Namrata Sharma, professor of ophthalmology at AIIMS’s RP Centre and vice-president of the Eye Bank Association of India.

She emphasized that India’s organ transplantation laws—as outlined in the Gazette of India—must be followed, but health is a state subject, meaning individual states may have their own policies. “The legislation should ensure equitable and uniform distribution of tissues across the country," she added.

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Dr. Sharma highlighted the urgency of corneal transplants, noting that both reversible and irreversible blindness caused by infections, injuries, and chemical trauma are common. “In the 0-50 age group, younger patients are particularly affected, with corneal blindness being a leading cause," she said.

Pandemic disruption

Before the pandemic, India collected around 52,000 corneas annually, but Covid-19 disrupted donation efforts, leading to an 80% decline in collections. Though the numbers rebounded to 48,000 corneas last year, they remain far short of the country’s needs.

With only 25,000 transplants performed annually and 200,000 corneas required to clear the backlog, the pressure on the system is mounting. Experts estimate that 100,000 new patients are added to the waiting list each year.

To further streamline the donation process, the health ministry is also considering changes for medico-legal cases. The proposal allows corneas to be retrieved before post-mortem examinations, provided a no-objection certificate (NOC) is obtained from the police, forensic teams, and family members.

Regulations and legislation are essential to protect the interests of donor families, healthcare teams, and recipients while avoiding any miscommunication, said Dr. Radhika Tandon, professor of ophthalmology at AIIMS’s RP Eye Centre.

Dr. Tandon noted that the presumed consent policy, though not finalized yet, is aimed at creating an ecosystem that facilitates cornea donation and ensures timely transplants.

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The government’s push for a national eye bank registry is part of its broader effort to improve coordination and ensure timely treatment for patients with vision impairments. Queries sent to the health ministry spokesperson regarding the new policy went unanswered.