AERB Licence for X-Ray and CT in India: Process, Renewals, Compliance

Any medical X-ray, dental X-ray, mammography or CT installation in India requires authorisation from the Atomic Energy Regulatory Board (AERB) under the Atomic Energy (Radiation Protection) Rules, 2004. Operating an unlicensed installation isn't merely a paperwork gap — it carries seizure, sealing and prosecution risk under the Atomic Energy Act. For a diagnostic centre owner, the AERB process is one of the longest-lead-time items in setup, and getting the sequence right saves months. This guide walks the e-LORA workflow, the RSO appointment, the periodic QA expectations and the renewal cycle.

AERB regulation works on the principle that every radiation source has an identifiable owner, an identifiable safety officer, an approved room layout that shields personnel and the public, and ongoing quality-assurance evidence that the equipment performs within acceptable limits.

The e-LORA portal: the single point of entry

All medical radiation licensing in India runs through AERB's e-LORA (e-Licensing of Radiation Applications) portal. The portal handles institution registration, equipment registration, layout approval, licence issuance, renewal and compliance reporting. Direct paper applications are no longer accepted for routine medical X-ray and CT.

Registration on e-LORA is the first step and is straightforward: institution details, premises address, ownership, contact person. This creates the institutional identity against which every subsequent equipment and licence is mapped.

The licensing sequence

For a new diagnostic-centre X-ray or CT installation, the realistic sequence is:

1. Institution registration on e-LORA (1–2 days)

2. RSO nomination — appoint a Radiological Safety Officer with AERB-recognised qualification

3. Equipment selection and OEM coordination — confirm the unit is on the AERB-approved equipment register (most major OEMs are; verify before ordering)

4. Layout drawing preparation — by a qualified consultant, showing room dimensions, equipment position, control booth, shielding specification (typically lead-equivalent thickness on every relevant wall)

5. Layout approval application on e-LORA, with shielding calculation

6. Layout approval — typically 30–60 days

7. Equipment installation at site, witnessed by RSO; site survey and shielding verification

8. Type approval verification for the specific unit

9. Licence application with installation certificates, site survey, RSO acceptance

10. Licence issuance — typically 30–60 days from complete application

End-to-end, 90–180 days for X-ray; longer for CT due to the more complex layout. The most common delay is rework on layout drawings or shielding calculations — engage an experienced consultant.

The RSO: a real role, not a signature on a form

The Radiological Safety Officer (RSO) is the technically responsible person for radiation safety at the installation. Qualification requires either a recognised medical-physics MSc or a Diploma in Radiological Physics (DipRP) plus AERB certification, with the precise grade (RSO-Level I, II or III) varying by modality:

• Level I: general medical diagnostic X-ray

• Level II: includes CT, mammography, fluoroscopy

• Level III: includes radiotherapy and nuclear medicine

The RSO doesn't have to be full-time — a part-time RSO is common at smaller centres — but they must be reachable, must conduct or oversee the periodic QA programme, and must investigate any incident. A "name on paper" RSO who is absent in practice is a regulatory risk.

Shielding calculations and layout approval

The layout approval is technical work. The drawing must show:

• Room dimensions and orientation

• Tube position, beam direction(s)

• Adjacent occupied and unoccupied areas (above, below, sides)

• Control booth position with operator shielding

• Lead-equivalent thickness on every wall, floor, ceiling, door and window

• Warning signage positions

Shielding calculation follows NCRP / IAEA methodology, with workload, use factor and occupancy factor for each barrier. Inadequate shielding (typically because workload estimates are too low or wall thicknesses follow rules of thumb rather than calculation) is a common rework reason. A consultant who has done dozens of similar installations is worth their fee.

Equipment registration

Every X-ray and CT unit must be individually registered on e-LORA under your institution. The OEM provides type-approval certificate, X-ray tube certification and dosimetry data. The licensee uploads these and links the equipment to the approved layout.

Refurbished equipment is acceptable but requires additional documentation — the refurbisher's type-approval transfer, current tube data, and a site acceptance test before the licence is granted.

