Regulatory Mechanism for Diagnostic Radiology (DR) Facilities in India

Abstract

Radiology is one kind of diagnostic imaging technology for early diagnosis and prevention of disease that employs X-ray ionizing radiation for imaging of anatomical structure inside the body. The X-ray beam passing through the body gets attenuated by a varying degree depending upon the bone density, soft tissue content, muscle, water content, etc., inside the body and the transmitted X-ray beam is used to form an image of anatomical structure inside the body. At present, around 90,000 X-ray machines are in operation in India. In order to ensure safety of personnel involved in operation of different types of diagnostic radiology equipment as well as safety of the members of public, Atomic Energy Regulatory Board (AERB) exercises the powers conferred by the Atomic Energy Act, 1962 in India. The Mission of AERB is to ensure that safe use of ionizing radiation and nuclear energy in India does not cause any undue risk to the health of people and the environment. AERB issues different types of consents like registration, license for operation of diagnostic radiology facility. Before issue of consent, detailed reviews are carried out, and consent is issued for a specific period of time. Regular, special or surprise inspections are also carried out for verification of radiological safety status in diagnostic radiology facilities. Chairman, AERB, is the competent authority under the Atomic Energy (Radiation Protection) Rules, 2004 and issues time to time directives and notifications prescribing dose limits, radiation warning symbol, etc. AERB publishes several safety related documents like codes, guides, and standards for effective regulation of stakeholders like manufacturers, suppliers, service agencies, and users of diagnostic radiology equipment in the country. It is mandatory to obtain license/registration from AERB for operation of diagnostic radiology equipment. In order to strengthen and streamline the process, AERB has launched a web-based application named e-Licensing of Radiation Applications (e-LORA) for automation of regulatory process. With the increasing number of diagnostic radiology facilities in today’s scenario, effective regulatory control is a challenging task. This paper brings out different modalities of effective and efficient regulation of diagnostic radiology facilities of the country, detailing on the varied experiences acquired in the process, as well as preparedness of the regulatory body in meeting up with the challenges in future.