The Central Government, through a notification dated November 6, 2025, has introduced the Transplantation of Human Organs and Tissues (Amendment) Rules, 2025.
The amendment makes a minor but notable change to Form 15 of the 2014 Rules, under the section dedicated to Corneal Transplantation Centres. In the second column of Form 15, against entry ‘C’, the word “Specular” has been replaced with the words and brackets “Specular (optional).”
Impact
This change makes Specular Microscopy an optional requirement for the accreditation or authorization of a Corneal Transplantation Centre, rather than a mandatory one.
Specular microscopy is a non-invasive photographic technique used to assess the health and density of the endothelial cells (the innermost layer of the cornea). By making the requirement optional, the government may be aiming to:
- Ease the regulatory burden on some eye banks or corneal transplant centers, particularly those in areas where access to this specific equipment might be limited.
- Streamline the authorization process for facilities that meet all other critical safety and quality standards but may not possess a specular microscope.