By Adv. Aparna Bhide, Advocate at Lex Credence on June 15, 2020 

When applications of Nuclear Technology are considered, they are predominantly limited to the sectors of defense, energy, infrastructure and other industrial based usages. Nuclear Technology in the sector of healthcare is rarely a point of contention; however, a technology so potentially and positively placed must receive investigation and importance as one of the peaceful uses thereof. Nuclear technology in medicine has helped to achieve a paradigm shift in techniques of diagnosis and treatment of aliments from traditional exploratory techniques to non-invasive and painless procedures. Nuclear Medicine in the form of radio-pharmaceuticals offer an array of therapeutic treatments to cure life-threatening diseases such as cancer, and that is only the tip of range of applications the technology has in the field of healthcare.

In order to ensure proper use of radioactive material, to set the limits of medical diagnosis and treatments, to lay down framework for permissible research work, to ensure health and safety of patients as well as medical workers as well as the sustainable use, and to avoid any adverse impact on the environment, the Atomic Energy Regulatory Board (AERB) was constituted in India under the Atomic Energy Act, 1962. AERB is primarily responsible for Document Development, in simple terms; AERB lays down the safety requirements, codes, standards, guidelines, and manuals for particular practices/ applications to assure safety, under provisions of Atomic Energy (Radiation Protection) Rules, 2004.

AERB is also the licensing authority for facilities such as RIA laboratories, biomedical research facilities using radioactive material, gamma irradiation chambers, and for the manufacturers and suppliers of radio-active elements as well. In order to operate a facility, it is mandatory to acquire license from AERB. Such licenses can be granted by AERB by setting out some pre-conditions and limitations. To ensure smooth regulation of facilities, AERB has milestone development and periodical reviews for quality assessments, transport and disposal of the nuclear waste. AERB has also laid down several guidelines for the handling of radio-isotopes for treatment and diagnostic purposes. Right from laying down the quantities that should be used to the procedure that is to be followed everything has been elaborately set out. Radio-therapy is a procedure that requires controlled exposure of the cells to the radiations and hence requires a lot of skill on the part of the doctor. AERB’s Safety Code on Radiation Therapy Sources, Equipment and Installations spells out the basic qualifications of Medical Physicist/Radiation Physicist/Radiological Physicist and Radiological Safety Officer including basic degree in physics, course work, internship, experience in handling radiation installation and equipment. This fulfillment is a pre-requisite for acquiring eligibility handling the nuclear medicine. However, the real question arises when there is damage caused, not because the medical practitioner has inadequate expertise but due to fault in equipment/machinery. Prior to the amendment of the Consumer Protection Act, 2019, this question attacked the very root of inadequate framework, however with the definition of “product liability” being added in the amendment, now the manufacturer cannot evade his liability when the product is faulty. However, establishing the same shall take its own course and as of yet there have been no path breaking judgments. It also leaves in its wake the question of need of a separate dedicated forum to engage issues of such vitality.

The guidelines are specifically laid down in consonance with the International Atomic Energy Agency (IAEA) guidelines and have to be strictly adhered to, which includes the basic principle of autonomy and beneficence. Radio-pharmaceuticals are not for everyone, not just because of the costs involved but due to their acquired suitability, and therefore, while considering the treatment, a practitioner has to take into consideration the risks and benefits ratio as well.

AERB is also responsible for the Safety Reviews, Assessments, Inspections and Enforcement. Even though AERB is currently regulating the nuclear technology in India, it is not a statutory body and is established under an executive order, its legal status is that of an office exercising delegated functions and not an independent regulator, AERB is subordinate to the Department of Atomic Energy (DAE), and therefore, a crucial question on its independence is raised from time to time. A need for a statutory body was flagged by IAEA for greater authority to regulate which can only be changed through the Parliament and not by any Government order/resolution. In the light of the recommendation of IAEA, The Nuclear Safety Regulatory Authority (NSRA) Bill was introduced in 2011, and even though the bill carves an independent autonomous body that is not under the control of the government, established by the statute, it has concerns such as conflict of interest and independence of members, as a result of which, the lapsed bill needs some rework before being re-introduced in the parliament.

India has an underrated potential to tap the nuclear technology in healthcare, however without effective regulation and stringent guidelines it will remain merely a dream.

The article represents the personal views of the author.


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