Periodic QA: the ongoing requirement

A licensed installation must undertake Quality Assurance tests periodically. Frequency and parameters depend on modality:

• General X-ray: annual QA (tube output, kVp accuracy, beam alignment, half-value layer, leakage, exposure timer accuracy)

• CT: annual QA plus daily/weekly checks (water phantom CT number, slice thickness, low-contrast detectability, dose index)

• Mammography: monthly QA on resolution, contrast, dose

QA is performed by the RSO or a qualified medical physicist; reports go on file and may be requested at any compliance audit. Maintain at least three years of QA reports on site.

Personnel monitoring

Anyone occupationally exposed (radiographer, sonographer who occasionally assists, RSO) must wear a personal dosimeter (TLD badge or OSL) issued by an AERB-recognised personnel-monitoring service. Quarterly readings are reviewed by the RSO. Cumulative dose limits (currently 20 mSv/year average over 5 years, 50 mSv in any single year) apply.

Dosimetry records are retained for the duration of employment plus 30 years.

Renewals and licence currency

X-ray and CT licences are typically issued for 5 years initially, renewable through the same e-LORA portal. Renewal requires:

• Continuing RSO appointment

• Current QA reports

• Personnel monitoring data

• Any layout changes (room modifications, equipment replacement) declared

Start the renewal process 60–90 days before expiry — a lapsed licence requires fresh installation re-acceptance, not just a renewal.

What an AERB audit looks for

Audits at smaller centres are infrequent in practice but can be triggered by complaint, incident or scheduled regional sweep. Auditors typically examine:

• Valid licence displayed in the X-ray/CT room

• RSO present or contactable, qualifications verified

• Layout matches approved drawing (no equipment moved, no wall removed)

• QA reports for the past period available

• Personnel dosimeter records up to date

• Warning signage, light, door interlocks functioning

• Pregnancy declaration / screening policy in place

A well-run installation passes a routine audit in a few hours.

Coordinating with other licences

The AERB licence interacts with:

• Clinical Establishment Registration — the centre's overarching registration

• PCPNDT (if ultrasound also offered) — separate licence

• Biomedical waste authorisation — covers contrast media disposal, see our BMW guide

• Pollution Control Board NOC — required for the BMW authorisation

Apply for AERB in parallel with the others; serial application adds months.

Products commonly used at this stage

A working radiology room runs through consumables daily: 70% IPA for skin prep before contrast injection and surface wipe-down, surface disinfectant concentrate for daily floor cleaning, and gel-coupling consumables where ultrasound is co-located (bulk ultrasound gel). Pioma Chemtech, a specialty chemical manufacturer based in India, supplies these in diagnostic-centre pack sizes.

Frequently Asked Questions

Can I install an X-ray machine before getting AERB approval?

No. The sequence is: layout approval, then installation, then licence. Installing before approval risks rejection of the installation entirely and forced repositioning.

How long does AERB licensing take?

90–180 days for general X-ray from application to licence in hand, longer for CT. The layout-approval step and the licence-application step are the longest poles. Start early.

Do I need a separate licence for each X-ray machine?

Each installed unit is registered and licensed individually under the institution's e-LORA registration. A multi-machine centre will hold multiple equipment licences linked to one institution.

Is dental X-ray covered by the same process?

Yes — dental intraoral X-ray, panoramic and CBCT units all require AERB registration and licensing through e-LORA, with proportionate layout and QA requirements.

What happens if my RSO leaves?

Notify AERB through e-LORA within the prescribed period (typically 30 days), appoint a replacement RSO and update the licence record. Operating without an RSO is a compliance violation.

Can a single RSO cover multiple centres?

Yes, with limits — a part-time RSO can cover multiple installations within reasonable geographic proximity. AERB places limits on the number of installations one RSO may cover, which depends on the modality and workload.

What's the typical cost of layout approval and licensing?

AERB fees themselves are modest (a few thousand rupees per equipment licence). The substantial costs are consultant fees for layout design (₹50,000–2,00,000 depending on complexity), lead shielding installation (₹5–15 lakh for an X-ray room, more for CT), and the RSO's annual retainer.

AERB compliance is a long-term commitment, not a one-time setup. Build the QA and dosimetry routines into the centre's operating rhythm from day one and the periodic audits become uneventful.

— Available for bulk and commercial supply. Contact us to discuss radiology-suite consumables.