Lok Sabha Question No. 2867 (UNSTARRED), answered on 2019-07-10
Subject: Registration of Scan Machines in Hospitals
Ministry: ATOMIC ENERGY
Asked by: Suresh Kodikunnil

## GOVERNMENT OF INDIA DEPARTMENT OF ATOMIC ENERGY

## LOK SABHA UNSTARRED QUESTION 2867

TO BE ANSWERED ON 10.07.2019

## REGISTRATION OF SCAN MACHINES IN HOSPITALS

## 2867.  SHRI  KODIKUNNIL SURESH:

Will the Prime Minister be pleased to state:

- (a) whether  the  Government  is  aware  of  instances  and  reports  that  despite  a stringent  regulatory  mechanism  in  place,  several  hospitals  and  healthcare diagnostic institutions are using scan machines and x-ray units without approval from the Atomic Energy Regulatory Board (AERB);
- (b) if so, the details thereof and the reaction of the Government thereto;
- (c) whether  AERB  is  giving  online  registration  without  any  physical  verification and bypassing regulatory protocols;
- (d) if so, details thereof; and
- (e) whether  the  Government    has  reviewed  or  proposes  to  review  the  process  of registration comprehensively and   if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE FOR PERSONNEL, PUBLIC GRIEVANCES & PENSIONS AND PRIME MINISTER'S OFFICE (Dr. JITENDRA SINGH):

- (a) Atomic  Energy  Regulatory  Board  (AERB)  is  the  regulatory  authority  for issuing  Licenses/Registration  for  X-ray  facilities  from  radiation  safety  view point. AERB is aware that in spite of its continuous regulatory efforts, there may be some X-ray centres that are using X-ray units without obtaining mandatory  approval from AERB.  At  present, 69,030 diagnostic X-ray equipment  are  licensed  by  AERB  through  its  online  system  namely  elicensing of radiation applications (e-LORA) as on June 2019.
- (b) AERB is continuously putting all regulatory efforts to bring diagnostic Xray  equipment,  in  the  country,  under  its  regulatory  ambit  by  increasing awareness  in  close  coordination  with  Ministry of  Health,  States/Union Territories through the  respective  district Law  Enforcement  Authorities and District Health Authorities and through AERB's Regional Regulatory Centres.

- (c)  &  (d)    AERB  issues  licence  to  operate  only  equipment  that  have  obtained  Type (design) approval from AERB. The Type approval process involves physical verification  of  every  model  of  X-ray  equipment  and  ensures  in-built  design safety  for  protection  of  patient  and  radiation  worker.  As  part  of  its  online registration  process,  in  the  first  stage,  AERB  verifies  institution  details through  review  of  legal  documents  such  as  institution  PAN  CARD  and certification of State/ Local Authorities issued for the institution.
- (e) Yes  Sir.  AERB  has  already  comprehensively  reviewed  the  regulatory requirements and incorporated in AERB Safety Code {AERB/RF-MED/ SC3  (Rev.2),  2016},  based  on  which  the  process  of  registration  was implemented in the e-LORA online system.  AERB continuously reviews its regulatory  mechanism  based  on  feedback  obtained  from  the  stakeholders, international requirements etc., of licensing and revises its licensing process without compromising the radiation safety.

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