TAG: GS 3: SCIENCE AND TECHNOLOGY
THE CONTEXT: The Union Health Ministry of India has recently issued a comprehensive directive aimed at enhancing the regulation of organ transplants within the country.
EXPLANATION:
- This directive is a response to growing concerns over malpractice and the commercialization of organ transplants, particularly involving foreign nationals.
Implementation of Unique NOTTO-ID
- One of the key measures introduced by the directive is the requirement for all cases of organ transplants, whether from living or deceased donors, to be assigned a unique National Organ and Tissue Transplant Organisation (NOTTO)-ID.
- This ID will be generated by hospitals through the NOTTO website, ensuring a standardized and traceable system for monitoring transplant cases.
- The directive explicitly aims to eliminate commercial dealings in organs, especially those involving foreign citizens.
- This step is crucial in safeguarding the ethical principles of organ donation and transplantation, prioritizing altruism over financial gain.
- To ensure compliance with regulations and to curb any illegal activities, the Ministry calls for stricter monitoring of organ transplants by local authorities.
- Appropriate State authorities, appointed under the Transplantation of Human Organs and Tissues Act (THOTA), 1994, are tasked with investigating transplants involving foreign nationals and taking appropriate action against any violations.
- In addition to deceased donor transplants, the directive emphasizes the importance of regulating living donor transplants.
- NOTTO-ID must be generated for both donors and recipients within 48 hours post-surgery, enabling efficient tracking and allocation of organs.
Quality Assurance and Inspection
- The Ministry highlights the need for regular inspection of registered hospitals conducting organ transplants.
- State authorities are required to monitor these hospitals on-site to ensure the quality of transplantation, post-operative follow-up, and overall outcomes.
- Any violations of THOTA, 1994, and its rules are subject to investigation, with potential consequences including the suspension of registration for performing organ transplants.
Data Collection and Sharing
- Efficient data collection and sharing are vital for effective regulation and oversight.
- The Ministry emphasizes the importance of states regularly sharing data related to organ donation and transplantation with NOTTO.
- This ensures comprehensive monitoring and enables informed decision-making at the national level.
Regulation of Foreign Nationals
- Special provisions within THOTA, 1994, govern organ transplants involving foreign nationals.
- Prior approval from the authorization committee is required for such transplants, along with certification of the relationship between the donor and recipient by senior embassy officials.
- These measures aim to verify the authenticity of documents, prevent commercial exploitation, and ensure that donations are made out of genuine altruism.
Transplantation of Human Organs and Tissues Act (THOTA), 1994:
- The Transplantation of Human Organs Act (THOA), 1994 was enacted in the year 1994 and has been adopted in all States except erstwhile State of J&K and Andhra Pradesh which have their own legislation in this regard.
- Main purpose of the Act is to regulate the removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs.
- The Act was amended in 2011 and the Transplantation of Human Organs (Amendment) Act 2011, has come into force on 10-1-2014 in the States of Goa, Himachal Pradesh, West Bengal, and Union Territories.
- Other States who have adopted the amendment Act till date are Rajasthan, Sikkim, Jharkhand, Kerala, Orissa, Punjab, Maharashtra, Assam, Haryana, Manipur, Gujarat, Bihar and Uttar 2 Pradesh. The amended Act is now named Transplantation of Human Organs and Tissues Act (THOTA), 1994.
- Brain Stem death is recognized as a legal death in India under the Transplantation of Human Organs and Tissues Act, since 1994 like many other countries, which has revolutionized the concept of organ donation after death.
- After natural cardiac death only a few organs/tissues can be donated (like cornea, bone, skin and blood vessels) whereas after brain stem death almost 37 different organs and tissues can be donated including vital organs such as kidneys, heart, liver and lungs.
National Organ and Tissue Transplant Organisation (NOTTO):
- National Organ and Tissue Transplant Organization (NOTTO) is a National level organization set up under Directorate General of Health Services, Ministry of Health and Family.
- This has been mandated as per the Transplantation of Human Organs (Amendment) Act 2011.
- National Network division of NOTTO would function as apex centre for All India activities of coordination and networking for procurement and distribution of Organs and Tissues and registry of Organs and Tissues Donation and Transplantation in the country.