AERB License for Companies Working with Radioactive Materials

India's Radiation Regulatory Landscape Is Changing

India's nuclear and radiation sector has historically been one of the most restricted for foreign direct investment. The Atomic Energy Act, 1962, placed virtually all nuclear activities under government control, with no pathway for private or foreign participation in most segments. That changed fundamentally in December 2025 with the enactment of the Sustainable Harnessing and Advancement of Nuclear Energy for Transforming India (SHANTI) Act, 2025.

The SHANTI Act, which received Presidential assent on December 20, 2025, repeals both the Atomic Energy Act, 1962, and the Civil Liability for Nuclear Damage Act, 2010. For the first time, it permits private sector participation in nuclear power plant construction, operation, equipment manufacturing, and other aspects of the nuclear fuel cycle — subject to AERB licensing and regulatory oversight.

For foreign companies, this creates new opportunities in radiation equipment manufacturing, nuclear medicine, industrial radiography, and potentially nuclear power generation. But every one of these activities requires AERB licensing, and the licensing process is rigorous, technically demanding, and non-negotiable.

What Is AERB and Why Does It Matter?

The Atomic Energy Regulatory Board (AERB) was constituted on November 15, 1983, by the President of India to carry out regulatory and safety functions under the Atomic Energy Act. The SHANTI Act, 2025, gives AERB statutory recognition for the first time — previously it operated as an executive body under the Department of Atomic Energy (DAE).

AERB's mandate covers:

• Nuclear facilities: Nuclear power plants, research reactors, fuel cycle facilities, waste management plants
• Radiation facilities: Medical diagnostic and therapeutic equipment (X-ray machines, CT scanners, linear accelerators, cobalt therapy units), industrial radiography, nucleonic gauges, well-logging equipment, radiation processing plants (food irradiation, sterilisation)
• Radioactive materials: Sealed and unsealed sources, transport of radioactive materials, import/export of radioactive substances
• Consumer products: Products containing radioactive materials (smoke detectors, luminous dials, static eliminators)

No person or entity — Indian or foreign-owned — may possess, use, transport, import, export, or dispose of radioactive materials or radiation-generating equipment in India without appropriate AERB consent.

AERB License Categories

AERB uses a graded consenting approach. The type of consent required depends on the hazard level of the facility or activity:

Licence (Highest Level)

Required for facilities with the highest radiation hazards. This includes nuclear power plants, research reactors, fuel reprocessing plants, industrial radiography using sealed sources (cobalt-60, iridium-192), and teletherapy/brachytherapy installations. A licence involves comprehensive safety review, including site evaluation, design review, construction inspection, commissioning oversight, and periodic operational safety reviews.

Authorisation (Medium Level)

Required for facilities with moderate radiation hazards, including nuclear medicine departments using unsealed radioactive sources, radiation processing plants (gamma irradiation for food preservation and medical device sterilisation), and accelerator facilities for industrial and research applications. Authorisation involves detailed safety assessment but with less intensive review than a full licence.

Registration (Lowest Level)

Required for facilities with lower radiation hazards, including medical diagnostic X-ray equipment (conventional X-ray, CT scanners, cath labs, C-arms, mammography machines, dental X-rays), nucleonic gauges, and general-purpose industrial X-ray equipment. Registration involves standard safety review and is processed through the eLORA online system.

The eLORA Online Licensing System

AERB's Electronic Licensing of Radiation Applications (eLORA) system is the mandatory portal for applying for, tracking, and renewing radiation facility consents. All applications must be submitted through eLORA — AERB does not accept physical applications for radiation facilities.

