Transplantation of Human Organs and Tissues (Amendment) Rules, 2025

• 12 Nov 2025

Source: PIB 

Why in News?

The Union Ministry of Health and Family Welfare has notified the Transplantation of Human Organs and Tissues (Amendment) Rules, 2025 under the Transplantation of Human Organs and Tissues Act (THOTA), 1994 to simplify corneal transplantation protocols and promote equitable access to organ and tissue transplantation services across India.

What are the Key Highlights of the Transplantation of Human Organs and Tissues (Amendment) Rules, 2025? 

• Eases Equipment Requirements: The mandatory requirement for clinical specular microscopes in corneal transplantation centres has been removed. 
  • These microscopes, used to assess corneal cell health, were often expensive and difficult to procure for smaller centres. 
  • The amendment will ease infrastructure and operational hurdles for smaller eye centres, improving access to corneal transplant services nationwide. 

Significance 

• Promotes Equitable Healthcare: Expands access to organ, tissue, and eye donation services across regions, aligning with the goals of the National Organ Transplant Programme (NOTP). 
• Boosts Eye Donation Efforts: Encourages more institutions to participate in eye donation and corneal transplantation, increasing the availability of donor tissue. 
• Addresses Corneal Blindness: Helps tackle one of India’s leading causes of visual impairment by improving access to timely treatment. 
  • Corneal Blindness is vision impairment or blindness caused by damage or disease of the cornea (the transparent part of the eye that covers the iris and the pupil and allows light to enter the inside), often due to infection, injury, malnutrition, or genetic disorders. 
  • According to the Indian Journal of Ophthalmology, corneal blindness is the second-leading cause of blindness after cataract among Indians, affecting 1.2 million people, with 25,000–30,000 new cases each year.

What is Transplantation of Human Organs and Tissues Act, 1994? 

• Background: Before 1994, India lacked a unified law on organ transplantation, relying on scattered state acts like the Bombay Corneal Grafting Act (1957) and Maharashtra Kidney Transplantation Act (1982).  
  • Rising illegal organ trade, especially in kidneys, led to public and expert demand for national regulation. The 1994 Act was framed on the recommendations of a committee led by Dr. L. M. Singhvi (1991) to ensure ethical and transparent transplantation. 
• THOTA, 1994: It was enacted to regulate the removal, storage, and transplantation of human organs and tissues for therapeutic purposes, and to prevent commercial dealings in human organs. 
  • The Act facilitates the ethical retrieval of organs from brain-dead individuals and tissue transplantation in India by establishing a clear legal framework for donation and medical procedures. 
  • It promotes transparency and accountability in the retrieval, storage, and transplantation of human organs and tissues. 
• Major Provisions of the Act: Defines the terms donor, recipient, and near relative to prevent misuse. 
  • It specifies that organ removal can be done only for therapeutic purposes and with informed consent. 
  • Establishes Authorization Committees to regulate transplantation activities. 
• Amendments and Rules: The 2011 Amendment expanded the scope of the Act through the Transplantation of Human Organs (Amendment) Act, 2011, broadening coverage to include more organs and tissues. 
  • The Transplantation of Human Organs and Tissues Rules, 2014 were notified to operationalize the provisions of the Act. 
• Implementation and Adoption by States: Since health is a State subject, states must adopt the Act for it to be applicable. 
  • The 1994 Act applies to all States and Union Territories, except Andhra Pradesh and Telangana, which have their own laws.

National Organ Transplant Programme (NOTP) 

• About: The Ministry of Health and Family Welfare, is implementing the NOTP to promote equitable access to organ and tissue donation and transplantation across all States and Union Territories. 
• Institutional Framework:  NOTTO (National Organ and Tissue Transplant Organisation) functions as the apex body in New Delhi, supported by Regional Organ and Tissue Transplant Organisations (ROTTOs) and State Organ and Tissue Transplant Organisations (SOTTOs). 
• Key Components: The programme includes setting up State Organ and Tissue Transplant Organisations (SOTTOs) in every State and UT, along with National, Regional, and State Bio-material Centres.  
  • It provides financial aid to improve organ transplant facilities, trains medical professionals, and supports hiring transplant coordinators in medical colleges and trauma centres. 
  • Additionally, it ensures post-transplant immunosuppressant drugs for Below Poverty Line (BPL) patients. 
• Achievements: India’s organ transplants increased from 4,990 in 2013 to 18,911 in 2024. India ranks 3rd globally in total organ transplants, behind the US and China, and 1st in living donor transplants. 

Frequently Asked Questions (FAQs) 

1. What is the Transplantation of Human Organs and Tissues Act (THOTA), 1994? 
THOTA, 1994 is the central law regulating removal, storage and transplantation of human organs and tissues for therapeutic purposes and prohibiting commercial dealings in organs. 

2. What are the key highlights of the Transplantation of Human Organs and Tissues (Amendment) Rules, 2025? 
The 2025 Rules remove the mandatory clinical specular microscope requirement for corneal centres, easing infrastructure hurdles and improving access to corneal transplantation especially in smaller and rural centres. 

3. What is the National Organ Transplant Programme (NOTP)? 
NOTP is the Government of India’s programme to promote organ and tissue donation nationwide via NOTTO (national), ROTTOs (regional) and SOTTOs (state), tissue banks, training, funding and awareness campaigns. 

UPSC Civil Services Examination, Previous Year Questions (PYQs)

Prelims 

Q. Consider the following statements: (2020)

1. Genetic changes can be introduced in the cells that produce eggs or sperms of a prospective parent. 
2. A person’s genome can be edited before birth at the early embryonic stage. 
3. Human induced pluripotent stem cells can be injected into the embryo of a pig. 

Which of the statements given above is/are correct? 

(a) 1 only 

(b)  2 and 3 only 

(c) 2 only  

(d) 1, 2 and 3 

Ans: (d)  

Q. With reference to the scientific progress of ancient India, which of the statements given below are correct? (2012) 

1. Different kinds of specialised surgical instruments were in common use by the 1st century AD. 
2. Transplant of internal organs in the human body had begun by the beginning of the 3rd century AD. 
3. The concept of sine of an angle was known in 5th century AD. 
4. The concept of cyclic quadrilaterals was known in 7th century AD. 

Select the correct answer using the codes given below: 

(a) 1 and 2 only 

(b) 3 and 4 only 

(c) 1, 3 and 4 only 

(d) 1, 2, 3 and 4 

Ans: (c)