The concept of informed consent specific to medical research and treatment is still alien to many medical researchers and practitioners and to millions of Indians. The doctor-patient relationship in India is governed more by trust where the doctor is the authoritative person. Therefore, the benefit of informed consent does not reach all patients in day-to-day medical practice. To complicate the issue, the Indian law is not specific about the age at which a person can give valid consent. The Indian Penal Code is silent about the legal validity of consent given by persons between 12 and 18 years of age. Similarly, the age at which the 'Right to Confidentiality' begins is yet to be defined either by the statute or by the courts. Hence, there is a need for a clear statutory provision to remove the anomalies and ambiguities regarding the age of consent to undergo invasive therapeutic or investigative procedures, participate in clinical trials, as well as define the age at which a person's right to medical confidentiality begins.
In 1994, the Government of India enacted the Transplantation of Human Organs Act (THOA) to prevent commercial dealings in human organs. However, a greater number of scandals involving medical practitioners and others in the kidney trade has surfaced periodically in every state in India. The present regulatory system has failed mainly due to the misuse of Section 9(3) of the THOA, which approves the consent given by a live unrelated donor for the removal of organs for the reason of affection or attachment towards the recipient or for any other special reason. Currently in India, approximately 3500-4000 kidney transplants and 150-200 liver transplants are performed annually. However, the availability of organs from brain-dead persons is very low. As a result, live related or unrelated donors form the main source of organ transplantation. Therefore, physicians and policy-makers should re-examine the value of introducing regulated incentive-based organ donation to increase the supply of organs for transplantation and to end unlawful financial transaction.