Step-by-Step eLORA Process

1. Institute Registration: Register your organisation on eLORA (https://elora.aerb.gov.in). Submit organisation details, contact person information, type of activity, and supporting documents. AERB reviews and creates the institute's account upon approval
2. Application Submission: Select the appropriate consent category (Licence, Authorisation, or Registration) and complete the application form. Upload required documents including equipment details, layout plans, shielding calculations, RSO credentials, and safety protocols
3. AERB Review: AERB's regulatory staff reviews the application for completeness and technical compliance. Additional information may be requested. For higher-hazard facilities, site inspection may be required
4. Consent Issuance: Upon satisfactory review, AERB issues the consent with specified conditions. The consent specifies the equipment/source, location, Radiation Safety Officer, and validity period
5. Renewal: Consents must be renewed before expiry. For nuclear power plants, the licence validity is 5 years. For radiation facilities, registration validity varies from 3-5 years depending on the equipment type

Required Documents for Foreign-Owned Companies

In addition to the standard documentation, foreign-owned companies operating in India must provide:

• Certificate of incorporation of the Indian entity (foreign companies must operate through an Indian subsidiary — a wholly owned subsidiary or joint venture incorporated under the Companies Act, 2013)
• Proof of premises ownership or lease agreement
• Equipment purchase invoice and model details, including AERB Type Approval certificate for the equipment (or Type Registration for imported sources)
• Layout plan showing the radiation installation area with shielding specifications
• RSO appointment letter and training certificates
• Manufacturer's Type Approval Certificate (for Indian-manufactured equipment) or Source Type Registration (for imported radioactive sources)

Radiation Safety Officer (RSO) Requirements

Every facility handling radioactive materials must designate a Radiation Safety Officer (RSO) approved by AERB. This is a non-negotiable requirement — operating without an approved RSO is a violation of the Atomic Energy (Radiation Protection) Rules, 2004.

RSO Qualifications

Minimum qualifications vary by facility type but generally require:

• Degree or diploma in electrical, electronic, biomedical, or mechanical engineering, or a basic science degree with physics as a subject, from a recognised university
• Certification from an AERB-recognised training programme in radiation safety and quality assurance relevant to the facility type (e.g., "Radiation Safety and Quality Assurance in Diagnostic Radiology" for medical facilities)
• For nuclear facilities, additional specialised training and experience requirements apply

RSO Responsibilities

The RSO is responsible for ensuring compliance with all radiation safety regulations, monitoring radiation exposure of workers, maintaining dose records, conducting area radiation surveys, managing radioactive waste disposal, responding to radiation emergencies, and serving as the primary point of contact with AERB.

For foreign companies, a critical practical consideration: the RSO must be based in India and available at the facility. Companies cannot appoint a remote RSO located outside India. This means foreign companies establishing radiation facilities must either hire an Indian RSO or sponsor a qualified foreign national with appropriate work authorisation.

The SHANTI Act 2025: What Changes for Foreign Companies

The SHANTI Act represents the most significant reform of India's nuclear regulatory landscape in six decades. Key provisions relevant to foreign companies:

Private Sector Participation

For the first time, private entities — including Indian companies with foreign shareholding — can build, own, operate, and decommission nuclear power plants as Independent Power Producers (IPPs), subject to AERB licensing. Previously, only the Nuclear Power Corporation of India Limited (NPCIL) could own and operate nuclear power plants.

FDI Provisions

The SHANTI Act permits foreign direct investment of up to 49% in specified nuclear activities under the automatic route. However, the Act explicitly excludes companies incorporated outside India from directly setting up nuclear power plants — foreign participation must be through an Indian-incorporated company. Strategic activities including enrichment of nuclear material, production of heavy water, and management of spent fuel beyond on-site storage remain exclusively with the Central Government.

AERB's Enhanced Authority

The SHANTI Act gives AERB statutory backing for the first time. AERB's powers now include the authority to grant, suspend, modify, and revoke licences; conduct inspections at any time; impose penalties for non-compliance; and require decommissioning of non-compliant facilities. This statutory recognition strengthens AERB's regulatory independence from the DAE — a reform that international bodies like the IAEA had recommended for years.

Nuclear Liability Framework

The Act establishes a graded liability framework replacing the earlier flat cap under the Civil Liability for Nuclear Damage Act, 2010. This is significant for foreign equipment suppliers, as the previous unlimited right of recourse against suppliers had been a major deterrent to foreign participation in India's nuclear programme.

Sector-Specific Licensing Considerations

Medical Equipment (Diagnostic and Therapeutic)

Foreign medical device companies manufacturing or importing radiation-generating equipment (X-ray machines, CT scanners, linear accelerators) must obtain AERB Type Approval (for Indian manufacture) or Type Registration (for imports) before the equipment can be installed. End-user facilities must separately obtain eLORA registration. The typical timeline from application to registration is 4-8 weeks for diagnostic equipment and 3-6 months for therapeutic equipment.

