**Executive Summary**
This document is the answer to Unstarred Question No. 1138, to be answered on December 5th, 2025, regarding corneal transplantation centres in India. The Minister of State in the Ministry of Health and Family Welfare responded to questions about a notification issued on November 6, 2025, related to the mandatory requirement of clinical specular microscopes. The document also addresses concerns about quality control, financial assistance, and regulation of corneal transplantation.
**Key Points / Main Content**
* **Clinical Specular Microscopes:**
* A gazetted notification dated November 6, 2025, amended Form-15 under the Transplantation of Human Organs and Tissues Rules, 2014, making the requirement of a clinical specular microscope for registration of corneal transplantation centres optional.
* **Basis for Amendment:**
* The amendment was based on recommendations from technical experts, program experts, and other stakeholders.
* **Quality and Safety of Corneal Grafts:**
* The relaxation is not expected to compromise the quality or safety of corneal grafts, as corneal tissues are processed and evaluated by a registered eye bank where a specular microscope is mandatory.
* **Financial Assistance:**
* The National Organ Transplant Program (NOTP) provides financial assistance for infrastructure and equipment to establish biomaterial centres at the regional or state level.
* **Regulation of Cornea Donation and Transplantation:**
* Cornea donation and transplantation are regulated under the Transplantation of Human Organs and Tissues Act, 1994 (THOTA).
* The Act provides for an Appropriate Authority to be appointed by each state to investigate breaches of the Act and related rules.
**Impact Analysis**
**Corneal Transplantation Centres:**
* **Impact:** The requirement of specular microscopes for registration is now optional.
* **Action Required:** Review and adjust procedures in line with the new guidelines, particularly considering the availability of registered eye banks for tissue processing and evaluation.
**Technical Experts, Program Experts, and Stakeholders:**
* **Impact:** Their recommendations were used to support the changes to the regulations for transplantation.
* **Action Required:** Continue to review and revise the process based on feedback of new changes.
**Registered Eye Banks:**
* **Impact:** Eye Banks will need to assess and process corneal tissues.
* **Action Required:** Comply with mandatory specular microscope requirements.
**Smaller Eye Hospitals and Rural Transplant Centers:**
* **Impact:** Potential for financial assistance through NOTP.
* **Action Required:** Apply for financial assistance from NOTP to establish biomaterial centres.
**State Governments (Through Appointed Authorities):**
* **Impact:** Responsible for enforcing the Transplantation of Human Organs and Tissues Act, 1994 (THOTA).
* **Action Required:** Ensure appropriate authorities are appointed and that they investigate any breaches of the Act and Rules.
Key Entities Referenced
Transplantation of Human Organs and Tissues Act, 1994 (THOTA): Act regulating cornea donation and transplantation in India.
Ministry of Health and Family Welfare: Primary ministry responsible for health-related policies and programs.
Transplantation of Human Organs and Tissues Rules, 2014: Rules governing the process of organ and tissue transplantation, including cornea transplantation.
National Organ Transplant Program (NOTP): Program providing financial assistance to biomaterial centres.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 1138
TOBE ANSWERED ON05TH DECEMBER, 2025
CORNEALTRANSPLANTATIONCENTRES
1138. SHRISURESHKUMAR SHETKAR:
SHRIMANICKAMTAGORE B:
Willthe Ministerof HEALTHANDFAMILYWELFAREbe pleasedto state:
(a)whether the Government hasissued anynotification onNovember 6,2025,toremove the
mandatory requirement of clinical specular microscopes in corneal transplantation centres
based onthe recommendation of anyexpert medicalcommitteeand if so, the detailsthereof;
(b) whether the Government has conducted any field study or impact assessment before
amendingthe Transplantation of Human Organs andTissuesRules, 2025and if so, the details
thereof;
(c) whether this relaxation is likely to compromise the quality or safety of corneal grafts,
particularlyincentres lackingadvanceddiagnostic facilities andif so, the detailsthereof;
(d) whether the Government has established alternative quality-control or monitoring
mechanisms to ensure donor cornea health in the absence of specular microscopy and if so,
the detailsthereof;
(e) whether smaller eye hospitals and rural transplant centers are being provided with
financial or technical assistance under the (NOTP) following this amendment and if so, the
detailsthereof; and
(f) whether the Government proposes toissue uniform operating guidelinestoprevent misuse
of donor corneasor unethicalpractices inunregulatedcentersandif so, the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SHRIPRATAPRAO JADHAV)
(a)Yes.TheGovernmenthasissuedaGazettednotificationdated6November,2025amending
Form-15 under the Transplantation of Human Organs and Tissues Rules, 2014, wehreby the
requirementofaclinicalspecularmicroscopeforregistrationofcornealtransplantationcentres
hasbeenmadeoptional.
(b) The aforesaid amendment has been made based on the recommendations of technical
experts, program expertsandotherstakeholders.(c) & (d) Such relaxation is not likely to compromise the quality or safety of corneal grafts,
particularly in centres lacking advanced diagnostic facilities as the corneal tissues are first
processed andevaluatedby a registered eye bank,where SpecularMicroscope ismandatory.
(e) Under National Organ Transplant Program (NOTP), financial assistance is provided for
infrastructure and equipment required for establishing biomaterial centres at the regional or
statelevel.
(f) The cornea donation and transplantation, is regulated under the Transplantation of Human
Organs and Tissues Act, 1994 (THOTA). The Act provides for one or more Appropriate
Authority tobeappointedbythe respective Statefor thepurposes oftheAct andtoinvestigate
anybreachofprovisionsoftheActandRulesthereunderandtakeappropriateaction.
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