The court established that regulatory authority must be exercised within the framework of existing law, acknowledging the responsibilities assigned by the Atomic Energy Act and associated rules.

JUDGMENT

Dated this the 1st day of December, 2021

S.Manikumar, C.J.

Instant public interest litigation is filed seeking for the following reliefs:

“i) Issue a Writ of Mandamus or any other appropriate writ order or direction commanding the respondents to conduct proper verification and site inspection before providing registrations to new X ray units and to inspect the existing units periodically so as to ensure that all the units are functioning in compliance with Atomic Energy (Radiation Protection) Rules 2004 and the regulations prescribed by the 4th respondent in this regard.

ii) Issue a Writ of Mandamus or any other appropriate writ order or direction commanding the respondents to make provisions to conduct inspections on all institutions which has X ray or any other radiation sourced equipments on a quarterly basis.

iii) Issue a Writ of Mandamus or any other appropriate writ order or direction commanding the respondents to establish a state level authority to function as an enforcing authority for the 4th respondent or in the alternative to direct respondents 1, 2 and 4 to renew Ext. P2 Memorandum of Understanding so as to re-enable the 3rd respondent to carry out its functions efÏciently.”

2. Short facts leading to the filing of the writ petition are as hereunder:

Being aggrieved by the non-functioning of the Directorate of Radiation (DRS), 3rd respondent herein, the petitioner has approached this court. DRS being the enforcing authority of Atomic Energy Regulatory Board (AERB), authorized to carry out pre-installation and regulatory inspection of medical diagnostic facilities in Kerala using radiation sourced equipments. DRS was constituted in Kerala as per an MoU signed between AERB and the State Government of Kerala. On 31.12.2016, the validity of the MoU has expired and since then DRS has become non-functional.

Registration and licensing of new medical diagnostic facilities is being provided by AERB directly through an online platform named "e-LORA", without conducting any pre- installation site inspection and verification of the diagnostic radiation sourced equipments. In the absence of a proper regulatory authority, several diagnostic units using radiation sourced equipments are mushrooming in various parts of the State, in violation of the provisions envisaged in Rule 30 of the Atomic Energy (Radiation Protection) Rules, 2004.

3. On behalf of the Directorate of Radiation Safety (respondent No.3), a statement dated 14.03.2019 has been filed. Relevant paragraphs of the same read thus:

“3. It is true that there should be some mechanism to check and monitor the functioning of all medical diagnostic X-ray facilities in Private and Government Sector within the State of Kerala. The Directorate of Radiation Safety was the body authorised for the same and was effectively functioning upto 31.12.2016. Thereafter, the authorization for acting on behalf of AERB was not renewed from 01.01.2017 and on the direction from AERB to stop all regulatory inspections till signing of the new MoU, the Government of Kerala directed the Directorate to stop all regulatory inspections and now there is no periodical inspection either by the Directorate of Radiation Safety or by the AERB in the state of Kerala.

4. As per the various provisions of the Atomic Energy Act , 1962, the responsibility to ensure the radiation safety is vested with the 4th respondent Atomic Energy Regulation Board. The Radiation Protection Rules, 2004 is also framed under the , 1962 for the purpose of monitoring all stages of licensing X-ray installations like siting, installation, services, commissioning and de- commissioning.

5. The increased use of Medical Diagnostic X Ray can increase the cancer risk, mutation in the exposed population and genetic disorders in the off springs. Even small radiation dose to an individual carry some risk. Foetal irradiation can cause mental retardation. Hence it is necessary to keep the radiation as low as reasonably achievable (ALARA) which is t