Industrial Radiography

Companies performing industrial radiography (using sealed radioactive sources like cobalt-60 or iridium-192 for weld inspection, pipeline testing, etc.) require a full AERB Licence — the highest consent category. This involves rigorous safety review, certified radiographers, approved transport containers, and emergency response procedures. Foreign companies in the oil and gas, power, or infrastructure sectors frequently require this licence for quality assurance operations.

Nuclear Equipment Manufacturing

Under the SHANTI Act, private companies can now manufacture nuclear equipment — reactors, fuel assemblies, control systems, safety equipment. Foreign technology partnerships and joint ventures in nuclear equipment manufacturing are now possible, subject to the 49% FDI cap and AERB licensing for the manufacturing facility. India's target of 22 GW nuclear capacity by 2032 and 100 GW by 2047 creates significant manufacturing demand.

Radiation Processing (Food and Medical Sterilisation)

Radiation processing plants using gamma irradiation (typically cobalt-60) for food preservation, medical device sterilisation, or material modification require AERB Authorisation. Foreign companies in the food processing or medical device sector may find this avenue relevant, particularly given India's growing food export market and domestic medical device manufacturing ambitions.

Penalties for Non-Compliance

Operating without AERB consent or violating licence conditions carries severe consequences under the Atomic Energy (Radiation Protection) Rules, 2004 and the SHANTI Act, 2025:

• Licence suspension or revocation: AERB can immediately suspend or revoke a licence for safety violations, removing the legal basis for the facility to operate
• Criminal penalties: Under the Atomic Energy Act (for facilities still governed by transitional provisions) and the SHANTI Act, violations can attract imprisonment and fines. Section 24 of the Atomic Energy Act provides for imprisonment up to 5 years and fines for contravention of rules made under the Act
• Facility closure: AERB can order immediate cessation of operations and decommissioning of non-compliant facilities
• Import restrictions: Equipment imported without Type Registration can be seized and the importer penalised under both AERB regulations and customs law

For foreign companies, AERB non-compliance can also trigger FEMA issues if the underlying business activity becomes illegal, potentially affecting the validity of the FDI itself. Engaging a specialised compliance advisor is strongly recommended — our FDI advisory service can help navigate the intersection of AERB licensing and foreign investment compliance.

Practical Steps for Foreign Companies

1. Establish an Indian entity: Foreign companies cannot directly hold an AERB licence. Incorporate a private limited company or wholly owned subsidiary in India using SPICe+ form. A resident director is mandatory for all Indian companies
2. Verify FDI eligibility: Confirm that the specific nuclear/radiation activity is open to foreign investment. Most radiation applications (medical, industrial, research) permit 100% FDI under the automatic route. Nuclear power generation permits up to 49% FDI. See our complete FDI sectoral caps guide for the full breakdown
3. Appoint an RSO: Hire or designate a qualified Radiation Safety Officer with AERB-approved training. This must be done before applying for consent
4. Apply through eLORA: Register the Indian entity on the eLORA portal and submit the consent application with all required documentation
5. Prepare for inspection: For higher-category consents (Licence and Authorisation), prepare for AERB site inspection covering physical infrastructure, shielding adequacy, safety systems, emergency procedures, and personnel training
6. Maintain ongoing compliance: File periodic safety reports, maintain dose records, report any radiation incidents to AERB within prescribed timelines, and renew consents before expiry

Key Takeaways

• Every company working with radioactive materials in India needs AERB consent — the type (Licence, Authorisation, or Registration) depends on the hazard level of the activity
• The SHANTI Act 2025 opens nuclear activities to private and foreign participation for the first time, with up to 49% FDI in specified nuclear activities under the automatic route
• All applications go through the eLORA online system: No physical applications are accepted for radiation facilities
• A Radiation Safety Officer (RSO) is mandatory and must be physically present in India with AERB-approved qualifications and training
• Foreign companies must operate through an Indian entity: AERB licences are issued to Indian-incorporated companies, not to foreign parent entities