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Government Issues Amendment to Transplantation of Human Organs and Tissues Rules 2025

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The Ministry of Health and Family Welfare has issued an amendment to the Transplantation of Human Organs and Tissues Rules, 2014. The notification, dated 6 November 2025 and published in New Delhi, has introduced a specific modification related to the requirements for corneal transplantation centres.

Key Change Introduced in the Amendment

Under the newly issued Transplantation of Human Organs and Tissues (Amendment) Rules, 2025, a change has been made in Form 15, which outlines conditions and facilities required for transplantation centres. In the section related to corneal transplantation centres, the term “Specular” has been replaced with “Specular (optional)”.

This adjustment indicates that the availability of specular microscopy, which is used to assess the health of the corneal endothelium, will now be considered optional rather than mandatory in approved corneal transplantation centres.

Relevant Authority and Legal Reference

The amendment has been issued under the powers provided by Section 24 of the Transplantation of Human Organs and Tissues Act, 1994. The notification has been authorized by Vijay Nehra, Joint Secretary, Ministry of Health and Family Welfare, with reference number F. No. T-32/842/R&D/NOTTO/25-MS.

Background

The principal rules governing human organ and tissue transplantation were earlier notified in March 2014. The latest amendment focuses only on the operational requirements for corneal transplant units and does not alter other procedural or regulatory provisions relating to organ transplantation.